A Phase 2/3 Double Blinded, Randomized, Placebo-Controlled Study in Healthy Adult Volunteers in Vietnam to Examine the Safety and Immunogenicity of a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVACFLU-S) Produced by IVAC
Phase: PHASE2
Conditions: Influenza, Human
Sponsor: Institute of Vaccines and Medical Biologicals, Vietnam

IVACFLU-S, Phase 2/3  
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MINISTRY OF HEALTH 
RESEARCH PROTOCOL OF VACCINE CLINICAL TRIAL 
A PHASE 2 / 3 DOUBLE BLINDED, RANDOMIZED, PLACEBO-
CONTROLLED STUDY IN HEALTHY ADULT VOLUNTEERS  IN 
VIETNAM TO EXAMINE THE SAFETY AND IMMUNOGENICITY OF A 
SEASONAL TRIVALENT INACTIVATED SPLIT  VIRION INFLUENZA 
VACCINE (IVACFLU-S) PRODUCED BY IVAC  
Protocol Number: IVACFLU-S-0203 
Vietnam MOH Reference: VX.2016.06 
PATH 051 
Version Number: 4.0 
Date: 09/02/2017 
SUMMARY NAME: SEASONAL TRIVALENT INACTIVATED SPLIT VIRION INFLUENZA 
VACCINE CLINICAL TRIAL (IVACFLU-S) – PHASE 2/3 
Principal Investigator: Dr. Phan Cong Hung 
Investigator’s Institution: Pasteur Institute, Ho Chi Minh City, Vietnam 
Sponsor: Institute of Vaccines and Medical Biologicals (IVAC), Vietnam 
Manufacturer: Institute of Vaccines and Medical Biologicals (IVAC), Vietnam 
Authority Agency: Ministry of Health, Vietnam 
Planned time:  March 2017 to October 2017 
Total budget: VND 8.9 billion  
In which: from Government budget for Science and Technology VND 0 
Other source: funded by PATH VND 8.9 billion 
 
 
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STATEMENT OF COMPLIANCE 
Version: 4.0 
Dated 09/0212017 
I am Dr. Phan Cong Hung, principal investigator of the study "A Phase 2/3 Double Blinded, 
Randomized, Placebo-Controlled Study in Adult Volunteers (age 18-60) in Vietnam to Examine 
the Safety and lmmunogenicity of a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine 
(IVACFLU..S) Produced by IVAC". By signing below to ensure that the study will be carried out on 
schedule, content of approved protocol, and in accordance with Good Clinical Practice (GCP) as 
required by applicable rules of Vietnam: Decision No. 79912008/QD-BYT, on "Guidance on Good 
Clinical Practice," Circular No. 03/2012fTT-BYT on "Guidance on Clinical Trial" and Decision 
No.22/2009ITT-BYT on "Medical Product Registration,• Decision 1248/QD BYT on the National 
Guidelines on ethical issues in biomedical research; Decision 111/QD BYT on the guidelines on 
organizational and operational principles for IRBs; and Dispatch 6586/BYT-K2DT on the 
guidelines on recording/reporting SAE in clinical trial. 
The study informed consent documents will embody the elements of consent as described in the 
Declaration of Helsinki, 2013. 
All key personnel (those responsible for the design and conduct of this study} will have completed 
Human Subjects Protection Training prior to interaction with any participants or to have access to 
their confidential study data. 
Ho Chi Minh City, date 09 month 02 year 2017 
Principal Investigator 
Phan Cong Hung, MD 
Pasteur Institute in Ho Chi Minh City 
167 Pasteur, Ward No 8, District No 3, 
Ho Chi Minh City, Vietnam 
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TABLE OF CONTENTS 
1 
Key Roles for Individuals and Institutions Involved ........................................... 1 
2 
Background Information and Scientific Rationale .............................................. 4 
2.1 
Background Information .................................................................................................. 4 
2.1.1 
Overview of Influenza disease ................................................................................................. 4 
2.1.2 
Seasonal Influenza .................................................................................................................... 4 
2.1.3 
Seasonal Influenza in Vietnam ................................................................................................ 5 
2.1.4 
Treatment and Prevention (vaccine, biological) ................................................................... 8 
2.1.5 
Summary results of related preclinical trials ........................................................................ 8 
2.1.6 
Results of Clinical Trial............................................................................................................. 9 
2.2 
Data on Clinical Trials from Seasonal Vaccines Similar to IVACFLU-S ................. 15 
2.2.1 
Flucelvax – Seqirus, Inc .......................................................................................................... 15 
2.2.2 
Fluzone®– Sanofi Pasteur ........................................................................................................ 16 
2.2.3 
Fluarix – GSK ............................................................................................................................ 18 
2.3 
Rationale of Current Study ............................................................................................ 19 
2.4 
Dose Rationale ................................................................................................................ 20 
2.5 
Potential Risks and Benefits of Inactivated, split Influenza Vaccine ..................... 20 
2.5.1 
Potential Risks .......................................................................................................................... 20 
2.5.2 
Potential Benefits ..................................................................................................................... 21 
3 
Study Objectives and Endpoints .......................................................................... 21 
3.1 
Study Objectives ............................................................................................................. 21 
3.1.1 
Primary Objectives, Phase 2 ................................................................................................... 21 
3.1.2 
Primary Objectives, Phase 3 ................................................................................................... 21 
3.1.3 
Secondary Objective, Phase 3 ................................................................................................ 21 
3.2 
Study Outcome Measures (Endpoints) ....................................................................... 21 
3.2.1 
Primary Endpoints .................................................................................................................... 21 
3.2.2 
Secondary Immunogenicity Endpoints, Phase 3 ................................................................. 22 
4 
Study Design ........................................................................................................... 23 
4.1 
Study Design ................................................................................................................... 23 
4.2 
Design Rational ............................................................................................................... 26 
4.3 
Study sites ....................................................................................................................... 26 
5 
Study Enrollment and Withdrawal ....................................................................... 27 
5.1 
Description of Participants, Source of Participants .................................................. 27 
5.2 
Participant Inclusion Criteria ........................................................................................ 28 
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5.3 
Participant Exclusion Criteria ....................................................................................... 28 
5.4 
Treatment Assignment Procedures ............................................................................. 29 
5.4.1 
Randomization Procedures..................................................................................................... 29 
5.4.2 
Blinding and Unblinding Procedures .................................................................................... 30 
5.4.3 
Reasons for Withdrawal .......................................................................................................... 30 
5.4.4 
Handling of Withdrawals ......................................................................................................... 30 
5.4.5 
Strategies to Maintain and Recruit Additional Participants ............................................... 30 
6 
Termination of the Trial .......................................................................................... 31 
6.1 
Termination According to the Protocol ....................................................................... 31 
6.2 
Suspension and/or Premature Termination of the Trial ........................................... 31 
7 
Study Products ........................................................................................................ 31 
7.1 
Study Product Descriptions .......................................................................................... 31 
7.1.1 
Acquisition ................................................................................................................................ 31 
7.1.2 
Formulation, Packaging and Labeling (Seasonal influenza vaccine, IVACFLU-S) ......... 32 
7.1.3 
Stability and Storage ................................................................................................................ 34 
7.1.4 
Lot number, Expiry date, Quality control results of study vaccine lots ........................... 34 
7.2 
Dosage, Preparation and Administration of Study Products .................................. 35 
7.2.1 
Dosage and Schedule .............................................................................................................. 35 
7.2.2 
Precautions and Warnings ...................................................................................................... 35 
7.2.3 
Preparation and Administration ............................................................................................. 35 
7.3 
Modification of Study Product for a Participant ........................................................ 36 
7.4 
Accountability Procedures for Study Product ........................................................... 36 
7.5 
Assessment of Compliance with Use of the Study Products .................................. 37 
7.6 
Concomitant Medications/Treatment .......................................................................... 37 
7.7 
Unauthorized Products .................................................................................................. 37 
8 
Study Schedule; Description of Visits ................................................................ 38 
8.1 
Screening ......................................................................................................................... 38 
8.1.1 
Screening and Enrollment/Vaccination (S1/D1) ................................................................... 39 
8.2 
Follow-up Periods ........................................................................................................... 40 
8.2.1 
First Week after Injection (Days 1 to 7) ................................................................................. 40 
8.2.2 
Seventh Day after Injection (Day 8 ± 1) ................................................................................. 40 
8.2.3 
Second and Third weeks after Injection (Days 9-21) ........................................................... 41 
8.2.4 
Final Visit (Day 22; ± 1) ............................................................................................................ 41 
8.2.5 
Final Study Visit (Day 91; ± 7) ................................................................................................. 41 
8.3 
Early Termination Visit................................................................................................... 42 
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8.4 
Unscheduled Visits ......................................................................................................... 42 
9 
Study Evaluations ................................................................................................... 42 
9.1 
Clinical Evaluations ........................................................................................................ 42 
9.1.1 
Vital Signs .................................................................................................................................. 42 
9.1.2 
Medical History ......................................................................................................................... 42 
9.1.3 
Physical Examination .............................................................................................................. 43 
9.1.4 
Injection Site Examination ...................................................................................................... 44 
9.2 
Laboratory Evaluations ................................................................................................. 44 
9.2.1 
Clinical Laboratory Evaluations ............................................................................................. 44 
9.2.2 
Special Assays ......................................................................................................................... 44 
9.2.3 
Preparation, Processing, and Transport Specimens .......................................................... 44 
10 
Assessment of Safety and Adverse Events ....................................................... 46 
10.1 
Adverse Events ............................................................................................................... 46 
10.1.1 
Solicited Local and Systemic Adverse Events ................................................................. 46 
10.1.2 
Unsolicited Adverse Events ................................................................................................ 47 
10.2 
Serious Adverse Events ................................................................................................ 47 
10.3 
AE/SAE Reporting Period and Parameter ................................................................... 48 
10.4 
Severity of Event ............................................................................................................. 48 
10.5 
Relationship to Study Vaccines ................................................................................... 49 
10.6 
Follow up of AE ............................................................................................................... 50 
10.7 
General Guidelines for Recording AEs ....................................................................... 50 
10.8 
Unexpected Allergic Reaction ...................................................................................... 51 
10.9 
Reporting Procedures .................................................................................................... 51 
10.9.1 
Serious Adverse Events ...................................................................................................... 51 
10.9.2 
Reporting of AEs .................................................................................................................. 52 
10.9.3 
Other Unexpected Issues/Unanticipated Problems......................................................... 52 
10.9.4 
Reporting of Pregnancy ...................................................................................................... 52 
11 
Safety Oversight ..................................................................................................... 52 
11.1 
Protocol Safety Review Team ....................................................................................... 52 
11.1.1 
Expedited Safety Review ..................................................................................................... 53 
11.1.2 
Study Safety Pauses ............................................................................................................ 53 
11.2 
Data Safety Monitoring Board ...................................................................................... 53 
12 
Monitoring and Auditing ........................................................................................ 53 
12.1 
Monitoring Plan ............................................................................................................... 53 
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12.2 
Set-up Visit (Site Initiation) ........................................................................................... 54 
12.3 
Routine Monitoring Visits .............................................................................................. 54 
12.4 
Close-out Visit ................................................................................................................. 55 
12.5 
Audits and Inspections .................................................................................................. 55 
13 
Statistical Considerations ..................................................................................... 55 
13.1 
Study Hypothesis ........................................................................................................... 55 
13.2 
Sample Size Considerations ......................................................................................... 56 
13.3 
Safety ................................................................................................................................ 56 
13.4 
Immunogenicity .............................................................................................................. 57 
13.4.1 
Probability for demonstrating seroconversion criteria for licensure ........................... 58 
13.4.2 
Probability for demonstrating seroprotection criteria for licensure ............................. 58 
13.5 
Data Analysis................................................................................................................... 59 
13.6 
Definition of Analysis Sets ............................................................................................ 59 
13.7 
Analysis of Safety Endpoints........................................................................................ 60 
13.8 
Analysis of Immunogenicity Endpoints ...................................................................... 60 
13.9 Interim Analysis ........................................................................................................ 61 
14 
Data Management ................................................................................................... 62 
14.1 
Case Report Form (CRF) ............................................................................................... 62 
14.2 
Source Documents and Source Document Access .................................................. 63 
14.3 
Database Management and Analysis Software .......................................................... 63 
14.4 
Entering, Cleaning and Management of Database .................................................... 63 
14.5 
Source Data Verification ................................................................................................ 63 
14.6 
Database Locking Procedures ..................................................................................... 64 
14.7 
Study Record Retention ................................................................................................ 64 
15 
Quality Control and Quality Assurance .............................................................. 64 
15.1 
General Considerations ................................................................................................. 64 
15.2 
Trainings .......................................................................................................................... 64 
16 
Ethics/Protection of Human Subjects ................................................................. 65 
16.1 
Ethical Standard .............................................................................................................. 65 
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16.2 
Financing and Insurance ............................................................................................... 65 
16.3 
Assurance of Emergency Medical Care and Care for other Adverse Events ....... 65 
16.4 
Institutional Review Boards and Independent Ethics Committee .......................... 66 
16.5 
Media Planning for Participant and Community Engagement ................................ 66 
16.6 
Informed Consent Process ........................................................................................... 67 
16.7 
Inclusion of Women, Minorities, and Children ........................................................... 68 
16.8 
Participant Confidentiality: ........................................................................................... 69 
16.8.1 
Confidentiality of Data ......................................................................................................... 69 
16.8.2 
Confidentiality of Participant Records .............................................................................. 69 
16.9 
Sharing of Study Results ............................................................................................... 70 
16.9.1 
Sharing of Study Results with the Participant ................................................................. 70 
16.9.2 
Incidental Health Findings .................................................................................................. 70 
16.9.3 
Sharing of Study Results with the Community ................................................................ 70 
16.10 
Study Discontinuation ................................................................................................ 70 
16.11 
Future Use of Stored Specimens.............................................................................. 70 
16.12 
Potential Risks and How They are Addressed ....................................................... 71 
16.13 
Benefits to Study Participants .................................................................................. 72 
17 
Noncompliance and Unanticipated Problems ................................................... 72 
18 
Human Resource for the Study ............................................................................ 73 
18.1 
Human Resource for the Study .................................................................................... 73 
18.2 
Training Plan ................................................................................................................... 73 
19 
Clinical Study Report and Publication Policy .................................................... 73 
19.1 
Clinical Study Report ..................................................................................................... 73 
19.2 
Publication Policy ........................................................................................................... 74 
APPENDIX A: Table of Grading Severity ....................................................................... 77 
APPENDIX B: Roles and responsibilities matrix ......................................................... 81 
APPENDIX C: Template of interim study report of the phase 2/3 ............................. 88 
APPENDIX D: Assessment of Understanding .............................................................. 89 
APPENDIX E: Quality Certification by NICBV for study product lots ....................... 90 
 
 
 
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LIST OF ABBREVIATIONS 
AE 
Adverse Event 
BARDA 
Biomedical Advanced Research and Development Authority 
CI 
Confidence Interval 
cm 
Centimeter 
CRF 
Case Report Form 
°C 
Degrees Celsius 
D 
Day 
DSMB 
Data and Safety Monitoring Board 
EIA 
Enzyme Immunoassay 
GCP 
Good Clinical Practice 
GMFRs 
Geometric Mean Fold Rises 
GMT 
Geometric Mean Titer 
HA 
Hemagglutinin 
HAI 
Hemagglutination Inhibition 
hCG 
Human Chorionic Gonadotropin 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
ICMJE 
International Committee of Medical Journal Editors 
IEC 
Independent Ethics Committee 
IP 
Investigational Product 
IRB 
Institutional Review Board 
IVAC 
Institute of Vaccines and Medical Biologicals 
L 
Liter 
MDCK 
Madin-Darby Canine Kidney 
Mcg 
Microgram 
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mL 
Milliliter 
Mm 
Millimeter 
MNT 
Microneutralization test 
MOH 
Ministry of Health 
N 
number (typically refers to number of participants) 
NA 
Neuraminidase 
PI 
Principal Investigator 
PBS 
Phosphate buffered saline 
PSRT 
Protocol Safety Review Team 
RBC 
Red Blood Cell 
SAE 
Serious Adverse Event 
SOP 
Standard Operating Procedure 
SRID 
Single Radiation Immunodiffusion  
TBD 
To Be Designated 
TCID 
Tissue Culture Infectious Dose 
US 
United States 
WHO 
World Health Organization 
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PROTOCOL SUMMARY 
Title: 
A Phase 2/3 Double Blinded, Randomized, Placebo-
Controlled Study in Healthy Adult Volunteers in Vietnam to 
Examine the Safety and Immunogenicity of a Seasonal 
Trivalent 
Inactivated 
Split 
Virion 
Influenza 
Vaccine 
(IVACFLU-S) produced by IVAC 
 
Description of Study 
Design: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This is a phase 2/3, double-blind, placebo-controlled trial of 
888 adults, ages 18 to 60 years old randomized to receive 
vaccine or placebo according to schema below.  Phase 2 will 
be conducted at 1 site of Long An (252 subjects).  Following 
a determination of safety of vaccine in phase 2 study by 
Protocol Safety Review Team (PSRT) review and with 
approval from Vietnam Ministry of Health (MOH), Phase 3 
enrollment will commence at 2 sites, Long An (252 subjects, 
including 210 vaccine recipients and 42 placebo recipients) 
and Dong Nai (384 subjects, including 320 vaccine recipients 
and 64 placebo recipients).   
Safety will be assessed in all Phase 2 and 3 participants 
through Day 91. Safety data till Day 8 post-vaccination from 
the phase 2 study will be presented to Protocol Safety Review 
Team (PSRT) for evaluation and an interim report will be filed 
with local institutional review board (IRB) and MOH. 
Immunogenicity will be assessed only in Phase 3 
participants. Blood samples will be collected in a subset of 
252 individuals (210 vaccine recipients and 42 placebo 
recipients) randomized at one of the study sites  to get 
evaluable samples from at least 200 vaccine recipients (100 
each from both age groups) and 40 placebo recipients (20 
each from both age groups) 21 days after vaccination.  
Approximate participant distribution based on age, study arm 
and study will be as follows: 
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Study Hypothesis: 
 
  
 
 
 
 
 
Safety: 
A single dose of seasonal trivalent inactivated split virion 
influenza vaccine (IVACFLU-S) will be safe and well tolerated 
in adults 18 to 60 years of age. 
Immunogenicity: 
A single dose of seasonal trivalent inactivated split virion 
influenza 
vaccine 
(IVACFLU-S) 
will 
induce 
immune 
responses to each of the three vaccine antigens to meet one 
or both age group specific Vietnam Ministry of Health (MOH) 
licensure requirements.  
Criteria 
18 – 45 year 
old 
46 – 60 year 
old 
Seroprotection (HAI 
≥1:40) 
≥70% 
≥60% 
Seroconversion 
≥40% 
≥30% 
HAI GMT increase 
≥2.5 times 
≥2.0 times 
 
Age 
group 
IVACFLU-S 
Placebo 
Total 
Phase 2 
18 - 45 
105 
21  
126 
46 - 60 
105 
21  
126 
Phase 3 
18 - 45 
265 
53  
318 
46 - 60 
265 
53 
318 
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Study Objectives, Phase 2: 
 
 
 
 
 
Primary 
Safety:  To evaluate the safety profile of a single 
intramuscular dose of IVACFLU-S seasonal trivalent 
inactivated split virion influenza vaccine in adults, 18 to 60 
years of age. 
Study Objectives, Phase 3: 
 
Primary 
Safety: To evaluate the safety profile of a single 
intramuscular dose of IVACFLU-S seasonal trivalent 
inactivated split virion influenza vaccine in adults, 18 to 60 
years of age. 
Immunogenicity: To evaluate the immune response at Day 
22 to each of the three vaccine antigens after a single 
intramuscular dose of IVACFLU-S seasonal trivalent 
inactivated split virion influenza vaccine  in adults,  18 to 45 
and 46 to 60 years of age. 
Secondary 
To evaluate the immune response at Day 22 to each of the 
three vaccine antigens after a single dose  of IVACFLU-S 
seasonal trivalent inactivated split virion influenza vaccine in 
adults with and without pre-existing Hemaglutination 
Inhibition (HAI) antibody 
Study Endpoints: 
Primary Safety Endpoints, Phase 2 and 3  
The number and proportion of participants reporting the 
following events: 
A.  Solicited local adverse events, including redness / 
erythema, swelling / induration, pain within 30 minutes of 
vaccination and over a 7-day period (Days 1-7) post-
vaccination. 
B.  Solicited systemic adverse events, including fever, 
fatigue/malaise, muscle aches, joint aches, chills, nausea, 
vomiting and headache within 30 minutes of vaccination and 
over a 7-day period (Days 1-7) post-vaccination. 
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C. Unsolicited Adverse Events (AEs) occurring within 21 days 
post vaccination.  
D.  Serious Adverse Events (SAE) occurring during the entire 
study period (Days 1-91).   
 
Primary Immunogenicity Endpoint, Phase 3 
A. Number and percentage of participants by age groups 
(18-45, 46-60) with seroconversion against each of the 3 
vaccine antigens post-vaccination.  Seroconversion is 
defined as a serum HAI antibody titer meeting the 
following criteria: 
• 
Pre-vaccination titer <1:10 and a post-vaccination 
titer measured on Day 22 of ≥1:40 or 
• 
Pre-vaccination titer ≥1:10 and at least a four-fold 
increase in post vaccination measured on Day 22 
B.  Number and percentage of participants by age groups 
(18-45, 46-60) with a HAI antibody titer ≥1:40 to each of the 
3 vaccine antigens measured on Day 22 post vaccination 
C.  Geometric mean titers (GMTs) of serum HAI antibodies 
pre- (Day 1) and post vaccination (Day 22) by age groups 
(18-45, 46-60) for each of the 3 vaccine antigens 
D.  Geometric mean fold rises (GMFRs) of serum HAI 
antibodies (post vaccination/pre-vaccination) by age groups 
(18-45, 46-60) for each of the 3 vaccine antigens 
Secondary Immunogenicity Endpoints, Phase 3 
A. Number and percentage of participants by age groups 
(18-45, 46-60) who develop at least a four-fold increase 
in HAI antibody titer to each of the vaccine antigen post 
vaccination measured on Day 22 by pre-vaccination HAI 
antibody titer of  <1:10 or ≥1:10. 
B. Geometric mean titers (GMTs) of serum HAI antibodies 
pre- (Day 1) and post vaccination (Day 22) by age groups 
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(18-45, 46-60) for each of the 3 vaccine antigens by pre-
vaccination HAI antibody titer of <1:10 or ≥1:10. 
C. Geometric mean fold rises (GMFRs) of serum HAI 
antibodies (post vaccination/pre-vaccination) by age 
groups (18-45, 46-60) for each of the 3 vaccine by pre-
vaccination HAI antibody titer of <1:10 or ≥1:10. 
Participant Eligibility 
Inclusion criteria 
All participants must meet all of the following criteria to be 
considered eligible to participate in the study: 
 
Aged 
18 
through 
60 
years 
on 
the 
day 
of 
screening/enrollment. 
 
Literate (by self-report) and willing to provide written 
informed consent.  
 
Able to attend all scheduled visits and to comply with all 
trial procedures. 
 
Healthy or medically stable, as established by medical 
history and physical examination.  For individuals with 
medical conditions, symptoms/signs, if present must be 
stable under controlled or unchanged for the past 3 
months. If medication is used to treat the condition, the 
medication dose must have been stable for at least 1 
month preceding vaccination. 
 
For  females participants: 
 
Not breastfeeding or pregnant (based on negative urine 
pregnancy test) or plan to become pregnant up to Day 22. 
Women who are not surgically sterile (hysterectomy or 
tubal ligation) or post-menopausal for more than 1 year 
must have negative pregnancy test and, be willing to 
utilize reliable birth control measures (intrauterine device, 
hormonal contraception, condom or diaphragm with 
spermicide) through the Day 22 visit.   
 
Exclusion Criteria 
Participants meeting any of the following criteria will be 
excluded from participation: 
 
Current or recent (within two weeks of enrollment) acute 
severe illness with or without fever. 
 
Participation in another clinical trial involving any therapy 
within the previous three months or planned enrollment 
in such a trial during the period of this study. 
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 
Receipt of any non-study vaccine within 4 weeks prior to 
enrollment or refusal to postpone receipt of such 
vaccines until after the Day 22 visit. 
 
Received seasonal influenza vaccine in last 6 months 
Receipt of immune globulin or other blood products 
within 3 months prior to study enrollment or planned 
receipt of such products prior to the Day 22 visit. 
 
Known or suspected congenital or acquired 
immunodeficiency. 
 
Chronic administration (defined as more than 14 
consecutively-prescribed days) of immunosuppressant 
or other immune-modulating therapy within six months 
prior to study enrollment. (For corticosteroids, this 
means prednisone or equivalent, ≥ 0.5 mg per kg per 
day; topical steroids are allowed.) 
 
Unstable illness by history or physical examination that 
in the opinion of the investigator, might interfere with the 
conduct or results of the study or pose additional risk to 
the participant.  
 
Hypersensitivity after previous administration of any 
vaccine. 
 
Suspected or known hypersensitivity to any of the study 
vaccine components, including chicken or egg protein, 
and rubber (from the vaccine vial stoppers).  
 
Bleeding disorder or receipt of anticoagulants in the 3 
weeks preceding inclusion. 
 
Known active tuberculosis or symptoms of active 
tuberculosis, regardless of cause (self-report). 
 
Current alcohol or drug addiction that in the opinion of 
the Investigator, might interfere with the ability to comply 
with trial procedures. 
 
History of Guillain-Barré Syndrome 
 
Neoplastic disease or any hematologic malignancy.  
 
Any condition that, in the opinion of the investigator, 
would increase the health risk to the participant if he/she 
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participates in the study, or would interfere with the 
evaluation of the study objectives. 
Statistical Consideration 
The sample size for this study was selected for primary safety 
and immunogenicity analysis to satisfy the MOH licensure 
requirement for influenza vaccine in adults from age 18 
through 60.  Total sample size for the Phase 2 is 
approximately 252 participants (to have at least 200 
randomized to vaccine and 40 randomized to placebo at the 
end of the study).  Phase 3 sample size is approximately 636 
participants (to have at least 500 randomized to vaccine and 
100 randomized to placebo at the end of the study).  So at 
least 700 evaluable participants will be randomized to 
IVACFLU-S arm in the phase 2/3 study. There are two types 
of immunogenicity measurements against each of the 3 
vaccine antigens, percentages of subjects with immune 
response and Geometric Mean Titers (GMT) that will be used 
to evaluate this study objective. For each percentage of 
subjects with the defined immune responses, the percentage 
and its corresponding 2-sided exact (Clopper-Pearson) 
binomial 95% confidence interval (95% CI) around the 
percentage will be computed for each treatment group and 
by age group. GMT along with the corresponding two-sided 
95% CIs, by exponentiating the corresponding log-
transformed means and their 95% CIs, will be summarized 
by treatment group on Day1 and Day 22. The same approach 
will be used to summarize GMFR of Day 22/Day1 separately 
by treatment group and age group. For the solicited local and 
systemic/general adverse events, Fisher’s exact test for two 
proportions or the Cochran-Mantel-Haenszel test for severity 
grade categories at 2-sided 0.05 alpha will be used to 
compare the treatment groups. No formal hypothesis testing 
with multiplicity adjustment will be performed. Furthermore, 
no statistical testing will be performed for unsolicited AEs 
including SAEs. 
Study Population: 
Approximately 888 male and female adults, 18 to 60 years of 
age at the time of enrollment                                        
Phase: 
2/3 
Number of Sites: 
Study is multicenter with Phase 2 conducted at 1 site of Long 
An and Phase 3 conducted at 2 sites, Long An and Dong Nai: 
 
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 Study Duration: 
The total duration for this study is approximately 22 months; 
with approximately 12 months (Sep 2016 to Sep 2017) for 
preparation and implementation of both phases of the study ; 
and approximately 10 months for data analysis, CSR 
completion and review, approval by local IRBs and Ministry 
of Health. 
Participation Duration: 
Approximately 3 months 
Description of Agent or 
Intervention: 
 
Seasonal trivalent inactivated influenza vaccine (TIV), 
inactivated split virion, purified by sucrose gradient 
ultracentrifugation (IVAC, NhaTrang, Vietnam), or placebo 
(IVAC, Nha Trang, Vietnam). The vaccine will be produced 
in embryonated chicken eggs, and inactivated with 
formaldehyde. The dose of the vaccine to be tested is 15 
mcg of each of the three components per 0.5 mL. The 
vaccine strains are  
 
NYMC BX-35 reassortant of B/Brisbane/60/2008 (B) 
 
NYMC X‐179A reassortant of A/California/7/2009 
(H1N1) 
 
NYMC X-263B reassortant of H3/A/Hong 
Kong/4801/2014 (H3N2) 
Placebo is PBS with pH  7.2; 0.5 ml/per dose 
Estimated Time to 
Complete Enrollment: 
Approximate enrollment duration will be 3 weeks for phase 2 
and 5 weeks for phase 3 study 
 
 
 
 
 
 
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Table 1: Schedule of events 
Study Activities 
Study Day (# days from D1) 
 
S1/D1* 
(up to -4/ 
D1 
Clinic Visit 
D1 to 
D7 
D8 
(+/- 1) 
Clinic 
Visit 
D9  to 
D21 
D22 
(+/- 1) 
Clinic 
Visit 
D91 
(+/- 7) 
Telephonic 
contact 
Information process and written informed consent 
X  
 
 
 
 
 
Collect baseline demographic data 
X 
 
 
 
 
 
Collect/review medical history 
X 
 
 
 
 
 
Perform screening physical examination 
X 
 
 
 
 
 
Perform vital signs & targeted physical examination (symptom based & 
reactogenicity only) 
X* 
 
X 
 
 
 
Perform urine pregnancy check (women) 
X* 
 
 
 
 
 
Check/confirm inclusion/exclusion criteria  
X* 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
Collect serum for influenza serology  
X** 
 
 
 
X 
 
Administer one dose of study product (vaccine or placebo) 
X 
 
 
 
 
 
Observe for 30 Minutes; record and manage immediate reactions 
X 
 
 
 
 
 
Instruct participant on use of  Dairy card 
X 
 
 
 
 
 
Participant records solicited reactogenicity and unsolicited AEs in Dairy 
cards 
X 
X 
 
 
 
 
Clinical staff reviews interim AEs/SAEs with participant; records in CRF 
 
 
X 
 
X 
SAE only 
Report SAEs to Sponsor, IRBs and regulatory authorities 
X 
X 
X 
X 
X 
X 
Participant completion of study 
 
 
 
 
 
X 
*If Day 1 is conducted on a different day from S1, eligibility must be confirmed again on Day of Injection (D1); including Targeted physical examination 
(PE); inclusion/exclusion; urine pregnancy test.   
** Sera samples will be collected prior to vaccination in phase 3 study at one site (Ben Luc).  
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RESEARCH PROTOCOL 
1 
Key Roles for Individuals and Institutions Involved 
Principal 
Investigator: 
Dr. Phan Cong Hung 
Co-Principal 
Investigator 
Dr. Nguyen Trong Toan 
Investigator’s 
Institution: 
Pasteur Institute, Ho Chi Minh City, Vietnam 
Institutional 
Review Boards:  
Pasteur Institute IRB; WHO ERC and EC, MOH, Vietnam 
Manufacturer 
Institute of Vaccines and Medical Biologicals (IVAC) 
9 Pasteur, Nha Trang, Vietnam 
Contact: Le Van Be, MD, PhD, Director 
phone: (+84 90) 3501529 
fax: (+84 58) 3823815 
email: ivaclevabe@dng.vnn.vn or ivaclevanbe@gmail.com 
Sponsor 
Institute of Vaccines and Medical Biologicals (IVAC) 
9 Pasteur, Nha Trang, Vietnam 
Contact: Le Van Be, MD, PhD, Director 
phone: (+84 90) 3501529 
fax: (+84 58) 3823815 
email: ivaclevabe@dng.vnn.vn or ivaclevanbe@gmail.com 
Contract Research 
Organization 
QuintilesIMS 
Plaza Building 
4820 Emperor Boulevard 
Durham, North Carolina 27703 
 
Phone: (+1 919) 998 2000 
Clinical Site,  
Phase 2 
Only one site at District Health Center of Ben Luc district, Long An 
province where study activities (including screening, vaccinations, 
and follow-up visits as well as data entry) will be conducted.  
CRFs will be kept in the District Health Center  and Pasteur Institute 
HCM city during study implementation, long term CRF storage will 
be at.IVAC 
Clinical Sites, 
Phase 3  
 
Phase 3 will be conducted at 2 sites: 
 
District Health Center of Ben Luc district, Long An province 
 
District Health Center of Long Thanh district, Dong Nai 
province 
All study activities (including screening, blood draws (Ben Luc only), 
vaccinations, and follow-up visits as well as data entry) will be 
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conducted at these district health centers. CRFs will be kept in the 
District Health Centers and Pasteur Institute HCM city during study 
implementation, long term CRF storage will be at IVAC. 
Clinical and 
Specialty 
Laboratories:  
VisMederi srl 
Strada del Petriccio e Belriguardo, 35 
53100 Siena, Italia 
phone +39 0577 381253 – 55 
fax: +39 0577 381258 
info@vismederi.com 
vismederi@pec.it 
Attn: Elisa Llorente Pastor 
Email: llorentepastor@vismederiresearch.com 
 
Sponsor Medical 
Monitor: 
Le Van Be, MD, PhD, Director 
phone: (+84 90) 3501529 
fax: (+84 58) 3823815 
email: ivaclevabe@dng.vnn.vn or ivaclevanbe@gmail.com 
CRO Medical 
Monitor: 
TBD 
PATH Medical 
Officer(s): 
 
Tushar Tewari, MD 
Senior Medical Officer, Clinical and Regulatory Affairs 
Vaccine Development Global Program—PATH 
2201 Westlake Avenue, Suite 200 
Seattle, WA 98121 USA 
 
Tran Cong Thang, MD 
PATH Vietnam 
11th Floor, Hanoi Towers,  
49 Hai Ba Trung Street  
Hanoi 10000 Vietnam 
 
Data Management 
Organization: 
 
QuintilesIMS 
PATH Clinical 
Operations 
Specialists: 
Renee Holt, RN, JD, MPH 
Clinical Operations Specialist 
Vaccine Development Global Program—PATH 
2201 Westlake Avenue, Suite 200 
Seattle, WA 98121 USA 
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Other information 
(Funders) 
PATH Vietnam office 
11th Floor, Hanoi Towers 
49 Hai Ba Trung 
Hoan Kiem District 
Hanoi, Vietnam  
 
PATH US office 
2201 Westlake Avenue, Suite 200.  
Seattle, WA 98121, USA  
Technical support 
PATH Vietnam office 
11th Floor, Hanoi Towers 
49 Hai Ba Trung 
Hoan Kiem District 
Hanoi, Vietnam  
 
PATH US office 
2201 Westlake Avenue, Suite 200.  
Seattle, WA 98121, USA 
 
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2 
Background Information and Scientific Rationale 
2.1 
Background Information 
2.1.1 Overview of Influenza disease 
Influenza is one of the major infectious disease threats to the human population due to both the 
adverse health impact of annual influenza epidemics and the detrimental global consequences of 
influenza pandemics [1,2]. The effects of an influenza are likely to be greatest in resource-limited 
countries where individuals may be more susceptible to severe outcomes of influenza due to 
underlying nutritional deficiencies and concomitant illness, limited access to health care, and the 
lack of widespread use of vaccines against common causes of bacterial pneumonia.  
Influenza virus affects individuals of all ages, causes repeated infections throughout life, and is 
responsible for annual worldwide epidemics. While influenza leads to a self-limited respiratory 
disease in the majority of individuals, it can be deadly in others. The seriousness of influenza in 
young children, older adults, and persons of all ages with certain underlying medical conditions is 
the reason why many countries have recommendations to vaccinate such individuals and their 
close contacts every year. 
A distinct feature of influenza virus is its ability to mutate, leading to antigenic changes that require 
the introduction of new vaccine strains each year. Seasonal changes in the surface glycoproteins 
enable the viruses to evade immunity induced by strains circulating previously. For this reason, 
natural infection or vaccination are generally only protective against infection for one influenza 
season. Evolutionary pressures lead to the emergence of new influenza strains to which there is 
decreased immunity in the population. 
2.1.2 Seasonal Influenza  
Seasonal influenza viruses circulate widely and cause disease in humans every year. The 
circulation of influenza virus is detected globally in various geographies of North America, Europe, 
Asia, Oceania and South America. In temperate climates, disease tends to occur seasonally in 
the winter months, spreading from person-to-person through sneezing, coughing, or touching 
contaminated surfaces. Seasonal influenza viruses can cause mild to severe illness and even 
death, particularly in some high-risk individuals. Persons at increased risk for severe disease 
include pregnant women, the very young and very old, immune-compromised people, and people 
with chronic underlying medical conditions. As mentioned above seasonal influenza viruses 
evolve continuously, which means that people can get infected multiple times throughout their 
lives. Therefore the components of seasonal influenza vaccines are reviewed frequently (currently 
biannually) and updated periodically to ensure continued effectiveness of the vaccines. 
 
There are three large groupings or types of seasonal influenza viruses, labeled A, B, and C. Type 
A influenza viruses are further divided into subtypes according to the specific variety and 
combinations of two proteins that occur on the surface of the virus, the hemagglutinin or “H” 
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protein and the neuraminidase or “N” protein. Type C influenza causes milder infections and is 
associated with sporadic cases and minor localized outbreaks. As influenza C poses much less 
of a disease burden than influenza A (A/H1N1 and A/H3N2 subtypes) and B, only the latter two 
are included in seasonal influenza vaccines. 
 
2.1.3 Seasonal Influenza in Vietnam 
The WHO’s Global Influenza Programme (GIP) is involved in world-wide influenza surveillance. 
Global Influenza Programme (GIP) collects and analyzes virological and epidemiological 
influenza surveillance data from around the world [3]. The regular sharing of quality influenza 
surveillance and monitoring data by countries allows WHO to: 
 
provide information about pattern of influenza transmission globally to allow 
countries to better prepare for upcoming seasons; 
 
describe critical features of influenza epidemiology including risk groups, 
transmission characteristics, and impact; 
 
monitor global trends in influenza transmission; and 
 
support the selection of influenza strains for vaccine production. 
 
Vietnam has also been a part of this surveillance network. Surveillance data of influenza in 
Vietnam indicated that, of 29,499 specimens tested from 2006 to 2011, 5241 (17.8%) were 
positive for influenza infection [4]. Analysis of monthly data showed year-round circulation (Fig. 1 
and Fig. 2), and some peak activity in July to August (Fig. 2). Subtype A H1N1 and type B viruses 
were the most frequently reported in 2006 (43.5 and 53.7%, respectively) and 2008 (40.8 and 
41.3%, respectively), whereas A H3N2 subtype (73.9%) and type B viruses (25.1%) were the 
ones most frequently reported in 2007. Influenza A(H1N1)pdm09 emerged (46.6%) in mid-2009 
and persisted in 2010 (28.0%), when it co-circulated with subtype A H3 (71.5%) viruses. In 2011, 
A(H1N1)pdm09 was the influenza virus most frequently reported (74.1%), followed by type B 
viruses (22.1%, Fig. 3) [4]. 
 
 
 
 
 
 
 
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Fig. 1. Monthly distribution of samples testing positive for influenza virus or viral nucleic 
acid by year in Vietnam, 2006–2011 
 
a This represents the samples testing positive on any given month, as a percentage of all the samples that tested positive during the year.  
 
 
Fig. 2. Monthly patterns of influenza trends in samples testing positive to influenza virus 
or viral nucleic acid in Vietnam, 2006-2011 
 
 
a This represents the mean value for the samples testing positive on any given month from 2006 to 2011 as a percentage of all the 
samples that tested positive during each year.  
 
 
 
 
 
 
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: 
Fig. 3. Influenza virus types and subtypes identified, by year in Vietnam, 2006–2011 
 
 
The latest information from end of year 2015 (week 43-53) and 2016 (Week1-39) from the WHO 
for seasonal influenza in Vietnam is available. The figure 4 shows for 2015 A(H3) predominating 
in weeks 43-53, with some specimens positive for B and A (H1N1.  For 2016, A(H1N1) continues 
to be the predominant strain from weeks 9 – 24 with B strain of undetermined lineage accounting 
for one third to half of all the specimens reported for the same period [5]. From week 26-39 A (H3) 
is the predominant subtype identified with B strain of undetermined lineage and A(H1N1)pdm09 
also identified during this period.  
Fig. 4. Influenza viruses surveillance in Vietnam, 2015-2016 
 
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2.1.4 Treatment and Prevention (vaccine, biological) 
Multiple manufacturers around the globe have developed various seasonal trivalent influenza 
vaccines and have tested these candidates in many trials in healthy adults and used them yearly 
before the influenza season. The choice of strains to include in the vaccine is guided by the “WHO 
Global Action Plan”, an initiative to support development of new influenza vaccines, increase 
demand for seasonal vaccines, and enhance influenza vaccine production capacity [3]. With 
support from international donors, including the US Department of Health and Human Services, 
the WHO leads a program to support influenza vaccine manufacturers in developing countries 
that is crucial to increasing overall manufacturing capacity as well as to enhancing regional access 
to vaccines. In the first phase of the plan, the WHO provided funding and assistance to 
manufacturers in six countries, including Vietnam, to establish influenza vaccine production 
capacity. 
Since 2008, IVAC has received technical assistance from PATH and WHO to develop and 
produce vaccines for A/H1N1/09, A/H5N1, A/H7N9 and seasonal flu vaccines under the guidance 
from the MOH. 
2.1.5 Summary results of related preclinical trials 
Three clinical lots of trivalent split inactivated seasonal vaccine formulated with the strains 
recommended for the 2016-2017 season were successfully manufactured, tested and released 
by IVAC in the late fourth quarter of 2016. WHO recommends that influenza vaccines for use in 
the 2016-2017 northern hemisphere influenza season contain the following viruses: 
 
NYMC BX-35 reassortant of B/Brisbane/60/2008 (B) 
 
NYMC X‐179A reassortant of A/California/7/2009 (H1N1) 
 
NYMC X-263B reassortant of H3/A/Hong Kong/4801/2014 (H3N2) 
Among circulating influenza B viruses, there are two distinct lineages. The B/Brisbane/60/2008-
like viruses are from the influenza B/Victoria lineage and represent the predominant circulating 
influenza B virus [6]. 
The Preclinical evaluation was conducted with all three lots of seasonal vaccine used in the phase 
1 study. The vaccine demonstrated good immunogenicity in mouse studies (quantitated by 
hemagglutination inhibition comparable to that induced by a comparator vaccine), and an 
acceptable safety profile in general safety and toxicology studies in experimental animals (rabbit, 
mice and guinea pig).. 
The trivalent split inactivated seasonal vaccine lots which were produced by IVAC with strains 
recommended for the flu season of 2016-2017 and that will be used for the phase 2/3 study, IVAC 
has only conducted an additional pre-clinical study (September, 2016) of 3 bulk lots (with all 3 
strains) for evaluation of safety and immunogenicity. The result showed the vaccine was well 
tolerated, safe and immunogenic in experimental animals with intramuscular administration. 
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2.1.6 Results of Clinical Trial 
A phase 1 clinical trial of the IVAC inactivated split virion influenza vaccine was conducted in 60 
healthy adults, 18 through 45 years of age, in Hung Ha District, Thai Binh Province, Vietnam in 
2015 [7].  Participants were randomized to either placebo or vaccine containing 15 µg of HAI 
antigen from the following 3 viral strains:    
• 
NYMC BX-51B reassortant of B/Massachusetts/2/2012 (B) 
• 
 NYMC X‐179A reassortant of A/California/7/2009 (H1N1) and 
• 
NYMC X-223 A reassortant of H3/A/Texas/50/2012 (H3N2).    
Table 2 summarizes the demographic and baseline characteristic of the study population. 
Table 2 Summary of Demographics and Baseline Characteristics   
 
Characteristics 
Vaccine (N=30) 
Placebo (N-30) 
n 
% 
n 
% 
Gender 
    Male 
3 
10 
9 
30 
    Female 
27 
90 
21 
70 
Age 
     Mean 
37.7 
37.8 
     Minimum / Maximum 
27 / 45 
21 / 45 
 
Safety Results of Phase 1 IVACFLU-S Seasonal Flu Vaccine Trial 
The safety results can be summarized as follows: 
No local or systemic solicited AEs were reported within 30 minutes after vaccination.  All 
participants were observed to have oral temperature with in normal range (<37.7ºC; Grade 0) 
Overall, 20 participants (66.7 %) on vaccine and 8 participants (26.7%) on placebo, reported at 
least 1 local solicited AE on Day 1.  Among vaccine recipients who experienced local reactions, 
pain and tenderness at the injection site were the most common reaction (Table 3).  Majority were 
assessed as mild and resolved spontaneously within 24-48 hours and.  By day 7, only 1 participant 
(3.3%) on placebo reported at least 1 local solicited AE.  In contrast no participant on vaccine 
reported any local solicited AE beyond day 4 [7]. 
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No participant reported fever (oral temperature >37.7ºC).  Overall, the number of participants who 
reported any systemic solicited AEs at Day 1 and their severity were similar across vaccine and 
placebo groups (8 participants [26.7%] on vaccine and 7 participants [23.3%] on placebo).  The 
majority of systemic solicited AEs reported by participants on vaccine were mild (Table 3) and 
none lasted beyond 6 days.  In contrast in the group randomized to placebo, 2 participants 
reported severe reactions (fatigue and joint ache) and 3 participants reported multiple solicited 
systemic adverse events up to Day 7 (Figure 5).   
There were no deaths, SAEs, or discontinuation due to AEs reported in the study.  There were no 
clinically significant abnormalities observed in the clinical laboratory results or product-related 
trends based on a review of the mean and median laboratory values at each scheduled 
evaluation, vital signs, and physical examination evaluations during the study (data not shown). 
The incidence of unsolicited AEs (Table 4) were similar across vaccine and placebo groups (7 
participants [23.3%] each).  All unsolicited AEs reported in the study were mild in intensity and 
were considered to be not related to the investigational product by the Principal Investigator. 
Overall the vaccine was safe and well tolerated with a safety profile similar to licensed seasonal 
influenza vaccine.  
Table 3: Summary of Solicited Local and Systemic Adverse Events for Vaccine and 
placebo Recipients Occurring from Day 1-7 After Vaccination Based on Most Severe 
Symptom Reported 
  
Vaccine (N=30) 
Placebo (N=30) 
Solicited Adverse Event 
Mild 
Moderate 
Severe 
Mild 
Moderate 
Severe 
  
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
n (%) 
Injection site 
 
   Pain  
17 (56.7) 
2 (6.7) 
0 
5 (16.7) 
0 
0 
   Tenderness  
16 (53.3) 
1 (3.3) 
0 
9 (30.0) 
0 
0 
   Hardness  
0 
1 (3.3) 
0 
0 
0 
0 
   Swelling  
0 
1 (3.3) 
0 
0 
0 
0 
Systemic symptoms 
 
   Headache 
6 (20.0) 
1 (3.3) 
0 
8 (26.7) 
1 (3.3) 
0 
   Tiredness/discomfort 
5 (16.7) 
2 (6.7) 
0 
6 (20.0) 
1 (3.3) 
1 (3.3) 
   Chills 
2 (6.7) 
0 
0 
3 (10.0) 
1 (3.3) 
0 
   Muscle Aches 
3 (10.0) 
0 
0 
4 (13.3) 
1 (3.3) 
0 
   Vomiting 
1 (3.3) 
0 
0 
1 (3.3) 
0 
0 
   Joint Aches 
0 
1 (3.3) 
0 
1 (3.3) 
0 
1 (3.3) 
   Nausea 
0 
0 
0 
3 (10.0) 
0 
0 
 
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Figure 5: Number of Participants Reporting Any Solicited Systemic Adverse Events Day 1 
to 7 Following Vaccination  
 
 
Overall, 14 subjects (23.3%) reported at least 1 unsolicited AE: 7 subjects (23.3%) each on 
vaccine and placebo. The overall summary of unsolicited AEs are presented in Table 4. 
 
Table 4: Summary of unsolicited events 
 
Unsolicited event 
Vaccine  
 (N=30)  
 n (%) 
Placebo  
 (N=30)  
 n (%) 
Total  
 (N=60)  
 n (%) 
 
Total number of unsolicited AEs 
7 
7 
14 
Subjects with at 
least one unsolicited AE 
7 (23.3) 
7 (23.3) 
14 (23.3) 
At least one vaccine related unsolicited 
AE 
0 
0 
0 
At least one severe unsolicited AE 
0 
0 
0 
Subjects  
requiring  
treatment  during  
the 
study 
5 (16.7) 
3 (10.0) 
8 (13.3) 
Number of subjects died 
0 
0 
0 
N– Total number of subjects in each group; n – Total number of subjects meeting the event. 
Any solicited sign or symptom starting after 7 days post-vaccination will be recorded as an Unsolicited AE. 
 
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Overall, the most frequently reported AEs were in the System Organ Class of infections and 
infestations (6 subjects [10.0%]); respiratory thoracic and mediastinal disorders (4 subjects 
[6.7%]); and general disorders and administration site conditions (Table 5). 
Table 5: Summary of Unsolicited Adverse Events by System Organ Class and Preferred 
Term  
System Organ Class/ Preferred term 
Vaccine  
(N=30)  
 n (%) 
Placebo  
(N=30)  
 n (%) 
Total  
(N=60)  
 n (%) 
Number of Subjects with at least one AE 
7 (23.3) 
7 (23.3) 
14 (23.3) 
Infections and infestations 
5 (16.7) 
1  (3.3) 
6 (10.0) 
     Herpes zoster 
1  (3.3) 
0 
1  (1.7) 
     Influenza 
1  (3.3) 
0 
1  (1.7) 
     Nasopharyngitis 
1  (3.3) 
0 
1  (1.7) 
     Pharyngitis 
1  (3.3) 
0 
1  (1.7) 
     Upper respiratory tract infection 
0 
1  (3.3) 
1  (1.7) 
     Urinary tract infection 
1  (3.3) 
0 
1  (1.7) 
Respiratory, thoracic and mediastinal disorders 
1  (3.3) 
3 (10.0) 
4  (6.7) 
     Oropharyngeal pain 
0 
2  (6.7) 
2  (3.3) 
     Rhinorrhea 
1  (3.3) 
1  (3.3) 
2  (3.3) 
General disorders and administration site 
conditions 
0 
2  (6.7) 
2  (3.3) 
     Fatigue 
0 
1  (3.3) 
1  (1.7) 
     Non-cardiac chest pain 
0 
1  (3.3) 
1  (1.7) 
Musculoskeletal and connective tissue disorders 
1  (3.3) 
0 
1  (1.7) 
     Arthralgia 
1  (3.3) 
0 
1  (1.7) 
Nervous system disorders 
0 
1  (3.3) 
1  (1.7) 
     Headache 
0 
1  (3.3) 
1  (1.7) 
N– Total number of subjects in each group; n – Total number of subjects meeting the event. 
Percentages were based on the total number of subjects under each vaccine group (N). 
Adverse Event terms were coded by System Organ Class and Preferred Term using MedDRA version 18.1. 
Subjects experiencing multiple events within the same SOC or preferred term were counted only once under 
those categories. 
Any solicited sign or symptom starting after 7 days post-vaccination will be recorded as an Unsolicited AE. 
 
Immunogenicity Results of Phase 1 IVACFLU-S Seasonal Flu Vaccine Trial 
Immune responses were measured at baseline and 21 days after vaccination. Approximately 50% 
of the participants had antibody titer ≥1:40 baseline by HAI and Microneutralization Test (MNT) 
to A/H3N2 (Table 6).  Nevertheless, the proportion of participants achieving a ≥ 4-fold rise in HAI 
and MNT titer against all three viral strains was high (Table 7A).  Of the 16 participants with HAI 
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titer ≥1:40 at baseline to A/H3N2, 12 developed 4 fold or greater rise in HAI antibody following 
vaccination.  No placebo participants developed a 4 fold rise in HAI and MNT antibody following 
vaccination. The vaccine also induced strong HAI seroprotection response (Table 7B), well above 
90% for all three viral strains.  
 Table 6:  Baseline titer ≥1:40 by HAI and MNT for vaccine and placebo recipients 
 Vaccine 
HAI 
MNT 
N=30 
HAI 
95%CI 
MNT 
95%CI 
A/H1N1 
5 (16.7) 
(5.6, 34.7) 
4 (13.3) 
(3.8, 30.7) 
A/H3N2 
16 (53.3) 
(34.3, 71.7) 
16 (53.3) 
(34.3, 71.7) 
B 
3 (10.0) 
(2.1, 26.5) 
11 (36.7) 
(19.9, 56.1) 
Placebo  
N=30 
HAI 
95%CI 
MNT 
95%CI 
A/H1N1 
6 (20.0) 
(7.7, 38.6) 
5 (16.7) 
(5.6, 34.7) 
A/H3N2 
16 (53.3) 
(34.3, 71.7) 
15 (50.0) 
(31.3, 68.7) 
B 
0 (0.0) 
(0.0, 11.6) 
9 (30.0) 
(14.7, 49.4) 
 
Table 7:   
 
A. Seroconversion rates by HAI and MNT for vaccine and placebo recipients 21 days 
after vaccination 
Vaccine 
HAI 
MNT 
N=30 
n=30 (%) 
95% CI 
n=30 (%) 
95% CI 
A/H1N1 
28 (93.3) 
(77.9, 99.2) 
28 (93.3) 
(77.9, 99.2) 
A/H3N2 
25 (83.3) 
(65.3, 94.4) 
25 (83.3) 
(65.3, 94.4) 
B 
23 (76.7) 
(57.7, 90.1) 
21 (70.0) 
(50.6, 85.3) 
Placebo 
N=30 
n=30 (%) 
95% CI 
n=30 (%) 
95% CI 
A/H1N1 
0 (0.0) 
(0.0, 11.6) 
0 (0.0) 
(0.0, 11.6) 
A/H3N2 
0 (0.0) 
(0.0, 11.6) 
0 (0.0) 
(0.0, 11.6) 
B 
0 (0.0) 
(0.0, 11.6) 
0 (0.0) 
(0.0, 11.6) 
 
Seroconversion is defined as a serum HAI titer meeting the following criteria: 
 
pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1:40 or 
 
pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination measured 
on Day 22 
 
B. Seroprotection rates (Titer ≥1:40) by HAI and MNT for vaccine and placebo recipients 
21 days after vaccination 
Vaccine 
HAI 
MNT 
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N=30 
N, % 
95% CI 
N, % 
95% CI 
A/H1N1 
29 (96.7) 
(82.8, 99.9) 
29 (96.7) 
(82.8, 99.9) 
A/H3N2 
29 (96.7) 
(82.8, 99.9) 
29 (96.7) 
(82.8, 99.9) 
B 
28 (93.3) 
(77.9, 99.2) 
26 (86.7) 
(69.3, 96.2) 
Placebo 
N=30 
N, % 
95% CI 
N, % 
95% CI 
A/H1N1 
6 (20.0) 
(7.7, 38.6) 
5 (16.7) 
(5.6, 34.7) 
A/H3N2 
16 (53.3) 
(34.3, 71.7) 
14 (46.7) 
(28.3, 65.7) 
B 
0 (0.0) 
(0.0, 11.6) 
9 (30.0) 
(14.7, 49.4) 
Seroprotection: Number and percentage of subjects with a serum Hemagglutination Inhibition (HAI) antibody titer ≥ 
1:40 to each of the 3 vaccine components measured on Day 22 post-vaccination 
Geometric mean titer (GMT) responses by HAI and MNT showed a strong response to all 3 viral 
strains, H1N1>H3N2>B, post-vaccination (Table 8).  GMT at baseline was low and there was no 
rise in antibodies among placebo participants. For participants randomized to vaccine HAI GMT 
rose to 37.2 (A/H1N1), 16.2 (A/H3N2), and 7.8 (B) folds after vaccination.  Geometric mean titers 
by MNT to all 3 viral strains were of similar magnitude as seen with HAI. 
 
Table 8: Geometric Mean Titer (GMT) response by HAI and MNT for vaccine and placebo 
recipients 
  
HAI 
MNT 
Vaccine (n=30) 
H1N1 
H3N2 
B 
H1N1 
H3N2 
B 
GMT 
Day 1 
10.0 
39.5 
8.8 
8.7 
38.6 
16.2 
  
Day 22 
371.9 
640.0 
68.1 
417.4 
670.3 
201.6 
  
Fold 
37.2 
16.2 
7.7 
47.9 
17.3 
12.4 
 Placebo (n=30) 
H1N1 
H3N2 
B 
H1N1 
H3N2 
B 
GMT 
Day 1 
10.6 
35.6 
6.9 
10.8 
40.0 
14.6 
  
Day 22 
10.7 
33.6 
7.0 
10.5 
39.1 
14.3 
  
Fold 
1.0 
0.9 
1.0 
1.0 
1.0 
1.0 
 
In summary the data from the phase 1 trial showed the vaccine to be safe and well tolerated.  The 
vaccine was able to induce strong immune response, even among individuals with pre-existing 
HAI antibodies [7].  Both the safety profile and immunogenicity responses of IVACFLU-S are 
comparable to licensed inactivated seasonal influenza vaccines (Section 2.2). Furthermore, the 
immune responses, even at the LB of 95% CI, exceeded the European Medicine Agency and 
Vietnam Ministry of Health serological criteria for regulatory approval of seasonal influenza 
vaccines. (8) 
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2.2 
Data on Clinical Trials from Seasonal Vaccines Similar to IVACFLU-S 
2.2.1 Flucelvax – Seqirus, Inc  
Flucelvax (Influenza Vaccine), a vaccine for intramuscular injection, is a “subunit” influenza 
vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells, a 
continuous cell line. These cells were adapted to grow freely in suspension in culture medium. 
The 
virus 
is 
inactivated 
with 
ß-propiolactone, 
disrupted 
by 
the 
detergent 
cetyltrimethylammonium bromide and purified through several process steps. Each of the 3 
virus strains is produced and purified separately then pooled to formulate the trivalent vaccine. 
The following safety profile is in the package insert for Flucelvax [9]: 
 
Table 9: Solicited Adverse Reactions in the Safety Population1 Reported Within 7 
Days of Vaccination in Study1 
 
Adults 18 through 49 Years 
 
Percentages (%) 
Flucelvax 
 N=3813 
Placebo (PBS)  
N=3894 
Local adverse reactions 
 
Injection site pain 
30 
10 
Erythema 
13 
10 
Induration 
6 
3 
Swelling 
6 
3 
Ecchymosis 
4 
4 
Systemic adverse reactions 
 
Headache 
15 
15 
Fatigue 
10 
10 
Myalgia 
12 
7 
Malaise 
8 
6 
Chills 
6 
6 
Arthralgia 
3 
3 
Sweating 
3 
3 
Fever (≥38o C) 
1 
<1 
1Safety population: all participants in the exposed population who provided post vaccination safety data 
Flucelvax has the following efficacy profile, as stated in its package insert: 
 
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Table 10: Percentage (%) of participants with Post-Vaccination HAI Titers ≥ 1:40 and 
Seroconversion in Adult Flucelvax Recipients 18 through 49 Years and 50 through 64 
Years of Age 
 
 
 
18 through 49 Years 
50 through 64 Years 
Study 
Vaccine 
strain 
% 
HAI Titer≥1:40 
(95% CI) 
% 
Seroconversion1 
(95% CI) 
% 
HAI Titer≥1:40 
(95% CI) 
% 
Seroconversion1 
(95% CI) 
 
 
N=228 
N=228 
 
 
 
Study 1 US, 
Finland, 
Poland 
2007– 
2008 
N=228 
 
A/H1N1 
99 
(97-100) 
 
78 
(72-83) 
 
 
A/H3N2 
 
99 
(98-100) 
 
59 
(53-66) 
 
 
B 
78 
(72-83) 
51 
(45-58) 
 
 
 
 
N=478 
N=478 
N=340 
N=340 
Study 2 
Poland 
2004– 
A/H1N1 
 
94 
(91-96) 
 
73 
(69-77) 
 
84 
(79-88) 
 
57 
(52-63) 
 
 
18 through 49 Years 
50 through 64 Years 
2005 
N=818 
A/H3N2 
 
99 
(98-100) 
 
63 
(59-68) 
 
99 
(97-100) 
 
66 
(61-71) 
B 
93 
(90-95) 
88 
(84-90) 
87 
(83-90) 
77 
(70-79) 
 
 
 
N=307 
 
N=307 
 
 
 
Study 3 
US 
2005– 
2006 
N=307 
A/H1N1 
96 
(94-98) 
62 
(57-68) 
 
 
A/H3N2 
91 
(87-94) 
85 
(81-89) 
 
 
B 
94 
(91-96) 
77 
(72-81) 
 
 
 
1 Rates of seroconversion = percentage of participants with either a pre-vaccination HAI titer < 1:10 
and a post-vaccination HAI titer ≥ 1:40 or a pre-vaccination HAI titer ≥ 1:10 and at least a four-fold rise 
in post-vaccination HAI antibody titer 
2.2.2 Fluzone®– Sanofi Pasteur  
 
Fluzone (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, 
prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing 
allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and 
purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus 
is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), 
producing a “split virus”. The split virus is further purified and then suspended in sodium 
phosphate-buffered isotonic sodium chloride solution. Fluzone has the following safety profile as 
stated in the package insert [10]: 
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Table 11: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events 
within 7 Days after Vaccination with Fluzone, Adults 18 Through 64 Years of Age 
 
 
(Na=1392-1394) 
Percentage 
 
 
Any 
 
Grade 2b 
 
Grade 3c 
Injection-Site Erythema 
13.2 
2.1 
0.9 
Injection-Site Induration 
10.0 
2.3 
0.5 
Injection-Site Swelling 
8.4 
2.1 
0.9 
Injection-Site Pain 
53.7 
5.8 
0.8 
Injection-Site Pruritus 
9.3 
0.4 
0.0 
Injection-Site Ecchymosis 
6.2 
1.1 
0.4 
Headache 
30.3 
6.5 
1.6 
Myalgia 
30.8 
5.5 
1.4 
Malaise 
22.2 
5.5 
1.8 
Shivering 
6.2 
1.1 
0.6 
Feverd (≥99.5°F) 
2.6 
0.4 
0.2 
a N is the number of vaccinated participants with available data for the events listed 
b Grade 2 - Injection-site erythema, Injection-site induration, Injection-site swelling, and Injection-site ecchymosis: ≥ 
2.5 cm to <5 cm; Injection-site pain and Injection-site pruritus: sufficiently discomforting to interfere with normal 
behavior or activities; Fever: >100.4°F to ≤102.2°F; Headache, Myalgia, Malaise, and Shivering: interferes with daily 
activities 
c Grade 3 - Injection-site erythema, Injection-site induration, Injection-site swelling, and Injection-site ecchymosis: 
≥5 cm; Injection-site pain: incapacitating, unable to perform usual activities; Injection-site pruritus: incapacitating, 
unable to perform usual activities, may have/or required medical care or absenteeism; Fever: >102.2°F; 
Headache, 
Myalgia, Malaise, and Shivering: prevents daily activities 
d Fever - The percentage of temperature measurements that were taken by oral or axillary routes, or not recorded 
were 99.6%, 0.0%, and 0.4%, respectively 
 
Fluzone has the following efficacy profile, as stated in its package insert: 
 
Table 12: Percentage (%) with Pre and Post-Vaccination HAI Titers ≥1:40 and 
Seroconversion in Adult Fluzone Recipients 18 through 64 Years of Age 
 
Antigen 
Pre-Vaccination Titer ≥1:40 
% (95% CI) N=1285-1286 
Post-Vaccinationa 
Titer ≥1:40 
% (95% CI) N=1283-1285 
Seroconversionb 
 
% (95% CI) N=1283-1285 
A (H1N1) 
39.1 (36.4; 41.8) 
91.7 (90.0; 93.1) 
60.5 (57.7; 63.2) 
A (H3N2) 
33.6 (31.0; 36.2) 
91.4 (89.8; 92.9) 
74.8 (72.3; 77.1) 
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B 
41.2 (38.5; 44.0) 
89.3 (87.4; 90.9) 
54.2 (51.4; 56.9) 
a Post-vaccination HAI titers drawn at 28 days post-dose 
b Seroconversion: Paired samples with pre-vaccination HAI titer <1:10 and post-vaccination (28 days post-
dose) titer ≥1:40 or a minimum 4-fold increase for participants with pre-vaccination titer ≥1:10 
2.2.3 Fluarix – GSK  
FLUARIX is a vaccine prepared from influenza viruses propagated in embryonated chicken eggs. 
Each of the influenza viruses is produced and purified separately. After harvesting the virus-
containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using 
a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following 
dilution, the vaccine is further purified by diafiltration. Each influenza virus solution is inactivated 
by the consecutive effects of sodium deoxycholate and formaldehyde leading to the production of 
a “split virus.” Each split inactivated virus is then suspended in sodium phosphate-buffered 
isotonic sodium chloride solution. The vaccine is formulated from the 3 split inactivated virus 
solutions. The following safety profile is reported in the package insert for Fluarix [11]: 
 
Table 13: Incidence of Solicited Local Adverse Reactions or General Adverse Events 
within 4 Days of Vaccination in Adults Aged 18 through 64 Years  
 
 
Fluarix N = 760 
% 
Place bo N = 192 
% 
Local Adve rse Re actions 
Pain 
55 
12 
Redness 
18 
10 
Swelling 
9 
6 
Ge ne ral Adve rse Eve nts 
Musc le aches 
23 
12 
Fatigue 
20 
18 
Headache 
19 
21 
Arthralgia 
6 
6 
Shivering 
3 
3 
Fever ≥100.4°F (38.0°C) 
2 
2 
 
Fluarix has the following efficacy reported in its package insert: 
 
Table 14: Rates with HAI Tite rs ≥1:40 and Rates of Se roconve rsion to Each Antige n 
following Fluarix or Place bo (21 Days afte r Vaccination) in Adults Age d 18 through 64 
Years 
 
 
 
 
 
 
 
 
 
 
 
 
 
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FLUARIXb N = 745 
Place bo 
% (95% CI) 
N = 190 
% (95% CI) 
Pre - 
Post- 
Pre - 
Post- 
vaccination 
vaccination 
vaccination 
vaccination 
With HAI Titers ≥1:40 
A/New Caledonia/20/99 (H1N1) 
54.8 
96.6 
52.1 
51.1 
(51.1, 58.4) 
(95.1, 97.8) 
(44.8, 59.4) 
(43.7, 58.4) 
A/Wyoming/3/2003 (H3N2) 
68.7 
99.1 
65.3 
65.3 
(65.3, 72) 
(98.1, 99.6) 
(58, 72) 
(58, 72) 
B/Jiangsu/10/2003 
49.5 
98.8 
48.9 
51.1 
(45.9, 53.2) 
(97.7, 99.4) 
(41.6, 56.3) 
(43.7, 58.4) 
Se roconve rsion 
Post-vaccination 
Post-vaccination 
A/New Caledonia/20/99 (H1N1) 
59.6 
0 
(56, 63.1) 
(0, 1.9) 
A/Wyoming/3/2003 (H3N2) 
61.9 
1.1 
(58.3, 65.4) 
(0.1, 3.8) 
B/Jiangsu/10/2003 
77.6 
1.1 
(74.4, 80.5) 
(0.1, 3.8) 
2.3 
Rationale of Current Study 
Vaccination is currently the most effective means of preventing influenza infection.  However 
global influenza vaccine coverage is low and vaccine production capacity is concentrated mostly 
in industrialized countries.  In the event of antigenic shift in the hemagglutinin (HA) of influenza 
leading to pandemic influenza, it is probable that global supply of a pandemic influenza will be 
limited due to insufficient vaccine production capacity.   It is also recognized that pandemic 
vaccine production capacity is dependent on seasonal vaccine capacity and demand, and the 
dependence of this demand on evidence and policies supporting the use of influenza vaccines.  
WHO GAP with financial support from Biomedical Advanced Research and Development 
Authority (BARDA) -  the US Department of Health and Human Services and technical assistance 
from PATH have provided technical and financial support to Institute of Vaccine and Medical 
Biologics (IVAC) for improving technology, scaling-up, production of clinical lots and carrying out 
pre-clinical studies and clinical trials. The goal is to have a licensed, Vietnamese-made seasonal 
influenza vaccine and through that expertise to eventually develop and gain approval of a 
pandemic influenza vaccine. 
The phase 1 trial of the IVAC seasonal trivalent inactivated split virion influenza vaccine 
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completed in Mar, 2016 identified no safety concerns and demonstrated the vaccine to be highly 
immunogenic [7].  Given the promising findings, the current study proposes to expand on the 
safety data of the vaccine and to confirm the immunological findings, including individuals up to 
age 60 with the goal of seeking regulatory approval for indication in non-elderly adults based on 
the Vietnam Ministry of Health Guidance on Clinical Trial of Influenza Vaccine serological criteria 
for assessing seasonal influenza [8].  The immediate benefit of licensure of a seasonal influenza 
vaccine in this age group will be among health care workers (HCW) who are at higher risk of 
influenza infection as compared to healthy adults who work in non-health care settings [12]. 
Furthermore vaccinating health care workers against influenza reduces the transmission of the 
virus in health care settings, decreases staff illness and absenteeism, and indirectly benefits 
patients by decreasing their chance of being infected [13]. In particular patients who are too young 
to receive the vaccine (<6 months of age) and those who have poor immunological responses 
(elderly and immune-compromised).  Recent epidemiological data also suggest that vaccinating 
non-elderly (<65 years old) adults may also protect higher risk individuals in their community, with 
the potential to prevent up to 5.9% of influenza diagnosis in elderly individuals [14]. Seasonal 
vaccine is also recommended by WHO to be administrated to pregnant women in order to protect 
the fetus and mother during the pregnancy. Finally, licensure initially in this age group will also 
help facilitate future bridging licensure studies in other populations that are vulnerable to influenza 
infection and its complications.   
2.4 
Dose Rationale 
The rationale for dose selection of seasonal influenza vaccines is widely accepted in the scientific 
community. This study uses the WHO-recommended dose of 15 mcg of HA per strain as 
measured by single radiation immunodiffusion (SRID) assay. 
2.5 
Potential Risks and Benefits of Inactivated, split Influenza Vaccine 
2.5.1 Potential Risks 
 
We expect this study vaccine to cause side effects similar to those seen in the Phase 1 study and 
in other inactivated, trivalent influenza vaccines particularly other split virion influenza vaccines. 
From worldwide use, we know that administering seasonal influenza vaccine may cause the 
participant immediate mild pain in the arm. Other side effects include pain and inflammation 
(redness/swelling) at the injection site or systemic symptoms such as headache, fever, 
tiredness, and body aches. It is very rare, but serious or allergic reactions may also happen. 
These potential risks are addressed by several measures: 
 
The study is supervised by a physician and the study staff are trained and equipped 
to handle any vaccine reaction. To manage immediate reactions, participants remain 
at the study site at least 30 minutes after injection. 
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 
The safety of the study is overseen by a Protocol Safety Review Team (PSRT) 
that meets regularly (generally weekly) to review safety information up to Day 22. 
 
The study staff check in with the participants at 1 day following vaccination to check 
on their health status. 
2.5.2 Potential Benefits 
It is possible that a participant may not benefit from trial participation as some will receive 
placebo. Even though the IVACFLU-S vaccine contains virus strains recommended by the 
WHO in February 2016 for use in the 2016-2017 Northern hemisphere influenza season [6], 
there is the possibility that these may not match the circulating strains in the community.  
Furthermore, the IVACFLU-S vaccine is not licensed and its efficacy is being evaluated in 
the current trial.   
3 
Study Objectives and Endpoints 
3.1 
Study Objectives 
3.1.1 Primary Objectives, Phase 2 
Safety:  To evaluate the safety profile of a single intramuscular dose of IVACFLU-S seasonal 
trivalent inactivated split virion influenza vaccine in adults, 18 to 60 years of age. 
3.1.2 Primary Objectives, Phase 3 
Safety:  To evaluate the safety profile of a single intramuscular dose of IVACFLU-S seasonal 
trivalent split virion, inactivated influenza vaccine in adults, 18 to 60 years of age. 
Immunogenicity: To evaluate the immune response at Day 22 to each of the three vaccine 
antigens after a single intramuscular dose of IVACFLU-S seasonal trivalent split virion, inactivated 
influenza vaccine in adults,  18 to 45 and 46 to 60 years of age. 
3.1.3 Secondary Objective, Phase 3 
Immunogenicity: To evaluate the immune response at Day 22 to each of the three vaccine 
antigens after a single dose of IVACFLU-S seasonal trivalent split virion, inactivated influenza 
vaccine in adults with and without pre-existing Hemagglutination Inhibition (HAI) antibody 
3.2 
Study Outcome Measures (Endpoints) 
3.2.1 Primary Endpoints 
A. Primary Safety Endpoints, Phase 2 and 3  
The number and proportion of participants reporting the following events: 
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A. Solicited local adverse events, including redness / erythema, swelling / induration, pain 
within 30 minutes of vaccination and over a 7-day period (Days 1-7) post-vaccination. 
B. Solicited systemic adverse events, including fever, fatigue/malaise, muscle aches, joint 
aches, chills, nausea, vomiting, and headache within 30 minutes of vaccination and over 
a 7-day period (Days 1-7) post-vaccination. 
C. Unsolicited Adverse Events (AEs) occurring within 21 days post vaccination.  
D. Serious Adverse Events (SAE) occurring during the entire study period (Days 1-91).  
 
B. Primary Immunogenicity Endpoint, Phase 3 
A. Number and percentage of participants by age groups (18-45, 46-60) with seroconversion 
against each of the 3 vaccine antigens post-vaccination.  Seroconversion is defined as a 
serum HAI antibody titer meeting the following criteria: 
 
pre-vaccination titer <1:10 and a post-vaccination titer measured on Day 22 of 
≥1:40 or 
 
pre-vaccination titer ≥1:10 and at least a four-fold increase in post vaccination 
measured on Day 22  
B. Number and percentage of participants by age groups (18-45, 46-60) with a HAI antibody 
titer ≥1:40 to each of the 3 vaccine antigens measured on Day 22 post vaccination 
C. Geometric mean titers (GMTs) of serum HAI antibodies pre- (Day 1) and post vaccination 
(Day 22) by age groups (18-45, 46-60) for each of the 3 vaccine antigens 
D. Geometric mean fold rises (GMFRs) of serum HAI antibodies (post vaccination/pre-
vaccination) by age groups (18-45, 46-60) for each of the 3 vaccine antigens 
3.2.2 Secondary Immunogenicity Endpoints, Phase 3 
A. Number and percentage of participants by age groups (18-45, 46-60) who develop at least 
a four-fold increase in HAI antibody titer to each of the vaccine antigen post vaccination 
measured on Day 22 by pre-vaccination HAI antibody titer of  <1:10 or ≥1:10. 
B. Geometric mean titers (GMTs) of serum HAI antibodies pre- (Day 1) and post vaccination 
(Day 22) by age groups (18-45, 46-60) for each of the 3 vaccine antigens by pre-
vaccination HAI antibody titer of <1:10 or ≥1:10. 
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C. Geometric mean fold rises (GMFRs) of serum HAI antibodies (post vaccination/pre-
vaccination) by age groups (18-45, 46-60) for each of the 3 vaccine antigens by pre-
vaccination HAI antibody titer of <1:10 or ≥1:10. 
4 
Study Design 
4.1 
Study Design 
This is a phase 2/3, double-blind, randomized, placebo-controlled trial to evaluate the safety and 
immunogenicity of a single dose the IVACFLU-S seasonal trivalent inactivated influenza vaccine 
in male and female, ages 18 to 60 years old.  Phase 2 will be conducted at 1 site of Long An and 
will involve 252 participants randomized to receive either IVACFLU-S or placebo at a ratio of 5:1.  
Following determination of safe to proceed based on PSRT review of Day 8 safety data from all 
Phase 2 participants and with approval from Vietnam Ministry of Health (MOH), Phase 3 
enrollment will commence at 2 sites of Long An and Dong Nai. The Phase 3 components will 
include 636 participants randomized to receive either IVACFLU-S or placebo at a ratio of 5:1.  
Randomization of both Phase 2 and 3 volunteers will be stratified by age group as per schema 
below (Table 15). The sample size takes into account a dropout rate of 5% in the vaccine group 
to have at least 200 participants in phase 2 and 500 participants in phase 3 at the end of the 
study. 
Table 15: Schema for randomization 
 
  
 
 
 
 
 
 
Figure 1: Enrollment and schedule of trial activities 
Age 
group 
IVACFLU-S 
Placebo 
Total 
Phase 2 
18 - 45 
105 
21 
126 
46 - 60 
105 
21 
126 
Phase 3 
18 - 45 
265 
53 
318 
46 - 60 
265 
53 
318 
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Figure 2: Summary of study design   
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Phase 2:  
 
 
 
 
 
 
Phase 3:  
 
 
 
 
 
 
 
 
S1/D1 
S1/D1 
Randomized block 
 18-45 yrs of age: 126 
105 vaccine 
21 placebo 
46-60 yrs of age: 126 
21 vaccine 
105 placebo 
Screening by interviewing medical history and conducting 
physical examination to have 252 eligible participants  
S1/D1 
S1/D1 
 18-45 yrs of age: 126 
105 vaccine 
21 placebo 
46-60 yrs of age: 126 
21 placebo 
105 vaccine 
Screening by interviewing medical history and conducting 
physical examination to have 636 eligible participants 
252 at Ben Luc 
S1/D1 
S1/D1 
 18-45 yrs of age: 192 
160 vaccine 
32 placebo 
46-60 yrs of age: 192 
32 pleacebo 
160 vaccine 
384 at Long Thanh  
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Safety will be assessed in all Phase 2 and 3 participants through Day 91. Immunogenicity will be 
assessed only in Phase 3 participants. Blood samples will be collected at Day 1 before vaccination 
in a subset of 252 individuals randomized at one of the study sites  to get evaluable samples from 
at least 200 vaccine recipients (100 each from both age groups) and 40 placebo recipients (20 
each from both age groups) and 21 days after vaccination.  
4.2 
Design Rational 
Inactivated influenza vaccine has a well established safety profile having been prescribed to 
millions of individuals globally, including children, the elderly, pregnant women, individuals with 
chronic disease and immune suppression.  Inactivated influenza vaccine also has well established 
international guidance including quantification of antigen, manufacturing, testing specifications for 
final bulk and final products, and requirements for national control authorities [15,16].  Because 
of predictable immunogenicity, dose finding studies of traditional, non-adjuvanted inactivated 
influenza are often not required. In agreement with National Regulatory Authorities (NRAs), 
several manufacturers have initiated pivotal licensure Phase 3 inactivated influenza vaccine trials 
after encouraging safety and immunogenicity data from Phase 1 without conducting Phase 2 
studies. Subsequent to NRA approval, these vaccines received or were submitted for WHO 
prequalification. This approach towards clinical development and licensure of influenza vaccine 
was presented by the WHO at the IVAC-Vietnam MOH (representatives from Administration of 
Science, Technology and Training (ASTT)) consultative meeting conducted on 1 March 2016. A 
follow-up consultative meeting with the ASTT representatives, MOH held on 20 April 2016 
included presentation of the IVACFLU-S Phase 1 safety and immunogenicity data; and feedback 
by MOH of a preliminary P2/3 study design. Based on the Phase 1 results and experience of 
licensure procedures from other manufacturers and countries that did not include Phase 2 trial, 
the ASTT representatives, MOH endorsed this current Phase 2/3 design and that the 
immunogenicity data will be based on HAI only and that evaluation of efficacy will be based on 
HAI immunogenicity results instead of protective efficacy. 
With this seamless phase 2/3 design, the transition procedure from the phase 2 to the phase 3 
will be as follows: 
• 
Investigator will prepare the interim study report with information on trial performance, 
participant dispositions, demographic and key baseline characteristics, blinded data on 
solicited AEs and unsolicited AEs (please see the interim study report template in the 
appendix C) until day 8 of the last participants of the phase 2. 
• 
 This report will be submitted to the IRB of PI HCM and then to MOH IEC for expedited 
review and approval in order to check if there is any concern on the safety or trial 
performance before moving to the phase 3. 
• 
The tentative break for the review by both committees is about 8 weeks since the last 
participants in the phase 2 complete the D8 visit. 
4.3 
Study sites 
The Phase 2 of this study will be conducted in District Health Center (DHC) of Ben Luc, Long An 
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Province. The Phase 3 of the study will be conducted at 2 sites: District Health Center (DHC) of 
Ben Luc, Long An Province and District Health Center (DHC) of Long Thanh, Dong Nai Province. 
In both phases of the study, most of study activities  will be conducted in the District Health 
Centers (DHC) of Ben Luc and Long Thanh. Study subjects will be transported by car to DHCs 
for study visits. District Health Centers and District Hospitals of Ben Luc and Long Thanh are very 
close to each other which makes the referral convenient in case of any medical emergency. 
The Preventive Medicine Center (PMC) of Long An province and District Health Center (DHC) of 
Ben Luc district have been satellite sites for several vaccine clinical trials (including phase 1 of 
H1N1 and A/H5N1 influenza vaccines by IVAC) conducted in collaboration with Pasteur Institute 
in Ho Chi Minh city (PI HCMC). The staff of the DHC, as well as the staff of PMC, have experience 
in implementing vaccine trials. They also have experience in working with contract research 
organizations (CROs). The Preventive Medicine Center (PMC) of Dong Nai province and District 
Health Center (DHC) of Long Thanh district have some experience in conducting epidemiological 
studies and surveillance such as Dengue and diabetes. The DHCs of both districts manage and 
control the Expanded Program for Immunization (EPI) program and have pre-qualified WHO cold 
chain equipment for vaccine storage. 
5 
Study Enrollment and Withdrawal 
5.1 
Description of Participants, Source of Participants 
This trial will enroll approximately 888 male and female adults age 18 to 60 years from the Long 
An and Dong Nai Provinces in Vietnam. Pregnant women, breast feeding women and children 
are excluded from the study. 
 
The study staff will work through the appropriate health district and commune health workers to 
recruit potential participants, using IRB-approved methods. For recruitment, each village keeps 
population/household register books that contain information on the composition of each family in 
the village. The commune staff will work with population collaborators/village health workers to 
make a list of potential study participants from these register books to identify which families to 
approach. They will go household to household and use information from the protocol (specifically 
the “Information Sheet” from the consent document) to highlight the broad concepts of the study 
and eligibility criteria. They will assess interest of potentially eligible people and create a list from 
their household visits. These people will be invited to an information meeting to learn more about 
the study. After the information session, each person will have a 1:1 meeting with the study PIs 
to further discuss the trial and ask any questions they have. The investigator will assess the 
potential participant’s understanding of key aspects of the study, such as the voluntary nature of 
study participation and potential risks and benefits, using an assessment of understanding. The 
investigator will review with the particiant any answers they did not understand in order to clarify 
any misunderstandings. Only after that will the participant sign the ICF, if they are interested. 
 
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The study staff will follow inclusion/exclusion criteria to determine eligibility. Screening will be 
conducted on all people interested in joining the study who have signed the study consent, and 
their results will be reviewed with them, regardless of eligibility.  
5.2 
Participant Inclusion Criteria 
All participants must meet all of the following criteria to be considered eligible to participate in the 
study: 
 
Aged 18 through 60 years on the day of screening/enrollment. 
 
Literate (by self-report) and willing to provide written informed consent.  
 
Able to attend all scheduled visits and to comply with all trial procedures. 
 
Healthy or medically stable, as established by medical history and physical examination.  For 
individuals with medical conditions, symptoms/signs, if present must be stable under 
controlled or unchanged for the past 3 months. If medication is used to treat the condition, the 
medication dose must have been stable for at least 1 month preceding vaccination. 
 
For female participants: 
• 
Not breastfeeding or pregnant (based on negative urine pregnancy test) or plan to become 
pregnant up to Day 22. Women who are not surgically sterile (hysterectomy or tubal 
ligation) or post-menopausal for more than 1 year must have negative pregnancy test and, 
be willing to utilize reliable birth control measures (intrauterine device, hormonal 
contraception, condom or diaphragm with spermicide) through the Day 22 visit.   
5.3 
Participant Exclusion Criteria 
Participants meeting any of the following criteria will be excluded from participation: 
 
Current or recent (within two weeks of enrollment) acute severe illness with or without fever. 
 
Participation in another clinical trial involving any therapy within the previous three months or 
planned enrollment in such a trial during the period of this study. 
 
Receipt of any non-study vaccine within 4 weeks prior to enrollment or refusal to postpone 
receipt of such vaccines until after the Day 22 visit. 
 
Received seasonal influenza vaccine in last 6 months  
 
Receipt of immune globulin or other blood products within 3 months prior to study enrollment 
or planned receipt of such products prior to the Day 22 visit. 
 
Known or suspected congenital or acquired immunodeficiency. 
 
Chronic administration (defined as more than 14 consecutively-prescribed days) of 
immunosuppressants or other immune-modulating therapy within six months prior to study 
enrollment. (For corticosteroids, this means prednisone or equivalent, ≥ 0.5 mg per kg per 
day; topical steroids are allowed.) 
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 
Unstable illness by history or physical examination, that in the opinion of the investigator, 
might interfere with the conduct or results of the study or pose additional risk to the participant.  
 
Hypersensitivity after previous administration of any vaccine. 
 
Suspected or known hypersensitivity to any of the study vaccine components, including 
chicken or egg protein, and rubber (from the vaccine vial stoppers).  
 
Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion. 
 
Known active tuberculosis or symptoms of active tuberculosis, regardless of cause (self-
report). 
 
Current alcohol or drug addiction that in the opinion of the Investigator, might interfere with 
the ability to comply with trial procedures. 
 
History of Guillain-Barré Syndrome 
 
Neoplastic disease or any hematologic malignancy.  
 
Any condition that, in the opinion of the investigator, would increase the health risk to the 
participant if he/she participates in the study, or would interfere with the evaluation of the study 
objectives. 
5.4 
Treatment Assignment Procedures  
5.4.1 Randomization Procedures 
This is a double-blind, randomized, controlled trial with 2 groups: vaccine and placebo. The ratio 
of vaccine to placebo recipients will be 5:1. Each participant will be assigned a unique screening 
number assigned by the investigator after signing the informed consent. After an individual is 
determined to be eligible for study participation, the participant will be randomized according to 
age group by assigning a unique participant identification number sequentially in ascending order 
from the randomization schedule.  
The complete randomization schedule that contains the participant identification number and the 
corresponding randomization assignment will be produced using computer software prior to the 
initiation of the study.  
The Investigator will maintain a screening/enrollment log. The log will contain essential 
information including participant name, date of screening, gender, date of birth, whether or not 
the participant meets eligibility criteria, whether participant is enrolled and date, and if not enrolled, 
reason why the participant is not enrolled or not randomized. 
Once a participant identification number has been assigned to a participant, it will not be used 
again. Additional participants may be randomized into the study at the discretion of the sponsor 
in the case of any participant who is randomized but does not receive any study vaccine. 
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5.4.2 Blinding and Unblinding Procedures  
The randomization will be conducted by an organization or individual not involved in the conduct 
of the study.  
The randomization lists for participants will be used by IVAC to label study vaccine and placebo 
vials and then will be immediately sealed. It will be opened only after the clinical trial database is 
declared complete and locked. In the case of any unblinding, researchers must report this in 
writing to the overseeing Ethics Committee. 
The vaccine and placebo vials will be packaged and labeled in such a way that they have similar 
appearance. The labeling will be done at IVAC before study vaccine and placebo are shipped. 
Study product injected into each participant will be recorded on the Case Report Form (CRF) 
using the exact allocation code for each product received by each participant.  
The allocation codes link treatment identification with each participant via participant identification 
numbers. These will be maintained in a secure location, by an individual not involved in the 
conduct of the study. If any participant experiences an SAE possibly related to receipt of study 
treatment and the investigator determines it is necessary to unblind, treatment allocation to the 
participant may be communicated to the investigator. 
5.4.3 Reasons for Withdrawal  
Participants in this study receive only one dose of study product, administered at time enrollment, 
Day 1. Furthermore, the safety follow-up is minimally intrusive and of short duration. Given these 
factors and the importance of collecting full safety data from all participants, the reasons for 
terminating from the study should be minimal but may include the following: 
 
Participant withdraws consent. 
 
PI decides that termination is in the best interest of the participant. 
 
The sponsor terminates the study. 
5.4.4 Handling of Withdrawals 
If a participant withdraws from the study for any reason prior to the planned study duration, every 
attempt is made to document the participant’s health status and follow procedures outlined in 
section 8.3  
5.4.5 Strategies to Maintain and Recruit Additional Participants 
This is a relatively short trial with only one injection and 3 planned in-clinic study visits and one 
final study visit via telephone per participant. Strategies to maintain retention in the trial include 
treating them respectfully, making sure they understand the study and potential side effects, and 
close communication with each participant about how the study unfolds. Given the short duration 
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of the trial and anticipated side effects of the study vaccine, participant withdrawal and loss of 
follow-up is expected to be low. Participants who discontinue after the trial is closed to enrollment 
will not be replaced. 
6 
Termination of the Trial  
6.1 
Termination According to the Protocol 
Termination of the trial is the date of the last visit (Day 91) of the last participant participating in 
the trial, according to the trial scheme. 
6.2 
Suspension and/or Premature Termination of the Trial 
The trial might be suspended at any time by IVAC, the Vietnam MOH, any ethical review 
committee overseeing this study, or by the investigator for any safety concern. This includes, for 
example, and without limitation, an SAE resulting in death or an unusually high rate of SAEs. 
IVAC may suspend the study in the event that study conduct is found to be below GCP standards. 
In the event of new data that indicate an increased level of risk to participating participants, the 
clinical trial will be suspended until IVAC, the Vietnam MOH, and all ethical review committees 
have reviewed relevant data and agreed that the trial may continue. 
7 
Study Products 
7.1 
Study Product Descriptions 
7.1.1 Acquisition 
IVAC will provide both the study vaccine and placebo for this trial. 
IVACFLU-S is seasonal inactivated, split virion, trivalent influenza vaccine (A/H3N2, A/H1N1, and 
B), produced in GCP facility by IVAC uses embryonated chicken eggs. This vaccine is purified by 
sucrose gradient ultracentrifugation (Alfa Wassermann, West Caldwell, NJ), and inactivated with 
formaldehyde. The following vaccine strains are recommened by WHO for the influenza season 
of 2016-2017 in northern hemisphere: 
- NYMC X-179A (A/California/07/2009)   (H1N1) 
- NYMC X-263B (A/HongKong/4801/2014)  (H3N2) 
- NYMC BX-35 (B/Brisbane/60/2008) (B)  
The investigator or qualified designated staff member will be personally responsible for vaccine 
receipt and management. IVAC will determine with the investigator or the designated staff 
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member, the date(s) and time(s) of delivery of vaccine to the study clinic. Study vaccine and 
placebo, manufactured by IVAC, will be supplied to the study clinic by IVAC under controlled 
temperature conditions. 
7.1.2 Formulation, Packaging and Labeling (Seasonal influenza vaccine, IVACFLU-S) 
IVACFLU-S is formulated to contain 15 mcg hemagglutinin (HA) from each of the three vaccine 
strains per 0.5 mL dose, and filled in single dose vials. Each 0.5 mL dose may contain residual 
amounts of formaldehyde (not more than 0.02%). 
IVACFLU-S is a transparent, colorless or opaque white solution, sterile. Antibiotics are not used 
in the manufacture of IVACFLU-S. IVACFLU-S does not contain latex. The future package insert 
will describe the vaccine as follows: 
 
Placebo  
Placebo is the Phosphate Buffered Saline (PBS) manufactured by IVAC with pH 7.2, will also be 
in 0.5 mL single-dose vials. The formulation is as follows: 
NaCl: 
4.500 mg 
Na2HPO4.2H2O: 
0.685 mg 
NaH2PO4.2H2O: 
0.186 mg 
Water For Injection (qs): 
0.5 mL 
 
Packaging 
 
Product name: 
Seasonal Influenza Vaccine 
Trademark: 
IVACFLU-S 
Active substance: 
Surface antigen containing hemagglutinin (HA) 
Formulation: 
15µg (mcg) HA  of each of the three strains in 0.5* mL PBS 
pH 7.2  
*Volume is slightly higher to allow 0.5mL to be extracted 
Product form: 
Trivalent, purified split virion, inactivated 
Pharmaceutical form: 
Injectable biologic 
Administration route: 
Intramuscular (IM) 
Dosage: 
0.5 mL per dose 
Storage:  
From + 2OC to+ 8OC, avoid freezing 
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IVACFLU-S vaccine and placebo will be filled in glass vials at a dose volume of 0.5 ml, and 
covered with a pharmaceutically acceptable rubber stopper, sealing aluminum cap and single-
use flip-off plastic lid. Packaging will be done to assure that the vials are intact and vaccine of 
high quality. A continuous temperature data logger will be placed inside each carton box to 
monitor product temperature during the process of transportation, storage, and delivery of the 
product. The carton boxes will also be labeled with “product to be used for clinical trial purposes 
only” and information on the product storage temperature (from +2oC to +8oC).   
The study product must not be used if the package or labeling appears to be tampered with, the 
label is illegible or the physical properties (color and transparency) are altered. 
Picture of vaccine vial and box: 
 
Picture of placebo vial and box: 
 
Sample of blinding label: 
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7.1.3 Stability and Storage 
Study product must be stored at a temperature between +2 degrees Celsius (°C) to +8°C. The 
shelf-life is 12 months in that condition. Storage temperature must be monitored daily and 
documented on an appropriate form. Back-up power or storage must be available in case of 
primary power failure. Study vaccine and placebo must never be frozen. Their temperature will 
be monitored at the manufacturer, during transport, and at the clinical trial site. 
In certain instances during transportation and storage for e.g. at some point during movement of  
IP from the IVAC cold store to the refrigerated truck, from refrigerated truck/fridge to cold boxes 
or vaccine carriers etc., study product may be exposed  to temperatures outside recommended  
storage temperature range. If the study product is exposed to the temperature not exceeding 220C 
for less than 10 minutes and the number of such temperature excursions are no more than 5 
times, then the study product can be used. In case of other accidental disruptions of the cold 
chain, the products may not be administered and the investigator or the responsible person should 
contact IVAC to receive further instructions. In such cases, the investigator must receive written 
consent (through facsimile or emailed, scanned copy) of IVAC before any study product may be 
used. 
7.1.4 Lot number, Expiry date, Quality control results of study vaccine lots 
 In 2016, IVAC had produced 3 lots of study vaccine which are 004-01-16, 005-01-16, 006-01-
16. These vaccine lots were tested by National Institute for Control of Vaccines and Biologocals 
(NICVB) and met the quality requirement with corresponding certification numbers 
00416/VXVR-NC, 00516/VXVR-NC and  00616/VXVR-NC dated 22/12/2016; and one lot of 
placebo 007P-01-16 was also tested by NICBV with certification number 00716/VXVR-NC dated 
29/12/2016. 
 
The vaccine lot number IVACFLU-S 004-01-16 (manufacturing date 29/11/2016, expiration date 
05/12/2017) and placebo lot number VACFLU-S 007P-01-16 (manufacturing date  02/12/2016, 
expiration date 05/12/2017) were used as study materials in this phase 2/3 clinical trial. Details 
on the test results of these lots are in the appendix E “Quality certification by NICBV” for the 
study product lots.  
 
Other detailed information on the 2 study product lots can be found in the Investigator Brochure 
(IB). 
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7.2 
Dosage, Preparation and Administration of Study Products 
7.2.1 Dosage and Schedule 
A single dose level of IVACFLU-S will be evaluated in this study. The dose will be a total of 0.5 
mL containing 15 mcg HA for each component. The vaccine is to be delivered intramuscularly 
preferably into the deltoid of the non-dominant arm.  
7.2.2 Precautions and Warnings 
1. IVACFLU-S is only to be used for adults 18 to 60 years of age participating in this study 
who meet the inclusion/exclusion criteria. It is forbidden to use the vaccine for any other 
purpose. 
2. Strict compliance with the regulations of the MOH on the use of vaccines and biologicals 
is required. 
3. Vaccination must be intramuscularly preferably into the deltoid of the non-dominant arm.  
4. Study product vials that have had any temperature excursions outside the allowable 
time/temperature enumerated in section 7.1.3, may not be used. Contact IVAC for further 
instructions. 
5. IVACFLU-S or placebo solution is a homogenous preparation, colorless or opaque white. 
Do not inject if the study product vial appears to have unusual content or if the liquid in the 
vials has changed color. 
6. Only health workers who have been trained and have valid certificate of safe immunization 
for this research study may administer study product to enrolled participants, assuring 
proper intramuscular injection technique and sterile injection. 
7. Only one person may be injected with one needle and syringe. 
8. Study participants must remain in the clinic and be monitored for 30 minutes after 
vaccination. 
9. The study vaccination clinic should have adequate facilities for monitoring and treating any 
reactions. Drugs to treat anaphylaxis must be available, as must specialist doctors for such 
an emergency. Prompt referral to additional needed facilities must be available. 
7.2.3 Preparation and Administration 
To prepare and administer study product, vaccination facilities and investigators must comply with 
current Minsitry of Health regulations on vaccination. The step-by-step instructions for the 
investigator (or delegated staff) are as follows: 
• 
Wash hands or clean hands with hand sanitizer. Prepare the study vaccine/placebo, 
needles, syringes, and sharps safety box ahead of time.  
• 
Specific study procedures will be developed and include selecting the appropriate vial for 
each participant, gently shaking the vaccine vial, withdraw the 0.5-mL dose of study 
vaccine/placebo from the vial using a sterile needle and syringe. Careful records must be 
maintained to ensure and document that each participant receives the correct dose. Once 
the dose vial has been penetrated, the withdrawn study vaccine/placebo should be used 
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promptly.  
• 
Make sure you have sufficient equipment to provide every participant with a safe injection 
and to dispose of injection materials safely.  
• 
Make sure you have emergency drug and equipment kits in both the vaccination area and 
the observation area. 
• 
Greet the participant in a friendly manner. Ask whether he/she has any questions or 
concerns about injection and respond to his/her questions and concerns in a truthful and 
pleasant manner. 
• 
Confirm the participant identity. 
• 
Ensure the participant is seated.   
• 
Inform the participant that for consistency in the study, all participants will be vaccinated 
preferably in the deltoid of the non-dominant arm.  
• 
Use the cotton swab with 700 alcohol to clean and disinfect the site for injection  
• 
Inject intramuscularly the entire contents of the syringe into the deltoid region of the upper 
arm.  
• 
While the plunger is still depressed, remove the needle from the participant’s arm. 
• 
Apply a dry cotton swab with pressure to the injection site.  
• 
Do not recap the needle. Dispose of the needle and syringe in a sharps container. Store 
the empty vial in a safe place (not the refrigerator) until the end of the study. The vial must 
not be disposed of until monitors have verified that it is allowed.  
• 
Record the date of vaccination and vaccine vial number on the participant’s vaccination 
CRF. 
• 
Ask the participant to rest for 30 Minutes.  
• 
While the participant is resting, provide the Diary Card, ruler and thermometer and explain 
how to use them for recording symptoms. Remind them of upcoming phone calls/visits. 
• 
For 30 Minutes following vaccination, observe the participant and ask about the 
participant’s well-being. 
• 
Before the participant leaves, instruct the participant to seek medical assistance if adverse 
events occur that require medical evaluation and treatment. 
7.3 
Modification of Study Product for a Participant 
There is no dose adjustment for the product in the study. 
7.4 
Accountability Procedures for Study Product 
The study vaccine and placebo will be kept in a secure place in cold storage (with backup power 
and/or storage) at the District Health Centers segregated from other products. During the study, 
the investigator or the person in charge of research product management will record information 
related to the delivery of vaccine and placebo to the trial site, conduct inventory at the trial site, 
check the number of doses given to the participants, check the number of unused doses. At the 
end of the study, the site will receive instruction from the Sponsor regarding the final disposition 
of any remaining study products. 
At the vaccination site  
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On scheduled vaccination days, study vaccine and placebo will be kept in the cold boxes with 
proper temperature control and monitoring. 
Standard procedures will be followed at the trial site to maintain proper transport, receipt, storage 
and return of study products. 
In the case of interruptions of the cold chain other than that described in the section 7.1.3 above, 
the investigator or qualified designated staff member must contact IVAC to get further instructions. 
The investigator must receive the written consent from IVAC before clinical trial products can be 
used. 
7.5 
Assessment of Compliance with Use of the Study Products 
Compliance with use of the study products will be closely monitored during the trial by the 
research team, IVAC and trial monitors.   
7.6 
Concomitant Medications/Treatment 
Concomitant medications for the treatment of pre-existing medical condition, and per AEs / SAEs 
reporting period outlined in Table 1 and Section 10.3 will be documented throughout the course 
of the study. Treatment of conditions that are not exclusionary should continue, if needed by the 
participant. Subsequent changes in concomitant treatment during the trial must also be reflected 
in the CRF. Women included in the trial who are using hormonal contraception for pregnancy 
prevention should using these products through Day 22. Use of such products must also be 
documented in the CRF. 
7.7 
Unauthorized Products 
The following products are not authorized to be used during the study: 
1. Any concomitant medicine or biologic specifically prescribed for the treatment of a 
condition which is an exclusion criterion for participation in the trial.  
2. All non-study vaccines or biologics (including blood products). (Can be used after 
Day 22.) 
Other concomitant products are allowed. 
Participants will be requested not to take analgesic or antipyretic drugs in a preventive way (before 
or soon after injection), as such medications might change the reactogenicity profiles of study 
vaccine and placebo. Participants may take antipyretic drugs after injection, however, to treat a 
high fever. 
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If during the trial a situation arises where there is an adverse reaction or AE requiring treatment 
and prescription of unauthorized products or products not stipulated by the protocol, then such 
products may be prescribed. However, IVAC must be informed of such an occurrence within 48 
hours. Information on the products (trade name, dosing or change in dosing, indications, start 
date, and termination date) must be recorded in the CRF. 
8 
Study Schedule; Description of Visits 
The total duration for this study is approximately 22 months; with approximately 12 months (Sep 
2016 to Sep 2017) for preparation and implementation of both phases of the study ; and 
approximately 10 months for data analysis, CSR completion and review, approval by local IRBs 
and Ministry of Health. The recruitment and screening is expected to take no more than 3 weeks 
for phase 2 and 5 weeks for phase 3 study. In both the studies there are 3 scheduled in-clinic 
visits and one final study visit via telephone. 
 
The total expected duration of the study:  
First participant enrolled in study 
D1 of first participant 
The last participant enrolled in study 
For phase 2: Day 1 of last subject is estimated 
approximately 3 weeks from Day 1 of first subject 
For Phase 3: Day 1 of last subject is estimated 
approximately 4-5 months from Day 1 of first 
subject from phase 2 
The last participant  completes the trial 
D91 of last participant 
Lock database 
approximately 4 weeks after D91 of last participant 
Clinical trial report 
Approximately 5 months from database lock  
8.1 
Screening 
Prior to inclusion into the vaccine study, each participant will be screened through medical history 
interview and general physical examination. Because screening procedures are required to 
assess eligibility, they will be performed only after a study consent form has been signed. The 
investigator or designee will record the screening IDs of all participants who enter screening; 
whether they entered the trial or failed screening, and the reason for screen failure on the 
screening/enrollment log.  
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8.1.1 Screening and Enrollment/Vaccination (S1/D1)  
After assessing understanding and obtaining consent for the study, participants will be 
screened for eligibility through medical history review and general physical examination. 
Women of child bearing potential will have a urine pregnancy test. Screening and 
enrollment/vaccination will occur on the same day (S1/Day 1), although there is a 4-day window 
allowed, if the participant has second thoughts and needs more time to consider trial 
participation. If S1 and D1 are conducted separately, a targeted (symptom-based) physical 
exam with vital signs (heart rate, temperature, blood pressure), urine pregnancy test (for women 
of child bearing potential only), and brief medical history update will be performed on the day 
of vaccination (Day 1) to ensure continued eligibility 
After participants are consented, the following activities will occur: 
1. The participant will be interviewed to collect baseline demographic data  
2. A study clinician will interview the participant to collect a detailed medical history.  
3. For women with child bearing potential, a urine pregnancy test will be done. 
4. A study clinician will perform a general physical examination. Results will be reviewed 
by study staff and with the participant to confirm eligibility prior to conduct of further 
procedures. If a person is considered ineligible based on medical history and physical 
examination, the study clinician will tell the person that he or she is not eligible. 
5. For participants at one site in the phase 3 only: Prior to administration of study 
product to 252participants at the Ben Luc site in the Phase 3, a blood specimen for HAI 
test will be collected.   Specimen collection information must be documented on the 
CRF. About 5 mLs of blood will be collected. There will be no blood collection in the 
Phase 2 study.  
6. The person performing the injection will confirm that the study product about to be 
injected is the correct one for this participant. 
7. The participant will be administered one injection of study product in the deltoid muscle, 
preferably the non-dominant arm. (This may be switched to the dominant arm if the 
participant desires). 
8. The participant will be observed for 30 minutes after administration. If the participant 
experiences an immediate adverse reaction, he/she will be treated and the event will be 
recorded on the appropriate CRF. 
9. The participant will be given a Diary Card, thermometer and ruler in which the participant 
will be asked to record any local and/or systemic reactions that might appear starting 
from the evening of Day 1 to Day 7. Concomitant medications and other AEs may be 
recorded on the Dairy Card, too. The participant will be instructed how to use the Diary 
Card, thermometer and ruler. All relevant explanations should be included in the Diary 
Card. The Diary Card will also have contact information for the investigators, should the 
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participant have any questions. The participant will be informed that a member of the 
investigator’s team will visit the participant the next 24 hours (Day 2) in phase 2 and 
visit/call in phase 3 and also call her/him 4 days (Day 5) after vaccination to check on 
the participant’s completion of the Dairy Card and participant’s well-being. 
10. The participant will be instructed that if the participant experiences an AE requiring 
medical care, the participant should inform the investigator as soon as possible and 
seek medical care as appropriate. If the participant visits a health care provider, the 
participant should be sure to inform the health care provider of participation in this study 
and provide the health care provider with the investigator’s contact information. 
 
8.2 
Follow-up Periods 
8.2.1 First Week after Injection (Days 1 to 7)  
1. The participant will complete the Diary Card daily, starting on the evening reporting any 
local or systemic reactions experienced and medications taken.  
2. The participant will have been instructed that if he/she experiences an AE requiring 
medical care, the participant should inform the investigator as soon as possible and seek 
medical care as appropriate. If the participant visits a health care provider, the participant 
should be sure to inform the health care provider of participation in this study and provide 
the health care provider with the investigator’s contact information.  The participant should 
obtain in writing the names of medications prescribed by the health care provider.  
3. One day after vaccination (Day 2) a member of the investigator’s clinical team will visit the 
participant in phase 2 and visit/call in phase 3 and also call on 4 days (Day 5) to check 
that the participant is correctly completing the Diary Card and to check on the participant’s 
well-being. If local and systemic reactions suspected to be Grade 3 or higher are reported, 
the participant will be requested to return to the study clinic for evaluation. 
8.2.2 Seventh Day after Injection (Day 8 ± 1)  
1. Study staff will confirm participant identity. 
2. Study staff will review the participant Diary Card and interim history with the participant 
and inquire about any new medical events since medical histories were last updated. 
Any AEs that have occurred and meet reporting requirements, will be recorded in the 
appropriate section(s) of the CRF. Diary Card information will be entered into the 
database. 
3. The participant will have temperature, pulse rate, and blood pressure recorded. A study 
clinician will perform a targeted (symptom based) physical examination and record the 
information Results will be reviewed by study staff and with the participant.  
4. The participant will be instructed to inform the investigator as soon as possible if he/she 
experiences an AE requiring medical care and to seek medical care as appropriate. If 
the participant visits a health care provider, the participant should be sure to inform the 
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health care provider of participation in this study and give the health care provider the 
contact information for the investigator. 
8.2.3 Second and Third weeks after Injection (Days 9-21)  
There are no scheduled visits during this period. Participants may be asked to come to the study 
clinic if the investigator follows up on any laboratory or clinical issue. The participant will inform 
the study clinic of any medical events and seek medical care as needed. The participant will be 
instructed to give the contact information of the study investigator in case they consult any health 
care provider outside the study. 
8.2.4 Final Visit (Day 22; ± 1) 
Day 22 is the last scheduled in-clinic visit for the participants for closing out AEs and reported 
medications (Phase 2 & Phase 3) and collection of immunogenicity samples for the Phase 3 
portion of the study.   
1. Study staff will confirm participant identity. 
2. Phase 2 & 3: Study staff will review interim medical histories and concomitant medications 
with the participant since these were last updated. Results will be recorded in the 
appropriate section of the CRFs. 
3. Phase 3 only: Blood specimens from participants who underwent blood collection at 
enrollment (S1/D1) will be collected for anti-influenza serologic assays. Specimen 
collection information must be documented on the CRF and in specimen collection logs. 
About 5 mL of blood will be collected. 
8.2.5 Final Study Visit (Day 91; ± 7)  
1. The participant will be contacted via telephone and identity confirmed.  
2. Study staff will review interim medical histories and concomitant medications with the 
participant since these were last updated. No new concomitant medication will be 
recorded unless it relates to a newly identified SAE. 
3. Study staff will ask about any medical event that would constitute an SAE since the last 
visit. No new AE information will be recorded unless it qualifies as an SAE.  
4. If an SAE is reported, the clinician should record the SAE on the appropriate form, notify 
the entities who require notification, and refer the participant for treatment of the SAE, 
if warranted.  
After recording the information, the participant will be discharged from the study.  
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8.3 
Early Termination Visit 
If a participant withdraws from the study for any reason prior to the planned study duration, every 
attempt is made to complete the following: 
 
Report of local and systemic reactogenicity and AEs are reviewed by PI (or designee).  
 
For participants (from one site in the phase 3) who withdraw from the study prior to 
scheduled immunogenicity laboratory testing, specimens are obtained for immunogenicity 
analysis if the participants agree to do so. 
 
Diary Card information is reviewed with the volunteer in detail by site staff, if in use since 
the last visit. 
 
Injection site(s) examination and a full physical examination are performed (if indicated). 
IVAC must be informed within 48 hours of all instances of the premature termination of a 
participant’s participation in the trial. 
If the participant develops a reaction to study vaccine which the investigator believes threatens 
the participant’s well-being, the withdrawn participant must be treated or transferred to a treatment 
facility. 
8.4 
Unscheduled Visits 
Participants may present to the study center during operating hours for an unscheduled visit 
should they experience any AE or if the participant’s condition requires medical intervention. Data 
for any examinations or other procedures performed on the participant at an unscheduled visit 
must be recorded on the appropriate CRFs.  
9 
Study Evaluations 
9.1 
Clinical Evaluations 
9.1.1 Vital Signs 
 
Temperature in degrees Celsius (recorded to the nearest 0.1 degree) will be measured by 
oral thermometer. 
 
Blood pressure in mm of mercury and  pulse rates in beats per minute will be measured by 
automated device or manually 
9.1.2 Medical History 
At enrollment, medical histories must be thoroughly reviewed with the participant. The following 
medical conditions, in particular, will be assessed: 
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 
Current or recent (within two weeks of enrollment) acute illness with or without fever. 
 
Recent vaccination history. 
 
Recent  receipt  of  immune  globulin  or  other  blood  products,  or  injected  or  oral 
corticosteroids or other immune modulator therapy within 3 months before enrollment. 
 
Hypersensitivity of any kind, but particularly to vaccines. 
 
Clinically relevant history of renal, gastrointestinal, hepatic, cardiovascular, hematological, 
dermatological, endocrine, neurological, pulmonary or immunological diseases. 
 
Seizures, including history of febrile seizures, or any other neurologic disorder. 
 
Known or suspected immunologic impairment of any kind. 
 
Known HIV infection. 
 
Known active TB disease. 
 
Alcohol or drug use. 
 
Concomitant medications that are ongoing (including trade name, dosing, indications, start 
date). 
 
For women, pregnancy, menstrual and contraceptive history and/or history of surgical 
sterility. 
9.1.3 Physical Examination 
General Physical Examinations 
Qualified study clinicians will conduct a physical examination of all participants at S1/D1. This 
physical examination will include the following: 
 
Recording of general appearance 
 
Physical examination of all organ systems. This includes the following: 
o neurologic examination, including cranial nerve examination 
o chest auscultation 
o examination of lymph nodes (axillary and cervical) 
o heart auscultation 
o abdomen palpation (to check for liver size) 
 
Measurement of the following vital signs: 
o body temperature  
o blood pressure 
o pulse/heart rate 
* Grade 1 elevated blood pressure (140 to < 160 mmHg systolic OR 90 to < 100 mmHg diastolic) 
will not be considered to be exclusionary at screening, unless judged to be clinically significant by 
the PI.  
Targeted Physical Examination 
The targeted Physical examination focuses on symptoms reported by the participant and the 
presence or absence of local and systemic reactogenicity. If no symptoms are reported by the 
participant, the Targeted PE does not need to be performed. The exam will be made by a clinician 
on Day 1(only if D1 is on a different day from S1) and Day 8. Evaluation must be made prior to 
administration of injection of study product if done on Day 1. 
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9.1.4 Injection Site Examination 
Assessment of local Injection site reaction 30 minutes after vaccination will be done by trained 
study personnel and graded for severity according to the toxicity grading table in Appendix A 
 
Erythema /redness will be examined under proper lighting conditions and measured with a 
ruler if present. 
 
Swelling/induration will be examined by palpation and visual inspection under proper lighting 
conditions.  The examiner may temporarily mark skin at margins of visible swelling/induration, 
then measure with a ruler the maximum diameter 
 
Pain will be assessed by (a) inquiring as to whether there is significant discomfort at rest 
and/or (b) whether movement of the injection site causes discomfort, impacts limb movement 
or daily activity. 
9.2 
Laboratory Evaluations 
9.2.1 Clinical Laboratory Evaluations 
Pregnancy Test 
In order to confirm pregnancy status of females with potential to become pregnant, a qualitative 
human chorionic gonadotropin (hCG) test will be done on a urine sample. Pregnancy testing will 
be done on Day S1/D1, before vaccination. If Day S1 and D1 are conducted separately, the urine 
pregnancy test most be done on both visits. No injection of study product may be given to a 
woman without a pregnancy test being done and to any woman with a positive pregnancy test. 
 
There are no safety laboratory tests in the study. 
9.2.2 Special Assays  
The HAI is the most frequently used serologic test for determining immunologic response to 
influenza vaccination. Serum specimens will be tested for the presence and titer of HAI antibodies 
to each one of the influenza strains represented in the vaccine. This testing will be performed by 
VisMederi srl laboratory, Siena, Italy, by using a validated assay. For these assays, serum 
specimen collection will occur on Days 1 and 22. Sample collection on Day 1 must occur prior to 
administration of study product.  
9.2.3 Preparation, Processing, and Transport Specimens 
Blood Specimens 
Blood (serum) will be collected for HAI antibody serology. 
Collection of Blood 
Following universal precautions, blood will be collected from the forearm into tubes appropriate 
for collection of serum for HAI assay. Volumes of blood required for HAI assays at different time-
points are shown in the table below. 
 
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Collection 
Tube 
Volume 
of blood 
S1/D1 
(pre-vac) 
D22 
(Last study 
visit) 
Serum for anti-
influenza 
serologic assays 
Serum 
separator 
5 mL tube 
 

 

 
(The total volume of blood planned to be collected from each participant during the course of the 
study will be less than 15 milliliters.)  
Processing of Sera  
Immediately after collection, the blood specimen tube will be made to stand upright to clot at room 
temperature before transport to the laboratory at Pasteur Institute. At the laboratory, specimens 
will be centrifuged before division. 
Division of Sera 
Serum specimens for anti-influenza serologic assays will be divided. Specimen division should 
be performed for only one participant at a time to avoid mixing blood tubes. Each serum specimen 
will be divided into 4 aliquots as follows: 
– 
1st aliquot: 0.6 mL for HAI assay 
– 
2nd aliquot: 0.6 mL for back up 1 for HAI assay 
– 
3rd aliquot: 0.6 mL for back up 2 for HAI assay 
– 
4th aliquot: the remaining serum sample for back up and archive 
 
 
The study participant number, date of collection, blood specimen number, number of divisions 
obtained, and the date and time of division will be specified on a serologic specimen log form. 
On this form, comments may be made on the quality of specimens (e.g., hemolyzed, 
contaminated, etc.). 
 
Conditions for Transport and Storage of Sera 
Serum specimens for anti-influenza serologic assays will be immediately put in the freezer equal 
or lower than –20˚C after division and stored at this temperature until use. All handling will be 
done to prevent unnecessary freeze-thaw cycles (i.e., back-up samples should not be thawed 
unless required for testing). Temperature monitoring will be done to assure maintenance of cold 
chain and specimen quality.  
Urine Specimens 
Urine will be collected for pregnancy testing on visit S1/D1 (prior to vaccination). If D1 is conducted 
separately from S1, a urine pregnancy test should be done at each visit and prior to vaccination 
on D1.  
No urine specimens will be stored after testing. 
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10 Assessment of Safety and Adverse Events 
10.1 Adverse Events 
An Adverse Event is any unfavorable and unintended sign (including a designated out-of-range 
laboratory finding), symptom, or disease temporally associated with the use of a study product, 
whether or not considered related to the product. The occurrence of an AE might come to the 
attention of study personnel during study visits and interviews of a study participant presenting 
for medical care. Information to be collected on AEs includes event description, time of onset, 
clinician’s 
assessment 
of 
severity, 
relationship 
to 
study 
product, 
and 
time 
of 
resolution/stabilization of the event. AE assessment should be made only by those with the 
training and authority to make a diagnosis. 
Any medical condition that was present at the time that the participant was enrolled should not be 
reported as an AE, but should be reported as a pre-existing condition on the Medical History 
Form. However, if this condition occurs with greater frequency or severity during the study, it 
should be recorded as an AE 
10.1.1 Solicited Local and Systemic Adverse Events 
 
Solicited adverse events are pre-specific local and systemic adverse events that are common 
or known to be associated with vaccination that are actively monitored as indicators of vaccine 
reactogenicity.  Investigators will not be required to assess causality of solicited adverse 
events if the onset is during the solicitation periods. If a solicited adverse event progresses 
beyond the solicited period, it will continue to be reported as a solicited adverse event.  If the 
solicited adverse event occurs after the solicitation period it will be reported as an unsolicited 
AE. 
 
For this trial, solicited local and systemic AEs will be assessed by study staff 30 minutes after 
vaccination then daily for 7 days by the participants. Participants will be provided a 
thermometer, ruler and a diary to record the presence or absence of solicited AEs, severity of 
the solicited AE and use of concomitant medication.  The severity of the solicited local and 
systemic adverse events will be graded using the Toxicity Table for Grading Adverse Events 
(Appendix A).  The specific solicited local and systemic adverse events that will be reported 
for this trial are: 
 
Solicited local adverse event (at site of injection): 
 
Erythema / redness – based on size in cm 
 
Swelling / induration (hardness at site of injection ) – based on size in cm 
 
Pain 
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 
Systemic Reactions: 
 
Fever--Body temperature  
 
Fatigue/malaise 
 
Generalized muscle aches  
 
Joint aches 
 
Chills 
 
Nausea 
 
Vomiting 
 
Headache 
10.1.2 Unsolicited Adverse Events 
Unsolicited adverse events are any AEs that occur any time after the vaccine/placebo is given 
(temporally related to study product), whether or not deemed “related” to the product, and are not 
solicited (specifically asked of the participant).  Unsolicited AEs can be observed by study staff 
while the participant is at a clinic for a study visit or reported by the participant at any time.  Any 
sign or symptom that would normally be considered a “solicited AE” (for example, fever, nausea, 
injection site pain) starting after 7 days post-vaccination will be recorded as an unsolicited AE. 
10.2 Serious Adverse Events 
An SAE is defined as an AE that meets one of the following conditions: 
 
Death. 
 
Life-threatening (participant at immediate risk of death.) (The term “life-threatening” in the 
definition of “serious” refers to an event in which the patient was at risk of death at the time of 
the event; it does not refer to an event that hypothetically might have caused death if it were 
more severe). 
 
Requires inpatient hospitalization or prolongation of existing hospitalization. 
 
Results in congenital anomaly/birth defect. (Only in the case of a woman becoming pregnant 
during the study period after administration of at least one injection of study product. All 
pregnancies must be followed to term and outcome reported to IVAC and regulatory 
agencies.) 
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 
Results in a persistent or significant disability or incapacity. 
 
Important medical events that might not result in death, be life-threatening, or require 
hospitalization might be considered SAEs when, based upon appropriate medical judgment, 
the event might jeopardize the well-being of the participant and require medical or surgical 
intervention to prevent one of the outcomes listed above. (Medical and scientific judgment 
should be exercised in deciding whether reporting these events is appropriate.) 
All SAEs must be reviewed and evaluated by a study clinician to determine relationship to study 
vaccine as outlined in Section 10.5 and recorded on an SAE form and reported, as specified in 
Section 10.9. All such SAEs should also be followed until satisfactory resolution or until the 
investigator deems the event to be chronic or the participant to be stable. 
10.3 AE/SAE Reporting Period and Parameter 
Safety events are reported from the time of study injection (Day 1) through completion of the study 
at Day 91. Specifically, solicited AEs to assess local and systemic reactogenicities will be 
collected at 30 minutes and then daily for 7 days thereafter.  If a solicited AE starts during the 7 
days post vaccination period and continues beyond the 7 days it will continue to be reported as a 
solicited AE.  SAEs will be reported from Day 1 through the end of the study at Day 91. Unsolicited 
AEs will be reported from Day 1 to Day 22 inclusive.   
10.4 Severity of Event  
This study will use the Toxicity Table for Grading Adverse Events (see appendix A). For events 
not included in the table, the following guidelines will be used to quantify intensity not included on 
the table, the following guidelines will be used to quantify intensity: 
 
Grade 
Description for grading when an event is not on Toxicity Table 
1 (Mild) 
Mild symptoms causing no or minimal interference with usual social & 
functional activities with intervention not indicated. 
2 (Moderate) 
Moderate symptoms causing greater than minimal interference with usual 
social & functional activities with intervention indicated.   
3 (Severe) 
Severe symptoms causing inability to perform usual social & functional 
activities with intervention or hospitalization indicated.   
4 (Life 
threatening) 
Potentially life-threatening symptoms causing inability to perform basic self-
care functions with intervention indicated to prevent permanent impairment, 
persistent disability, or death.   
 
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Basic Self-care Functions – Adult: Activities such as bathing, dressing, toileting, transfer/movement, 
continence, and feeding. 
Usual Social & Functional Activities – Adult: Activities which adults perform on a routine basis and 
those which are part of regular activities of daily living, for example going to work, shopping, cooking, 
use of transportation or pursuing a hobby. 
 
Changes in Severity of an Event 
Changes in the severity of an AE should be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. AEs characterized as intermittent require 
documentation of onset and duration of each episode. 
10.5 Relationship to Study Vaccines 
The clinician’s assessment of an AE's relationship to study product is part of the documentation 
process. The clinician must determine whether there is a reasonable possibility that the 
investigational product(s) caused or contributed to an AE. It is essential to have the best 
assessment possible as to whether adverse events are related to investigational products. 
The relationship assessment, based on clinical judgment, should rely on the following: 
 
A temporal (time-based) relationship between the event and administration of the 
investigational product 
 
A plausible biological mechanism for the investigational product to cause the AE 
 
A possible alternative etiology for the AE 
 
Previous reports of similar AEs associated with the investigational product or other 
vaccines in the same class 
To help assess, the following guidelines will be used: 
Related – There is a reasonable possibility that the study vaccine caused the AE. “Reasonable 
possibility” means that there is evidence to suggest a causal relationship between the study 
product and the AE. 
Not Related – There is not a reasonable possibility that the administration of the study product 
caused the event. 
Any solicited local or systemic reactogenicity that occurs during the 5-day period post-injection 
is automatically regarded as related. 
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10.6 Follow up of AE  
All reported AEs should be followed until resolution or stabilization, or until the participant’s 
participation in the study ends. Participants who have an ongoing study product-related SAE at 
study completion or at discontinuation from the study will be followed by the PI or his designee 
until the event is resolved or determined to be irreversible, chronic, or stable by the PI.  
10.7 General Guidelines for Recording AEs  
To improve the quality and precision of acquired AE data, the PI should observe the following 
guidelines: 
 
Whenever possible, use recognized medical terms when recording AEs on the AE CRF.  
Do not use colloquialisms and/or abbreviations. 
 
If known, record the diagnosis (i.e., disease or syndrome) rather than component signs, 
symptoms and laboratory values on the AE CRF (e.g., record congestive heart failure 
rather than dyspnea, rales, and cyanosis). However, signs and symptoms that are 
considered unrelated to an encountered syndrome or disease should be recorded as 
individual AEs on the CRF (e.g., if congestive heart failure and severe headache are 
observed at the same time, each event should be recorded as an individual AE). 
 
AEs occurring secondary to other events (e.g., sequelae) should be identified by the 
primary cause. A “primary” AE, if clearly identifiable, generally represents the most 
accurate clinical term to record on the AE CRF.  If a primary serious AE (SAE) is recorded 
on an SAE CRF, events occurring secondary to the primary event should be described in 
the narrative description of the case. 
 
For example: 
Orthostatic 
hypotension 
 
Fainting and 
fall to floor 
 
Head 
trauma 
 
Neck pain 
The primary AE is orthostatic hypotension. 
 
Death is an outcome of an event. The event that resulted in the death should be recorded 
and reported on the SAE CRF. 
 
For hospitalizations for surgical or diagnostic procedures, the illness leading to the surgical 
or diagnostic procedure should be recorded as the SAE, not the procedure itself. The 
procedure should be captured in the case narrative as part of the action taken in response 
to the illness. 
 
Pregnancies are not considered AEs. Participants will be instructed to notify the study 
team if they become pregnant during the course of the study. They will be recorded on a 
separate Pregnancy CRF. Pregnancy outcomes that include stillbirth and any congenital 
anomalies must be reported as SAEs. 
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10.8 Unexpected Allergic Reaction 
Immediate Reactions (within 30 minutes) 
All participants will be observed for 30 minutes after administration of study product, with 
appropriate medical treatment readily available in case of an anaphylactic reaction following the 
administration of study product. Immediate reactions will be assessed by a study physician or 
appropriately trained medical staff. All reactions that occur during this time will be recorded on the 
CRF. Any immediate reaction which meets the criteria for an SAE must also be documented on 
an SAE form. 
Emergency medicines will be available at the study clinic to be ready to give first aid if any adverse 
reactions or events should occur among any participant participating in this research. If 
anaphylaxis occurs after vaccination, it must be treated in accordance with current MOH 
regulations on handling anaphylaxis. Treatment for mild reactions after vaccination will be per 
"Guidance on the treatment of post injection reactions" issued under the Decision No 2535  by 
Ministry of Health, Vietnam (17). The applied treatment methods must be recorded and kept in 
the participant file. . 
10.9 Reporting Procedures 
10.9.1 Serious Adverse Events 
All SAEs must be documented and reported to IVAC or its designate, even if the investigator 
considers that the SAE is not related to treatment. The study clinician will complete a Serious 
Adverse Event Form within the following timelines of such events:  
 
All deaths and immediately life-threatening events, whether related or unrelated, will be 
recorded on the Serious Adverse Event Form and sent by fax or email within 24 hours of site 
awareness.  
 
SAEs other than death and immediately life-threatening events (i.e., events resulting in 
hospitalization or prolongation of hospitalization; persistent or significant disability or 
incapacity, or other significant events determined by the investigator to be SAEs), regardless 
of relationship, will be reported via email or fax by the site within 24 hours of becoming aware 
of the event.  
IVAC will be primarily responsible for medical monitoring of serious adverse events documented 
by the investigator. Investigator and PI HCM City will be responsible for reporting the SAEs to 
local regulatory authorities in accordance with local regulatory safety reporting guidelines. Medical 
Officers from PATH serving as technical consultants will review all serious adverse events and 
provide guidance regarding SAE management including classification and reporting. Details for 
review of serious adverse events and other unanticipated problems will be in an SOP drafted prior 
to study initiation. 
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10.9.2 Reporting of AEs 
Collected SAEs and AEs will be reported to responsible ethical review committees according to 
their requested timelines. An SOP for reporting to the responsible committees will be developed 
with reporting requirements and timelines prior to study initiation. It will be the investigator’s 
responsibility to assure that all reportable events are reported to the proper authority or to IVAC 
and/or its designate in a timely manner and according to the SOP. PATH technical consultants 
may assist the investigator with regulatory reporting, per the finalized SOP. 
10.9.3 Other Unexpected Issues/Unanticipated Problems 
During study process, if there are any problems related to the trial (unanticipated problems), the 
Principal Investigator is responsible for reporting to IVAC and PATH to discuss reasonable ways 
of handling the problem. The Principal Investigator is responsible for reporting any unanticipated 
problems that affect the health, welfare or rights of study participants or that may impact the 
integrity of the study data to the ethics committees involved in the review of the research. The 
Principal Investigator should maintain written documentation of all unanticipated problems and 
their reporting and resolution. 
10.9.4 Reporting of Pregnancy 
Although women are not tested for pregnancy after vaccination and women are supposed to use 
effective birth control until Day 22, it is possible that a woman could report a pregnancy during 
the study. All pregnancies detected among women enrolled in the trial who receive study product 
must be reported on a Pregnancy Report CRF. All pregnancies must be followed to term and 
outcome reported to IVAC and regulatory agencies. Unblinding of allocation of treatment of female 
participants who become pregnant will not occur until after study completion, unless medically 
indicated.  
11 Safety Oversight 
11.1 Protocol Safety Review Team 
Routine safety monitoring will be conducted by the Protocol Safety Review Team (PSRT).  The 
PSRT will comprised of at least 4 members: the sponsor Medical Monitor, PATH Medical Officer/s, 
Contract Research Organization (CRO) Pharmacovigilance Medical Monitor and protocol 
Principal Investigator (or designate).  PSRT members are selected based of their experience and 
expertise in the conduct and safety oversight of vaccine clinical trials.    
 
During the vaccination phase of the trial, the PSRT reviews blinded cumulative solicited local and 
systemic reactions and AEs on a weekly basis. Frequencies of review post the vaccination phase 
will be at the discretion of the PSRT but no less than once a month.   
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11.1.1 Expedited Safety Review  
Safety events listed in table 1 require expedited PSRT review within 36 hours of submission of 
the safety information to data management and or SAE reporting system.  Members of the PSRT 
will be notified of these events through the CRO pharmacovigilance system.  
 
Event and relationship to study agent as assessed 
by investigator or CRO Pharmacovigilance 
Medical Monitor 
Severity Grade 
SAE, related 
All grades 
Unsolicited AE, related 
4 
Local reactions – erythema or induration 
4 
11.1.2  Study Safety Pauses 
This study has no formal pause rules.  However if during the weekly or expedited safety reviews 
the PSRT identifies safety concerns that warrant  a safety pause, the PSRT will notify the sponsor.  
If a decision is made to pause the study, all enrollment will be held pending wider consultation 
with the PATH, funders and sponsor on whether to lift the pause or discontinued the study 
prematurely.   
 
IVAC retains the right to temporarily suspend or prematurely discontinue this study at any time 
for matters related to safety. If the study is stopped or suspended prematurely, IVAC will inform 
the local principal investigator as well as regulatory authorities about the decision and the reasons 
for termination or suspension. If such action is taken, all efforts must be made to ensure the safety 
of the participants enrolled in the study. The principal investigator will assist IVAC in informing the 
responsible IEC and provide the reason for the suspension or termination. In case of premature 
study or study clinic closure, the monitor will conduct all activities as indicated in the close out 
monitoring visit. 
11.2 Data Safety Monitoring Board 
Given the wide global experience with seasonal influenza vaccines and the safety profile 
observed in the Phase 1 study, there will not be any Data Safety Monitoring Board (DSMB) for 
this study. The PSRT will be responsible for close safety oversight of the study. 
12 Monitoring and Auditing 
12.1 Monitoring Plan 
Individuals qualified by education, training and experience will carefully monitor the study. The 
study monitors (from QuintilesIMS) will periodically contact the site and perform on-site visits. 
The extent, nature, and frequency of site visits will be based on such considerations as study 
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objectives, study design and complexity, and enrollment rate; periodicity and nature of monitoring 
activities will be described in the Monitoring Plan. The Monitoring Plan will detail reporting 
requirements to IVAC to keep it apprised of study progress. Representatives of IVAC or its 
designees may participate in monitoring visits or visit the study clinic on its own to provide proper 
oversight. 
12.2 Set-up Visit (Site Initiation) 
The study monitor will contact the site prior to the start of the study to discuss the protocol and 
data collection procedures with site personnel. Prior to enrollment of participants at the study 
clinic, specific regulatory documents must be available, including approvals from the Vietnam 
Ministry of Health and from institutional review boards of the participating institutions. Curriculum 
vitae for key investigators must also be available. IVAC or CRO will inform the investigator of any 
additional documents that need to be provided. 
12.3 Routine Monitoring Visits 
Monitoring will be conducted according to an agreed upon Monitoring Plan. The study may use a 
Risk Based Monitoring approach that will be targeted to issues most critical to the rights and 
welfare of study participants and the veracity and integrity of study data. The individuals 
responsible for monitoring the study will periodically review the progress of the study and should 
have access to all records necessary to ensure the ethical and safe conduct of the study and the 
integrity/validity of the recorded data. 
During site visits and contacts, the monitor will: 
 
1. Assess if consent was properly obtained 
2. Assess adherence to the protocol eligibility criteria  
3. Look for evidence that randomization was followed 
4. Look for evidence that blinding was maintained 
5. Check on study conduct and documentation of procedures/assessments related to the 
study endpoints: 
 
Specimens obtained correctly 
 
Specimens labeled correctly 
 
6. Check on study conduct and documentation of protocol-required safety assessments, 
including SAEs 
7. Ensure that there is documentation of withdrawals and deaths and reasons provided. 
As part of study conduct, the Principal Investigator agrees to allow the monitor direct access to 
all relevant documents and to allocate his/her time and the time of his/her staff to the monitor to 
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discuss findings and any relevant issues. The study consent also makes participants aware that 
medical records relevant to events in the study may be accessed and viewed by people 
conducting and overseeing the study. 
The Principal Investigator also agrees to allow representatives of IVAC or its designees to 
occasionally accompany the monitor during site visits. 
12.4 Close-out Visit 
Upon completion of the study, the study monitor and the investigator will conduct the following 
activities: 
 
Data clarification and/or resolution. 
 
Accounting, reconciliation and disposition of used and unused study products according 
to the instructions of the sponsor. 
 
Review of site study records for completeness. 
 
Ensure study data is handled according to instructions by IVAC.  
12.5 Audits and Inspections 
For the purpose of compliance with applicable regulatory guidelines IVAC or its designees or 
national regulatory authorities may conduct a site audit. This could occur at any time from site 
initiation to after conclusion of the study. If the national regulatory authority requests an inspection, 
the Principal Investigator must inform IVAC immediately about this request. 
The Principal Investigator will allow the auditor direct access to all relevant documents and to 
allocate his/her time and the time of his/her staff to the auditor to discuss findings and any relevant 
issues. 
13 Statistical Considerations 
13.1 Study Hypothesis 
Safety: 
A single dose of seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) will be 
safe and well tolerated in adults 18 to 60 years of age. 
Immunogenicity: 
A single dose of IVACFLU-S seasonal trivalent split, inactivated influenza vaccine will induce 
immune responses to each of the three vaccine antigens to meet one or both age group specific 
Vietnam Ministry of Health licensure requirements. 
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13.2 Sample Size Considerations 
This is a Phase 2/3 trial with primary objective to evaluate the safety and immunogenicity of one 
dose of IVACFLU-S. The sample size for this study was selected in response to MOH’s 
requirement for additional safety data from Phase 2 before proceeding to Phase 3 and for primary 
safety and immunogenicity analysis to satisfy the MOH licensure requirement for influenza 
vaccine in adults from age 18 through 60.  Total sample size for the Phase 2 is approximately 250 
participants (at least 200 randomized to vaccine and 40 randomized to placebo).  Phase 3 sample 
size is approximately 650 participants (at least 500 randomized to vaccine and 100 randomized 
to placebo).  The two age groups (18 to 45, 46 to 60) will be equally distributed in both phases of 
the study. Block randomization will be stratified by site and age group. To account for potential 
drop-outs (expected to be low) and to address the challenge of stopping enrollment at a precise 
number due to the large sample size, sample size allows for an overage of approximately 5%. 
The sample size of this trial reflects guidance and endorsement by MOH at the MOH-IVAC 
Consultation Meeting held on 20 April 2016.   . 
13.3 Safety 
There will be 740 subjects randomized to IVACFLU-S arm in the phase 2/3 study; with account 
of 5% drout-out rate; there would be at least 700 evaluable participants for safety anaalysis. If no 
vaccine-related serious adverse events are observed in 700 vaccine recipients, study would able 
to exclude events occurring at approximately 0.43% based on the upper bound of the one sided 
95% Confidence Interval (CI)) using the Clopper-Pearson method. The probability of observing at 
least one vaccine-related serious adverse event in 700 subjects is 90 % and >95% if the true rate 
of such events is 0.33 % and 0.43% respectively. The precision of the estimate of AEs judged to 
be related to IVACFLU-S as bounded by 95% CI is presented in Table 16. 
However, the full analysis population will be used for safety analysis, not the assumed number of 
700 valuable subject. 
Table 16: Exact 95% Confidence Intervals around Potential Number of Study Related 
Adverse Events 
Sample size 
Number of events 
2-sided exact 95% CI 
700 
0 
[0, 0.52*] 
 
1 
[<0.01, 0.79] 
 
2 
[0.03, 1.02] 
 
3 
[0.08, 1.24] 
 
5 
[0.23, 1.65] 
*one sided,97.5% CI 
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13.4 Immunogenicity 
The Vietnam MOH guidance on serological immune response requirements [11] for influenza 
vaccine as summarized in Table 17 is a modification of the EMEA/CPMP serological criteria for 
assessing seasonal influenza for licensure [18].   
Table 17:  Vietnam MOH Criteria for Evaluation of Influenza Vaccine Immune Responses 
 
Age Group 
 
18 – 45 
46 
Proportion achieving a HAI titer ≥ 1:40 
(seroprotection) 
≥70% 
≥60% 
Proportion achieving at least 4 fold rise in HAI 
titer (seroconversion) 
≥40% 
≥30% 
GMT rise in HAI titer 
≥2.5 times 
≥2.0 times 
 
Of the three criteria, seroconversion has been the most frequent criteria not meeting licensure 
threshold [19]. Though the study assumption is based on Phase 1 immunogenicity data for adults 
18-45 years of age, we anticipate the immune response in those 46 - 60 will be comparable since 
significant decline in antibody response is most associated with those who are ≥65 years of age 
[20]. Taken together with the immunogenicity results of the IVACFLU-S phase 1 study (section 
2.1.6), the sample size consideration for immunogenicity for the study was based on the precision 
of the estimate of percent of vaccine recipients with HAI seroconversion and seroprotection 
responses.  With a sample size of 100 evaluable vaccine recipients from each age group, the 
study provides the precision of immunogenicity response as estimated by width of 95% CI of ≤ 
±10.2% around the range of estimated response rate (Table 18).  An increase in sample size by 
50% to 150 provides very limited statistical benefit as it only reduces the maximal width of 95% 
CI by 1.9% to ≤ ±8.3%. All power calculations were made using 10000 simulations of binomial 
responses to each strain, based on assumed true response rates and pass/fail criteria. All 
calculations were made using SAS version 9.3. 
Table 18:  Observed Response Rate in 100 participants receiving study vaccine and 
Corresponding 95% CI 
Number of responder (%) 
2-sided exact 95% CI 
90 (90%) 
[82.4%, 95.1%]  
80 (80%) 
[70.8%, 87.3%]  
70 (70%) 
[60.0%, 78.8%]  
60 (60%) 
[49.7%, 69.7%]  
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13.4.1 Probability for demonstrating seroconversion criteria for licensure 
For the 18-45 year old cohort, if the true seroconversion response to each strain is ≥49%, then 
there is 91% probability that the point estimate for seroconversion to all three strains will be ≥40%.  
Likewise, if the true seroconversion response to each strain is ≥60%, then there is 92% probability 
that the lower bound of the exact 95% CI for seroconversion to all strains will be ≥40%.  For the 
older age cohort (46-60 year old), if the true seroconversion response to each strain is ≥39%, 
then there is 93% probability that the point estimate for seroconversion to all three strains will be 
≥30%.  Given that the lowest seroconversion response in the IVAC Phase 1 trial was to B viral 
strain at 76.7% (95% CI, 57.7 90.1), there is high probability (Table 19) of demonstrating age 
group specific seroconversion requirement with a sample size of 100 evaluable participants per 
age group who received the study vaccine. 
 
Table 19: Probability of demonstrating seroconversion response to all 3 viral strains by 
age groups and assumed true response to each viral strain 
13.4.2 Probability for demonstrating seroprotection criteria for licensure 
For the 18-45 year old cohort there is 92% probability that the point estimate for seroprotection 
to all three strains will be ≥ 70% if the true response to each strain is ≥78%.  Likewise if the true 
response to each strain is ≥87%, then there is 95% probability that the lower bound of the exact 
95% CI for seroprotection to all strains will be ≥70%.  In the older age cohort (46-60 year old), if 
the true seroprotection response to each strain is ≥69%, then there is 93% probability that the 
point estimate for seroprotection to all three strains will be ≥60%. Given that the lowest 
seroprotection response in the IVAC Phase 1 trial was to B viral strain at 93.3% (95% CI 77.9; 
99.2), there is high probability (Table 20) of demonstrating age group specific seroprotection 
requirement with a sample size of 100 evaluable participants per age group who received the 
study vaccine.  
50 (50%) 
[39.8%, 60.2%]  
40 (40%) 
[30.3%, 50.3%]  
30 (30%) 
[21.2%, 39.9%] 
 
True response 
Age group (point 
estimate response) 
Probability > 90% 
Probability > 95% 
Probability > 99% 
18-45 (≥40%) 
≥49% 
≥51% 
≥54% 
46- 60 (≥30%) 
≥39% 
≥40% 
≥43% 
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Table 20: Probability of demonstrating seroprotection response to all 3 viral strains by 
age groups and assumed true response to each viral strain 
13.5 Data Analysis  
A detailed Statistical Analysis Plan (SAP) for preparation of the final study report will be prepared 
by the CRO statistican. The SAP will be submitted to PATH and IVAC for approval prior to 
database lock and unblinding. Analysis will be conducted only after all related data have been 
cleaned and locked.  Given the short duration of clinical follow-up and potential delays in 
generating immunogenicity results, analysis of safety and immunogenicity data can be conducted 
independently.  All statistical analyses will be performed using recent version of data management 
software. 
13.6 Definition of Analysis Sets 
Definitions of populations to be analyzed are: 
Enrolled Population  
All screened participants who are randomized, regardless of the participant’s randomization and 
treatment status in the trial. 
Full Analysis (FA) Population  
All participants in the enrolled population who were randomized and received a study vaccination. 
This population will serve as the primary analysis population for all safety objectives. The analysis 
based on this population will serve as the supportive results for all safety objectives. Participants 
will be analyzed as randomized.  
Per Protocol (PP) population  
All participants in the Full Analysis population who have valid post vaccination immunogenicity 
measures with no major protocol violations that are determined to potentially interfere with the 
 
True response 
Age group (point 
estimate response) 
Probability > 90% 
Probability > 95% 
Probability > 99% 
18-45 (≥70%) 
≥ 78% 
≥ 79% 
≥ 81% 
46- 60 (≥60%) 
≥ 69% 
≥ 70% 
≥ 72% 
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immunogenicity assessment of the study vaccine. This population will serve as the primary 
analysis population for all immunogenicity objectives.  
The criteria for exclusion of participants from the Per Protocol Population will be established 
before breaking the blind and will be based on the blinded review of protocol violations.  
13.7 Analysis of Safety Endpoints 
The safety profile of IVACFLU-S will be evaluated by the number and proportion of participants 
experiencing AEs by severity, relatedness to vaccination of the following four categories for all 
participants and by age group (solicited AEs will be considered related to study product):  
A. Solicited local adverse events, including redness / erythema, swelling / induration vital, pain 
within 30 minutes of vaccination and over a 7-day period (Days 1-7) post-vaccination. 
B. Solicited systemic adverse events, including fever, fatigue, malaise, muscle aches, joint 
aches, chills, nausea, vomiting, and headache within 30 minutes of vaccination and over a 7-
day period (Days 1-7) post-vaccination. 
C. Unsolicited AEs occurring within 21 days post vaccination.  
D. Serious Adverse Events occurring during the entire study period (Days 1-91).  .  
Counts of all events will be reported and summarized according to event severity, as “any local 
AE”, or “any systemic AE”, and by relationship to administration of study product, as deemed by 
a blinded study clinician. Percentages of participants experiencing each reaction or event, or at 
least one reaction or event will be calculated along with two-sided exact 95% CIs. For solicited 
AEs, Fisher’s exact test or Cochran-Mantel-Haenszel test will be used to compare the proportion 
of participants between the two treatment groups. In addition, no formal hypothesis testing with 
multiplicity adjustment will be performed. No statistical testing will be performed for unsolicited 
AEs; including SAEs.  
13.8 Analysis of Immunogenicity Endpoints 
Primary Endpoint: 
A. Number and percentage of participants with seroconversion against each of the 3 vaccine 
antigens post-vaccination.  Seroconversion is defined as a serum HAI antibody titer meeting the 
following criteria: 
• 
pre-vaccination titer <1:10 and a post-vaccination titer measured on Day 22 of ≥1:40 or 
• 
pre-vaccination titer ≥1:10 and at least a four-fold increase in post vaccination measured on 
Day 22 
B. Number and percentage of participants with a HAI antibody titer ≥1:40 to each of the 3 vaccine 
antigens measured on Day 22 post vaccination 
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C. Geometric mean titers (GMTs) of serum HAI antibodies pre- (Day 1) and post vaccination 
(Day 22) for each of the 3 vaccine antigens 
D. Geometric mean fold rises (GMFRs) of serum HAI antibodies (post vaccination/pre-
vaccination) for each of the 3 vaccine antigens 
Titers below the lowest limit of quantitation (i.e. below the starting dilution of assay reported as “< 
10”) will be set to half that limit (i.e. 10/ 2 = 5). If a titer is reported as greater or equal to the upper 
limit of the assay, it will be set to that limit. 
Secondary Immunogenicity Endpoints: 
The secondary immunogenicity endpoints will be analyzed by the following: 
A. Number and percentage of participants who develop at least a four-fold increase in HAI 
antibody titer to each of the vaccine antigen post vaccination measured on Day 22 by pre-
vaccination HAI antibody titer of  <1:10 or ≥1:10. 
B. Geometric mean titers (GMTs) of serum HAI antibodies pre- (Day 1) and post vaccination 
(Day 22) for each of the 3 vaccine antigens by pre-vaccination HAI antibody titer of <1:10 or 
≥1:10. 
C. Geometric mean fold rises (GMFRs) of serum HAI antibodies (post vaccination/pre-
vaccination) for each of the 3 vaccine antigens by pre-vaccination HAI antibody titer of <1:10 
or ≥1:10. 
The licenture requirements are based on on the point estimate of response in the vaccine group 
and are not based on comparison to a control. So there will be no formal statistical testing to 
compare immune response between vaccine and placebo. There are two types of immunogenicity 
measurements against each of the 3 vaccine antigens, percentages of subjects with immune 
response and Geometric Mean Titers (GMT) that will be used to evaluate this study objective. For 
each percentage of subjects with the defined immune responses, the percentage and its 
corresponding 2-sided exact (Clopper-Pearson) binomial 95% confidence interval (95% CI) 
around the percentage will be computed for each treatment group and by age group. GMT along 
with the corresponding two-sided 95% CIs, by exponentiating the corresponding log-transformed 
means and their 95% CIs, will be summarized by treatment group on Day1 and Day 22. The same 
approach will be used to summarize GMFR of Day 22/Day1 separately by treatment group and 
age group.  
13.9 Interim Analysis 
All the safety data till day 8 from participants in the phase 2 will be analyzed and reviewed by the 
PSRT team. In addition all grade 3 and above unsolicited AEs and SAEs till the data cutoff date 
will also be part of interim report. The same data will be presented to IRBs and MOH for review 
and approval before initiating phase 3 study.  
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14 Data Management 
The PI is responsible for ensuring the accuracy, completeness, and timeliness of the data 
reported. Data collection is the responsibility of the clinical trial staff at the study site under the 
supervision of the site PIs or designee.  Data collection must be completed as soon as possible 
to allow for timely review of safety information.  A CRO with data management expertise will be 
contracted to be responsible for data management activities, including quality review, analysis, 
and reporting of the study data according to SOPs. 
14.1 Case Report Form (CRF) 
CRFs will be developed and data will be managed to the extent possible in accordance with 
internationally agreed-upon standards, such as the Clinical Data Acquisition Standards 
Harmonization, which defines basic standards for the collection of clinical trial data, and/or The 
Society for Clinical Data Management’s Good Clinical Data Management Guidelines (21).  The 
study will use paper CRFs and transfer the data into an electronic CRF provided by the Data 
Management CRO. 
All the information required by the study protocol must be recorded on the paper CRF provided 
by the sponsor. All data must be entered legibly. An explanation must be provided for any missing 
data. Data entered onto the paper CRFs must be accurate, legible, contemporaneous, original 
(or traceable to the original source) and attributable.  
All source documents and CRFs should be completed in a neat, legible manner to ensure 
accurate interpretation of data. Black or blue ink is required to ensure clarity of reproduced copies. 
When making changes or corrections, study staff are to cross out the original entry with a single 
line, and initial and date the change. Do not erase, overwrite, or use correction fluid or tape on 
the original. All clinical source documents and laboratory reports must be reviewed by the 
Principal Investigator or designated qualified experts, who will ensure that they are accurate and 
complete. 
The investigator must sign and date each CRF or a set of CRFs for each participant, attesting to 
his/her responsibility for the quality of all data recorded and that the data represent a complete 
and accurate record of each participant’s participation in the study. 
All participants will be assigned a unique screening number and participant identification number 
at study enrollment – one or both of these numbers will be included on all forms and in the trial 
database and will serve to link study data to specific individuals. CRFs will be entered, verified for 
accuracy, linked by study participant number, and managed using database management 
software, with proper security and controls and the ability to identify who is entering or making 
changes to the data in the system. Immunologic data will be sent separately to the data 
management center from the testing laboratory via secured electronic transmission.  
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14.2 Source Documents and Source Document Access 
Prior to the start of the trial, the sponsor will determine which documents or data fields completed 
by the investigative team will be considered source documents and documented on a Source 
Documentation Table. Source documents for this study may be outpatient charts, inpatient charts, 
laboratory analysis forms, questionnaires, and specimen collection logs. For many data fields, the 
paper CRF will be the source document.  
Only authorized study staff and representatives of IVAC, study monitors authorized by IVAC, 
PATH, members of ethics review committees, and regulatory agencies may have direct access 
to source documents containing participant data. Participant identification will be revealed to 
authorized representatives of these organizations only when necessary.  
14.3 Database Management and Analysis Software 
A CRO will be hired to perform data management for this study. The software used for data 
management will depend on what is suggested by the CRO, however, it will be validated and will 
meet widely accepted criteria for maintaining an electronic study database.  
All statistical analyses will be performed using a recent version of standard data management 
software. 
Medical history and AEs will be coded using a recent version of the MedDRA dictionary. The 
frequency count and percentage of participants will be summarized according to the coded terms 
of system organ class and preferred term. Participant-wise data listings will be provided. 
14.4 Entering, Cleaning and Management of Database 
A CRO will develop a procedure for entering, cleaning and managing the database. The CRO will 
perform data management, data analysis and report writing. A Data Management Plan will be 
drafted by the CRO and submitted to IVAC or its designees to approve before implementation. 
14.5 Source Data Verification 
For source data verification (SDV), the monitor (on behalf of the study Sponsor) must have direct 
access to source documents that support the data recorded, e.g., medical records, original 
laboratory records and ICFs. If source data are electronic, these data must be printed, signed and 
dated by the site PI and stored in the participant’s study file. Essential documents, including ICFs, 
must be filed and kept in the study files. 
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14.6 Database Locking Procedures 
A final database lock for the primary safety analysis will occur after all participants have completed 
all follow-up visits, including the Day 91 safety contact, review of the severity of any AEs has been 
performed and finalized, all data queries have been resolved to the satisfaction of the sponsor 
and monitoring is complete.  
Immunology data will be maintained in a separate immunology database. These data will also be 
locked. 
14.7 Study Record Retention 
Study data will be kept for 15 years after completion of the study. No records will be destroyed 
without the written consent of IVAC. It is the responsibility of IVAC to inform the PI when these 
documents no longer need to be retained. 
15 Quality Control and Quality Assurance 
15.1 General Considerations 
The study will be conducted in accordance with the procedures specified in the protocol and staff 
will be guided by written procedures that further explain important protocol implementation 
activities. Study data collection forms will be designed to guide staff on study conduct; forms also 
will include areas for documenting that activities did, in fact, occur (even if these activities did not 
require recording of data) and in the appropriate sequence. All study staff must attend mandatory 
protocol implementation training prior to participant enrollment. 
Written procedures will be developed for key study procedures and refined/revised as necessary.  
Study data are recorded on CRFs and then entered into the database throughout the study. After 
data have been entered in the study database, they are checked systematically by data 
management staff according to a pre-specified data validation plan. Queries are generated for 
site staff to clarify or correct throughout the study. An audit trail will be kept of all changes to the 
data. All listings of the database will be reviewed and discussed for assessment of consistency 
and medical plausibility. After resolution of all issues the database will be locked.  
15.2 Trainings 
Each member of the research team will have documentation of his or her qualifications and 
experience to conduct his or her study responsibilities. In addition, the research team will be 
trained on all aspects of conducting the protocol. The study monitor is authorized to conduct re-
training, if it is identified as a need from monitoring findings. 
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16 Ethics/Protection of Human Subjects 
16.1 Ethical Standard 
This study will be conducted in full conformity with the Vietnam GCP guidelines of MOH, and with 
the Declaration of Helsinki, in addition to all other Vietnam MOH regulatory requirements and 
current laws in order to ensure the best protection for study participants. 
 
Study participants may not forego vaccination with a licensed, seasonal influenza vaccine while 
participating in this study. The vaccination with a licensed influenza vaccine will not be provided as 
part of the study. However the participants will not be stopped from receiving a licensed influenza 
vaccine after day 22, from outside the study. The participants should inform the study team if and 
when they receive a licensed influenza vaccine. Currently, imported seasonal influenza vaccines 
have been used in fee-based immunization services, mostly in big cities in Vietnam and the prices 
are not affordable for population in lower income groups especially at rural areas. Vietnam 
government has not introduced seasonal flu vaccine in national immunization program 
yet. Therefore, the availability of seasonal flu vaccines is limited or vaccines are not 
undertaken widely in Vietnam, even among high risk groups (health care workers, 
pregnant women, chronic respiratory disease group) 
16.2  Financing and Insurance 
PATH will fund this trial. Any financial engagement with the clinical study clinic will be regulated 
by a separate agreement.  
IVAC will maintain insurance to cover treatment for study related injuries and other insurance as 
necessary to meet its obligations under Vietnam law. This product liability insurance will cover 
product related injuries that cause death, illness leading to hospitalization, and disability. In 
addition, IVAC and PI HCMC will have an agreement letters with Ben Luc and Long Thanh district 
hospitals involved in the trial to provide treatment for any injuries for trial participants, whether or 
not the injuries are serious or caused by the vaccine. 
16.3 Assurance of Emergency Medical Care and Care for other Adverse Events 
Study participants will be observed by qualified clinicians after each vaccination, and emergency 
care will be immediately available to participants who need it. If additional urgent care or resources 
are needed, depending on each case, the participant will be provided urgent care and transported 
to a hospital at higher level if needed.  
 
Most adverse events that are expected and non-emergent can be handled at the study clinic by 
the clinical staff as they occur at no cost to the participant. These could be events such as fainting 
or feeling lightheaded, or swelling from the injection of the study products or blood draws.   
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16.4 Institutional Review Boards and Independent Ethics Committee 
No human subject research activities will be conducted without the review and approval of all 
relevant ethics committees of the entities involved in the study. The protocol and all amendments 
will have initial and continuing review and approval by an independent ethics committee (IEC) 
responsible for clinical trials in Vietnam. This IEC is the Vietnam MOH Ethics Committee, which 
is the ultimate authority for decisions related to this trial. The MOH will acknowledge the review 
by participating institutions’ IRBs which are designed to ensure that their staff meet their 
responsibilities in conducting this human subjects research. In Vietnam, the investigator is 
responsible for completing and submitting to the MOH the complete set of documents on the 
clinical trial for their review of the clinical trial application. 
The study clinic’s institution maintains an institutional review board. This study will be reviewed 
and approved by the institution’s IRB prior to submission of Vietnam MOH IEC. All amendments 
will be approved by Vietnam MOH IEC before implementation, as appropriate. 
The PI or designee shall maintain copies of all application documents and forward copies of all 
IRB and IEC documents and approvals to IVAC or its designee prior to the start of the study. The 
approval letters must identify all documents approved and list the study clinic, the study 
investigator, protocol title, version number, and date and, ICF version number and date, and the 
date of IRB or IEC approval. The PI will sign all approved versions of the protocol. 
The PI is responsible for notifying the IEC and all IRBs of problems related to risks for participants, 
according to the requirements of the IEC and each IRB. 
The PI may not change or deviate from the protocol without prior written IRB/ IEC approval of 
appropriate amendments, except when necessary to eliminate immediate hazards to the 
participants or when the changes involve only logistical or administrative aspects of the study 
(e.g., change of telephone number, etc.). 
IVAC will report to the MOH and the IEC/IRBs any new information related to the study vaccine 
which possibly affect the safety of participants or their risk/benefit ratio for participating in this trial. 
Reports on the implementation of projects are to be periodically submitted to the Ethics 
Committee of the MOH. 
The PI will be responsible for reporting to the MOH and the IEC/IRBs when the clinical study has 
been completed. This must occur within 90 days after the last involvement of participants in any 
study procedure. If the clinical study is terminated earlier than planned, the notice must be 
submitted to the MOH and the IEC/IRBs within 15 days and the reasons must be clearly explained. 
16.5 Media Planning for Participant and Community Engagement 
To establish trust and support from the community, the study team, along with the representatives 
of the provincial preventive medicine centers and district health centers will hold meetings in the 
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commune of the study site location to provide information on the seasonal influenza, risks to 
people with underlining diseases, mortality, prevention methods, common adverse reactions after 
vaccination and research efforts of Vietnam in developing this vaccine to the whole population of 
participating communes.  
Before conducting the study, a risk media plan will be developed between WHO, IVAC, and NIHE 
in case there is media interest in the study. This plan will address issues such as who are 
appropriate contacts for each of the trial partners in case of contact by the media; identification of 
appropriate spokesperson for each entity; and an Internal Q&A on the vaccine candidate, trial, 
partner(s), project, and other issues as necessary.  
16.6 Informed Consent Process 
The potential participants who agree to participate will then be invited to attend meetings to hear 
additional information and, if interested, sign the ICF to allow screening to begin. During 
implementation, the participants will be made aware of any new information relating to products 
or the clinical trial that may affect their decision to remain in the study. 
 
The following issues must be included in discussions with potential participants prior to obtaining 
their informed consent to participate in the study: 
 
Discussion with the participants of the purpose of research, the time duration that the 
participants need to participate, the procedures involved in the study, the scientific 
evidence that justifies conducting this experimental trial in humans, and the potential risks 
and known benefits of participating in the research. 
 
Randomization and the chance of receiving either the study vaccine or the placebo. 
 
That the study staff will not know which study product (vaccine or placebo) the participant 
will receive and that the study staff and participant will have no way to choose which 
product is received by the participant. 
 
That the participant’s participation is voluntary, and the participant’s refusal to participate 
will not result in any fine or in any loss of rights or access to medical care that the 
participant is normally already entitled receive.  
 
That in the event of unforeseen circumstances or needs, the investigator may decide to 
withdraw the participant from continued participation in the research even without the 
consent of the participant. 
 
That the participant will be provided with the results of any new important findings related 
to the trial or the study vaccine which may influence the participant’s decision on whether 
to continue to participate in the research. 
 
That the participant will be told the number of other participants participating in the 
research. 
 
That the participant will be told who to notify as the point of contact with the investigator 
and IRBs in case the research participant would like to know more information regarding 
the trial and his/her rights as a research participant. 
 
That the investigator is responsible for collecting from the participant signed and dated 
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written informed consent forms regarding participation in the study before the participant 
may participate in the research; that the participant will be given a signed and dated copy 
of the form to keep; and that the investigator must keep the original signed and dated 
informed consent form in the investigator’s research files. 
 
At the first meeting, participants will be told information about the purpose of the study and the 
procedures involved, as well as the possible risks, benefits and alternatives to joining the study. 
The participant will be informed of the voluntary nature of participation in the trial and that the 
volunteer has the right to refuse to join or to withdraw from the trial at any time, and that this 
refusal will not affect the quality of the participant’s care.  
Written informed consent of the participant must be obtained before performing any trial 
procedures. Participants will be made aware that authorized representatives of health agencies 
and IVAC will have access to their confidential medical information for the purposes of monitoring 
trial conduct or performing audits. 
Written informed consent will be obtained from each participant before screening in duplicate on 
Day S1. On Day 1, after a participant is fully screened and eligibility is confirmed for entry the 
participant will be randomized to receive either vaccine or placebo. If Day 1 is conducted on a 
different day from S1 (there is 4-day window), eligibility must be confirmed again on Day of 
Injection (D1) including Targeted physical examination (PE) and urine pregnancy test.   
ICFs will embody the elements of consent as described in the Declaration of Helsinki and the ICH 
Harmonized Tripartite Guidelines for Good Clinical Practice. Original ICFs must be kept on file by 
the investigator for possible inspection by regulatory authorities or IVAC. The participant must 
receive a copy (or second original) of the signed and dated ICF(s), and any subsequent updates 
or amendments to the ICF. The study monitor shall check the documentation of the individual 
ICFs during each monitoring visit. 
Participants will be informed that they will be compensated for 450.000 VND (~20 USD) per site 
visit for their time and effort for participation in this trial and for travel to and meals during study 
visits.   
16.7 Inclusion of Women, Minorities, and Children 
Enrollment in this study is open to healthy adults of any gender and race or ethnicity who are able 
to read the study consent and complete the Diary Cards. Pregnant women and children are 
excluded from the study because safety has not been determined in these populations. No person 
may be denied enrollment based on gender or race or ethnicity. The investigator may enroll 
different races and ethnicities in proportion to their presence in the local population; however, no 
special recruitment methods will be used to ensure certain levels of participation by any specific 
minorities residing in the source population. The trial is open to adults 18 through 60 years of age 
only.  
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16.8 Participant Confidentiality: 
16.8.1 Confidentiality of Data 
By signing the protocol, the Principal Investigator agrees that the study protocol, documentation, 
data, and all other information generated regarding the vaccines will be held in strict confidence. 
The investigator may divulge such information within regulatory restrictions and ethical 
considerations only to ethical review committees or similar expert boards or committees, and their 
affiliated institutions and employees, only under an appropriate understanding of confidentiality 
with such board or committee, and their affiliated institutions and employees. No information 
concerning the study or the data may be released to any unauthorized third party without prior 
written approval of IVAC. Any regulatory agency deemed appropriate, may consult study 
documents in order to verify CRF data. Investigators will ensure that all employees involved in 
the study respect confidentiality. 
Medical information about individual participants obtained during the course of this study is 
confidential and may not be disclosed to third parties, except authorized monitors, auditors or 
inspectors or as a requirement by law. Confidentiality will be ensured by the use of study 
participant numbers for the identification of each participant; these study participant numbers will 
also be used for participant data in the participant files at the site and for the CRFs. 
16.8.2 Confidentiality of Participant Records 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and 
their agents. This confidentiality is extended to cover testing of biological specimens in addition 
to the clinical information relating to participating participants. 
Study participants will not be identified by name on any data collection form or on any other 
documentation sent to IVAC and will not be reported by name in any report or publication resulting 
from data collected in this study. 
Documents and data pertaining to the study will be kept in a locked room or in locked files under 
the responsibility of the Principal Investigator. IVAC will conduct periodic monitoring visits to 
ensure that the data are stored securely. Only study clinicians, study staff, monitors or the sponsor 
or its designee will be granted access to the study data and records. Study data will be kept for 
15 years after completion of the study, in compliance with Vietnam law. 
The PI will keep individual data confidential to the extent permitted by law. Information will not be 
released to anyone other than the participant unless required to do so by law or directed by the 
participant (e.g., to release information to his or her health care provider). 
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16.9 Sharing of Study Results 
16.9.1 Sharing of Study Results with the Participant 
When the clinical study report is completed, the investigator will share summary results (without 
any identifiers) with participants via printed materials. These will be submitted for approval by all 
applicable ethics committees before distribution to study participants. 
16.9.2 Incidental Health Findings 
The investigator may release participant physical examination results data to the participant’s 
primary care physician only if the participant agrees in writing. The clinical staff will share and 
discuss any incidental health findings with the participant and help the participant seek proper 
medical follow-up.  
16.9.3 Sharing of Study Results with the Community 
After the study results are approved by the Independent Ethic Committee, Ministry of Health, a 
workshop will be organized to report the results to national and local level with the participation of 
sponsor, study group representatives, representatives of Ministry of Health, the authorities and 
health officials of the provincial, district and commune levels. The results of this study will later be 
published in peer-review international and national scientific journals to share information for the 
international community. 
16.10 Study Discontinuation 
Study discontinuation is not expected to occur. However, if the study is discontinued for safety 
reasons, participants will be informed of the reasons for discontinuation and of the 
implications/potential consequences for the participant. 
16.11 Future Use of Stored Specimens 
Blood specimens will be maintained to allow re-testing either in Vietnam or outside Vietnam, if 
needed and for characterizing assays in the development of seasonal influenza vaccine. The 
specimens will be maintained at IVAC or a storage place designated by IVAC. Specimens will not 
be labeled with any personally-identifying information. The use of the specimens will be for 
laboratory quality control only and do not constitute human subjects research as the purpose is 
not generalizable knowledge, however, if a participant does not consent to their samples being 
used in this way, the samples will be destroyed when they are no longer needed for the study 
results.      
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16.12  Potential Risks and How They are Addressed 
Physical Risks: The main risks of this study are risks of physical injury. Administration of study 
product may cause the participant immediate mild pain in the arm. Other side effects include pain 
and inflammation at the injection site or systemic symptoms such as fever and body aches. These 
are all explained to participants in the consent form. 
Serious or allergic reactions also may be possible. This risk is addressed by trying to screen out 
people who have had an allergic reaction to vaccines in the past and who may have an allergy to 
one of the components of the vaccine. Should an allergic reaction occur with vaccination, the 
study clinic will follow its SOP for handling medical emergencies and have supportive medicines 
in place, in addition to trained staff. 
Besides administration of study product, collection of blood specimens may cause some 
discomfort to participants. Venipuncture is sometimes associated with fainting, discomfort or pain, 
bleeding, bruising, redness, swelling, local hardness, and/or infection at the puncture site. This 
risk is addressed by having trained staff draw the blood. 
Study participants will be observed closely by qualified clinicians and care will be immediately 
available to participants after vaccination, including emergency care, if needed. If additional 
urgent care or resources are needed, the participant will be transported to a local hospital. This 
hospital will be identified by the investigator prior to study initiation. The study will provide this 
care to the participant at no cost to the participant. 
In the case of expected and unexpected reactions after the use of vaccines, study participants 
will receive appropriate medical care and treatment. IVAC will pay the entire cost of medical 
treatment and resolve these cases according to current regulations in Vietnam. 
Medical care will be provided for participants in this study. This includes the following: 
 
monitoring of participants closely for 30 minutes after vaccination and providing 
emergency care for any immediate reactions.  
 
monitoring of participants for adverse events which are not life-threatening and providing 
care for these at nearby local hospitals and treatment centers. 
 
monitoring of participants for severe adverse events and providing care for these at local 
hospitals and treatment centers. 
During the study period if serious adverse event occurs that is related to the participant’s 
participation in the trial or to the study products, IVAC will ensure coverage for the full cost of 
treatment according to the laws of Vietnam for research participants. The study clinic will establish 
an agreement with nearby treatment centers to provide treatment at no cost to the participant for 
abnormal reactions that are not life-threatening, but nonetheless warrant medical observation or 
care. 
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Risks to Privacy: Anyone participating in research using their real name and medical information 
can face a loss of privacy. These risks are mitigated by using unique IDs in place of a participant’s 
name, restricting access to study information, and not naming or identifying a participant in any 
publication.  
16.13 Benefits to Study Participants 
Study participants may not benefit from being in the study, however, there is potential for some 
benefit: 
 
People may benefit from the physical exams that is done in the study, as it may reveal 
information about their health that they did not know before.  
17 Noncompliance and Unanticipated Problems 
Noncompliance includes protocol deviations and violations, as stated below. 
Protocol deviations: Any departure from the approved protocol, trial documents or any other 
information relating to the conduct of the trial that does not result in harm to the trial participants 
and does not significantly affect the study outcomes or data integrity or ethical conduct. Examples 
of deviations may include, but are not limited to: 
 
A missed protocol visit or a protocol visit date deviation outside the study visit window 
 
Isolated incident of a missed or incomplete study evaluation (e.g. exam) 
Protocol Violation: Any departure from the approved protocol, trial documents or any other 
information relating to the conduct of the study which may affect the safety of trial participants or 
the study outcome. Examples of violations may include, but are not limited to: 
 
Failure to obtain informed consent (i.e. no documentary evidence); 
 
Enrolment of participants that do not meet the inclusion/exclusion criteria; 
 
Undertaking a procedure not approved by the IRB or Licensing Authority (unless for 
immediate safety reasons); 
 
Failure to report adverse events, serious adverse events in accordance with the legislation 
and sponsor and protocol requirements, such that trial participants, or the public, are put 
at significant risk; 
 
Investigational Product(s) dispensing, labeling or dosing error. 
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Unanticipated Problems: Problems that may or may not be adverse events but that, when they 
occur, are unexpected in terms of the frequency or severity (for AEs); related to the research; and 
put the participants or others at a greater risk of physical, psychological, economical, or social 
harm than what was previously known or recognized. 
It is the responsibility of the site to use continuous vigilance to identify and report deviations and 
unanticipated problems to IVAC in a timely manner after identification. If required, reports of 
protocol deviations/violations must be sent to the research ethics committees overseeing the 
research.  The PI and his/her staff are responsible for knowing and adhering to their research 
ethics committee’s/IRB’s requirements for reporting noncompliance and unanticipated problems. 
18 Human Resource for the Study 
18.1 Human Resource for the Study 
The study research team will be qualified by experience, education, and training to conduct their 
responsibilities on this study.  
 
The study clinic will make arrangements with local health centers to adequately care for 
participants who experience side effects/illnesses that need care beyond what the study clinic can 
provide. 
 
The research team may use Commune Health Centers to prepare a list for potential participants, 
keep contact with study participants, and conduct home visits (if needed).  
18.2 Training Plan 
All key personnel (those responsible for the design and conduct of this study) will have completed 
Human Subjects Protection and/or GCP Training, as appropriate to their role, prior to interaction 
with any participants or to having access to their confidential study data. In addition, staff will be 
trained on any written procedures that pertain to their role in the study.  
19 Clinical Study Report and Publication Policy 
19.1 Clinical Study Report 
A Clinical Study Report (CSR) comprised of text and results tables reflecting all safety and 
immunogenicity data will be generated by IVAC or its designates. The CSR will be compliant with 
ICH E: 3 guidelines. 
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All data, documents, any recordings and information transferred to any contractor or obtained or 
prepared by any contractor, his/her consultants or persons associated by contractual relationships 
with any contractor during the trials, belong to IVAC. 
 
Following completion of the clinical study report, the investigators, working with IVAC and 
representatives, are expected to publish the results, negative or positive, of this research in peer-
reviewed scientific journal(s). IVAC may not prohibit the public dissemination of the results of this 
trial. 
19.2 Publication Policy 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted 
a trials-registration policy as a condition for publication. This policy requires that all clinical trials 
be registered in a public trials registry. It will be the responsibility of IVAC/PATH to register this 
trial in an acceptable registry. ICMJE authorship criteria will be strictly followed for publication of 
any manuscript(s) arising from this trial.  
 
Ho Chi Minh City, date      month      year 20.... 
 Director of the Institution  
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 
 
 
 
Phan Cong Hung, MD 
 
Hanoi, date       month      year 20..... 
Director of the Administration of Science Technology and Training 
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REFERENCES 
1. Fineberg HV. Pandemic preparedness and response–lessons from the H1N1 influenza of 
2009. N Engl J Med 2014;370:1335–42. 
2. Lafond KE, Nair H, Rasooly MH, Valente F, Booy R, Rahman M, et al. Global role and 
burden of influenza in pediatric respiratory hospitalizations, 1982–2012: a systematic 
analysis. PLoS Med 2016;13:e1001977. 
3. Friede M, Palkonyay L, Alfonso C, Pervikov Y, Torelli G, Wood D, et al. WHO initiative to 
increase global and equitable access to influenza vaccine in the event of a pandemic: 
supporting developing country production capacity through technology transfer. Vaccine 
2011;29(Suppl 1):A2–7. 
4. Saha S, Chadha M, Al MA, Rahman M, Sturm-Ramirez K, Chittaganpitch M, et 
al.Influenza seasonality and vaccination timing in tropical and subtropical areas of 
southern and south-eastern Asia. Bull World Health Organ 2014;92:318–30. 
5. WHO FluNet, Influenza Laboratory Suveillance Information by the Global Influenza 
Surveillance 
and 
Response 
System 
(GISRS) 
(www.who.int/flunet)   
<http://gamapserver.who.int/gareports/Default.aspx?ReportNo=1>, [accessed on 17 
October 2016]. 
6. http://www.who.int/influenza/vaccines/virus/candidates_reagents/2016_17_north 
[accessed on 17 October 2016]. 
7. Anh DD, Thiem VD, Anh NT, Huong VM, Nga NT, Thang TC, Thai DH, Chien VC, Holt R, 
Wahid R, Flores J, Berlanda Scorza F, Taylor DN.Randomized safety and immunogenicity 
trial of a seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) in healthy 
young Vietnamese adults. Vaccine. 2016 Oct 26;34(45):5457-5462.  
8. Guidance on Clinical Trial of Influenza Vaccine. Ministry Of Health (Administration of 
Science Technology And Training), Hanoi, Vietnam, 2013. 
9. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UC
M329134.pdf [accessed on 17 October 2016].  
10. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UC
M305089.pdf [accessed on 17 October 2016]. 
11. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UC
M335392.pdf [accessed on 17 October 2016]. 
 
12. Stefan P. Kuster,  Prakesh S. Shah,  Brenda L. Coleman,  Po-Po Lam,  Agnes Tong,  Anne 
Wormsbecker,  Allison McGeer. Incidence of Influenza in Healthy Adults and Healthcare 
Workers: A Systematic Review and Meta-Analysis PLOS Published: October 18, 2011 
13. Pearson ML, Bridges CB, Harper SA. Influenza vaccination of health-care personnel 
[published correction appears in MMWR Recomm Rep. 2006;55(9):252]. MMWR 
Recomm Rep 2006;55(RR-2):1–16  
14. Taksler GB, Rothberg MB, Cutler DM. Association of Influenza Vaccination Coverage in 
Younger Adults With Influenza-Related Illness in the Elderly. Clin Infect Dis. 2015 Nov 
15;61(10):1495-503. doi: 10.1093/cid/civ630 
15. World Health Organization WHO Technical Report Series, No. 927, 2005 Annex 3 
Recommendations for the production and control of influenza vaccine (inactivated) 
[accessed on 17 October 2016]. 
16. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/
WC500139747.pdf [accessed on 17 October 2016]. 
 
• 
The Guidance on the treatment of post injection reactions issued under the decision No 
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2535/QD-BYT by Ministry of Health, Vietnam;http://vncdc.gov.vn/vi/huong-dan-giam-sat-
phong-chong-dich-benh/329/quyet-dinh-ve-viec-ban-hanh-huong-dan-theo-doi-cham-
soc-xu-tri-phan-ung-sau-tiem-chung 
 
17. Committee for Proprietary Medicinal Products (CPMP). Note for guidance on 
harmonization of requirements for influenza vaccines. CPMP/BWP/214/96. The European 
Agency for the Evaluation of Medicinal Products (EMEA), March 1997 
18. Voordouw AC, Beyer WE, Smith DJ, Sturkenboom MC, Stricker BH. Evaluation of 
serological trials submitted for annual re-licensure of influenza vaccines to regulatory 
authorities between 1992 and 2002. Vaccine. 2009 Dec 11;28(2):392-7.  
19. Goodwin K, Viboud C, Simonsen L .Antibody response to influenza vaccination in the 
elderly: a quantitative review.. Vaccine. 2006 Feb 20;24(8):1159-69.  
20. https://www.cdisc.org/sites/default/files/members/standard/foundational/cdash/cdash_std
_1_1_2011_01_18.pdf [accessed on 28 Nov 2016] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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APPENDIX A: Table of Grading Severity 
IVACFLU-S  
TABLE OF GRADING SEVERITY FOR CERTAIN EVENTS1 
I. Instructions and Clarifications 
Estimating Severity Grade for Parameters Not Identified in the Table 
In order to grade a clinical AE that is not identified in the DAIDS AE grading table, refer to the 
protocol. 
Determining Severity Grade for Parameters “Between Grades” 
If the severity of a clinical AE could fall under either one of two grades (e.g., the severity of an 
AE could be either Grade 2 or Grade 3), select the higher of the two grades for the AE. If a 
laboratory value that is graded as a multiple of the ULN or LLN falls between two grades, select 
the higher of the two grades for the AE. For example, Grade 1 is 2.5 x ULN and Grade 2 is 2.6 x 
ULN for a parameter. If the lab value is 2.53 x ULN (which is between the two grades), the 
severity of this AE would be Grade 2, the higher of the two grades. 
Values Below Grade 1 
Any laboratory value that is between either the LLN or ULN and Grade 1 should not be graded. 
Determining Severity Grade when Local Laboratory Normal Values Overlap with Grade 1 
Ranges 
In these situations, the severity grading is based on the ranges in the DAIDS AE Grading Table, 
even when there is a reference to the local lab LLN. 
For example: Phosphate, Serum, Low, Adult and Pediatric > 14 years Grade 1 range is 2.50 
mg/dL - < LLN. A particular laboratory’s normal range for Phosphate is 2.1 – 3.8 mg/dL. A 
participant’s actual lab value is 2.5. In this case, the value of 2.5 exceeds the LLN for the local 
lab, but will be graded as Grade 1 per DAIDS AE Grading Table. 
_______________________________________ 
1 Based On The DAIDS Table For Grading the Severity of Adult And Pediatric Adverse Events, Version 2.0, November 2014; and 
Guidance For Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials; FDA, 2007.
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II. Definitions of terms used in the Table: 
Basic Self-care  
Functions Adult 
Activities such as bathing, dressing, toileting, 
transfer/movement, continence, and feeding. 
LLN 
Lower limit of normal 
Medical Intervention 
 
Use of pharmacologic or biologic agent(s) for 
treatment of an AE 
NA 
Not Applicable 
Operative Intervention 
Surgical OR other invasive mechanical 
procedures. 
ULN 
Upper limit of normal 
Usual Social & Functional Activities 
Adult 
Adaptive tasks and desirable activities, such 
as going to work, shopping, cooking, use of 
transportation, pursuing a hobby, etc.  
 
 
 
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PARAMETER 
GRADE 1 
MILD 
GRADE 2 
MODERATE 
GRADE 3 
SEVERE 
GRADE 4 
POTENTIALLY 
LIFE-THREATENING 
ESTIMATING SEVERITY GRADE 
 
Blood Pressure 
Abnormalities--
Hypertension 
140 to < 160 mmHg 
systolic OR 90 to < 
100 mmHg diastolic  
≥ 160 to < 180 mmHg 
systolic OR ≥ 100 to < 
110 mmHg diastolic  
≥ 180 mmHg systolic 
OR ≥ 110 mmHg 
diastolic  
Life-threatening 
consequences in a 
participant not 
previously diagnosed 
with hypertension (e.g., 
malignant hypertension) 
OR Hospitalization 
indicated  
SYSTEMIC 
Acute Allergic 
Reaction  
Localized urticaria 
(wheals) with no 
medical intervention 
indicated  
Localized urticaria with 
intervention indicated 
OR Mild angioedema 
with no intervention 
indicated  
Generalized urticaria 
OR Angioedema with 
intervention indicated 
OR Symptoms of mild 
bronchospasm  
Acute anaphylaxis OR 
Life-threatening 
bronchospasm OR 
Laryngeal edema  
Chills  
Symptoms causing no 
or minimal 
interference with 
usual social & 
functional activities  
Symptoms causing 
greater than minimal 
interference with usual 
social & functional 
activities  
Symptoms causing 
inability to perform usual 
social & functional 
activities  
NA  
Fatigue or Malaise  
Report only one  
Symptoms causing no 
or minimal 
interference with 
usual social & 
functional activities  
Symptoms causing 
greater than minimal 
interference with usual 
social & functional 
activities  
Symptoms causing 
inability to perform usual 
social & functional 
activities  
Incapacitating 
symptoms of fatigue or 
malaise causing inability 
to perform basic self-
care functions  
Arthralgia (Joint 
Pain) 
Joint pain causing no 
or minimal 
interference with 
usual social & 
functional activities  
Joint pain causing 
greater than minimal 
interference with usual 
social & functional 
activities  
Joint pain causing 
inability to perform usual 
social & functional 
activities  
Incapacitating joint pain 
causing inability to 
perform basic self-care 
functions  
Fever (non-axillary 
temperatures only)  
38.0 to < 38.6°C  
≥ 38.6 to < 39.3°C  
 
≥ 39.3 to < 40.0°C  
≥ 40.0°C  
Fever (axillary)  
37.7 – 38.1°C 
38.2 – 38.8°C 
38.9 – 40.0°C 
> 40.0°C 
Nausea  
Transient (< 24 hours) 
or intermittent AND 
No or minimal 
interference with oral 
intake  
Persistent nausea 
resulting in decreased 
oral intake for 24 to 48 
hours  
Persistent nausea 
resulting in minimal oral 
intake for > 48 hours 
OR Rehydration 
indicated (e.g., IV fluids)  
Life-threatening 
consequences (e.g., 
hypotensive shock)  
Vomiting  
Transient or 
intermittent AND No 
or minimal 
interference with oral 
intake  
Frequent episodes 
with no or mild 
dehydration  
Persistent vomiting 
resulting in orthostatic 
hypotension OR 
Aggressive rehydration 
indicated (e.g., IV fluids)  
Life-threatening 
consequences (e.g., 
hypotensive shock  
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PARAMETER 
GRADE 1 
MILD 
GRADE 2 
MODERATE 
GRADE 3 
SEVERE 
GRADE 4 
POTENTIALLY 
LIFE-THREATENING 
Headache  
Symptoms causing no 
or minimal 
interference with 
usual social & 
functional activities  
Symptoms causing 
greater than minimal 
interference with usual 
social & functional 
activities  
Symptoms causing 
inability to perform usual 
social & functional 
activities  
Symptoms causing 
inability to perform basic 
self-care functions OR 
Hospitalization indicated 
OR Headache with 
significant impairment of 
alertness or other 
neurologic function  
INJECTION SITE REACTIONS 
Injection Site Pain or 
Tenderness  
Report only one  
Pain or tenderness 
causing no or minimal 
limitation of use of 
limb  
Pain or tenderness 
causing greater than 
minimal limitation of 
use of limb  
Pain or tenderness 
causing inability to 
perform usual social & 
functional activities  
Pain or tenderness 
causing inability to 
perform basic self-care 
function OR 
Hospitalization indicated  
Injection Site 
Erythema or 
Redness  
Report only one  
> 15 years of age  
2.5 to < 5 cm in 
diameter OR 6.25 to < 
25 cm2 surface area 
AND Symptoms 
causing no or minimal 
interference with 
usual social & 
functional activities  
≥ 5 to < 10 cm in 
diameter OR ≥ 25 to < 
100 cm2 surface area 
OR Symptoms 
causing greater than 
minimal interference 
with usual social & 
functional activities  
≥ 10 cm in diameter OR 
≥ 100 cm2 surface area 
OR Ulceration OR 
Secondary infection OR 
Phlebitis OR Sterile 
abscess OR Drainage 
OR Symptoms causing 
inability to perform usual 
social & functional 
activities  
Potentially life-
threatening 
consequences (e.g., 
abscess, exfoliative 
dermatitis, necrosis 
involving dermis or 
deeper tissue)  
Injection Site 
Induration or 
Swelling  
Report only one  
> 15 years of age  
Same as for Injection 
Site Erythema or 
Redness, > 15 years 
of age  
Same as for Injection 
Site Erythema or 
Redness, > 15 years 
of age  
Same as for Injection 
Site Erythema or 
Redness, > 15 years of 
age  
Same as for Injection 
Site Erythema or 
Redness, > 15 years of 
age  
 
 
 
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APPENDIX B: Roles and responsibilities matrix 
 
ACTIVITY 
PI HCMC 
(Investigator, 
Clinical Trial Unit, 
Clinical Site, 
Laboratories) 
PATH WHO 
IVAC 
(Sponsor) 
CRO  
 
 
 
 
 
 
 
 
Objective 1: Phase 2/3 Study Developed 
1 
Develop protocol  
 
PATH WHO IVAC 
CRO 
 
Draft protocol synopsis 
prepared 
C 
R/A 
C 
C 
I 
 
Protocol drafted 
C 
R/A 
C 
C 
I 
 
Protocol finalized and 
ready for submission 
A 
R/A 
C 
A 
I 
2 
Prepare investigational product and 
placebo 
PATH WHO IVAC 
CRO 
 
Prepare summary batch 
record for production 
and QC testing for 3 lots 
I 
I 
I 
R/A 
 
 
Send samples of 3 lots 
to NICVB for release 
testing 
I 
I 
I 
R/A 
 
 
Filling, packaging, 
labelling investigational 
product and placebo 
I 
C 
I 
R/A 
 
 
QC testing for placebo 
I 
I 
I 
R/A 
 
 
Coding investigational 
products  
I 
A 
I 
A 
R 
 
Labeling of 
investigational products 
I 
I 
I 
R/A 
I 
3 
Select CTU and site 
 
PATH WHO IVAC 
CRO 
 
Clinical site(s) initially 
assessed/proposed 
C 
R 
I 
C/A 
 
 
Clinical site agreed upon 
R 
I 
I 
A 
 
 
Specialty (serology) 
lab(s) initially 
assessed/proposed 
C 
R 
I 
C/A 
 
 
Specialty (serology) 
lab(s) agreed upon 
C 
R 
I 
A 
 
4 
Register Phase 2/3 
study 
 
PATH WHO IVAC 
CRO 
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ACTIVITY 
PI HCMC 
(Investigator, 
Clinical Trial Unit, 
Clinical Site, 
Laboratories) 
PATH WHO 
IVAC 
(Sponsor) 
CRO  
 
Petition to conduct 
clinical trial submitted 
(including proposed site, 
PI and Protocol 
Synopsis) 
I 
C 
I 
R/A 
 
 
Investigator's Brochure 
updated for submission 
I 
C 
I 
R/A 
 
 
- Summary information 
on investigational 
product updated 
I 
C 
I 
R/A 
 
 
-Summary information 
on MSV/WSV updated 
I 
C 
I 
R/A 
 
 
- Lot release certificates 
from NICVB for 3 
consecutive lots 
obtained 
I 
C 
I 
R/A 
I 
 
Receives MOH approval 
or address MOH 
feedback on 
"registration" 
I 
C 
I 
R/A 
I 
5 
Develop 
investigational dossier 
 
PATH WHO IVAC 
CRO 
 
Investigator's Brochure 
provided to site 
I 
I 
I 
R/A 
I 
 
Informed consent forms 
(ICFs) developed 
according the protocol 
and translated 
C 
R 
I 
C/A 
I 
 
Clinical Trial Agreement 
(CTA) drafted 
C 
R/A 
I 
C 
I 
 
CTU/site budget 
preparation 
C 
R/A 
I 
I 
 
 
Additional specialty lab 
budget preparation 
C 
R/A 
I 
I 
 
 
Contract for Clinical trial 
and MOU prepared and 
signed 
A 
R/A 
I 
A 
I 
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ACTIVITY 
PI HCMC 
(Investigator, 
Clinical Trial Unit, 
Clinical Site, 
Laboratories) 
PATH WHO 
IVAC 
(Sponsor) 
CRO  
 
Insurances for subjects 
I 
I 
I 
R/A 
I 
 
Clinical Trial Agreement 
signed by parties after 
MOH approval 
R 
R/A 
I 
R 
I 
6 
 "Investigational 
dossier" approved 
 
PATH WHO IVAC 
CRO 
 
"Application" form 
submitted to PI HCMC’s 
IRB 
R 
C 
I 
C 
I 
 
Obtain approval letter 
and meeting minutes of 
the IRB of PI HCMC 
Review Meeting 
R 
C 
I 
C 
I 
 
Obtain supporting letter 
from Provincial Level 
and People’s Committee  
R 
C 
I 
C 
I 
 
Submission packages to 
MOH’s IRB 
R 
C 
I 
C 
I 
 
Present/Defend the 
dossier to MOH 
R 
C 
I 
C 
I 
 
Receives approval or 
feedback from MOH on 
investigational dossier 
R 
I 
I 
I 
I 
 
Addresses any issues 
raised by MOH 
R 
R/A 
I 
R 
I 
 
Submit package and 
obtain approval from 
WIRB (PATH REC) 
I 
R/A 
I 
I 
I 
 
Objective 2: Phase 2/3 Study Implemented 
7 
Pre- trial preparation 
 
PATH WHO IVAC 
CRO 
 
Pre-study progress 
reporting 
R/A 
R/A 
I 
I 
I 
 
Randomization plan 
developed 
I 
R/A 
I 
C 
R 
 
Clinical monitoring plan 
developed 
I 
C/A 
I 
A 
R 
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ACTIVITY 
PI HCMC 
(Investigator, 
Clinical Trial Unit, 
Clinical Site, 
Laboratories) 
PATH WHO 
IVAC 
(Sponsor) 
CRO  
 
Safety monitoring plan 
developed 
I 
C/A 
I 
A 
R 
 
Interim SAP and 
immunogenicity analysis 
plans 
I 
C/A 
I 
A 
R 
 
Study registered with 
international trial registry 
(e.g. clinicaltrials.gov) 
I 
R 
I 
A 
I 
 
Lab reagents/materials 
for taking blood 
purchased 
R 
R/A 
I 
I 
 
 
Preparation meeting 
with field site staff and 
community 
R/A 
C 
I 
C 
I 
 
The list of eligible 
subjects constructed 
R/A 
C 
I 
C 
I 
8 
Develop study 
materials 
 
 
 
 
 
 
Investigator's File 
established (including all 
logs) 
R 
R/A 
I 
C 
R 
 
Protocol issued to 
investigative staff 
C 
R/A 
I 
R/A 
I 
 
Site SOP’s developed 
R/A 
R/A 
I 
A 
I 
 
eCRFs and completion 
guidelines developed 
C 
C 
I 
I 
R/A 
 
SOPs relating to cold 
chain maintenance 
developed 
A 
R/A 
I 
R/A 
I 
 
Manual of Operations 
Developed 
C 
R/A 
I 
C 
I 
 
Pharmacy and Lab 
Manuals Developed 
C 
R/A 
I 
C 
I 
 
ICF printed 
R 
C 
I 
I 
A 
 
CRFs printed and 
transported to site 
C 
C 
I 
I 
R/A 
9 
Pre-trial training 
 
PATH WHO IVAC 
CRO 
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ACTIVITY 
PI HCMC 
(Investigator, 
Clinical Trial Unit, 
Clinical Site, 
Laboratories) 
PATH WHO 
IVAC 
(Sponsor) 
CRO  
 
Training Plan Developed 
R 
R/A 
I 
C 
C 
 
RE/GCP training for 
required personnel 
provided 
R 
C 
I 
C 
I 
 
Protocol training for sub-
investigators and staff 
provided 
R 
R/A 
I 
C 
I 
 
Data management 
training 
C 
C 
I 
I 
R/A 
 
Trial practice run training 
conducted 
R 
R/A 
I 
C 
I 
10 Vaccine transportation and management 
PATH WHO IVAC 
CRO 
 
Pre-trial cold-chain 
assessment 
C 
R/A 
I 
R/A 
I 
 
Provide Product 
Certificate of Analysis to 
site 
I 
I 
I 
R/A 
I 
 
Provide shipment 
information to site and/or 
handling agent 
I 
C 
I 
R/A 
I 
 
Shipment of vaccine to 
site 
I 
I 
I 
R/A 
I 
 
Receipt of vaccine at 
site 
R/A 
I 
I 
C 
I 
 
Return of unused 
vaccine to manufacturer 
R/A 
I 
I 
C 
A 
11 
Overall study 
responsibilities 
fulfilled 
 
PATH WHO IVAC 
CRO 
 
Investigative staff 
identified, recruited 
and/or hired 
R 
C/A 
I 
C/A 
I 
 
Implementation Plan 
Developed 
R 
C/A 
I 
C 
C 
 
Financial management 
R/A 
R/A 
I 
I 
 
 
Study teleconference 
organization 
I 
C 
I 
A 
R/A 
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                        Date: 09/02/2017 
 
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ACTIVITY 
PI HCMC 
(Investigator, 
Clinical Trial Unit, 
Clinical Site, 
Laboratories) 
PATH WHO 
IVAC 
(Sponsor) 
CRO  
 
Study teleconference 
participation 
R 
R 
I 
R 
R/A 
 
Study implementation 
R/A 
C/A 
I 
C/A 
C 
 
Progress reports to 
WHO, PATH and IVAC 
R 
A 
I 
A 
R/A 
 
Reports to Safety 
Monitoring Groups 
C 
R/A 
I 
C 
R/A 
12 Conduct transport and testing of biological 
specimens 
PATH WHO IVAC 
CRO 
 
Specialty Laboratory(s) 
(serology) 
 
 
 
 
 
 
Coordination of transport 
of samples from site to 
specialty lab(s) 
R/A 
C 
I 
C 
I 
 
Laboratory sample 
testing 
I 
C/A 
I 
C 
I 
13 Clinical/Medical 
Monitoring 
 
PATH WHO IVAC 
CRO 
 
CRO identified for site 
monitoring 
I 
C 
R/A 
I 
 
 
CRO appoints medical 
monitor 
I 
R/A 
I 
C 
R/A 
 
Conduct/participate  pre-
study site visits 
C 
R 
I 
C/A 
I 
 
Conduct site 
initiation/activation 
C 
C 
I 
C 
R/A 
 
Conduct interim 
monitoring 
C 
C 
I 
I 
R/A 
14 Develop Statistical 
Analysis Plan (SAP) 
 
PATH WHO IVAC 
CRO 
 
Develop SAP 
I 
C 
I 
I 
R/A 
 
Approve SAP 
I 
R/A 
I 
A 
C 
15 Clinical Study Report 
 
PATH WHO IVAC 
CRO 
 
Write Clinical Study 
Report 
I 
C 
I 
C 
R/A 
 
Write Clinical Study 
Report MOH template 
C 
R/A 
I 
C 
I 
600
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S, Phase 2/3 
                     Version: 4.0 
                                                                                  CONFIDENTIAL 
 
                        Date: 09/02/2017 
 
Page 87/91 
 
 
 
ACTIVITY 
PI HCMC 
(Investigator, 
Clinical Trial Unit, 
Clinical Site, 
Laboratories) 
PATH WHO 
IVAC 
(Sponsor) 
CRO  
 
Review Drafts of CSR; 
Approve of Final CSR 
I 
R/A 
I 
R/A 
C 
16 Trial Master File (TMF) 
 
PATH WHO IVAC 
CRO 
 
Develop and Manage 
Trial Master File 
C 
I 
I 
C 
R/A 
 
Ensure completeness of 
TMF 
R 
C/A 
I 
C 
C 
 
Submit TMF to Sponsor 
I 
I 
I 
C 
R/A 
 
Note: 
R = Responsibility 
C = Consulted 
I = Informed 
A = Approved 
 
 
 
 
 
 
 
 
 
 
 
 
601
IVACFLU-S
Protocol No: IVACFLU-S-0203
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Dated: 12 March 2018

IVACFLU-S, Phase 2/3 
                     Version: 4.0 
                                                                                  CONFIDENTIAL 
 
                        Date: 09/02/2017 
 
Page 88/91 
 
 
APPENDIX C: Template of interim study report of the phase 2/3 
 
1. Cover pages (according to the CSR template by MOH VN) 
- 
Study title, protocol number 
- 
Key individuals and institution involving the study. 
- 
Timeline of study implementation of the phase 2 
2. Protocol synopsis  
3. Study plan 
4. Overall phase 2 status until D8 
- 
Enrollment/screening counts: total participants screened/enrolled/failured 
- 
Screening failure summary: illegibility, withdraw consent, study no longer for enrollment, 
others.. 
- 
Study progress: total S1/D1 visit, total D8 visit 
- 
Early termination 
- 
Protocol violation/deviation 
- 
Demographic and key baseline characteristics 
 
5. Overall Reactogencicity report until D8 (blinded data and not presented by 
treatment group) 
- 
Local solicited AEs 
- 
Systemic solicited AEs 
6. Demographic and baseline characteristics 
7. Unsolicited AEs until D8 and grade 3 and above unsolicited AEs till data cut-
off date (blinded data and not presented by treatment group) 
8. SAEs till data cut-off date 
9. Conclusion 
602
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S, Phase 2/3 
                     Version: 4.0 
                                                                                  CONFIDENTIAL 
 
                        Date: 09/02/2017 
 
Page 89/91 
 
 
APPENDIX D: Assessment of Understanding 
List of questions to evaluate the understanding of consent process by participants 
 
Directions: After providing and explaining information about the study in the information 
sheet, and answering questions asked by participant. It is necessary to evaluate the 
understanding of participant in order to see if they correctly understand about the study 
before asking she/he to sign in the consent form. Investigator should ask all questions 
below, if the participant answers well those questions, she/he will be asked to sign the ICF. 
If she/he cannot or wrongly answer any question, investigator has to explain again to 
her/him and asks some more questions to make sure the correct understanding by 
participant before signing the ICF. 
 
Read this to the participant: We have talked about the study together. Now I want to ask 
you some questions to see how well I explained the study to you.  
1. Can you tell me which vaccine is tested in this study and what disease is this vaccine 
trying to prevent? 
2. Is your participation in this study voluntary or are you forced to join it?  
3. If you join the study do you have to stay in it, even if you want to leave it early? 
4. Will everyone in the study get the study vaccine? 
5. According to you, does your participation bring any benefit for yourself and for the 
community (other people)? 
6. According to you, what reactions/risks may you have if you participate in this study 
(receive the study product)?
603
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S, Phase 2/3 
                     Version: 4.0 
                                                                                  CONFIDENTIAL 
 
                        Date: 09/02/2017 
 
Page 90/91 
 
 
APPENDIX E: Quality Certification by NICBV for study product lots 
Product name: IVACFLU-S (Trivalent, inactivated, split virion seasonal influenza vaccine) 
Lot number: 004-01-16 
Packaging unit: 0.5ml/dose/vial 
Manufacture date:  29 November, 2016 
Expired date: 05 December, 2017 
Manufacturer: Institute of Vaccine and Medical Biologicals (IVAC) 
RESULTS: 
 
# 
Indicator/Testi
ng 
Acceptance criteria of the 
manufacturer 
Result 
Evaluation 
1. 
Filling volume 
≥  volume in label (0.5 
ml/vial) 
0,596;  0,604;  0,596; 
0,596;  0,599 
Pass 
2. 
Visual 
The 
solution 
is 
clear,  
colorless or opaque white, 
no sediment, no particle 
Pass 
Pass 
3. 
Sterility 
No growth of bacteria and 
fungi in culture medium after 
14 days 
Pass 
Pass 
4. 
pH 
6.5 – 7.5 
7.04 
Pass 
5. 
Identity 
Positive 
reaction 
with 
specific antiserum of each 
strain 
Positive 
Pass 
6. 
HA content 
(potency) 
≥ 15g for each strain 
Type B: 17,92 g/dose 
 
Type H1N1:19,71 g/ dose 
Type H3N2: 20,03 g/ dose 
7. 
Endotoxin 
≤ 100 EU 
8 EU/dose 
Pass 
8. 
General safety 
All the mice and guinea pigs 
are in good health and gain 
weight  after 7 monitoring 
days 
Pass 
Pass 
9. 
Protein content 
(g/dose) 
≤ 300 µg/ml 
288.47 
Pass 
10. 
Formaldehyde 
content (%) 
≤ 0.02 % 
0.00055 % 
Pass 
604
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S, Phase 2/3 
                     Version: 4.0 
                                                                                  CONFIDENTIAL 
 
                        Date: 09/02/2017 
 
Page 91/91 
 
 
 
 
 
Product name: PLACEBO 
Lot number: 007P-01-16 
Packaging: 0.5ml/dose/vial 
Manufacture date: 02 December 2016 
Expired date: 05 December 2017 
Manufacturer: Institute of Vaccine and Medical Biologicals (IVAC) 
RESULTS: 
 
# 
Indicator/Testing 
Acceptance criteria of the 
manufacturer 
Result 
Evaluation 
1 
Visual 
The solution is clear,  colorless or 
opaque white, no sediment, no 
particle 
Pass 
Pass 
2 
Filling volume 
≥  volume in label (0.5 ml/vial) 
0,598;  0,594;  
0,595; 
0,594;  
0,592   
Pass 
3 
Sterility 
No growth of bacteria and fungi in 
culture medium after 14 days 
Pass 
Pass 
4 
pH 
6.5 – 7.5 
7.21 
Pass 
5 
Endotoxin 
≤ 1.25 EU 
0.625 EU/dose 
Pass 
6 
General safety 
All the mice and guinea pigs are in 
good health and gain weight  after 
7 monitoring days 
Pass 
Pass 
7 
NaCl content (%) 
≤ 1% 
0.90% 
Pass 
 
 
 
605
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

16.1.2 
Sample case report form 
Document 
Date 
Annotated Case Report Form, Version 4 
02 May 2017 
Blank Subject Diary Card, Version 1 
14 December 2016 
eCRF Design Approval Form, Version 4 
02 May 2017 
 
606
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Annotated Study Book for Study Design: IVACFLU-S-0203
Study Design Version: 1.0
Sponsor: Institute of Vaccines and Medical Biologicals (IVAC)
Protocol: IVACFLU-S-0203
eCRF Version 04.00
IYA06804
Generated by Central Designer TM
May 2, 2017 8:49PM
607
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Time and Events Schedule For Study Design: IVACFLU-S-0203
Element
System
Assessment
CRF
System 
Screening
(SCRVIS)
[S]
System 
Enrollment
(ENRVIS)
[S]
Screening
(SCR)
[S]
Day 
1
(DAY 
1)
[U]
Day 
2
(Day 
2)
[S]
Day 
5
(Day 
5)
[S]
Day 
8
(DAY 
8)
[S]
Day 
22
(DAY 
22)
[S]
Day 
91
(Day 
91)
[S]
Unscheduled 
Visit
(UNS VIS)
[U/R]
Log
(LOG 
VIS)
[U]
Common
(Common)
[U]
End 
of 
Study
(EOS)
[U]
Visit Start Hours
0
0
0
1
25
121
193
529
2185
2186
2187
2188
2189
1 
SYSTEM SCREENING
SYSSCR
1
2 
SYSTEM ENROLLMENT
ENROL
1
3 
DATE OF VISIT
DOV
1
1
1
1
1
1
1
1
4 
SUBJECT IDENTIFICATION FORM
SUBID
2
5 
DEMOGRAPHICS
DEMOG
3
6 
CURRENT MEDICAL CONDITION
MHX
4
2-DF
7 
SCREENING PHYSICAL EXAM
PE
5
8 
URINE PREGNANCY TEST
UPREG
6-DF
4-DF
5-DF
9 
RANDOMIZATION
ELIG
7
5-DF
10 TARGETED PE
TPE
3-DF
2
3
3-DF
11 ANTI-INFLUENZA SEROLOGIC ASSAY
ANTI INF 
SER
6-DF
2-DF
4-DF
12 VACCINATION 
VAC
7
13 30-MINUTE REACTOGENICITY
ROG
8
14 CONTACT
TELECONT
2
2
2
15 SOLICITED LOCAL REACTOGENICITY
LOCAL
3
16 SOLICITED SYSTEMIC REACTOGENICITY
SYSTEMIC
4
17 UNSCHEDULED ASSESSMENT FORMS
UNSFM
2
18 LOG
LOGFM
1
19 UNSOLICITED ADVERSE EVENT
AEUNSOL
2-DF-
RF
20 SERIOUS ADVERSE EVENT
SAE
3-DF-
RF
21 CONCOMITANT MEDICATIONS
CM
4-DF-
RF
22 MISSED VISIT FORM
MISSED 
VISIT FORM
1
23 REPORT OF PREGNANCY
REPORT OF 
PREGNANCY
2-DF
24 END OF STUDY
EOSFM
1
25 INVESTIGATOR SIGNATURE
SIGN
2
Key:    [S] = Scheduled Visit    [D] = Dynamic Visit    [U] = Unscheduled Visit    [R] = Repeating Visit
C = Common Form    DF = Dynamic Form    RF = Repeating Form
608
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: SYSTEM SCREENING (SYSSCR) [SYSSCR]
System Screening [SYSSCRSC]
1.
Subject Initials [hidden]
[Initials] 
[SUBINI]
A3
2.*

Date of birth
[Date of birth] 
[SCRDOBDT] 
Req/Unk
 / Req/Unk
 / Req
 (1918-2018)
   Key:  [*] = Item is required  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_SYSSCR
Data Variable RefName RD Column Name Column Data Type
SUBINI
SUBINI
VARCHAR2
SUBINI_ND
VARCHAR2
SCRDOBDT
SCRDOBDT
DATE
SCRDOBDT_DTS
VARCHAR2
SCRDOBDT_DTR
VARCHAR2
SCRDOBDT_ND
VARCHAR2
609
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: SYSTEM ENROLLMENT (ENROL) [SYSENR]
System Enrollment [SYSENRSC]
1.*

Screening ID
[Screening ID] 
[SCRNUMZ]
A5
2.
InForm Subject ID [hidden]
[InForm Subject ID] 
[INSUBJID] 
A20
   Key:  [] = Source verification required  [] = ASCII Only
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_SYSENR
Data Variable RefName RD Column Name Column Data Type
SCRNUMZ
SCRNUMZ
VARCHAR2
SCRNUMZ_ND
VARCHAR2
INSUBJID
INSUBJID
VARCHAR2
INSUBJID_ND
VARCHAR2

610
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: DATE OF VISIT (DOV) [DOV1]
Date of Visit [DOVSC]
1.*

Date of Visit
[Date of Visit] 
[DOVDT] 
Req
 / Req
 / Req
 (2017-2018)
   Key:  [*] = Item is required  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_DOV1
Data Variable RefName RD Column Name Column Data Type
DOVDT
DOVDT
DATE
DOVDT_DTS
VARCHAR2
DOVDT_ND
VARCHAR2
611
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: Subject identification form (SUBID) [SUBID]
SUBIDSC [SUBIDSC]
1.*

Screening ID
[Screening ID] 
[SCRNUMZ]
A5
2.
InForm Subject ID [hidden]
[InForm Subject ID] 
[INSUBJID] 
A20
3.
Update Subject Randomization Number
[Update Subject Randomization Number] 
[SUBRAND] 
[A:1] 
Yes
   Key:  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
Study Object Descriptions: Subject identification form
Type
RefName
Description
Form
SUBID
SUBJECT IDENTIFICATION FORM
RDE Analytics: RD_SUBID
Data Variable RefName RD Column Name Column Data Type
SCRNUMZ
SCRNUMZ
VARCHAR2
SCRNUMZ_ND
VARCHAR2
INSUBJID
INSUBJID
VARCHAR2
INSUBJID_ND
VARCHAR2
SUBRAND
SUBRAND_C
VARCHAR2
SUBRAND
VARCHAR2
SUBRAND_ND
VARCHAR2
612
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: DEMOGRAPHICS (DEMOG) [DM]
Subject Information [DM1SC]
1.*

Informed Consent Signed
[ Informed Consent for Screening 1] 
[ICFA] 
[A:1] 
[ICFADT] 
Yes
Date of signing
Req
 / Req
 / Req
 (2017-2018)
[A:2] 
No
Demographic Details [DM2SC]
2.*

Date of birth
[Date of birth] 
[DOBDT] 
Req/Unk
 / Req/Unk
 / Req
 (1918-2018)
3.*

Ethnicity
[Ethnicity] 
[DMETH] 
[A:1] 
Kinh
[A:2] 
Khmer
[A:3] 
Hoa
[A:4] 
Other
4.*

Sex
[Sex] 
[GENDER] 
[A:1] 
Male
[A:2] 
[BEARING] 
Female 
Is subject of child bearing potential?
[A:1] 
Yes
[A:2] 
No
   Key:  [*] = Item is required  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_DM
Data Variable RefName RD Column Name
Column Data Type
ICFA
ICFA_C
VARCHAR2
ICFA
VARCHAR2
ICFA_ND
VARCHAR2
ICFA - ICFADT
ICFADT
DATE
ICFADT_DTS
VARCHAR2
DOBDT
DOBDT
DATE
DOBDT_DTS
VARCHAR2
DOBDT_DTR
VARCHAR2
DOBDT_ND
VARCHAR2
DMETH
DMETH_ND
VARCHAR2
DMETH - Kinh
DMETH_CITMETH1_C
VARCHAR2
DMETH_CITMETH1
VARCHAR2
DMETH - Khmer
DMETH_CITMETH2_C
VARCHAR2
DMETH_CITMETH2
VARCHAR2
DMETH - Hoa
DMETH_CITMETH3_C
VARCHAR2
DMETH_CITMETH3
VARCHAR2
DMETH - Other
DMETH_CITMETH4_C
VARCHAR2
DMETH_CITMETH4
VARCHAR2
GENDER
GENDER_C
VARCHAR2
GENDER
VARCHAR2
GENDER_ND
VARCHAR2
GENDER - BEARING
BEARING_C
VARCHAR2
BEARING
VARCHAR2
613
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: CURRENT MEDICAL CONDITION (MHX) [MHX]
Current Medical Condition [MHXSC]
Please record all current medical conditions on Current Medical Condition form in Screening visit; Please ONLY record concurrent medical conditions if any updates on Day 1.
1.*

Does the subject have any current medical conditions/ updates on Day 1? 
[Any current medical conditions/ updates on Day 1? ] 
[MHYN] 
[A:1] 
Yes
[A:2] 
No
Current Medical Condition Number
System
Condition
Taking Medication for this current condition? 
2.

CURRENT MEDICAL CONDITION Entry [MHX1SC]
2.1
Current Medical Condition Number [read-only]
[Current Medical Condition Number] 
[MHNUM] 
N3
2.2*

System
[System] 
[MHSYS] 
[A:1] 
Ears, nose and throat
[A:2] 
Eyes
[A:3] 
Respiratory
[A:4] 
Cardiovascular
[A:5] 
Gastrointestinal
[A:6] 
Hepatic
[A:7] 
Renal
[A:8] 
Urogenital
[A:9] 
Neurological
[A:10] 
Endocrine
[A:11] 
Musculoskeletal
[A:12] 
Skin
[A:13] 
Psychiatric
[A:14] 
Drug allergies
[A:99] 
[MHSYSSP] 
Other System specify
A200
2.3*

Condition
[Condition] 
[MHTERM] 
A200
2.4*

Taking Medication for this current condition? 
[Taking Medication for this current condition? ] 
[MHMED] 
[A:1] 
Yes, Please complete Concomitant Medications form
[A:2] 
No
   Key:  [*] = Item is required  [] = Source verification required  [] = ASCII Only
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_MHX
Data Variable RefName RD Column Name Column Data Type
MHYN
MHYN_C
VARCHAR2
MHYN
VARCHAR2
MHYN_ND
VARCHAR2
RD_MHX_MHX1SC
MHNUM
MHNUM
NUMBER
MHNUM_ND
VARCHAR2
MHSYS
MHSYS_C
VARCHAR2
MHSYS
VARCHAR2
MHSYS_ND
VARCHAR2
MHSYS - MHSYSSP
MHSYSSP
VARCHAR2
MHTERM
MHTERM
VARCHAR2
MHTERM_ND
VARCHAR2
MHMED
MHMED_C
VARCHAR2
MHMED
VARCHAR2
MHMED_ND
VARCHAR2


614
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: SCREENING PHYSICAL EXAM (PE) [PE]
Screening Examination Details [PESC]
1.*

Examination Date
[Examination Date] 
[PEVSDT] 
Req
 / Req
 / Req
 (2017-2018)
Vital Signs [PE1SC]
2.*

Body temperature (oral)
[Body temperature] 
[VSTEMCMP] 
[VSTEMP] 
Body temperature (oral) xx.x
 °C
[VSTRE] 
Finding
[A:1] 
Normal
[A:2] 
Abnormal - NCS
[A:3] 
[VSTGR] 
Abnormal - CS 
Grading Scale
[A:0] 
Ungradable
[A:1] 
1 (38.0 – <38.6°C) 
[A:2] 
2 (38.6 – <39.3°C)
[A:3] 
3 (39.3 – <40.0°C)
[A:4] 
4 (≥ 40.0°C)
3.*

Blood Pressure
[Blood Pressure] 
[VSBPCMP] 
[VSBPCOM] 
[SYSBP] 
N3
 mmHg
Systolic
[DIABP] 
N3
 mmHg
Diastolic
[VSBRE] 
Finding
[A:1] 
Normal
[A:2] 
Abnormal - NCS
[A:3] 
[VBSGR] 
Abnormal - CS 
Grading Scale
[A:0] 
0 Ungradable
[A:1] 
1 140 to < 160 mmHg systolic OR 90 to < 100 mmHg diastolic
[A:2] 
2 ≥ 160 to < 180 mmHg systolic OR ≥ 100 to < 110 mmHg diastolic
[A:3] 
3 ≥ 180 mmHg systolic OR ≥110 mmHg diastolic
[A:4] 
4 Life Threatening
4.*

Pulse Rate
[Pulse Rate] 
[VSHRCMP] 
[VSHR] 
Pulse Rate N3
 beats/min
[VSHRE] 
Finding
[A:1] 
Normal
[A:2] 
Abnormal - NCS
[A:3] 
[HRSPec] 
Abnormal - CS, Specify
A200
Physical Examination [PE2SC]
5.*

Are there any abnormal and clinically significant PE findings?
[Any abnormal and clinically significant PE findings?] 
[PERES] 
[A:1] 
Yes
[A:2] 
No
If Yes, please complete Abnormal Findings below.
PE number
Area/System
Finding
6.

Abnormal Findings Entry [PE3SC]
6.1
PE number [read-only]
[PE number] 
[PENUM] 
N3
6.2*

Area/System
[Area/System] 
[PESYSPD] 
[A:1] 
[PESYS] 
[clPESYS]
[A:2] 
[PEDESOTH] 
Other, specify:
A100
6.3*

Finding
[Finding] 
[PERES1] 
[A:1] 
Abnormal, NCS
[A:2] 
[PECM] 
Abnormal, CS
Please specify Current Medical Condition #
A200
   Key:  [*] = Item is required  [] = Source verification required  [b] = Base Unit  [] = ASCII Only
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
Codelist Values Tables: SCREENING PHYSICAL EXAM
Codelist RefName Codelist Data Type Label
Code Codelist Item RefName Data Variable RefName
clPESYS
String
General Appearance
1
citmPESYS1
PESYS
ENT
2
citmPESYS2
Neurologic
8
citmPESYS8
Chest auscultation
6
citmPESYS6
Lymph nodes (cervical & axillary)
4
citmPESYS4
Abdomen palpation
7
citmPESYS7
Musculoskeletal
9
citmPESYS9
RDE Analytics: RD_PE
Data Variable RefName RD Column Name Column Data Type
PEVSDT
PEVSDT
DATE
PEVSDT_DTS
VARCHAR2
[b]
[b]
[b]
[b]



615
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

PEVSDT_ND
VARCHAR2
VSTEMCMP
VSTEMCMP_ND
VARCHAR2
VSTEMCMP - VSTEMP
VSTEMP
FLOAT
VSTEMP_U
VARCHAR2
VSTEMCMP - VSTRE
VSTRE_C
VARCHAR2
VSTRE
VARCHAR2
VSTEMCMP - VSTGR
VSTGR_C
VARCHAR2
VSTGR
VARCHAR2
VSBPCMP
VSBPCMP_ND
VARCHAR2
VSBPCMP - SYSBP
SYSBP
NUMBER
SYSBP_U
VARCHAR2
VSBPCMP - DIABP
DIABP
NUMBER
DIABP_U
VARCHAR2
VSBPCMP - VSBRE
VSBRE_C
VARCHAR2
VSBRE
VARCHAR2
VSBPCMP - VBSGR
VBSGR_C
VARCHAR2
VBSGR
VARCHAR2
VSHRCMP
VSHRCMP_ND
VARCHAR2
VSHRCMP - VSHR
VSHR
NUMBER
VSHR_U
VARCHAR2
VSHRCMP - VSHRE
VSHRE_C
VARCHAR2
VSHRE
VARCHAR2
VSHRCMP - HRSPec
HRSPEC
VARCHAR2
PERES
PERES_C
VARCHAR2
PERES
VARCHAR2
PERES_ND
VARCHAR2
RD_PE_PE3SC
PENUM
PENUM
NUMBER
PENUM_ND
VARCHAR2
PESYSPD
PESYSPD_C
VARCHAR2
PESYSPD
VARCHAR2
PESYSPD_ND
VARCHAR2
PESYSPD - PESYS
PESYS_C
VARCHAR2
PESYS
VARCHAR2
PESYSPD - PEDESOTH
PEDESOTH
VARCHAR2
PERES1
PERES1_C
VARCHAR2
PERES1
VARCHAR2
PERES1_ND
VARCHAR2
PERES1 - PECM
PECM
VARCHAR2
616
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: URINE PREGNANCY TEST (UPREG) [UPREG]
Urine Pregnancy Test [UPREGSC]
1.*

Date of Urine Collection
[Date of Urine Collection] 
[UPREGDT] 
Req
 / Req
 / Req
 (2017-2018)
2.*

Result Reading Time
[Result Reading Time] 
[UPREGTM] 
Req
 : Req
 24-hour clock
3.*

Result:
[Result] 
[UPREGRES] 
[A:1] 
Positive
[A:2] 
Negative
   Key:  [*] = Item is required  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_UPREG
Data Variable RefName RD Column Name Column Data Type
UPREGDT
UPREGDT
DATE
UPREGDT_DTS
VARCHAR2
UPREGDT_ND
VARCHAR2
UPREGTM
UPREGTM
DATE
UPREGTM_TMS
VARCHAR2
UPREGTM_ND
VARCHAR2
UPREGRES
UPREGRES_C
VARCHAR2
UPREGRES
VARCHAR2
UPREGRES_ND
VARCHAR2
617
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: RANDOMIZATION (ELIG) [ELIG]
Subject Eligibility [IE1SC]
1.*

Is the subject eligible?
[Is the subject eligible?] 
[ELIGYN] 
[A:1] 
Yes
[A:2] 
[ELIGRES] 
No; specify any reason/criteria that can make subject ineligible
[A:1] 
[ELIGCMP] 
Not meeting 
inclusion/exclusion: 
Please specify the 
number
[ELIGNUM] 
A200
[A:2] 
Refused to come for screening 
[A:3] 
Study no longer open for enrollment 
[A:4] 
[ELIGOTHC] 
Other; Specify
A200
Randomization [IE2SC]
2.

Was subject RANDOMIZED?
[Was subject RANDOMIZED?] 
[ELIGRANDYN] 
[A:1] 
[ELIGYCMP] 
Yes
[ELIGSUBID] 
Subject Identification:
A5
[A:2] 
[ELIGSFREAS] 
No, specify reason why subject was not randomized:
[A:1] 
Subject has second thoughts and needs more time to consider trial participation
[A:2] 
Withdrew consent
[A:4] 
[ELIGSFREASOTH] 
Other
Please specify details:
A200
   Key:  [*] = Item is required  [] = Source verification required  [] = ASCII Only
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_ELIG
Data Variable RefName
RD Column Name Column Data Type
ELIGYN
ELIGYN_C
VARCHAR2
ELIGYN
VARCHAR2
ELIGYN_ND
VARCHAR2
ELIGYN - ELIGRES
ELIGRES_C
VARCHAR2
ELIGRES
VARCHAR2
ELIGYN - ELIGNUM
ELIGNUM
VARCHAR2
ELIGYN - ELIGOTHC
ELIGOTHC
VARCHAR2
ELIGRANDYN
ELIGRANDYN_C
VARCHAR2
ELIGRANDYN
VARCHAR2
ELIGRANDYN_ND
VARCHAR2
ELIGRANDYN - ELIGSUBID
ELIGSUBID
VARCHAR2
ELIGRANDYN - ELIGSFREAS
ELIGSFREAS_C
VARCHAR2
ELIGSFREAS
VARCHAR2
ELIGRANDYN - ELIGSFREASOTH ELIGSFREASOTH
VARCHAR2




618
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: TARGETED PE (TPE) [TPE]
Targeted PE [TPESC]
1.*

Was the Targeted PE done? 
[Was the Targeted PE done?] 
[PETVSYN] 
[A:1] 
[PETVSDT] 
Yes
Examination Date
Req
 / Req
 / Req
 (2017-2018)
[A:2] 
No
Vital Signs [TPE1SC]
2.

Body temperature (oral)
[Body temperature] 
[VSTEMPCMP1] 
[VSTEMP1] 
xx.x
 °C
[VSTEMPF] 
Finding
[A:1] 
Normal
[A:2] 
Abnormal, NCS
[A:3] 
[VSTEMP1GR] 
Abnormal, CS 
Grading Scale
[A:0] 
Ungradable
[A:1] 
1 (38.0 – <38.6°C) 
[A:2] 
2 (38.6 – <39.3°C)
[A:3] 
3 (39.3 – <40.0°C)
[A:4] 
4 (≥ 40.0°C)
3.

Blood Pressure
[Blood Pressure] 
[VSBPCMP2] 
[VSBPCMP1] 
[SYSBP1] 
N3
 mmHg
Systolic
[DIABP1] 
N3
 mmHg
Diastolic
[VSBPF] 
Finding
[A:1] 
Normal
[A:2] 
Abnormal, NCS
[A:3] 
[VBBPG1] 
Abnormal, CS 
Grading Scale
[A:0] 
0 Ungradable
[A:1] 
1 140 to < 160 mmHg systolic OR 90 to < 100 mmHg diastolic
[A:2] 
2 ≥ 160 to < 180 mmHg systolic OR ≥ 100 to < 110 mmHg diastolic
[A:3] 
3 ≥ 180 mmHg systolic OR ≥110 mmHg diastolic
[A:4] 
4 Life Threatening
4.

Pulse Rate
[Pulse Rate] 
[VSHRCMP1] 
[VSHR1] 
N3
 beats/min
[VSHRF] 
Finding
[A:1] 
Normal
[A:2] 
Abnormal, NCS
[A:3] 
[VSBPSP1] 
Abnormal, CS
Specify:
A200
Targeted Physical Examination [TPE2SC]
5.

Physical examination is not required unless subject reports 
symptoms. Did the subject have any symptoms that required 
evaluation? 
[Did the subject have any symptoms that required evaluation?] 
[PETVSYN1] 
[A:1] 
Yes
[A:2] 
No
If Yes, please complete Abnormal Findings below.
PE number
Area/System
Finding
6.

Abnormal Findings Entry [TPE3SC]
6.1
PE number [read-only]
[PE number] 
[TPENUM]
N3
6.2*

Area/System
[Area/System] 
[TPESYSPD] 
[A:1] 
[TPESYS] 
[clTPESYS]
[A:2] 
[TPEDESOTH] 
Other, specify:
A200
6.3*

Finding
[Finding] 
[TPERES] 
[A:1] 
Abnormal, NCS
[A:2] 
[TPEDES] 
Abnormal, CS 
Specify current medical condition number if Day 1, AE number if other visit
A200
   Key:  [*] = Item is required  [] = Source verification required  [b] = Base Unit  [] = ASCII Only
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
Codelist Values Tables: TARGETED PE
Codelist RefName Codelist Data Type Label
Code Codelist Item RefName Data Variable RefName
clTPESYS
String
ENT
1
citmTPESYS1
TPESYS
Neurological
2
citmTPESYS2
Chest auscultation 3
citmTPESYS3
Heart auscultation
4
citmTPESYS4
Abdomen
5
citmTPESYS5
Lymph nodes
6
citmTPESYS6
[b]
[b]
[b]
[b]



619
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

RDE Analytics: RD_TPE
Data Variable RefName
RD Column Name Column Data Type
PETVSYN
PETVSYN_C
VARCHAR2
PETVSYN
VARCHAR2
PETVSYN_ND
VARCHAR2
PETVSYN - PETVSDT
PETVSDT
DATE
PETVSDT_DTS
VARCHAR2
VSTEMPCMP1
VSTEMPCMP1_ND
VARCHAR2
VSTEMPCMP1 - VSTEMP1
VSTEMP1
FLOAT
VSTEMP1_U
VARCHAR2
VSTEMPCMP1 - VSTEMPF
VSTEMPF_C
VARCHAR2
VSTEMPF
VARCHAR2
VSTEMPCMP1 - VSTEMP1GR VSTEMP1GR_C
VARCHAR2
VSTEMP1GR
VARCHAR2
VSBPCMP2
VSBPCMP2_ND
VARCHAR2
VSBPCMP2 - SYSBP1
SYSBP1
NUMBER
SYSBP1_U
VARCHAR2
VSBPCMP2 - DIABP1
DIABP1
NUMBER
DIABP1_U
VARCHAR2
VSBPCMP2 - VSBPF
VSBPF_C
VARCHAR2
VSBPF
VARCHAR2
VSBPCMP2 - VBBPG1
VBBPG1_C
VARCHAR2
VBBPG1
VARCHAR2
VSHRCMP1
VSHRCMP1_ND
VARCHAR2
VSHRCMP1 - VSHR1
VSHR1
NUMBER
VSHR1_U
VARCHAR2
VSHRCMP1 - VSHRF
VSHRF_C
VARCHAR2
VSHRF
VARCHAR2
VSHRCMP1 - VSBPSP1
VSBPSP1
VARCHAR2
PETVSYN1
PETVSYN1_C
VARCHAR2
PETVSYN1
VARCHAR2
PETVSYN1_ND
VARCHAR2
RD_TPE_TPE3SC
TPENUM
TPENUM
NUMBER
TPENUM_ND
VARCHAR2
TPESYSPD
TPESYSPD_C
VARCHAR2
TPESYSPD
VARCHAR2
TPESYSPD_ND
VARCHAR2
TPESYSPD - TPESYS
TPESYS_C
VARCHAR2
TPESYS
VARCHAR2
TPESYSPD - TPEDESOTH
TPEDESOTH
VARCHAR2
TPERES
TPERES_C
VARCHAR2
TPERES
VARCHAR2
TPERES_ND
VARCHAR2
TPERES - TPEDES
TPEDES
VARCHAR2
620
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: ANTI-INFLUENZA SEROLOGIC ASSAY (ANTI INF SER) [AISA]
Anti-Influenza Serologic Assay [AISASC]
1.*

Was the blood sample collected?
[Was the blood sample collected?] 
[AISPERF] 
[A:1] 
[AISADT] 
Yes
Date and Time of blood collection
Req
 / Req
 / Req
 (2017-2018)
Req
: Req
 24-hour clock
[A:2] 
No
   Key:  [*] = Item is required  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_AISA
Data Variable RefName RD Column Name Column Data Type
AISPERF
AISPERF_C
VARCHAR2
AISPERF
VARCHAR2
AISPERF_ND
VARCHAR2
AISPERF - AISADT
AISADT
DATE
AISADT_DTS
VARCHAR2
621
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: VACCINATION (VAC) [VAC]
Subject Vaccination [VAC3SC]
1.*

Was the subject given an injection of the study product at this 
visit?
[Was the subject given an injection of the study product at this 
visit?] 
[VACCYN] 
[A:1] 
Yes
[A:2] 
[VACOTH] 
No
please specify reason and please complete Day 1 visit.
A200
Randomization Code [VAC1SC]
2.

Study product code:
[Study product code] 
[ELIGPROD] 
A5
Vaccination [VAC2SC]
3.

Date and Time of Vaccination
[Date and Time of Vaccination] 
[VACDT] 
Req
 / Req
 / Req
 (2017-2018)
Req
 : Req
 24-hour clock
4.

In which arm was the injection given?
[In which arm was the injection given?] 
[VACARM] 
[A:1] 
Left
[A:2] 
Right
   Key:  [] = Source verification required  [] = ASCII Only
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_VAC
Data Variable RefName RD Column Name Column Data Type
VACCYN
VACCYN_C
VARCHAR2
VACCYN
VARCHAR2
VACCYN_ND
VARCHAR2
VACCYN - VACOTH
VACOTH
VARCHAR2
ELIGPROD
ELIGPROD
VARCHAR2
ELIGPROD_ND
VARCHAR2
VACDT
VACDT
DATE
VACDT_DTS
VARCHAR2
VACDT_ND
VARCHAR2
VACARM
VACARM_C
VARCHAR2
VACARM
VARCHAR2
VACARM_ND
VARCHAR2


622
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: 30-MINUTE REACTOGENICITY (ROG) [ROG]
30 Minutes [ROG4SC]
1.*

Temperature
[Temperature] 
[ROGTEMCO] 
[ROGTEMP30] 
Temperature (oral) xx.x
 °C
[ROGTEMFD] 
Finding [A:1] 
Normal
[A:2] 
Abnormal, NCS
[A:3] 
[ROGYGS30] 
Abnormal, CS 
Grading Scale
[A:0] 
Ungradable
[A:1] 
1 (38.0 – <38.6°C) 
[A:2] 
2 (38.6 – <39.3°C)
[A:3] 
3 (39.3 – <40.0°C)
[A:4] 
4 (≥ 40.0°C)
2.*

Any local / systemic reaction?
[Any local / systemic reaction?] 
[ROGYN30] 
[A:2] 
No
[A:1] 
Yes
(If Yes, complete below)
30 Minutes Local Reactions [ROG5SC]
3.

Redness (cm)
[Redness] 
[ROGREDPD30] 
[A:1] 
None
[A:2] 
[ROGRED30CO] 
[ROGRED30] 
xx.x
 cm
[ROGRED30GR] 
Grade [A:0] 
Ungradable
[A:1] 
1, 2.5 to < 5 cm in diameter
[A:2] 
2, 5 to < 10 cm in diameter
[A:3] 
3, >= 10 cm in diameter
[A:4] 
4, Necrosis, or exfoliative dermatitis (for redness)
4.

Swelling (cm)
[Swelling] 
[ROGSWELLPD30] 
[A:1] 
None
[A:2] 
[ROGSWE30CO] 
[ROGSWELL30] 
xx.x
 cm
[ROGSWE30GR] 
Grade [A:0] 
Ungradable
[A:1] 
1, 2.5 to < 5 cm in diameter
[A:2] 
2, 5 to < 10 cm in diameter
[A:3] 
3, >= 10 cm in diameter
[A:4] 
4, Necrosis, or exfoliative dermatitis (for redness)
5.

Induration (hardness) (cm)
[Induration] 
[ROGINDPD30] 
[A:1] 
None
[A:2] 
[ROGIND30CO] 
[ROGIND30] 
xx.x
cm
[ROGIND30GR] 
Grade [A:0] 
Ungradable
[A:1] 
1, 2.5 to < 5 cm in diameter
[A:2] 
2, 5 to < 10 cm in diameter
[A:3] 
3, >= 10 cm in diameter
[A:4] 
4, Necrosis, or exfoliative dermatitis (for redness)
6.

Pain
[Pain] 
[ROGPAIN30] 
[clROGRES]
7.

Tenderness
[Tenderness] 
[ROGTEND30] 
[clROGRES]
30 Minutes Systemic Reactions [ROG6SC]
8.

Fatigue/Malaise
[Fatigue/Malaise] 
[ROGTIRED30] 
[clROGRES]
9.

Generalized Muscle Aches
[Generalized Muscle Aches] 
[ROGMUSCLE30]
[clROGRES]
10.

Joint Aches
[Joint Aches] 
[ROGJOINT30] 
[clROGRES]
11.

Chills
[Chills] 
[ROGCHILLS30]
[clROGRES]
12.

Nausea
[Nausea] 
[ROGNAUSEA30]
[clROGRES]
13.

Vomiting
[Vomiting] 
[ROGVOM30] 
[clROGRES]
14.

Headache
[Headache] 
[ROGHEAD30] 
[clROGRES]
   Key:  [] = Source verification required  [b] = Base Unit
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
Codelist Values Tables: 30-MINUTE REACTOGENICITY
Codelist RefName Codelist Data Type Label
Code Codelist Item RefName Data Variable RefName
clROGRES
String
0, None
1
citmROGRES1
ROGPAIN30, 
ROGTEND30, 
ROGTIRED30, 
ROGMUSCLE30, 
ROGJOINT30, 
ROGCHILLS30, 
ROGNAUSEA30, 
ROGVOM30, 
ROGHEAD30
1, Mild
2
citmROGRES2
2, Moderate
3
citmROGRES3
3, Severe
4
CITMROGRES4
4, Potentially Life Threatening 5
citmRoGERRE5
RDE Analytics: RD_ROG
Data Variable RefName
RD Column Name
Column Data Type
ROGTEMCO
ROGTEMCO_ND
VARCHAR2
ROGTEMCO - ROGTEMP30
ROGTEMP30
FLOAT
[b]
[b]
[b]
[b]
623
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

ROGTEMP30_U
VARCHAR2
ROGTEMCO - ROGTEMFD
ROGTEMFD_C
VARCHAR2
ROGTEMFD
VARCHAR2
ROGTEMCO - ROGYGS30
ROGYGS30_C
VARCHAR2
ROGYGS30
VARCHAR2
ROGYN30
ROGYN30_C
VARCHAR2
ROGYN30
VARCHAR2
ROGYN30_ND
VARCHAR2
ROGREDPD30
ROGREDPD30_C
VARCHAR2
ROGREDPD30
VARCHAR2
ROGREDPD30_ND
VARCHAR2
ROGREDPD30 - ROGRED30
ROGRED30
FLOAT
ROGRED30_U
VARCHAR2
ROGREDPD30 - ROGRED30GR
ROGRED30GR_C
VARCHAR2
ROGRED30GR
VARCHAR2
ROGSWELLPD30
ROGSWELLPD30_C
VARCHAR2
ROGSWELLPD30
VARCHAR2
ROGSWELLPD30_ND VARCHAR2
ROGSWELLPD30 - ROGSWELL30
ROGSWELL30
FLOAT
ROGSWELL30_U
VARCHAR2
ROGSWELLPD30 - ROGSWE30GR ROGSWE30GR_C
VARCHAR2
ROGSWE30GR
VARCHAR2
ROGINDPD30
ROGINDPD30_C
VARCHAR2
ROGINDPD30
VARCHAR2
ROGINDPD30_ND
VARCHAR2
ROGINDPD30 - ROGIND30
ROGIND30
FLOAT
ROGIND30_U
VARCHAR2
ROGINDPD30 - ROGIND30GR
ROGIND30GR_C
VARCHAR2
ROGIND30GR
VARCHAR2
ROGPAIN30
ROGPAIN30_C
VARCHAR2
ROGPAIN30
VARCHAR2
ROGPAIN30_ND
VARCHAR2
ROGTEND30
ROGTEND30_C
VARCHAR2
ROGTEND30
VARCHAR2
ROGTEND30_ND
VARCHAR2
ROGTIRED30
ROGTIRED30_C
VARCHAR2
ROGTIRED30
VARCHAR2
ROGTIRED30_ND
VARCHAR2
ROGMUSCLE30
ROGMUSCLE30_C
VARCHAR2
ROGMUSCLE30
VARCHAR2
ROGMUSCLE30_ND
VARCHAR2
ROGJOINT30
ROGJOINT30_C
VARCHAR2
ROGJOINT30
VARCHAR2
ROGJOINT30_ND
VARCHAR2
ROGCHILLS30
ROGCHILLS30_C
VARCHAR2
ROGCHILLS30
VARCHAR2
ROGCHILLS30_ND
VARCHAR2
ROGNAUSEA30
ROGNAUSEA30_C
VARCHAR2
ROGNAUSEA30
VARCHAR2
ROGNAUSEA30_ND
VARCHAR2
ROGVOM30
ROGVOM30_C
VARCHAR2
ROGVOM30
VARCHAR2
ROGVOM30_ND
VARCHAR2
ROGHEAD30
ROGHEAD30_C
VARCHAR2
ROGHEAD30
VARCHAR2
ROGHEAD30_ND
VARCHAR2
624
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: Contact (TELECONT) [TELECONT]
Contact [TELECONT]
1.*

Date of contact
[Date of contact] 
[TELEDATE] 
Req
 / Req
 / Req
 (2017-2018)
2.*

Subject Contacted?
[Subject Contacted?] 
[TELEYN] 
[A:1] 
Yes
[A:2] 
No
   Key:  [*] = Item is required  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
Study Object Descriptions: Contact
Type
RefName
Description
Form
TELECONT
CONTACT
RDE Analytics: RD_TELECONT
Data Variable RefName RD Column Name Column Data Type
TELEDATE
TELEDATE
DATE
TELEDATE_DTS
VARCHAR2
TELEDATE_ND
VARCHAR2
TELEYN
TELEYN_C
VARCHAR2
TELEYN
VARCHAR2
TELEYN_ND
VARCHAR2
625
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: SOLICITED LOCAL REACTOGENICITY (LOCAL) [SLR]
Completed based on Memory Aids and Interview with Subject
Local Reactogenicity [SLRSC]
1.*

Did the subject report any local reactogenicity during Days 1 to 7?
[Did the subject report any local reactogenicity during Days 1 to 7?] 
[SLRYN] 
[A:1] 
Yes
[A:2] 
No
Pain at injection site [SLR2SC]
2.

Pain at injection site
[Pain at injection site] 
[SLRPAINWK] 
[A:1] 
None all week
3.

Evening Day 1
[Day 1 Pain at injection site] 
[SLRPAIND1] 
[clROGRES]
4.

Day 2
[Day 2 Pain at injection site] 
[SLRPAIND2] 
[clROGRES]
5.

Day 3
[Day 3 Pain at injection site] 
[SLRPAIND3] 
[clROGRES]
6.

Day 4
[Day 4 Pain at injection site] 
[SLRPAIND4] 
[clROGRES]
7.

Day 5
[Day 5 Pain at injection site] 
[SLRPAIND5] 
[clROGRES]
8.

Day 6
[Day 6 Pain at injection site] 
[SLRPAIND6] 
[clROGRES]
9.

Day 7
[Day 7 Pain at injection site] 
[SLRPAIND7] 
[clROGRES]
10.

After Day 7: Ongoing?
[Ongoing] 
[SLRPAINONG] 
[A:2] 
No
[A:1] 
[SLRPAINONGCMP] 
Yes
[SLRPAINSEV] 
Highest severity until resolution: [clSEV]
[SLRPAINEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
Tenderness at injection site [SLR3SC]
11.

Tenderness at injection site
[Tenderness at injection site] 
[SLRTENDWK] 
[A:1] 
None all week
12.

Evening Day 1
[Day 1 Tenderness at injection site] 
[SLRTENDD1] 
[clROGRES]
13.

Day 2
[Day 2 Tenderness at injection site] 
[SLRTENDD2] 
[clROGRES]
14.

Day 3
[Day 3 Tenderness at injection site] 
[SLRTENDD3] 
[clROGRES]
15.

Day 4
[Day 4 Tenderness at injection site] 
[SLRTENDD4] 
[clROGRES]
16.

Day 5
[Day 5 Tenderness at injection site] 
[SLRTENDD5] 
[clROGRES]
17.

Day 6
[Day 6 Tenderness at injection site] 
[SLRTENDD6] 
[clROGRES]
18.

Day 7
[Day 7 Tenderness at injection site] 
[SLRTENDD7] 
[clROGRES]
19.

After Day 7: Ongoing?
[Ongoing] 
[SLRTENDONG] 
[A:2] 
No
[A:1] 
[SLRTENDONGCMP] 
Yes
[SLRTENDSEV] 
Highest severity until resolution: [clSEV]
[SLRTENDEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
Redness at injection site [SLR4SC]
20.

Redness at injection site
[Redness at injection site] 
[SLRREDWK] 
[A:1] 
None all week
21.

Evening Day 1
[Day 1 Redness at injection site] 
[SLRREDD1] 
[clROGRES]
22.

Day 2
[Day 2 Redness at injection site] 
[SLRREDD2] 
[clROGRES]
23.

Day 3
[Day 3 Redness at injection site] 
[SLRREDD3] 
[clROGRES]
24.

Day 4
[Day 4 Redness at injection site] 
[SLRREDD4] 
[clROGRES]
25.

Day 5
[Day 5 Redness at injection site] 
[SLRREDD5] 
[clROGRES]
26.

Day 6
[Day 6 Redness at injection site] 
[SLRREDD6] 
[clROGRES]
27.

Day 7
[Day 7 Redness at injection site] 
[SLRREDD7] 
[clROGRES]
28.

After Day 7: Ongoing?
[Ongoing] 
[SLRREDONG] 
[A:2] 
No
[A:1] 
[SLRREDONGCMP] 
Yes
[SLRREDSEV]
Highest severity until resolution: [clSEV]
[SLRREDEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
Swelling at injection site [SLR5SC]
29.

Swelling at injection site
[Swelling at injection site] 
[SLRSWELLWK] 
[A:1] 
None all week
30.

Evening Day 1
[Day 1 Swelling at injection site] 
[SLRSWELLD1] 
[clROGRES]
626
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

31.

Day 2
[Day 2 Swelling at injection site] 
[SLRSWELLD2] 
[clROGRES]
32.

Day 3
[Day 3 Swelling at injection site] 
[SLRSWELLD3] 
[clROGRES]
33.

Day 4
[Day 4 Swelling at injection site] 
[SLRSWELLD4] 
[clROGRES]
34.

Day 5
[Day 5 Swelling at injection site] 
[SLRSWELLD5] 
[clROGRES]
35.

Day 6
[Day 6 Swelling at injection site] 
[SLRSWELLD6] 
[clROGRES]
36.

Day 7
[Day 7 Swelling at injection site] 
[SLRSWELLD7] 
[clROGRES]
37.

After Day 7: Ongoing?
[Ongoing] 
[SLRSWELLONG] 
[A:2] 
No
[A:1] 
[SLRSWELLONGCMP] 
Yes
[SLRSWELLSEV]
Highest severity until resolution: [clSEV]
[SLRSWELLEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
Hardness at injection site [SLR6SC]
38.

Hardness at injection site
[Hardness at injection site] 
[SLRINDWK] 
[A:1] 
None all week
39.

Evening Day 1
[Day 1 Hardness at injection site] 
[SLRINDD1] 
[clROGRES]
40.

Day 2
[Day 2 Hardness at injection site] 
[SLRINDD2] 
[clROGRES]
41.

Day 3
[Day 3 Hardness at injection site] 
[SLRINDD3] 
[clROGRES]
42.

Day 4
[Day 4 Hardness at injection site] 
[SLRINDD4] 
[clROGRES]
43.

Day 5
[Day 5 Hardness at injection site] 
[SLRINDD5] 
[clROGRES]
44.

Day 6
[Day 6 Hardness at injection site] 
[SLRINDD6] 
[clROGRES]
45.

Day 7
[Day 7 Hardness at injection site] 
[SLRINDD7] 
[clROGRES]
46.

After Day 7: Ongoing?
[Ongoing] 
[SLRINDONG] 
[A:2] 
No
[A:1] 
[SLRINDONGCMP] 
Yes
[SLRINDSEV] 
Highest severity until resolution: [clSEV]
[SLRINDEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
   Key:  [*] = Item is required  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
Codelist Values Tables: SOLICITED LOCAL REACTOGENICITY
Codelist RefName Codelist Data Type Label
Code Codelist Item RefName Data Variable RefName
clROGRES
String
0, None
1
citmROGRES1
SLRPAIND1, 
SLRPAIND2, 
SLRPAIND3, 
SLRPAIND4, 
SLRPAIND5, 
SLRPAIND6, 
SLRPAIND7, 
SLRTENDD1, 
SLRTENDD2, 
SLRTENDD3, 
SLRTENDD4, 
SLRTENDD5, 
SLRTENDD6, 
SLRTENDD7, 
SLRREDD1, 
SLRREDD2, 
SLRREDD3, 
SLRREDD4, 
SLRREDD5, 
SLRREDD6, 
SLRREDD7, 
SLRSWELLD1, 
SLRSWELLD2, 
SLRSWELLD3, 
SLRSWELLD4, 
SLRSWELLD5, 
SLRSWELLD6, 
SLRSWELLD7, 
SLRINDD1, 
SLRINDD2, 
SLRINDD3, 
SLRINDD4, 
SLRINDD5, 
SLRINDD6, 
SLRINDD7
1, Mild
2
citmROGRES2
2, Moderate
3
citmROGRES3
3, Severe
4
CITMROGRES4
4, Potentially Life Threatening 5
citmRoGERRE5
clSEV
String
Grade 1
1
citmSEV1
SLRPAINSEV, 
SLRTENDSEV, 
SLRREDSEV, 
SLRSWELLSEV, 
SLRINDSEV
Grade 2
2
citmSEV2
Grade 3
3
citmSEV3
Grade 4
4
citmSEV4
RDE Analytics: RD_SLR
Data Variable RefName
RD Column Name
Column Data Type
SLRYN
SLRYN_C
VARCHAR2
SLRYN
VARCHAR2
SLRYN_ND
VARCHAR2
627
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

SLRPAINWK
SLRPAINWK_C
VARCHAR2
SLRPAINWK
VARCHAR2
SLRPAINWK_ND
VARCHAR2
SLRPAIND1
SLRPAIND1_C
VARCHAR2
SLRPAIND1
VARCHAR2
SLRPAIND1_ND
VARCHAR2
SLRPAIND2
SLRPAIND2_C
VARCHAR2
SLRPAIND2
VARCHAR2
SLRPAIND2_ND
VARCHAR2
SLRPAIND3
SLRPAIND3_C
VARCHAR2
SLRPAIND3
VARCHAR2
SLRPAIND3_ND
VARCHAR2
SLRPAIND4
SLRPAIND4_C
VARCHAR2
SLRPAIND4
VARCHAR2
SLRPAIND4_ND
VARCHAR2
SLRPAIND5
SLRPAIND5_C
VARCHAR2
SLRPAIND5
VARCHAR2
SLRPAIND5_ND
VARCHAR2
SLRPAIND6
SLRPAIND6_C
VARCHAR2
SLRPAIND6
VARCHAR2
SLRPAIND6_ND
VARCHAR2
SLRPAIND7
SLRPAIND7_C
VARCHAR2
SLRPAIND7
VARCHAR2
SLRPAIND7_ND
VARCHAR2
SLRPAINONG
SLRPAINONG_C
VARCHAR2
SLRPAINONG
VARCHAR2
SLRPAINONG_ND
VARCHAR2
SLRPAINONG - SLRPAINSEV
SLRPAINSEV_C
VARCHAR2
SLRPAINSEV
VARCHAR2
SLRPAINONG - SLRPAINEDAT
SLRPAINEDAT
DATE
SLRPAINEDAT_DTS
VARCHAR2
SLRTENDWK
SLRTENDWK_ND
VARCHAR2
SLRTENDWK - None all week
SLRTENDWK_CITMNONEWEEK1_C
VARCHAR2
SLRTENDWK_CITMNONEWEEK1
VARCHAR2
SLRTENDD1
SLRTENDD1_C
VARCHAR2
SLRTENDD1
VARCHAR2
SLRTENDD1_ND
VARCHAR2
SLRTENDD2
SLRTENDD2_C
VARCHAR2
SLRTENDD2
VARCHAR2
SLRTENDD2_ND
VARCHAR2
SLRTENDD3
SLRTENDD3_C
VARCHAR2
SLRTENDD3
VARCHAR2
SLRTENDD3_ND
VARCHAR2
SLRTENDD4
SLRTENDD4_C
VARCHAR2
SLRTENDD4
VARCHAR2
SLRTENDD4_ND
VARCHAR2
SLRTENDD5
SLRTENDD5_C
VARCHAR2
SLRTENDD5
VARCHAR2
SLRTENDD5_ND
VARCHAR2
SLRTENDD6
SLRTENDD6_C
VARCHAR2
SLRTENDD6
VARCHAR2
SLRTENDD6_ND
VARCHAR2
SLRTENDD7
SLRTENDD7_C
VARCHAR2
SLRTENDD7
VARCHAR2
SLRTENDD7_ND
VARCHAR2
SLRTENDONG
SLRTENDONG_C
VARCHAR2
SLRTENDONG
VARCHAR2
SLRTENDONG_ND
VARCHAR2
SLRTENDONG - SLRTENDSEV
SLRTENDSEV_C
VARCHAR2
SLRTENDSEV
VARCHAR2
SLRTENDONG - SLRTENDEDAT
SLRTENDEDAT
DATE
SLRTENDEDAT_DTS
VARCHAR2
SLRREDWK
SLRREDWK_ND
VARCHAR2
SLRREDWK - None all week
SLRREDWK_CITMNONEWEEK1_C
VARCHAR2
SLRREDWK_CITMNONEWEEK1
VARCHAR2
SLRREDD1
SLRREDD1_C
VARCHAR2
SLRREDD1
VARCHAR2
SLRREDD1_ND
VARCHAR2
SLRREDD2
SLRREDD2_C
VARCHAR2
SLRREDD2
VARCHAR2
SLRREDD2_ND
VARCHAR2
SLRREDD3
SLRREDD3_C
VARCHAR2
SLRREDD3
VARCHAR2
SLRREDD3_ND
VARCHAR2
SLRREDD4
SLRREDD4_C
VARCHAR2
SLRREDD4
VARCHAR2
SLRREDD4_ND
VARCHAR2
SLRREDD5
SLRREDD5_C
VARCHAR2
SLRREDD5
VARCHAR2
628
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

SLRREDD5_ND
VARCHAR2
SLRREDD6
SLRREDD6_C
VARCHAR2
SLRREDD6
VARCHAR2
SLRREDD6_ND
VARCHAR2
SLRREDD7
SLRREDD7_C
VARCHAR2
SLRREDD7
VARCHAR2
SLRREDD7_ND
VARCHAR2
SLRREDONG
SLRREDONG_C
VARCHAR2
SLRREDONG
VARCHAR2
SLRREDONG_ND
VARCHAR2
SLRREDONG - SLRREDSEV
SLRREDSEV_C
VARCHAR2
SLRREDSEV
VARCHAR2
SLRREDONG - SLRREDEDAT
SLRREDEDAT
DATE
SLRREDEDAT_DTS
VARCHAR2
SLRSWELLWK
SLRSWELLWK_ND
VARCHAR2
SLRSWELLWK - None all week
SLRSWELLWK_CITMNONEWEEK1_C VARCHAR2
SLRSWELLWK_CITMNONEWEEK1
VARCHAR2
SLRSWELLD1
SLRSWELLD1_C
VARCHAR2
SLRSWELLD1
VARCHAR2
SLRSWELLD1_ND
VARCHAR2
SLRSWELLD2
SLRSWELLD2_C
VARCHAR2
SLRSWELLD2
VARCHAR2
SLRSWELLD2_ND
VARCHAR2
SLRSWELLD3
SLRSWELLD3_C
VARCHAR2
SLRSWELLD3
VARCHAR2
SLRSWELLD3_ND
VARCHAR2
SLRSWELLD4
SLRSWELLD4_C
VARCHAR2
SLRSWELLD4
VARCHAR2
SLRSWELLD4_ND
VARCHAR2
SLRSWELLD5
SLRSWELLD5_C
VARCHAR2
SLRSWELLD5
VARCHAR2
SLRSWELLD5_ND
VARCHAR2
SLRSWELLD6
SLRSWELLD6_C
VARCHAR2
SLRSWELLD6
VARCHAR2
SLRSWELLD6_ND
VARCHAR2
SLRSWELLD7
SLRSWELLD7_C
VARCHAR2
SLRSWELLD7
VARCHAR2
SLRSWELLD7_ND
VARCHAR2
SLRSWELLONG
SLRSWELLONG_C
VARCHAR2
SLRSWELLONG
VARCHAR2
SLRSWELLONG_ND
VARCHAR2
SLRSWELLONG - SLRSWELLSEV
SLRSWELLSEV_C
VARCHAR2
SLRSWELLSEV
VARCHAR2
SLRSWELLONG - SLRSWELLEDAT SLRSWELLEDAT
DATE
SLRSWELLEDAT_DTS
VARCHAR2
SLRINDWK
SLRINDWK_ND
VARCHAR2
SLRINDWK - None all week
SLRINDWK_CITMNONEWEEK1_C
VARCHAR2
SLRINDWK_CITMNONEWEEK1
VARCHAR2
SLRINDD1
SLRINDD1_C
VARCHAR2
SLRINDD1
VARCHAR2
SLRINDD1_ND
VARCHAR2
SLRINDD2
SLRINDD2_C
VARCHAR2
SLRINDD2
VARCHAR2
SLRINDD2_ND
VARCHAR2
SLRINDD3
SLRINDD3_C
VARCHAR2
SLRINDD3
VARCHAR2
SLRINDD3_ND
VARCHAR2
SLRINDD4
SLRINDD4_C
VARCHAR2
SLRINDD4
VARCHAR2
SLRINDD4_ND
VARCHAR2
SLRINDD5
SLRINDD5_C
VARCHAR2
SLRINDD5
VARCHAR2
SLRINDD5_ND
VARCHAR2
SLRINDD6
SLRINDD6_C
VARCHAR2
SLRINDD6
VARCHAR2
SLRINDD6_ND
VARCHAR2
SLRINDD7
SLRINDD7_C
VARCHAR2
SLRINDD7
VARCHAR2
SLRINDD7_ND
VARCHAR2
SLRINDONG
SLRINDONG_C
VARCHAR2
SLRINDONG
VARCHAR2
SLRINDONG_ND
VARCHAR2
SLRINDONG - SLRINDSEV
SLRINDSEV_C
VARCHAR2
SLRINDSEV
VARCHAR2
SLRINDONG - SLRINDEDAT
SLRINDEDAT
DATE
SLRINDEDAT_DTS
VARCHAR2
629
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: SOLICITED SYSTEMIC REACTOGENICITY (SYSTEMIC) [SSR]
Systemic Reactogenicity [SSRSC]
1.*

Did the subject report any systemic reactogenicity during Days 1 to 7?
[Did the subject report any systemic reactogenicity during Days 1 to 7?] 
[SSRYN] 
[A:1] 
Yes
[A:2] 
No
Temperature (oral) [SLR1SC_1]
2.*

Evening Day 1
[Day 1 Temperature] 
[SLRTEMPD1_1] 
xx.x
 °C
3.*

Day 2
[Day 2 Temperature] 
[SLRTEMPD2_1] 
xx.x
 °C
4.*

Day 3
[Day 3 Temperature] 
[SLRTEMPD3_1] 
xx.x
 °C
5.*

Day 4
[Day 4 Temperature] 
[SLRTEMPD4_1] 
xx.x
 °C
6.*

Day 5
[Day 5 Temperature] 
[SLRTEMPD5_1] 
xx.x
 °C
7.*

Day 6
[Day 6 Temperature] 
[SLRTEMPD6_1] 
xx.x
 °C
8.*

Day 7
[Day 7 Temperature] 
[SLRTEMPD7_1] 
xx.x
 °C
9.*

After Day 7: Ongoing?
[Ongoing] 
[SLRTEMPONG_1] 
[A:2] 
No
[A:1] 
[SLRTEMPONGCMP_1] 
Yes [SLRTEMPSEV_1] 
Highest severity until resolution:
[A:0] 
Ungradable
[A:1] 
1 (38.0 – <38.6°C) 
[A:2] 
2 (38.6 – <39.3°C)
[A:3] 
3 (39.3 – <40.0°C)
[A:4] 
4 (≥ 40.0°C)
[SLRTEMPEDAT_1] 
End date Req
 / Req
 / Req
 (2017-2018)
Fatigue/Malaise [SSR1SC]
10.

Fatigue/Malaise
[Fatigue/Malaise] 
[SSRTIREDWK] 
[A:1] 
None all week
11.

Evening Day 1
[Day 1 Fatigue/Malaise] 
[SSRTIREDD1] 
[clROGRES]
12.

Day 2
[Day 2 Fatigue/Malaise] 
[SSRTIREDD2] 
[clROGRES]
13.

Day 3
[Day 3 Fatigue/Malaise] 
[SSRTIREDD3] 
[clROGRES]
14.

Day 4
[Day 4 Fatigue/Malaise] 
[SSRTIREDD4] 
[clROGRES]
15.

Day 5
[Day 5 Fatigue/Malaise] 
[SSRTIREDD5] 
[clROGRES]
16.

Day 6
[Day 6 Fatigue/Malaise] 
[SSRTIREDD6] 
[clROGRES]
17.

Day 7
[Day 7 Fatigue/Malaise] 
[SSRTIREDD7] 
[clROGRES]
18.

After Day 7: Ongoing?
[Ongoing] 
[SSRTIREDONG] 
[A:2] 
No
[A:1] 
[SSRTIREDCMP] 
Yes
[SSRTIREDSEV]
Highest severity until resolution: [clSEV]
[SSRTIREDEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
Generalized Muscle Aches [SSR2SC]
19.

Generalized Muscle Aches
[Generalized Muscle Aches] 
[SSRMUSWK] 
[A:1] 
None all week
20.

Evening Day 1
[Day 1 Generalized Muscle Aches] 
[SSRMUSD1] 
[clROGRES]
21.

Day 2
[Day 2 Generalized Muscle Aches] 
[SSRMUSD2] 
[clROGRES]
22.

Day 3
[Day 3 Generalized Muscle Aches] 
[SSRMUSD3] 
[clROGRES]
23.

Day 4
[Day 4 Generalized Muscle Aches] 
[SSRMUSD4] 
[clROGRES]
24.

Day 5
[Day 5 Generalized Muscle Aches] 
[SSRMUSD5] 
[clROGRES]
25.

Day 6
[Day 6 Generalized Muscle Aches] 
[SSRMUSD6] 
[clROGRES]
26.

Day 7
[Day 7 Generalized Muscle Aches] 
[SSRMUSD7] 
[clROGRES]
27.

After Day 7: Ongoing?
[Ongoing] 
[SSRMUSONG] 
[A:2] 
No
[A:1] 
[SSRMUSONGCMP] 
Yes
[SSRMUSSEV]
Highest severity until resolution: [clSEV]
[SSRMUSEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
Joint Aches [SSR3SC]
28.

Joint Aches
[Joint Aches] 
[SSRJNTWK] 
[A:1] 
None all week
29. Evening Day 1
[SSRJNTD1] 
[b]
[b]
[b]
[b]
[b]
[b]
[b]
630
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018


[Day 1 Joint Aches] 
[clROGRES]
30.

Day 2
[Day 2 Joint Aches] 
[SSRJNTD2] 
[clROGRES]
31.

Day 3
[Day 3 Joint Aches] 
[SSRJNTD3] 
[clROGRES]
32.

Day 4
[Day 4 Joint Aches] 
[SSRJNTD4] 
[clROGRES]
33.

Day 5
[Day 5 Joint Aches] 
[SSRJNTD5] 
[clROGRES]
34.

Day 6
[Day 6 Joint Aches] 
[SSRJNTD6] 
[clROGRES]
35.

Day 7
[Day 7 Joint Aches] 
[SSRJNTD7] 
[clROGRES]
36.

After Day 7: Ongoing?
[Ongoing] 
[SSRJNTONG] 
[A:2] 
No
[A:1] 
[SSRJNTONGCMP] 
Yes
[SSRJNTSEV]
Highest severity until resolution: [clSEV]
[SSRJNTEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
Chills [SSR4SC]
37.

Chills
[Chills] 
[SSRCHILWK] 
[A:1] 
None all week
38.

Evening Day 1
[Day 1 Chills] 
[SSRCHILD1] 
[clROGRES]
39.

Day 2
[Day 2 Chills] 
[SSRCHILD2] 
[clROGRES]
40.

Day 3
[Day 3 Chills] 
[SSRCHILD3] 
[clROGRES]
41.

Day 4
[Day 4 Chills] 
[SSRCHILD4] 
[clROGRES]
42.

Day 5
[Day 5 Chills] 
[SSRCHILD5] 
[clROGRES]
43.

Day 6
[Day 6 Chills] 
[SSRCHILD6] 
[clROGRES]
44.

Day 7
[Day 7 Chills] 
[SSRCHILD7] 
[clROGRES]
45.

After Day 7: Ongoing?
[Ongoing] 
[SSRCHILONG] 
[A:2] 
No
[A:1] 
[SSRCHILONGCMP] 
Yes
[SSRCHILSEV]
Highest severity until resolution: [clSEV]
[SSRCHILEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
Nausea [SSR5SC]
46.

Nausea
[Nausea] 
[SSRNAUWK] 
[A:1] 
None all week
47.

Evening Day 1
[Day 1 Nausea] 
[SSRNAUD1] 
[clROGRES]
48.

Day 2
[Day 2 Nausea] 
[SSRNAUD2] 
[clROGRES]
49.

Day 3
[Day 3 Nausea] 
[SSRNAUD3] 
[clROGRES]
50.

Day 4
[Day 4 Nausea] 
[SSRNAUD4] 
[clROGRES]
51.

Day 5
[Day 5 Nausea] 
[SSRNAUD5] 
[clROGRES]
52.

Day 6
[Day 6 Nausea] 
[SSRNAUD6] 
[clROGRES]
53.

Day 7
[Day 7 Nausea] 
[SSRNAUD7] 
[clROGRES]
54.

After Day 7: Ongoing?
[Ongoing] 
[SSRNAUONG] 
[A:2] 
No
[A:1] 
[SSRNAUONGCMP] 
Yes
[SSRNAUSEV]
Highest severity until resolution: [clSEV]
[SSRNAUEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
Vomiting [SSR6SC]
55.

Vomiting
[Vomiting] 
[SSRVOMWK] 
[A:1] 
None all week
56.

Evening Day 1
[Day 1 Vomiting] 
[SSRVOMD1] 
[clROGRES]
57.

Day 2
[Day 2 Vomiting] 
[SSRVOMD2] 
[clROGRES]
58.

Day 3
[Day 3 Vomiting] 
[SSRVOMD3] 
[clROGRES]
59.

Day 4
[Day 4 Vomiting] 
[SSRVOMD4] 
[clROGRES]
60.

Day 5
[Day 5 Vomiting] 
[SSRVOMD5] 
[clROGRES]
61. Day 6
[Day 6 Vomiting] 
[SSRVOMD6] 
631
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018


[clROGRES]
62.

Day 7
[Day 7 Vomiting] 
[SSRVOMD7] 
[clROGRES]
63.

After Day 7: Ongoing?
[Ongoing] 
[SSRVOMONG] 
[A:2] 
No
[A:1] 
[SSRVOMONGCMP] 
Yes
[SSRVOMSEV] 
Highest severity until resolution: [clSEV]
[SSRVOMEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
Headache [SSR7SC]
64.

Headache
[Headache] 
[SSRHEADWK] 
[A:1] 
None all week
65.

Evening Day 1
[Day 1 Headache] 
[SSRHEADD1] 
[clROGRES]
66.

Day 2
[Day 2 Headache] 
[SSRHEADD2] 
[clROGRES]
67.

Day 3
[Day 3 Headache] 
[SSRHEADD3] 
[clROGRES]
68.

Day 4
[Day 4 Headache] 
[SSRHEADD4] 
[clROGRES]
69.

Day 5
[Day 5 Headache] 
[SSRHEADD5] 
[clROGRES]
70.

Day 6
[Day 6 Headache] 
[SSRHEADD6] 
[clROGRES]
71.

Day 7
[Day 7 Headache] 
[SSRHEADD7] 
[clROGRES]
72.

After Day 7: Ongoing?
[Ongoing] 
[SSRHEADONG] 
[A:2] 
No
[A:1] 
[SSRHEADONGCMP] 
Yes
[SSRHEADSEV] 
Highest severity until resolution: [clSEV]
[SSRHEADEDAT] 
End date Req
 / Req
 / Req
 (2017-2018)
   Key:  [*] = Item is required  [] = Source verification required  [b] = Base Unit
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
Codelist Values Tables: SOLICITED SYSTEMIC REACTOGENICITY
Codelist RefName Codelist Data Type Label
Code Codelist Item RefName Data Variable RefName
clROGRES
String
0, None
1
citmROGRES1
SSRTIREDD1, 
SSRTIREDD2, 
SSRTIREDD3, 
SSRTIREDD4, 
SSRTIREDD5, 
SSRTIREDD6, 
SSRTIREDD7, 
SSRMUSD1, 
SSRMUSD2, 
SSRMUSD3, 
SSRMUSD4, 
SSRMUSD5, 
SSRMUSD6, 
SSRMUSD7, 
SSRJNTD1, 
SSRJNTD2, 
SSRJNTD3, 
SSRJNTD4, 
SSRJNTD5, 
SSRJNTD6, 
SSRJNTD7, 
SSRCHILD1, 
SSRCHILD2, 
SSRCHILD3, 
SSRCHILD4, 
SSRCHILD5, 
SSRCHILD6, 
SSRCHILD7, 
SSRNAUD1, 
SSRNAUD2, 
SSRNAUD3, 
SSRNAUD4, 
SSRNAUD5, 
SSRNAUD6, 
SSRNAUD7, 
SSRVOMD1, 
SSRVOMD2, 
SSRVOMD3, 
SSRVOMD4, 
SSRVOMD5, 
SSRVOMD6, 
SSRVOMD7, 
SSRHEADD1, 
SSRHEADD2, 
SSRHEADD3, 
SSRHEADD4, 
SSRHEADD5, 
SSRHEADD6, 
SSRHEADD7
1, Mild
2
citmROGRES2
2, Moderate
3
citmROGRES3
3, Severe
4
CITMROGRES4
4, Potentially Life Threatening 5
citmRoGERRE5
clSEV
String
Grade 1
1
citmSEV1
SSRTIREDSEV, 
SSRMUSSEV, 
SSRJNTSEV, 
SSRCHILSEV, 
SSRNAUSEV, 
SSRVOMSEV, 
SSRHEADSEV
Grade 2
2
citmSEV2
Grade 3
3
citmSEV3
Grade 4
4
citmSEV4
RDE Analytics: RD_SSR
Data Variable RefName
RD Column Name
Column Data Type
SSRYN
SSRYN_C
VARCHAR2
SSRYN
VARCHAR2
SSRYN_ND
VARCHAR2
632
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

SLRTEMPD1_1
SLRTEMPD1_1
FLOAT
SLRTEMPD1_1_U
VARCHAR2
SLRTEMPD1_1_ND
VARCHAR2
SLRTEMPD2_1
SLRTEMPD2_1
FLOAT
SLRTEMPD2_1_U
VARCHAR2
SLRTEMPD2_1_ND
VARCHAR2
SLRTEMPD3_1
SLRTEMPD3_1
FLOAT
SLRTEMPD3_1_U
VARCHAR2
SLRTEMPD3_1_ND
VARCHAR2
SLRTEMPD4_1
SLRTEMPD4_1
FLOAT
SLRTEMPD4_1_U
VARCHAR2
SLRTEMPD4_1_ND
VARCHAR2
SLRTEMPD5_1
SLRTEMPD5_1
FLOAT
SLRTEMPD5_1_U
VARCHAR2
SLRTEMPD5_1_ND
VARCHAR2
SLRTEMPD6_1
SLRTEMPD6_1
FLOAT
SLRTEMPD6_1_U
VARCHAR2
SLRTEMPD6_1_ND
VARCHAR2
SLRTEMPD7_1
SLRTEMPD7_1
FLOAT
SLRTEMPD7_1_U
VARCHAR2
SLRTEMPD7_1_ND
VARCHAR2
SLRTEMPONG_1
SLRTEMPONG_1_C
VARCHAR2
SLRTEMPONG_1
VARCHAR2
SLRTEMPONG_1_ND
VARCHAR2
SLRTEMPONG_1 - SLRTEMPSEV_1
SLRTEMPSEV_1_C
VARCHAR2
SLRTEMPSEV_1
VARCHAR2
SLRTEMPONG_1 - SLRTEMPEDAT_1 SLRTEMPEDAT_1
DATE
SLRTEMPEDAT_1_DTS
VARCHAR2
SSRTIREDWK
SSRTIREDWK_ND
VARCHAR2
SSRTIREDWK - None all week
SSRTIREDWK_CITMNONEWEEK1_C VARCHAR2
SSRTIREDWK_CITMNONEWEEK1
VARCHAR2
SSRTIREDD1
SSRTIREDD1_C
VARCHAR2
SSRTIREDD1
VARCHAR2
SSRTIREDD1_ND
VARCHAR2
SSRTIREDD2
SSRTIREDD2_C
VARCHAR2
SSRTIREDD2
VARCHAR2
SSRTIREDD2_ND
VARCHAR2
SSRTIREDD3
SSRTIREDD3_C
VARCHAR2
SSRTIREDD3
VARCHAR2
SSRTIREDD3_ND
VARCHAR2
SSRTIREDD4
SSRTIREDD4_C
VARCHAR2
SSRTIREDD4
VARCHAR2
SSRTIREDD4_ND
VARCHAR2
SSRTIREDD5
SSRTIREDD5_C
VARCHAR2
SSRTIREDD5
VARCHAR2
SSRTIREDD5_ND
VARCHAR2
SSRTIREDD6
SSRTIREDD6_C
VARCHAR2
SSRTIREDD6
VARCHAR2
SSRTIREDD6_ND
VARCHAR2
SSRTIREDD7
SSRTIREDD7_C
VARCHAR2
SSRTIREDD7
VARCHAR2
SSRTIREDD7_ND
VARCHAR2
SSRTIREDONG
SSRTIREDONG_C
VARCHAR2
SSRTIREDONG
VARCHAR2
SSRTIREDONG_ND
VARCHAR2
SSRTIREDONG - SSRTIREDSEV
SSRTIREDSEV_C
VARCHAR2
SSRTIREDSEV
VARCHAR2
SSRTIREDONG - SSRTIREDEDAT
SSRTIREDEDAT
DATE
SSRTIREDEDAT_DTS
VARCHAR2
SSRMUSWK
SSRMUSWK_ND
VARCHAR2
SSRMUSWK - None all week
SSRMUSWK_CITMNONEWEEK1_C
VARCHAR2
SSRMUSWK_CITMNONEWEEK1
VARCHAR2
SSRMUSD1
SSRMUSD1_C
VARCHAR2
SSRMUSD1
VARCHAR2
SSRMUSD1_ND
VARCHAR2
SSRMUSD2
SSRMUSD2_C
VARCHAR2
SSRMUSD2
VARCHAR2
SSRMUSD2_ND
VARCHAR2
SSRMUSD3
SSRMUSD3_C
VARCHAR2
SSRMUSD3
VARCHAR2
SSRMUSD3_ND
VARCHAR2
SSRMUSD4
SSRMUSD4_C
VARCHAR2
SSRMUSD4
VARCHAR2
SSRMUSD4_ND
VARCHAR2
SSRMUSD5
SSRMUSD5_C
VARCHAR2
SSRMUSD5
VARCHAR2
SSRMUSD5_ND
VARCHAR2
SSRMUSD6
SSRMUSD6_C
VARCHAR2
SSRMUSD6
VARCHAR2
633
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

SSRMUSD6_ND
VARCHAR2
SSRMUSD7
SSRMUSD7_C
VARCHAR2
SSRMUSD7
VARCHAR2
SSRMUSD7_ND
VARCHAR2
SSRMUSONG
SSRMUSONG_C
VARCHAR2
SSRMUSONG
VARCHAR2
SSRMUSONG_ND
VARCHAR2
SSRMUSONG - SSRMUSSEV
SSRMUSSEV_C
VARCHAR2
SSRMUSSEV
VARCHAR2
SSRMUSONG - SSRMUSEDAT
SSRMUSEDAT
DATE
SSRMUSEDAT_DTS
VARCHAR2
SSRJNTWK
SSRJNTWK_ND
VARCHAR2
SSRJNTWK - None all week
SSRJNTWK_CITMNONEWEEK1_C
VARCHAR2
SSRJNTWK_CITMNONEWEEK1
VARCHAR2
SSRJNTD1
SSRJNTD1_C
VARCHAR2
SSRJNTD1
VARCHAR2
SSRJNTD1_ND
VARCHAR2
SSRJNTD2
SSRJNTD2_C
VARCHAR2
SSRJNTD2
VARCHAR2
SSRJNTD2_ND
VARCHAR2
SSRJNTD3
SSRJNTD3_C
VARCHAR2
SSRJNTD3
VARCHAR2
SSRJNTD3_ND
VARCHAR2
SSRJNTD4
SSRJNTD4_C
VARCHAR2
SSRJNTD4
VARCHAR2
SSRJNTD4_ND
VARCHAR2
SSRJNTD5
SSRJNTD5_C
VARCHAR2
SSRJNTD5
VARCHAR2
SSRJNTD5_ND
VARCHAR2
SSRJNTD6
SSRJNTD6_C
VARCHAR2
SSRJNTD6
VARCHAR2
SSRJNTD6_ND
VARCHAR2
SSRJNTD7
SSRJNTD7_C
VARCHAR2
SSRJNTD7
VARCHAR2
SSRJNTD7_ND
VARCHAR2
SSRJNTONG
SSRJNTONG_C
VARCHAR2
SSRJNTONG
VARCHAR2
SSRJNTONG_ND
VARCHAR2
SSRJNTONG - SSRJNTSEV
SSRJNTSEV_C
VARCHAR2
SSRJNTSEV
VARCHAR2
SSRJNTONG - SSRJNTEDAT
SSRJNTEDAT
DATE
SSRJNTEDAT_DTS
VARCHAR2
SSRCHILWK
SSRCHILWK_ND
VARCHAR2
SSRCHILWK - None all week
SSRCHILWK_CITMNONEWEEK1_C
VARCHAR2
SSRCHILWK_CITMNONEWEEK1
VARCHAR2
SSRCHILD1
SSRCHILD1_C
VARCHAR2
SSRCHILD1
VARCHAR2
SSRCHILD1_ND
VARCHAR2
SSRCHILD2
SSRCHILD2_C
VARCHAR2
SSRCHILD2
VARCHAR2
SSRCHILD2_ND
VARCHAR2
SSRCHILD3
SSRCHILD3_C
VARCHAR2
SSRCHILD3
VARCHAR2
SSRCHILD3_ND
VARCHAR2
SSRCHILD4
SSRCHILD4_C
VARCHAR2
SSRCHILD4
VARCHAR2
SSRCHILD4_ND
VARCHAR2
SSRCHILD5
SSRCHILD5_C
VARCHAR2
SSRCHILD5
VARCHAR2
SSRCHILD5_ND
VARCHAR2
SSRCHILD6
SSRCHILD6_C
VARCHAR2
SSRCHILD6
VARCHAR2
SSRCHILD6_ND
VARCHAR2
SSRCHILD7
SSRCHILD7_C
VARCHAR2
SSRCHILD7
VARCHAR2
SSRCHILD7_ND
VARCHAR2
SSRCHILONG
SSRCHILONG_C
VARCHAR2
SSRCHILONG
VARCHAR2
SSRCHILONG_ND
VARCHAR2
SSRCHILONG - SSRCHILSEV
SSRCHILSEV_C
VARCHAR2
SSRCHILSEV
VARCHAR2
SSRCHILONG - SSRCHILEDAT
SSRCHILEDAT
DATE
SSRCHILEDAT_DTS
VARCHAR2
SSRNAUWK
SSRNAUWK_ND
VARCHAR2
SSRNAUWK - None all week
SSRNAUWK_CITMNONEWEEK1_C
VARCHAR2
SSRNAUWK_CITMNONEWEEK1
VARCHAR2
SSRNAUD1
SSRNAUD1_C
VARCHAR2
SSRNAUD1
VARCHAR2
SSRNAUD1_ND
VARCHAR2
634
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

SSRNAUD2
SSRNAUD2_C
VARCHAR2
SSRNAUD2
VARCHAR2
SSRNAUD2_ND
VARCHAR2
SSRNAUD3
SSRNAUD3_C
VARCHAR2
SSRNAUD3
VARCHAR2
SSRNAUD3_ND
VARCHAR2
SSRNAUD4
SSRNAUD4_C
VARCHAR2
SSRNAUD4
VARCHAR2
SSRNAUD4_ND
VARCHAR2
SSRNAUD5
SSRNAUD5_C
VARCHAR2
SSRNAUD5
VARCHAR2
SSRNAUD5_ND
VARCHAR2
SSRNAUD6
SSRNAUD6_C
VARCHAR2
SSRNAUD6
VARCHAR2
SSRNAUD6_ND
VARCHAR2
SSRNAUD7
SSRNAUD7_C
VARCHAR2
SSRNAUD7
VARCHAR2
SSRNAUD7_ND
VARCHAR2
SSRNAUONG
SSRNAUONG_C
VARCHAR2
SSRNAUONG
VARCHAR2
SSRNAUONG_ND
VARCHAR2
SSRNAUONG - SSRNAUSEV
SSRNAUSEV_C
VARCHAR2
SSRNAUSEV
VARCHAR2
SSRNAUONG - SSRNAUEDAT
SSRNAUEDAT
DATE
SSRNAUEDAT_DTS
VARCHAR2
SSRVOMWK
SSRVOMWK_ND
VARCHAR2
SSRVOMWK - None all week
SSRVOMWK_CITMNONEWEEK1_C
VARCHAR2
SSRVOMWK_CITMNONEWEEK1
VARCHAR2
SSRVOMD1
SSRVOMD1_C
VARCHAR2
SSRVOMD1
VARCHAR2
SSRVOMD1_ND
VARCHAR2
SSRVOMD2
SSRVOMD2_C
VARCHAR2
SSRVOMD2
VARCHAR2
SSRVOMD2_ND
VARCHAR2
SSRVOMD3
SSRVOMD3_C
VARCHAR2
SSRVOMD3
VARCHAR2
SSRVOMD3_ND
VARCHAR2
SSRVOMD4
SSRVOMD4_C
VARCHAR2
SSRVOMD4
VARCHAR2
SSRVOMD4_ND
VARCHAR2
SSRVOMD5
SSRVOMD5_C
VARCHAR2
SSRVOMD5
VARCHAR2
SSRVOMD5_ND
VARCHAR2
SSRVOMD6
SSRVOMD6_C
VARCHAR2
SSRVOMD6
VARCHAR2
SSRVOMD6_ND
VARCHAR2
SSRVOMD7
SSRVOMD7_C
VARCHAR2
SSRVOMD7
VARCHAR2
SSRVOMD7_ND
VARCHAR2
SSRVOMONG
SSRVOMONG_C
VARCHAR2
SSRVOMONG
VARCHAR2
SSRVOMONG_ND
VARCHAR2
SSRVOMONG - SSRVOMSEV
SSRVOMSEV_C
VARCHAR2
SSRVOMSEV
VARCHAR2
SSRVOMONG - SSRVOMEDAT
SSRVOMEDAT
DATE
SSRVOMEDAT_DTS
VARCHAR2
SSRHEADWK
SSRHEADWK_ND
VARCHAR2
SSRHEADWK - None all week
SSRHEADWK_CITMNONEWEEK1_C
VARCHAR2
SSRHEADWK_CITMNONEWEEK1
VARCHAR2
SSRHEADD1
SSRHEADD1_C
VARCHAR2
SSRHEADD1
VARCHAR2
SSRHEADD1_ND
VARCHAR2
SSRHEADD2
SSRHEADD2_C
VARCHAR2
SSRHEADD2
VARCHAR2
SSRHEADD2_ND
VARCHAR2
SSRHEADD3
SSRHEADD3_C
VARCHAR2
SSRHEADD3
VARCHAR2
SSRHEADD3_ND
VARCHAR2
SSRHEADD4
SSRHEADD4_C
VARCHAR2
SSRHEADD4
VARCHAR2
SSRHEADD4_ND
VARCHAR2
SSRHEADD5
SSRHEADD5_C
VARCHAR2
SSRHEADD5
VARCHAR2
SSRHEADD5_ND
VARCHAR2
SSRHEADD6
SSRHEADD6_C
VARCHAR2
SSRHEADD6
VARCHAR2
SSRHEADD6_ND
VARCHAR2
SSRHEADD7
SSRHEADD7_C
VARCHAR2
SSRHEADD7
VARCHAR2
635
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

SSRHEADD7_ND
VARCHAR2
SSRHEADONG
SSRHEADONG_C
VARCHAR2
SSRHEADONG
VARCHAR2
SSRHEADONG_ND
VARCHAR2
SSRHEADONG - SSRHEADSEV
SSRHEADSEV_C
VARCHAR2
SSRHEADSEV
VARCHAR2
SSRHEADONG - SSRHEADEDAT
SSRHEADEDAT
DATE
SSRHEADEDAT_DTS
VARCHAR2
636
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: UNSCHEDULED ASSESSMENT FORMS (UNSFM) [UNSFM]
Unscheduled Assessment Forms [UNSFMSC]
1.*

Reason for Unscheduled visit
[Reason for Unscheduled visit] 
[UNSREAS] 
[A:3] 
Physical examination
[A:4] 
Evaluation of health concern 
[A:5] 
Evaluation of suspected pregnancy
[A:6] 
[UNSREASOTH] 
Other, specify
A200
2.*

Unscheduled Assessment Forms
[Unscheduled Assessment Forms] 
[UNSFORM] 
[A:1] 
Targeted PE
[A:4] 
Urine Pregnancy Test
[A:6] 
Anti-Influenza Serologic Assay
   Key:  [*] = Item is required  [] = Source verification required  [] = ASCII Only
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_UNSFM
Data Variable RefName
RD Column Name
Column Data Type
UNSREAS
UNSREAS_C
VARCHAR2
UNSREAS
VARCHAR2
UNSREAS_ND
VARCHAR2
UNSREAS - UNSREASOTH
UNSREASOTH
VARCHAR2
UNSFORM
UNSFORM_ND
VARCHAR2
UNSFORM - Targeted PE
UNSFORM_CITMUNLIST1_C VARCHAR2
UNSFORM_CITMUNLIST1
VARCHAR2
UNSFORM - Urine Pregnancy Test
UNSFORM_CITMUNLIST4_C VARCHAR2
UNSFORM_CITMUNLIST4
VARCHAR2
UNSFORM - Anti-Influenza Serologic Assay UNSFORM_CITMUNLIST6_C VARCHAR2
UNSFORM_CITMUNLIST6
VARCHAR2

637
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: LOG (LOGFM) [LOGFM]
Log [LOGFMSC]
1.*

Were any Unsolicited Adverse Events reported?
[Were any Unsolicited Adverse Events reported?] 
[LOGAE] 
[A:1] 
Yes
[A:2] 
No
If Yes, please record the details on the AEUNSOL form.
2.*

Were any Serious Adverse Events reported?
[Were any Serious Adverse Events reported?] 
[LOGSAE] 
[A:1] 
Yes
[A:2] 
No
If Yes, please record the details on the SAE form.
3.*

Were any Concomitant Medications reported?
[Were any Concomitant Medications reported?] 
[LOGCM] 
[A:1] 
Yes
[A:2] 
No
If Yes, please record the details on the CM form.
   Key:  [*] = Item is required  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_LOGFM
Data Variable RefName RD Column Name Column Data Type
LOGAE
LOGAE_C
VARCHAR2
LOGAE
VARCHAR2
LOGAE_ND
VARCHAR2
LOGSAE
LOGSAE_C
VARCHAR2
LOGSAE
VARCHAR2
LOGSAE_ND
VARCHAR2
LOGCM
LOGCM_C
VARCHAR2
LOGCM
VARCHAR2
LOGCM_ND
VARCHAR2
638
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: UNSOLICITED ADVERSE EVENT (AEUNSOL) - Repeating Form [AE]
#
AE Number
Adverse Event
Start Date
Stop Date
Severity
Serious?
Treatment Required
Action Taken
Relationship to Study Product
Outcome
1
Unsolicited Adverse Event [AESC]
1.
AE Number [read-only]
[AE Number] 
[AENUM]
N3
2.*

Adverse Event
[Adverse Event] 
[AETERM] 
A200
3.*

Start Date
[Start Date] 
[AESTDT] 
Req
 / Req
 / Req
 (2017-2018)
4.

Stop Date
[Stop Date] 
[AEEDT] 
Req
 / Req
 / Req
 (2017-2018)
5.*

Severity
[Severity] 
[AEINT] 
[A:1] 
Mild (Grade 1)
[A:2] 
Moderate (Grade 2)
[A:3] 
Severe (Grade 3)
[A:4] 
Life threatening (Grade 4)
6.*

Serious?
[Serious?] 
[AESER] 
[A:1] 
Yes: Complete the SAE form and report to sponsor, IRB and regulatory authorities. 
[A:2] 
No
7.*

Treatment Required
[Treatment Required] 
[AETRT] 
[A:1] 
Yes
[A:2] 
No
Note: If Yes, please report the medication on the CM form.
8.*

Action Taken
[ Action Taken] 
[AEACN] 
[A:1] 
None
[A:2] 
Discontinued
[A:3] 
[AEACNO] 
Other, please specify
A128
9.*

Relationship to Study Product
[Relationship to Study Product] 
[AEREL] 
[A:1] 
Related
[A:2] 
Not Related
10.*

Outcome
[Outcome] 
[AEOUT] 
[A:1] 
Resolved
[A:2] 
Ongoing
[A:3] 
Death
[A:4] 
Severity / frequency increased
[A:6] 
Stable/Chronic condition
[A:5] 
Unknown
   Key:  [*] = Item is required  [] = Source verification required  [] = ASCII Only
   Note: Associated form = CONCOMITANT MEDICATIONS.
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_AE
Data Variable RefName RD Column Name Column Data Type
AENUM
AENUM
NUMBER
AENUM_ND
VARCHAR2
AETERM
AETERM
VARCHAR2
AETERM_ND
VARCHAR2
AESTDT
AESTDT
DATE
AESTDT_DTS
VARCHAR2
AESTDT_ND
VARCHAR2
AEEDT
AEEDT
DATE
AEEDT_DTS
VARCHAR2
AEEDT_ND
VARCHAR2
AEINT
AEINT_C
VARCHAR2
AEINT
VARCHAR2
AEINT_ND
VARCHAR2
AESER
AESER_C
VARCHAR2
AESER
VARCHAR2
AESER_ND
VARCHAR2
AETRT
AETRT_C
VARCHAR2
AETRT
VARCHAR2
AETRT_ND
VARCHAR2
AEACN
AEACN_C
VARCHAR2
AEACN
VARCHAR2
AEACN_ND
VARCHAR2
AEACN - AEACNO
AEACNO
VARCHAR2
AEREL
AEREL_C
VARCHAR2
AEREL
VARCHAR2
AEREL_ND
VARCHAR2
AEOUT
AEOUT_C
VARCHAR2
AEOUT
VARCHAR2
AEOUT_ND
VARCHAR2


639
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: SERIOUS ADVERSE EVENT (SAE) - Repeating Form [SAE]
#
SAE 
Number
Type of 
Report
Sex
Date of 
birth
Serious Adverse Event 
Name(s)
Onset 
Date
Resolved 
Date
Serious 
Criteria
Severity Relationship to Study 
Product
Outcome
Event Description/Case 
Narrative
1
Directions: Complete ONE SAE per form. If multiple SAEs, complete a form for each SAE.
Serious Adverse Event [SAESC]
1.
SAE Number [read-only]
[SAE Number] 
[SAENUM] 
N3
2.*

Type of Report
[Type of Report] 
[SAERPT] 
[A:1] 
Initial
[A:2] 
Follow-up
[A:3] 
Final
3.
Sex [read-only]
[Sex] 
[SAEGENDER] 
[A:1] 
Male
[A:2] 
Female
4.
Date of birth [read-only]
[Date of birth] 
[SAEDOBDT] 
Req/Unk
 / Req/Unk
 / Req
 (1918-2018)
5.*

Serious Adverse Event Name(s)
[Serious Adverse Event Name(s)] 
[SAETERM] 
A200
6.*

Onset Date
[Onset Date] 
[SAESTDT] 
Req
 / Req
 / Req
 (2017-2018)
7.

Resolved Date
[Resolved Date] 
[SAEEDT] 
Req
 / Req
 / Req
 (2017-2018)
8.*

Serious Criteria (check all that apply)
[Serious Criteria] 
[SAECRIT] 
[A:1] 
[SAEDCMP] 
Death
[DCAUSE] 
Primary Cause of Death
A200
[DEATHDT] 
Date of death Req
 / Req
 / Req
(2017-2018)
[DEATHCERT] 
Was a death certificate obtained?
[A:1] 
Yes
[A:2] 
No
[A:3] 
Pending
[AUTOPSY] 
Was Autopsy performed?
[A:1] 
[SAEREPORT] 
Yes
Is the report available?
[A:1] 
Yes
[A:2] 
No
[A:2] 
No
[A:3] 
Pending
[A:2] 
Life-threatening
[A:3] 
[SAEHOSCMP] 
Initial or prolonged hospitalization
[HOSADDT] 
Admission Date Req
 / Req
 / Req
 (2017-2018)
[HOSDSDT] 
Discharge Date Req
 / Req
 / Req
 (2017-2018)
[A:4] 
Persistent or significant disability/incapacity
[A:5] 
Congenital anomaly/birth defect
[A:6] 
[SAESOT] 
Medically significant event
Please specify reason
A200
9.*

Severity
[Severity] 
[SAEINT] 
[A:1] 
Mild
[A:2] 
Moderate
[A:3] 
Severe
[A:4] 
Life threatening
10.*

Relationship to Study Product
[Relationship to Study Product] 
[SAEREL] 
[A:1] 
Not Related
[A:2] 
[SAERELSP] 
Related
Please provide investigator rationale
A200
11.*

Outcome
[Outcome] 
[SAEOUT] 
[A:1] 
Resolved
[A:2] 
Ongoing
[A:3] 
Become stable/chronic
[A:4] 
Death
[A:5] 
Unknown
Narrative [SAE4SC]
12.*

Event Description/Case Narrative
Description of the clinical presentation/course of the event(s), 
dates, times, treatment, and any other assessments which help 
explain the event.
[Event Description/Case Narrative] 
[SAENCOM] 
A2000





640
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

13.
SAE Count [hidden]
[SAE Count] 
[SAEC] 
N3
   Key:  [] = Source verification required  [] = ASCII Only
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_SAE
Data Variable RefName
RD Column Name
Column Data Type
SAENUM
SAENUM
NUMBER
SAENUM_ND
VARCHAR2
SAERPT
SAERPT_C
VARCHAR2
SAERPT
VARCHAR2
SAERPT_ND
VARCHAR2
SAEGENDER
SAEGENDER_C
VARCHAR2
SAEGENDER
VARCHAR2
SAEGENDER_ND
VARCHAR2
SAEDOBDT
SAEDOBDT
DATE
SAEDOBDT_DTS
VARCHAR2
SAEDOBDT_DTR
VARCHAR2
SAEDOBDT_ND
VARCHAR2
SAETERM
SAETERM
VARCHAR2
SAETERM_ND
VARCHAR2
SAESTDT
SAESTDT
DATE
SAESTDT_DTS
VARCHAR2
SAESTDT_ND
VARCHAR2
SAEEDT
SAEEDT
DATE
SAEEDT_DTS
VARCHAR2
SAEEDT_ND
VARCHAR2
SAECRIT
SAECRIT_ND
VARCHAR2
SAECRIT - Death
SAECRIT_SAEDCMP_C
VARCHAR2
SAECRIT_SAEDCMP
VARCHAR2
SAECRIT - DCAUSE
DCAUSE
VARCHAR2
SAECRIT - DEATHDT
DEATHDT
DATE
DEATHDT_DTS
VARCHAR2
SAECRIT - DEATHCERT
DEATHCERT_C
VARCHAR2
DEATHCERT
VARCHAR2
SAECRIT - AUTOPSY
AUTOPSY_C
VARCHAR2
AUTOPSY
VARCHAR2
SAECRIT - SAEREPORT
SAEREPORT_C
VARCHAR2
SAEREPORT
VARCHAR2
SAECRIT - Life-threatening
SAECRIT_CITMSAECRT2_C
VARCHAR2
SAECRIT_CITMSAECRT2
VARCHAR2
SAECRIT - Initial or prolonged hospitalization
SAECRIT_SAEHOSCMP_C
VARCHAR2
SAECRIT_SAEHOSCMP
VARCHAR2
SAECRIT - HOSADDT
HOSADDT
DATE
HOSADDT_DTS
VARCHAR2
SAECRIT - HOSDSDT
HOSDSDT
DATE
HOSDSDT_DTS
VARCHAR2
SAECRIT - Persistent or significant disability/incapacity SAECRIT_CITMSAECRT4_C
VARCHAR2
SAECRIT_CITMSAECRT4
VARCHAR2
SAECRIT - Congenital anomaly/birth defect
SAECRIT_CITMSAECRT5_C
VARCHAR2
SAECRIT_CITMSAECRT5
VARCHAR2
SAECRIT - Medically significant event
SAECRIT_SAESOT_C
VARCHAR2
SAECRIT_SAESOT
VARCHAR2
SAECRIT - SAESOT
SAESOT
VARCHAR2
SAEINT
SAEINT_C
VARCHAR2
SAEINT
VARCHAR2
SAEINT_ND
VARCHAR2
SAEREL
SAEREL_C
VARCHAR2
SAEREL
VARCHAR2
SAEREL_ND
VARCHAR2
SAEREL - SAERELSP
SAERELSP
VARCHAR2
SAEOUT
SAEOUT_C
VARCHAR2
SAEOUT
VARCHAR2
SAEOUT_ND
VARCHAR2
SAENCOM
SAENCOM
VARCHAR2
SAENCOM_ND
VARCHAR2
SAEC
SAEC
NUMBER
SAEC_ND
VARCHAR2
641
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: CONCOMITANT MEDICATIONS (CM) - Repeating Form [CM]
#
CM Sequence Number
Medication Name
Dose
Unit
Route of Administration
Frequency
Start Date
Stop Date
Indication
1
Concomitant Medications [CMSC]
1.
CM Sequence Number [read-only]
[CM Sequence Number] 
[CMSEQ] 
N3
2.*

Medication Name
[Medication Name] 
[CMDRUG] 
A200
3.*

Dose
[Dose] 
[CMDOSE] 
A100
4.*

Unit
[Unit] 
[CMUNIT] 
[A:1] 
[UNITLIST] 
[clCMUNIT]
[A:2] 
[UNITOT] 
Other
Please specify
A100
5.*

Route of Administration
[Route of Administration] 
[CMROUTE] 
[A:1] 
[RLIST] 
[clCMROUT]
[A:2] 
[ROUTOT] 
Other
Please specify
A100
6.*

Frequency
[Frequency] 
[CMFREQ] 
[A:1] 
[FREQLIST] 
[clCMFREQ]
[A:2] 
[FREQOT] 
Other
Please specify
A100
7.*

Start Date
[Start Date] 
[CMSTDT] 
Req/Unk
 / Req/Unk
 / Req
 (1956-2018)
8.*

Stop Date
[Stop Date] 
[CMEND] 
[A:1] 
[CMENDT] 
Req/Unk
 / Req/Unk
/ Req
 (2017-2018)
[A:2] 
Ongoing
9.*

Indication
[Indication] 
[CMIND] 
[A:3] 
[CMMH] 
Current Medical Condition
[CMMHNO_1] 
Current Medical 
Condition 1
N2
[CMMHNO_2] 
Current Medical 
Condition 2
N2
[CMMHNO_3] 
Current Medical
Condition 3
N2
[CMMHNO_4] 
Current Medical
Condition 4
N2
[CMMHNO_5] 
Current Medical 
Condition 5
N2
[A:1] 
[CMAE] 
Unsolicited AE
[CMAENO_1] 
Unsolicited AE 1
N2
[CMAENO_2] 
Unsolicited AE 2
N2
[CMAENO_3] 
Unsolicited AE 3
N2
[CMAENO_4] 
Unsolicited AE 4
N2
[CMAENO_5] 
Unsolicited AE 5
N2
[A:2] 
[CMINDSAECM] 
Solicited 
AE
[CMSAECAT] 
[A:1] 
30-Min
[A:2] 
Follow-Up
[SystemLocal] 
System / Local
[A:1] 
[CMSYS] 
System [A:1] 
Temperature (oral)
[A:2] 
Fatigue/Malaise
[A:3] 
Generalized Muscle 
Aches
[A:4] 
Joint Aches
[A:5] 
Chills
[A:6] 
Nausea
[A:7] 
Vomiting
[A:8] 
Headache
[A:2] 
[CMLOC] 
Local [A:1] 
Pain at injection 
site
[A:2] 
Tenderness at 
injection site
[A:3] 
Redness at 
injection site
[A:4] 
Swelling at 
injection site
[A:5] 
Hardness at 
injection site
[A:99] 
[CMINDOTH] 
Other, Please specify:
A200
   Key:  [*] = Item is required  [] = Source verification required  [] = ASCII Only
   Note: Associated form = UNSOLICITED ADVERSE EVENT.
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
Codelist Values Tables: CONCOMITANT MEDICATIONS
Codelist RefName Codelist Data Type Label
Code Codelist Item RefName Data Variable RefName
clCMUNIT
String
amp = ampules
1
citmCMUNIT1
UNITLIST
cap = capsules
2
citmCMUNIT2
g = gram
3
citmCMUNIT3
mg = milligram
4
citmCMUNIT4
mcg = microgram
5
citmCMUNIT5
gtts = drops
6
citmCMUNIT6
mL = milliliters
7
citmCMUNIT7
puffs = puffs
8
citmCMUNIT8
tab = tablets
9
citmCMUNIT9
sup = suppository 10
citmCMUNIT10
vial = vials
11
citmCMUNIT11
oint = ointment
12
citmCMUNIT12






642
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

pas = paste
13
citmCMUNIT13
clCMROUT
String
1 = oral
1
citmCMROUT1
RLIST
2 = intramuscular
2
citmCMROUT2
3 = subcutaneous
3
citmCMROUT3
4 = intravenous
4
citmCMROUT4
5 = aerosol
5
citmCMROUT5
6 = apply on skin
6
citmCMROUT6
7 = Other
7
citmCMROUT7
clCMFREQ
String
1 = QD
1
citmCMFREQ1
FREQLIST
2 = BID
2
citmCMFREQ2
3 = TID
3
citmCMFREQ3
4 = QID
4
citmCMFREQ4
5 = as needed
5
citmCMFREQ5
6 = one time
6
citmCMFREQ6
7 = at bed time
7
citmCMFREQ7
RDE Analytics: RD_CM
Data Variable RefName
RD Column Name
Column Data Type
CMSEQ
CMSEQ
NUMBER
CMSEQ_ND
VARCHAR2
CMDRUG
CMDRUG
VARCHAR2
CMDRUG_ND
VARCHAR2
CMDOSE
CMDOSE
VARCHAR2
CMDOSE_ND
VARCHAR2
CMUNIT
CMUNIT_C
VARCHAR2
CMUNIT
VARCHAR2
CMUNIT_ND
VARCHAR2
CMUNIT - UNITLIST
UNITLIST_C
VARCHAR2
UNITLIST
VARCHAR2
CMUNIT - UNITOT
UNITOT
VARCHAR2
CMROUTE
CMROUTE_C
VARCHAR2
CMROUTE
VARCHAR2
CMROUTE_ND
VARCHAR2
CMROUTE - RLIST
RLIST_C
VARCHAR2
RLIST
VARCHAR2
CMROUTE - ROUTOT
ROUTOT
VARCHAR2
CMFREQ
CMFREQ_C
VARCHAR2
CMFREQ
VARCHAR2
CMFREQ_ND
VARCHAR2
CMFREQ - FREQLIST
FREQLIST_C
VARCHAR2
FREQLIST
VARCHAR2
CMFREQ - FREQOT
FREQOT
VARCHAR2
CMSTDT
CMSTDT
DATE
CMSTDT_DTS
VARCHAR2
CMSTDT_DTR
VARCHAR2
CMSTDT_ND
VARCHAR2
CMEND
CMEND_C
VARCHAR2
CMEND
VARCHAR2
CMEND_ND
VARCHAR2
CMEND - CMENDT
CMENDT
DATE
CMENDT_DTS
VARCHAR2
CMENDT_DTR
VARCHAR2
CMIND
CMIND_C
VARCHAR2
CMIND
VARCHAR2
CMIND_ND
VARCHAR2
CMIND - CMMHNO_1
CMMHNO_1
NUMBER
CMIND - CMMHNO_2
CMMHNO_2
NUMBER
CMIND - CMMHNO_3
CMMHNO_3
NUMBER
CMIND - CMMHNO_4
CMMHNO_4
NUMBER
CMIND - CMMHNO_5
CMMHNO_5
NUMBER
CMIND - CMAENO_1
CMAENO_1
NUMBER
CMIND - CMAENO_2
CMAENO_2
NUMBER
CMIND - CMAENO_3
CMAENO_3
NUMBER
CMIND - CMAENO_4
CMAENO_4
NUMBER
CMIND - CMAENO_5
CMAENO_5
NUMBER
CMIND - 30-Min
CMSAECAT_CLIT30MIN_C
VARCHAR2
CMSAECAT_CLIT30MIN
VARCHAR2
CMIND - Follow-Up
CMSAECAT_CLITFOLLOWUP_C
VARCHAR2
CMSAECAT_CLITFOLLOWUP
VARCHAR2
CMIND - System
SYSTEMLOCAL_CMSYS_C
VARCHAR2
SYSTEMLOCAL_CMSYS
VARCHAR2
CMIND - Temperature (oral)
CMSYS_CLITTEMPERATURE_C
VARCHAR2
CMSYS_CLITTEMPERATURE
VARCHAR2
CMIND - Fatigue/Malaise
CMSYS_CLITFATIGUEMALAISE_C
VARCHAR2
CMSYS_CLITFATIGUEMALAISE
VARCHAR2
CMIND - Generalized Muscle Aches
*CMSYS_CLITGENERALIZEDMUSCLEACHES_C VARCHAR2
*CMSYS_CLITGENERALIZEDMUSCLEACHES
VARCHAR2
CMIND - Joint Aches
CMSYS_CLITJOINTACHES_C
VARCHAR2
CMSYS_CLITJOINTACHES
VARCHAR2
643
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

CMIND - Chills
CMSYS_CLITCHILLS_C
VARCHAR2
CMSYS_CLITCHILLS
VARCHAR2
CMIND - Nausea
CMSYS_CLITNAUSEA_C
VARCHAR2
CMSYS_CLITNAUSEA
VARCHAR2
CMIND - Vomiting
CMSYS_CLITVOMITING_C
VARCHAR2
CMSYS_CLITVOMITING
VARCHAR2
CMIND - Headache
CMSYS_CLITHEADACHE_C
VARCHAR2
CMSYS_CLITHEADACHE
VARCHAR2
CMIND - Local
SYSTEMLOCAL_CMLOC_C
VARCHAR2
SYSTEMLOCAL_CMLOC
VARCHAR2
CMIND - Pain at injection site
CMLOC_CLITPAIN_C
VARCHAR2
CMLOC_CLITPAIN
VARCHAR2
CMIND - Tenderness at injection site CMLOC_CLITTENDERNESS_C
VARCHAR2
CMLOC_CLITTENDERNESS
VARCHAR2
CMIND - Redness at injection site
CMLOC_CLITREDNESS_C
VARCHAR2
CMLOC_CLITREDNESS
VARCHAR2
CMIND - Swelling at injection site
CMLOC_CLITSWELLING_C
VARCHAR2
CMLOC_CLITSWELLING
VARCHAR2
CMIND - Hardness at injection site
CMLOC_CLITHARDNESS_C
VARCHAR2
CMLOC_CLITHARDNESS
VARCHAR2
CMIND - CMINDOTH
CMINDOTH
VARCHAR2
  Key: [*] = The column and/or table name in the actual RDE extract may be different.
644
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: MISSED VISIT FORM (MISSED VISIT FORM) [MISSFORM]
Missing Visit [ScMissingVisit]
1.*

Were any study visits missed?
[Any Missing Visit?] 
[MISSYN] 
[A:1] 
Yes
[A:2] 
No
Study day that was missed
Reason visit was missed
Comment
2.

MISSED VISIT FORM Entry [ScMISSEDVISITFORM]
2.1*

Study day that was missed
[Study day that was missed] 
[MISSDAY] 
[A:1] 
Day 2
[A:2] 
Day 5
[A:3] 
Day 8
[A:4] 
Day 22
[A:5] 
Day 91
2.2*

Reason visit was missed
[Reason visit was missed] 
[MISSREA] 
[A:1] 
Unable to contact subject after repeated attempts
[A:2] 
Unable to schedule visit within the window
[A:3] 
Subject is early discontinued (early termination)
[A:4] 
Subject is hospitalized
[A:5] 
Subject is deceased
[A:6] 
[MISSSPEC] 
Other, please specify.
A200
2.3

Comment
[Comment] 
[MISSCOM] 
A200
   Key:  [] = Source verification required  [] = ASCII Only
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
Study Object Descriptions: MISSED VISIT FORM
Type
RefName
Description
Form
MISSFORM
MISSED VISIT FORM
Section
ScMISSEDVISITFORM
MISSED VISIT FORM
RDE Analytics: RD_MISSFORM
Data Variable RefName
RD Column Name
Column Data Type
MISSYN
MISSYN_C
VARCHAR2
MISSYN
VARCHAR2
MISSYN_ND
VARCHAR2
*RD_MISSFORM_SCMISSEDVISITFORM
MISSDAY
MISSDAY_C
VARCHAR2
MISSDAY
VARCHAR2
MISSDAY_ND
VARCHAR2
MISSREA
MISSREA_C
VARCHAR2
MISSREA
VARCHAR2
MISSREA_ND
VARCHAR2
MISSREA - MISSSPEC
MISSSPEC
VARCHAR2
MISSCOM
MISSCOM
VARCHAR2
MISSCOM_ND
VARCHAR2
  Key: [*] = The column and/or table name in the actual RDE extract may be different.


645
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: REPORT OF PREGNANCY (REPORT OF PREGNANCY) [PREGRPT]
REPORT OF PREGNANCY [scPREGRPT]
1.*

Pregnancy test date
[Pregnancy test date] 
[PREGDATE] 
Req
 / Req
 / Req
 (2017-2018)
2.*

Date of last menstrual period
[Date of last menstrual period] 
[MENSDATE] 
Req
 / Req/Unk
 / Req
 (2017-2018)
3.*

Estimated date of delivery
[Estimated date of delivery] 
[DELIDATE] 
Req
 / Req/Unk
 / Req
 (2017-2018)
4.*

1, Pregnancy History:
[Pregnancy History:] 
[NewCompound] 
[PREGBEFO] 
1.1, Has the woman been pregnant before?
[A:1] 
[ANOMALY] 
Yes
1.2, Any history of fetal anomalies?
[A:1] 
Yes
[A:2] 
No
[PREMATUR] 
1.3, Any history of premature births?
[A:1] 
Yes
[A:2] 
No
[DEATH] 
1.4, Any history of fetal deaths? 
[A:1] 
Yes
[A:2] 
No
[STILLBRT] 
1.5, Any history of still births?
[A:1] 
Yes
[A:2] 
No
[MISCARRY] 
1.6, Any history of miscarriage?
[A:1] 
Yes
[A:2] 
No
[PREGOTH] 
1.7 Other problem? 
[A:1] 
[PREGSPEC] 
Yes, Specify:
A200
[A:2] 
No
[A:2] 
No, Skip To 2
5.*

2, Were there any medications taken during the time of 
conception or during the pregnancy?
[Medications taken] 
[PREGMED] 
[A:1] 
Yes, Please complete Concomitant Medications form
[A:2] 
No
6.*

3, Any additional information?
[Any additional information?] 
[ADDINFO] 
[A:1] 
[PREGDESC] 
Yes
Describe: 
A200
[A:2] 
No
7.*

Is subject willing to be contacted after delivery? 
[ Is subject willing to be contacted after delivery? ] 
[PREGCONT] 
[A:1] 
Yes
[A:2] 
No
   Key:  [*] = Item is required  [] = Source verification required  [] = ASCII Only
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
Study Object Descriptions: REPORT OF PREGNANCY
Type
RefName
Description
Form
PREGRPT
REPORT OF PREGNANCY
Section
scPREGRPT
REPORT OF PREGNANCY
RDE Analytics: RD_PREGRPT
Data Variable RefName
RD Column Name
Column Data Type
PREGDATE
PREGDATE
DATE
PREGDATE_DTS
VARCHAR2
PREGDATE_ND
VARCHAR2
MENSDATE
MENSDATE
DATE
MENSDATE_DTS
VARCHAR2
MENSDATE_DTR
VARCHAR2
MENSDATE_ND
VARCHAR2
DELIDATE
DELIDATE
DATE
DELIDATE_DTS
VARCHAR2
DELIDATE_DTR
VARCHAR2
DELIDATE_ND
VARCHAR2
NewCompound
NEWCOMPOUND_ND VARCHAR2
NewCompound - PREGBEFO
PREGBEFO_C
VARCHAR2
PREGBEFO
VARCHAR2
NewCompound - ANOMALY
ANOMALY_C
VARCHAR2
ANOMALY
VARCHAR2
NewCompound - PREMATUR PREMATUR_C
VARCHAR2
PREMATUR
VARCHAR2
NewCompound - DEATH
DEATH_C
VARCHAR2
DEATH
VARCHAR2
NewCompound - STILLBRT
STILLBRT_C
VARCHAR2
STILLBRT
VARCHAR2
NewCompound - MISCARRY
MISCARRY_C
VARCHAR2
MISCARRY
VARCHAR2
NewCompound - PREGOTH
PREGOTH_C
VARCHAR2
PREGOTH
VARCHAR2
NewCompound - PREGSPEC
PREGSPEC
VARCHAR2
PREGMED
PREGMED_C
VARCHAR2


646
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

PREGMED
VARCHAR2
PREGMED_ND
VARCHAR2
ADDINFO
ADDINFO_C
VARCHAR2
ADDINFO
VARCHAR2
ADDINFO_ND
VARCHAR2
ADDINFO - PREGDESC
PREGDESC
VARCHAR2
PREGCONT
PREGCONT_C
VARCHAR2
PREGCONT
VARCHAR2
PREGCONT_ND
VARCHAR2
647
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: END OF STUDY (EOSFM) [EOSFM]
End of Study [EOSSC]
1.*

Has the participant completed the study?
[Has the participant completed the study?] 
[EOSYN] 
[A:1] 
[EOSDT] 
Yes
Date subject completed study:
Req
 / Req
 / Req
 (2017-2018)
[A:2] 
[EOSCMP] 
No
[EOSRES] 
Primary Reason for Subject Discontinuation:
[A:1] 
Voluntary withdrawal
[A:2] 
Lost to follow-up
[A:4] 
Sponsor decision
[A:5] 
Investigator decision
[A:6] 
[EOSAENUM] 
AE or SAE 
If AE or SAE, please specify
A200
[A:7] 
[EOSRSNOT] 
Other reason (specify)
A200
[EOSVISDT] 
Date of last study contact for subject Req
 / Req
 / Req
 (2017-2018)
   Key:  [*] = Item is required  [] = Source verification required  [] = ASCII Only
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_EOSFM
Data Variable RefName RD Column Name Column Data Type
EOSYN
EOSYN_C
VARCHAR2
EOSYN
VARCHAR2
EOSYN_ND
VARCHAR2
EOSYN - EOSDT
EOSDT
DATE
EOSDT_DTS
VARCHAR2
EOSYN - EOSRES
EOSRES_C
VARCHAR2
EOSRES
VARCHAR2
EOSYN - EOSAENUM
EOSAENUM
VARCHAR2
EOSYN - EOSRSNOT
EOSRSNOT
VARCHAR2
EOSYN - EOSVISDT
EOSVISDT
DATE
EOSVISDT_DTS
VARCHAR2


648
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

IVACFLU-S-0203: INVESTIGATOR SIGNATURE (SIGN) [PISIGN]
Signature [SIGNSC]
1.*

I, the undersigned, hereby certify that I have reviewed the data of CRF and found them 
to be complete and accurate.
[I, the undersigned, hereby certify that I have reviewed the data of CRF and found them 
to be complete and accurate.] 
[SIGNY] 
[A:1] 
Yes
   Key:  [*] = Item is required  [] = Source verification required
   Note: Source verification critical settings made in InForm will override any settings made in Central Designer.
RDE Analytics: RD_PISIGN
Data Variable RefName RD Column Name
Column Data Type
SIGNY
SIGNY_ND
VARCHAR2
SIGNY - Yes
SIGNY_CITMSIGNY1_C VARCHAR2
SIGNY_CITMSIGNY1
VARCHAR2
649
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

InForm Special Properties For Study Design: IVACFLU-S-0203
InForm Special Property
Property Type Data Object RefName Data Object Path RefName
Screening
Visit
SCRVIS
SCRVIS
Enrollment
Visit
ENRVIS
ENRVIS
Screening
Form
SYSSCR
SCRVIS.SYSSCR
Enrollment
Form
SYSENR
ENRVIS.SYSENR
Patient Identification
Form
SUBID
SCR.SUBID
Study Completion
Form
EOSFM
EOS.EOSFM
Reg Docs
Form
Unassigned
Unassigned
Visit Report
Form
Unassigned
Unassigned
Initials (Screening)
Item
SUBINI
SCRVIS.SYSSCR.SYSSCRSC.SUBINI
DOB (Screening)
Item
SCRDOBDT
SCRVIS.SYSSCR.SYSSCRSC.SCRDOBDT
Screening date (Screening)
Item
Unassigned
Unassigned
Patient No. (Enrollment)
Item
INSUBJID
SCR.SUBID.SUBIDSC.INSUBJID
ENRVIS.SYSENR.SYSENRSC.INSUBJID
Initials (Patient Identification)
Item
Unassigned
Unassigned
Completion status (Study Completion)
Item
EOSYN
EOS.EOSFM.EOSSC.EOSYN
Drop out reason (Study Completion)
Item
EOSRES
EOS.EOSFM.EOSSC.EOSCMP.EOSRES
DOV (Date of Visit)
Item
DOVDT
UNSVIS.DOV1.DOVSC.DOVDT
D1.DOV1.DOVSC.DOVDT
SCR.DOV1.DOVSC.DOVDT
Day2.DOV1.DOVSC.DOVDT
Day5.DOV1.DOVSC.DOVDT
D8.DOV1.DOVSC.DOVDT
D22.DOV1.DOVSC.DOVDT
D91.DOV1.DOVSC.DOVDT
VIS5.DOV1.DOVSC.DOVDT
Randomization field (Randomization)
Item
ELIGSUBID
D1.ELIG.IE2SC.ELIGYCMP.ELIGSUBID
SCR.ELIG.IE2SC.ELIGYCMP.ELIGSUBID
650
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Personal/Protected Health Information Table: IVACFLU-S-0203
Item RefName
Section RefName
Form RefName
No items have been defined as "Personal/Protected Health Information".
Please note: emails sent from the trial server by the InForm application are not encrypted. If you are subject to HIPAA requirements, you should identify and block all 
Personal/Protected Health Information items that may be included in email notifications.
651
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unit Conversions For Study Design: IVACFLU-S-0203
No unit conversion data.
652
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Review States for Study: IVACFLU-S-0203
No Review States have been defined.
653
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Participant ID |___|___|___|___| 
TAKE-HOME DIARY CARD 
__________________________________________________________________________________________ 
IVACFLU-S-0203                                                                                                                                    Page 1 of 9                                       
Version 1.0, dated 14/12/2016 
(This part is completed by INVESTIGATOR) 
FULL NAME of participant: ______________________________________ 
Date of vaccination: __ __/__ __/2017 
 
Vaccinated arm:  
     
 Left 
      
 Right 
Date of the next visit: __ __/__ __/2017 
Date of diary card collection: __ __/__ __/2017 
After reviewing the diary card completed by the participant, the investigator needs to answer 
the following question: 
Does the participant have any signs and symptoms which are continuing on day 7? 
 No 
 Yes   Investigator to complete the form titled “Post-vaccination monitoring after 
day 7” and instruct the participant to monitor ongoing signs and symptoms 
FULL NAME of investigator: ____________________________ Signature: ______________ 
 
 
654
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Participant ID 
|___|___|___|___| 
TAKE-HOME DIARY CARD 
__________________________________________________________________________________________ 
IVACFLU-S-0203                                                                                                                                    Page 2 of 9                                       
Version 1.0, dated 14/12/2016 
INSTRUCTIONS 
1. Take your temperature by mouth each day using the thermometer we gave you. 
 
 Start taking your temperature later today. 
 Take it around the same time each day. 
 Wait 15 minutes if you had a hot or cold drink. 
 Insert the thermometer into your mouth under your tongue. Close 
your mouth. 
 Wait for the beep or other indication that the temperature is 
ready. 
 Write the temperature in the space on the Diary Card. If you take 
your temperature more than once during the day, write the highest 
temperature for the day on the Diary Card. 
2. Each day, look at your arm where you received the injection. 
 
 
 
 Check for redness and swelling. Touch your arm and feel for 
hardness at the injection site. 
 If you do not find anything, check “None” on the diary card for 
the day. 
 If you see or feel something, place a mark with a pen on either 
side of the area. Measure the widest part of it with the ruler we 
have given you. 
 Record your measurement on the Diary Card. If you do more 
than one measurement during the day, record the largest 
measurement for each day on the Diary Card. 
 Example: This person had redness at the injection site. They put 
dots with a pen at the widest points of the redness and measured 
it. It measured 2.4 cm. They wrote 2.4 cm on the Diary Card for 
that day. 
3. Severity of symptoms: 
None: 
Mild: 
Moderate: 
 
Severe: 
 
I did not have any discomfort 
I only had minor discomfort. I did my usual activities 
I noticed the  
symptom. It bothered  me enough that I did  not do as  much as I 
usually do 
I really noticed the symptom. It kept me from doing many of the things I 
wanted or needed to do 
4. Please contact the study site using the number below if you have any questions:  
 
 
655
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
Participant ID |___|___|___|___| 
TAKE-HOME DIARY CARD 
LOCAL REACTIONS within 7 days post-vaccination 
 
________________________________________________________________________________________________________________________________________ 
IVACFLU-S-0203                                                                                                                                                                                                                                Page 3 of 9                                 
Version 1.0, dated 14/12/2016 
 
Evening  
Day 1 
(Day of 
vaccination) 
___/___/2017 
Day 2 
___/___/2017 
Day 3 
___/___/2017 
Day 4 
___/___/2017 
Day 5 
___/___/2017 
Day 6 
___/___/2017 
Day 7 
___/___/2017 
Oral 
temperature 
__ __,__°C 
__ __,__°C 
__ __,__°C 
__ __,__°C 
__ __,__°C 
__ __,__°C 
__ __,__°C 
Pain at 
injection 
site 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
Tenderness 
at injection 
site 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
656
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
Participant ID |___|___|___|___| 
TAKE-HOME DIARY CARD 
LOCAL REACTIONS within 7 days post-vaccination 
 
________________________________________________________________________________________________________________________________________ 
IVACFLU-S-0203                                                                                                                                                                                                                                Page 4 of 9                                 
Version 1.0, dated 14/12/2016 
 
Evening  
Day 1 
(Day of 
vaccination) 
___/___/2017 
Day 2 
___/___/2017 
Day 3 
___/___/2017 
Day 4 
___/___/2017 
Day 5 
___/___/2017 
Day 6 
___/___/2017 
Day 7 
___/___/2017 
Redness at 
injection 
site 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
Swelling at 
injection 
site 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
Hardness at 
injection 
site 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 None 
 Yes, 
measurement: 
__ __ mm 
 
 
 
 
657
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Participant ID |___|___|___|___| 
TAKE-HOME DIARY CARD 
SYSTEMIC REACTIONS within 7 days post-vaccination 
________________________________________________________________________________________________________________________________________ 
IVACFLU-S-0203                                                                                                                                                                                                                                Page 5 of 9                                 
Version 1.0, dated 14/12/2016 
 
Evening  
Day 1 
(Day of 
vaccination) 
___/___/2017 
Day 2 
___/___/2017 
Day 3 
___/___/2017 
Day 4 
___/___/2017 
Day 5 
___/___/2017 
Day 6 
___/___/2017 
Day 7 
___/___/2017 
Tiredness/
discomfor
t 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
Muscle 
Aches 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
Joint 
Aches 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
658
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Participant ID |___|___|___|___| 
TAKE-HOME DIARY CARD 
SYSTEMIC REACTIONS within 7 days post-vaccination 
________________________________________________________________________________________________________________________________________ 
IVACFLU-S-0203                                                                                                                                                                                                                                Page 6 of 9                                 
Version 1.0, dated 14/12/2016 
 
Evening  
Day 1 
(Day of 
vaccination) 
___/___/2017 
Day 2 
___/___/2017 
Day 3 
___/___/2017 
Day 4 
___/___/2017 
Day 5 
___/___/2017 
Day 6 
___/___/2017 
Day 7 
___/___/2017 
Headache 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
Chills 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
Nausea 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
659
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Participant ID |___|___|___|___| 
TAKE-HOME DIARY CARD 
SYSTEMIC REACTIONS within 7 days post-vaccination 
________________________________________________________________________________________________________________________________________ 
IVACFLU-S-0203                                                                                                                                                                                                                                Page 7 of 9                                 
Version 1.0, dated 14/12/2016 
 
Evening  
Day 1 
(Day of 
vaccination) 
___/___/2017 
Day 2 
___/___/2017 
Day 3 
___/___/2017 
Day 4 
___/___/2017 
Day 5 
___/___/2017 
Day 6 
___/___/2017 
Day 7 
___/___/2017 
Vomiting 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
 None 
 Yes, grading:  
       Mild 
       Moderate 
       Severe 
660
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Participant ID |___|___|___|___| 
TAKE-HOME DIARY CARD 
______________________________________________________________________________________________
IVACFLU-S-0203                                                                                                                                           Page 8 of 9                                             
Version 1.0, dated 14/12/2016 
Other COMPLAINT or ILLNESS: 
Did you have any other things that bothered you?       
 Yes             
 No 
Record any other complaints or illness which developed or worsened during the 7-day follow-up 
period after receiving the study injection. 
List each illness or complaint separately. 
You may call study doctor for any other complaints or illness. 
Complaint or illness 
Start date 
Last day the illness or 
complaint presents (*) 
Example: Cough 
21/07/2017 
23/07/2017 
1. 
 
 
2. 
 
 
3. 
 
 
4. 
 
 
5. 
 
 
(*) Write “continuing” if the illness is still going on day 7. 
MEDICATIONS:  
Did you take any medications during the 7 days after your injection?      
 
 
 
 Yes             
 No  
If you took medication, list the medication in the table below and bring your prescription or 
medications or the used packaging box/blister with you to the study site. 
Medication you took 
Why you took the 
medication 
Start date 
Last day you took 
medication (*) 
Example: Paracetamol 
Fever 
21/07/2017 
22/07/2017 
1. 
 
 
 
2. 
 
 
 
3. 
 
 
 
4. 
 
 
 
5. 
 
 
 
(*) Write “continuing” if you still took medication on day 7. 
661
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
Participant ID |___|___|___|___| 
TAKE-HOME DIARY CARD 
Other notes (if any) 
_______________________________________________________________________________________ 
IVACFLU-S-0203                                                                                                                              Page 9 of 9                                              
Version 1.0, dated 14/12/2016 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
____________________________________________________________________ 
 
662
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

~ 
Ou1n11leslMS-
eCRF Design Approval Form 
Sponsor Name: Institute of 
Vaccines and Medical 
Biologicals (IVAC) 
Protocol Number: IVACFLU-S-
0203 
Pa e 1 of 2 
Institute 
Medical 
of 
Vaccines 
and 
Sponsor: 
(IVAC) 
Protocol: 
IVACFLU-S-0203 
Protocol Version: 
4.0 
Biologicals 
Project Database ID: 
Date: 
Protocol Date: 
IYA06804 
11 May2017 
(ddmmmyyyy) 
9Feb2017 
(ddmmmyyyy) 
Annotated Trial Design (ATD) I Annotated Study Book (ASB) I CRF Design Specification I Study Blank CRF 
and Study Unique CRF (aCRF): 
Version Number: 
V4.0 
Version Date: 
2May2017 
(ddmmmyyyy) 
Authorization confirms review and approval of the eCRF design. QuintileslMS authorization is obtained using 
electronic signatures in ELVIS. Signature line and Date are used only if the corresponding Role is with the 
Sponsor. 
Name: 
Tushar Tewari/ Tran Thang 
Title: 
Sponsor Representative 
Role: 
Senior Medical Officer 
Name: 
Shirley Xiong 
Title: 
Data Team Lead 
Name: 
Lianying Zhao 
Title: 
Technical Designer 
Name: 
Suman Kapoor 
Title: 
Statistical Team Lead 
Name: 
Hong Anh Nguyen 
Title: 
Clinical Lead 
Name: 
Niamh Page 
Title: 
Lifecycle Safety 
Name: 
Flora Amos 
Title: 
Therapeutic Medical Advisor (TMA) 
Form No: CS_FM_DM 118 Revision 8 
Effective Date: 01 Mar2017 
/"', 
Signature: 
r I ? YcP(tid-
I 
~ 
Date: 
µf( )/0/( 3-
(ddmmmyyyy) 
A4 
Signature: 
Date: 
(ddmmmyyyy) 
Signature: 
Date: 
(ddmmmyyyy) 
Signature: 
Date: 
(ddmmmyyyy) 
Reference CS_Wl_DM0404 
Copyright © 2008, 2009 , 2011-2013, 2015, 2017 QuintileslMS. All rights reserved. The contents of this document are confidential 
and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly 
prohibited. 
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.gi Ou1nt1leslMS · 
eCRF Design Approval Form 
Name: 
Signature: 
Sponsor Name: Institute of 
Vaccines and Medical 
Biologicals (IVAC) 
Protocol Number: IVACFLU-S-
0203 
Pa e 2 of 2 
Title: 
Clinical Event Validation and Adjudication (CEVA) 
Date: 
(ddmmmyyyy) 
Name: 
""-···- ····-
Title: 
Epidemiologist 
Additional Information: 
Version 
Version Date 
(dd-mmm-yyyy) 
V1 .0 
28-Feb-2017 
V2.0 
1 O-Mar-2017 
V3.0 
21-Mar-2017 
V4.0 
2-May-2017 
Form No: CS_FM_DM118 Revision 8 
Effective Date: 01Mar2017 
··-· ···-
- -······ ----·--·-· 
-
·····-
... . -----·-··-···· 
Document Version History 
Significant Changes 
Initial version 
1. 
Add two new visits. Day 2 and Day 5. 
2. 
Update Day 91 telephone contact form to Contact form 
3. 
Add 'Result Reading Time' item on Urine pregna ncy test from. 
4. 
Update 'Indication' field Current Medica l Condition and Unsolicited 
AE from free text to variable box 
Add 'Day 2' and 'Day 5' in the 'study day that was missed field' on 
'Missed visit' form . 
1. 
Year range for CM start date, change from 2017-2018 to 1956-2018 
2. 
Add item 3 "Update Subject Randomization Number" onto subject 
identification form 
Reference: CS_Wl_DM0404 
Copyright© 2008, 2009, 2011-2013, 2015, 2017 QuintileslMS. All rights reserved. The contents of this document are confidential 
and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly 
prohibited. 
664
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Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
Document Approval Signature(s) 
This document has been signed electronically in compliance with Quintiles electronic 
signature policies and procedures. This page is a manifestation of the electronic signatures, 
which may be confirmed within the Quintiles source system in accordance with Quintiles 
records retention policies. 
Note: the Title field in the signature block has been intentionally left blank. 
 
 
 
UserName: Zhao, Lianying  (q820274)
Title:  
Date: Thursday, 11 May 2017, 06:34 AM   Eastern Time
Meaning: I Approve the Document
 ================================================
UserName: Page, Niamh  (q601811)
Title:  
Date: Thursday, 11 May 2017, 07:27 AM   Eastern Time
Meaning: I Approve the Document
 ================================================
UserName: Nguyen, Hong Anh  (q813460)
Title:  
Date: Thursday, 11 May 2017, 08:30 AM   Eastern Time
Meaning: I Approve the Document
 ================================================
UserName: Xiong, Shirley  (q832662)
Title:  
Date: Thursday, 11 May 2017, 09:42 PM   Eastern Time
Meaning: I Approve the Document
 ================================================
UserName: Kapoor, Suman  (q805805)
Title:  
Date: Thursday, 11 May 2017, 10:20 PM   Eastern Time
Meaning: I Approve the Document
 ================================================
665
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
Document Approval Signature(s) 
This document has been signed electronically in compliance with Quintiles electronic 
signature policies and procedures. This page is a manifestation of the electronic signatures, 
which may be confirmed within the Quintiles source system in accordance with Quintiles 
records retention policies. 
Note: the Title field in the signature block has been intentionally left blank. 
 
 
 
UserName: Amos, Flora  (q828871)
Title:  
Date: Thursday, 11 May 2017, 11:38 PM   Eastern Time
Meaning: I Approve the Document
 ================================================
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16.1.3 
List of IECs or IRBs and Representative Written Information for 
Subject and Sample Consent Forms 
16.1.3.1. 
List of IRBS and/or IECs by Investigator 
Study Center 
IRB/EC Name/Address 
201 and 203  
The World Health Organization Research Ethics Review Committee 
20, Avenue Appia –CH-1211 Geneva 27, Switzerland 
 
Pasteur Institute Ethics Committee in Biomedical Research 
Pasteur Institute in Ho Chi Minh City 
167 Pasteur, Ward 8, District 3 
Ho Chi Minh City, Vietnam 
 
Ethics Committee in Biomedical Research - Ministry of Health  
138 Giang Vo Street, Ba Dinh Street 
Hanoi, Vietnam 
 
 
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16.1.3.2. 
Sample of Written Subject Information and Consent Form 
Document 
Date 
Site Specific Information Sheet and Informed Consent Forms 
(Phase 2), Site 201, Version 4 
09 February 2017 
Site Specific Information Sheet and Informed Consent Forms 
(Phase 3), Site 201, Version 4 
09 February 2017 
Site Specific Information Sheet and Informed Consent Forms 
(Phase 3), Site 203, Version 4 
09 February 2017 
 
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_ Phase 2_Ben Luc                                                                                                                         Page 1 of 8
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INFORMATION SHEET and INFORMED CONSENT FORMS
for “screening” and “participation in the research study” entitled:
A PHASE 2/3 DOUBLE BLINDED, RANDOMIZED, PLACEBO-CONTROLLED STUDY IN HEALTHY
ADULT VOLUNTEERS IN VIETNAM TO EXAMINE THE SAFETY AND IMMUNOGENICITY OF 
SEASONAL TRIVALENT INACTIVATED SPLIT VIRION INFLUENZA VACCINE (IVACFLU-S)
PRODUCED BY IVAC 
Sponsor:
Institute of Vaccines and Medical Biologicals (IVAC)
Funder:
PATH
Study implementer:
Pasteur Institute in Ho Chi Minh City (PIHCMC)
Full name of volunteer: 
Participant screening code:
Participant identification code
(if recruited): 
CONSENT FOR PHASE 2
Introduction
You are invited to participate in a research study. This is a study of an experimental seasonal influenza vaccine called 
IVACFLU-S. We will call it the “study vaccine.” The study vaccine has not been approved for sale in Vietnam. It can 
only be used in research. This vaccine was made in Vietnam by the Institute of Vaccines and Biologicals (IVAC), 
Ministry of Health. 
The vaccine was used in a Phase 1 study of 60 people in the Hung Ha district health center. In the Phase 1 study, the 
vaccine did not cause any serious health problems. Most of the side effects were mild and did not last long. Now we 
will test the study vaccine in a larger study of about 888 people. If the study shows good results, IVAC will apply to 
license the vaccine in Vietnam. The study is a combination of a Phase 2 study and a Phase 3 study. You are being 
asked to join the Phase 2 part of the study with 252 participants. For this study, we want to see if the study 
vaccine continues to be safe for people to use. You will not have any blood drawn in this study. 
The following groups are involved in the study: Institute of Vaccines and Biologicals, the Pasteur Institute, Ho Chi 
Minh City, Long An Preventive Medicine Centers and the Ben Luc district health centers. The study is funded through 
the US Biomedical Advanced Research and Development Authority (BARDA), PATH, an international nonprofit 
organization, and the World Health Organization (WHO).
This information sheet explains the study and your part in the study. Please take as much time as you need to read this 
information. Talk with friends, relatives and your doctor if you wish.  You can ask us any questions you want.
What you should know about this study:
1.
Being in this study is voluntary. You can refuse to join or leave any time after you have joined without penalty 
or loss of any rights you normally have.
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IVACFLU-S-0203_ICF_ Phase 2_Ben Luc                                                                                                                         Page 2 of 8
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2.
You may or may not benefit from being in the study. If you join, you may help other people in your 
community and Vietnam. 
3.
You will receive 1 injection of the study vaccine or a placebo. The placebo is sterile salt water. It will not 
prepare your body to fight influenza infections. You and the researcher will not know if you were given study 
vaccine or placebo until the end of the study. This is decided by chance. However, each person in the study 
has a greater chance of getting the study vaccine. For every person who gets the placebo, 5 people will get the 
study vaccine.
4.
You will have physical examinations by a clinician. If you are a woman, you will have a urine test for 
pregnancy. You must agree to use birth control until 3 weeks (21 days) after your injection. We will counsel 
you on reliable birth control methods (intrauterine devices, hormonal contraception, condoms or diaphragm 
with spermicide) and help you get it for free.
5.
In research of vaccines, there is a risk of harm. Please take your time to understand the risks. Ask any 
questions you have.
6.
During the study, we will tell you of any new information about the vaccine. This new information might 
affect your decision to stay in the study. You may leave the study at any time.
What is a seasonal influenza vaccine?
The influenza virus is a very small germ that can be passed from person to person through the fluids in your nose, 
throat, mouth and lungs. Influenza virus can cause an illness in a person’s airways that lasts about one week. Usually, 
the illness comes with a high fever, cough, headache and tiredness. Some influenza illnesses can be severe, especially 
among the young, old, and people with chronic diseases.
Most healthy people do not think of the flu as a serious illness. They may feel bad and miss some work. They are not 
aware that the flu causes many hospitalizations and early deaths for the young, old, and persons with chronic diseases.
The flu has been linked with increases in miscarriage and heart attacks. In this study, we will teach you how to prevent 
getting the flu and giving it to others.
A vaccine is one of the best protections against influenza. There are different types of influenza and even those types 
may change slightly from one year to the next. Every year, the World Health Organization (WHO) receives 
information from countries all over the world about what types of influenza they are seeing in their country. The 
WHO uses this information to predict which types of influenza may be causing problems in the coming year. It tells 
the vaccine manufactures what type of vaccine they should make each year to help fight influenza infection. 
Companies can put together several types of influenza vaccines into one injection. This is called seasonal influenza 
vaccine.
What should I know about the study vaccine manufactured by IVAC?
IVAC made the influenza vaccine that will be used in this study. The WHO and PATH (an international nonprofit 
organization) have supported IVAC to make influenza vaccine. They helped IVAC meet the standards necessary to 
make a good product. The vaccine has had testing done to show that it was made correctly. The tests showed that
study vaccine can be used in humans in vaccine studies. The vaccine cannot give you influenza. 
What is the goal of this study?
This study’s goal is to describe the safety and the body's responses to 1 injection of the study vaccine. 
How is the vaccine given? 
We will give the vaccine by injecting it into the muscle of your upper arm. 
We will give it only once.
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IVAC                                                                                                                                                                                      PIHCMC
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We divide the people in the study into 2 groups. One group (210 people) will get an injection of the study vaccine and 
the other group (42 people) will get an injection of a liquid that does not have the vaccine in it (the placebo). The 
placebo is sterile salt water. A computer decides which group you are in. Neither you nor the study doctor can decide
or will know. In this study, people have a much greater chance of getting the study vaccine than getting the placebo. 
For every person who gets the placebo in the study, 5 will get the study vaccine.
How long will I be in this study?
If you join, you will be in the study for about 3 months after your injection. However, you will only need to come to 
the study site during the first 3 weeks. 
What will happen during screening for this study?
If you agree to be in this study, we will do some things to see if you can join; this is called “screening”. You will be 
provided information about the study and you need to sign this consent before we do any screening.
1.
For screening:

A clinician will ask about your health history.

The clinician will do a physical exam. We will take your temperature, pulse, and blood pressure.

If you are a woman who is able to get pregnant, we will do a urine pregnancy test see if you are pregnant. 
Pregnant women cannot get the study products.
2.
Women who could become pregnant must have already been using reliable birth control (intrauterine device, 
hormonal contraception, or condoms) to be in the study.
We will go over the results of screening with you. If we find you have a health issue, we will advise you on how to get 
proper treatment. Because we cannot tell ahead of time how many people who enter screening will qualify and want to 
join the study, we may have to exclude some people from the study, even if they qualify and want to join. 
What will happen in this study?
If the questions and the physical exam show that you can be in the study, we will ask if you still would like to join. If 
you agree, you can have the study injection the same day as your screening visit. You can take a few more days to 
think about it, if you want. You can always change your mind if you do not want to be in the study. Nothing bad will 
happen if you decide not to join or leave after you have joined.
1.
Product injection:

If the injection is given to you on a different day from the screening visit, we will again take your 
temperature, pulse and blood pressure and do a urine pregnancy test on women who can become pregnant. 
Pregnant women will not receive the injection.

We will give you your injection of study vaccine or placebo. The injection will be into a muscle in your 
upper arm.

You will be asked to stay in the study clinic for at least 30 minutes. During this time, the study staff will 
check to see if you have any reactions to the injection.

The study staff will show you how to complete a Diary Card. We want you to record any reaction or 
medical event and any medications you take on this form. Record each day for 7 days since the day of 
your injection.
2.
The study staff will visit your home one day after your injection and call you 4 days after your injection to check 
on your well-being and see if you are completing the Diary Card. 
3.
Seven (7) days after you are given the injection, you will return to the study clinic. 

We will take your oral temperature, pulse, and blood pressure. A clinician will do a physical exam only if 
you report symptoms.
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_ Phase 2_Ben Luc                                                                                                                         Page 4 of 8
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
We will go over the Diary Card with you to make sure we understand what you wrote.
4.
Over the next 2 weeks (14 days) you will have no clinic visits, but we want you to tell us if you have any health 
concerns. If needed, we will examine you or refer you to care.
5.
Twenty-one (21) days after you are given the injection, you will return to the study clinic. 

We will take your temperature, pulse, and blood pressure. The clinician will do a physical exam only 
if you report symptoms. 

If you are a women who could become pregnant, we will tell you that you no longer need to use birth 
control for the study.
6.
Three months after your injection a member of the study staff will call you. 

We will ask about health problems you told us were continuing at your last visit. 

We will ask you about medications you told us you were still using at your last visit. 

We will ask about any new, serious health problems that may have happened since we saw you last.

We will thank you for being in the study. This will end your study participation. 
7.
After the Phase 2 part of the study, we will do a Phase 3 part. It will take many months to finish the study and 
know the results. When we know the results, we will send you a letter so that you know the study results, too. 
In summary, if you join the study:

You will visit the Study Clinic 3 times over about 3 weeks and one time for consent meeting.

Women will provide a urine sample before their injection. We will use it for a pregnancy test. Women should 
be using reliable birth control for at least 3 weeks after their injection.

You will receive only 1 injection of study vaccine or placebo.

You will be completing a Diary Card for 7 days since the date of the injection

We will visit your home one day after the injection and call you 4 days after the injection to check on your 
well-being.

We will contact you about 3 months after the injection to find out about your health

During the study, we will tell you about new information or changes in the study that may affect your health 
or your willingness to continue.

You will be informed about the study results and all exams related to your health.

We will send you a letter with the study results, including what study product you received. 
Almost all of the procedures we do in this study are like what happens when you have regular health care. The part of 
this study that is not standard treatment is when we give you the study vaccine or placebo.
What are my responsibilities?

Tell us if you have ever had a bad reaction to a vaccine or allergy to eggs, chicken or rubber.

Inform us if you are pregnant or breast feeding.

Come to the study visits and do your best to follow directions.

Tell us if you have moved.

Tell us if you do not like something about the study.

Tell us if you want to leave the study.

Tell your study doctor about any changes in your health that occur during the study as well as any changes in 
your medications during the study.

While participating in this study, you may not take part in any other research project.
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_ Phase 2_Ben Luc                                                                                                                         Page 5 of 8
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What harm could happen?
Sometimes bad things can happen in a study of a vaccine. Think about these when deciding if you want to join. Here
is what we know that could happen during the study:

Receiving the injection of vaccine or placebo can cause pain, redness, swelling, hardness or infection where 
the needle was put in. Also the whole body may feel feverish or have muscle aches or nausea (feeling like you 
may throw up). In the earlier study of the vaccine, people report pain and tenderness the most. Most of the 
side effects were mild, meaning that people did not limit their activities because of the injection.

It is very rare, but sometimes people have a serious allergic reaction to a vaccine. This can be life-threatening. 
We can provide emergency care, if needed.

There may be harm, even serious harm that we do not know about yet.

We do not know if the study vaccine is safe for use in pregnancy. That is why we ask women to agree to use 
reliable birth control during the study.

We do our best to keep your study records and private information confidential. However, there is always a 
risk that someone who is not supposed to may see your information by accident. If this happens, we will tell 
you.

To be in the study, you must not have had a flu vaccine in the past 6 months and you must wait until 3 weeks 
after your injection to have any licensed vaccines. Because of this, it is possible that you could get exposed to 
seasonal influenza and get the flu during the study. We will teach you ways to protect yourself and others 
from the flu.
What if I am injured?
If you have an injury and need help, contact Dr. Phan Cong Hung or Dr. Hoang Anh Thang to let him know what is 
happening. Their numbers are at the end of this form. Dr. Phan Cong Hung or Dr. Hoang Anh Thang can consult and 
help you get the care you need. The IVAC has arranged for the Ben Luc district hospital to provide you with free 
treatment for any injuries that happen during the study. The IVAC does not plan to pay any additional money to you 
unless directed by the Ministry of Health, which reviews research injuries.
What if I become pregnant?
We will test for pregnancy before you receive your injection. If you become pregnant and have received an injection 
on the study, we will ask you to stay in the study. Because you received a study product, we want to watch after your 
health. If the study ends and you are still pregnant, we will stay in touch with you to report on the outcome of the 
pregnancy and health of the baby.
What are the known benefits of participating in this research study?
There may not be any benefit to you personally. However, you may benefit from the physical exams. If you receive 
the study vaccine, we do not know if it will protect you against an infection with seasonal influenza. People in the 
study will contribute information about a vaccine against influenza. This may eventually help Vietnam have access to 
a new influenza vaccine that is made locally. 
What are my alternatives to participating in this research study?
You can choose not to join the study. You can get an approved seasonal influenza vaccine from a public or private 
health care center, however, you will have to pay for the vaccine.
What if I want to leave the study?
If you want to leave the study, please tell us. We will ask you to come for at least one more study visit just to check on 
your health.
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_ Phase 2_Ben Luc                                                                                                                         Page 6 of 8
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Can I be taken off the study without my consent?
The researcher can take you off the study for the following reasons:

You have trouble following the directions of the study staff

We find out you have been enrolled in the study, but you should not have been enrolled.
In most cases, we will ask you to stay in the study and continue to be assessed by the study staff. If you are asked (or 
choose) to leave the study altogether, we will ask about your health before you leave.
Who will see my personal information in this research study?
We will keep all of your personal information confidential unless the law requires us to release it. 
We keep your study forms locked. The following people/groups will be allowed to see your confidential information:

People involved in doing the research

People paying for the study

People from groups that make sure the study is being done well

People from health agencies that keep track of an illness you may have
We will take great care with information that can identify you, such as your name. Your name will be seen only by
people who need to see it for their work on the study. For example, the study staff need to know your name. Also, 
study monitors will come to the site to check your consent form, which has your name. You will not be identified by 
name in publications of this study.
Will I be paid for my participation in the study? 

There are no costs to you for participation in this study.

All physical exams will be free of cost to you.

You will receive payment for your time and effort to be in this study. You will receive VND 450,000 for each 
study visit to the Health Center. Therefore, if you participate in all activities until the end of the study, you 
will receive a total amount of VND 1,800,000 for 3 site visits and a consent meeting.
How will I know the study results?
The researchers will provide a written summary of the study results to you. This could take a year or longer from 
when you started the study. Also, information about the study will be posted on a public website called 
clinicaltrials.gov. You can go to www.clinicaltrials.gov to view this or other studies. Your personal information is 
kept out of any study reports.
We will review any individual safety results with you as they are available during the study. 
Who may I contact if I have additional questions?
The study staff can answer anything you do not understand. 
You should immediately report to Dr. Phan Cong Hung or Dr. Hoang Anh Thang or other study staff if:

You are having any injuries that you think may be caused by being in the study.

You are in need of urgent medical care.
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_ Phase 2_Ben Luc                                                                                                                         Page 7 of 8
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Dr. Phan Cong Hung (PI)
Pasteur Institute in Ho Chi Minh City
168 Pasteur Street, Ward 8, District 3,
HCM City.
Cell phone: 093 528 8287
Dr. Hoang Anh Thang
Pasteur Institute in Ho Chi Minh City
168 Pasteur street, Ward 8, District 3,
HCM City.
Cell phone: 090 322 4407
You may also contact the administrator of the research ethics committee with any questions or concerns about how 
you are being treated on this study or your rights as a study volunteer:
IRB of Pasteur Institute in Ho Chi Minh City
Phone: 08 3820 4013
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_ Phase 2_Ben Luc                                                                                                                         Page 8 of 8
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A PHASE 2/3 DOUBLE BLINDED, RANDOMIZED, PLACEBO-CONTROLLED STUDY IN 
HEALTHY ADULT VOLUNTEERS IN VIETNAM TO EXAMINE THE SAFETY AND 
IMMUNOGENICITY OF SEASONAL TRIVALENT INACTIVATED SPLIT VIRION 
INFLUENZA VACCINE (IVACFLU-S) PRODUCED BY IVAC
INFORMED CONSENT FORM FOR PHASE 2
I,
attest that:

I have read and understand the information about the clinical study.

I was informed by the researchers about this study and enrollment procedures. 

I have had a chance to ask questions about this study. My questions have been answered to my 
satisfaction.

I have had enough time to think about my participation in this study.

I have been given this information sheet, which describes this study.

I understand that I have the right to refuse to join or withdraw from this study. I may withdraw at any 
time and for any reason. 

I am aware that study information could be published in medical journals or put on a public website. 
I am aware that this may be done to help medical science. I am aware that my identity will be 
masked.

I know that if I request it, you will share my screening physical exam results with my regular doctor.

I agree to participate in the Phase 2 part of the study.
Full name of volunteer (PRINTED NAME):_____________________________________
Signature of volunteer ____________________________________
Time: ___ ___:___ ___  Date:___/___/____
Part to be completed by researcher
I provided information to the volunteer on nature and purpose of this study and potential risks and benefits 
of participation in this study.
Name and Signature of researcher: ____________________________________Date:___/___/____
(Dr. Phan Cong Hung or designee)
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Ben Luc                                                                                                                        Page 1 of 9
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INFORMATION SHEET and INFORMED CONSENT FORMS
for “screening” and “participation in the research study” entitled:
A PHASE 2/3 DOUBLE BLINDED, RANDOMIZED, PLACEBO-CONTROLLED STUDY IN HEALTHY
ADULT VOLUNTEERS IN VIETNAM TO EXAMINE THE SAFETY AND IMMUNOGENICITY OF 
SEASONAL TRIVALENT INACTIVATED SPLIT VIRION INFLUENZA VACCINE (IVACFLU-S)
PRODUCED BY IVAC 
Sponsor:
Institute of Vaccines and Medical Biologicals (IVAC)
Funder:
PATH
Study implementer:
Pasteur Institute in Ho Chi Minh City (PIHCMC)
Full name of volunteer: 
Address:
Participant screening code:
Participant identification code
(if recruited): 
CONSENT FOR PHASE 3 - BEN LUC DISTRICT HEALTH CENTER, LONG AN 
PROVICE
Introduction
You are invited to participate in a research study. This is a study of an experimental seasonal influenza vaccine called 
IVACFLU-S. We will call it the “study vaccine.” The study vaccine has not been approved for sale in Vietnam. It can 
only be used in research. This vaccine was made in Vietnam by the Institute of Vaccines and Biologicals (IVAC), 
Ministry of Health. 
The vaccine was used in a Phase 1 study of 60 people in the Hung Ha district health center. In the Phase 1 study, the 
vaccine did not cause any serious health problems. Most of the side effects were mild and did not last long. Now we 
will test the study vaccine in a larger study of about 888 people. If the study shows good results, IVAC will apply to 
license the vaccine in Vietnam. The study is a combination of a Phase 2 study and a Phase 3 study. 
You are being asked to join the Phase 3 part of the study. About 252 people participated in the Phase 2 study in 
Ben Luc, Long An. Among them, 210 received the study vaccine. The vaccine was considered acceptable to be used 
in this Phase 3 part of the study with 636 people. We want to see if the study vaccine continues to be safe for people to 
use and if it is likely to protect people from the influenza virus.
The following groups are involved in the study: Institute of Vaccines and Biologicals, the Pasteur Institute, Ho Chi 
Minh City, Long An and Dong Nai Preventive Medicine Centers and the Ben Luc and Long Thanh district health 
centers. The study is funded through the US Biomedical Advanced Research and Development Authority (BARDA), 
PATH, an international nonprofit organization, and the World Health Organization (WHO).
This information sheet explains the study and your part in the study. Please take as much time as you need to read this 
information. Talk with friends, relatives and your doctor if you wish.  You can ask us any questions you want.
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Ben Luc                                                                                                                        Page 2 of 9
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What you should know about this study:
1.
Being in this study is voluntary. You can refuse to join or leave any time after you have joined without penalty 
or loss of any rights you normally have.
2.
You may or may not benefit from being in the study. If you join, you may help other people in your 
community and Vietnam. 
3.
You will receive 1 injection of the study vaccine or a placebo. The placebo is sterile salt water. It will not 
prepare your body to fight influenza infections. You and the researcher will not know if you were given study 
vaccine or placebo until the end of the study. This is decided by chance. However, each person in the study 
has a greater chance of getting the study vaccine. For every person who gets the placebo, 5 people will get the 
study vaccine.
4.
You will have physical examinations and 2 blood draws by a clinician.
5.
If you are a woman, you will have a urine test for pregnancy. You must agree to use birth control until 3 
weeks (21 days) after your injection. We will counsel you on reliable birth control methods (intrauterine 
devices, hormonal contraception, condoms or diaphragm with spermicide) and help you get it for free.
6.
In research of vaccines, there is a risk of harm. Please take your time to understand the risks. Ask any 
questions you have.
7.
During the study, we will tell you of any new information about the vaccine. This new information might 
affect your decision to stay in the study. You may leave the study at any time.
What is a seasonal influenza vaccine?
The influenza virus is a very small germ that can be passed from person to person through the fluids in your nose, 
throat, mouth and lungs. Influenza virus can cause an illness in a person’s airways that lasts about one week. Usually, 
the illness comes with a high fever, cough, headache and tiredness. Some influenza illnesses can be severe, especially 
among the young, old, and people with chronic diseases.
Most healthy people do not think of the flu as a serious illness. They may feel bad and miss some work. They are not 
aware that the flu causes many hospitalizations and early deaths for the young, old, and persons with chronic diseases.
The flu has been linked with increases in miscarriage and heart attacks. In this study, we will teach you how to prevent 
getting the flu and giving it to others.
A vaccine is one of the best protections against influenza. There are different types of influenza and even those types 
may change slightly from one year to the next. Every year, the World Health Organization (WHO) receives 
information from countries all over the world about what types of influenza they are seeing in their country. The 
WHO uses this information to predict which types of influenza may be causing problems in the coming year. It tells 
the vaccine manufactures what type of vaccine they should make each year to help fight influenza infection. 
Companies can put together several types of influenza vaccines into one injection. This is called seasonal influenza 
vaccine.
What should I know about the study vaccine manufactured by IVAC?
IVAC made the influenza vaccine that will be used in this study. The WHO and PATH (an international nonprofit 
organization) have supported IVAC to make influenza vaccine. They helped IVAC meet the standards necessary to 
make a good product. The vaccine has had testing done to show that it was made correctly. The tests showed that
study vaccine can be used in humans in vaccine studies. The vaccine cannot give you influenza. 
What is the goal of this study?
This study’s goal is to describe the safety and the body's responses to 1 injection of the study vaccine. 
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Ben Luc                                                                                                                        Page 3 of 9
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How is the vaccine given? 
We will give the vaccine by injecting it into the muscle of your upper arm. 
We will give it only once.
We divide the people in the study into 2 groups. One group (530 people) will get an injection of the study vaccine and 
the other group (106 people) will get an injection of a liquid that does not have the vaccine in it (the placebo). The 
placebo is sterile salt water. A computer decides which group you are in. Neither you nor the study doctor can decide
or will know. In this study, people have a much greater chance of getting the study vaccine than getting the placebo. 
For every person who gets the placebo in the study, 5 will get the study vaccine.
How long will I be in this study?
If you join, you will be in the study for about 3 months after your injection. However, you will only need to come to 
the study site during the first 3 weeks. 
What will happen during screening for this study?
If you agree to be in this study, we will do some things to see if you can join; this is called “screening”. You will be 
provided information about the study and you need to sign this consent before we do any screening.
1.
For screening:

A clinician will ask about your health history.

The clinician will do a physical exam. We will take your temperature, pulse, and blood pressure.

If you are a woman who is able to get pregnant, we will do a urine pregnancy test see if you are pregnant. 
Pregnant women cannot get the study products.
2.
Women who could become pregnant must have already been using reliable birth control (intrauterine device, 
hormonal contraception, or condoms) to be in the study.
We will go over the results of screening with you. If we find you have a health issue, we will advise you on how to get 
proper treatment. Because we cannot tell ahead of time how many people who enter screening will qualify and want to 
join the study, we may have to exclude some people from the study, even if they qualify and want to join. 
What will happen in this study?
If the questions and the physical exam show that you can be in the study, we will ask if you still would like to join. If 
you agree, you can have the study injection the same day as your screening visit. You can take a few more days to 
think about it, if you want. You can always change your mind if you do not want to be in the study. Nothing bad will 
happen if you decide not to join or leave after you have joined.
1.
Product injection:

If the injection is given to you on a different day from the screening visit, we will again take your 
temperature, pulse and blood pressure and do a urine pregnancy test on women who can become pregnant. 
Pregnant women will not receive the injection.

Before your first injection: The clinician will collect 5 mL (a teaspoon) of blood from a vein in your arm. 
This blood sample will be used to check to see if your body has reacted to the influenza virus in the past.

We will give you your injection of study vaccine or placebo. The injection will be into a muscle in your 
upper arm.

You will be asked to stay in the study clinic for at least 30 minutes. During this time, the study staff will 
check to see if you have any reactions to the injection.

The study staff will show you how to complete a Diary Card. We want you to record any reaction or 
medical event and any medications you take on this form. Record each day for 7 days since the day of 
your injection.
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Ben Luc                                                                                                                        Page 4 of 9
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2.
The study staff will visit your home or call you one day after your injection and call you 4 days after your 
injection to check on your well-being and see if you are completing the Diary Card. 
3.
Seven (7) days after you are given the injection, you will return to the study clinic. 

We will take your oral temperature, pulse, and blood pressure. A clinician will do a physical exam only if 
you report symptoms.

We will go over the Diary Card with you to make sure we understand what you wrote.
4.
Over the next 2 weeks (14 days) you will have no clinic visits, but we want you to tell us if you have any health 
concerns. If needed, we will examine you or refer you to care.
5.
Twenty-one (21) days after you are given the injection, you will return to the study clinic. 

We will take your temperature, pulse, and blood pressure. The clinician will do a physical exam only 
if you report symptoms. 

We will take 5 mL (a teaspoon) of blood from a vein in your arm to see how your body is reacting to 
the influenza vaccine or placebo.

If you are a women who could become pregnant, we will tell you that you no longer need to use birth 
control for the study.
6.
Three months after your injection a member of the study staff will call you. 

We will ask about health problems you told us were continuing at your last visit. 

We will ask you about medications you told us you were still using at your last visit. 

We will ask about any new, serious health problems that may have happened since we saw you last.

We will thank you for being in the study. This will end your study participation. 
7.
After the last person finishes the Phase 3 study, it will take about 6 months to know the results. When we know 
the results, we will send you a letter so that you know the study results, too. 
In summary, if you join the study:

You will visit the Study Clinic 3 times over about 3 weeks and one time for consent meeting.

Women will provide a urine sample before their injection. We will use it for a pregnancy test. Women should 
be using reliable birth control for at least 3 weeks after their injection.

You will receive only 1 injection of study vaccine or placebo.

You will have 2 blood draws from a vein in your arm.

You will be completing a Diary Card for 7 days since the date of the injection.

We will visit your home or call you one day after the injection and call you 4 days after the injection to check 
on your well-being.

We will contact you about 3 months after the injection to find out about your health

During the study, we will tell you about new information or changes in the study that may affect your health 
or your willingness to continue.

You will be informed about the study results and all exams related to your health.

We will send you a letter with the study results, including what study product you received. 
Almost all of the procedures we do in this study are like what happens when you have regular health care. The part of 
this study that is not standard treatment is when we give you the study vaccine or placebo.
What will happen to my blood samples? 
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Ben Luc                                                                                                                        Page 5 of 9
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Testing in the Study: We will test blood samples to see if there is an immune response to the vaccine. Those who get 
the placebo will not have this immune response. Your samples will be sent to a laboratory in Italy for this testing. We 
will compare the responses of those who got the vaccine to those who got the placebo. 
Quality Control by Pasteur Institute Laboratory during the Study: Also, we will use blood samples to help staff 
at Pasteur Institute Laboratories learn to conduct testing for influenza viruses. We will use a number in place of your 
name on the labels of the blood samples. The Pasteur Institute Lab will check its results against the results from the 
laboratory in Italy.
Using Left-over Samples: There may be blood samples left over after the study ends. If you agree, we want to 
continue to use these samples to help improve the quality of testing for influenza or influenza vaccines by Vietnam 
laboratories. The samples will have a number in place of your name. After 5 years, we will destroy any samples that 
remain. At the end of this form, we will ask you if you will allow this use of your left-over samples. You can say “no” 
and still be in this study. You can also say “yes” and change your mind later.
What are my responsibilities?

Tell us if you have ever had a bad reaction to a vaccine or allergy to eggs, chicken or rubber.

Inform us if you are pregnant or breast feeding.

Come to the study visits and do your best to follow directions.

Tell us if you have moved.

Tell us if you do not like something about the study.

Tell us if you want to leave the study.

Tell your study doctor about any changes in your health that occur during the study as well as any changes in 
your medications during the study.

While participating in this study, you may not take part in any other research project.
What harm could happen?
Sometimes bad things can happen in a study of a vaccine. Think about these when deciding if you want to join. Here
is what we know that could happen during the study:

Drawing blood can cause pain, redness, bruising, swelling, or infection. It is rare, but sometimes people faint 
when having blood taken.

Receiving the injection of vaccine or placebo can cause pain, redness, swelling, hardness or infection where 
the needle was put in. Also the whole body may feel feverish or have muscle aches or nausea (feeling like you 
may throw up). In the earlier study of the vaccine, people report pain and tenderness the most. Most of the 
side effects were mild, meaning that people did not limit their activities because of the injection.

It is very rare, but sometimes people have a serious allergic reaction to a vaccine. This can be life-threatening. 
We can provide emergency care, if needed.

There may be harm, even serious harm that we do not know about yet.

We do not know if the study vaccine is safe for use in pregnancy. That is why we ask women to agree to use 
reliable birth control during the study.

We do our best to keep your study records and private information confidential. However, there is always a 
risk that someone who is not supposed to may see your information by accident. If this happens, we will tell 
you.

To be in the study, you must not have had a flu vaccine in the past 6 months and you must wait until 3 weeks 
after your injection to have any licensed vaccines. Because of this, it is possible that you could get exposed to 
seasonal influenza and get the flu during the study. We will teach you ways to protect yourself and others 
from the flu.
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Ben Luc                                                                                                                        Page 6 of 9
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What if I am injured?
If you have an injury and need help, contact Dr. Phan Cong Hung or Dr. Hoang Anh Thang to let him know what is 
happening. Their numbers are at the end of this form. Dr. Phan Cong Hung or Dr. Hoang Anh Thang can consult and 
help you get the care you need. The IVAC has arranged for the Ben Luc district hospital to provide you with free 
treatment for any injuries that happen during the study. The IVAC does not plan to pay any additional money to you 
unless directed by the Ministry of Health, which reviews research injuries.
What if I become pregnant?
We will test for pregnancy before you receive your injection. If you become pregnant and have received an injection 
on the study, we will ask you to stay in the study. Because you received a study product, we want to watch after your 
health. If the study ends and you are still pregnant, we will stay in touch with you to report on the outcome of the 
pregnancy and health of the baby.
What are the known benefits of participating in this research study?
There may not be any benefit to you personally. However, you may benefit from the physical exams. If you receive 
the study vaccine, we do not know if it will protect you against an infection with seasonal influenza. People in the 
study will contribute information about a vaccine against influenza. This may eventually help Vietnam have access to 
a new influenza vaccine that is made locally. 
What are my alternatives to participating in this research study?
You can choose not to join the study. You can get an approved seasonal influenza vaccine from a public or private 
health care center, however, you will have to pay for the vaccine.
What if I want to leave the study?
If you want to leave the study, please tell us. We will ask you to come for at least one more study visit just to check on 
your health.
Can I be taken off the study without my consent?
The researcher can take you off the study for the following reasons:

You have trouble following the directions of the study staff

We find out you have been enrolled in the study, but you should not have been enrolled.
In most cases, we will ask you to stay in the study and continue to be assessed by the study staff. If you are asked (or 
choose) to leave the study altogether, we will ask about your health before you leave.
Who will see my personal information in this research study?
We will keep all of your personal information confidential unless the law requires us to release it. 
We keep your study forms locked. The following people/groups will be allowed to see your confidential information:

People involved in doing the research

People paying for the study

People from groups that make sure the study is being done well

People from health agencies that keep track of an illness you may have
We will take great care with information that can identify you, such as your name. Your name will be seen only by
people who need to see it for their work on the study. For example, the study staff need to know your name. Also, 
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Ben Luc                                                                                                                        Page 7 of 9
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study monitors will come to the site to check your consent form, which has your name. You will not be identified by 
name in publications of this study.
Will I be paid for my participation in the study? 

There are no costs to you for participation in this study.

All physical exams will be free of cost to you.

You will receive payment for your time and effort to be in this study. You will receive VND 450,000 for each 
study visit to the Health Center. Therefore, if you participate in all activities until the end of the study, you 
will receive a total amount of VND 1,800,000 for 3 site visits and a consent meeting.
How will I know the study results?
The researchers will provide a written summary of the study results to you. This could take a year or longer from 
when you started the study. Also, information about the study will be posted on a public website called 
clinicaltrials.gov. You can go to www.clinicaltrials.gov to view this or other studies. Your personal information is 
kept out of any study reports.
We will review any individual safety results with you as they are available during the study.
Who may I contact if I have additional questions?
The study staff can answer anything you do not understand. 
You should immediately report to Dr. Phan Cong Hung or Dr. Hoang Anh Thang or other study staff if:

You are having any injuries that you think may be caused by being in the study.

You are in need of urgent medical care.
Dr. Phan Cong Hung (PI)
Pasteur Institute in Ho Chi Minh City
168 Pasteur Street, Ward 8, District 3,
HCM City.
Cell phone: 093 528 8287
Dr. Hoang Anh Thang
Pasteur Institute in Ho Chi Minh City
168 Pasteur Street, Ward 8, District 3,
HCM City.
Cell phone: 090 322 4407
You may also contact the administrator of the research ethics committee with any questions or concerns about how 
you are being treated on this study or your rights as a study volunteer:
IRB of Pasteur Institute - Ho Chi Minh City
Phone: 08 3820 4013
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Ben Luc                                                                                                                        Page 8 of 9
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A PHASE 2/3 DOUBLE BLINDED, RANDOMIZED, PLACEBO-CONTROLLED STUDY IN 
HEALTHY ADULT VOLUNTEERS IN VIETNAM TO EXAMINE THE SAFETY AND 
IMMUNOGENICITY OF SEASONAL TRIVALENT INACTIVATED SPLIT VIRION 
INFLUENZA VACCINE (IVACFLU-S) PRODUCED BY IVAC
INFORMED CONSENT FORM FOR PHASE 3 - BEN LUC DISTRICT HEALTH CENTER, LONG 
AN PROVINCE
I,
attest that:

I have read and understand the information about the clinical study.

I was informed by the researchers about this study and enrollment procedures. 

I have had a chance to ask questions about this study. My questions have been answered to my 
satisfaction.

I have had enough time to think about my participation in this study.

I have been given this information sheet, which describes this study.

I understand that I have the right to refuse to join or withdraw from this study. I may withdraw at any 
time and for any reason. 

I am aware that study information could be published in medical journals or put on a public website. 
I am aware that this may be done to help medical science. I am aware that my identity will be 
masked.

I know that if I request it, you will share my screening physical exam results with my regular doctor.

I agree to participate in the Phase 3 part of the study.

Using left-over samples: Will you allow the use of any left over blood samples for 5 years to help 
laboratories in Vietnam improve their ability to test for influenza or influenza vaccines? (You can 
say “no” and still be in this vaccine study.) Please sign either box below.
Full name of volunteer (PRINTED NAME): __________________________________
Signature of volunteer ____________________________________
Time: ___ ___:___ ___ Date:___/___/____
Part to be completed by researcher
I provided information to the volunteer on nature and purpose of this study and potential risks and benefits 
of participation in this study.
Yes
Signature: ________________________________________
No
Signature:________________________________________
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Ben Luc                                                                                                                        Page 9 of 9
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Name and Signature of researcher: ____________________________________Date:___/___/____
(Dr. Phan Cong Hung or designee)
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Long Thanh                                                                                                                    Page 1 of 8
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INFORMATION SHEET and INFORMED CONSENT FORMS
for “screening” and “participation in the research study” entitled:
A PHASE 2/3 DOUBLE BLINDED, RANDOMIZED, PLACEBO-CONTROLLED STUDY IN HEALTHY
ADULT VOLUNTEERS IN VIETNAM TO EXAMINE THE SAFETY AND IMMUNOGENICITY OF 
SEASONAL TRIVALENT INACTIVATED SPLIT VIRION INFLUENZA VACCINE (IVACFLU-S)
PRODUCED BY IVAC 
Sponsor:
Institute of Vaccines and Medical Biologicals (IVAC)
Funder:
PATH
Study implementer:
Pasteur Institute in Ho Chi Minh City (PIHCMC)
Full name of volunteer: 
Address:
Participant screening code:
Participant identification code
(if recruited): 
CONSENT FOR PHASE 3 - LONG THANH DISTRICT HEALTH CENTER, DONG NAI 
PROVINCE
Introduction
You are invited to participate in a research study. This is a study of an experimental seasonal influenza vaccine called 
IVACFLU-S. We will call it the “study vaccine.” The study vaccine has not been approved for sale in Vietnam. It can 
only be used in research. This vaccine was made in Vietnam by the Institute of Vaccines and Biologicals (IVAC), 
Ministry of Health. 
The vaccine was used in a Phase 1 study of 60 people in the Hung Ha district health center. In the Phase 1 study, the 
vaccine did not cause any serious health problems. Most of the side effects were mild and did not last long. Now we 
will test the study vaccine in a larger study of about 888 people. If the study shows good results, IVAC will apply to 
license the vaccine in Vietnam. The study is a combination of a Phase 2 study and a Phase 3 study. 
You are being asked to join the Phase 3 part of the study. About 252 people participated in the Phase 2 study in 
Ben Luc, Long An. Among them, 210 received the study vaccine. The vaccine was considered acceptable to be used 
in this Phase 3 part of the study with 636 people. We want to see if the study vaccine continues to be safe for people to 
use and if it is likely to protect people from the influenza virus. You will not have any blood drawn in this study. 
The following groups are involved in the study: Institute of Vaccines and Biologicals, the Pasteur Institute, Ho Chi 
Minh City, Long An and Dong Nai Preventive Medicine Centers and the Ben Luc and Long Thanh district health 
centers. The study is funded through the US Biomedical Advanced Research and Development Authority (BARDA), 
PATH, an international nonprofit organization, and the World Health Organization (WHO).
This information sheet explains the study and your part in the study. Please take as much time as you need to read this 
information. Talk with friends, relatives and your doctor if you wish.  You can ask us any questions you want.
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Long Thanh                                                                                                                    Page 2 of 8
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What you should know about this study:
1.
Being in this study is voluntary. You can refuse to join or leave any time after you have joined without penalty 
or loss of any rights you normally have.
2.
You may or may not benefit from being in the study. If you join, you may help other people in your 
community and Vietnam. 
3.
You will receive 1 injection of the study vaccine or a placebo. The placebo is sterile salt water. It will not 
prepare your body to fight influenza infections. You and the researcher will not know if you were given study 
vaccine or placebo until the end of the study. This is decided by chance. However, each person in the study 
has a greater chance of getting the study vaccine. For every person who gets the placebo, 5 people will get the 
study vaccine.
4.
You will have physical examinations.
5.
If you are a woman, you will have a urine test for pregnancy. You must agree to use birth control until 3 
weeks (21 days) after your injection. We will counsel you on reliable birth control methods (intrauterine 
devices, hormonal contraception, condoms or diaphragm with spermicide) and help you get it for free.
6.
In research of vaccines, there is a risk of harm. Please take your time to understand the risks. Ask any 
questions you have.
7.
During the study, we will tell you of any new information about the vaccine. This new information might 
affect your decision to stay in the study. You may leave the study at any time.
What is a seasonal influenza vaccine?
The influenza virus is a very small germ that can be passed from person to person through the fluids in your nose, 
throat, mouth and lungs. Influenza virus can cause an illness in a person’s airways that lasts about one week. Usually, 
the illness comes with a high fever, cough, headache and tiredness. Some influenza illnesses can be severe, especially 
among the young, old, and people with chronic diseases.
Most healthy people do not think of the flu as a serious illness. They may feel bad and miss some work. They are not 
aware that the flu causes many hospitalizations and early deaths for the young, old, and persons with chronic diseases.
The flu has been linked with increases in miscarriage and heart attacks. In this study, we will teach you how to prevent 
getting the flu and giving it to others.
A vaccine is one of the best protections against influenza. There are different types of influenza and even those types 
may change slightly from one year to the next. Every year, the World Health Organization (WHO) receives 
information from countries all over the world about what types of influenza they are seeing in their country. The 
WHO uses this information to predict which types of influenza may be causing problems in the coming year. It tells 
the vaccine manufactures what type of vaccine they should make each year to help fight influenza infection. 
Companies can put together several types of influenza vaccines into one injection. This is called seasonal influenza 
vaccine.
What should I know about the study vaccine manufactured by IVAC?
IVAC made the influenza vaccine that will be used in this study. The WHO and PATH (an international nonprofit 
organization) have supported IVAC to make influenza vaccine. They helped IVAC meet the standards necessary to 
make a good product. The vaccine has had testing done to show that it was made correctly. The tests showed that
study vaccine can be used in humans in vaccine studies. The vaccine cannot give you influenza. 
What is the goal of this study?
This study’s goal is to describe the safety and the body's responses to 1 injection of the study vaccine. 
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IVAC                                                                                                                                                                                      PIHCMC
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How is the vaccine given? 
We will give the vaccine by injecting it into the muscle of your upper arm. 
We will give it only once.
We divide the people in the study into 2 groups. One group (530 people) will get an injection of the study vaccine and 
the other group (106 people) will get an injection of a liquid that does not have the vaccine in it (the placebo). The 
placebo is sterile salt water. A computer decides which group you are in. Neither you nor the study doctor can decide
or will know. In this study, people have a much greater chance of getting the study vaccine than getting the placebo. 
For every person who gets the placebo in the study, 5 will get the study vaccine.
How long will I be in this study?
If you join, you will be in the study for about 3 months after your injection. However, you will only need to come to 
the study site during the first 3 weeks. 
What will happen during screening for this study?
If you agree to be in this study, we will do some things to see if you can join; this is called “screening”. You will be 
provided information about the study and you need to sign this consent before we do any screening.
1.
For screening:

A clinician will ask about your health history.

The clinician will do a physical exam. We will take your temperature, pulse, and blood pressure.

If you are a woman who is able to get pregnant, we will do a urine pregnancy test see if you are pregnant. 
Pregnant women cannot get the study products.
2.
Women who could become pregnant must have already been using reliable birth control (intrauterine device, 
hormonal contraception, or condoms) to be in the study.
We will go over the results of screening with you. If we find you have a health issue, we will advise you on how to get 
proper treatment. Because we cannot tell ahead of time how many people who enter screening will qualify and want to 
join the study, we may have to exclude some people from the study, even if they qualify and want to join. 
What will happen in this study?
If the questions and the physical exam show that you can be in the study, we will ask if you still would like to join. If 
you agree, you can have the study injection the same day as your screening visit. You can take a few more days to 
think about it, if you want. You can always change your mind if you do not want to be in the study. Nothing bad will 
happen if you decide not to join or leave after you have joined.
1.
Product injection:

If the injection is given to you on a different day from the screening visit, we will again take your 
temperature, pulse and blood pressure and do a urine pregnancy test on women who can become pregnant. 
Pregnant women will not receive the injection.

We will give you your injection of study vaccine or placebo. The injection will be into a muscle in your 
upper arm.

You will be asked to stay in the study clinic for at least 30 minutes. During this time, the study staff will 
check to see if you have any reactions to the injection.

The study staff will show you how to complete a Diary Card. We want you to record any reaction or 
medical event and any medications you take on this form. Record each day for 7 days since the day of 
your injection.
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IVACFLU-S-0203_ICF_Phase 3_Long Thanh                                                                                                                    Page 4 of 8
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2.
The study staff will visit your home or call you one day after your injection and call you 4 days after your 
injection to check on your well-being and see if you are completing the Diary Card. 
3.
Seven (7) days after you are given the injection, you will return to the study clinic. 

We will take your oral temperature, pulse, and blood pressure. A clinician will do a physical exam only if 
you report symptoms.

We will go over the Diary Card with you to make sure we understand what you wrote.
4.
Over the next 2 weeks (14 days) you will have no clinic visits, but we want you to tell us if you have any health 
concerns. If needed, we will examine you or refer you to care.
5.
Twenty-one (21) days after you are given the injection, you will return to the study clinic. 

We will take your temperature, pulse, and blood pressure. The clinician will do a physical exam only 
if you report symptoms. 

If you are a women who could become pregnant, we will tell you that you no longer need to use birth 
control for the study.
6.
Three months after your injection a member of the study staff will call you. 

We will ask about health problems you told us were continuing at your last visit. 

We will ask you about medications you told us you were still using at your last visit. 

We will ask about any new, serious health problems that may have happened since we saw you last.

We will thank you for being in the study. This will end your study participation. 
7.
After the last person finishes the Phase 3 study, it will take about 6 months to know the results. When we know 
the results, we will send you a letter so that you know the study results, too. 
In summary, if you join the study:

You will visit the Study Clinic 3 times over about 3 weeks and one time for consent meeting.

Women will provide a urine sample before their injection. We will use it for a pregnancy test. Women should 
be using reliable birth control for at least 3 weeks after their injection.

You will receive only 1 injection of study vaccine or placebo.

You will be completing a Diary Card for 7 days since the date of the injection.

We will visit your home or call you one day after the injection and call you 4 days after the injection to check 
on your well-being.

We will contact you about 3 months after the injection to find out about your health

During the study, we will tell you about new information or changes in the study that may affect your health 
or your willingness to continue.

You will be informed about the study results and all exams related to your health.

We will send you a letter with the study results, including what study product you received. 
Almost all of the procedures we do in this study are like what happens when you have regular health care. The part of 
this study that is not standard treatment is when we give you the study vaccine or placebo.
What are my responsibilities?

Tell us if you have ever had a bad reaction to a vaccine or allergy to eggs, chicken or rubber.

Inform us if you are pregnant or breast feeding.

Come to the study visits and do your best to follow directions.
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Long Thanh                                                                                                                    Page 5 of 8
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
Tell us if you have moved.

Tell us if you do not like something about the study.

Tell us if you want to leave the study.

Tell your study doctor about any changes in your health that occur during the study as well as any changes in 
your medications during the study.

While participating in this study, you may not take part in any other research project.
What harm could happen?
Sometimes bad things can happen in a study of a vaccine. Think about these when deciding if you want to join. Here
is what we know that could happen during the study:

Receiving the injection of vaccine or placebo can cause pain, redness, swelling, hardness or infection where 
the needle was put in. Also the whole body may feel feverish or have muscle aches or nausea (feeling like you 
may throw up). In the earlier study of the vaccine, people report pain and tenderness the most. Most of the 
side effects were mild, meaning that people did not limit their activities because of the injection.

It is very rare, but sometimes people have a serious allergic reaction to a vaccine. This can be life-threatening. 
We can provide emergency care, if needed.

There may be harm, even serious harm that we do not know about yet.

We do not know if the study vaccine is safe for use in pregnancy. That is why we ask women to agree to use 
reliable birth control during the study.

We do our best to keep your study records and private information confidential. However, there is always a 
risk that someone who is not supposed to may see your information by accident. If this happens, we will tell 
you.

To be in the study, you must not have had a flu vaccine in the past 6 months and you must wait until 3 weeks 
after your injection to have any licensed vaccines. Because of this, it is possible that you could get exposed to 
seasonal influenza and get the flu during the study. We will teach you ways to protect yourself and others 
from the flu.
What if I am injured?
If you have an injury and need help, contact Dr. Phan Cong Hung or Dr. Hoang Anh Thang to let him know what is 
happening. Their numbers are at the end of this form. Dr. Phan Cong Hung or Dr. Hoang Anh Thang can consult and 
help you get the care you need. The IVAC has arranged for the Long Thanh district hospital to provide you with free 
treatment for any injuries that happen during the study. The IVAC does not plan to pay any additional money to you 
unless directed by the Ministry of Health, which reviews research injuries.
What if I become pregnant?
We will test for pregnancy before you receive your injection. If you become pregnant and have received an injection 
on the study, we will ask you to stay in the study. Because you received a study product, we want to watch after your 
health. If the study ends and you are still pregnant, we will stay in touch with you to report on the outcome of the 
pregnancy and health of the baby.
What are the known benefits of participating in this research study?
There may not be any benefit to you personally. However, you may benefit from the physical exams. If you receive 
the study vaccine, we do not know if it will protect you against an infection with seasonal influenza. People in the 
study will contribute information about a vaccine against influenza. This may eventually help Vietnam have access to 
a new influenza vaccine that is made locally. 
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Long Thanh                                                                                                                    Page 6 of 8
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What are my alternatives to participating in this research study?
You can choose not to join the study. You can get an approved seasonal influenza vaccine from a public or private 
health care center, however, you will have to pay for the vaccine.
What if I want to leave the study?
If you want to leave the study, please tell us. We will ask you to come for at least one more study visit just to check on 
your health.
Can I be taken off the study without my consent?
The researcher can take you off the study for the following reasons:

You have trouble following the directions of the study staff

We find out you have been enrolled in the study, but you should not have been enrolled.
In most cases, we will ask you to stay in the study and continue to be assessed by the study staff. If you are asked (or 
choose) to leave the study altogether, we will ask about your health before you leave.
Who will see my personal information in this research study?
We will keep all of your personal information confidential unless the law requires us to release it. 
We keep your study forms locked. The following people/groups will be allowed to see your confidential information:

People involved in doing the research

People paying for the study

People from groups that make sure the study is being done well

People from health agencies that keep track of an illness you may have
We will take great care with information that can identify you, such as your name. Your name will be seen only by
people who need to see it for their work on the study. For example, the study staff need to know your name. Also, 
study monitors will come to the site to check your consent form, which has your name. You will not be identified by 
name in publications of this study.
Will I be paid for my participation in the study? 

There are no costs to you for participation in this study.

All physical exams will be free of cost to you.

You will receive payment for your time and effort to be in this study. You will receive VND 450,000 for each 
study visit to the Health Center. Therefore, if you participate in all activities until the end of the study, you 
will receive a total amount of VND 1,800,000 for 3 site visits and a consent meeting.
How will I know the study results?
The researchers will provide a written summary of the study results to you. This could take a year or longer from 
when you started the study. Also, information about the study will be posted on a public website called 
clinicaltrials.gov. You can go to www.clinicaltrials.gov to view this or other studies. Your personal information is 
kept out of any study reports.
We will review any individual safety results with you as they are available during the study.
Who may I contact if I have additional questions?
The study staff can answer anything you do not understand. 
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Long Thanh                                                                                                                    Page 7 of 8
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You should immediately report to Dr. Phan Cong Hung or Dr. Hoang Anh Thang or other study staff if:

You are having any injuries that you think may be caused by being in the study.

You are in need of urgent medical care.
Dr. Phan Cong Hung (PI)
Pasteur Institute in Ho Chi Minh City
168 Pasteur Street, Ward 8, District 3,
HCM City.
Cell phone: 093 528 8287
Dr. Hoang Anh Thang
Pasteur Institute in Ho Chi Minh City
168 Pasteur Street, Ward 8, District 3,
HCM City.
Cell phone: 090 322 4407
You may also contact the administrator of the research ethics committee with any questions or concerns about how 
you are being treated on this study or your rights as a study volunteer:
IRB of Pasteur Institute - Ho Chi Minh City
Phone: 08 3820 4013
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IVAC                                                                                                                                                                                      PIHCMC
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IVACFLU-S-0203_ICF_Phase 3_Long Thanh                                                                                                                    Page 8 of 8
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A PHASE 2/3 DOUBLE BLINDED, RANDOMIZED, PLACEBO-CONTROLLED STUDY IN 
HEALTHY ADULT VOLUNTEERS IN VIETNAM TO EXAMINE THE SAFETY AND 
IMMUNOGENICITY OF SEASONAL TRIVALENT INACTIVATED SPLIT VIRION 
INFLUENZA VACCINE (IVACFLU-S) PRODUCED BY IVAC
INFORMED CONSENT FORM FOR PHASE 3 - LONG THANH DISTRICT HEALTH CENTER, 
DONG NAI PROVINCE
I,
attest that:

I have read and understand the information about the clinical study.

I was informed by the researchers about this study and enrollment procedures. 

I have had a chance to ask questions about this study. My questions have been answered to my 
satisfaction.

I have had enough time to think about my participation in this study.

I have been given this information sheet, which describes this study.

I understand that I have the right to refuse to join or withdraw from this study. I may withdraw at any 
time and for any reason. 

I am aware that study information could be published in medical journals or put on a public website. 
I am aware that this may be done to help medical science. I am aware that my identity will be 
masked.

I know that if I request it, you will share my screening physical exam results with my regular doctor.

I agree to participate in the Phase 3 part of the study.
Full name of volunteer (PRINTED NAME): __________________________________
Signature of volunteer ____________________________________
Time: ___ ___:___ ___ Date:___/___/____
Part to be completed by researcher
I provided information to the volunteer on nature and purpose of this study and potential risks and benefits 
of participation in this study.
Name and Signature of researcher: ____________________________________Date:___/___/____
(Dr. Phan Cong Hung or designee)
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16.1.4 
List and description of Investigators and other important participants 
in the study 
Principal Investigators at study centers that consented at least 1 subject are listed below. 
Curriculum vitae for the Principal Investigators are available upon request. 
Study Center 
Principal Investigator 
Investigator Address 
201  
(District Health 
Center of Ben Luc 
district, Long An 
Province) 
 
PI: Dr. Phan Cong Hung 
Co-PI: Dr. Nguyen Trong Toan 
Pasteur Institute in Ho Chi Minh City 
167 Pasteur, Ward 8, District 3 
Ho Chi Minh City 
Vietnam 
203  
(District Health 
Center of Long 
Thanh district, Dong 
Nai Province) 
 
PI: Dr. Phan Cong Hung 
Co-PI: Dr. Nguyen Trong Toan 
 
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16.1.5 
Signatures of principal investigator(s) and sponsor's responsible 
medical officer 
The signatures of Sponsor’s representative and Principal Investigator are available on Title 
Page (Page 2) of this CSR. 
 
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16.1.6 
Listing of subjects receiving test drug(s)/investigational product(s) 
from specific batches 
Products 
Lot 
Manufacturing 
Date 
Expiry 
Date 
Manufacturer 
IVACFLU-S 
15 mcg 
004-01-16 
29/11/16 
05/12/17 
IVAC 
PLACEBO 
007P-01-16 
02/12/16 
05/12/17 
IVAC 
 
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16.1.7 
Randomization scheme and codes 
Document 
IVACFLU-S-0203 Subject Randomization 
IVACFLU-S-0203 Randomization Specification Document Version 2, Dated 
31 March 2017 
 
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Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SA001 (A001) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:08:53:00 
A001 
Y 
IVACFLU-S-0203-201-SA002 (A003) 
PLACEBO 
PLACEBO 
20Mar2017:08:43:00 
A003 
Y 
IVACFLU-S-0203-201-SA003 (A004) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:08:47:00 
A004 
Y 
IVACFLU-S-0203-201-SA004 (A005) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:08:59:00 
A005 
Y 
IVACFLU-S-0203-201-SA005 (A002) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:08:39:00 
A002 
Y 
IVACFLU-S-0203-201-SA006 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA007 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA008 (A006) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:09:05:00 
A006 
Y 
IVACFLU-S-0203-201-SA009 (A007) 
PLACEBO 
PLACEBO 
20Mar2017:09:07:00 
A007 
Y 
IVACFLU-S-0203-201-SA010 (A010) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:09:20:00 
A010 
Y 
IVACFLU-S-0203-201-SA011 (A011) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:09:24:00 
A011 
Y 
IVACFLU-S-0203-201-SA012 (A009) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:09:15:00 
A009 
Y 
IVACFLU-S-0203-201-SA013 (A012) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:09:36:00 
A012 
Y 
IVACFLU-S-0203-201-SA014 (A013) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:09:41:00 
A013 
Y 
IVACFLU-S-0203-201-SA015 (A019) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:10:18:00 
A019 
Y 
IVACFLU-S-0203-201-SA016 (A008) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:09:11:00 
A008 
Y 
IVACFLU-S-0203-201-SA017 (A015) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:09:50:00 
A015 
Y 
IVACFLU-S-0203-201-SA018 (A018) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:10:16:00 
A018 
Y 
IVACFLU-S-0203-201-SA019 (A017) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:09:55:00 
A017 
Y 
IVACFLU-S-0203-201-SA020 (A016) 
PLACEBO 
PLACEBO 
20Mar2017:09:53:00 
A016 
Y 
IVACFLU-S-0203-201-SA021 (A014) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:09:45:00 
A014 
Y 
IVACFLU-S-0203-201-SA022 (A020) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:11:51:00 
A020 
Y 
IVACFLU-S-0203-201-SA023 (A021) 
PLACEBO 
PLACEBO 
22Mar2017:08:32:00 
A021 
Y 
IVACFLU-S-0203-201-SA024 (A022) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:08:46:00 
A022 
Y 
IVACFLU-S-0203-201-SA025 (A023) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:09:07:00 
A023 
Y 
IVACFLU-S-0203-201-SA026 (A024) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:09:10:00 
A024 
Y 
IVACFLU-S-0203-201-SA027 (A026) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:00:00 
A026 
Y 
IVACFLU-S-0203-201-SA028 (A025) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:10:55:00 
A025 
Y 
IVACFLU-S-0203-201-SA029 (A029) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:18:00 
A029 
Y 
IVACFLU-S-0203-201-SA030 (A027) 
PLACEBO 
PLACEBO 
22Mar2017:11:06:00 
A027 
Y 
IVACFLU-S-0203-201-SA031 (A030) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:20:00 
A030 
Y 
IVACFLU-S-0203-201-SA032 (A031) 
PLACEBO 
PLACEBO 
22Mar2017:11:22:00 
A031 
Y 
IVACFLU-S-0203-201-SA033 (A032) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:24:00 
A032 
Y 
IVACFLU-S-0203-201-SA034 (A033) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:26:00 
A033 
Y 
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Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SA035 (A038) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:36:00 
A038 
Y 
IVACFLU-S-0203-201-SA036 (A037) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:34:00 
A037 
Y 
IVACFLU-S-0203-201-SA037 (A036) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:32:00 
A036 
Y 
IVACFLU-S-0203-201-SA038 (A035) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:29:00 
A035 
Y 
IVACFLU-S-0203-201-SA039 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA040 (A034) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:27:00 
A034 
Y 
IVACFLU-S-0203-201-SA041 (A028) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:16:00 
A028 
Y 
IVACFLU-S-0203-201-SA042 (A040) 
PLACEBO 
PLACEBO 
22Mar2017:12:00:00 
A040 
Y 
IVACFLU-S-0203-201-SA043 (A039) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:38:00 
A039 
Y 
IVACFLU-S-0203-201-SA044 (A041) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:08:19:00 
A041 
Y 
IVACFLU-S-0203-201-SA045 (A042) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:08:21:00 
A042 
Y 
IVACFLU-S-0203-201-SA046 (A044) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:08:40:00 
A044 
Y 
IVACFLU-S-0203-201-SA047 (A043) 
PLACEBO 
PLACEBO 
23Mar2017:08:38:00 
A043 
Y 
IVACFLU-S-0203-201-SA048 (A045) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:08:42:00 
A045 
Y 
IVACFLU-S-0203-201-SA049 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA050 (A047) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:09:57:00 
A047 
Y 
IVACFLU-S-0203-201-SA051 (A046) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:09:53:00 
A046 
Y 
IVACFLU-S-0203-201-SA052 (A050) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:10:53:00 
A050 
Y 
IVACFLU-S-0203-201-SA053 (A053) 
PLACEBO 
PLACEBO 
23Mar2017:11:02:00 
A053 
Y 
IVACFLU-S-0203-201-SA054 (A048) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:10:42:00 
A048 
Y 
IVACFLU-S-0203-201-SA055 (A056) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:11:16:00 
A056 
Y 
IVACFLU-S-0203-201-SA056 (A051) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:10:55:00 
A051 
Y 
IVACFLU-S-0203-201-SA057 (A049) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:10:44:00 
A049 
Y 
IVACFLU-S-0203-201-SA058 (A057) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:11:19:00 
A057 
Y 
IVACFLU-S-0203-201-SA059 (A052) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:11:00:00 
A052 
Y 
IVACFLU-S-0203-201-SA060 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA061 (A055) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:11:06:00 
A055 
Y 
IVACFLU-S-0203-201-SA062 (A058) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:11:32:00 
A058 
Y 
IVACFLU-S-0203-201-SA063 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA064 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA065 (A054) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:11:04:00 
A054 
Y 
IVACFLU-S-0203-201-SA066 (A061) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:01:00 
A061 
Y 
IVACFLU-S-0203-201-SA067 (A062) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:05:00 
A062 
Y 
IVACFLU-S-0203-201-SA068 (A060) 
PLACEBO 
PLACEBO 
23Mar2017:13:57:00 
A060 
Y 
IVACFLU-S-0203-201-SA069 (A059) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:13:55:00 
A059 
Y 
IVACFLU-S-0203-201-SA070 (A066) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:15:00 
A066 
Y 
699
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SA071 (A072) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:39:00 
A072 
Y 
IVACFLU-S-0203-201-SA072 (A076) 
PLACEBO 
PLACEBO 
23Mar2017:15:36:00 
A076 
Y 
IVACFLU-S-0203-201-SA073 (A077) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:15:41:00 
A077 
Y 
IVACFLU-S-0203-201-SA074 (A063) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:08:00 
A063 
Y 
IVACFLU-S-0203-201-SA075 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA076 (A064) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:10:00 
A064 
Y 
IVACFLU-S-0203-201-SA077 (A068) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:21:00 
A068 
Y 
IVACFLU-S-0203-201-SA078 (A069) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:26:00 
A069 
Y 
IVACFLU-S-0203-201-SA079 (A065) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:13:00 
A065 
Y 
IVACFLU-S-0203-201-SA080 (A071) 
PLACEBO 
PLACEBO 
23Mar2017:14:37:00 
A071 
Y 
IVACFLU-S-0203-201-SA081 (A070) 
PLACEBO 
PLACEBO 
23Mar2017:14:30:00 
A070 
Y 
IVACFLU-S-0203-201-SA082 (A067) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:17:00 
A067 
Y 
IVACFLU-S-0203-201-SA083 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA084 (A073) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:43:00 
A073 
Y 
IVACFLU-S-0203-201-SA085 (A075) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:15:01:00 
A075 
Y 
IVACFLU-S-0203-201-SA086 (A074) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:45:00 
A074 
Y 
IVACFLU-S-0203-201-SA087 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA088 (A079) 
PLACEBO 
PLACEBO 
24Mar2017:08:12:00 
A079 
Y 
IVACFLU-S-0203-201-SA089 (A080) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:08:19:00 
A080 
Y 
IVACFLU-S-0203-201-SA090 (A078) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:08:04:00 
A078 
Y 
IVACFLU-S-0203-201-SA091 (A081) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:08:58:00 
A081 
Y 
IVACFLU-S-0203-201-SA092 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA093 (A082) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:08:59:00 
A082 
Y 
IVACFLU-S-0203-201-SA094 (A083) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:09:14:00 
A083 
Y 
IVACFLU-S-0203-201-SA095 (A092) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:10:25:00 
A092 
Y 
IVACFLU-S-0203-201-SA096 (A085) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:09:29:00 
A085 
Y 
IVACFLU-S-0203-201-SA097 (A086) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:09:32:00 
A086 
Y 
IVACFLU-S-0203-201-SA098 (A084) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:09:27:00 
A084 
Y 
IVACFLU-S-0203-201-SA099 (A089) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:10:08:00 
A089 
Y 
IVACFLU-S-0203-201-SA100 (A088) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:09:42:00 
A088 
Y 
IVACFLU-S-0203-201-SA101 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA102 (A090) 
PLACEBO 
PLACEBO 
24Mar2017:10:12:00 
A090 
Y 
IVACFLU-S-0203-201-SA103 (A091) 
PLACEBO 
PLACEBO 
24Mar2017:10:16:00 
A091 
Y 
IVACFLU-S-0203-201-SA104 (A087) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:09:36:00 
A087 
Y 
IVACFLU-S-0203-201-SA105 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA106 (A094) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:10:52:00 
A094 
Y 
700
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SA107 (A093) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:10:37:00 
A093 
Y 
IVACFLU-S-0203-201-SA108 (A095) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:11:05:00 
A095 
Y 
IVACFLU-S-0203-201-SA109 (A098) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:02:00 
A098 
Y 
IVACFLU-S-0203-201-SA110 (A097) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:00:00 
A097 
Y 
IVACFLU-S-0203-201-SA111 (A096) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:13:54:00 
A096 
Y 
IVACFLU-S-0203-201-SA112 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA113 (A105) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:34:00 
A105 
Y 
IVACFLU-S-0203-201-SA114 (A104) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:31:00 
A104 
Y 
IVACFLU-S-0203-201-SA115 (A103) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:27:00 
A103 
Y 
IVACFLU-S-0203-201-SA116 (A114) 
PLACEBO 
PLACEBO 
24Mar2017:14:59:00 
A114 
Y 
IVACFLU-S-0203-201-SA117 (A102) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:25:00 
A102 
Y 
IVACFLU-S-0203-201-SA118 (A099) 
PLACEBO 
PLACEBO 
24Mar2017:14:12:00 
A099 
Y 
IVACFLU-S-0203-201-SA119 (A100) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:15:00 
A100 
Y 
IVACFLU-S-0203-201-SA120 (A101) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:23:00 
A101 
Y 
IVACFLU-S-0203-201-SA121 (A108) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:44:00 
A108 
Y 
IVACFLU-S-0203-201-SA122 (A115) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:15:03:00 
A115 
Y 
IVACFLU-S-0203-201-SA123 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA124 (A107) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:42:00 
A107 
Y 
IVACFLU-S-0203-201-SA125 (A106) 
PLACEBO 
PLACEBO 
24Mar2017:14:40:00 
A106 
Y 
IVACFLU-S-0203-201-SA126 (A109) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:46:00 
A109 
Y 
IVACFLU-S-0203-201-SA127 (A110) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:50:00 
A110 
Y 
IVACFLU-S-0203-201-SA128 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA129 (A111) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:52:00 
A111 
Y 
IVACFLU-S-0203-201-SA130 (A113) 
PLACEBO 
PLACEBO 
24Mar2017:14:56:00 
A113 
Y 
IVACFLU-S-0203-201-SA131 (A112) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:54:00 
A112 
Y 
IVACFLU-S-0203-201-SA132 (A116) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:16:40:00 
A116 
Y 
IVACFLU-S-0203-201-SA133 (A122) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:14:08:00 
A122 
Y 
IVACFLU-S-0203-201-SA134 (A117) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:13:53:00 
A117 
Y 
IVACFLU-S-0203-201-SA135 (A118) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:13:55:00 
A118 
Y 
IVACFLU-S-0203-201-SA136 (A120) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:14:02:00 
A120 
Y 
IVACFLU-S-0203-201-SA137 (A119) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:14:00:00 
A119 
Y 
IVACFLU-S-0203-201-SA138 (A121) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:14:04:00 
A121 
Y 
IVACFLU-S-0203-201-SA139 (A123) 
PLACEBO 
PLACEBO 
26Mar2017:14:12:00 
A123 
Y 
IVACFLU-S-0203-201-SA140 (A124) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:14:14:00 
A124 
Y 
IVACFLU-S-0203-201-SA141 (A125) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:14:18:00 
A125 
Y 
IVACFLU-S-0203-201-SA142 (A126) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:14:40:00 
A126 
Y 
701
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SA143 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA144 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA145 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA146 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA147 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA148 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA149 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA150 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA151 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA152 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA153 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA154 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA155 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA156 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA157 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA158 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA159 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA160 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA161 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA162 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA163 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA164 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA165 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA166 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA167 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA168 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA169 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA170 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA171 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA172 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA173 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA174 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA175 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA176 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA177 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA178 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
702
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SA179 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA180 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA181 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA182 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA183 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA184 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA185 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA186 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA187 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA188 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA189 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA190 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA191 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA192 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA193 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA194 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA195 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA196 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA197 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA198 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA199 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA200 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA201 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA202 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA203 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA204 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA205 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SA206 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB001 (B001) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:09:29:00 
B001 
Y 
IVACFLU-S-0203-201-SB002 (B003) 
PLACEBO 
PLACEBO 
20Mar2017:10:24:00 
B003 
Y 
IVACFLU-S-0203-201-SB003 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB004 (B007) 
PLACEBO 
PLACEBO 
20Mar2017:10:42:00 
B007 
Y 
IVACFLU-S-0203-201-SB005 (B002) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:10:21:00 
B002 
Y 
IVACFLU-S-0203-201-SB006 (B008) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:10:45:00 
B008 
Y 
IVACFLU-S-0203-201-SB007 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB008 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
703
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SB009 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB010 (B010) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:11:11:00 
B010 
Y 
IVACFLU-S-0203-201-SB011 (B005) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:10:33:00 
B005 
Y 
IVACFLU-S-0203-201-SB012 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB013 (B004) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:10:29:00 
B004 
Y 
IVACFLU-S-0203-201-SB014 (B006) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:10:37:00 
B006 
Y 
IVACFLU-S-0203-201-SB015 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB016 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB017 (B009) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:10:52:00 
B009 
Y 
IVACFLU-S-0203-201-SB018 (B011) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:11:20:00 
B011 
Y 
IVACFLU-S-0203-201-SB019 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB020 (B013) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:11:29:00 
B013 
Y 
IVACFLU-S-0203-201-SB021 (B012) 
IVACFLU-S 
IVACFLU-S 
20Mar2017:11:26:00 
B012 
Y 
IVACFLU-S-0203-201-SB022 (B015) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:08:55:00 
B015 
Y 
IVACFLU-S-0203-201-SB023 (B014) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:08:43:00 
B014 
Y 
IVACFLU-S-0203-201-SB024 (B026) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:10:29:00 
B026 
Y 
IVACFLU-S-0203-201-SB025 (B016) 
PLACEBO 
PLACEBO 
22Mar2017:09:00:00 
B016 
Y 
IVACFLU-S-0203-201-SB026 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB027 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB028 (B018) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:09:21:00 
B018 
Y 
IVACFLU-S-0203-201-SB029 (B028) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:10:38:00 
B028 
Y 
IVACFLU-S-0203-201-SB030 (B029) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:10:53:00 
B029 
Y 
IVACFLU-S-0203-201-SB031 (B019) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:09:49:00 
B019 
Y 
IVACFLU-S-0203-201-SB032 (B017) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:09:13:00 
B017 
Y 
IVACFLU-S-0203-201-SB033 (B021) 
PLACEBO 
PLACEBO 
22Mar2017:10:03:00 
B021 
Y 
IVACFLU-S-0203-201-SB034 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB035 (B022) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:10:05:00 
B022 
Y 
IVACFLU-S-0203-201-SB036 (B020) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:09:58:00 
B020 
Y 
IVACFLU-S-0203-201-SB037 (B024) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:10:15:00 
B024 
Y 
IVACFLU-S-0203-201-SB038 (B023) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:10:13:00 
B023 
Y 
IVACFLU-S-0203-201-SB039 (B032) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:00:00 
B032 
Y 
IVACFLU-S-0203-201-SB040 (B030) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:10:57:00 
B030 
Y 
IVACFLU-S-0203-201-SB041 (B033) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:12:00 
B033 
Y 
IVACFLU-S-0203-201-SB042 (B034) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:11:11:00 
B034 
Y 
IVACFLU-S-0203-201-SB043 (B027) 
PLACEBO 
PLACEBO 
22Mar2017:10:35:00 
B027 
Y 
IVACFLU-S-0203-201-SB044 (B031) 
PLACEBO 
PLACEBO 
22Mar2017:11:04:00 
B031 
Y 
704
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SB045 (B025) 
IVACFLU-S 
IVACFLU-S 
22Mar2017:10:22:00 
B025 
Y 
IVACFLU-S-0203-201-SB046 (B035) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:08:29:00 
B035 
Y 
IVACFLU-S-0203-201-SB047 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB048 (B036) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:08:45:00 
B036 
Y 
IVACFLU-S-0203-201-SB049 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB050 (B037) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:08:59:00 
B037 
Y 
IVACFLU-S-0203-201-SB051 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB052 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB053 (B044) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:10:21:00 
B044 
Y 
IVACFLU-S-0203-201-SB054 (B039) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:09:48:00 
B039 
Y 
IVACFLU-S-0203-201-SB055 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB056 (B038) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:09:20:00 
B038 
Y 
IVACFLU-S-0203-201-SB057 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB058 (B040) 
PLACEBO 
PLACEBO 
23Mar2017:09:59:00 
B040 
Y 
IVACFLU-S-0203-201-SB059 (B041) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:10:04:00 
B041 
Y 
IVACFLU-S-0203-201-SB060 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB061 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB062 (B042) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:10:06:00 
B042 
Y 
IVACFLU-S-0203-201-SB063 (B046) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:10:32:00 
B046 
Y 
IVACFLU-S-0203-201-SB064 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB065 (B045) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:10:29:00 
B045 
Y 
IVACFLU-S-0203-201-SB066 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB067 (B043) 
PLACEBO 
PLACEBO 
23Mar2017:10:11:00 
B043 
Y 
IVACFLU-S-0203-201-SB068 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB069 (B047) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:10:35:00 
B047 
Y 
IVACFLU-S-0203-201-SB070 (B048) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:10:50:00 
B048 
Y 
IVACFLU-S-0203-201-SB071 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB072 (B049) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:14:58:00 
B049 
Y 
IVACFLU-S-0203-201-SB073 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB074 (B051) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:15:17:00 
B051 
Y 
IVACFLU-S-0203-201-SB075 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB076 (B050) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:15:03:00 
B050 
Y 
IVACFLU-S-0203-201-SB077 (B053) 
PLACEBO 
PLACEBO 
23Mar2017:15:29:00 
B053 
Y 
IVACFLU-S-0203-201-SB078 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB079 (B055) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:15:50:00 
B055 
Y 
IVACFLU-S-0203-201-SB080 (B056) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:15:54:00 
B056 
Y 
705
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SB081 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB082 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB083 (B052) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:15:26:00 
B052 
Y 
IVACFLU-S-0203-201-SB084 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB085 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB086 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB087 (B054) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:15:38:00 
B054 
Y 
IVACFLU-S-0203-201-SB088 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB089 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB090 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB091 (B057) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:16:18:00 
B057 
Y 
IVACFLU-S-0203-201-SB092 (B058) 
IVACFLU-S 
IVACFLU-S 
23Mar2017:16:20:00 
B058 
Y 
IVACFLU-S-0203-201-SB093 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB094 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB095 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB096 (B061) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:08:21:00 
B061 
Y 
IVACFLU-S-0203-201-SB097 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB098 (B060) 
PLACEBO 
PLACEBO 
24Mar2017:08:14:00 
B060 
Y 
IVACFLU-S-0203-201-SB099 (B064) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:08:40:00 
B064 
Y 
IVACFLU-S-0203-201-SB100 (B059) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:08:10:00 
B059 
Y 
IVACFLU-S-0203-201-SB101 (B062) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:08:34:00 
B062 
Y 
IVACFLU-S-0203-201-SB102 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB103 (B063) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:08:37:00 
B063 
Y 
IVACFLU-S-0203-201-SB104 (B065) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:08:47:00 
B065 
Y 
IVACFLU-S-0203-201-SB105 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB106 (B069) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:09:20:00 
B069 
Y 
IVACFLU-S-0203-201-SB107 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB108 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB109 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB110 (B067) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:09:08:00 
B067 
Y 
IVACFLU-S-0203-201-SB111 (B066) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:09:01:00 
B066 
Y 
IVACFLU-S-0203-201-SB112 (B068) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:09:10:00 
B068 
Y 
IVACFLU-S-0203-201-SB113 (B070) 
PLACEBO 
PLACEBO 
24Mar2017:10:18:00 
B070 
Y 
IVACFLU-S-0203-201-SB114 (B075) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:10:33:00 
B075 
Y 
IVACFLU-S-0203-201-SB115 (B071) 
PLACEBO 
PLACEBO 
24Mar2017:10:20:00 
B071 
Y 
IVACFLU-S-0203-201-SB116 (B072) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:10:22:00 
B072 
Y 
706
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SB117 (B074) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:10:30:00 
B074 
Y 
IVACFLU-S-0203-201-SB118 (B073) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:10:28:00 
B073 
Y 
IVACFLU-S-0203-201-SB119 (B076) 
PLACEBO 
PLACEBO 
24Mar2017:10:39:00 
B076 
Y 
IVACFLU-S-0203-201-SB120 (B077) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:18:00 
B077 
Y 
IVACFLU-S-0203-201-SB121 (B078) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:14:37:00 
B078 
Y 
IVACFLU-S-0203-201-SB122 (B079) 
PLACEBO 
PLACEBO 
24Mar2017:15:06:00 
B079 
Y 
IVACFLU-S-0203-201-SB123 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB124 (B081) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:15:12:00 
B081 
Y 
IVACFLU-S-0203-201-SB125 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB126 (B080) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:15:08:00 
B080 
Y 
IVACFLU-S-0203-201-SB127 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB128 (B083) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:15:21:00 
B083 
Y 
IVACFLU-S-0203-201-SB129 (B085) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:15:32:00 
B085 
Y 
IVACFLU-S-0203-201-SB130 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB131 (B082) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:15:14:00 
B082 
Y 
IVACFLU-S-0203-201-SB132 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB133 (B086) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:15:43:00 
B086 
Y 
IVACFLU-S-0203-201-SB134 (B084) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:15:28:00 
B084 
Y 
IVACFLU-S-0203-201-SB135 (B087) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:15:49:00 
B087 
Y 
IVACFLU-S-0203-201-SB136 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB137 (B093) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:16:14:00 
B093 
Y 
IVACFLU-S-0203-201-SB138 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB139 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB140 (B088) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:15:51:00 
B088 
Y 
IVACFLU-S-0203-201-SB141 (B090) 
PLACEBO 
PLACEBO 
24Mar2017:16:01:00 
B090 
Y 
IVACFLU-S-0203-201-SB142 (B091) 
PLACEBO 
PLACEBO 
24Mar2017:16:05:00 
B091 
Y 
IVACFLU-S-0203-201-SB143 (B092) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:16:11:00 
B092 
Y 
IVACFLU-S-0203-201-SB144 (B089) 
IVACFLU-S 
IVACFLU-S 
24Mar2017:15:54:00 
B089 
Y 
IVACFLU-S-0203-201-SB145 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB146 (B095) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:08:21:00 
B095 
Y 
IVACFLU-S-0203-201-SB147 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB148 (B101) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:08:50:00 
B101 
Y 
IVACFLU-S-0203-201-SB149 (B094) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:08:17:00 
B094 
Y 
IVACFLU-S-0203-201-SB150 (B097) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:08:26:00 
B097 
Y 
IVACFLU-S-0203-201-SB151 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB152 (B096) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:08:23:00 
B096 
Y 
707
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SB153 (B098) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:08:29:00 
B098 
Y 
IVACFLU-S-0203-201-SB154 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB155 (B099) 
PLACEBO 
PLACEBO 
26Mar2017:08:31:00 
B099 
Y 
IVACFLU-S-0203-201-SB156 (B102) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:08:52:00 
B102 
Y 
IVACFLU-S-0203-201-SB157 (B106) 
PLACEBO 
PLACEBO 
26Mar2017:09:13:00 
B106 
Y 
IVACFLU-S-0203-201-SB158 (B103) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:08:55:00 
B103 
Y 
IVACFLU-S-0203-201-SB159 (B104) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:08:59:00 
B104 
Y 
IVACFLU-S-0203-201-SB160 (B100) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:08:43:00 
B100 
Y 
IVACFLU-S-0203-201-SB161 (B107) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:07:00 
B107 
Y 
IVACFLU-S-0203-201-SB162 (B119) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:49:00 
B119 
Y 
IVACFLU-S-0203-201-SB163 (B113) 
PLACEBO 
PLACEBO 
26Mar2017:09:28:00 
B113 
Y 
IVACFLU-S-0203-201-SB164 (B111) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:23:00 
B111 
Y 
IVACFLU-S-0203-201-SB165 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB166 (B108) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:09:00 
B108 
Y 
IVACFLU-S-0203-201-SB167 (B109) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:16:00 
B109 
Y 
IVACFLU-S-0203-201-SB168 (B105) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:01:00 
B105 
Y 
IVACFLU-S-0203-201-SB169 (B110) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:20:00 
B110 
Y 
IVACFLU-S-0203-201-SB170 (B117) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:45:00 
B117 
Y 
IVACFLU-S-0203-201-SB171 (B115) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:41:00 
B115 
Y 
IVACFLU-S-0203-201-SB172 (B118) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:47:00 
B118 
Y 
IVACFLU-S-0203-201-SB173 (B114) 
PLACEBO 
PLACEBO 
26Mar2017:09:39:00 
B114 
Y 
IVACFLU-S-0203-201-SB174 (B116) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:43:00 
B116 
Y 
IVACFLU-S-0203-201-SB175 (B122) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:54:00 
B122 
Y 
IVACFLU-S-0203-201-SB176 (B112) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:26:00 
B112 
Y 
IVACFLU-S-0203-201-SB177 (B121) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:53:00 
B121 
Y 
IVACFLU-S-0203-201-SB178 (B120) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:09:51:00 
B120 
Y 
IVACFLU-S-0203-201-SB179 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB180 (B123) 
PLACEBO 
PLACEBO 
26Mar2017:10:00:00 
B123 
Y 
IVACFLU-S-0203-201-SB181 (B124) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:10:07:00 
B124 
Y 
IVACFLU-S-0203-201-SB182 (B125) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:10:35:00 
B125 
Y 
IVACFLU-S-0203-201-SB183 (B126) 
IVACFLU-S 
IVACFLU-S 
26Mar2017:10:57:00 
B126 
Y 
IVACFLU-S-0203-201-SB184 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB185 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB186 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB187 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB188 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
708
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SB189 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB190 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB191 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB192 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB193 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB194 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB195 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB196 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB197 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB198 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB199 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB200 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB201 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB202 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB203 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB204 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB205 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB206 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB207 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB208 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB209 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB210 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB211 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB212 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB213 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB214 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB215 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB216 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB217 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB218 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB219 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB220 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB221 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB222 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SB223 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC001 (C018) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:42:00 
C018 
Y 
709
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SC002 (C072) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:09:23:00 
C072 
Y 
IVACFLU-S-0203-201-SC003 (C069) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:08:56:00 
C069 
Y 
IVACFLU-S-0203-201-SC004 (C068) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:08:46:00 
C068 
Y 
IVACFLU-S-0203-201-SC005 (C081) 
PLACEBO 
PLACEBO 
11Jun2017:11:10:00 
C081 
Y 
IVACFLU-S-0203-201-SC006 (C001) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:08:21:00 
C001 
Y 
IVACFLU-S-0203-201-SC007 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC008 (C070) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:08:59:00 
C070 
Y 
IVACFLU-S-0203-201-SC009 (C082) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:11:31:00 
C082 
Y 
IVACFLU-S-0203-201-SC010 (C008) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:09:29:00 
C008 
Y 
IVACFLU-S-0203-201-SC011 (C005) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:09:12:00 
C005 
Y 
IVACFLU-S-0203-201-SC012 (C011) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:09:50:00 
C011 
Y 
IVACFLU-S-0203-201-SC013 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC014 (C006) 
PLACEBO 
PLACEBO 
08Jun2017:09:18:00 
C006 
Y 
IVACFLU-S-0203-201-SC015 (C004) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:09:00:00 
C004 
Y 
IVACFLU-S-0203-201-SC016 (C014) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:15:00 
C014 
Y 
IVACFLU-S-0203-201-SC017 (C015) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:20:00 
C015 
Y 
IVACFLU-S-0203-201-SC018 (C013) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:05:00 
C013 
Y 
IVACFLU-S-0203-201-SC019 (C002) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:08:42:00 
C002 
Y 
IVACFLU-S-0203-201-SC020 (C016) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:26:00 
C016 
Y 
IVACFLU-S-0203-201-SC021 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC022 (C009) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:09:36:00 
C009 
Y 
IVACFLU-S-0203-201-SC023 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC024 (C012) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:01:00 
C012 
Y 
IVACFLU-S-0203-201-SC025 (C073) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:09:35:00 
C073 
Y 
IVACFLU-S-0203-201-SC026 (C017) 
PLACEBO 
PLACEBO 
08Jun2017:10:40:00 
C017 
Y 
IVACFLU-S-0203-201-SC027 (C095) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:11:00 
C095 
Y 
IVACFLU-S-0203-201-SC028 (C094) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:08:00 
C094 
Y 
IVACFLU-S-0203-201-SC029 (C097) 
PLACEBO 
PLACEBO 
11Jun2017:15:18:00 
C097 
Y 
IVACFLU-S-0203-201-SC030 (C086) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:14:12:00 
C086 
Y 
IVACFLU-S-0203-201-SC031 (C090) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:14:31:00 
C090 
Y 
IVACFLU-S-0203-201-SC032 (C085) 
PLACEBO 
PLACEBO 
11Jun2017:14:09:00 
C085 
Y 
IVACFLU-S-0203-201-SC033 (C091) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:14:35:00 
C091 
Y 
IVACFLU-S-0203-201-SC034 (C084) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:14:05:00 
C084 
Y 
IVACFLU-S-0203-201-SC035 (C020) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:14:27:00 
C020 
Y 
IVACFLU-S-0203-201-SC036 (C023) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:15:09:00 
C023 
Y 
IVACFLU-S-0203-201-SC037 (C019) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:14:10:00 
C019 
Y 
710
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SC038 (C123) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:14:21:00 
C123 
Y 
IVACFLU-S-0203-201-SC039 (C089) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:14:24:00 
C089 
Y 
IVACFLU-S-0203-201-SC040 (C024) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:15:20:00 
C024 
Y 
IVACFLU-S-0203-201-SC041 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC042 (C096) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:15:00 
C096 
Y 
IVACFLU-S-0203-201-SC043 (C021) 
PLACEBO 
PLACEBO 
08Jun2017:14:37:00 
C021 
Y 
IVACFLU-S-0203-201-SC044 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC045 (C092) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:50:00 
C092 
Y 
IVACFLU-S-0203-201-SC046 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC047 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC048 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC049 (C022) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:14:44:00 
C022 
Y 
IVACFLU-S-0203-201-SC050 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC051 (C088) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:14:27:00 
C088 
Y 
IVACFLU-S-0203-201-SC052 (C083) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:14:00:00 
C083 
Y 
IVACFLU-S-0203-201-SC053 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC054 (C064) 
PLACEBO 
PLACEBO 
11Jun2017:08:21:00 
C064 
Y 
IVACFLU-S-0203-201-SC055 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC056 (C063) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:08:07:00 
C063 
Y 
IVACFLU-S-0203-201-SC057 (C062) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:08:04:00 
C062 
Y 
IVACFLU-S-0203-201-SC058 (C071) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:09:05:00 
C071 
Y 
IVACFLU-S-0203-201-SC059 (C087) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:14:00 
C087 
Y 
IVACFLU-S-0203-201-SC060 (C061) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:07:56:00 
C061 
Y 
IVACFLU-S-0203-201-SC061 (C065) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:08:26:00 
C065 
Y 
IVACFLU-S-0203-201-SC062 (C067) 
PLACEBO 
PLACEBO 
11Jun2017:08:40:00 
C067 
Y 
IVACFLU-S-0203-201-SC063 (C066) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:08:29:00 
C066 
Y 
IVACFLU-S-0203-201-SC064 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC065 (C029) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:09:03:00 
C029 
Y 
IVACFLU-S-0203-201-SC066 (C034) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:03:00 
C034 
Y 
IVACFLU-S-0203-201-SC067 (C025) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:08:26:00 
C025 
Y 
IVACFLU-S-0203-201-SC068 (C028) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:08:58:00 
C028 
Y 
IVACFLU-S-0203-201-SC069 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC070 (C031) 
PLACEBO 
PLACEBO 
10Jun2017:09:18:00 
C031 
Y 
IVACFLU-S-0203-201-SC071 (C111) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:08:22:00 
C111 
Y 
IVACFLU-S-0203-201-SC072 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC073 (C027) 
PLACEBO 
PLACEBO 
10Jun2017:08:43:00 
C027 
Y 
711
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SC074 (C116) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:08:49:00 
C116 
Y 
IVACFLU-S-0203-201-SC075 (C030) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:09:12:00 
C030 
Y 
IVACFLU-S-0203-201-SC076 (C032) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:09:52:00 
C032 
Y 
IVACFLU-S-0203-201-SC077 (C026) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:08:40:00 
C026 
Y 
IVACFLU-S-0203-201-SC078 (C039) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:49:00 
C039 
Y 
IVACFLU-S-0203-201-SC079 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC080 (C108) 
PLACEBO 
PLACEBO 
11Jun2017:16:27:00 
C108 
Y 
IVACFLU-S-0203-201-SC081 (C040) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:53:00 
C040 
Y 
IVACFLU-S-0203-201-SC082 (C102) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:54:00 
C102 
Y 
IVACFLU-S-0203-201-SC083 (C106) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:20:00 
C106 
Y 
IVACFLU-S-0203-201-SC084 (C033) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:00:00 
C033 
Y 
IVACFLU-S-0203-201-SC085 (C103) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:57:00 
C103 
Y 
IVACFLU-S-0203-201-SC086 (C107) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:22:00 
C107 
Y 
IVACFLU-S-0203-201-SC087 (C100) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:41:00 
C100 
Y 
IVACFLU-S-0203-201-SC088 (C098) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:23:00 
C098 
Y 
IVACFLU-S-0203-201-SC089 (C105) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:04:00 
C105 
Y 
IVACFLU-S-0203-201-SC090 (C093) 
PLACEBO 
PLACEBO 
11Jun2017:15:03:00 
C093 
Y 
IVACFLU-S-0203-201-SC091 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC092 (C099) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:38:00 
C099 
Y 
IVACFLU-S-0203-201-SC093 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC094 (C038) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:47:00 
C038 
Y 
IVACFLU-S-0203-201-SC095 (C036) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:36:00 
C036 
Y 
IVACFLU-S-0203-201-SC096 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC097 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC098 (C041) 
PLACEBO 
PLACEBO 
10Jun2017:10:57:00 
C041 
Y 
IVACFLU-S-0203-201-SC099 (C010) 
PLACEBO 
PLACEBO 
08Jun2017:09:45:00 
C010 
Y 
IVACFLU-S-0203-201-SC100 (C037) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:43:00 
C037 
Y 
IVACFLU-S-0203-201-SC101 (C101) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:44:00 
C101 
Y 
IVACFLU-S-0203-201-SC102 (C035) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:26:00 
C035 
Y 
IVACFLU-S-0203-201-SC103 (C042) 
PLACEBO 
PLACEBO 
10Jun2017:13:45:00 
C042 
Y 
IVACFLU-S-0203-201-SC104 (C007) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:09:24:00 
C007 
Y 
IVACFLU-S-0203-201-SC105 (C125) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:15:19:00 
C125 
Y 
IVACFLU-S-0203-201-SC106 (C124) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:14:54:00 
C124 
Y 
IVACFLU-S-0203-201-SC107 (C060) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:38:00 
C060 
Y 
IVACFLU-S-0203-201-SC108 (C054) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:56:00 
C054 
Y 
IVACFLU-S-0203-201-SC109 (C056) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:03:00 
C056 
Y 
712
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SC110 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC111 (C058) 
PLACEBO 
PLACEBO 
10Jun2017:15:21:00 
C058 
Y 
IVACFLU-S-0203-201-SC112 (C051) 
PLACEBO 
PLACEBO 
10Jun2017:14:46:00 
C051 
Y 
IVACFLU-S-0203-201-SC113 (C003) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:08:54:00 
C003 
Y 
IVACFLU-S-0203-201-SC114 (C126) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:15:25:00 
C126 
Y 
IVACFLU-S-0203-201-SC115 (C059) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:28:00 
C059 
Y 
IVACFLU-S-0203-201-SC116 (C044) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:02:00 
C044 
Y 
IVACFLU-S-0203-201-SC117 (C045) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:09:00 
C045 
Y 
IVACFLU-S-0203-201-SC118 (C043) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:13:50:00 
C043 
Y 
IVACFLU-S-0203-201-SC119 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC120 (C047) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:17:00 
C047 
Y 
IVACFLU-S-0203-201-SC121 (C050) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:27:00 
C050 
Y 
IVACFLU-S-0203-201-SC122 (C055) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:58:00 
C055 
Y 
IVACFLU-S-0203-201-SC123 (C048) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:20:00 
C048 
Y 
IVACFLU-S-0203-201-SC124 (C052) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:49:00 
C052 
Y 
IVACFLU-S-0203-201-SC125 (C053) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:44:00 
C053 
Y 
IVACFLU-S-0203-201-SC126 (C046) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:14:00 
C046 
Y 
IVACFLU-S-0203-201-SC127 (C057) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:15:00 
C057 
Y 
IVACFLU-S-0203-201-SC128 (C049) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:24:00 
C049 
Y 
IVACFLU-S-0203-201-SC129 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC130 (C119) 
PLACEBO 
PLACEBO 
12Jun2017:09:09:00 
C119 
Y 
IVACFLU-S-0203-201-SC131 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC132 (C078) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:10:55:00 
C078 
Y 
IVACFLU-S-0203-201-SC133 (C077) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:10:45:00 
C077 
Y 
IVACFLU-S-0203-201-SC134 (C120) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:09:05:00 
C120 
Y 
IVACFLU-S-0203-201-SC135 (C122) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:10:18:00 
C122 
Y 
IVACFLU-S-0203-201-SC136 (C075) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:10:11:00 
C075 
Y 
IVACFLU-S-0203-201-SC137 (C076) 
PLACEBO 
PLACEBO 
11Jun2017:10:15:00 
C076 
Y 
IVACFLU-S-0203-201-SC138 (C079) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:10:59:00 
C079 
Y 
IVACFLU-S-0203-201-SC139 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC140 (C080) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:11:14:00 
C080 
Y 
IVACFLU-S-0203-201-SC141 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC142 (C118) 
PLACEBO 
PLACEBO 
12Jun2017:08:57:00 
C118 
Y 
IVACFLU-S-0203-201-SC143 (C121) 
PLACEBO 
PLACEBO 
12Jun2017:10:10:00 
C121 
Y 
IVACFLU-S-0203-201-SC144 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC145 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
713
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SC146 (C115) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:08:38:00 
C115 
Y 
IVACFLU-S-0203-201-SC147 (C114) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:08:34:00 
C114 
Y 
IVACFLU-S-0203-201-SC148 (C112) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:08:26:00 
C112 
Y 
IVACFLU-S-0203-201-SC149 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC150 (C117) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:09:17:00 
C117 
Y 
IVACFLU-S-0203-201-SC151 (C109) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:08:13:00 
C109 
Y 
IVACFLU-S-0203-201-SC152 (C113) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:08:28:00 
C113 
Y 
IVACFLU-S-0203-201-SC153 (C110) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:08:16:00 
C110 
Y 
IVACFLU-S-0203-201-SC154 (C074) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:09:52:00 
C074 
Y 
IVACFLU-S-0203-201-SC155 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SC156 (C104) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:00:00 
C104 
Y 
IVACFLU-S-0203-201-SD001 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD002 (D071) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:09:11:00 
D071 
Y 
IVACFLU-S-0203-201-SD003 (D077) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:10:07:00 
D077 
Y 
IVACFLU-S-0203-201-SD004 (D076) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:09:44:00 
D076 
Y 
IVACFLU-S-0203-201-SD005 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD006 (D074) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:09:27:00 
D074 
Y 
IVACFLU-S-0203-201-SD007 (D103) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:12:16:00 
D103 
Y 
IVACFLU-S-0203-201-SD008 (D075) 
PLACEBO 
PLACEBO 
11Jun2017:09:40:00 
D075 
Y 
IVACFLU-S-0203-201-SD009 (D073) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:09:19:00 
D073 
Y 
IVACFLU-S-0203-201-SD010 (D008) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:37:00 
D008 
Y 
IVACFLU-S-0203-201-SD011 (D003) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:11:00 
D003 
Y 
IVACFLU-S-0203-201-SD012 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD013 (D006) 
PLACEBO 
PLACEBO 
08Jun2017:10:31:00 
D006 
Y 
IVACFLU-S-0203-201-SD014 (D004) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:23:00 
D004 
Y 
IVACFLU-S-0203-201-SD015 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD016 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD017 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD018 (D108) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:10:25:00 
D108 
Y 
IVACFLU-S-0203-201-SD019 (D001) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:08:37:00 
D001 
Y 
IVACFLU-S-0203-201-SD020 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD021 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD022 (D070) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:09:08:00 
D070 
Y 
IVACFLU-S-0203-201-SD023 (D102) 
PLACEBO 
PLACEBO 
12Jun2017:10:56:00 
D102 
Y 
IVACFLU-S-0203-201-SD024 (D118) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:14:40:00 
D118 
Y 
IVACFLU-S-0203-201-SD025 (D005) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:28:00 
D005 
Y 
714
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SD026 (D007) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:33:00 
D007 
Y 
IVACFLU-S-0203-201-SD027 (D002) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:09:57:00 
D002 
Y 
IVACFLU-S-0203-201-SD028 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD029 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD030 (D009) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:10:44:00 
D009 
Y 
IVACFLU-S-0203-201-SD031 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD032 (D072) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:10:37:00 
D072 
Y 
IVACFLU-S-0203-201-SD033 (D116) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:16:12:00 
D116 
Y 
IVACFLU-S-0203-201-SD034 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD035 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD036 (D084) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:14:48:00 
C084 
Y 
IVACFLU-S-0203-201-SD037 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD038 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD039 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD040 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD041 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD042 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD043 (D020) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:15:13:00 
D020 
Y 
IVACFLU-S-0203-201-SD045 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD046 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD047 (D023) 
PLACEBO 
PLACEBO 
08Jun2017:15:51:00 
D023 
Y 
IVACFLU-S-0203-201-SD048 (D019) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:15:05:00 
D019 
Y 
IVACFLU-S-0203-201-SD049 (D017) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:14:55:00 
D017 
Y 
IVACFLU-S-0203-201-SD050 (D016) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:14:52:00 
D016 
Y 
IVACFLU-S-0203-201-SD051 (D117) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:14:30:00 
D117 
Y 
IVACFLU-S-0203-201-SD052 (D120) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:14:58:00 
D120 
Y 
IVACFLU-S-0203-201-SD053 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD054 (D013) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:14:35:00 
D013 
Y 
IVACFLU-S-0203-201-SD055 (D018) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:15:00:00 
D018 
Y 
IVACFLU-S-0203-201-SD056 (D022) 
PLACEBO 
PLACEBO 
08Jun2017:15:42:00 
D022 
Y 
IVACFLU-S-0203-201-SD057 (D011) 
PLACEBO 
PLACEBO 
08Jun2017:14:18:00 
D011 
Y 
IVACFLU-S-0203-201-SD058 (D010) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:14:14:00 
D010 
Y 
IVACFLU-S-0203-201-SD059 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD060 (D014) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:14:42:00 
D014 
Y 
IVACFLU-S-0203-201-SD061 (D012) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:14:31:00 
D012 
Y 
IVACFLU-S-0203-201-SD062 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
715
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SD063 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD064 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD065 (D119) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:14:46:00 
D119 
Y 
IVACFLU-S-0203-201-SD066 (D015) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:15:59:00 
D015 
Y 
IVACFLU-S-0203-201-SD067 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD068 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD069 (D021) 
IVACFLU-S 
IVACFLU-S 
08Jun2017:15:30:00 
D021 
Y 
IVACFLU-S-0203-201-SD070 (D122) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:16:06:00 
D122 
Y 
IVACFLU-S-0203-201-SD071 (D044) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:36:00 
D044 
Y 
IVACFLU-S-0203-201-SD072 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD073 (D069) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:08:53:00 
D069 
Y 
IVACFLU-S-0203-201-SD074 (D066) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:08:11:00 
D066 
Y 
IVACFLU-S-0203-201-SD075 (D068) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:08:43:00 
D068 
Y 
IVACFLU-S-0203-201-SD076 (D065) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:08:00:00 
D065 
Y 
IVACFLU-S-0203-201-SD077 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD078 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD079 (D032) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:09:35:00 
D032 
Y 
IVACFLU-S-0203-201-SD080 (D029) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:09:22:00 
D029 
Y 
IVACFLU-S-0203-201-SD081 (D045) 
PLACEBO 
PLACEBO 
10Jun2017:14:40:00 
D045 
Y 
IVACFLU-S-0203-201-SD082 (D030) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:09:26:00 
D030 
Y 
IVACFLU-S-0203-201-SD083 (D067) 
PLACEBO 
PLACEBO 
11Jun2017:08:19:00 
D067 
Y 
IVACFLU-S-0203-201-SD084 (D027) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:08:36:00 
D027 
Y 
IVACFLU-S-0203-201-SD085 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD086 (D026) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:08:34:00 
D026 
Y 
IVACFLU-S-0203-201-SD087 (D049) 
PLACEBO 
PLACEBO 
10Jun2017:15:05:00 
D049 
Y 
IVACFLU-S-0203-201-SD088 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD089 (D025) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:08:22:00 
D025 
Y 
IVACFLU-S-0203-201-SD090 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD091 (D031) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:09:31:00 
D031 
Y 
IVACFLU-S-0203-201-SD092 (D028) 
PLACEBO 
PLACEBO 
10Jun2017:09:07:00 
D028 
Y 
IVACFLU-S-0203-201-SD093 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD094 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD095 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD096 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD097 (D036) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:08:00 
D036 
Y 
IVACFLU-S-0203-201-SD098 (D034) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:09:47:00 
D034 
Y 
716
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SD099 (D052) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:24:00 
D052 
Y 
IVACFLU-S-0203-201-SD100 (D024) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:08:30:00 
D024 
Y 
IVACFLU-S-0203-201-SD101 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD102 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD103 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD104 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD105 (D043) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:32:00 
D043 
Y 
IVACFLU-S-0203-201-SD106 (D041) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:11:00:00 
D041 
Y 
IVACFLU-S-0203-201-SD107 (D089) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:08:00 
C089 
Y 
IVACFLU-S-0203-201-SD108 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD109 (D094) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:32:00 
D094 
Y 
IVACFLU-S-0203-201-SD110 (D093) 
PLACEBO 
PLACEBO 
11Jun2017:16:29:00 
D093 
Y 
IVACFLU-S-0203-201-SD111 (D095) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:34:00 
D095 
Y 
IVACFLU-S-0203-201-SD112 (D085) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:14:52:00 
D085 
Y 
IVACFLU-S-0203-201-SD113 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD114 (D096) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:40:00 
D096 
Y 
IVACFLU-S-0203-201-SD115 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD116 (D040) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:41:00 
D040 
Y 
IVACFLU-S-0203-201-SD117 (D035) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:09:56:00 
D035 
Y 
IVACFLU-S-0203-201-SD118 (D033) 
PLACEBO 
PLACEBO 
10Jun2017:09:43:00 
D033 
Y 
IVACFLU-S-0203-201-SD119 (D112) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:10:42:00 
D112 
Y 
IVACFLU-S-0203-201-SD120 (D087) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:35:00 
D087 
Y 
IVACFLU-S-0203-201-SD121 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD122 (D037) 
PLACEBO 
PLACEBO 
10Jun2017:10:18:00 
D037 
Y 
IVACFLU-S-0203-201-SD123 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD124 (D097) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:37:00 
D097 
Y 
IVACFLU-S-0203-201-SD125 (D088) 
PLACEBO 
PLACEBO 
11Jun2017:15:47:00 
D088 
Y 
IVACFLU-S-0203-201-SD126 (D038) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:23:00 
D038 
Y 
IVACFLU-S-0203-201-SD127 (D092) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:24:00 
D092 
Y 
IVACFLU-S-0203-201-SD129 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD130 (D086) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:15:30:00 
D086 
Y 
IVACFLU-S-0203-201-SD131 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD132 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD133 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD134 (D042) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:11:03:00 
D042 
Y 
IVACFLU-S-0203-201-SD135 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
717
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SD136 (D039) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:10:31:00 
D039 
Y 
IVACFLU-S-0203-201-SD137 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD138 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD139 (D091) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:13:00 
D091 
Y 
IVACFLU-S-0203-201-SD140 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD141 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD142 (D056) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:44:00 
D056 
Y 
IVACFLU-S-0203-201-SD143 (D115) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:11:16:00 
D115 
Y 
IVACFLU-S-0203-201-SD144 (D057) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:47:00 
D057 
Y 
IVACFLU-S-0203-201-SD145 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD146 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD147 (D051) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:18:00 
D051 
Y 
IVACFLU-S-0203-201-SD148 (D050) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:13:00 
D050 
Y 
IVACFLU-S-0203-201-SD149 (D047) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:53:00 
D047 
Y 
IVACFLU-S-0203-201-SD150 (D055) 
PLACEBO 
PLACEBO 
10Jun2017:15:41:00 
D055 
Y 
IVACFLU-S-0203-201-SD151 (D054) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:35:00 
D054 
Y 
IVACFLU-S-0203-201-SD152 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD153 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD154 (D114) 
PLACEBO 
PLACEBO 
12Jun2017:11:12:00 
D114 
Y 
IVACFLU-S-0203-201-SD155 (D048) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:00:00 
D048 
Y 
IVACFLU-S-0203-201-SD156 (D059) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:56:00 
D059 
Y 
IVACFLU-S-0203-201-SD157 (D064) 
PLACEBO 
PLACEBO 
10Jun2017:16:17:00 
D064 
Y 
IVACFLU-S-0203-201-SD158 (D124) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:16:14:00 
D124 
Y 
IVACFLU-S-0203-201-SD159 (D062) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:16:13:00 
D062 
Y 
IVACFLU-S-0203-201-SD160 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD161 (D046) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:14:51:00 
D046 
Y 
IVACFLU-S-0203-201-SD162 (D060) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:59:00 
D060 
Y 
IVACFLU-S-0203-201-SD163 (D061) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:16:05:00 
D061 
Y 
IVACFLU-S-0203-201-SD164 (D100) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:09:13:00 
D100 
Y 
IVACFLU-S-0203-201-SD165 (D123) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:16:10:00 
D123 
Y 
IVACFLU-S-0203-201-SD166 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD167 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD168 (D058) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:53:00 
D058 
Y 
IVACFLU-S-0203-201-SD169 (D125) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:16:31:00 
D125 
Y 
IVACFLU-S-0203-201-SD170 (D063) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:16:11:00 
D063 
Y 
IVACFLU-S-0203-201-SD171 (D121) 
PLACEBO 
PLACEBO 
12Jun2017:16:02:00 
D121 
Y 
718
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SD172 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD173 (D099) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:08:54:00 
D099 
Y 
IVACFLU-S-0203-201-SD174 (D053) 
IVACFLU-S 
IVACFLU-S 
10Jun2017:15:31:00 
D053 
Y 
IVACFLU-S-0203-201-SD175 (D079) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:10:35:00 
D079 
Y 
IVACFLU-S-0203-201-SD176 (D101) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:09:28:00 
D101 
Y 
IVACFLU-S-0203-201-SD177 (D083) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:11:18:00 
D083 
Y 
IVACFLU-S-0203-201-SD178 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD179 (D111) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:10:37:00 
D111 
Y 
IVACFLU-S-0203-201-SD180 (D106) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:10:13:00 
D106 
Y 
IVACFLU-S-0203-201-SD181 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD182 (D082) 
PLACEBO 
PLACEBO 
11Jun2017:10:50:00 
D082 
Y 
IVACFLU-S-0203-201-SD183 (D098) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:08:44:00 
D098 
Y 
IVACFLU-S-0203-201-SD184 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD185 (D110) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:10:34:00 
D110 
Y 
IVACFLU-S-0203-201-SD186 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD187 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD188 (D104) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:09:48:00 
D104 
Y 
IVACFLU-S-0203-201-SD189 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD190 (D078) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:10:18:00 
D078 
Y 
IVACFLU-S-0203-201-SD191 (D080) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:10:38:00 
D080 
Y 
IVACFLU-S-0203-201-SD192 (D109) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:10:30:00 
D109 
Y 
IVACFLU-S-0203-201-SD193 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD194 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD195 (D107) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:10:22:00 
D107 
Y 
IVACFLU-S-0203-201-SD196 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD197 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD198 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD199 (D113) 
PLACEBO 
PLACEBO 
12Jun2017:10:50:00 
D113 
Y 
IVACFLU-S-0203-201-SD200 (D126) 
IVACFLU-S 
IVACFLU-S 
12Jun2017:16:35:00 
D126 
Y 
IVACFLU-S-0203-201-SD201 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD202 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD203 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD204 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD205 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD206 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-201-SD207 (D081) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:10:41:00 
D081 
Y 
719
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-201-SD208 (D105) 
PLACEBO 
PLACEBO 
12Jun2017:10:02:00 
D105 
Y 
IVACFLU-S-0203-201-SD209 (D090) 
IVACFLU-S 
IVACFLU-S 
11Jun2017:16:15:00 
D090 
Y 
IVACFLU-S-0203-203-SE001 (E025) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:15:42:00 
E025 
Y 
IVACFLU-S-0203-203-SE002 (E007) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:09:25:00 
E007 
Y 
IVACFLU-S-0203-203-SE003 (E038) 
PLACEBO 
PLACEBO 
05Jul2017:17:15:00 
E038 
Y 
IVACFLU-S-0203-203-SE004 (E040) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:17:30:00 
E040 
Y 
IVACFLU-S-0203-203-SE005 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE006 (E009) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:09:55:00 
E009 
Y 
IVACFLU-S-0203-203-SE007 (E018) 
PLACEBO 
PLACEBO 
05Jul2017:13:57:00 
E018 
Y 
IVACFLU-S-0203-203-SE008 (E187) 
PLACEBO 
PLACEBO 
10Jul2017:08:25:00 
E187 
Y 
IVACFLU-S-0203-203-SE009 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE010 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE011 (E039) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:17:27:00 
E039 
Y 
IVACFLU-S-0203-203-SE012 (E010) 
PLACEBO 
PLACEBO 
05Jul2017:10:08:00 
E010 
Y 
IVACFLU-S-0203-203-SE013 (E017) 
PLACEBO 
PLACEBO 
05Jul2017:13:52:00 
E017 
Y 
IVACFLU-S-0203-203-SE014 (E015) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:13:41:00 
E015 
Y 
IVACFLU-S-0203-203-SE015 (E005) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:09:03:00 
E005 
Y 
IVACFLU-S-0203-203-SE016 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE017 (E023) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:15:04:00 
E023 
Y 
IVACFLU-S-0203-203-SE018 (E014) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:10:49:00 
E014 
Y 
IVACFLU-S-0203-203-SE019 (E037) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:17:02:00 
E037 
Y 
IVACFLU-S-0203-203-SE020 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE021 (E013) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:10:41:00 
E013 
Y 
IVACFLU-S-0203-203-SE022 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE023 (E036) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:16:59:00 
E036 
Y 
IVACFLU-S-0203-203-SE024 (E012) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:10:27:00 
E012 
Y 
IVACFLU-S-0203-203-SE025 (E165) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:09:14:00 
E165 
Y 
IVACFLU-S-0203-203-SE026 (E029) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:16:01:00 
E029 
Y 
IVACFLU-S-0203-203-SE027 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE028 (E003) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:08:56:00 
E003 
Y 
IVACFLU-S-0203-203-SE029 (E021) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:14:36:00 
E021 
Y 
IVACFLU-S-0203-203-SE030 (E030) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:16:16:00 
E030 
Y 
IVACFLU-S-0203-203-SE031 (E019) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:14:01:00 
E019 
Y 
IVACFLU-S-0203-203-SE032 (E027) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:15:52:00 
E027 
Y 
IVACFLU-S-0203-203-SE033 (E020) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:14:06:00 
E020 
Y 
IVACFLU-S-0203-203-SE034 (E190) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:08:52:00 
E190 
Y 
720
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SE035 (E028) 
PLACEBO 
PLACEBO 
05Jul2017:15:56:00 
E028 
Y 
IVACFLU-S-0203-203-SE036 (E002) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:08:51:00 
E002 
Y 
IVACFLU-S-0203-203-SE037 (E155) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:07:54:00 
E155 
Y 
IVACFLU-S-0203-203-SE038 (E016) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:13:47:00 
E016 
Y 
IVACFLU-S-0203-203-SE039 (E001) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:08:33:00 
E001 
Y 
IVACFLU-S-0203-203-SE040 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE041 (E173) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:14:04:00 
E173 
Y 
IVACFLU-S-0203-203-SE042 (E024) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:15:36:00 
E024 
Y 
IVACFLU-S-0203-203-SE043 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE044 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE045 (E011) 
PLACEBO 
PLACEBO 
05Jul2017:10:14:00 
E011 
Y 
IVACFLU-S-0203-203-SE046 (E026) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:15:47:00 
E026 
Y 
IVACFLU-S-0203-203-SE047 (E035) 
PLACEBO 
PLACEBO 
05Jul2017:16:54:00 
E035 
Y 
IVACFLU-S-0203-203-SE048 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE049 (E032) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:16:33:00 
E032 
Y 
IVACFLU-S-0203-203-SE050 (E033) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:16:37:00 
E033 
Y 
IVACFLU-S-0203-203-SE051 (E158) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:18:00 
E158 
Y 
IVACFLU-S-0203-203-SE052 (E170) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:56:00 
E170 
Y 
IVACFLU-S-0203-203-SE053 (E174) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:14:39:00 
E174 
Y 
IVACFLU-S-0203-203-SE054 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE055 (E034) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:16:45:00 
E034 
Y 
IVACFLU-S-0203-203-SE056 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE057 (E185) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:08:14:00 
E185 
Y 
IVACFLU-S-0203-203-SE058 (E183) 
PLACEBO 
PLACEBO 
10Jul2017:08:02:00 
E183 
Y 
IVACFLU-S-0203-203-SE059 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE060 (E022) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:14:43:00 
E022 
Y 
IVACFLU-S-0203-203-SE061 (E154) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:07:50:00 
E154 
Y 
IVACFLU-S-0203-203-SE062 (E182) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:17:13:00 
E182 
Y 
IVACFLU-S-0203-203-SE063 (E031) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:16:29:00 
E031 
Y 
IVACFLU-S-0203-203-SE064 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE065 (E006) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:09:15:00 
E006 
Y 
IVACFLU-S-0203-203-SE066 (E004) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:09:00:00 
E004 
Y 
IVACFLU-S-0203-203-SE067 (E008) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:09:40:00 
E008 
Y 
IVACFLU-S-0203-203-SE068 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE069 (E181) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:17:07:00 
E181 
Y 
IVACFLU-S-0203-203-SE070 (E171) 
PLACEBO 
PLACEBO 
09Jul2017:13:57:00 
E171 
Y 
721
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SE071 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE072 (E164) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:09:07:00 
E164 
Y 
IVACFLU-S-0203-203-SE073 (E041) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:17:35:00 
E041 
Y 
IVACFLU-S-0203-203-SE074 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE075 (E166) 
PLACEBO 
PLACEBO 
09Jul2017:09:42:00 
E166 
Y 
IVACFLU-S-0203-203-SE076 (E172) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:14:00:00 
E172 
Y 
IVACFLU-S-0203-203-SE077 (E178) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:16:42:00 
E178 
Y 
IVACFLU-S-0203-203-SE078 (E159) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:23:00 
E159 
Y 
IVACFLU-S-0203-203-SE079 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE080 (E054) 
PLACEBO 
PLACEBO 
06Jul2017:09:38:00 
E054 
Y 
IVACFLU-S-0203-203-SE081 (E053) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:09:19:00 
E053 
Y 
IVACFLU-S-0203-203-SE082 (E058) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:29:00 
E058 
Y 
IVACFLU-S-0203-203-SE083 (E046) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:08:42:00 
E046 
Y 
IVACFLU-S-0203-203-SE084 (E057) 
PLACEBO 
PLACEBO 
06Jul2017:10:26:00 
E057 
Y 
IVACFLU-S-0203-203-SE085 (E071) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:18:00 
E071 
Y 
IVACFLU-S-0203-203-SE086 (E051) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:09:09:00 
E051 
Y 
IVACFLU-S-0203-203-SE087 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE088 (E180) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:17:04:00 
E180 
Y 
IVACFLU-S-0203-203-SE089 (E061) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:11:01:00 
E061 
Y 
IVACFLU-S-0203-203-SE090 (E070) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:04:00 
E070 
Y 
IVACFLU-S-0203-203-SE091 (E064) 
PLACEBO 
PLACEBO 
06Jul2017:11:23:00 
E064 
Y 
IVACFLU-S-0203-203-SE092 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE093 (E085) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:52:00 
E085 
Y 
IVACFLU-S-0203-203-SE094 (E047) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:08:47:00 
E047 
Y 
IVACFLU-S-0203-203-SE095 (E044) 
PLACEBO 
PLACEBO 
06Jul2017:08:42:00 
E044 
Y 
IVACFLU-S-0203-203-SE096 (E043) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:08:27:00 
E043 
Y 
IVACFLU-S-0203-203-SE097 (E060) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:57:00 
E060 
Y 
IVACFLU-S-0203-203-SE098 (E052) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:09:14:00 
E052 
Y 
IVACFLU-S-0203-203-SE099 (E056) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:15:00 
E056 
Y 
IVACFLU-S-0203-203-SE100 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE101 (E081) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:24:00 
E081 
Y 
IVACFLU-S-0203-203-SE102 (E065) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:11:27:00 
E065 
Y 
IVACFLU-S-0203-203-SE103 (E066) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:11:31:00 
E066 
Y 
IVACFLU-S-0203-203-SE104 (E048) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:08:53:00 
E048 
Y 
IVACFLU-S-0203-203-SE105 (E069) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:00:00 
E069 
Y 
IVACFLU-S-0203-203-SE106 (E045) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:08:37:00 
E045 
Y 
722
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SE107 (E079) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:53:00 
E079 
Y 
IVACFLU-S-0203-203-SE108 (E068) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:13:57:00 
E068 
Y 
IVACFLU-S-0203-203-SE109 (E179) 
PLACEBO 
PLACEBO 
09Jul2017:16:45:00 
E179 
Y 
IVACFLU-S-0203-203-SE110 (E077) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:39:00 
E077 
Y 
IVACFLU-S-0203-203-SE111 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE112 (E063) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:11:16:00 
E063 
Y 
IVACFLU-S-0203-203-SE113 (E078) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:42:00 
E078 
Y 
IVACFLU-S-0203-203-SE114 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE115 (E050) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:09:04:00 
E050 
Y 
IVACFLU-S-0203-203-SE116 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE117 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE118 (E059) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:50:00 
E059 
Y 
IVACFLU-S-0203-203-SE119 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE120 (E075) 
PLACEBO 
PLACEBO 
06Jul2017:14:32:00 
E075 
Y 
IVACFLU-S-0203-203-SE121 (E049) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:08:58:00 
E049 
Y 
IVACFLU-S-0203-203-SE122 (E073) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:24:00 
E073 
Y 
IVACFLU-S-0203-203-SE123 (E076) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:35:00 
E076 
Y 
IVACFLU-S-0203-203-SE124 (E080) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:20:00 
E080 
Y 
IVACFLU-S-0203-203-SE125 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE126 (E186) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:08:18:00 
E186 
Y 
IVACFLU-S-0203-203-SE127 (E189) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:08:35:00 
E189 
Y 
IVACFLU-S-0203-203-SE128 (E177) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:16:31:00 
E177 
Y 
IVACFLU-S-0203-203-SE129 (E062) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:11:09:00 
E062 
Y 
IVACFLU-S-0203-203-SE130 (E083) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:39:00 
E083 
Y 
IVACFLU-S-0203-203-SE131 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE132 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE133 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE134 (E082) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:27:00 
E082 
Y 
IVACFLU-S-0203-203-SE135 (E112) 
PLACEBO 
PLACEBO 
07Jul2017:16:59:00 
E112 
Y 
IVACFLU-S-0203-203-SE136 (E084) 
PLACEBO 
PLACEBO 
06Jul2017:15:44:00 
E084 
Y 
IVACFLU-S-0203-203-SE137 (E042) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:08:04:00 
E042 
Y 
IVACFLU-S-0203-203-SE138 (E072) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:21:00 
E072 
Y 
IVACFLU-S-0203-203-SE139 (E111) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:16:55:00 
E111 
Y 
IVACFLU-S-0203-203-SE140 (E160) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:31:00 
E160 
Y 
IVACFLU-S-0203-203-SE141 (E163) 
PLACEBO 
PLACEBO 
09Jul2017:08:55:00 
E163 
Y 
IVACFLU-S-0203-203-SE142 (E184) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:08:06:00 
E184 
Y 
723
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SE143 (E191) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:09:02:00 
E191 
Y 
IVACFLU-S-0203-203-SE144 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE145 (E161) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:39:00 
E161 
Y 
IVACFLU-S-0203-203-SE146 (E074) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:28:00 
E074 
Y 
IVACFLU-S-0203-203-SE147 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE148 (E175) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:15:12:00 
E175 
Y 
IVACFLU-S-0203-203-SE149 (E055) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:09:49:00 
E055 
Y 
IVACFLU-S-0203-203-SE150 (E168) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:13:00 
E168 
Y 
IVACFLU-S-0203-203-SE151 (E067) 
PLACEBO 
PLACEBO 
06Jul2017:13:46:00 
E067 
Y 
IVACFLU-S-0203-203-SE152 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE153 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE154 (E100) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:13:46:00 
E100 
Y 
IVACFLU-S-0203-203-SE155 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE156 (E106) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:15:12:00 
E106 
Y 
IVACFLU-S-0203-203-SE157 (E097) 
PLACEBO 
PLACEBO 
07Jul2017:11:19:00 
E097 
Y 
IVACFLU-S-0203-203-SE158 (E093) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:11:02:00 
E093 
Y 
IVACFLU-S-0203-203-SE159 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE160 (E088) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:09:41:00 
E088 
Y 
IVACFLU-S-0203-203-SE161 (E110) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:16:00:00 
E110 
Y 
IVACFLU-S-0203-203-SE162 (E098) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:11:23:00 
E098 
Y 
IVACFLU-S-0203-203-SE163 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE164 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE165 (E087) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:09:30:00 
E087 
Y 
IVACFLU-S-0203-203-SE166 (E104) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:14:18:00 
E104 
Y 
IVACFLU-S-0203-203-SE167 (E096) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:11:15:00 
E096 
Y 
IVACFLU-S-0203-203-SE168 (E156) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:11:00 
E156 
Y 
IVACFLU-S-0203-203-SE169 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE170 (E162) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:48:00 
E162 
Y 
IVACFLU-S-0203-203-SE171 (E094) 
PLACEBO 
PLACEBO 
07Jul2017:11:06:00 
E094 
Y 
IVACFLU-S-0203-203-SE172 (E101) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:13:51:00 
E101 
Y 
IVACFLU-S-0203-203-SE173 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE174 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE175 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE176 (E099) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:13:42:00 
E099 
Y 
IVACFLU-S-0203-203-SE177 (E108) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:15:48:00 
E108 
Y 
IVACFLU-S-0203-203-SE178 (E105) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:14:23:00 
E105 
Y 
724
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SE179 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE180 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE181 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE182 (E102) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:14:04:00 
E102 
Y 
IVACFLU-S-0203-203-SE183 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE184 (E091) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:10:18:00 
E091 
Y 
IVACFLU-S-0203-203-SE185 (E092) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:10:36:00 
E092 
Y 
IVACFLU-S-0203-203-SE186 (E167) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:09:52:00 
E167 
Y 
IVACFLU-S-0203-203-SE187 (E089) 
PLACEBO 
PLACEBO 
07Jul2017:09:46:00 
E089 
Y 
IVACFLU-S-0203-203-SE188 (E095) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:11:10:00 
E095 
Y 
IVACFLU-S-0203-203-SE189 (E107) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:15:40:00 
E107 
Y 
IVACFLU-S-0203-203-SE190 (E086) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:09:19:00 
E086 
Y 
IVACFLU-S-0203-203-SE191 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE192 (E109) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:15:56:00 
E109 
Y 
IVACFLU-S-0203-203-SE193 (E103) 
PLACEBO 
PLACEBO 
07Jul2017:14:09:00 
E103 
Y 
IVACFLU-S-0203-203-SE194 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE195 (E157) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:14:00 
E157 
Y 
IVACFLU-S-0203-203-SE196 (E090) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:09:51:00 
E090 
Y 
IVACFLU-S-0203-203-SE197 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE198 (E129) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:10:06:00 
E129 
Y 
IVACFLU-S-0203-203-SE199 (E148) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:15:31:00 
E148 
Y 
IVACFLU-S-0203-203-SE200 (E121) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:37:00 
E121 
Y 
IVACFLU-S-0203-203-SE201 (E147) 
PLACEBO 
PLACEBO 
08Jul2017:15:28:00 
E147 
Y 
IVACFLU-S-0203-203-SE202 (E113) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:07:55:00 
E113 
Y 
IVACFLU-S-0203-203-SE203 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE204 (E137) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:13:37:00 
E137 
Y 
IVACFLU-S-0203-203-SE205 (E146) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:15:10:00 
E146 
Y 
IVACFLU-S-0203-203-SE206 (E123) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:57:00 
E123 
Y 
IVACFLU-S-0203-203-SE207 (E150) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:15:38:00 
E150 
Y 
IVACFLU-S-0203-203-SE208 (E143) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:14:35:00 
E143 
Y 
IVACFLU-S-0203-203-SE209 (E114) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:07:59:00 
E114 
Y 
IVACFLU-S-0203-203-SE210 (E135) 
PLACEBO 
PLACEBO 
08Jul2017:10:57:00 
E135 
Y 
IVACFLU-S-0203-203-SE211 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE212 (E134) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:10:52:00 
E134 
Y 
IVACFLU-S-0203-203-SE213 (E124) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:09:18:00 
E124 
Y 
IVACFLU-S-0203-203-SE214 (E127) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:09:45:00 
E127 
Y 
725
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SE215 (E169) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:53:00 
E169 
Y 
IVACFLU-S-0203-203-SE216 (E116) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:13:00 
E116 
Y 
IVACFLU-S-0203-203-SE217 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE218 (E138) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:13:41:00 
E138 
Y 
IVACFLU-S-0203-203-SE219 (E119) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:29:00 
E119 
Y 
IVACFLU-S-0203-203-SE220 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE221 (E128) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:10:00:00 
E128 
Y 
IVACFLU-S-0203-203-SE222 (E144) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:14:39:00 
E144 
Y 
IVACFLU-S-0203-203-SE223 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE224 (E131) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:10:18:00 
E131 
Y 
IVACFLU-S-0203-203-SE225 (E151) 
PLACEBO 
PLACEBO 
08Jul2017:15:59:00 
E151 
Y 
IVACFLU-S-0203-203-SE226 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE227 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE228 (E118) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:26:00 
E118 
Y 
IVACFLU-S-0203-203-SE229 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE230 (E153) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:16:19:00 
E153 
Y 
IVACFLU-S-0203-203-SE231 (E149) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:15:35:00 
E149 
Y 
IVACFLU-S-0203-203-SE232 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE233 (E130) 
PLACEBO 
PLACEBO 
08Jul2017:10:10:00 
E130 
Y 
IVACFLU-S-0203-203-SE234 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE235 (E115) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:04:00 
E115 
Y 
IVACFLU-S-0203-203-SE236 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE237 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE238 (E152) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:16:10:00 
E152 
Y 
IVACFLU-S-0203-203-SE239 (E132) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:10:22:00 
E132 
Y 
IVACFLU-S-0203-203-SE240 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE241 (E122) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:49:00 
E122 
Y 
IVACFLU-S-0203-203-SE242 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE243 (E126) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:09:40:00 
E126 
Y 
IVACFLU-S-0203-203-SE244 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE245 (E145) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:14:43:00 
E145 
Y 
IVACFLU-S-0203-203-SE246 (E120) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:33:00 
E120 
Y 
IVACFLU-S-0203-203-SE247 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE248 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE249 (E125) 
PLACEBO 
PLACEBO 
08Jul2017:09:22:00 
E125 
Y 
IVACFLU-S-0203-203-SE250 (E139) 
PLACEBO 
PLACEBO 
08Jul2017:14:01:00 
E139 
Y 
726
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SE251 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE252 (E176) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:15:19:00 
E176 
Y 
IVACFLU-S-0203-203-SE253 (E192) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:09:18:00 
E192 
Y 
IVACFLU-S-0203-203-SE254 (E141) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:14:12:00 
E141 
Y 
IVACFLU-S-0203-203-SE255 (E117) 
PLACEBO 
PLACEBO 
08Jul2017:08:16:00 
E117 
Y 
IVACFLU-S-0203-203-SE256 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE257 (E142) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:14:22:00 
E142 
Y 
IVACFLU-S-0203-203-SE258 (E133) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:10:41:00 
E133 
Y 
IVACFLU-S-0203-203-SE259 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE260 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SE261 (E140) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:14:08:00 
E140 
Y 
IVACFLU-S-0203-203-SE262 (E188) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:08:32:00 
E188 
Y 
IVACFLU-S-0203-203-SE263 (E136) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:11:02:00 
E136 
Y 
IVACFLU-S-0203-203-SG001 (G187) 
PLACEBO 
PLACEBO 
10Jul2017:08:49:00 
G187 
Y 
IVACFLU-S-0203-203-SG002 (G014) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:16:12:00 
G014 
Y 
IVACFLU-S-0203-203-SG003 (G004) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:09:29:00 
G004 
Y 
IVACFLU-S-0203-203-SG004 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG005 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG006 (G002) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:08:28:00 
G002 
Y 
IVACFLU-S-0203-203-SG007 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG008 (G010) 
PLACEBO 
PLACEBO 
05Jul2017:14:31:00 
G010 
Y 
IVACFLU-S-0203-203-SG009 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG010 (G020) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:17:10:00 
G020 
Y 
IVACFLU-S-0203-203-SG011 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG012 (G005) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:09:47:00 
G005 
Y 
IVACFLU-S-0203-203-SG013 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG014 (G006) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:10:18:00 
G006 
Y 
IVACFLU-S-0203-203-SG015 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG016 (G011) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:14:59:00 
G011 
Y 
IVACFLU-S-0203-203-SG017 (G007) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:10:23:00 
G007 
Y 
IVACFLU-S-0203-203-SG018 (G016) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:16:25:00 
G016 
Y 
IVACFLU-S-0203-203-SG019 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG020 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG021 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG022 (G001) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:08:07:00 
G001 
Y 
IVACFLU-S-0203-203-SG023 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
727
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SG024 (G013) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:15:33:00 
G013 
Y 
IVACFLU-S-0203-203-SG025 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG026 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG027 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG028 (G003) 
PLACEBO 
PLACEBO 
05Jul2017:08:46:00 
G003 
Y 
IVACFLU-S-0203-203-SG029 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG030 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG031 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG032 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG033 (G015) 
PLACEBO 
PLACEBO 
05Jul2017:16:20:00 
G015 
Y 
IVACFLU-S-0203-203-SG034 (G023) 
PLACEBO 
PLACEBO 
05Jul2017:17:38:00 
G023 
Y 
IVACFLU-S-0203-203-SG035 (G022) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:17:22:00 
G022 
Y 
IVACFLU-S-0203-203-SG036 (G021) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:17:18:00 
G021 
Y 
IVACFLU-S-0203-203-SG037 (G145) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:35:00 
G145 
Y 
IVACFLU-S-0203-203-SG038 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG039 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG040 (G008) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:10:54:00 
G008 
Y 
IVACFLU-S-0203-203-SG041 (G143) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:08:00 
G143 
Y 
IVACFLU-S-0203-203-SG042 (G012) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:15:11:00 
G012 
Y 
IVACFLU-S-0203-203-SG043 (G142) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:04:00 
G142 
Y 
IVACFLU-S-0203-203-SG044 (G147) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:09:03:00 
G147 
Y 
IVACFLU-S-0203-203-SG045 (G017) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:16:41:00 
G017 
Y 
IVACFLU-S-0203-203-SG046 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG047 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG048 (G140) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:16:05:00 
G140 
Y 
IVACFLU-S-0203-203-SG049 (G019) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:17:06:00 
G019 
Y 
IVACFLU-S-0203-203-SG050 (G144) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:26:00 
G144 
Y 
IVACFLU-S-0203-203-SG051 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG052 (G155) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:09:00 
G155 
Y 
IVACFLU-S-0203-203-SG053 (G166) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:13:49:00 
G166 
Y 
IVACFLU-S-0203-203-SG054 (G009) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:11:06:00 
G009 
Y 
IVACFLU-S-0203-203-SG055 (G183) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:16:19:00 
G183 
Y 
IVACFLU-S-0203-203-SG056 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG057 (G176) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:15:27:00 
G176 
Y 
IVACFLU-S-0203-203-SG058 (G178) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:15:44:00 
G178 
Y 
IVACFLU-S-0203-203-SG059 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
728
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SG060 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG061 (G123) 
PLACEBO 
PLACEBO 
08Jul2017:11:07:00 
G123 
Y 
IVACFLU-S-0203-203-SG062 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG063 (G018) 
IVACFLU-S 
IVACFLU-S 
05Jul2017:16:49:00 
G018 
Y 
IVACFLU-S-0203-203-SG064 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG065 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG066 (G150) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:09:22:00 
G150 
Y 
IVACFLU-S-0203-203-SG067 (G179) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:15:48:00 
G179 
Y 
IVACFLU-S-0203-203-SG068 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG069 (G040) 
PLACEBO 
PLACEBO 
06Jul2017:10:41:00 
G040 
Y 
IVACFLU-S-0203-203-SG070 (G043) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:11:06:00 
G043 
Y 
IVACFLU-S-0203-203-SG071 (G039) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:37:00 
G039 
Y 
IVACFLU-S-0203-203-SG072 (G025) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:08:08:00 
G025 
Y 
IVACFLU-S-0203-203-SG073 (G037) 
PLACEBO 
PLACEBO 
06Jul2017:10:22:00 
G037 
Y 
IVACFLU-S-0203-203-SG074 (G030) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:09:34:00 
G030 
Y 
IVACFLU-S-0203-203-SG075 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG076 (G028) 
PLACEBO 
PLACEBO 
06Jul2017:09:24:00 
G028 
Y 
IVACFLU-S-0203-203-SG077 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG078 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG079 (G044) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:11:12:00 
G044 
Y 
IVACFLU-S-0203-203-SG080 (G032) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:09:55:00 
G032 
Y 
IVACFLU-S-0203-203-SG081 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG082 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG083 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG084 (G054) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:01:00 
G054 
Y 
IVACFLU-S-0203-203-SG085 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG086 (G042) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:53:00 
G042 
Y 
IVACFLU-S-0203-203-SG087 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG088 (G036) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:18:00 
G036 
Y 
IVACFLU-S-0203-203-SG089 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG090 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG091 (G052) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:49:00 
G052 
Y 
IVACFLU-S-0203-203-SG092 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG093 (G159) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:28:00 
G159 
Y 
IVACFLU-S-0203-203-SG094 (G035) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:09:00 
G035 
Y 
IVACFLU-S-0203-203-SG095 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
729
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SG096 (G029) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:09:28:00 
G029 
Y 
IVACFLU-S-0203-203-SG097 (G045) 
NOT ASSIGNED 
NOT ASSIGNED 
06Jul2017:00:00:00 
Y 
IVACFLU-S-0203-203-SG098 (G034) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:04:00 
G034 
Y 
IVACFLU-S-0203-203-SG099 (G046) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:11:20:00 
G046 
Y 
IVACFLU-S-0203-203-SG100 (G033) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:00:00 
G033 
Y 
IVACFLU-S-0203-203-SG101 (G041) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:47:00 
G041 
Y 
IVACFLU-S-0203-203-SG102 (G097) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:16:17:00 
G097 
Y 
IVACFLU-S-0203-203-SG103 (G100) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:16:30:00 
G100 
Y 
IVACFLU-S-0203-203-SG104 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG105 (G038) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:10:33:00 
G038 
Y 
IVACFLU-S-0203-203-SG106 (G153) 
PLACEBO 
PLACEBO 
09Jul2017:10:06:00 
G153 
Y 
IVACFLU-S-0203-203-SG107 (G031) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:09:43:00 
G031 
Y 
IVACFLU-S-0203-203-SG108 (G057) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:12:00 
G057 
Y 
IVACFLU-S-0203-203-SG109 (G053) 
PLACEBO 
PLACEBO 
06Jul2017:14:57:00 
G053 
Y 
IVACFLU-S-0203-203-SG110 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG111 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG112 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG113 (G141) 
PLACEBO 
PLACEBO 
09Jul2017:07:58:00 
G141 
Y 
IVACFLU-S-0203-203-SG114 (G050) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:14:00 
G050 
Y 
IVACFLU-S-0203-203-SG115 (G026) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:08:13:00 
G026 
Y 
IVACFLU-S-0203-203-SG116 (G059) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:13:00 
G059 
Y 
IVACFLU-S-0203-203-SG117 (G062) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:16:02:00 
G062 
Y 
IVACFLU-S-0203-203-SG118 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG119 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG120 (G027) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:08:19:00 
G027 
Y 
IVACFLU-S-0203-203-SG121 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG122 (G055) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:05:00 
G055 
Y 
IVACFLU-S-0203-203-SG123 (G169) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:14:19:00 
G169 
Y 
IVACFLU-S-0203-203-SG124 (G096) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:16:12:00 
G096 
Y 
IVACFLU-S-0203-203-SG125 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG126 (G024) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:07:58:00 
G024 
Y 
IVACFLU-S-0203-203-SG127 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG128 (G051) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:46:00 
G051 
Y 
IVACFLU-S-0203-203-SG129 (G148) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:09:10:00 
G148 
Y 
IVACFLU-S-0203-203-SG130 (G058) 
PLACEBO 
PLACEBO 
06Jul2017:15:16:00 
G058 
Y 
IVACFLU-S-0203-203-SG131 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
730
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SG132 (G161) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:40:00 
G161 
Y 
IVACFLU-S-0203-203-SG133 (G095) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:16:08:00 
G095 
Y 
IVACFLU-S-0203-203-SG134 (G094) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:16:04:00 
G094 
Y 
IVACFLU-S-0203-203-SG135 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG136 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG137 (G102) 
PLACEBO 
PLACEBO 
07Jul2017:16:38:00 
G102 
Y 
IVACFLU-S-0203-203-SG138 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG139 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG140 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG141 (G157) 
PLACEBO 
PLACEBO 
09Jul2017:10:21:00 
G157 
Y 
IVACFLU-S-0203-203-SG142 (G152) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:09:46:00 
G152 
Y 
IVACFLU-S-0203-203-SG143 (G189) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:08:59:00 
G189 
Y 
IVACFLU-S-0203-203-SG144 (G158) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:24:00 
G158 
Y 
IVACFLU-S-0203-203-SG145 (G146) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:08:59:00 
G146 
Y 
IVACFLU-S-0203-203-SG146 (G060) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:48:00 
G060 
Y 
IVACFLU-S-0203-203-SG147 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG148 (G048) 
PLACEBO 
PLACEBO 
06Jul2017:14:08:00 
G048 
Y 
IVACFLU-S-0203-203-SG149 (G156) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:17:00 
G156 
Y 
IVACFLU-S-0203-203-SG150 (G101) 
PLACEBO 
PLACEBO 
07Jul2017:16:46:00 
G101 
Y 
IVACFLU-S-0203-203-SG151 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG152 (G049) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:14:11:00 
G049 
Y 
IVACFLU-S-0203-203-SG153 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG154 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG155 (G138) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:15:51:00 
G138 
Y 
IVACFLU-S-0203-203-SG156 (G103) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:16:50:00 
G103 
Y 
IVACFLU-S-0203-203-SG157 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG158 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG159 (G174) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:14:43:00 
G174 
Y 
IVACFLU-S-0203-203-SG160 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG161 (G099) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:16:26:00 
G099 
Y 
IVACFLU-S-0203-203-SG162 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG163 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG164 (G047) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:13:53:00 
G047 
Y 
IVACFLU-S-0203-203-SG165 (G056) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:09:00 
G056 
Y 
IVACFLU-S-0203-203-SG166 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG167 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
731
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SG168 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG169 (G181) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:16:12:00 
G181 
Y 
IVACFLU-S-0203-203-SG170 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG171 (G171) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:14:26:00 
G171 
Y 
IVACFLU-S-0203-203-SG172 (G061) 
IVACFLU-S 
IVACFLU-S 
06Jul2017:15:56:00 
G061 
Y 
IVACFLU-S-0203-203-SG173 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG174 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG175 (G098) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:16:21:00 
G098 
Y 
IVACFLU-S-0203-203-SG176 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG177 (G173) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:14:35:00 
G173 
Y 
IVACFLU-S-0203-203-SG178 (G081) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:10:44:00 
G081 
Y 
IVACFLU-S-0203-203-SG179 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG180 (G080) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:10:32:00 
G080 
Y 
IVACFLU-S-0203-203-SG181 (G069) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:08:42:00 
G069 
Y 
IVACFLU-S-0203-203-SG182 (G078) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:10:23:00 
G078 
Y 
IVACFLU-S-0203-203-SG183 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG184 (G077) 
PLACEBO 
PLACEBO 
07Jul2017:10:12:00 
G077 
Y 
IVACFLU-S-0203-203-SG185 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG186 (G079) 
PLACEBO 
PLACEBO 
07Jul2017:10:27:00 
G079 
Y 
IVACFLU-S-0203-203-SG187 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG188 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG189 (G092) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:15:17:00 
G092 
Y 
IVACFLU-S-0203-203-SG190 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG191 (G064) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:08:11:00 
G064 
Y 
IVACFLU-S-0203-203-SG192 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG193 (G072) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:09:00:00 
G072 
Y 
IVACFLU-S-0203-203-SG194 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG195 (G084) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:10:57:00 
G084 
Y 
IVACFLU-S-0203-203-SG196 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG197 (G075) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:09:56:00 
G075 
Y 
IVACFLU-S-0203-203-SG198 (G066) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:08:25:00 
G066 
Y 
IVACFLU-S-0203-203-SG199 (G082) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:10:49:00 
G082 
Y 
IVACFLU-S-0203-203-SG200 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG201 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG202 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG203 (G083) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:10:53:00 
G083 
Y 
732
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SG204 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG205 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG206 (G090) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:14:43:00 
G090 
Y 
IVACFLU-S-0203-203-SG207 (G088) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:14:28:00 
G088 
Y 
IVACFLU-S-0203-203-SG208 (G085) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:11:26:00 
G085 
Y 
IVACFLU-S-0203-203-SG209 (G172) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:14:29:00 
G172 
Y 
IVACFLU-S-0203-203-SG210 (G068) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:08:37:00 
G068 
Y 
IVACFLU-S-0203-203-SG211 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG212 (G071) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:08:55:00 
G071 
Y 
IVACFLU-S-0203-203-SG213 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG214 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG215 (G063) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:08:05:00 
G063 
Y 
IVACFLU-S-0203-203-SG216 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG217 (G091) 
PLACEBO 
PLACEBO 
07Jul2017:15:04:00 
G091 
Y 
IVACFLU-S-0203-203-SG218 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG219 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG220 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG221 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG222 (G170) 
PLACEBO 
PLACEBO 
09Jul2017:14:23:00 
G170 
Y 
IVACFLU-S-0203-203-SG223 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG224 (G093) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:15:26:00 
G093 
Y 
IVACFLU-S-0203-203-SG225 (G167) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:13:53:00 
G167 
Y 
IVACFLU-S-0203-203-SG226 (G177) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:15:32:00 
G177 
Y 
IVACFLU-S-0203-203-SG227 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG228 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG229 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG230 (G115) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:09:53:00 
G115 
Y 
IVACFLU-S-0203-203-SG231 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG232 (G120) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:10:33:00 
G120 
Y 
IVACFLU-S-0203-203-SG233 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG234 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG235 (G188) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:08:56:00 
G188 
Y 
IVACFLU-S-0203-203-SG236 (G116) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:09:56:00 
G116 
Y 
IVACFLU-S-0203-203-SG237 (G135) 
PLACEBO 
PLACEBO 
08Jul2017:15:20:00 
G135 
Y 
IVACFLU-S-0203-203-SG238 (G104) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:08:00 
G104 
Y 
IVACFLU-S-0203-203-SG239 (G108) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:09:01:00 
G108 
Y 
733
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SG240 (G113) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:09:30:00 
G113 
Y 
IVACFLU-S-0203-203-SG241 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG242 (G112) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:09:26:00 
G112 
Y 
IVACFLU-S-0203-203-SG243 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG244 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG245 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG246 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG247 (G124) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:13:47:00 
G124 
Y 
IVACFLU-S-0203-203-SG248 (G130) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:14:31:00 
G130 
Y 
IVACFLU-S-0203-203-SG249 (G107) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:45:00 
G107 
Y 
IVACFLU-S-0203-203-SG250 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG251 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG252 (G118) 
PLACEBO 
PLACEBO 
08Jul2017:10:26:00 
G118 
Y 
IVACFLU-S-0203-203-SG253 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG254 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG255 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG256 (G121) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:10:37:00 
G121 
Y 
IVACFLU-S-0203-203-SG257 (G110) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:09:09:00 
G110 
Y 
IVACFLU-S-0203-203-SG258 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG259 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG260 (G164) 
PLACEBO 
PLACEBO 
09Jul2017:10:50:00 
G164 
Y 
IVACFLU-S-0203-203-SG261 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG262 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG263 (G132) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:14:56:00 
G132 
Y 
IVACFLU-S-0203-203-SG264 (G109) 
PLACEBO 
PLACEBO 
08Jul2017:09:05:00 
G109 
Y 
IVACFLU-S-0203-203-SG265 (G128) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:14:05:00 
G128 
Y 
IVACFLU-S-0203-203-SG266 (G126) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:13:54:00 
G126 
Y 
IVACFLU-S-0203-203-SG267 (G129) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:14:15:00 
G129 
Y 
IVACFLU-S-0203-203-SG268 (G111) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:09:15:00 
G111 
Y 
IVACFLU-S-0203-203-SG269 (G122) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:10:45:00 
G122 
Y 
IVACFLU-S-0203-203-SG270 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG271 (G134) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:15:16:00 
G134 
Y 
IVACFLU-S-0203-203-SG272 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG273 (G106) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:41:00 
G106 
Y 
IVACFLU-S-0203-203-SG274 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG275 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
734
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SG276 (G127) 
PLACEBO 
PLACEBO 
08Jul2017:13:58:00 
G127 
Y 
IVACFLU-S-0203-203-SG277 (G137) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:15:46:00 
G137 
Y 
IVACFLU-S-0203-203-SG278 (G125) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:13:51:00 
G125 
Y 
IVACFLU-S-0203-203-SG279 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG280 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG281 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG282 (G105) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:08:20:00 
G105 
Y 
IVACFLU-S-0203-203-SG283 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG284 (G119) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:10:30:00 
G119 
Y 
IVACFLU-S-0203-203-SG285 (G131) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:14:52:00 
G131 
Y 
IVACFLU-S-0203-203-SG286 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG287 (G114) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:09:49:00 
G114 
Y 
IVACFLU-S-0203-203-SG288 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG289 (G160) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:32:00 
G160 
Y 
IVACFLU-S-0203-203-SG290 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG291 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG292 (G162) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:43:00 
G162 
Y 
IVACFLU-S-0203-203-SG293 (G149) 
PLACEBO 
PLACEBO 
09Jul2017:09:18:00 
G149 
Y 
IVACFLU-S-0203-203-SG294 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG295 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG296 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG297 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG298 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG299 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG300 (G139) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:15:55:00 
G139 
Y 
IVACFLU-S-0203-203-SG301 (G133) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:15:24:00 
G133 
Y 
IVACFLU-S-0203-203-SG302 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG303 (G180) 
PLACEBO 
PLACEBO 
09Jul2017:15:51:00 
G180 
Y 
IVACFLU-S-0203-203-SG304 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG305 (G151) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:09:39:00 
G151 
Y 
IVACFLU-S-0203-203-SG306 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG307 (G163) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:47:00 
G163 
Y 
IVACFLU-S-0203-203-SG308 (G186) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:08:39:00 
G186 
Y 
IVACFLU-S-0203-203-SG309 (G182) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:16:16:00 
G182 
Y 
IVACFLU-S-0203-203-SG310 (G136) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:15:42:00 
G136 
Y 
IVACFLU-S-0203-203-SG311 (G154) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:10:03:00 
G154 
Y 
735
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Unique Subject Identifier 
Planned Treatment 
Actual Treatment 
Date of Randomization 
Randomization 
Number 
Randomization 
Flag 
IVACFLU-S-0203-203-SG312 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG313 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG314 (G117) 
IVACFLU-S 
IVACFLU-S 
08Jul2017:10:14:00 
G117 
Y 
IVACFLU-S-0203-203-SG315 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG316 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG317 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG318 (G089) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:14:37:00 
G089 
Y 
IVACFLU-S-0203-203-SG319 (G065) 
PLACEBO 
PLACEBO 
07Jul2017:08:19:00 
G065 
Y 
IVACFLU-S-0203-203-SG320 (G175) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:15:01:00 
G175 
Y 
IVACFLU-S-0203-203-SG321 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG322 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG323 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG324 (G074) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:09:35:00 
G074 
Y 
IVACFLU-S-0203-203-SG325 (G070) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:08:47:00 
G070 
Y 
IVACFLU-S-0203-203-SG326 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG327 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG328 (G067) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:08:30:00 
G067 
Y 
IVACFLU-S-0203-203-SG329 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG330 (G073) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:09:24:00 
G073 
Y 
IVACFLU-S-0203-203-SG331 (G076) 
PLACEBO 
PLACEBO 
07Jul2017:10:00:00 
G076 
Y 
IVACFLU-S-0203-203-SG332 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG333 (G087) 
PLACEBO 
PLACEBO 
07Jul2017:14:14:00 
G087 
Y 
IVACFLU-S-0203-203-SG334 (G168) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:14:07:00 
G168 
Y 
IVACFLU-S-0203-203-SG335 (G086) 
IVACFLU-S 
IVACFLU-S 
07Jul2017:14:00:00 
G086 
Y 
IVACFLU-S-0203-203-SG336 (G165) 
IVACFLU-S 
IVACFLU-S 
09Jul2017:13:45:00 
G165 
Y 
IVACFLU-S-0203-203-SG337 (G184) 
PLACEBO 
PLACEBO 
10Jul2017:07:52:00 
G184 
Y 
IVACFLU-S-0203-203-SG338 (G193) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:09:21:00 
G193 
Y 
IVACFLU-S-0203-203-SG339 (G190) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:09:07:00 
G190 
Y 
IVACFLU-S-0203-203-SG340 (G192) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:09:14:00 
G192 
Y 
IVACFLU-S-0203-203-SG341 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
IVACFLU-S-0203-203-SG342 (G185) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:08:29:00 
G185 
Y 
IVACFLU-S-0203-203-SG343 (G191) 
IVACFLU-S 
IVACFLU-S 
10Jul2017:09:11:00 
G191 
Y 
IVACFLU-S-0203-203-SG344 ( ) 
SCREEN FAILURE 
SCREEN FAILURE 
 
736
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

Randomization Specification 
PATH / IVAC
IVACFLU-S-0203
Page 1 of 12
Document:
\\quintiles.net\Enterprise\Sites\gbthv\QTHVRANDOM\IVAC\IVACFLU-S-0203\03
Rando specification\IVACFLU-S-0203_RandoSpec_BLINDED_2017_03_31_v2_0
Author:
Maria Efstathiou
Version Number: 2.0
Version Date: 
31MAR2017
Template No:  CS_TP_BS025 Revision 5
Reference:  CS_WI_BS002
Effective Date: 01Nov2016
Copyright © 2009, 2010, 2011, 2014, 2016 QuintilesIMS. All rights reserved.
The contents of this document are confidential and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries.  
Unauthorized use, disclosure or reproduction is strictly prohibited.
Randomization Specification
MINISTRY OF HEALTH 
RESEARCH PROTOCOL OF VACCINE CLINICAL TRIAL 
A PHASE 2/3 DOUBLE BLINDED, RANDOMIZED, PLACEBO-CONTROLLED 
STUDY IN HEALTHY ADULT VOLUNTEERS IN VIETNAM TO EXAMINE THE 
SAFETY AND IMMUNOGENICITY OF A SEASONAL TRIVALENT INACTIVATED 
SPLIT VIRION INFLUENZA VACCINE (IVACFLU-S) PRODUCED BY IVAC
Study Number: IVACFLU-S-0203
Author: Maria Efstathiou
Department: Biostatistics
QuintilesIMS QTHV
737
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

PATH/IVAC 
0> QuintileslMS' 
Randomization Specification 
IV ACFLU-S-0203 
Page 2 of 12 
Randomization Biostatistician 
(required): 
Statistical Team Lead: 
Randomization Implementer 
(required): 
Customer approval (if 
required): 
Authorization 
Maria Efstathiou 
Name 
Suman Kapoor 
Name 
Dr Phan Cong Hung 
Name 
Tushar Tewari 
Name 
Thang Tran 
Name 
Date 
Signature 
Date 
Signature 
Date 
Signature 
Date 
Signature 
Date 
Document: 
\\auintiles.net\Enterorise\Sites\gbthv\QTHVRANDOM\IV AC\IV ACFLU-S-0203\03 
Rando specification\IV ACFLU-S-0203_RandoSpec_BLINDED_20 I 7 _03_3 I_ v2_0.docx 
Author· 
Maria Efstathiou 
Version Number: 
2.0 
Version Date: 
31MAR2017 
Template No: CS_TP _88025 Revision 5 
Effective Date: 01 Nov2016 
Copyright© 2009, 2010, 2011, 2014, 2016 QuintileslMS. All rights reserved. 
Reference: CS_Wl_BS002 
The contents of this document are confidential and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries. 
Unauthorized use, disclosure or reproduction is strictly prohibited. 
738
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

eQ> QuintiteslMs· 
PATH II\ AC 
IVACFLL -S-0203 
Randomization Specification 
Page 2 of 12 
Authorization 
Randomization Biostatistician 
Maria Efstathiou 
(required): 
Signature 
Date 
Name 
Statistical Team Lead: 
Suman Kagoor 
svY7\P\1\ 1< c-p ou-1\ . 
3/ftvq} { 'rt-
Name 
Signature' 
I 
Dite " 
Randomization Implementer 
Dr Phan Cong Hung 
(required): 
Name 
Signature 
Date 
Customer approval (if 
Tushar Tewari 
required): 
Name 
Signature 
Date 
Thang Tran 
Name 
Signature 
Date 
Document: 
\\auintiles.net\Entemrise\Sites\!!bthv\OTHVRANDOM\IV AC\IV ACFLU-S-0 03\03 
Rando specification\IV ACFLU-S-0203 _ RandoSpec _BLINDED_ 2017 _ 03 _ 31 v2 0 
Author: 
Maria Efstathiou 
Version Number: 
2.0 
Version Date: 
31MAR2 bl7 
Template No: CS_ TP _BS025 Revision 5 
Reference: ~S_Wl_BS002 
Effective Date: 01 Nov2016 
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PATH/IVAC 
@auintileslMs· 
IV ACFLU-S-0203 
Randomization Specification 
Page 2of12 
Authorization 
Randomization Biostatistician 
Maria Efstathiou 
(required): 
Signature 
Date 
Name 
Statistical Team Lead: 
Suman Ka11oor 
Name 
Signature 
Date 
Randomization Implementer 
Dr Phan Cong Hung 
(required): 
Name 
[;./, 
Date 
Customer approval (if 
Tushar Tewari 
DZ\ /rf i.. ~2 01; 
required): 
Name 
Signaffu.e 
Date 
Thang Tran 
Name 
Signature 
Date 
Document: 
\\guintiles.net\Enterorise\Sites\gbthv\QTHVRANDOM\IV AC\IV ACFLU-S-0203\03 
Rando specification\IV ACFLU-S-0203 _ RandoSpec _BLINDED_ 2017 _ 03 _ 3 l _ v2 _ 0 
Author: 
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Version Number: 
2.0 
Version Date: 
31MAR2017 
Template No: CS_TP _BS025 Revision 5 
Effective Date: 01Nov2016 
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Reference: CS_Wl_BS002 
The contents of this document are confidential and proprietary to Quintiles I MS Holdings, Inc. and its subsidiaries. 
Unauthorized use, disclosure or reproduction is strictly prohibited. 
740
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

@ Qu1ntiteslMS" 
Randomization Specification 
Randomization Biostatistician 
(required): 
Statistical Team Lead: 
Randomization Implementer 
(required): 
Customer approval (if 
required): 
Authorization 
Maria Efstathiou 
Name 
Suman Kapoor 
Name 
Dr Phan Cong Hung 
Name 
Tushar Tewari 
Name 
Thang Tran 
Name 
Signature 
Signature 
Signature 
Signature 
Signature 
PATH/ IVAC 
IV ACFLU-S-0203 
Page 2 of 12 
Date 
Date 
Date 
Date 
Document: 
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Maria Efstathiou 
Version Number: 
2.0 -
-
-
Author: 
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741
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Version 1.0
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PATH/IVAC 
'©> QuintileslMs· 
Randomization Specification 
IV ACFLU-S-0203 
Page 2 of 12 
Randomization Biostatistician 
(required): 
Statistical Team Lead: 
Randomization Implementer 
(required): 
Customer approval (if 
required): 
Authorization 
Maria Efstathiou 
Name 
Suman Kapoor 
Name 
Dr Phan Cong Hung 
Name 
Tushar Tewari 
Name 
Thang Tran 
Name 
Signature 
Date 
Signature 
Date 
Signature 
Date 
Signature 
Date 
~ 
·' 
:;:::::=-== 
Signature 
Document: 
\\guintiles.net\Enterprise\Sites\gbthv\QTHVRANDOM\IV AC\IV ACFLU-S-0203\03 
Rando specification\IV ACFLU-S-0203_RandoSpec_BLINDED _20 17 _03_3 I_ v2_0.docx 
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PATH / IVAC
IVACFLU-S-0203
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Document:
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Rando specification\IVACFLU-S-0203_RandoSpec_BLINDED_2017_03_31_v2_0
Author:
Maria Efstathiou
Version Number: 2.0
Version Date: 
31MAR2017
Template No:  CS_TP_BS025 Revision 5
Reference:  CS_WI_BS002
Effective Date: 01Nov2016
Copyright © 2009, 2010, 2011, 2014, 2016 QuintilesIMS. All rights reserved.
The contents of this document are confidential and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries.  
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1. Modification History
Unique 
Identifie
r for this 
Version
Date of the 
Document 
Version
Author 
Significant Changes from 
Previous Authorized Version
0.1 
12FEB2017 
Maria Efstathiou 
N/A – First Draft Version sent 
for review. 
0.2 
13FEB2017 
Maria Efstathiou 
Minor updates and typos 
corrected following QI internal 
review.
1.0 
17FEB2017 
Maria Efstathiou
1. Added name of 
randomization 
implementer on 
authorization page
2. Added details for 
distribution to the sites 
in section 12. 
2.0 
31MAR2017 
Maria Efstathiou
1. Authorisation page: 
corrected typo in 
Suman Kapoor’s name 
and removed Renee 
Holt’s name
2. Section 11, clarified 
that the blinded actual 
randomization was 
produced but not 
distributed and added 
reference to 
IVACFLU-S-
0203.SOP.04. 
3. Section 11, updated 
block attributes to $3.
4. Section 11, updated 
header in example 
schedule from ‘block 
number’ to ‘block 
identifier’. 
5. Section 11, updated 
Dummy_b labels in 
example to 
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IVACFLU-S-0203
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Document:
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Rando specification\IVACFLU-S-0203_RandoSpec_BLINDED_2017_03_31_v2_0
Author:
Maria Efstathiou
Version Number: 2.0
Version Date: 
31MAR2017
Template No:  CS_TP_BS025 Revision 5
Reference:  CS_WI_BS002
Effective Date: 01Nov2016
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“DUMMY_IVACFLU-
S”.
6. Section 12, removed 
row relating to 
distribution of actual 
blinded list to sites (not 
applicable); updated 
contact details for 
Maria Efstathiou and 
Suman Kapoor.
7. Section 9, removed 
note regarding IVAC 
being allowed to see 
the unblinded 
randomization 
specification.
2. Study Details
Protocol version and date V3.0, 03JAN2017
Study sample size 
Phase 2: 252 subjects
Phase 3: 636 subjects
Total: 252 + 636 = 888 subjects
Planned number of sites 
Phase 2: 1 site (Long An)
Phase 3: 2 sites (Long An; Dong Nai)
Study design
Parallel group
Crossover
Number of treatment 
groups / treatment 
sequences
2
Full description of 
treatment groups / 
treatment sequences
1 = IVACFLU-S
2 = PLACEBO
Ratio of subjects to 
treatment groups / 
treatment sequences
IVACFLU-S : PLACEBO: 5:1
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IVACFLU-S-0203
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Document:
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Rando specification\IVACFLU-S-0203_RandoSpec_BLINDED_2017_03_31_v2_0
Author:
Maria Efstathiou
Version Number: 2.0
Version Date: 
31MAR2017
Template No:  CS_TP_BS025 Revision 5
Reference:  CS_WI_BS002
Effective Date: 01Nov2016
Copyright © 2009, 2010, 2011, 2014, 2016 QuintilesIMS. All rights reserved.
The contents of this document are confidential and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries.  
Unauthorized use, disclosure or reproduction is strictly prohibited.
3. Randomization Requirements
Method of randomization
Central
Distributed
Subject or kit/component 
randomization schedule?
Subject only – complete Section 4
Kit/component only – complete Section 5
Subject and kit/component – complete Sections 4 and 
5
Stratified?
Yes – complete Section 6
No
Dynamic?
Yes – complete Section 7
No
Is a matching schedule 
required for replacing 
subjects who discontinue?
Yes – complete Section 8
No
Will randomized blocks 
be used?
Yes – complete Section 9
Specification must not be sent to blinded team 
members without redacting Section 9.
No
Is a dummy
randomization schedule 
required?
Yes
No
Is a partially unblinded 
randomization file 
required?
Yes – complete Section 10
No
4. Subject Randomization Numbers
Number of records (randomization 
numbers) to be generated:
Phase 2: 252 + 252 overage
Phase 3: 636 + 504 overage 
Format and range of randomization 
numbers
Phase 2
Long An, 18-45 years of age: A001 –
A126 and A127 – A252 (overage)
Long An, >45 – 60 years of age: B001 
– B126 and B127 – B252 (overage)
Phase 3
Long An, 18-45 years of age: C001 –
C126 and C127 – C252 (overage)
Long An, >45 – 60 years of age: D001 
– D126 and D127 – D252 (overage)
Dong Nai, 18 – 45 years of age: E001 –
E192 and E193 – E318 (overage)
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Document:
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Rando specification\IVACFLU-S-0203_RandoSpec_BLINDED_2017_03_31_v2_0
Author:
Maria Efstathiou
Version Number: 2.0
Version Date: 
31MAR2017
Template No:  CS_TP_BS025 Revision 5
Reference:  CS_WI_BS002
Effective Date: 01Nov2016
Copyright © 2009, 2010, 2011, 2014, 2016 QuintilesIMS. All rights reserved.
The contents of this document are confidential and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries.  
Unauthorized use, disclosure or reproduction is strictly prohibited.
Dong Nai, >45 – 60 years of age: G001 
– G192 and G193 – G318 (overage)
5. Kit/Component Identifiers
Generation of kit/component 
identifiers
Provided
Require generation
If provided, give details of source 
N/A
If generating, number of records 
(kit/component identifiers) to be 
generated:
Kit numbers are identical to Subject 
Randomization Numbers (cf. Section 4 above). 
If generating, format and range of 
kit/component identifiers
Kit numbers are identical to Subject 
Randomization Numbers (cf. Section 4 above).
6. Stratification Factors
Number of Stratification Factors 
Phase 2: 1 (age group)
Phase 3: 2 (age group and site)
Stratification Factor 1:
Description:
Site – applies to phase 3 only.
Include ‘Site’ in the schedule for phase 2, but 
only 1 site (Long An) is involved in phase 2. 
Number of levels:
2
Details of levels: 
Site: Long An
Site: Dong Nai
Stratification Factor 2:
Description:
Age group – applies to phase 2 and phase 3.
Number of levels:
2
Details of levels: 
Age group: 18 – 45 years of age
Age group: >45 – 60 years of age
7. Dynamic Randomization Methods
N/A
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Rando specification\IVACFLU-S-0203_RandoSpec_BLINDED_2017_03_31_v2_0
Author:
Maria Efstathiou
Version Number: 2.0
Version Date: 
31MAR2017
Template No:  CS_TP_BS025 Revision 5
Reference:  CS_WI_BS002
Effective Date: 01Nov2016
Copyright © 2009, 2010, 2011, 2014, 2016 QuintilesIMS. All rights reserved.
The contents of this document are confidential and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries.  
Unauthorized use, disclosure or reproduction is strictly prohibited.
8. Replacement Subject Numbers
Details of randomization numbers 
for replacement subjects 
N/A
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Rando specification\IVACFLU-S-0203_RandoSpec_BLINDED_2017_03_31_v2_0
Author:
Maria Efstathiou
Version Number: 2.0
Version Date: 
31MAR2017
Template No:  CS_TP_BS025 Revision 5
Reference:  CS_WI_BS002
Effective Date: 01Nov2016
Copyright © 2009, 2010, 2011, 2014, 2016 QuintilesIMS. All rights reserved.
The contents of this document are confidential and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries.  
Unauthorized use, disclosure or reproduction is strictly prohibited.
9. Block Size
If randomized blocks are required, 
will mixed blocks be used?
Yes
No
Will a different block size be used 
for any draft or dummy schedules?
Yes
No
Block size(s) 
INFORMATION REMOVED FOR BLINDED 
SPECIFICATION
** All block sizes must be redacted before 
distributing to blinded team members. **
Number of blocks
INFORMATION REMOVED FOR BLINDED 
SPECIFICATION
** Number of blocks must be redacted 
before distributing to blinded team 
members. **
Note: as per PATH procedures, the use of the mixed block size allows for blinded PATH / IVAC team 
members to review the randomisation specification, including block size. A blinded version will be 
created for review by the QuintilesIMS team.
10. Partial Unblinding
Partially unblinded treatment group 
/ treatment sequence identifiers
N/A
11. Output Files
The following files will be produced: 
IVACFLUS0203_RNDSBJKIT_ACTUAL_U:unblinded actual 
randomization schedule produced for drug packaging by IVAC. 
IVACFLUS0203_RNDSBJKIT_ACTUAL_B:blinded actual randomization 
schedule produced for randomisation implementation at site.UPDATE FOR 
V2.0: this was produced but not distributed to the sites, as a separate instruction 
was issued to the sites, describing the format of the randomisation numbers for 
each site and stratum. Instruction reference: IVACFLU-S-0203.SOP.04.
IVACFLUS0203_RNDSBJKIT_DUMMY_B:blinded dummy randomization 
schedule produced for blinded statistical programming purposes.
An example of the schedule structure is given below:
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Rando specification\IVACFLU-S-0203_RandoSpec_BLINDED_2017_03_31_v2_0
Author:
Maria Efstathiou
Version Number: 2.0
Version Date: 
31MAR2017
Template No:  CS_TP_BS025 Revision 5
Reference:  CS_WI_BS002
Effective Date: 01Nov2016
Copyright © 2009, 2010, 2011, 2014, 2016 QuintilesIMS. All rights reserved.
The contents of this document are confidential and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries.  
Unauthorized use, disclosure or reproduction is strictly prohibited.
Block number should be redacted before distributing to any blinded team 
members, even in an example
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Document:
\\quintiles.net\Enterprise\Sites\gbthv\QTHVRANDOM\IVAC\IVACFLU-S-0203\03
Rando specification\IVACFLU-S-0203_RandoSpec_BLINDED_2017_03_31_v2_0
Author:
Maria Efstathiou
Version Number: 2.0
Version Date: 
31MAR2017
Template No:  CS_TP_BS025 Revision 5
Reference:  CS_WI_BS002
Effective Date: 01Nov2016
Copyright © 2009, 2010, 2011, 2014, 2016 QuintilesIMS. All rights reserved.
The contents of this document are confidential and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries.  Unauthorized use, disclosure or reproduction is strictly prohibited.
Protocol 
Identifier
Schedule 
Type
Phase Site 
Age group  
Block 
Identifier
Randomiza
tion 
Number
Kit 
Identifier
Randomiz
ed 
Treatment 
Group
Numeric 
Random
ized 
treatmen
t group
Overage
IVACFL
U-S-0203
Actual_u 2 
Long 
An
18 – 45 years 
of age
XX 
A001 
A001 
IVACFL
U-S
1
No
. . . 
. . .
. . . 
. . . 
. . . 
. . .
IVACFL
U-S-0203
Actual_u 2 
Long 
An
18 – 45 years 
of age
XX 
A126 
A126 
PLACEB
O
2
No
. . . 
. . .
. . . 
. . . 
. . . 
. . .
IVACFL
U-S-0203
Actual_u 2 
Long 
An
18 – 45 years 
of age
XX 
A252 
A252 
IVACFL
U-S
1
Yes
…
…
…
…
…
 
…
…
…
…
…
…
o For the PDF files, each stratum will start on a new page. 
o Schedule type is ‘Actual_u’, ‘Actual_b’, ‘Dummy_b’ for the actual unblinded, actual blinded and dummy blinded schedules, 
respectively. 
o For the Dummy_b schedule, the block number will be reset to ‘01’ for all blocks prior to sending to the recipients specified in 
section 12. The randomised treatment group will be preceded by ‘DUMMY_’ (e.g. DUMMY_IVACFLU-S’). 
o For the Actual_b schedule, Block number, randomised treatment group and numeric randomised treatment group will be removed 
prior to sending to the recipients specified in section 12.UPDATE FOR V2.0: this was produced but not distributed to the sites, as 
a separate instruction was issued to the sites, describing the format of the randomisation numbers for each site and stratum.
Instruction reference: IVACFLU-S-0203.SOP.04.
o For the PDF files, overage numbers for each stratum will start on a separate page. 
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Rando specification\IVACFLU-S-0203_RandoSpec_BLINDED_2017_03_31_v2_0
Author:
Maria Efstathiou
Version Number: 2.0
Version Date: 
31MAR2017
Template No:  CS_TP_BS025 Revision 5
Reference:  CS_WI_BS002
Effective Date: 01Nov2016
Copyright © 2009, 2010, 2011, 2014, 2016 QuintilesIMS. All rights reserved.
The contents of this document are confidential and proprietary to Quintiles IMS Holdings, Inc. and its subsidiaries.  
Unauthorized use, disclosure or reproduction is strictly prohibited.
Variable name 
Label
Attributes
PROTID
Protocol Identifier 
$16.
SCHEDTYP 
Schedule Type 
$10.
PHASE
Phase
$1.
SITE
Site
$10.
AGEGRP
Age group
$22.
BLOCK
Block Identifier 
$3.
RND
Randomization Number $4.
KITID
Kit Identifier
$4.
RTREAT
Randomized Treatment 
Group
$20.
RTREATN 
Numeric Randomized 
Treatment Group
8.
OVERAGE 
Overage identifier 
$3.
12. Distribution Details For Randomization Schedule
Authoriz
ed 
recipient
s:
Contact Details: 
Files to be distributed:
Method 
of 
Distribu
tion:
Reason 
for 
Distribu
tion:
Hoàng 
Minh 
Hưng
IVAC 
pharmaci
st
Email address: 
hhung_nt@yahoo.com
Mobile #: 84-
985.715.096
Fax # : 058 3 823 815
IVACFLUS0203_RNDSBJKIT_ACTUAL
_U.PDF
IVACFLUS0203_RNDSBJKIT_ACTUAL
_U.CSV
Passwor
d-
protected 
email
Unblinde
dfor 
drug 
packagin
g
Maria 
Efstathio
u,
Quintiles
IMS 
randomis
ation 
statisticia
n
Maria.efstathiou@quint
ilesims.com
IVACFLUS0203_RNDSBJKIT_ACTUAL
_U.PDF
IVACFLUS0203_RNDSBJKIT_ACTUAL
_U.SAS7BDAT
IVACFLUS0203_RNDSBJKIT_ACTUAL
_U.CSV
IVACFLUS0203_RNDSBJKIT_ACTUAL
_B.PDF
IVACFLUS0203_RNDSBJKIT_ACTUAL
_B.SAS7BDAT
IVACFLUS0203_RNDSBJKIT_DUMMY_
B.PDF
IVACFLUS0203_RNDSBJKIT_DUM
MY_B.SAS7BDAT
N/A 
Reviewe
r and 
Secure 
storage 
of actual 
blinded 
and 
actual;
unblinde
d
schedule
s
Suman 
Kapoor, 
Quintiles
IMS 
Suman.kapoor@quintil
esims.com
IVACFLUS0203_RNDSBJKIT_DUMMY_
B.PDF
IVACFLUS0203_RNDSBJKIT_DUMMY_
B.SAS7BDAT
Email 
Blinded 
dummy 
schedule 
for 
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Rando specification\IVACFLU-S-0203_RandoSpec_BLINDED_2017_03_31_v2_0
Author:
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Version Number: 2.0
Version Date: 
31MAR2017
Template No:  CS_TP_BS025 Revision 5
Reference:  CS_WI_BS002
Effective Date: 01Nov2016
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Unauthorized use, disclosure or reproduction is strictly prohibited.
STL, 
QBAN
program 
develop
ment
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16.1.8 
Audit certificates 
Not Applicable 
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16.1.9 
Documentation of statistical methods 
Document 
Date 
Final SAP, Version 1 
11 August 2017 
Table and Listing Mock Shell, Version 1 
11 August 2017 
 
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STATISTICAL ANALYSIS PLAN: PROTOCOL IVACFLU-S-0203
Page 1 of 40
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics 
\Documentation\SAP\IVACFLU-S-0203_SAP_Draft v1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or 
reproduction is strictly prohibited. 
STATISTICAL ANALYSIS PLAN 
 
 
IVACFLU-S-0203, PHASE 2/3 
 
 
 A PHASE 2 / 3 DOUBLE BLINDED, RANDOMIZED, PLACEBO-CONTROLLED
STUDY IN HEALTHY ADULT VOLUNTEERS IN VIETNAM TO EXAMINE THE 
SAFETY AND IMMUNOGENICITY OF A SEASONAL TRIVALENT 
INACTIVATED SPLIT VIRION INFLUENZA VACCINE (IVACFLU-S) 
PRODUCED BY IVAC  
 
 
 
AUTHOR: REVATHI RAYADURGAM 
VERSION NUMBER AND DATE: DRAFT V1.0 11AUG2017 
 
 
755
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,,-::~ 
~s; 
STATISTICAL ANALYSIS PLAN: PROTOCOL IVA FLU-S-0203 
Page 2 of 40 
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE 
Statistical Analysis Plan Vl.O (Dated11AUG2017) for Protocol IVACFLU-S-0203 (V4.0 ated 
09FEB2017). 
Author: 
Position: 
Company: 
Name 
Revathi Rayadurgam 
Biostatistician 2 
QuintileslMS 
Signature 
Date 
········~ ··· · ·· 
I ~/Au6. I~ 
Upon review of this document, the undersigned approves this version of the Statistical Analysis Plan, authorizing 
that the content is acceptable for the reporting of this study. 
Approved By: 
Name 
Suresh Chenji 
Date 
JfJ 0c/ 2Pf?. 
Position: 
. 1V1a11a gE' rL ~i()~t;iti ?tics . 
Company: 
QuintileslMS 
; 
Approved By: 
Krista Yuhas 
f.J • '\.v; 
I -I 
· 
!) 
J ,. , 
..... -, 
'J / r 
Position: 
Company: 
Biostatistician, Center for Vaccine Innovation and Access (CVIA) 
PATH 
Approved By: 
Document: 
Author: 
Tushar Tewari 
Senior Medical Officer,9inica,I a.ncj ~e~ulatoryJl.ffa.irs 
I II E EDC-NAS01 A\Biosdata\Path\IVACFLU-S\IY A06804\Biostatistics 
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' 
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@ QuintileslMS~ 
~­
~ 
STATISTICAL ANALYSIS PLAN: PROTOCOL IVACFLU-S-0203 
Page 2 of 40 
STATISTICAL ANALYSIS PLAN SIGNATURE PAGE 
Statistical Analysis Plan Vl.O (Dated11AUG2017) for Protocol IVACFLU-S-0203 (V4.0 Dated 
09FEB2017). 
Name 
Signature __ 
Date 
Author: 
Revathi Rayadurgam 
-1. -
---··· ...... 
Position: 
Biostatistician 2 
QuintileslMS 
Upon review of this document, the undersigned approves this version of the Statistical Analysis Plan, authorizing 
t~~!-~~-~~()~!~~!~s~~-~~e~~-~l~!()~-!~~-~ep()~!!.1~ of th~s study._ 
... ---···-·-·-·-·-·-····-·-·-·-·-···-···- ..... -·· -·- ··-·-···--, 
Name 
, Date 
Suresh Chenji 
+-- ·-·· -· -·-··· ·--- .. ------i 
Approved By: 
i 
1 
Position: 
_ Manage~Biostatisti~S. 
Com~ny: 
QuintileslMS 
..... J 
Approved By: 
Position: 
~ompany_: 
. Approved By: 
Position: 
Company: 
Krista Yuhas 
-_ [ ~;()St;~_is_ti~~an!. Center f()r Va~cin_e lnn_ovati_cm and Access (~l~l 
PATH 
r Tushar Tewari 
i 
Senior Medical Officer, Clinical and Regulatory Affairs 
PATH 
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MODIFICATION HISTORY 
 
 
Unique Identifier for 
this Version 
Date of the Document 
Version  
Author 
Significant Changes 
from Previous 
Authorized Version 
 
 
Revathi Rayadurgam 
Not applicable. First 
version. 
 
 
 
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reproduction is strictly prohibited. 
TABLE OF CONTENTS 
 
Statistical Analysis Plan Signature Page ............................................................................................................... 2 
Modification History ............................................................................................................................................ 3 
Table of Contents ................................................................................................................................................ 4 
List Of Abbreviations ........................................................................................................................................... 8 
1. 
Introduction ....................................................................................................................................... 10 
2. 
Study Objectives ................................................................................................................................. 10 
2.1 
Primary Objectives, Phase 2 ................................................................................................................ 10 
2.2 
Primary Objectives, Phase 3 ................................................................................................................ 10 
2.3 
Secondary Objective, Phase 3 ............................................................................................................. 10 
2.4 
2.3 Assessment of Objectives .............................................................................................................. 10 
2.4.1 
2.3.1 Endpoint variables ..................................................................................................................... 10 
2.4.1.1 
Primary Safety Endpoints, Phase 2 and 3 ............................................................................................. 11 
2.4.1.2 
Primary Immunogenicity Endpoints, Phase 3 ....................................................................................... 11 
2.4.1.3 
Secondary Immunogenicity Endpoints, Phase 3 ................................................................................... 12 
3 
Study Design ...................................................................................................................................... 12 
3.1 
General Description ............................................................................................................................ 12 
3.1.1 
Randomization and Blinding ............................................................................................................... 14 
3.1.1.1 
Randomization procedures ................................................................................................................. 14 
3.1.1.2 
Blinding and unblinding procedures .................................................................................................... 14 
3.2 
Schedule of Events ............................................................................................................................. 15 
3.3 
Changes to Analysis from Protocol ...................................................................................................... 16 
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4 
Planned Analyses ............................................................................................................................... 17 
4.1 
Data and Safety Monitoring Board ...................................................................................................... 17 
4.2 
Interim Analysis .................................................................................................................................. 17 
4.3 
Final Analysis ...................................................................................................................................... 17 
5 
Analysis Sets ....................................................................................................................................... 17 
5.1 
Enrolled population ............................................................................................................................ 18 
5.2 
Full Analysis [FA] POPULATION ........................................................................................................... 18 
5.3 
Per Protocol [PP] population ............................................................................................................... 18 
6. 
General Considerations ...................................................................................................................... 18 
6.1 
Reference Start Date and Study Day ................................................................................................... 19 
6.2 
Baseline ............................................................................................................................................. 19 
6.3 
Derived Timepoints ............................................................................................................................ 19 
6.4 
Retests, Unscheduled Visits and Early Termination Data ..................................................................... 19 
6.5 
Windowing Conventions ..................................................................................................................... 20 
6.6 
Statistical Tests ................................................................................................................................... 20 
6.7 
Common Calculations ......................................................................................................................... 20 
6.8 
Software Version ................................................................................................................................ 20 
7. 
Statistical Considerations .................................................................................................................... 20 
7.1 
Adjustment for Covariates .................................................................................................................. 20 
7.2 
Multicenter Studies ............................................................................................................................ 21 
7.3 
Missing data ....................................................................................................................................... 21 
7.4 
Multiple Comparisons/ Multiplicity .................................................................................................... 21 
7.5 
Examination of Subgroups .................................................................................................................. 21 
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8. 
Output Presentations ......................................................................................................................... 21 
9. 
Disposition and Withdrawals .............................................................................................................. 22 
10. 
Demographic and other Baseline Characteristics ................................................................................. 22 
10.1 
Derivations ......................................................................................................................................... 22 
11. 
Current medical conditions ................................................................................................................. 23 
12. 
Medications ....................................................................................................................................... 23 
13. 
Study Medication Exposure ................................................................................................................ 23 
14. 
Study Medication Compliance ............................................................................................................ 23 
15. 
Efficacy Outcomes .............................................................................................................................. 23 
16. 
Immunogenicity analysis .................................................................................................................... 24 
16.1 
Statistical considerations .................................................................................................................... 24 
16.1.1 
Probability for demonstrating seroconversion criteria for licensure ..................................................... 25 
16.1.2 
Probability for demonstrating seroprotection criteria for licensure ..................................................... 26 
16.2 
Analysis of Immunogenicity Endpoints ................................................................................................ 26 
16.2.1 
Primary Immunogenicity Endpoints .................................................................................................... 26 
16.2.2 
Secondary Immunogenicity Endpoints ................................................................................................ 27 
16.3 
Variables & Derivations ...................................................................................................................... 28 
17. 
Safety Outcomes ................................................................................................................................ 29 
17.1 
Statistical considerations: ................................................................................................................... 29 
17.2 
Analysis of safety endpoints: .............................................................................................................. 30 
17.2.1 
Solicited Local and Systemic Adverse Events ....................................................................................... 30 
17.2.1.1 Presentation of 30-minute solicited local and systemic reactogenicity ................................................. 31 
17.2.1.2 Presentation of solicited local and systemic adverse events ................................................................ 32 
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17.2.2 
Unsolicited adverse events ................................................................................................................. 33 
17.2.3 
Serious Adverse Events ....................................................................................................................... 34 
17.3 
Deaths ................................................................................................................................................ 35 
17.4 
ECG Evaluations .................................................................................................................................. 36 
17.5 
Vital Signs ........................................................................................................................................... 36 
17.6 
Physical Examination .......................................................................................................................... 36 
18. 
Data Not Summarized or Presented .................................................................................................... 37 
APPENDIX 1 ....................................................................................................................................................... 38 
APPENDIX 2 ....................................................................................................................................................... 39 
APPENDIX 3 ....................................................................................................................................................... 39 
APPENDIX 4 ....................................................................................................................................................... 39 
 
 
 
 
 
 
 
 
 
 
 
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LIST OF ABBREVIATIONS 
 
ADaM 
Analysis Data Model 
AE 
Adverse Event 
CDISC 
Clinical Data Interchange Standards Consortium 
CI 
Confidence Interval 
cm 
Centimeter 
CPMP 
Committee for Proprietary Medicinal Products 
CRF 
Case Report Form 
DSMB 
Data and Safety Monitoring Board 
eCRF 
Electronic Case Report Form 
EMEA 
European Agency Evaluation of Medicinal Products 
 
FA 
Full Analysis Population 
GMFR 
Geometric Mean Fold Rise 
GMT 
Geometric Mean Titer 
HA 
Hemagglutinin 
HAI 
Hemagglutination Inhibition 
ICF 
Informed Consent Form 
IP 
Investigational Product 
IRB 
Institutional Review Board 
IVAC 
Institute of Vaccines and Medical Biologicals 
mL 
Milliliter 
MOH 
Ministry of Health 
PD 
Protocol Deviations 
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PE 
Physical Examination 
PI 
Principal Investigator 
PP 
Per Protocol Population 
PSRT 
Protocol Safety Review Team 
PT 
Preferred Term 
RCD 
Reverse Cumulative Distribution 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SAS 
Statistical Analysis System 
SOC 
System organ class 
SDTM 
Study Data Tabulation Model 
TLF 
Tables, Listings and Figures 
WHO 
World Health Organization 
 
 
 
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1. INTRODUCTION 
This document describes the rules and conventions to be used in the presentation and analysis of safety and  
immunogenicity data for Protocol IVACFLU-S-0203. It describes the data to be summarized and analyzed, 
including specifics of the statistical analyses to be performed.  
This statistical analysis plan (SAP) is based on Protocol version 4.0, dated 09Feb2017. 
2. STUDY OBJECTIVES 
2.1 PRIMARY OBJECTIVES, PHASE 2 
Safety: To evaluate the safety profile of a single intramuscular dose of IVACFLU-S seasonal trivalent inactivated 
split virion influenza vaccine in adults, 18 to 60 years of age. 
2.2 PRIMARY OBJECTIVES, PHASE 3 
Safety: To evaluate the safety profile of a single intramuscular dose of IVACFLU-S seasonal trivalent split virion 
inactivated influenza vaccine in adults, 18 to 60 years of age. 
Immunogenicity: To evaluate the immune response at Day 22 to each of the three vaccine antigens after a single 
intramuscular dose of IVACFLU-S seasonal trivalent split virion, inactivated influenza vaccine in adults, 18 to 45 
(inclusive) and 46-60 years of age. 
2.3 SECONDARY OBJECTIVE, PHASE 3 
Immunogenicity: To evaluate the immune response at Day 22 to each of the three vaccine antigens after a single 
dose of IVACFLU-S seasonal trivalent split virion inactivated influenza vaccine in adults with and without pre-
existing Hemagglutination Inhibition (HAI) antibody. 
2.4 ASSESSMENT OF OBJECTIVES 
2.4.1 ENDPOINT VARIABLES 
 
Solicited local adverse events (at site of injection): 
o 
Erythema / redness - based on size in cm 
o 
Swelling / induration (hardness at site of injection) - based on size in cm 
o 
Pain 
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 
Solicited systemic adverse events: 
o 
Fever-Body temperature 
o 
Fatigue/malaise 
o 
Generalized muscle aches 
o 
Joint aches 
o 
Chills 
o 
Nausea 
o 
Vomiting 
o 
Headache 
 
Unsolicited adverse events 
 
Serious adverse events 
 
Seroprotection 
 
Seroconversion  
 
Geometric mean titers (GMT)  of serum HAI antibodies 
 
Geometric mean fold rises (GMFR) of serum HAI antibodies 
2.4.1.1 PRIMARY SAFETY ENDPOINTS, PHASE 2 AND 3 
The number and proportion of participants reporting the following events: 
 
A. Solicited local adverse events, including redness / erythema, swelling / induration, pain within 30 
minutes of vaccination and over a 7-day period (Days 1-7) post-vaccination. 
 
B. Solicited systemic adverse events, including fever, fatigue/malaise, muscle aches, joint aches, chills, 
nausea, vomiting, and headache within 30 minutes of vaccination and over a 7-day period (Days 1-7) 
post-vaccination. 
 
C. Unsolicited Adverse Events (AEs) occurring within 21 days post vaccination. 
 
D. Serious Adverse Events (SAEs) occurring during the entire study period (Days 1-91). 
2.4.1.2 PRIMARY IMMUNOGENICITY ENDPOINTS, PHASE 3 
A. Number and percentage of participants by age groups (18-45, 46-60) with seroconversion against 
each of the 3 vaccine antigens post-vaccination. Seroconversion is defined as a serum HAI antibody 
titer meeting the following criteria: 
 
pre-vaccination titer <1.:10 and a post-vaccination titer measured on Day 22 of ≥1:40 or 
 
pre-vaccination titer ≥1:10 and at least a four-fold increase in post vaccination measured on Day 
22 
 
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B. Number and percentage of participants by age groups (18-45, 46-60) with a HAI antibody titer ≥1:40 
to each of the 3 vaccine antigens measured on Day 22 post vaccination 
 
C. GMTs of serum HAI antibodies pre- (Day 1) and post vaccination (Day 22) by age groups (18-45, 46-60) 
for each of the 3 vaccine antigens 
 
D. GMFRs of serum HAI antibodies (post vaccination/prevaccination) by age groups (18-45, 46-60) for 
each of the 3 vaccine antigens 
2.4.1.3 SECONDARY IMMUNOGENICITY ENDPOINTS, PHASE 3 
A. Number and percentage of participants by age groups (18-45, 46-60) who develop at least a four-fold 
increase in HAI antibody titer to each of the vaccine antigen post vaccination measured on Day 22 by 
pre-vaccination HAI antibody titer of <1:10 or ≥1:10. 
 
B. GMTs of serum HAI antibodies pre- (Day 1) and post vaccination (Day 22) by age groups (18-45, 46-60) 
for each of the 3 vaccine antigens by prevaccination HAI antibody titer of <1:10 or ≥1:10. 
 
C. GMFRs of serum HAI antibodies (post vaccination/prevaccination) by age groups (18-45, 46-60) for 
each of the 3 vaccine antigens by prevaccination HAI antibody titer of <1:10 or ≥1:10. 
3 STUDY DESIGN 
3.1 GENERAL DESCRIPTION 
 
This is a phase 2/3, double-blind, randomized, placebo-controlled trial to evaluate the safety and immunogenicity 
of a single dose of the IVACFLU-S seasonal influenza vaccine in male and female healthy adult volunteers, aged 18 
to 60 years old (inclusive). Subjects will receive a single dose of seasonal trivalent, split inactivated influenza 
vaccine (A/H1N1; A/H3N2 and B) or placebo (phosphate buffered saline). 
 
Phase 2 will be conducted at a single site, District Health Center of Ben Luc district in Long An Province. Phase 2 will 
involve 252 subjects randomized to receive either IVACFLU-S or placebo at a ratio of 5:1.  
 
Following determination of “safe to proceed” based on Protocol Safety Review Team (PSRT) review of Day 8 safety 
data from all Phase 2 subjects and with approval from Vietnam Ministry of Health (MOH), Phase 3 enrollment will 
commence at 2 sites, District Health Center of Ben Luc in Long An province and District Health Center of Long 
Thanh in Dong Nai province. 
 
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The Phase 3 components will include 636 subjects randomized to receive either IVACFLU-S or placebo at a ratio of 
5:1. Randomization of Phase 2 volunteers will be stratified by age group and Phase 3 volunteers will be stratified by 
site and age group, as per Figure 1. 
 
The sample size for this study was selected in response to the MOH’s requirement for additional safety data from 
Phase 2 before proceeding to Phase 3 and for primary safety and immunogenicity analysis to satisfy the MOH 
licensure requirement for influenza vaccine in adults from ages 18 through 60. The sample size reflects guidance 
and endorsement by MOH at the MOH-IVAC Consultation Meeting held on 20 April 2016. 
 
 
Figure 1: Summary of study design.  
 
 
 
S1: Day of Screening and Enrollment 
D1: Day of Vaccination  
Ben Luc and Long Thanh are the two study sites at Long An and Dong Nai provinces respectively. 
 
 
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3.1.1 RANDOMIZATION AND BLINDING 
3.1.1.1 RANDOMIZATION PROCEDURES 
This is a double-blind, randomized, controlled trial with 2 groups: vaccine and placebo. The ratio of vaccine to 
placebo recipients is 5:1.  
 
This seamless design has the block randomization conducted with age group as the stratification factor for both 
phase 2 and phase 3, having two levels of stratification. The two age groups are:  
 
1. 18-45 and  
2. 46-60. 
Block randomization for Phase 3 involves site as an additional stratification factor i.e., Phase 3 will be conducted at 
two sites i.e., District Health Center of Ben Luc in Long An province and District Health Center of Long Thanh in 
Dong Nai province. 
 
Each participant will be assigned a unique screening number assigned by the investigator after signing the informed 
consent. After an individual is determined to be eligible for study participation, the participant will be randomized 
according to age group by assigning a unique participant identification number sequentially in ascending order 
from the randomization schedule, which will contain the unique participant identification number and the 
corresponding randomization assignment and will be produced using computer software prior to the initiation of 
the study. 
 
Once a participant identification number has been assigned to a participant, it will not be used again. Additional 
participants may be randomized into the study at the discretion of the sponsor in the case of any participant who is 
randomized but does not receive any study vaccine. 
3.1.1.2 BLINDING AND UNBLINDING PROCEDURES 
The randomization will be conducted by an organization or individual not involved in the conduct of the study. 
 
The randomization lists for participants will be used by IVAC to label study vaccine and placebo vials and then will 
be immediately sealed. It will be opened only after the clinical trial database is declared complete and locked. In 
the case of any unblinding, researchers must report this in writing to the overseeing Ethics Committee. 
 
Study product injected into each participant will be recorded on the electronic Case Report Form (eCRF) using the 
exact allocation code for each product received by each participant. The allocation codes link treatment identification 
with each participant via participant identification numbers. These will be maintained in a secure location, by an 
individual not involved in the conduct of the study. If any participant experiences an SAE possibly related to receipt 
of study treatment and the investigator determines it is necessary to unblind, treatment allocation to the participant 
may be communicated to the investigator. 
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A blinded dummy randomization schedule was produced for blinded statistical programming purposes. 
 
An example of the schedule structure is given in Table 1. 
 
Table 1: Example structure of randomization schedule. 
 
3.2 SCHEDULE OF EVENTS 
Schedule of events can be found in Table 2.  
 
 
 
Protocol 
Identifier 
Schedule 
Type 
Phase 
Site 
Age 
group 
Block 
Number 
Randomization 
Number 
Kit 
Identifier 
Randomized 
Treatment 
Group 
Numeric 
Randomized 
treatment 
group 
Overage 
IVACFLU-
S-0203 
Actual_u 
2 
Long 
An 
18 – 
45 
years 
of 
age 
XX 
A001 
A001 
IVACFLU-S 
1 
No 
. . . 
. . . 
 
 
 
. . . 
. . . 
. . . 
. . . 
 
 
IVACFLU-
S-0203 
Actual_u 
2 
Long 
An 
18 – 
45 
years 
of 
age 
XX 
A126 
A126 
PLACEBO 
2 
No 
. . . 
. . . 
 
 
 
. . . 
. . . 
. . . 
. . . 
 
 
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Table 2: Schedule of events of the protocol synopsis of Protocol IVACFLU-S-0203, Phase 2/3, version 4.0 dated 
09Feb2017. 
 
3.3 CHANGES TO ANALYSIS FROM PROTOCOL 
No changes to planned analyses in the protocol will be applied. 
Study Activities 
Study Day (# days from D1) 
S1/D1*
(up to -4/ 
D1 
Clinic 
Visit 
D1 
to 
D7 
D8 
(+/- 1) 
Clinic 
Visit 
D9  to 
D21 
D22 
(+/- 1) 
Clinic 
Visit 
D91 
(+/- 7) 
Telephonic 
contact 
Information process and written informed 
consent 
X  
 
 
 
 
Collect baseline demographic data 
X
 
 
Collect/review medical history 
X
 
 
Perform screening physical examination
X
 
 
Perform vital signs & targeted physical 
examination (symptom based & reactogenicity 
only) 
X* 
 
X 
 
 
Perform urine pregnancy check (women)
X*
 
 
Check/confirm inclusion/exclusion criteria 
X*
 
 
Randomization 
X
 
 
Collect serum for influenza serology  
X**
 
X 
Administer one dose of study product (vaccine 
or placebo) 
X 
 
 
 
 
Observe for 30 Minutes; record and manage 
immediate reactions 
X 
 
 
 
 
Instruct participant on use of  Dairy card
X
 
 
Participant records solicited reactogenicity and 
unsolicited AEs in Diary cards 
X 
X 
 
 
 
Clinical staff reviews interim AEs/SAEs with 
participant; records in CRF 
 
 
X 
 
X 
SAE only
Report SAEs to Sponsor, IRBs and regulatory 
authorities 
X 
X 
X 
X 
X 
X
Participant completion of study 
 
 
X
*If Day 1 is conducted on a different day from S1, eligibility must be confirmed again on Day of Injection (D1); 
including Targeted physical examination (PE); inclusion/exclusion; urine pregnancy test.   
** Sera samples will be collected prior to vaccination in phase 3 study at one site (Ben Luc).  
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4 PLANNED ANALYSES 
The primary focus of this SAP is to describe safety analyses that will be conducted on the combined Phase 2 and 
Phase 3 data, as well as the immunogenicity analyses that will be conducted on the Phase 3 data. 
4.1 DATA AND SAFETY MONITORING BOARD 
Given the wide global experience with seasonal influenza vaccines and the safety profile observed in the Phase 1 
study, there will not be any Data Safety Monitoring Board (DSMB) for this study. The PSRT will be responsible for 
close safety oversight of the study. 
4.2 INTERIM ANALYSIS  
Blinded safety data up to Day 8 for Phase 2 subjects will be analysed and reviewed by the PSRT team. In addition, 
all grade 3 and above unsolicited AEs and SAEs until the data cut-off date will also be part of an interim report.  
This report will be submitted to the Pasteur Institute Ho Chi Minh City Institutional Review Board (IRB) and 
Vietnam Ministry of Health (MOH) for review and approval before initiating the Phase 3 study. 
4.3 FINAL ANALYSIS  
Analyses will be conducted only after all related data have been entered, cleaned, locked and the study datasets 
routinely unblinded. Given the short duration of clinical follow-up and potential delays in generating 
immunogenicity results, analysis of safety and immunogenicity data will be conducted independently. 
All final, planned analyses identified in this SAP will be performed by QuintilesIMS Biostatistics following:  
 
1. Sponsor authorization of the analysis sets; 
2. Sponsor authorization of the final SAP and Tables, Listings and Figures (TLF) Shells;  
3. Authorization of data issues log; 
4. Authorization of data handling report; 
5. Database lock; 
6. Routine unblinding of study datasets for analysis; and 
7. Identification of treatment deviations (randomized versus actual).  
 
5 ANALYSIS SETS 
Agreement and authorization by the sponsor of subjects included/excluded from each analysis set will be 
conducted prior to the unblinding of the study data.  
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5.1 ENROLLED POPULATION 
All screened subjects who are randomized, regardless of the subject’s randomization and treatment status in the 
trial. 
5.2 FULL ANALYSIS [FA] POPULATION  
All subjects in the enrolled population who were randomized and received a study vaccination. This population will 
serve as the primary analysis population for all safety objectives. The analysis based on this population will serve as 
the supportive results for all safety objectives. Subjects will be analyzed as randomized.  
5.3 PER PROTOCOL [PP] POPULATION 
Immunogenicity will be assessed only in Phase 3 subjects who are randomized at the Ben Luc site. All such subjects 
in the Full Analysis population who have valid post-vaccination immunogenicity measures with no major protocol 
violations that are determined to potentially interfere with the immunogenicity assessment of the study vaccine 
will be included. This population will serve as the primary analysis population for all immunogenicity objectives.  
 
The criteria for exclusion of subjects from the Per Protocol Population will be established before breaking the blind 
and will be based on the blinded review of protocol violations, which will be identified and categorized as described 
in Appendix 1. 
6. GENERAL CONSIDERATIONS 
By-subject data listings, summary tables, figures and statistical tests will be performed using SAS® Version 9.4  or 
higher. 
 
All clinical data, including laboratory and clinical data from an internal database will be provided as raw datasets. 
CDISC SDTM 3.2 compliant SAS datasets will then be generated. Coding of AEs and current medical conditions will 
be included in the SDTM datasets. 
 
Appropriate SAS programs will be prepared and validated according to QuintilesIMS standard operating  
procedures. 
 
The following descriptive statistics will be presented in summary tables: 
 
 
Continuous variables: Number (observed cases), mean, median, standard deviation (SD), minimum, 
and maximum 
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 
Categorical variables: Summarized by treatment group using frequency tables (frequency [n] and 
percentage [%]). Percentages will be calculated relative to the total number of subjects in the relevant 
analysis set with data available, if not otherwise specified. 
 
Two-sided exact 95% confidence intervals (CIs) will be presented unless otherwise specified.  
6.1 REFERENCE START DATE AND STUDY DAY 
Study day will be calculated relative to the reference start date, and will be used to show start/stop day of 
assessments and events.  
Reference start date is defined as the day of vaccination (Day 1), and will appear in every listing where an 
assessment date or event date appears.  
 
 
If the date of the event is on or after the reference date then:  
Study day = (date of event – reference date) + 1. 
 
 
If the date of the event is prior to the reference date then:  
Study day = (date of event – reference date). 
 
For the derivation of study day, time of day will be considered, if applicable. 
 
In the situation where the event date is partial or missing, Study day, and any corresponding durations will appear 
partial or missing in the listings i.e., Study day or any corresponding durations will not be computed. 
6.2 BASELINE 
Unless otherwise specified, Baseline is defined as the last non-missing measurement taken prior to vaccination 
start date and time (including unscheduled assessments). In the case where the last non-missing measurement 
and the reference start date coincide, that measurement will be considered pre-baseline, but Adverse Events 
(AEs) and medications commencing on the reference start date will be considered post-baseline. 
6.3 DERIVED TIMEPOINTS  
Not applicable. 
6.4 RETESTS, UNSCHEDULED VISITS AND EARLY TERMINATION DATA 
In general, for by-visit summaries, data recorded at the nominal visit will be presented. Unscheduled 
measurements will not be included in by-visit summaries. 
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In the case of a retest (same visit number assigned), the earliest available measurement for that visit will be used 
for by-visit summaries.  
 
Listings will include scheduled, unscheduled, retest and early termination data. 
6.5 WINDOWING CONVENTIONS  
No visit windowing will be performed for this study. 
6.6 STATISTICAL TESTS 
The default significance level will be 5%, confidence intervals will be 95%, and all tests will be two-sided, unless 
otherwise specified in the description of the analyses. 
6.7 COMMON CALCULATIONS 
For quantitative measurements, change from Baseline to Visit X will be calculated as: 
 
 
Test Value at Visit X – Baseline Value 
6.8 SOFTWARE VERSION 
All analyses will be conducted using SAS version 9.4 or higher. 
7. STATISTICAL CONSIDERATIONS 
7.1 ADJUSTMENT FOR COVARIATES 
No adjustment for covariates will be made.  
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7.2 MULTICENTER STUDIES 
Phase 2 will be conducted at a single site, District Health Center of Ben Luc district in Long An Province. Phase 3 
enrollment will be conducted at 2 sites, District Health Center of Ben Luc in Long An province and District Health 
Center of Long Thanh in Dong Nai province. 
The data collected from the two study sites will be pooled together for analyses with the below exceptions: 
 
Subject disposition summaries will be presented both pooled and separately by study site. 
 
Immunogenicity measurements and analyses will be conducted only in subjects studied at the Ben Luc 
site during Phase 3 
7.3 MISSING DATA 
Missing safety and immunogenicity data will not be imputed.  
7.4 MULTIPLE COMPARISONS/ MULTIPLICITY 
No multiplicity adjustment to the Type 1 probability of error, alpha, will be made for the multiple testing of 
immunogenicity endpoints corresponding to the three vaccine antigens under the intersection-union property. 
That is, the immune responses to each of the three vaccine antigens induced by IVACFLU-S seasonal trivalent 
split inactivated influenza vaccine need to meet Vietnam Ministry of Health licensure requirements. 
7.5 EXAMINATION OF SUBGROUPS 
1. All safety and immunogenicity analyses will be conducted for subgroups of age category i.e., 18-45 and 
46-60. 
2. Analysis of secondary immunogenicity endpoints, Phase 3, will be conducted for subgroups of pre-
vaccination HAI antibody titer i.e., <1:10 or ≥ 1:10 and subgroups of age category i.e., 18-45 and 46-60. 
8. OUTPUT PRESENTATIONS 
The shells provided with this SAP describe the presentations for this study and therefore the format and content 
of the summary TLFs to be provided by QuintilesIMS Biostatistics. 
 
Tables and figures will be presented for Phase 2 and Phase 3 subjects combined and pooled across study sites 
with the below exceptions: 
 
Subject disposition summaries will be reported separately by study site, in addition to being pooled 
across study sites. 
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 
Immunogenicity measurements will be from Phase 3 subjects at the Ben Luc site only; thus 
immunogenicity TLFs will be restricted to this subset. 
 
All table and figure summaries will be presented by treatment group both by age group (18-45, 46-60) and 
pooling across age groups. Additionally, for secondary immunogenicity endpoints, outputs will be presented by 
pre-vaccination HAI antibody titer (<1:10 or ≥ 1:10). 
9. DISPOSITION AND WITHDRAWALS 
All subjects who are screened will be accounted for in this study.  
 
Subject disposition, including the number (n) and percentage (%) of subjects in each treatment arm who completed 
the study and prematurely discontinued study participation (including primary reason for premature study 
discontinuation), will be tabulated for all subjects. 
 
By-subject data listing of the disposition data i.e., age group, site, treatment, study status, 
completion/discontinuation date, and reason for discontinuation will be presented.  
 
Frequency and percentage of subjects having critical, major and minor protocol deviations (see Appendix 1) will be 
presented by deviation category in vaccine, placebo and overall for all subjects in the FA Population. Subjects 
having multiple reasons for exclusion will be counted only once per each reason documented.  
 
10. 
DEMOGRAPHIC AND OTHER BASELINE CHARACTERISTICS 
Demographic data and other baseline characteristics will be presented both in summaries (by treatment group 
and overall) for the FA population and in listings for the Enrolled population.  
 
No statistical testing will be performed for demographic or other baseline characteristics. 
 
The following demographic and other baseline characteristics will be reported for this study: 
 
Age (years)  
 
Sex 
 
Ethnicity 
10.1 DERIVATIONS 
For randomized subjects, age is calculated as the number of years from the date of birth to randomization date. 
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11. 
CURRENT MEDICAL CONDITIONS 
Current Medical Condition information will be presented for the FA population for summarising and listing the 
data.  Current Medical Conditions will be coded using MedDRA dictionary version 20.0. The Current Medical 
Condition categories captured in the eCRF will be presented by system organ class (SOC) and preferred term (PT). 
The summaries will be presented by primary SOC and PT for vaccine, placebo and overall for all subjects in the FA 
population. A subject will be counted only once within the SOC and PT if the subject has multiple medical 
conditions within the same SOC and PT. 
A listing of current medical conditions will also be generated. 
12. 
MEDICATIONS 
Medications will be presented for the FA population and are not coded. 
 
Frequency and percentage of subjects receiving concomitant medications will be summarized by vaccine and 
placebo for each reported term.    
 
A subject will be counted only once under reported term if the subject receives same concomitant medication 
multiple times. 
 
By-subject listing of the data will be presented for the FA population. 
13. 
STUDY MEDICATION EXPOSURE 
The date and time of vaccination and location of vaccination will be presented in the listings. 
14. 
STUDY MEDICATION COMPLIANCE  
Not applicable for this study. 
15. 
EFFICACY OUTCOMES  
Not applicable for this study. 
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16. 
IMMUNOGENICITY ANALYSIS 
16.1 STATISTICAL CONSIDERATIONS 
The Vietnam MOH guidance on serological immune response requirements for influenza vaccine is a 
modification of the EMEA/CPMP serological criteria for assessing seasonal influenza for licensure. The age-
group specific MOH licensure requirements for influenza vaccine in adults are shown in Table 3. 
 
Table 3 Vietnam MOH Criteria for Evaluation of Influenza Vaccine Immune Responses 
 
Age Group 
18 – 45
46
Proportion achieving a HAI titer ≥ 1:40 
(seroprotection) 
≥70% 
≥60% 
Proportion achieving at least 4 fold rise in HAI titer 
(seroconversion) 
≥40% 
≥30% 
GMT rise in HAI titer 
≥2.5 times
≥2.0 times
 
Null hypothesis (H0): 
 
A single dose of IVACFLU-S seasonal trivalent split, inactivated influenza vaccine will not induce immune 
responses to each of the three vaccine antigens to meet one or both age group specific Vietnam Ministry of 
Health licensure requirements i.e., as mentioned in Table 3. 
 
Alternative hypothesis (H1): 
 
A single dose of IVACFLU-S seasonal trivalent split, inactivated influenza vaccine will induce immune 
responses to each of the three vaccine antigens to meet one or both age group specific Vietnam Ministry of 
Health licensure requirements i.e., as mentioned in Table 3. 
 
Of the three criteria, seroconversion has been the most frequent criteria not meeting licensure threshold. Though 
the study assumption is based on Phase 1 immunogenicity data for adults 18-45 years of age, we anticipate the 
immune response in those 46 - 60 will be comparable since significant decline in antibody response is most 
associated with those who are ≥65 years of age. 
 
Taken together with the immunogenicity results of the IVACFLU-S phase 1 study (refer to Section 2.1.6 in the 
protocol), the sample size consideration for immunogenicity for the study was based on the precision of the 
estimate of percent of vaccine recipients with HAI seroconversion and seroprotection responses. With a sample 
size of 100 evaluable vaccine recipients from each age group, the study provides the precision of immunogenicity 
response as estimated by width of 95% CI of ≤±10.2% around the range of estimated response rate (Table 4) 
 
 
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Table 4: Observed Response Rate in 100 participants receiving study vaccine and Corresponding 95% CI. 
Number of responders (%)
2-sided exact 95% CI 
90 (90%) 
[82.4%, 95.1%] 
80 (80%) 
[70.8%, 87.3%] 
70 (70%) 
[60.0%, 78.8%] 
60 (60%) 
[49.7%, 69.7%] 
50 (50%) 
[39.8%, 60.2%] 
40 (40%) 
[30.3%, 50.3%] 
30 (30%) 
[21.2%, 39.9%] 
 
An increase in sample size by 50% to 150 provides very limited statistical benefit as it only reduces the maximal 
width of 95% CI by 1.9% to ≤ ±8.3%. All power calculations were made using 10000 simulations of binomial 
responses to each strain, based on assumed true response rates and pass/fail criteria. All calculations were made 
using SAS version 9.3. 
16.1.1 
PROBABILITY FOR DEMONSTRATING SEROCONVERSION CRITERIA 
FOR LICENSURE 
For the 18-45 year old cohort, if the true seroconversion response to each strain is ≥49%, then there is 91% 
probability that the point estimate for seroconversion to all three strains will be ≥40%. 
 
Likewise, if the true seroconversion response to each strain is ≥60%, then there is 92% probability that the lower 
bound of the exact 95% CI for seroconversion to all strains will be ≥40%.  For the older age cohort (46-60 years old), 
if the true seroconversion response to each strain is ≥39%, then there is 93% probability that the point estimate for 
seroconversion to all three strains will be ≥30%. Given that the lowest seroconversion response in the IVAC Phase 1 
trial was to B viral strain at 76.7% (95% CI, 57.7 90.1), there is high probability  (Table 5) of demonstrating age 
group specific seroconversion requirement with a sample size of 100 evaluable participants per age group who 
received the study vaccine. 
 
Table 5: Probability of demonstrating seroconversion response to all 3 viral strains by age groups and assumed true 
response to each viral strain. 
Age group (point 
estimate response) 
True response 
Probability > 90% 
Probability > 95% 
Probability > 99% 
18-45 (≥40%) 
≥49% 
≥51% 
≥54% 
46- 60 (≥30%) 
≥39% 
≥40% 
≥43% 
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16.1.2 PROBABILITY FOR DEMONSTRATING SEROPROTECTION CRITERIA 
FOR LICENSURE 
For the 18-45 year old cohort there is 92% probability that the point estimate for seroprotection to all three strains 
will be ≥ 70% if the true response to each strain is ≥78%. Likewise if the true response to each strain is ≥87%, then 
there is 95% probability that the lower bound of the exact 95% CI for seroprotection to all strains will be ≥70%. In 
the older age cohort (46-60 years old), if the true seroprotection response to each strain is ≥69%, then there is 93% 
probability that the point estimate for seroprotection to all three strains will be ≥60%. Given that the lowest 
seroprotection response in the IVAC Phase 1 trial was to B viral strain at 93.3% (95% CI 77.9; 99.2), there is high 
probability (Table 6) of demonstrating age group specific seroprotection requirement with a sample size of 100 
evaluable participants per age group who received the study vaccine. 
 
Table 6: Probability of demonstrating seroprotection response to all 3 viral strains by age groups and assumed true 
response to each viral strain. 
16.2 ANALYSIS OF IMMUNOGENICITY ENDPOINTS 
16.2.1 PRIMARY IMMUNOGENICITY ENDPOINTS 
A. Number and percentage of subjects by age groups (18-45, 46-60) with seroconversion against each of the 
3 vaccine antigens post-vaccination. Seroconversion is defined as a serum HAI antibody titer meeting the 
following criteria: 
 
pre-vaccination titer <1:10 and a post-vaccination titer measured on Day 22 of ≥1:40 or 
 
pre-vaccination titer ≥1:10 and at least a four-fold increase in post vaccination titer measured on Day 
22 
 
B. Number and percentage of subjects by age groups (18-45, 46-60) with seroprotection, defined as a HAI 
antibody titer ≥1:40 to each of the 3 vaccine antigens measured on Day 22 post vaccination 
C. Geometric mean titers (GMTs) of serum HAI antibodies pre- (Day 1) and post vaccination  (Day 22) by age  
groups (18-45, 46-60) for each of the 3 vaccine antigens 
D. Geometric mean fold rises (GMFRs) of serum HAI antibodies (post vaccination/prevaccination) by age 
groups (18-45, 46-60) for each of the 3 vaccine antigens 
Age group (point 
estimate response) 
True response
Probability > 90% 
Probability > 95% 
Probability > 99% 
18-45 (≥70%) 
≥ 78%
≥ 79%
≥ 81%
46- 60 (≥60%) 
≥ 69%
≥ 70%
≥ 72%
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16.2.2 SECONDARY IMMUNOGENICITY ENDPOINTS 
 
A. Number and percentage of subjects by age groups (18-45, 46-60) who develop at least a four-fold increase 
in HAI antibody titer to each of the vaccine antigens post vaccination measured on Day 22 by pre-
vaccination HAI antibody titer of <1:10 or ≥1:10. 
B. Geometric mean titers (GMTs) of serum HAI antibodies pre- (Day 1) and post vaccination (Day 22) by age 
groups (18-45, 46-60) for each of the 3 vaccine antigens by prevaccination HAI antibody titer of <1:10 or 
≥1:10. 
C. Geometric mean fold rises (GMFRs) of serum HAI antibodies (post vaccination/prevaccination) by age 
groups (18-45, 46-60) for each of the 3 vaccine antigens by prevaccination HAI antibody titer of <1:10 or 
≥1:10. 
 
The following endpoints will be analyzed by age group: 
 
1. For each treatment group, the number and percentage of subjects with a serum HAI antibody titer ≥ 1:40 
to each of the 3 vaccine components measured on Day 22 post vaccination, will be presented along with 
two-sided exact 95% CIs using Clopper-Pearson method. 
 
2. For each treatment group, the number and percentage of subjects with seroconversion against each of the 
3 vaccine antigens post-vaccination will be presented along with two-sided exact 95% CIs using Clopper-
Pearson method.  
 
3. GMTs of serum HAI antibodies for each of the 3 antigens will be summarized at each time point (Day 1 and 
Day 22) by treatment group along with the corresponding two-sided 95% CIs, by exponentiating the 
corresponding log-transformed means and their 95% CIs.  
 
4. GMFRs of serum (HAI) antibodies (post-vaccination / pre-vaccination) for each of the 3 antigens will be 
summarized by treatment group along with the corresponding two-sided 95% CIs, by exponentiating the 
corresponding difference in log-transformed means between post-vaccination and pre-vaccination 
antibodies and their 95% CIs obtained via paired t-test method. 
 
The following endpoints will be analyzed by age group and pre-vaccination HAI antibody titer of <1:10 or ≥1:10: 
 
1. For each treatment group, the number and percentage of subjects who develop at least a four-fold 
increase in HAI antibody titer to each of the 3 vaccine antigens measured on Day 22 post vaccination, will 
be presented along with two-sided exact 95% CIs using Clopper-Pearson method. (Please refer to 
Appendix 2 for sample SAS code for 95% confidence interval for single proportion using Exact Clopper-
Pearson method). 
 
2. GMTs of serum HAI antibodies for each of the 3 antigens will be summarized at each time point (Day 1 and 
Day 22) by treatment group along with the corresponding two-sided 95% CIs, by exponentiating the 
corresponding log-transformed means and their 95% CIs. 
 
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3.  GMFRs of serum (HAI) antibodies (post-vaccination / pre-vaccination) for each of the 3 antigens will be 
summarized by treatment group along with the corresponding two-sided 95% CIs, by exponentiating the 
corresponding difference in log-transformed means between post-vaccination and pre-vaccination 
antibodies and their 95% CIs obtained via paired t-test method. 
 
Subject wise listing will be generated. 
 
Graphical representation of the data will be as follows: 
 
1. Geometric mean HAI titer for each of the 3 antigens at Days 1 and 22 will be plotted by vaccine group 
separately for each age group. 
2. Reverse Cumulative Distribution (RCD) plot will show reverse cumulative percentages for HAI titer for each 
of the 3 antigens at Day 1 and Day 22 by vaccine group and by age group. 
 
The immunogenicity analyses will be performed using PP population.  
 
All immunogenicity analyses will also be conducted using FA population as supportive analyses.  
16.3 VARIABLES & DERIVATIONS 
Titers below the limit of quantification (i.e. below the starting dilution of assay reported as “< 10”) will be set to 
half that limit (i.e. 10/ 2 = 5). If a titer is reported as greater or equal to the upper limit of the assay, it will be set 
to that limit. 
 
Fold increase (rise) [FI]:  
If “vpre” is a subject’s pre-vaccination (baseline) immunogenicity value and “vpost” the post-vaccination value, 
then the “fold increase (rise)” [FI] will be calculated as:    
FI = vpost / vpre 
 
Seroprotection:  
Taking influenza as an example, the threshold is an anti-HA antibody level of 40, and subjects with HAI antibody 
titre >=40  are said to be seroprotected for influenza.  
 
Seroconversion: 
Seroconversion is defined as  
 
pre-vaccination titer <1:10 and a post-vaccination titer measured on Day 22 of ≥1:40; or       
 
pre-vaccination titer ≥1:10 and at least a four-fold increase in post vaccination measured on Day 22  
 
i.e. subjects with an HAI antibody titer<10  and >=40 before vaccination and post vaccination i.e., on Day 
22 respectively; or 
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an HAI antibody titer>=10  and at least a four-fold increase in post vaccination measured on Day 22 i.e., 
FI>=4 
17. 
SAFETY OUTCOMES 
17.1 STATISTICAL CONSIDERATIONS: 
Null hypothesis (H0): 
 
A single dose of seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) is not safe and well 
tolerated in adults 18 to 60 years of age. 
 
Alternative hypothesis (H1): 
 
A single dose of seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) is safe and well 
tolerated in adults 18 to 60 years of age. 
 
The total sample size for Phase 2 and Phase 3 combined will be 888 subjects. With subjects randomized to 
IVACFLU-S or placebo at a randomization ratio of 5:1, there will be 740 subjects randomized to IVACFLU-S arm in 
the phase 2/3 study. Accounting for a 5% dropout rate, there would be at least 700 evaluable participants for 
safety analysis. If no vaccine-related serious adverse events are observed in 700 vaccine recipients, the study would 
able to exclude events occurring at approximately 0.43% based on the upper bound of the one sided 95% 
Confidence Interval (CI)) using the Clopper-Pearson method.  
 
The probability of observing at least one vaccine-related serious adverse event in 700 subjects is 90 % and >95% if 
the true rate of such events is 0.33 % and 0.43% respectively. The precision of the estimate of AEs judged to be 
related to IVACFLU-S as bounded by 95% CI is presented in Table 7. 
 
Table 7: Exact 95% Confidence Intervals around Potential Number of Study Related Adverse Events 
Sample size 
Number of events
2-sided exact 95% CI 
700 
0
[0, 0.52*] 
1
[<0.01, 0.79] 
2
[0.03, 1.02] 
3
[0.08, 1.24] 
5
[0.23, 1.65] 
*one sided, 97.5% CI 
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However, the full analysis population will be used for safety analysis, not the assumed number of 700 evaluable 
subjects. 
17.2 ANALYSIS OF SAFETY ENDPOINTS: 
The safety profile of IVACFLU-S will be evaluated by the number and proportion of subjects experiencing AEs by 
severity relatedness to vaccination in the following four categories for all subjects and by age group (solicited AEs 
will be considered related to study product):  
A. Solicited local adverse events, including redness / erythema, swelling / induration, pain within 
30 minutes of vaccination and over a 7-day period (Days 1-7) post-vaccination.  
B. Solicited systemic adverse events, including fever, fatigue, malaise, muscle aches, joint aches, 
chills, nausea, vomiting, and headache within 30 minutes of vaccination and over a 7-day 
period (Days 1-7) post-vaccination.  
C. Unsolicited AEs occurring within 21 days post vaccination.  
D. Serious Adverse Events occurring during the entire study period (Days 1 to 91).  
17.2.1 SOLICITED LOCAL AND SYSTEMIC ADVERSE EVENTS 
Solicited adverse events are pre-specified local and systemic adverse events that are common or known to be 
associated with vaccination that are actively monitored as indicators of vaccine reactogenicity. Investigators will not 
be required to assess causality of solicited adverse events if the onset is during the solicitation periods. If a solicited 
adverse event progresses beyond the solicited period, it will continue to be reported as a solicited adverse event. If 
the solicited adverse event occurs after the solicitation period it will be reported as an unsolicited AE.  
 
Any solicited local or systemic reactogenicity that occurs during the 5-day period post-injection is automatically 
regarded as related. 
 
Solicited local and systemic AEs will be assessed by study staff 30 minutes after vaccination then daily for 7 days by 
the subjects. 
 
 
Solicited local adverse event (at site of injection): 
 
Erythema / redness – based on size in cm 
 
Swelling / induration (hardness at site of injection ) – based on size in cm  
 
Pain 
                  
 
Systemic Reactions: 
 
Fever--Body temperature (measured in degrees Celsius) 
 
Fatigue/malaise 
 
Generalized muscle aches 
 
Joint aches 
 
Chills 
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 
Nausea 
 
Vomiting 
 
Headache 
 
Solicited local and systemic adverse events will be graded by a Principal Investigator (PI) using a standardized 
data collection instrument. Grading will use predefined scales based on functional assessment or magnitude of 
reaction, where available. Where grading scales are not provided, the reaction will be graded for severity based 
on interference with subject functionality, as for all other AEs. Severity of redness, swelling and induration at the 
injection site will always be graded based on the size. Temperature will be graded according to the following 
criteria: 
 
Ungradable  
 
Grade 1= ’38.0 - <38.6°C ‘ 
 
Grade 2= ‘38.6 – <39.3°C’ 
 
Grade 3=’ 39.3 – <40.0°C’ 
 
Grade 4=’ ≥ 40.0°C’  
17.2.1.1 PRESENTATION OF 30-MINUTE SOLICITED LOCAL AND 
SYSTEMIC REACTOGENICITY 
The following will be presented for the FA population: 
 
1. Subject-wise listing of 30-minute solicited local and systemic reactogenicity will be generated separately. 
 
2. Summary of 30-minute solicited local and systemic reactogenicity will be provided separately as follows: 
 
 
 
 
Count and percentages of participants experiencing each reaction or event, or at least one reaction or 
event will be calculated along with two-sided exact 95% CIs using Clopper-Pearson method (refer 
Appendix 2) for each treatment group, and by age group.  
 
Fisher’s exact test (refer Appendix 3) or Cochran-Mantel-Haenszel test (refer Appendix 4) will be used 
to compare the proportion of participants between the two treatment groups. 
 
3. Descriptive summary (as described for continuous variables in Section 6) of the size of the solicited local 
reactions captured in 30-minute reactogenicity page of the eCRF will be presented by vaccine and placebo. 
 
4. In addition, for all Solicited Local and Systemic Adverse Events, the following will be summarised by 
severity: 
 
Counts of all events will be reported and summarized, as “any local AE” or “any systemic AE”.  
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 
Percentages of subjects experiencing each reaction or event, at least one reaction or event will be 
calculated. This will be generated separately i.e., one output for Body temperature (Oral) and one 
output for all other adverse events, as the severity grades will be as follows: 
o 
Body temperature (Oral): 
 
Ungradable  
 
Grade 1= ’38.0 - <38.6°C ‘ 
 
Grade 2= ‘38.6 – <39.3°C’ 
 
Grade 3=’ 39.3 – <40.0°C’ 
 
Grade 4=’ ≥ 40.0°C’  
o 
For local and systemic adverse events:  
 
None 
 
Mild 
 
Moderate  
 
Severe 
 
Potentially Life Threatening 
17.2.1.2 PRESENTATION OF SOLICITED LOCAL AND SYSTEMIC ADVERSE 
EVENTS 
The following will be presented for the FA population: 
 
1. Subject-wise listing of solicited local and systemic adverse events will be generated separately. 
 
2. 
Summary of solicited local and systemic adverse events will be provided separately as follows: 
 
 
Counts and percentages of subjects experiencing each reaction or event, at least one reaction or 
event will be calculated.  
 
Number of events for each reaction or event will also be displayed.  
 
Event will be counted only one time if occurred on consecutive days. 
 
Percentages of participants experiencing each reaction or event, or at least one reaction or event will be 
calculated along with two-sided exact 95% CIs using Clopper-Pearson method (refer Appendix 2) for each 
treatment group and by age group. Fisher’s exact test (refer Appendix 3) or Cochran-Mantel-Haenszel test 
(refer Appendix 4) will be used to compare the proportion of participants between the two treatment 
groups. 
 
3. 
Summary of solicited local and systemic adverse events, as described in the above point 2 will be 
repeated i.e., summarized by day: 
 
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 
Counts and percentages of subjects experiencing each reaction or event, at least one reaction or 
event will be calculated.  
 
Number of events for each reaction or event will also be displayed. 
 
 
4. 
Descriptive summary (as described for continuous variables in Section 6) of the size of the solicited 
local reactions captured as per the eCRF will be presented by vaccine and placebo. 
 
In addition, for all Solicited Local and Systemic Adverse Events the following will be summarised by maximum 
severity until resolution: 
 
Counts of all events will be reported and summarized, as “any local AE” or “any systemic AE”.  
 
Percentages of subjects experiencing each reaction or event, at least one reaction or event will be 
calculated. This will be generated separately i.e., one output for Body temperature (Oral) and one 
output for all other adverse events, as the severity grades will be as follows: 
o 
Body temperature (Oral): 
 
Ungradable  
 
Grade 1= ’38.0 - <38.6°C ‘ 
 
Grade 2= ‘38.6 – <39.3°C’ 
 
Grade 3=’ 39.3 – <40.0°C’ 
 
Grade 4=’ ≥ 40.0°C’  
o 
For local and systemic adverse events:  
 
None 
 
Mild 
 
Moderate  
 
Severe 
 
Potentially Life Threatening 
17.2.2 UNSOLICITED ADVERSE EVENTS 
Unsolicited adverse events are any AEs that occur any time after the vaccine/placebo is given (temporally related to 
study product), whether or not deemed “related” to the product, and are not solicited (specifically asked of the 
participant). Unsolicited AEs can be observed by study staff while the participant is at a clinic for a study visit or 
reported by the participant at any time. Any sign or symptom that would normally be considered a “solicited AE” 
(for example, fever, nausea, injection site pain) starting after 7 days post-vaccination will be recorded as an 
unsolicited AE. 
 
No statistical testing will be performed for unsolicited AEs. Unsolicited AEs with a missing relationship to vaccine 
will not be imputed. 
 
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Subject-wise listing will be presented.  
 
The following will be presented for FA population:  
 
1. Summary of Unsolicited Events, i.e., summary displayed for the following: 
 
Total number of unsolicited AEs,  
 
Subjects with at least one unsolicited AE,  
 
At least one vaccine related unsolicited AE,  
 
At least one serious unsolicited AE,  
 
At least one severe unsolicited AE,  
 
At least one life threatening unsolicited AE,  
 
Subjects requiring treatment during the study,  
 
Subjects with unsolicited AEs leading to withdrawal, and  
 
Number of subjects died. 
 
2. Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term within Day 1 to Day 
22 
 
3. Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term and severity within 
Day 1 to Day 22 i.e.:  
 
All Adverse events are classified by severity as “Mild”, “Moderate”, “Severe” and “Life-
threatening”.  
 
    
 
Counts of all events will be reported and summarized, as “Any Unsolicited AE”. Percentages of 
subjects experiencing each reaction or event, at least one reaction or event will be calculated. 
 
4. Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term and relationship 
within Day 1 to Day 22 
 
5. Summary of Unsolicited Adverse Events requiring treatment by System Organ Class and Preferred Term 
within Day 1 to Day 22       
17.2.3 SERIOUS ADVERSE EVENTS 
Serious adverse events (SAEs) are those events recorded as “Serious” on the Adverse Events page of the (e)CRF. 
A summary of serious AEs by SOC and PT will be prepared. 
 
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No statistical testing will be performed for SAEs. 
 
Subject-wise listing will be presented. 
 
The following will be presented for FA population: 
 
1. Summary of Serious Events, i.e., summary displayed for the following: 
 
Total number of serious AEs,  
 
Subjects with at least one serious AE,  
 
At least one vaccine related serious AE,  
 
At least one serious AE,  
 
At least one severe serious AE,  
 
At least one life threatening serious AE,  
 
Subjects requiring treatment during the study,  
 
Subjects with serious AEs leading to withdrawal, and  
 
Number of subjects died. 
 
2. Summary of serious Adverse Events by System Organ Class and Preferred Term within Day 1 to Day 91 
 
3. Summary of serious Adverse Events by System Organ Class and Preferred Term and severity within Day 
1 to Day 91 i.e.: 
 
All Adverse events are classified by severity as “Mild”, “Moderate”, “Severe” and “Life-
threatening”.                         
 
Adverse events with missing severity will be considered as “Severe”.    
 
Counts of all events will be reported and summarized, as “Any Unsolicited AE”. Percentages of 
subjects experiencing each reaction or event, at least one reaction or event will be calculated. 
 
4. Summary of Serious Adverse Events by System Organ Class and Preferred Term and relationship within 
Day 1 to Day 91 
 
5. Summary of Serious Adverse Events requiring treatment by System Organ Class and Preferred Term 
within Day 1 to Day 91       
17.3  DEATHS 
Listing of deaths will be provided. 
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17.4 ECG EVALUATIONS  
No ECG data is collected in the study. 
17.5 VITAL SIGNS 
Vital sign measurements include body temperature (oral), blood pressure (systolic and diastolic) and heart rate 
collected at Screening and Day 8 of the study. 
 
The vital signs measurements, including abnormalities (grading for body temperature and blood pressure) and 
heart rate associated along with clinical significance (Yes/No) will be presented in the listings. 
 
The following summaries will be provided for vital signs data:  
 
Actual and change from Baseline to Day 8 
 
Actual and change from Baseline to Day 8 by grade 
 
Shift from Baseline to Day 8 by grade 
 
Number and percentage of subjects by clinical significance 
 
Number and percentage of subjects shift from Baseline to Day 8 by clinical significance 
17.6 PHYSICAL EXAMINATION  
General Physical Examinations: 
 
Qualified study clinicians will conduct a physical examination of all participants at S1/D1. This physical examination 
will include the following: 
 
Recording of general appearance 
 
 
Physical examination of all organ systems. This includes the following: 
o 
neurologic examination, including cranial nerve examination 
o 
chest auscultation 
o 
examination of lymph nodes (axillary and cervical) 
o 
heart auscultation 
o 
abdomen palpation (to check for liver size) 
 
 
Measurement of the following vital signs: 
o 
 body temperature 
o 
 blood pressure 
o 
 pulse/heart rate 
 
Grade 1 elevated blood pressure (140 to < 160 mmHg systolic OR 90 to < 100 mmHg diastolic) will not be 
considered to be exclusionary at screening, unless judged to be clinically significant by the PI. 
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Targeted Physical Examination 
 
The Targeted Physical Examination (PE) focuses on symptoms reported by the participant and the presence or 
absence of local and systemic reactogenicity. If no symptoms are reported by the participant, the Targeted PE does 
not need to be performed. The exam will be made by a clinician on D1 (only if D1 is on a different day from S1) and 
Day 8. Evaluation must be made prior to administration of injection of study product if done on Day 1. 
 
Subject-wise listing of the data will be presented. 
 
Summary of Shift from baseline to Day 8 by clinically significant abnormal physical examination will also be 
presented. 
18. 
DATA NOT SUMMARIZED OR PRESENTED 
The other variables and/or domains not summarized or presented are: 
 
Comments 
 
SAE narratives 
 
These domains and/or variables will not be summarized or presented, but will be available in the clinical study 
database, SDTM and/or ADaM datasets.  
 
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APPENDIX 1 
Protocol Deviation Classifications 
 
Categories 
Severity
 
Informed consent 
 
Eligibility and Entry Criteria 
 
Concomitant Medication Criteria 
 
Study Procedures Criteria 
 
Serious Adverse Event Criteria 
 
Randomization Criteria 
 
Visit Schedule Criteria 
 
Administrative Criteria 
 
Source Document Criteria 
 
RA or CEC Approvals Criteria 
 
IP Compliance 
 
Other Criteria 
 
 
Minor 
Deviations from accepted procedures that 
will not adversely affect subject/data, but 
should be dealt with appropriately. 
 
Major Protocol Deviation 
Issues that impact upon scientific, ethical, 
regulatory or business integrity and which, if 
left unattended could become critical. Such 
issues require timely action. 
 
Critical Protocol Deviation 
Issues that threaten scientific, ethical, 
regulatory or business integrity and could 
invalidate acceptability of a study (or part of 
it) to a customer or regulatory body, or 
invoke regulatory action which require 
immediate attention. 
Critical deviations include, but are not limited to: 
 Eligibility and entry criteria: subject was enrolled even though entry criteria were not satisfied  
 Subject did not sign ICF yet was enrolled into the study  
 Any study procedures on S1 day were done prior to consent being signed  
 
Major deviations include, but are not limited to:  
 Incorrect study product assigned and administered according to randomization  
 Incorrect version of signed ICF (not currently approved version)  
 ICF was not signed by either investigator or study participant  
 IP temperature excursion (important deviation if IP is not allowed to be used, minor deviation if IP is allowed to 
be used)  
 Subject does not complete more than 50% of subject diary card  
 Subject visit (D8, D22, D91) is not completed or not done Use of prohibited drugs during study period  
SAE not reported according to protocol requirement  
 Immunological sample is not collected as per protocol requirement (collected sample which cannot be analyzed 
is not considered as a deviation)  
 Loss of source documents  
 
Minor deviations include, but are not limited to:  
Subject visit is outside of visit window  
Incomplete source documents  
Procedures carried out by staff not delegated in the delegation log  
Temperature log is not maintained as per protocol requirement 
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Version Date: 
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reproduction is strictly prohibited. 
APPENDIX 2 
Sample SAS code for 95% confidence interval for single proportion using Exact Clopper-Pearson 
method: 
 
proc freq data =combb order=data; 
by _name_ atptn atpt mord parcat3n parcat3 cat; 
tables pflg / binomial (exact) alpha = 0.05; 
weight cnt/zero; 
ods output BinomialCLs = bin_ci; 
run; 
 
APPENDIX 3 
Sample SAS code to compute P-value based on Chi-square or Fisher’s exact test: 
 
%chi_fish  
(inds       =p_val1_s , 
                 
 byvar    = atptn atpt mord parcat3n parcat3 cat  , 
                 
 rowvar =_name_ , 
                  
 colvar   =pflg, 
                  
 count    =cnt , 
                  
 stat        =1 , 
                  
 method = , 
                 
 outds    =pvalue , 
                 
debug    = 0); 
APPENDIX 4 
Sample SAS code to compute P-value based on Cochran-Mantel-Haenszel test 
 
proc freq data= combb; 
      tables strat1 *Treatment* strat2/ cmh;  
      weight Count;     
   run; 
 
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PROTOCOL IVACFLU-S-0203  
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Version Number: 
1.0 
 
 
Version Date: 
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Template No:  CS_TP_BS016  Revision 4 
 
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ANNOTATED SHELLS 
 
IVACFLU-S, PHASE 2/3 
 
 
 
 
A PHASE 2 / 3 DOUBLE BLINDED, RANDOMIZED, PLACEBO-CONTROLLED STUDY IN 
HEALTHY ADULT VOLUNTEERS IN VIETNAM TO EXAMINE THE SAFETY AND 
IMMUNOGENICITY OF A SEASONAL TRIVALENT INACTIVATED SPLIT VIRION INFLUENZA 
VACCINE (IVACFLU-S) PRODUCED BY IVAC  
795
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TABLE AND LISTING MOCK SHELL 
OUTPUT TEMPLATES SIGNATURE PAGE 
Output Templates Vl.O (Dated 11AUG2017) for Protocol IVACFLU-S-0203 (Dated 09FEB2017). 
Name 
Signature 
Date 
Author: 
Revathi Rayadurgam 
t Lf {A uGi ( l q 
Position: 
Biostatistician 2 
Company: 
Quintiles! MS 
~SJ 
PROTOCOL IVACFLU-S-0203 
Page 2 of 51 
Upon review of this document, theundersigneciapproves thisversion of the Output templates, authorizing that the content is acceptable for the reporting of this study. 
Approved By: 
~~r::h Chenji 
· : si~~ D~t~ !~\)°" !Qc{? 
Position: 
Company: 
Approved By: 
Position: 
Company: 
Approved By: 
Position: 
Company: 
Manager, Biostatistics 
Quintiles! MS 
Krista Yuhas 
14- / f.fvc /? 1i 11 
... ( ; r 
~' 
~ . ,,. .., . t 
I 
Biostatistician, Center for Vaccine Innovation and Access (CVIA) 
PATH 
Tushar Tewari 
SeniorMedical Officer, Clinical and Regulatory Affairs 
PATH 
Document: 
\\IE EDC-NAS 01 AIB iosdata\Path\IV AC FLU-S\IY A06804\Biostatis tics \Documentation\SAP\IVACF LU-S-0203 _Mock_ Tables_ V1 . 0 
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Revathi Rayadurgam 
Template No: CS_ TP _BS016 Revision 4 
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Version Number: 
Version Date: 
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The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
1.0 
I !AUG 2017] 
796
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

@OuintileslMS" 
TABLE AND LISTING MOCK SHELL 
OUTPUT TEMPLATES SIGNATURE PAGE 
Output Templates Vl.O (Dated 11AUG2017) for Protocol IVACFLU-S-0203 (Dated 09FEB2017). 
Name 
Signature 
Date 
Author: 
Revathi Rayadurgam 
Position: 
Biostatistician 2 
Company: 
' QuintileslMS 
(@) 
PROTOCOL IVACFLU-S-0203 
Page 2 of Sl 
Upon review of this document, the undersigned approves this version of the Output templates, authorizing that the content is acceptable for the reporting of this study. 
Approved By: 
Position: 
C~mpany: 
Approved By: 
Position: 
Company: 
Approved By: 
Position: 
Company: 
Name 
! Signature 
1
: Date 
; 
Suresh Chenji 
1 
, 
I 
Manager, Biostatistics 
QuintileslMS 
· Krista Yuhas 
Biostatistician, Center for Vaccine ln_novation and Access (CVIA) 
PATH 
T"'h"T'w"; 
( \\~ 
Senior Medical Officer, Clinical and Regulatory Affairs 
PATH 
i 
--i 
! 
Document: 
\llEEDC-NAS01 A \Biosdata\Path\IVACFLU-SllY A06804\Biostatistics \Documentation\SAP\IV ACFLU-S-0203_Mock_ Tables_ V1. 0 
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1.0 
I !AUG 2017) 
797
IVACFLU-S
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TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
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MODIFICATION HISTORY 
 
 
 
 
 
 
 
 
 
 
Unique Identifier for 
this Version 
Date of the Document 
Version  
Author 
Significant Changes from  
Previous Authorized 
Version 
 
 
Revathi Rayadurgam 
Not applicable. First 
version. 
 
 
 
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Table of Contents 
Table 14.1.1.1 Subject Disposition Enrolled Population 
9 
Table 14.1.1.2 Protocol Deviations Full Analysis Population 
11 
Table 14.1.1.3 Analysis Sets Enrolled Population 
12 
Table 14.1.2.1 Demographics and Other Baseline Characteristics Full Analysis Population 
13 
Table 14.1.2.2 Summary of Current Medical Condition Full Analysis Population 
15 
Table 14.1.3.1 Summary of Concomitant Medications Full Analysis Population 
16 
Table 14.2.1.1 Seroconversion and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by Age group 
Per-protocol population 
17 
Table 14.2.1.2 Seroconversion and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by Age group 
Full Analysis population 
17 
Table 14.2.1.3 Seroprotection and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by Age group 
Per-protocol population 
18 
Table 14.2.1.4 Seroprotection and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by Age group 
Full Analysis population 
19 
Table 14.2.1.5 Geometric Mean titer (GMT) for the Hemagglutination Inhibition (HAI) Titers by Age group Per-protocol 
population 
19 
Table 14.2.1.6 Geometric Mean titer (GMT) for the Hemagglutination Inhibition (HAI) Titers by Age group Full Analysis 
population 
20 
Table 14.2.1.7 Geometric Mean Fold Rise (GMFR) for the Hemagglutination Inhibition (HAI) Titers by Age group Per-protocol 
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population 
20 
Table 14.2.1.8 Geometric Mean Fold Rise (GMFR) for the Hemagglutination Inhibition (HAI) Titers by Age group Full Analysis 
population 
20 
Table 14.2.1.9 Immune Response Rates and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by age 
group and  pre-vaccination titer group –four-fold rise - Per-protocol population 
21 
Table 14.2.1.10 Immune Response Rates and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by age 
group and  pre-vaccination titer group – four-fold rise - Full Analysis population 
22 
Table 14.2.1.11 Geometric Mean titer (GMT) for the Hemagglutination Inhibition (HAI) Titers by age group and pre-vaccination 
titer group - Per-protocol population 
22 
Table 14.2.1.12 Geometric Mean titer (GMT) for the Hemagglutination Inhibition (HAI) Titers by age group and pre-vaccination 
titer group  Full Analysis population 
23 
Table 14.2.1.13 Geometric Mean Fold Rise (GMFR) for the Hemagglutination Inhibition (HAI) Titers by age group and pre-
vaccination titer group  Per-protocol population 
23 
Table 14.2.1.14 Geometric Mean Fold Rise (GMFR) for the Hemagglutination Inhibition (HAI) Titers by age group and pre-
vaccination titer group  Full Analysis population 
24 
Figure 14.2.1.1  Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer)– Age group [18-45] - 
Per-protocol population 
25 
Figure 14.2.1.2   Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer) – Age group [18-45] - 
Full analysis population 
27 
Figure 14.2.1.3  Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer) – Age group 46-60 - 
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Per-protocol population 
27 
Figure 14.2.1.4  Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer) – Age group 46-60 – 
Full analysis population 
27 
Figure 14.2.1.5   Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer) – Overall - Per-
protocol population 
27 
Figure 14.2.1.6  Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer) – Overall – Full analysis 
population 
27 
Figure 14.2.1.7  Geometric Mean Titer (GMT) Plot for Hemagglutination Inhibition (HAI titer) at Day 1 and Day 22 by age 
group - Per-protocol population 
28 
Figure 14.2.1.8  Geometric Mean Titer (GMT) Plot for Hemagglutination Inhibition (HAI titer) at Day 1 and Day 22 by age 
group – Full analysis population 
29 
Table 14.3.1.1 Overview of Adverse Events Full Analysis Population 
30 
Table 14.3.2.1.1 Incidence of Solicited Local Adverse Events from Day 1 to Day 7  Full Analysis Population 
32 
Table 14.3.2.1.2 Incidence of Solicited Systemic Adverse Events from Day 1 to Day 7   Full Analysis Population 
32 
Table 14.3.2.1.3 Incidence of Solicited 30 minutes Local Adverse Event  Full Analysis Population 
34 
Table 14.3.2.1.4 Incidence of Solicited 30 minutes Systemic Adverse Event  Full Analysis Population 
34 
Table 14.3.2.1.5 Incidence of Solicited Local Adverse Event by Day Full Analysis Population 
35 
Table 14.3.2.1.6 Incidence of Solicited Systemic Adverse Event by Day Full Analysis Population 
36 
Table 14.3.2.1.7 Incidence of Solicited Local Adverse Events Captured within 30 minutes after Vaccination by severity Full 
Analysis Population 
36 
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Table 14.3.2.1.8 Incidence of Solicited Systemic Adverse Event Captured within 30 minutes after Vaccination by severity 
Full Analysis Population 
37 
Table 14.3.2.1.9 Summary of the Size of the Solicited Adverse Event Captured within 30 minutes after Vaccination    Full 
Analysis Population 
38 
Table 14.3.2.2.1 Summary of Solicited Local Adverse Event Captured by Maximum Severity between Day 1 to Day 7 Full Analysis 
Population 
39 
Table 14.3.2.2.2 Summary of Solicited Systemic Adverse Event Captured by Maximum severity between Day 1 to Day 7 Full 
Analysis Population 
39 
Table 14.3.3.1.1 Summary of Unsolicited Events Full Analysis Population 
40 
Table 14.3.3.1.2 Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term Full Analysis Population
 
41 
Table 14.3.3.1.3 Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term and severity Full Analysis 
Population 
42 
Table 14.3.3.1.4 Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term and Relationship Full 
Analysis Population 
43 
Table 14.3.3.1.5 Summary of Unsolicited Adverse Events Requiring Treatment by System Organ Class and Preferred Term Full 
Analysis Population 
44 
Table 14.3.4.1.1 Summary of Serious Adverse Events Full Analysis Population 
44 
Table 14.3.4.1.2 Summary of Serious Adverse Events by System Organ Class and Preferred Term Full Analysis Population 
44 
Table 14.3.4.1.3 Summary of Serious Adverse Events by System Organ Class and Preferred Term and Severity Full Analysis 
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Population 
44 
Table 14.3.4.1.4 Summary of Serious Adverse Events by System Organ Class and Preferred Term and Relationship Full Analysis 
Population 
44 
Table 14.3.4.1.5 Summary of Serious Adverse Events Requiring Treatment by System Organ Class and Preferred Term Full 
Analysis Population 
45 
Table 14.3.5.1 Deaths Full Analysis Population 
46 
Table 14.3.6.1 Summary of Vital Signs Full Analysis Population 
47 
Table 14.3.6.2 Shift from Baseline to Day 8 of Vital Signs by Grade Full Analysis Population 
48 
Table 14.3.6.3 Shift from Baseline to Day 8 of Clinically Significant Vital Signs Parameter Full Analysis Population 
50 
Table 14.3.7.1 Shift from Baseline to Day 8 by Clinically Significant Abnormal Physical Examination Full Analysis Population
 
51 
 
 
 
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Table 14.1.1.1 
Subject Disposition 
Enrolled Population 
Pooled sites: 
N = Total number of subjects in each group, n = Number of subjects in each category, % = Calculated relative to the total number of subjects randomized 
Source Data: Listing 16.2.1.1  
Programming note: Repeat the table for the following in the same table. Display each combination in separate page i.e., as shown above. 
 
• 
Pooled sites: Age group: 18-45, 
• 
Pooled Sites: Age group: 46-60,   
• 
Site 1: Overall, 
 
 
 
Vaccine 
N(=XX) 
n (%) 
 
Placebo 
N(=XX) 
n (%) 
 
Total 
N(=XX) 
n (%) 
<Overall>: 
 
 
 
 
NUMBER OF SCREENED SUBJECTS 
 
 
xx 
 
 
 
 
NUMBER OF SUBJECTS NOT RANDOMIZED 
 
 
xx 
 
 
 
 
NUMBER OF SUBJECTS RANDOMIZED 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
SUBJECTS COMPLETED THE STUDY 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
SUBJECTS DISCONTINUED STUDY 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AFTER SCREENING 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AFTER DAY 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AFTER DAY 8 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AFTER DAY 22 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
REASON FOR DISCONTINUATION OF STUDY 
 
 
 
  VOLUNTARY WITHDRAWAL 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  LOST TO FOLLOW-UP 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  SPONSOR DECISION 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  INVESTIGATOR DECISION 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  AE/SAE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  OTHER 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
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• 
Site 1: Age group: 18-45, 
• 
Site 1: Age group: 46-60,  
• 
Site 2: Pooled age groups, 
• 
Site 2: Age group: 18-45, 
• 
Site 2: Age group: 46-60 
 
Please note that “Overall” is the pooled age groups. Not to be included in the footnotes. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 14.1.1.2 
Protocol Deviations 
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60>  
Data is based on the combined phases 2 and 3, pooled across study sites. 
N= Total number of subjects in the relevant population, n= Number of subjects in each category, %= Calculated relative to the total number of subjects 
in the relevant population 
*The same subjects with multiple protocol deviations were counted only once in that category.  
The same subject meeting multiple protocol deviation criteria was counted under each criterion. 
Potential Protocol Deviations for the study are categorized according to the pre-defined categories within Clinical Trial Management System (CTMS). 
Source Data: Listing 16.2.2.1 
 
 
 
 
Vaccine 
N(=XX) 
n (%) 
 
Placebo 
N(=XX) 
n (%) 
 
Total 
N(=XX) 
n (%) 
 
 
 
 
Subjects With at Least One Protocol Deviation 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
Critical Deviations* 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
  Xxxxxxxx1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  … 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  … 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
Major Deviations* 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
  Xxxxxxxx1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  … 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  … 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
Minor Deviations* 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
  Xxxxxxxx1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  … 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  … 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
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Table 14.1.1.3 
Analysis Sets 
Enrolled Population 
Age Group: <Overall> <18-45> <46-60>  
 
 
 
Vaccine 
(N= XX) 
n (%) 
Placebo 
(N= XX) 
n (%) 
Total 
(N= XX) 
n (%) 
 
 
 
 
 
 
 
 
 
 
Number of Subjects included in the Full Analysis Population 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Number of Subjects Excluded from the Full Analysis Population 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Reason 01         
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Etc. 
 
 
 
 
 
 
 
 
 
Number of Subjects included in the Per-Protocol Population  
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Number of Subjects Excluded from Per-Protocol Population 
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
Reason 01         
 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
     Etc. 
 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
N= Total number of subjects in the relevant population, n= Number of subjects in each category, %= Calculated relative to the total number of subjects 
in the relevant population 
Source Data: Listing 16.2.1.3 
 
 
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Table 14.1.2.1 
Demographics and Other Baseline Characteristics 
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60>  
Data is based on the combined phases 2 and 3, pooled across study sites. 
Max: Maximum; Min; Minimum; SD: Standard Deviation 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects in each category, % = Calculated 
relative to the total number of subjects in the relevant population with data available 
*Percentages were based on the total number of female subjects in each group. 
Source Data: Listing 16.2.4.1 
 
 
 
 
Variable (Unit) 
 
 
 
Statistic 
 
 
Vaccine 
(N=XX) 
 
 
Placebo 
(N=XX) 
 
 
Total 
(N=XX) 
 
 
 
 
 
Age (Years) 
 
 
 
 
 
n 
xx 
xx 
xx 
 
Mean 
xx.x 
xx.x 
xx.x 
 
Median 
xx.x 
xx.xx 
xx.xx 
 
SD 
xx.xx 
xx.x 
xx.x 
 
Min, Max 
xx, xx 
xx, xx 
xx, xx 
Sex  
 
 
 
 
  Male 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Female 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
    Child bearing Potential*  
 
 
 
 
      Yes 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
      No 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
Ethnicity 
 
 
 
 
  Kinh 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Khmer 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Hoa 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Other 
n (%) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Programming Note: Add a “Missing” row in each category if it is applicable.  
 
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Table 14.1.2.2 
Summary of Current Medical Condition 
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60>  
 
System organ Class/Preferred Term 
 
Vaccine 
(N=XX) 
n (%) 
 
Placebo 
(N=XX) 
n (%) 
 
Total 
(N=XX) 
n (%) 
 
 
 
 
SOC 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Preferred Term 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Preferred Term 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  … 
 
 
 
 
 
 
 
SOC 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Preferred Term 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Preferred Term 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  … 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
MedDRA: Medical Dictionary for Regulatory Activities; SOC: System Organ Class; PT: Preferred Term 
 
N = Total number of subjects in the relevant population (per by-group stratification level, where relevant), n = Number of subjects in each category  
% = Calculated relative to the total number of subjects in the relevant population (per by-group stratification level, where relevant) 
Subjects experiencing multiple events within the same SOC or preferred term were counted only once under those categories. 
Current medical conditions were coded by System Organ Class and Preferred Term using MedDRA version 20.0. 
Source Data: Listing 16.2.4.2 
 
 
 
Programming Note:  Sorted by alphabetical order of system organ class and preferred term.  
 
 
 
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Table 14.1.3.1 
Summary of Concomitant Medications 
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60>  
 
Reported Term 
 
Vaccine 
(N=XX) 
n (%) 
 
Placebo 
(N=XX) 
n (%) 
 
Total 
(N=XX) 
n (%) 
 
 
 
 
Number of Subjects With at Least One Medication 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
  Reported Term 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  Reported Term 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
  … 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects in each category, % = Calculated 
relative to the total number of subjects in the relevant population 
Subjects with multiple usage of the same medication within the same reported term were counted only once. 
Concomitant medication: Defined as medication started on or after the day of vaccination or were ongoing on the date of vaccination or ended on or 
after the vaccination 
Source Data: Listing 16.2.4.3 
 
Programming Note: Sorted by alphabetical order of Reported term.  
 
 
 
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Table 14.2.1.1 
Seroconversion and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by Age group 
Per-protocol population 
Age Group: <Overall> <18-45> <46-60>  
Titers 
 Criteria 
Day 
          Vaccine  
           (N=xx) 
 
Placebo 
(N=xx) 
 
  
A/H1N1     
 
Seroconversion  
 
 
 
  
    n 
Day 22 
          xx 
           xx 
 
    n/N(%) 
 
          xx.x 
           xx.x 
 
    95% CI 
 
      [xx.xx, xx.xx] 
       [xx.xx, xx.xx] 
 
 
 
 
 
 
A/H3N2 
 
B 
 
 
 
 
       
 
 
 
 
 
Sera samples were collected in phase 3 study at one site (Ben Luc). 
N= Total number of subjects in each agegroup, n= Total number of subjects meeting the event, CI= Confidence Interval  
Percentages were based on the total number of subjects in each vaccine group (N). 
95% confidence interval for single proportion is calculated using Exact Clopper-Pearson method. 
Seroconversion is defined as a serum HAI antibody titer meeting the following criteria: 
Pre-vaccination titer <1:10 and a post-vaccination titer measured on Day 22 of ≥1:40 or Pre-vaccination titer ≥1:10 and at least a four-fold 
increase in post vaccination measured on Day 22 
Source: Listing 16.2.6.1 
Programming note: Repeat the shell for all the three age groups in the same table. 
 
 
Table 14.2.1.2 
Seroconversion and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by Age group 
Full Analysis population 
 
Same layout as for 14.2.1.3 
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Table 14.2.1.3 
Seroprotection and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by Age group 
Per-protocol population 
Age Group: <Overall> <18-45> <46-60>  
Titers 
 Criteria 
Day 
          Vaccine  
           (N=xx) 
 
Placebo 
(N=xx) 
 
  
A/H1N1     
 
Seroprotection  
 
 
 
  
    n 
Day 1 
          xx 
           xx 
 
    n/N(%) 
 
          xx.x 
           xx.x 
 
    95% CI 
 
      [xx.xx, xx.xx] 
       [xx.xx, xx.xx] 
 
 
 
 
 
 
 
Day 22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 1 to Day 22 
 
 
 
 
 
 
 
 
A/H3N2 
 
B 
 
 
 
 
       
 
 
 
 
 
Sera samples were collected in phase 3 study at one site (Ben Luc). 
N= Total number of subjects in each agegroup, n= Total number of subjects meeting the event, CI= Confidence Interval  
Percentages were based on the total number of subjects in each vaccine group (N). 
95% confidence interval for single proportion is calculated using Exact Clopper-Pearson method. 
Seroprotection: Hemagglutination Inhibition (HAI) antibody titer ≥ 1:40 
Source: Listing 16.2.6.1 
Programming note: Repeat the shell for all the three age groups in the same table. 
 
 
 
 
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Table 14.2.1.4 
Seroprotection and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by Age group 
Full Analysis population 
 
Same layout as for 14.2.1.3 
 
Table 14.2.1.5 
Geometric Mean titer (GMT) for the Hemagglutination Inhibition (HAI) Titers by Age group 
Per-protocol population 
 
Age Group: <Overall> <18-45> <46-60>  
Titers 
  
Day 
          Vaccine  
           (N=xx) 
 
Placebo 
(N=xx) 
 
 A/H1N1     GMT 
 
 
 
  
    n 
Day 1 
          xx 
           xx 
 
    Geometric mean titer 
 
          xx.x 
           xx.x 
 
    Geometric Standard Deviation 
 
          xx.x 
           xx.x 
 
    95% CI 
 
      [xx.xx, xx.xx] 
       [xx.xx, xx.xx] 
 
 
 
 
 
 
 
Day 22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 A/H3N2 
 
 
 
 
 
 
 
 
 
 B 
 
 
 
 
 
 
 
 
 
 
Sera samples were collected in phase 3 study at one site (Ben Luc). 
Notes: 
N– Total number of subjects in each agegroup; n – Total number of subjects with the titer measurement. 
The confidence intervals were constructed using t distribution. 
Pre-vaccination (Day 1) value is considered as baseline. 
Source: Listing 16.2.6.1 
Programming note: Repeat the shell for all the three age groups in the same table. 
 
 
 
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Table 14.2.1.6 
Geometric Mean titer (GMT) for the Hemagglutination Inhibition (HAI) Titers by Age group 
Full Analysis population 
 
Same layout as for 14.2.1.5 
 
 
 
 
 
Table 14.2.1.7 
Geometric Mean Fold Rise (GMFR) for the Hemagglutination Inhibition (HAI) Titers by Age group 
Per-protocol population 
Age Group: <Overall> <18-45> <46-60>  
 
Titers 
  
Day 
          Vaccine  
           (N=xx) 
 
 
Placebo 
(N=xx) 
 
 A/H1N1     GMFR 
 
 
 
 
  
    n 
Day 22/Day 1 
          xx 
 
           xx 
 
    Geometric mean fold ratio 
 
          xx.x 
 
           xx.x 
 
    Geometric Standard Deviation 
 
          xx.x 
 
           xx.x 
 
    95% CI 
 
      [xx.xx, xx.xx] 
 
       [xx.xx, xx.xx] 
 
 
 
 
 
 
 A/H3N2 
 
 
 
 
 
 
 
 
 
 
 
 B 
 
 
 
 
 
 
 
 
 
 
 
 
Sera samples were collected in phase 3 study at one site (Ben Luc). 
N– Total number of subjects in each agegroup; n – Total number of subjects with the titer measurements at both Day 1 and Day 22. 
The confidence intervals were constructed using paired t-test.  
Pre-vaccination (Day 1) value is considered as baseline. 
Source: Listing 16.2.6.1  
Programming note: Repeat the shell for all the three age groups in the same table. 
 
 
Table 14.2.1.8 
Geometric Mean Fold Rise (GMFR) for the Hemagglutination Inhibition (HAI) Titers by Age group 
Full Analysis population 
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Version Date: 
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Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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Same layout as for 14.2.1.7 
 
 
 
 
 
 
 
 
Table 14.2.1.9 
Immune Response Rates and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by age group and  
pre-vaccination titer group –four-fold rise - Per-protocol population 
 
Age Group: <Overall> <18-45> <46-60>  
Titers 
Pre-vaccination 
titer group 
< <1:10 > < ≥1:10 > 
  
Day 
          Vaccine  
           (N=xx) 
 
Placebo 
(N=xx) 
 
A/H1N1  
   <1:10 
Four-fold increase 
 
 
 
 
 
    n 
Day 22 
          xx 
           xx 
 
 
    n/N(%) 
 
          xx.x 
           xx.x 
 
 
    95% CI 
 
      [xx.xx, xx.xx] 
       [xx.xx, xx.xx] 
 
A/H1N1  
   ≥1:10 
Four-fold increase 
 
 
 
 
 
    n 
Day 22 
          xx 
xx 
 
 
    n/N(%) 
 
          xx.x 
           xx.x 
 
 
    95% CI 
 
      [xx.xx, xx.xx] 
       [xx.xx, xx.xx] 
 
 
A/H3N2 
B 
 
 
 
 
 
 
Sera samples were collected in phase 3 study at one site (Ben Luc). 
N– Total number of subjects in each group; n – Total number of subjects with four-fold increase on Day 22.  
Percentages were based on the total number of subjects in each vaccine group (N). 
95% confidence interval for single proportion is calculated using Exact Clopper-Pearson method. 
Pre-vaccination (Day 1) value is considered as baseline. 
Source: Listing 16.2.6.1 
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Version Number: 
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Version Date: 
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Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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Programming note: Repeat the shell for all the three age groups and also repeat H3N2 and B for both the pre-vaccination groups i.e., <1:10, ≥1:10 as 
presented for H1N1 in the same table. 
 
Table 14.2.1.10 
Immune Response Rates and 95% Confidence Intervals for the Hemagglutination Inhibition (HAI) Titers by age group and  
pre-vaccination titer group – four-fold rise - Full Analysis population 
 
 
Same layout as for 14.2.1.9 
 
 
 
Table 14.2.1.11 
Geometric Mean titer (GMT) for the Hemagglutination Inhibition (HAI) Titers by age group and pre-vaccination titer group - Per-protocol population 
 
Age Group: <Overall> <18-45> <46-60>  
Titers 
Pre-vaccination 
titer group 
< <1:10 > < ≥1:10 > 
  
Day 
          Vaccine  
           (N=xx) 
 
Placebo 
(N=xx) 
 
 H1N1           <1:10 
GMT 
 
 
 
  
        
    n 
Day 1 
          xx 
           xx 
 
 
    Geometric mean titer 
 
          xx.x 
           xx.x 
 
 
    Geometric Standard 
Deviation 
 
          xx.x 
           xx.x 
 
 
    95% CI 
 
      [xx.xx, xx.xx] 
       [xx.xx, xx.xx] 
 
 
 
 
 
 
 
 
 
Day 22 
 
 
 
 
 
 
 
 
 H1N1           ≥1:10 
GMT 
Day 1 
          xx 
           xx 
  
        
    n 
 
          xx.x 
           xx.x 
 
 
    Geometric mean titer 
 
          xx.x 
           xx.x 
 
 
    Geometric Standard 
Deviation 
 
      [xx.xx, xx.xx] 
       [xx.xx, xx.xx] 
 
 
    95% CI 
 
 
 
 
 
 
Day 22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
H3N2 
B 
 
     
 
 
 
 
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Version Date: 
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Effective Date: 01Apr2016 
 
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Sera samples were collected in phase 3 study at one site (Ben Luc). 
N– Total number of subjects in each age group; n – Total number of subjects with the titer measurement. 
The confidence intervals were constructed using t distribution. 
Pre-vaccination (Day 1) value is considered as baseline. 
Source: Listing 16.2.6.1 
 
Programming note: Repeat the shell for all the three age groups and also repeat H3N2 and B for both the pre-vaccination groups i.e., <1:10, ≥1:10 as 
presented for H1N1 in the same table. 
 
Table 14.2.1.12 
Geometric Mean titer (GMT) for the Hemagglutination Inhibition (HAI) Titers by age group and pre-vaccination titer group  
Full Analysis population 
 
Same layout as for 14.2.1.11 
 
 
Table 14.2.1.13 
Geometric Mean Fold Rise (GMFR) for the Hemagglutination Inhibition (HAI) Titers by age group and pre-vaccination titer group  
Per-protocol population 
 
Age Group: <Overall> <18-45> <46-60>  
Titers 
Pre-vaccination 
titer group 
< <1:10 > < ≥1:10 > 
  
Day 
          Vaccine  
           (N=xx) 
 
Placebo 
(N=xx) 
 
 H1N1           <1:10 
GMFR 
 
 
 
  
        
    n 
Day 22/Day 1 
          xx 
           xx 
 
 
    Geometric mean fold ratio 
 
          xx.x 
           xx.x 
 
 
    Geometric Standard 
Deviation 
 
          xx.x 
           xx.x 
 
 
    95% CI 
 
      [xx.xx, xx.xx] 
       [xx.xx, xx.xx] 
 
 
 
 
 
 
 H1N1           ≥1:10 
GMFR 
Day 22/Day 1 
          xx 
           xx 
  
        
    n 
 
          xx.x 
           xx.x 
 
 
    Geometric mean fold ratio 
 
          xx.x 
           xx.x 
 
 
    Geometric Standard 
Deviation 
 
      [xx.xx, xx.xx] 
       [xx.xx, xx.xx] 
 
 
    95% CI 
 
 
 
 
 
 
 
 
 
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H3N2 
B 
 
 
 
 
 
 
Sera samples were collected in phase 3 study at one site (Ben Luc). 
N– Total number of subjects in each age group; n – Total number of subjects with the titer measurements at both Day 1 and Day 22. 
The confidence intervals were constructed using t distribution. 
Pre-vaccination (Day 1) value is considered as baseline. 
Source: Listing 16.2.6.1 
 
Programming note: Repeat the shell for all the three age groups and also repeat H3N2 and B for both the pre-vaccination groups i.e., <1:10, ≥1:10 as 
presented for H1N1 in the same table. 
 
Table 14.2.1.14 
Geometric Mean Fold Rise (GMFR) for the Hemagglutination Inhibition (HAI) Titers by age group and pre-vaccination titer group  
Full Analysis population 
 
Same layout as for 14.2.1.13 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Version Number: 
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Version Date: 
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Figure 14.2.1.1  
Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer)– Age group [18-45] - Per-protocol population 
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Version Date: 
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Effective Date: 01Apr2016 
 
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Programming note: This graph is to be generated for all the three strains, each strain per page, on Day 1 and Day 22 in the same page. i.e., display 
H1N1 for both Day 1 and Day 22 in the same page. Repeat H3N2 and B as done for H1N1. All these to be generated in the same figure. 
 
Titer: <H1N1> <H3N2> <B> 
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Version Date: 
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Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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Figure 14.2.1.2   
Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer) – Age group [18-45] - Full analysis population 
 
Same as 14.2.1.1 
 
 
 
Figure 14.2.1.3  
Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer) – Age group 46-60 - Per-protocol population 
 
Same as 14.2.1.1 
 
Figure 14.2.1.4  
Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer) – Age group 46-60 – Full analysis population 
 
 
Same as 14.2.1.1 
 
Figure 14.2.1.5   
Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer) – Overall - Per-protocol population 
 
 
Same as 14.2.1.1 
 
Figure 14.2.1.6  
Reverse cumulative distribution curve for Hemagglutination Inhibition (HAI titer) – Overall – Full analysis population 
 
 
 
Same as 14.2.1.1 
 
 
 
 
 
 
 
 
 
 
 
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Version Date: 
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Effective Date: 01Apr2016 
 
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Figure 14.2.1.7  
Geometric Mean Titer (GMT) Plot for Hemagglutination Inhibition (HAI titer) at Day 1 and Day 22 by age group - Per-protocol population 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Programming note: Repeat the same graph in the same panel for other age groups  i.e., Age group: 
18-45, 46-60  
   Agegroup: Overall 
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Version Date: 
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Effective Date: 01Apr2016 
 
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Figure 14.2.1.8  
Geometric Mean Titer (GMT) Plot for Hemagglutination Inhibition (HAI titer) at Day 1 and Day 22 by age group – Full analysis population 
 
Same as 14.2.1.7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 14.3.1.1 
Overview of Adverse Events 
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60>   
Variable 
      Vaccine 
      (N=XX) 
n   (%)     [95% CI]*    E 
 
         Placebo 
         (N=XX) 
n   (%)       [95% CI]*  E 
 
 
 
p-value 
          Total 
          (N=XX) 
n   (%)    [95% CI]*     E 
 
 
 
 
 
Solicited AE: 30 minutes 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
  Solicited Local AEs 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
  Solicited Systemic AEs 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
  Solicited Local Severe AEs 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
  Solicited Systemic Severe AEs 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
Solicited AE: Day 1 to Day 7 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
  Solicited Local AEs 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
  Solicited Systemic AEs 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
  Solicited Local Severe AEs 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
  Solicited Systemic Severe AEs 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
Unsolicited AEs 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
xx (xx.x) [xx.xx, xx.xx] xx 
  Severe 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
xx (xx.x) [xx.xx, xx.xx] xx 
  Related 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
SAEs: At Any Time 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
xx (xx.x) [xx.xx, xx.xx] xx 
  Severe 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
xx (xx.x) [xx.xx, xx.xx] xx 
  Related 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
Deaths 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
Any AE leading to study 
withdrawal 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
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Data is based on the combined phases 2 and 3, pooled across study sites. 
 
AE: Adverse Events, SAE: Serious Adverse Events 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects in each category, E= Number of Adverse 
Events, % = Calculated relative to the total number of subjects in the relevant population 
Any solicited local or systemic reactogenicity that occurs during the 5-day period post-injection is automatically regarded as related. 
Solicited AEs captured within 30 minutes and between day 1 to day 7 after administration of treatment were considered. 
*95% confidence interval (CI) for single proportion: Calculated using Clopper-Pearson method for a single binomial proportion. 
p-value: Calculated using Fisher’s exact test  
Source Data: Listing 16.2.7.1, 16.2.7.2, 16.2.7.4, 16.2.7.5 
Programming Note: Please note that p-value calculated using Fisher’s exact test should be displayed for solicited AEs only. 
 
 
 
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Table 14.3.2.1.1 
Incidence of Solicited Local Adverse Events from Day 1 to Day 7  
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60>  
 
 
       Vaccine 
       (N=XX) 
n    (%)    [95% CI]*    E 
 
       Placebo 
       (N=XX) 
n   (%)     [95% CI]*     E 
P-value 
 
          Total 
          (N=XX) 
n    (%)    [95% CI]*    E 
 
 
 
 
 
  … 
 
 
 
 
Solicited Local Adverse 
Events 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
Xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
  Subjects with at least  
  one solicited Local AE 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
  Redness 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
  Swelling 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
  … 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
  … 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects in each category, E= Number of Adverse 
Events,  % = Calculated relative to the total number of subjects in the relevant population 
*95% confidence interval (CI) for single proportion: Calculated using Clopper-Pearson method for a single binomial proportion. 
P-value: Calculated using Fisher’s exact test or Cochran-Mantel-Haenszel test comparing vaccine groups. 
Event will be counted only one time if occurred on consecutive days. 
Source Data: Listing 16.2.7.1 
 
 
 
 
 
 
 
Table 14.3.2.1.2 
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Version Date: 
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Incidence of Solicited Systemic Adverse Events from Day 1 to Day 7   
Full Analysis Population 
 
Source Data: Listing 16.2.7.2. 
 
Programming Note: Repeat the template of Table 14.3.2.1.1 with appropriate changes. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Version Date: 
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Table 14.3.2.1.3 
Incidence of Solicited 30 minutes Local Adverse Event  
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60>   
 
 
 
Vaccine 
(N=XX) 
n   (%)    [95% CI]*     E 
 
Placebo 
(N=XX) 
n   (%)    [95% CI]*    E 
 
  
P-value 
 
Total 
(N=XX) 
n   (%)     [95% CI]*    E 
 
 
 
 
 
 
 
30 Minutes Local 
Reactogenicity 
 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
 
 
  Subjects with at 
least  
  one solicited Local 
AE 
 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
 
 
  Redness 
 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
 
 
  Swelling 
 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
 
 
 
 
 
 
  … 
 
xx (xx.x) [xx.xx, xx.xx] xx 
xx (xx.x) [xx.xx, xx.xx] xx 
 
0.xxxx 
xx (xx.x) [xx.xx, xx.xx] xx 
  … 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects in each category, E= Number of Adverse 
Events, % = Calculated relative to the total number of subjects in the relevant population 
Solicited local AEs captured within 30 minutes after administration of treatment were considered. 
*95% confidence interval (CI) for single proportion: Calculated using Clopper-Pearson method for a single binomial proportion. 
P-value: Calculated using Fisher’s exact test or Cochran-Mantel-Haenszel test comparing vaccine groups. 
Source Data: Listing 16.2.7.1 
 
 
 
    
 
Table 14.3.2.1.4 
Incidence of Solicited 30 minutes Systemic Adverse Event  
Full Analysis Population 
Source Data: Listing 16.2.7.2. 
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Version Date: 
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Programming Note: Repeat the template of Table 14.3.2.1.3 with appropriate changes. 
 
 
 
 
 
 
 
Table 14.3.2.1.5 
Incidence of Solicited Local Adverse Event by Day 
Full Analysis Population 
 
 
 
 
Day 
 
    Vaccine 
    (N=XX) 
n    (%)    E 
 
    Placebo 
     (N=XX) 
n   (%)    E 
 
Total 
(N=XX) 
n   (%)     E 
 
 
 
 
 
Solicited Local Adverse 
Events 
 
xx (xx.x) xx 
xx (xx.x) xx 
Xx (xx.x) xx 
 
 
 
 
 
  Subjects with at least  
  one solicited Local AE 
Day 1 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
 
  Redness 
 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
 
  Swelling 
 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
 
  … 
 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
  … 
 
 
 
 
 
 
 
 
 
 
Day 2 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
 
 
 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
 
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Author: 
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Version Number: 
1.0 
 
 
Version Date: 
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Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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  … 
 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects in each category, E= Number of Adverse 
Events, % = Calculated relative to the total number of subjects in the relevant population 
Solicited local AEs captured from Day 1 to Day 7 after administration of treatment were considered. 
 
Source Data: Listing 16.2.7.1 
 
Table 14.3.2.1.6 
Incidence of Solicited Systemic Adverse Event by Day 
Full Analysis Population 
Source Data: Listing 16.2.7.2. 
 
Programming Note: Repeat the template of Table 14.3.2.1.5 with appropriate changes. 
 
 
 
Table 14.3.2.1.7 
Incidence of Solicited Local Adverse Events Captured within 30 minutes after Vaccination by severity 
Full Analysis Population 
 
 Age Group: <Overall> <18-45> <46-60>  
 
Solicited Adverse Event 
Severity 
Vaccine 
(N=XX) 
n (%) E 
Placebo 
(N=XX) 
n (%) E 
Total 
(N=XX) 
n (%) E 
 
 
 
 
 
Swelling 
None 
Xx (xx.x) xx 
Xx (xx.x) xx 
Xx (xx.x) xx 
 
Mild 
Xx (xx.x) xx 
Xx (xx.x) xx 
Xx (xx.x) xx 
 
Moderate 
Xx (xx.x) xx 
Xx (xx.x) xx 
Xx (xx.x) xx 
 
Severe 
Xx (xx.x) xx 
Xx (xx.x) xx 
Xx (xx.x) xx 
 
Life Threatening 
Xx (xx.x) xx 
Xx (xx.x) xx 
Xx (xx.x) xx 
 
 
 
 
 
Redness 
None 
Xx (xx.x) xx 
Xx (xx.x) xx 
Xx (xx.x) xx 
  
Mild 
Xx (xx.x) xx 
Xx (xx.x) xx 
Xx (xx.x) xx 
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Version Number: 
1.0 
 
 
Version Date: 
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Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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Moderate 
Xx (xx.x) xx 
Xx (xx.x) xx 
Xx (xx.x) xx 
 
Severe 
Xx (xx.x) xx 
Xx (xx.x) xx 
Xx (xx.x) xx 
 
Life Threatening 
Xx (xx.x) xx 
Xx (xx.x) xx 
Xx (xx.x) xx 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
N= Total number of subjects in the relevant population per by-group stratification level, N= Number of subjects in each category, E= Number of Adverse 
Events, % = Calculated relative to the total number of subjects in the relevant population  
 
Source Data: Listing 16.2.7.1 
 
 
 
    
 
 
Table 14.3.2.1.8 
Incidence of Solicited Systemic Adverse Event Captured within 30 minutes after Vaccination by severity 
Full Analysis Population 
 
Source Data: Listing 16.2.7.1 
Programming Note: Repeat the template of Table 14.3.2.1.7 with corresponding Solicited Systemic events.  
 
 
 
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Version Number: 
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Version Date: 
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Template No:  CS_TP_BS016  Revision 4 
 
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Effective Date: 01Apr2016 
 
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Table 14.3.2.1.9 
Summary of the Size of the Solicited Adverse Event Captured within 30 minutes after Vaccination 
   Full Analysis Population 
 
Age Group: <Overall> <18-45> <46-60>  
Solicited Adverse Event 
Vaccine 
(N=XX) 
Placebo 
(N=XX) 
Total 
(N=XX) 
 
 
 
 
Swelling (cm) 
 
                                                        
  n 
xx 
xx 
xx 
  Mean 
xx.x 
xx.x 
xx.x 
  Median 
xx.x 
xx.x 
xx.x 
  SD 
xx.xx 
xx.xx 
xx.xx 
  Min, Max 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
Erythema/Redness (cm) 
 
 
 
Induration (cm) 
Temperature (0C) 
 
 
 
  
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
Max: Maximum; Min: Minimum; SD: Standard Deviation 
N= Total number of subjects in the relevant population per by-group stratification level. ; n= Number of subjects with the event. 
Solicited local AEs captured within 30 minutes after administration of treatment were considered. 
Source Data: Listing 16.2.7.1 
 
 
 
Programming Note: Present temperature also in addition to solicited local adverse events including in the data. 
    
 
 
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Version Number: 
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Version Date: 
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Template No:  CS_TP_BS016  Revision 4 
 
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Effective Date: 01Apr2016 
 
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Table 14.3.2.2.1 
Summary of Solicited Local Adverse Event Captured by Maximum Severity between Day 1 to Day 7 
Full Analysis Population 
 
Source Data: Listing 16.2.7.3 
 
Programming Note: Repeat the template of Table 14.3.2.1.7 
 
 
 
 
 
 
 
Table 14.3.2.2.2 
Summary of Solicited Systemic Adverse Event Captured by Maximum severity between Day 1 to Day 7 
Full Analysis Population 
 
Source Data: Listing 16.2.7.3 
Programming Note: Repeat the template of Table 14.3.2.1.7 with corresponding Solicited Systemic events.  
 
 
 
 
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Version Date: 
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Table 14.3.3.1.1 
Summary of Unsolicited Events 
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60>  
Unsolicited event 
Vaccine  
(N=xx) 
n (%) E 
Placebo 
(N=xx) 
n (%) E 
Total 
(N=xx) 
n (%) E 
 
 
 
 
Total number of unsolicited AEs 
xx 
xx 
xx 
Subjects with at least one unsolicited AE 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
At least one vaccine related unsolicited AE 
xx (xx.x) xx 
Xx (xx.x) xx 
xx (xx.x) xx 
At least one serious unsolicited AE 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
At least one severe unsolicited AE 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
At least one life threatening unsolicited AE 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
Subjects requiring treatment during the study 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
Subjects with unsolicited AEs leading to withdrawal 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
Number of subjects died 
xx (xx.x) xx 
xx (xx.x) xx 
xx (xx.x) xx 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
AE: Adverse Events 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects in each category, E= Number of Adverse 
Events, % = Calculated relative to the total number of subjects in the relevant population 
AEs captured through day 22 were considered. 
Any AE or solicited sign or symptom starting after 7 days post-vaccination will be recorded as an Unsolicited AE. 
Source Data: Listing 16.2.7.4 
 
 
 
 
 
 
 
 
 
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Version Date: 
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Table 14.3.3.1.2 
Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term 
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60>  
System Organ Class/ 
     Preferred term 
Vaccine  
(N=xx) 
n (%) 
Placebo 
 N=xx) 
n (%)  
Total 
(N=xx) 
n (%) 
 
 
 
 
Number of Subjects with at least one AE 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
  
  
  
System Organ Class 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
     Preferred Term 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
     Preferred Term 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
     Preferred Term 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
System Organ Class 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
     Preferred Term 1 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
     Preferred Term 2 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
     Preferred Term 3 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
... 
 
 
 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
AE: Adverse Events; MedDRA: Medical Dictionary for Regulatory Activities; 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects in each category, % = Calculated 
relative to the total number of subjects in the relevant population 
Adverse Event terms were coded by System Organ Class and Preferred term using MedDRA version 20.0. 
Subjects experiencing multiple events within the same SOC or preferred term were counted only once under those categories. 
Any AE or solicited sign or symptom starting after 7 days post-vaccination will be recorded as an Unsolicited AE. 
Source Data: Listing 16.2.7.4 
 
 
 
Programming Note: Sorted by alphabetical order of system organ class and preferred term.  
 
 
 
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Table 14.3.3.1.3 
Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term and severity 
Full Analysis Population 
 
Age Group: <Overall> <18-45> <46-60> 
System Organ 
Class/ 
Preferred 
Term 
Vaccine 
(N=xx) 
Placebo 
(N=xx) 
Total 
(N=xx) 
Mild 
n (%) 
Moderate 
n (%) 
Severe 
n (%) 
Life 
Threatening 
n (%) 
Mild 
n (%) 
Moderate 
n (%) 
Severe 
n (%) 
Life 
Threatening 
n (%) 
Mild 
n (%) 
Moderate 
n (%) 
Severe 
n (%) 
Life 
Threatening 
n (%) 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of 
Subjects with 
at least one 
AE 
xx 
(xx.x) 
xx (xx.x) xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
xx (xx.x) xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx 
(xx.x) 
Xx(xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
System Organ 
Class 1 
xx 
(xx.x) 
xx (xx.x) xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
xx (xx.x) xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx 
(xx.x) 
xx (xx.x) 
  Preferred    
  Term 1 
xx 
(xx.x) 
xx (xx.x) xx 
(xx.x) 
xx (xx.x) 
xx 
(xx.x) 
xx (xx.x) xx 
(xx.x) 
xx (xx.x) 
xx (xx.x) 
xx (xx.x) 
xx 
(xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
... 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
AE: Adverse Events; MedDRA: Medical Dictionary for Regulatory Activities; 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects in each category, % = Calculated 
relative to the total number of subjects in the relevant population 
Adverse Event terms were coded by System Organ Class and Preferred term using MedDRA version 20.0. 
Subjects experiencing multiple events within the same SOC or preferred term were counted only once under those categories. 
Any AE or solicited sign or symptom starting after 7 days post-vaccination will be recorded as an Unsolicited AE. 
Subjects experiencing multiple events within the same SOC or preferred term were counted only once under those categories and the subjects were counted for the maximum 
severity. 
Source Data: Listing 16.2.7.4 
 
Programming Note: Sorted by alphabetical order of system organ class and preferred term.  
 
 
 
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Table 14.3.3.1.4 
Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term and Relationship 
Full Analysis Population 
 
Age Group: <Overall> <18-45> <46-60> 
 
Vaccine 
(N=xx) 
 
Placebo 
(N=xx) 
 
Total 
(N=xx) 
System Organ Class/ 
  Preferred Term 
Related 
n (%) 
Not Related 
n (%) 
 
Related 
n (%) 
Not Related 
n (%) 
 
Related 
n (%) 
Not Related 
n (%) 
 
 
 
 
 
 
 
 
 
Number of Subjects with at least one AE 
xx (xx.x) 
xx (xx.x) 
 
xx (xx.x) 
xx (xx.x) 
 
xx (xx.x) 
xx (xx.x) 
System Organ Class 1 
xx (xx.x) 
xx (xx.x) 
 
xx (xx.x) 
xx (xx.x) 
 
xx (xx.x) 
xx (xx.x) 
  Preferred Term 1 
xx (xx.x) 
xx (xx.x) 
 
xx (xx.x) 
xx (xx.x) 
 
xx (xx.x) 
xx (xx.x) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
AE: Adverse Events; MedDRA: Medical Dictionary for Regulatory Activities; 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects in each category, % = Calculated 
relative to the total number of subjects in the relevant population. 
Adverse Event terms were coded by System Organ Class and Preferred term using MedDRA version 20.0. 
Subjects experiencing multiple events within the same SOC or preferred term were counted only once under those categories. 
Any AE or solicited sign or symptom starting after 7 days post-vaccination will be recorded as an Unsolicited AE. 
Subjects experiencing multiple events within the same SOC or preferred term were counted only once under those categories and the subjects were counted 
worst case relationship to study medication. 
Source Data: Listing 16.2.7.4 
 
 
 
 
Programming Note: Sorted by alphabetical order of system organ class and preferred term.  
 
 
 
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Table 14.3.3.1.5 
Summary of Unsolicited Adverse Events Requiring Treatment by System Organ Class and Preferred Term 
Full Analysis Population 
Source Data: Listing 16.2.7.4 
Programming Note: Repeat the template of Table 14.3.3.1.2 
 
 
 
Table 14.3.4.1.1 
Summary of Serious Adverse Events 
Full Analysis Population 
 
Source Data: Listing 16.2.7.5 
 
Programming Note: Repeat the template of Table 14.3.3.1.1 
 
 
Table 14.3.4.1.2 
Summary of Serious Adverse Events by System Organ Class and Preferred Term 
Full Analysis Population 
 
Source Data: Listing 16.2.7.5 
Programming Note: Repeat the template of Table 14.3.3.1.2 
 
 
 
Table 14.3.4.1.3 
Summary of Serious Adverse Events by System Organ Class and Preferred Term and Severity 
Full Analysis Population 
 
Source Data: Listing 16.2.7.5 
Programming Note: Repeat the template of Table 14.3.3.1.3 
 
 
 
Table 14.3.4.1.4 
Summary of Serious Adverse Events by System Organ Class and Preferred Term and Relationship 
Full Analysis Population 
 
Source Data: Listing 16.2.7.5 
Programming Note: Repeat the template of Table 14.3.3.1.4 
 
 
 
 
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Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
11AUG 2017] 
Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
 
 
Table 14.3.4.1.5 
Summary of Serious Adverse Events Requiring Treatment by System Organ Class and Preferred Term 
Full Analysis Population 
 
Source Data: Listing 16.2.7.5 
Programming Note: Repeat the template of Table 14.3.3.1.2 
 
 
 
 
 
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Document:  
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Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
11AUG 2017] 
Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Table 14.3.5.1 
Deaths 
Full Analysis Population 
Treatment  
Subject 
ID/ Site 
ID/ Age 
group 
Date/Study 
Day 
of Death 
Days since Vaccination 
Primary Cause 
of Death (eCRF) 
Death certificate 
Obtained 
Autopsy 
Performed 
(Yes/No) 
Report Available 
(Yes/No) 
 
 
 
  
 
 
 
Vaccine  
Xxxxx/ 
xxxxx/ 
xxxxx 
DDMMMYYYY 
xx 
xxxxxxxxxxxxx 
Yes 
Yes 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Days: Derived relative to administration date/time of vaccination. 
 
 
 
 
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Document:  
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Tables_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
11AUG 2017] 
Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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Table 14.3.6.1 
Summary of Vital Signs 
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60>  
 
 
 
 
Vaccine 
(N=xx) 
 
Placebo 
(N=xx) 
 
Total 
(N=xx) 
 
 
Assessment 
(Unit) 
Visit 
Outcome 
Statistic 
Actual 
CFB 
 
Actual 
CFB 
 
Actual 
CFB 
p-value^ 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body 
Temperature(0C) 
Screening 
 Result 
n 
xx 
 
 
xx 
 
 
xx 
 
 
 
 
 
Mean 
xx.x 
 
 
xx.x 
 
 
xx.x 
 
 
 
 
 
Median 
xx.x 
 
 
xx.x 
 
 
xx.x 
 
 
 
 
 
SD 
xx.xx 
 
 
xx.xx 
 
 
xx.xx 
 
 
 
 
 
Min, Max 
xx, xx 
 
 
xx, xx 
 
 
xx, xx 
 
 
 
 
 
Missing 
xx 
 
 
xx 
 
 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 8 
 Result 
n 
xx 
xx 
 
xx 
xx 
 
xx 
xx 
 
 
 
 
Mean 
xx.x 
xx.x 
 
xx.x 
xx.x 
 
xx.x 
xx.x 
0.xxxxx 
 
 
 
Median 
xx.x 
xx.x 
 
xx.x 
xx.x 
 
xx.x 
xx.x 
 
 
 
 
SD 
xx.xx 
xx.xx 
 
xx.xx 
xx.xx 
 
xx.xx 
xx.xx 
 
 
 
 
Min, Max 
xx, xx 
xx, xx 
 
xx, xx 
xx, xx 
 
xx, xx 
xx, xx 
 
 
 
 
missing 
xx 
xx 
 
xx 
xx 
 
xx 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
p-value* 
0.xxxxx 
 
 
0.xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
CFB: Change From Baseline; Max: Maximum; Min; Minimum; SD: Standard Deviation 
N= Total number of subjects in relevant population per by-group stratification level. n= Number of subjects with an assessment. 
^P-value was computed using or 2-sample t test comparing vaccine groups.  
* P-value was computed using paired t test comparing vaccine groups. 
Source Data: Listing 16.2.8.2 
 
 
 
 
Programming Note: Summarize for the parameters systolic blood pressure (mmHg), diastolic blood pressure (mmHg) and pulse rate (beats/min). 
 
 
 
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Document:  
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Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
11AUG 2017] 
Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Table 14.3.6.2 
Shift from Baseline to Day 8 of Vital Signs by Grade 
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60> 
Parameter 
(Unit) 
Baseline 
 
 
                       
 
Vaccine 
(N=xx) 
n (%) 
        Day 8 
 
 
 
Placebo 
(N=xx) 
n (%) 
Total 
(N=xx) 
n (%) 
 
1 
2 
3 
4 
 
1 
2 
3 
4 
 
1 
2 
3 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body 
Temperature 
(Oral)(0C)* 
1 
 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 
 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
Xx 
(xx.xx) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
N= Total number of subjects in the relevant population per by-group stratification level. n= Number of subjects with available response under each 
group at both visit. % = Calculated relative to the total number of subjects have measurable assessment for analysis in each group at both time points. 
Grades: 1- Mild; 2 – Moderate; 3 – Severe; 4 – Life-Threatening; 
*Body temperature collected in vital signs. 
Source Data: Listing 16.2.8.2 
 
 
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Document:  
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Tables_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
11AUG 2017] 
Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
 
Programming Note: Summarize for the parameters systolic blood pressure (mmHg), diastolic blood pressure (mmHg) and pulse rate (beats/min). 
    
 
 
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Document:  
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Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
11AUG 2017] 
Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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Table 14.3.6.3 
Shift from Baseline to Day 8 of Clinically Significant Vital Signs Parameter 
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60> 
Parameter (Unit) 
 
                         
 
Vaccine 
(N=xx) 
n (%) 
Day 8 
 
Placebo 
(N=xx) 
n (%) 
 
Baseline 
Normal 
Abnormal, NCS 
Abnormal, CS 
 
Normal 
Abnormal, NCS 
Abnormal, CS 
Body Temperature (0C) 
 
 
 
 
 
 
 
 
 
Normal 
xx (xx.x)  
xx (xx.x)  
xx (xx.x)  
 
xx (xx.x)  xx (xx.x)  
xx (xx.x)  
 
Abnormal, NCS 
xx (xx.x)  
xx (xx.x)  
xx (xx.x)  
 
xx (xx.x)  xx (xx.x)  
xx (xx.x)  
 
Abnormal, CS 
xx (xx.x)  
xx (xx.x)  
xx (xx.x)  
 
xx (xx.x)  xx (xx.x)  
xx (xx.x)  
… 
 
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
CS: Clinically Significant; NCS: Not Clinically Significant; 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects with available response under each 
group at both time point, % = Calculated relative to the total number of subjects have measurable assessment for analysis in each group at both visit 
 Percentages were based on the total number of subjects have measurable assessment for analysis in each group. 
Source Data: Listing 16.2.8.2 
Programming Note: Add Total Column also i.e., in addition to Vaccine and Placebo. 
Summarize for the parameters systolic blood pressure (mmHg), diastolic blood pressure (mmHg) and pulse rate (beats/min). 
    
 
 
 
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PROTOCOL IVACFLU-S-0203  
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Document:  
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Author: 
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Version Number: 
1.0 
 
 
Version Date: 
11AUG 2017] 
Template No:  CS_TP_BS016  Revision 4 
 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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Table 14.3.7.1 
Shift from Baseline to Day 8 by Clinically Significant Abnormal Physical Examination 
Full Analysis Population 
Age Group: <Overall> <18-45> <46-60> 
Area/ System 
 
Day 8 
 
Vaccine 
(N=xx) 
n (%) 
 
 
 
Placebo 
(N=xx) 
n (%) 
Baseline 
Abnormal, NCS 
Abnormal, CS 
 
Abnormal, NCS 
Abnormal, CS 
xxxxxxxxx 
 
 
 
 
 
 
 
Abnormal, NCS 
xx (xx.x)  
xx (xx.x)  
 
xx (xx.x)  
xx (xx.x)  
 
Abnormal, CS 
xx (xx.x)  
xx (xx.x)  
 
xx (xx.x)  
xx (xx.x)  
 
 
 
 
 
 
 
Data is based on the combined phases 2 and 3, pooled across study sites. 
CS: Clinically Significant; NCS: Not Clinically Significant; 
N= Total number of subjects in the relevant population per by-group stratification level, n= Number of subjects with available response under each 
group at both time points, % = Calculated relative to the total number of subjects have measurable assessment for analysis in each group at both visit 
Programming Note: Add Total Column also i.e., in addition to Vaccine and Placebo. 
 
Source Data: Listing 16.2.8.3 
 
 
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Version Number: 
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Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
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Effective Date: 01Apr2016 
 
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ANNOTATED SHELLS 
 
IVACFLU-S, PHASE 2/3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A PHASE 2 / 3 DOUBLE BLINDED, RANDOMIZED, PLACEBO-CONTROLLED STUDY IN 
HEALTHY ADULT VOLUNTEERS IN VIETNAM TO EXAMINE THE SAFETY AND 
IMMUNOGENICITY OF A SEASONAL TRIVALENT INACTIVATED SPLIT VIRION INFLUENZA 
VACCINE (IVACFLU-S) PRODUCED BY IVAC  
847
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

TABLE AND LISTING MOCK SHELL 
OUTPUT TEM PtAiCS-SfG-NA-Ti:tR-E-P-A:tiG-e-E----------
Output Templates Vl.O {Dated 11AUG2017) for Protocol IVACFLU-S-0203 (Dated 09FEB2017). 
Name 
Signature 
Date 
Revathi Rayadurgam 
.~·· 
!W Av(,. { l.1 
Biostatistician 2 
Company: 
Quintiles IMS 
@~ 
PROTOCOL IVACFLU-S-0203 
Page 2 of 26 
Upon review of this document, the undersigned approves this version of the Output templates, authorizing that the content is acceptable for the reporting of this study. 
Approved By: 
~:r::h chenii 
siet~ . ~~e/AA{qp/7 
Position: 
Manager, Biostatistics 
Company: 
Quintiles! MS 
Approved By: 
Position: 
Company: 
Approved By: 
Position: 
Company: 
. 
. ........ . 
Krista Yuhas 
//, • . ;:, 
~ / . 
J y 
~1,u././.A./ 1~ 
,/J./JY/.... 
· 
Biostalistician, Center for Vaccine Innovation nd Access (CVIAl 
PATH 
Tushar Tewari 
Senior Medical Officer,Clinical and Regulatory Affairs 
PATH 
Document: 
\\I EEDC-NASOlA \B iosdata \Path\IVACFLU-5\IY A06804\Biostatistics \Documentation \SAP\IVACF LU-5-0203 _ Mock_Listings_ Vl . 0 
Author: 
Revathi Rayadurgam 
Version Number: 
Template No: CS_ TP _BS016 Revision 4 
Effective Date: 01Apr2016 
Copyright© 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
Version Date: 
Reference CS_Wl_BS005 
1.0 
[11AUG2017] 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
848
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

@ OuintileslMS • 
TABLE AND LISTING MOCK SHELL 
OUTPUT TEMPLATES SIGNATURE PAGE 
Output Templates Vl.O (Dated 11AUG2017) for Protocol IVACFLU-S-0203 (Dated 09FEB2017). 
Name 
Signature 
Date 
Author: 
Revathi Rayadurgam 
Position: 
Biostatistician 2 
Company: 
Quintiles IMS 
® 
PROTOCOL IVACFLU-S-0203 
Page 2 of 26 
Upon review of this document, the undersigned approves this version of the Output templates, authorizing that the content is acceptable for the reporting of this study. 
Approved By: 
~~r::h Chenji 
) Signature 
. Date 
Ii 
Position: 
Manager, Biostatistics 
Company: 
Quintiles! MS 
Approved By: 
Position: 
Company: 
Approved By: 
Position: 
Company: 
Krista Yuhas 
Biostatistician, Center for Vaccine Innovation and Access (CVIA) 
PATH 
Tushar Tewari 
r~~ 
Senior Medical Officer, Clinical and Regulatory Affairs 
PATH 
Document: 
\\I EEDC-NASOlA \B iosdata \Path \I VACFLU-5\IY A06804 \Biostatistics \Documentation \SAP\IVACF LU-S-0203 _Mock_ Listings_ Vl. 0 
Author: 
Revathi Rayadurgam 
Version Number: 
Template No: CS_TP _BS016 Revision 4 
Effective Date: 01Apr2016 
Copyright© 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
Version Date: 
Reference: CS_Wl_BS005 
1.0 
[11AUG2017) 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
849
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 2 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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Please note that listing shells for immunogenicity endpoints are only needed for Phase 3 and 
all the listing shells other than immunogenicity are needed for both Phase 2 and Phase 3. 
 
 
 
850
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
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TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
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Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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OUTPUT TEMPLATES SIGNATURE PAGE 
Output Templates V1.0 (Dated 11AUG2017) for Protocol IVACFLU-S-0203 (Dated 09FEB2017). 
 
 
 
Name 
Signature 
Date 
Author: 
Revathi Rayadurgam 
 
 
Position: 
Biostatistician 2 
Company: 
Quintiles IMS 
 
 Upon review of this document, the undersigned approves this version of the Output templates, authorizing that the content is acceptable for the reporting of this study. 
 
Name 
Signature 
Date 
Approved By: 
Suresh Chenji 
 
 
 
Position: 
Manager, Biostatistics 
 
Company: 
QuintilesIMS 
 
Approved By: 
Krista Yuhas 
 
 
 
Position: 
Biostatistician, Center for Vaccine Innovation and Access (CVIA) 
 
Company: 
PATH 
 
Approved By: 
Tushar Tewari 
 
 
 
Position: 
Senior Medical Officer, Clinical and Regulatory Affairs 
 
Company: 
PATH 
851
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Document: 
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Author: 
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Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
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Effective Date: 01Apr2016 
 
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MODIFICATION HISTORY 
 
 
 
 
 
 
 
 
 
 
Unique Identifier for 
this Version 
Date of the Document 
Version  
Author 
Significant Changes from  
Previous Authorized 
Version 
 
 
Revathi Rayadurgam 
Not applicable. First 
version. 
 
 
 
 
 
 
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Document: 
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Version Date: 
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Table of Contents 
Listing 16.1.1.1 Eligibility Criteria All subjects 
7 
Listing 16.2.1.1 Subject Disposition All subjects 
8 
Listing 16.2.1.2 Subject Randomization Enrolled Population 
9 
Listing 16.2.1.3 Subject Population Enrolled Population 
10 
Listing 16.2.2.1 Protocol Deviations Full Analysis Population 
11 
Listing 16.2.4.1 Demographics and Baseline Characteristics Enrolled Population 
12 
Listing 16.2.4.2 Current Medical Condition Full Analysis Population 
13 
Listing 16.2.4.3 Concomitant Medication Full Analysis Population 
14 
Listing 16.2.5 Study Medication Full Analysis Population 
15 
Listing 16.2.6.1 Immunogenicity Result Per-Protocol Population 
16 
Listing 16.2.6.2 Immunogenicity Result- Antigens Per-Protocol Population 
17 
Listing 16.2.7.1 Solicited Local Reactogenicity Full Analysis Population 
18 
Listing 16.2.7.2 Solicited Systemic Reactogenicity Full Analysis Population 
19 
Listing 16.2.7.3 Local and Systemic Solicited Reactogenecity by Maximum Severity between Day 1 to Day 7 Full Analysis 
Population 
20 
Listing 16.2.7.4 Unsolicited Adverse Events Full Analysis Population 
21 
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Document: 
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Version Number: 
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Version Date: 
[11AUG2017] 
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Effective Date: 01Apr2016 
 
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Listing 16.2.7.5 Serious Adverse Events Full Analysis Population 
22 
Listing 16.2.8.1 Serum Collection Full Analysis Population 
23 
Listing 16.2.8.2 Physical Examination – Vital Signs Full Analysis Population 
24 
Listing 16.2.8.3 Physical Examination – Abnormal Findings Full Analysis Population 
25 
Listing 16.2.8.4 Pregnancy Report Full Analysis Population 
26 
 
 
 
854
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 7 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.1.1.1 
Eligibility Criteria 
All subjects 
Study day: Derived relative to administration date/time of vaccination. 
 
Programming Note: Sort by Subject ID. 
 
 
 
 
 
 
Subject ID/ Site 
ID/ Age Group 
Consent Given 
(Yes/No) 
 
Date of Informed 
Consent/Study Day 
 
Met Eligibility (Yes/No) 
If Not Met, Specification (eCRF) 
 
 
 
 
 
Xxxxx/ xxxx/ xxxx 
Yes 
DDMMMYYYY 
Yes 
 
 
 
 
 
 
xxxxx/ xxxx/ xxxx 
Yes 
DDMMMYYYY 
No 
Refused to come for screening 
 
 
 
 
 
xxxxx/ xxxx/ xxxx 
Yes 
DDMMMYYYY 
Yes 
 
 
 
 
 
 
xxxxx/ xxxx/ xxxx 
Yes 
DDMMMYYYY 
Yes 
 
 
 
 
 
 
855
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 8 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
 Listing 16.2.1.1 
Subject Disposition 
All subjects 
AE: Adverse Event. SAE: Serious Adverse Event. 
Study day: Derived relative to administration date/time of vaccination. 
 
 
 
 
 
 
 
Programming Note: Sort by Treatment and Subject ID 
 
 
 
 
 
Treatment 
 
Subject ID/ Site 
ID/ Age Group 
Subject Study Status 
 
Completion/ 
Discontinuation Date 
Study Day 
 
Reason for Discontinuation 
 
Other/AE/SAE/Specification (eCRF) 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
Completed 
DDMMMYYYY 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
Completed 
DDMMMYYYY 
 
 
 
 
 
 
 
 
Placebo 
xxxxx/ xxxx/ xxxx 
Completed 
DDMMMYYYY 
 
 
 
 
 
 
 
 
Placebo 
xxxxx/ xxxx/ xxxx 
Discontinued 
DDMMMYYYY 
Other 
xxxxxxxxxxxxxx 
 
 
 
 
 
 
856
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 9 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.1.2 
Subject Randomization 
Enrolled Population 
Study day: Derived relative to administration date/time of vaccination. 
 
 
 
 
Programming Note: Sort by Subject ID. 
 
 
 
Subject ID/ 
Site ID/ Age 
Group 
Subject Randomized 
(Yes/No) 
 
Date of 
Randomization/Study Day 
 
Randomization Number 
Treatment Description 
Reason If Not Randomized 
 
 
 
 
 
 
xxxxx/ xxxx/ 
xxxx 
Yes 
DDMMMYYYY/ xx 
xxxxx 
Vaccine 
 
 
 
 
 
 
 
xxxxx/ xxxx/ 
xxxx 
No 
 
xxxxx 
 
Lost to follow-up 
 
 
 
 
 
 
xxxxx/ xxxx/ 
xxxx 
Yes 
DDMMMYYYY/ xx 
xxxxx 
Placebo 
 
 
 
 
 
 
 
xxxxx/ xxxx/ 
xxxx 
Yes 
DDMMMYYYY/ xx 
xxxxx 
Placebo 
 
 
 
 
 
 
 
857
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 10 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.1.3 
Subject Population 
Enrolled Population 
 
 
 
 
 
 
Programming Note: Sort by Treatment and Subject ID 
 
 
  
 
Treatment 
 
Subject ID/ Site ID/ Age 
Group 
All Enrolled 
Population 
 
Full Analysis 
Population 
Per-Protocol Population  
Reason for Exclusion from the 
population 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
Yes 
Yes 
Yes 
xxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
Yes 
No 
No 
xxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
858
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 11 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.2.1 
Protocol Deviations 
Full Analysis Population 
Site ID: xxxxxx 
Potential Protocol Deviations for the study and categorize according to the pre-defined categories within the Clinical Trial Management System (CTMS). 
 
 
 
 
 
Programming Note: Sort by Treatment and Subject ID 
 
 
 
 
 
Treatment 
 
Subject ID/ Site ID/ 
Age Group 
Category 
Severity 
 
Protocol Deviation Term 
 
Deviation Description 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
Informed Consent 
Criteria 
Critical 
xxxxxxxx 
xxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
859
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 12 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.4.1 
Demographics and Baseline Characteristics 
Enrolled Population 
[a]: Applicable only for female subjects. 
 
 
 
 
Programming Note: Sort by Treatment and Subject ID. 
 
 
 
 
Treatment 
 
Subject ID/ Site 
ID/ Age Group 
Date of Birth/ 
Age(Years) 
 
Sex 
Ethnicity 
Child Bearing 
Potential [a] 
Urine Pregnancy Test 
Result[a] 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ 
xxxx 
DDMMMYYYY/ xx 
Male 
Kinh 
Yes 
Negative 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
860
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 13 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.4.2 
Current Medical Condition 
Full Analysis Population 
e-CRF: Electronic Case Report Form. MedDRA: Medical Dictionary for Regulatory Activities. 
[a]: Medical History terms (including other systems): Coded using MedDra version 20.0. 
 
 
 
 
Programming Note: Sort by Treatment, Subject ID and SOC 
 
 
 
 
 
Treatment 
 
Subject ID/ Site ID/ Age 
Group 
System Organ Class/ Preferred 
Term/Verbatim Term [a] 
 
Condition 
Medication Taken for this Current 
Condition (Yes/No) 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxxx/ xxxxxx/ xxxxxxx 
xxxxx 
No 
 
 
 
 
 
 
 
 
 
 
Placebo 
xxxxx/ xxxx/ xxxx 
xxxx/ xxxxxx/ xxxxxxx 
xxxx 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
861
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 14 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.4.3 
Concomitant Medication 
Full Analysis Population 
AE: Adverse Event. 
Study day: Derived relative to administration date/time of vaccination. 
Concomitant medication: Defined as medication started on or after the day of vaccination or were ongoing on the date of vaccination or ended on or 
after the vaccination. 
 
 
Programming Note: Sort by Treatment Subject ID and Start date. 
 
 
Treatment 
 
Subject ID/ Site 
ID/Age Group 
Medication 
Name 
Start Date/ Stop 
Date/Study Day 
 
Ongoing 
Dose/Unit/ 
Frequency 
Route of 
Administration 
Indication 
Specification 
(eCRF) 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxxxx 
DDMMMYYYY/ 
DDMMMYYYY/ xx 
No 
Xx/xx/xx 
Oral 
Unsolicited AE 
xxxxxxx 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxxxx 
DDMMMYYYY/ 
DDMMMYYYY/ xx 
No  
Xx/xx/xx 
xxxx 
xxxxxxx 
xxxxxxx 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxxxx 
DDMMMYYYY/ 
DDMMMYYYY/ xx 
No  
Xx/xx/xx 
xxxx 
xxxxxxxx 
xxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
862
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 15 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.5 
Study Medication 
Full Analysis Population 
Study day: Derived relative to administration date/time of vaccination. 
Please ensure that for all shells footnotes are relevant and complete 
 
NOTE: in eCRF is Product Code which means that we will be able to check “actual” treatment.  We have the RND number so we can check RND treatment if 
not as part of DS then at least here we need to show actual and randomized treatment and flag any deviations.  Also please ensure this is clarified in 
the SAP. 
 
Programming Note: Sort by Actual Treatment, Subject ID and Visit. 
 
 
 
 
 
 
 
 
 
Actual 
Treatment 
Randomized 
Treatment 
 
Subject ID/ Site 
ID/Age Group 
Visit 
Vaccination Date/Time 
(HH:MM)/Study Day 
 
Arm of 
Administration 
Treatment Deviation  
 
 
 
 
 
 
 
Vaccine 
Vaccine 
xxxxx/ xxxx/ xxxx 
Day 1 
DDMMMYYYY/HH:MM/ xx 
Left 
No 
 
 
 
 
 
 
 
Vaccine 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxxxx 
DDMMMYYYY/HH:MM/ xx 
Left 
No 
 
 
 
 
 
 
 
Vaccine 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxxxx 
DDMMMYYYY/HH:MM/ xx 
Right 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
863
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 16 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.6.1 
Immunogenicity Result 
Per-Protocol Population 
HAI: Hemagglutination Inhibition  
Study day: Derived relative to administration date/time of vaccination. 
 
Seroconversion is defined as a serum HAI antibody titer meeting the following criteria:  
• Pre-vaccination titer <1:10 and a post-vaccination titer measured on Day 22 of ≥1:40 or  
• Pre-vaccination titer ≥1:10 and at least a four-fold increase in post vaccination measured on Day 22  
 
Programming Note: Sort by Treatment, Subject ID and Visit. 
 
 
 
 
 
 
 
 
 
Treatment 
 
Subject ID/ 
Site ID/Age 
Group 
 
Visit 
 
Collection 
Date/Study Day 
Antigens 
HAI 
Titer 
Fold Increase 
(Day 22/Day 1) 
>=1:40 Titer 
(Yes/No) 
Seroconversion 
(Yes/No) 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ 
xxxx 
Day 1 
DDMMMYYYY/ xx 
H1N1 
xx 
xx 
Yes 
Yes 
 
 
 
 
 
 
 
 
 
 
 
Day 22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xxxxx/ xxxx/ 
xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
xxxxx/ xxxx/ 
xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
864
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 17 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.6.2 
Immunogenicity Result- Antigens 
Per-Protocol Population 
HAI: Hemagglutination Inhibition  
 
Programming Note: Sort by Treatment, Subject ID and Visit. 
 
 
 
 
 
 
 
 
 
 
 
Treatment 
Subject ID 
HAI(Titer) 
         H1N1 
 
        H3N2 
 
          B 
 
Day 1 
Day22 
Day1 
Day 22 
Day 1 
Day 22 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxx 
xxx 
xxx 
xxx 
xxx 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
865
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 18 of 27 
 
 
Document: 
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Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.7.1 
Solicited Local Reactogenicity 
Full Analysis Population 
CS: Clinically Significant; NCS: Not Clinically Significant; 
 
Programming Note: Sort by Treatment, Subject ID and Time point. 
 
 
 
Treatment 
 
Subject ID/ 
Site ID/ Age 
Group 
Temperature (0C)/ 
Finding 
Grade of 
Temperature 
Time Point 
Solicited Local Adverse Events 
Result 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ 
xxxx 
Xx/Normal 
 
30 Minute After 
Vaccination 
Redness (cm)/ Grade 
Xx/ xx 
 
 
 
 
 
Swelling (cm)/ Grade 
Xx/ xx 
 
 
 
 
 
Induration (Hardness) (cm)/ Grade 
Xx/ xx 
 
 
 
 
 
Pain 
Xx 
 
 
 
 
 
Tenderness 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day 1 
Redness  
Mild 
 
 
 
 
 
Swelling 
None 
 
 
 
 
 
Hardness 
Moderate 
 
 
 
 
 
Pain 
xx 
 
 
 
 
 
Tenderness 
xx 
 
 
 
 
 
 
 
 
 
 
 
Day 2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
… 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
866
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 19 of 27 
 
 
Document: 
\\IEEDC-NAS01A\Biosdata\Path\IVACFLU-S\IYA06804\Biostatistics \Documentation\SAP\IVACFLU-S-0203_Mock_Listings_V1.0 
Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.7.2 
Solicited Systemic Reactogenicity 
Full Analysis Population 
 
 
 
 
Programming Note: Sort by Treatment, Subject ID and Time point. 
 
 
Treatment 
 
Subject ID/ Site 
ID/ Age Group 
Time Point 
Solicited Systemic Adverse Events 
Result 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
30 Minute After Vaccination 
Fatigue/ Malaise 
Mild 
 
 
 
Generalized Muscle Aches 
Mild 
 
 
 
Joint Aches 
Moderate 
 
 
 
Chills 
Xxxx 
 
 
 
Nausea 
Xxx 
 
 
 
Vomiting 
Xxx 
 
 
 
Headache 
xxxx 
 
 
 
 
 
 
 
Day 1 
Temperature (0C) 
xxx 
 
 
 
Fatigue/ Malaise 
Mild 
 
 
 
Generalized Muscle Aches 
Mild 
 
 
 
Joint Aches 
Moderate 
 
 
 
Chills 
Xxxx 
 
 
 
Nausea 
Xxx 
 
 
 
Vomiting 
Xxx 
 
 
 
Headache 
xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
Day 2 
Temperature (0C) 
xxx 
 
 
 
Fatigue/ Malaise 
Mild 
 
 
 
Generalized Muscle Aches 
Mild 
 
 
 
… 
 
 
 
… 
 
 
 
 
 
 
 
867
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 20 of 27 
 
 
Document: 
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Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
 
Listing 16.2.7.3 
Local and Systemic Solicited Reactogenecity by Maximum Severity between Day 1 to Day 7 
Full Analysis Population 
 
 
 
 
Programming Note: Sort by Treatment and Subject ID. 
 
Treatment 
 
Subject 
ID/ 
Site 
ID/ Age 
Group 
Pain 
Tenderness 
Redness 
Swelling 
Hardness 
Temperature 
(0C) 
Fatigue/ 
Malaise 
Muscle 
Aches 
Joint 
Aches 
Chills 
Nausea 
Vomiting 
Headache 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ 
xxxx/ 
xxxx 
Mild 
xxxx 
xxx 
xxxx 
xxxx 
Grade 0 
Severe 
xxx 
xxx 
xxx 
xxx 
xxxx 
xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
868
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 21 of 27 
 
 
Document: 
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Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.7.4 
Unsolicited Adverse Events 
Full Analysis Population 
e-CRF: Electronic Case Report Form; MedDRA: Medical Dictionary for Regulatory Activities; SOC: System Organ Class 
Adverse Event terms were coded by SOC and Preferred Term using MedDRA version xx.x. 
Study day: Derived relative to administration date/time of vaccination. 
Duration is calculated based on start date and end date of AE. 
 
 
 
 
Programming Note: Sort by Treatment, Subject ID, SOC and Preferred Term. 
 
Treatment 
 
Subject 
ID/ Site 
ID/ Age 
Group 
SOC/ 
Preferred 
Term/ 
Verbatim 
Term 
Start Date/ 
End Date/ 
Study Day 
Duration of 
AE (Days) 
Severity/ 
Serious 
(Yes/No) 
Relationship to 
Study Product 
Action Taken/ 
Specification(e-
CRF) 
Outcome 
Treatment Required 
(Yes/No) 
 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ 
xxxx/ xxxx 
Xxx/ xxxxx/ 
xxxx 
DDMMMYYYY/ 
DDMMMYYYY/ xx 
xx 
Moderate/No Not Related 
None 
Resolved 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
869
IVACFLU-S
Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

 
 
 
 
TABLE AND  LISTING MOCK SHELL 
 
PROTOCOL IVACFLU-S-0203  
Page 22 of 27 
 
 
Document: 
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Author: 
Revathi Rayadurgam 
Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
Copyright © 2009, 2010, 2012, 2016 Quintiles Transnational Corp. All rights reserved. 
The contents of this document are confidential and proprietary to Quintiles Transnational Corp. Unauthorized use, disclosure or reproduction is strictly prohibited. 
 
Listing 16.2.7.5 
Serious Adverse Events 
Full Analysis Population 
SOC: System Organ Class; 
Adverse Event terms were coded by SOC and Preferred Term using MedDRA version xx.x. 
Study day: Derived relative to administration date/time of vaccination. 
 
Duration is calculated based on start date and end date of AE. 
 
 
 
 
Programming Note: Sort by Treatment, Subject ID, SOC and Preferred Term. 
 
 
 
Treatment 
 
Subject ID/ 
Site ID/Age 
Group 
SOC/ Preferred 
Term/ Verbatim Term 
Start Date/ End 
Date/  Study  Day 
Duration 
of AE 
Resolved 
Date 
Serious 
Criteria 
Severity 
Relationship to 
Study Product 
Outcome 
 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ 
xxxx/ xxxx 
Xxx/ xxxxx/ xxxx 
DDMMMYYYY/ 
DDMMMYYYY/ xx 
xx 
DDMMMYYYY 
Death/ 
DDMMMYYYY 
Moderate 
No 
Resolved 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Version Number: 
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Version Date: 
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Effective Date: 01Apr2016 
 
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Listing 16.2.8.1 
Serum Collection 
Full Analysis Population 
Study day: Derived relative to administration date/time of vaccination. 
 
 
 
Programming Note: Sort by Treatment and Subject ID. 
 
Treatment 
 
Subject ID/ Site ID/Age Group 
Visit 
Sample Collected 
Collection Date and Time/ Study Day 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxxx 
Yes 
DDMMMYYYY/HH:MM/ xx 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxxxx 
Yes 
DDMMMYYYY/HH:MM/ xx 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxxxx 
Yes 
DDMMMYYYY/HH:MM/ xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Author: 
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Version Number: 
1.0 
 
 
Version Date: 
[11AUG2017] 
Template No:  CS_TP_BS016  Revision 4 
Reference:  CS_WI_BS005 
Effective Date: 01Apr2016 
 
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Listing 16.2.8.2 
Physical Examination – Vital Signs 
Full Analysis Population 
CS: Clinically Significant; e-CRF: Electronic Case Report Form; PE: Physical Examination; NCS: Not Clinically Significant; 
[a]: Applicable only for Abnormal-Clinically significant PE findings. 
*denotes the baseline result. 
 
 
 
Programming Note: Sort by Treatment, Subject ID and Visit. 
 
Treatment 
 
Subject ID/ 
Site ID/Age 
Group 
Visit 
Assessment Date 
 
Vital Signs 
Result 
PE Finding/ 
Specify(e-CRF) 
Grading Scale 
[a] 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ 
xxxx 
Screening 
DDMMMYYYY 
Body Temperature (0C) 
Xxx* 
Normal 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ 
xxxx 
xxxxx 
DDMMMYYYY 
Systolic Blood 
Pressure(mmHg)  
Xxx 
Abnormal-NCS 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ 
xxxx 
xxxxx 
DDMMMYYYY 
Systolic Blood 
Pressure(mmHg)  
Xxx 
Abnormal-CS 
3 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ 
xxxx 
xxxxx 
DDMMMYYYY 
Pulse Rate (beats/min)  
Xxx 
Abnormal-CS/ 
xxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Version Number: 
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Version Date: 
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Effective Date: 01Apr2016 
 
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Listing 16.2.8.3 
Physical Examination – Abnormal Findings 
Full Analysis Population 
e-CRF: Electronic Case Report Form; CS: Clinically Significant; PE: Physical Examination; NCS: Not Clinically Significant; 
 
 
 
 
 
Programming Note: Sort by Treatment, Subject ID and Visit. 
 
 
 
Treatment 
 
Subject ID/ Site 
ID/Age Group 
Visit 
Assessment Date 
 
Area/System/  
Specify(e-CRF) 
Finding 
Description of 
Finding 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
Screening 
DDMMMYYYY 
Xxxxx 
Abnormal-NCS 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxxxx 
DDMMMYYYY 
xxxxx  
Abnormal-NCS 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ xxxx/ xxxx 
xxxxx 
DDMMMYYYY 
xxxxx  
Abnormal-CS 
xxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Version Number: 
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Version Date: 
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Effective Date: 01Apr2016 
 
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Listing 16.2.8.4 
Pregnancy Report 
Full Analysis Population 
 
 
Programming Note: Sort by Treatment and Subject ID. 
 
 
 
Treatment 
 
Subject 
ID/ 
Site 
ID/Age 
Group 
Test Date 
 
Date of Last 
Menstrual 
Period/ 
Estimated Date 
of Delivery 
Pregnancy 
History 
History of Fatal 
Anomalies/ 
History of 
Premature 
Births/ History 
of Fatal Deaths 
History of Still 
Births/ History 
of Miscarriage/ 
Other/ 
Specify(e-CRF) 
Medication 
Taken During 
Time of 
Contraception 
or During 
Pregnancy 
Additional 
Information/ 
Specify(e-CRF) 
Subject 
Willing to 
Contact After 
Delivery 
 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ 
xxxx/ 
xxxx 
DDMMMYYYY 
DDMMMYYYY/  
DDMMMYYYY 
Yes 
No/ No/ No 
No/ Yes/ No 
No 
Yes/ xxxxxx 
Yes 
 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ 
xxxx/ 
xxxx 
DDMMMYYYY 
DDMMMYYYY/  
DDMMMYYYY 
Yes 
Yes/ No/ No 
Yes/ No/ No 
No 
No 
Yes 
 
 
 
 
 
 
 
 
 
 
Vaccine 
xxxxx/ 
xxxx/ 
xxxx 
DDMMMYYYY 
DDMMMYYYY/  
DDMMMYYYY 
No 
 
 
 
No 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Version Number: 
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Version Date: 
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875
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Protocol No: IVACFLU-S-0203
Version 1.0
Dated: 12 March 2018

16.1.10 
Documentation of inter-laboratory standardization methods and 
quality assurance procedures 
Certifications of Accreditation 
Document 
Expiration Date 
Quality report by Vietnam Bureau of Accreditation (English 
Version) 
14 October 2016 
Quality report by Vietnam Bureau of Accreditation (Vietnamese 
Version) 
14 October 2016 
Pasteur Institute of Hochiminh City - Laboratory Respiratory 
Virus 
24 January 2017 
Pasteur Institute of Hochiminh City - Laboratory Respiratory 
Virus 
17 October 2020 
VidMederi Srl - Testing Laboratory 
17 December 2017 
VidMederi Srl - Medical Laboratory 
21 May 2019 
Criteria for Marked Vital Signs Abnormalities 
NA 
 
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MINISTRY OF SCIENCE AND 
TECHNOLOGY 
BUREAU OF ACCREDITATION 
 
SOCIALIST REPUBLIC OF VIETNAM 
Independence - Freedom - Happiness 
 
No.: 2271/VPCNCL 
Regarding the conformity assessment 
results 
Hanoi, date  14  month 10  year 2016   
To: LABORATORY OF RESPIRATORY VIRUS 
DEPARTMENT OF MICROBIOLOGY AND IMMUNOLOGY - PASTEUR 
INSTITUTE IN HO CHI MINH CITY 
Based on the surveillance visit report dated 12 - 13 July 2016, 
Based on the requests of the Certification Audit Team and the Review Committee dated 
22 September 2016. 
DIRECTOR OF BEREAU OF ACCREDITATION INFORMS THAT: 
Name of the organization recognized:  
LABORATORY OF RESPIRATORY VIRUS 
Of 
DEPARTMENT OF MICROBIOLOGY AND IMMUNOLOGY - PASTEUR 
INSTITUTE IN HO CHI MINH CITY 
Accreditation No. VILAS Med 012 according to the Decision No.: 520.2015 QD/VPCNCL 
dated 14 December 2015: Found to conform with the requirements for maintaining 
certification. 
Sincerely. 
Recipients: 
DIRECTOR 
 
- As mentioned above; 
- Filling: Office; 
- Laboratory Records. 
 
Signed and stamped 
 
 
VU XUAN THUY 
 
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.---~- Mod. 
L'ENTE ITALIANO DI ACCREDITAMENTO 
Membro de91i Acconii di Mutuo Rkonoscimento EA, lAF e llAC 
Signatory of EA, IAF and llAC Mutual Recognition Agn!Mlen" 
CERTIFICATO DI ACCREDITAMENTO 
Accreditation Certificate 
Accreditamento n° 
Accreditation n° 
Si dichiara che 
We declare that 
e Conforme ai requisiti 
della norma 
meets the requirements 
of the standard 
quale 
as 
1411 
VisMederi Sri 
Sede/Headquarters: 
Rev. 1 
Strada Petriccio e Belriguardo, 35 - 53100 Siena SI 
UNI CEI EN ISO/IEC 17025:2005 "Requisiti generali per la competenza dei 
Laboratori di prova e taratura" 
EN /SOI/EC 17025:2005 "General Requirements for the Competence of Testing 
and Calibration Laboratories" standard 
Laboratorio di Prova 
Testing Laboratory 
L'accreditamento attesta la competenza tecnica del Laboratorio relativamente allo scopo riportato nelle 
schede allegate al presente certificato. Le schede possono variare nel tempo. I requisiti gestionali della 
ISO/IEC 17025:2005 (sezione 4) sono scritti in un linguaggio idoneo all'attivita dei Laboratori di Prova, sono 
conformi ai principi della ISO 9001 :2008 ed allineati con i suoi requisiti applicabili. 
II presente certificato non e da ritenersi valido se non accompagnato dalle schede allegate e puo essere 
sospeso o revocato in qualsiasi momenta nel caso di inadempienza accertata da parte di ACCREDIA. 
La vigenza dell'accreditamento puo essere verificata sul sito WEB (www.accredla.it) o richiesta direttamente 
ai singoli Dipartimenti . 
The accreditation certifies the technical competence of the laboratory limited to the scope detailed in the 
attached Enclosure. The scope may vary in the time. The management system requirements in /SOI/EC 
17025:2005 (Section 4) are written in a language relevant to Testing Laboratories operations and meet the 
principles of ISO 9001 :2008 and are aligned with its pertinent requirements. 
The present certificate is valid only if associated to the annexed schedule, and can be suspended or 
withdrawn at any time in the event of non fulfilment as ascertained by ACCREDIA. 
The in force status of the accreditation may be checked in the WEB site (www.accredia.it) or on direct 
request to appointed Department. 
Data di 1 a emissione 
1st issue date 
2013-12-18 
Data di modifica 
Modification date 
2016-06-23 
II Direttore di Dipartimento 
Department Director 
(Dr.ssa Silvia Tramontin) 
Data di scadenza 
Expiring date 
2017-12-17 01-
•
I 
-
I 
" .• 
AC CR ED IA 
Sede operativa e legate: Via Guglielmo Saliceto, 7 /9 I 00161 Roma - Italy I Tel. +39 06 8440991 I Fax +39 06 8841199 
info@accredia.it I www.accredia.it I Partita IVA - Codice Fiscale 10566361001 
881
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.... 
ACC,~EDIA 
. , 
l'ENTE ITALIANO DI ACCREDrTAMENTO 
Membro degli Accardi di Mutuo Riconmcimento EA, IAF e ILAC 
Signatory of EA, IAF and llAC Mutual Recognition Agreements 
CERTIFICATO DI ACCREDITAMENTO 
Accreditation Certificate 
Accreditamento n° 
Accreditation n° 
Si dichiara che 
We declare that 
e Conforme ai requisiti 
della norma 
meets the requirements 
of the standard 
quale 
as 
0002 
VisMederi Sri 
Sede/Headquarters: 
Via Fiorentina 1 - 53100 Siena SI 
Rev. 1 
UNI EN ISO 15189:2013 "Laboratori medici - Requisiti riguardanti la qualita e la 
competenza" 
ISO 15189:2012 "Medical Laboratories - Requirements for Quality and 
Competence" standard 
Laboratorlo medico 
Medical Laboratory 
L'accreditamento attesta la competenza tecnica del Laboratorio relativamente allo scopo riportato nelle 
schede allegate al presente certificato. Le schede possono variare nel tempo. I requisiti gestionali della ISO 
15189:2012 (sezione 4) sono scritti in un linguaggio idoneo all'attivita dei Laboratori medici, sono conformi ai 
principi della ISO 9001 :2008 ed allineati con i suoi requisiti applicabili. 
II presente certificate non e da ritenersi valido se non accompagnato dalle schede allegate e puo essere 
sospeso o revocato in qualsiasi momenta nel caso di inadernpienza accertata da parte di ACCREDIA. 
La vlgenza dell'accreditamento pu6 essere verificata sul sito WEB (www.accredia.it) o richiesta direttamente 
al singoli Dipartimentl . 
The accreditation certifies the technical competence of the laboratory limited to the scope detailed in the 
attached Enclosure. The scope may vary in the time. The management system requirements in ISO 
15189:2012 (Section 4) are written in a language relevant to Medical Laboratories operations and meet the 
principles of ISO 9001 :2008 and are aligned with its pertinent requirements. 
The present certificate is valid only if associated to the annexed schedule, and can be suspended or 
withdrawn at any time in the event of non fulfilment as asce1tained by ACCREDIA. 
The in force status of the accreditation may be checked in the WEB site (www.accredia.it) or on direct 
request to appointed Department. 
Data di 1 a emissione 
1st issue date 
2015-05-22 
___ 
... 
Mod
-..· CA·01 r.W. 01 
AC CR ED IA 
Data di modifica 
Modification date 
2016-02-18 
II Direttore di Dipartimento 
Department Director 
(Dr.ssa Silvia Tramontin) 
Data di scadenza 
Expiring date 
2019-05-21 
~Pride 
/ (} f~~ President 
(Ing. Giuseppe Rossi) 
Pag. 1di1 
Sede operativa e /egale: Via Guglielmo Saliceto, 7 /9 I 00161 Roma - Italy I Tel. +39 06 8440991 I Fax +39 06 8841199 
info@accredia.it I www.accredia.it I Partita IVA - Cadice Fiscale 10566361001 
882
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Protocol No: IVACFLU-S-0203
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Dated: 12 March 2018

Criteria for Marked Vital Signs Abnormalities 
Vital sign 
Assessment criteria 
Body 
temperature 
(oral)  
 Normal: 36.4 - 37.2 0C. 
 Abnormal - NCS: 37.3 - 37.90C; OR < 36.40C and there are no clinical 
signs or symptoms which require intervention.  
 Abnormal - CS: ≥ 38.00C OR < 36.40C and there are clinical signs or 
symptoms which need intervention 
Blood 
pressure 
(mmHg) 
 Normal: 90 - 120 mmHg systolic OR 60 - 85 mmHg diastolic. 
 Abnormal - NCS: 
Upward trend 
- 
121 - 139 mmHg systolic AND/OR  
- 
86 - 89 mmHg diastolic 
Downward trend 
- 
85-89 mmHg systolic AND/OR 50 - 59 mmHg diastolic 
 For the participants who have grade 1 elevated blood pressure, the 
Investigator will judge if it is clinically significant or not based on 
the medical history and physical examination, e.g., history of 
elevated blood pressure, blood pressure monitoring and treatment, 
presence of clinical signs or symptoms which need intervention, 
presence of risk factors (obesity, too much alcohol, tobacco use); 
the Investigator should also refer to the local guideline for 
diagnosis and treatment of high blood pressure. If the findings are 
clinical significant, they should be graded according to the 
DAIDS Table For Grading the Severity in the protocol and MOP 
04. 
 Similarly, if the participants have < 85 mmHg systolic OR 
< 50mmHg diastolic; the Investigator will judge it is clinically 
significant when the participants have clinical signs or symptoms 
which need intervention.  
 For the 2 cases above, the Investigator should record the reason for his 
assessment in the subject binders.  
 Grade 2 elevated blood pressure will be judged to be clinically 
significant.  
 Note: 
 For those who have history of elevated blood pressure, they will be judged 
to be non-clinically significant and enrolled according to the criterium #4 
if they are stable for the past 3 months and the medication dose is stable 
for at least 1 month preceding vaccination. 
 For those who have clinically significant abnormalities, the study 
doctor will consult and refer the participants to the health facilities for 
diagnosis and treatment.  
883
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Protocol No: IVACFLU-S-0203
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Vital sign 
Assessment criteria 
 Life-threatening blood presure is defined to be grade 3 elevated 
blood pressure along with one of the following symptoms which 
require hospitalization indicated, e.g., headache, breathing difficulty, 
blurred vision, chest pain.  
Pulse rate 
 Normal: 60 - 90 beats/min. 
 Abnormal - NCS: 55 - < 60 beats/min or 91-100 beats/min. 
 Abnormal - CS: < 55 beats/min, or > 100 beats/min and there are clinical 
signs or symptoms which need intervention or there are abnormal cardiac 
findings after examination. For this case, the Investigator should record 
the reason for his assessment in the subject binder. 
 Note: There is no grading scale for pulse rate. 
 
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16.1.11 
Publications based on the study 
In Progression 
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16.1.12 
Important publications referenced in the report 
Available Upon Request. 
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