A Phase 2, Randomized, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Several Doses of Antigen and MF59 Adjuvant Content in a Monovalent H5N1 Pandemic Influenza Vaccine in Healthy Pediatric Subjects 6 Months to < 9 Years of Age
Phase: PHASE2
Conditions: Influenza, Human
Sponsor: Seqirus

Seqirus 
 
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CLINICAL STUDY PROTOCOL  
 
Study Number 
V87_30 
Protocol Version 
Version 5, Final, 24-JUN-2020 
Study Title 
A Phase 2, Randomized, Observer-Blind, Multicenter Study 
to Evaluate the Immunogenicity and Safety of Several Doses 
of Antigen and MF59 Adjuvant Content in a Monovalent 
H5N1 Pandemic Influenza Vaccine in Healthy Pediatric 
Subjects 6 Months to < 9 Years of Age 
Study Phase 
Phase 2 
Product Name 
H5N1 Pandemic influenza vaccine (surface antigen, 
inactivated, adjuvanted) 
Regulatory Agency 
 
IND: Not applicable 
Identifying Number(s)  
EudraCT number: 2016‐001898‐32 
Sponsor: 
Seqirus UK Ltd. 
 
Previous Version 
Final Version 4 
Date 
20-DEC-2019 
 
 
 
 
 
 
Property of Seqirus* 
Confidential 
May not be used, divulged, published or otherwise disclosed without written consent 
of Seqirus 
“Seqirus” includes all legal entities under which the company operates 

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Table of Contents 
PROTOCOL SYNOPSIS V87_30 ....................................................................................... 6 
Table 1: Vaccination schedule .................................................................................. 12 
Table 2: Time and Events Table ............................................................................... 15 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ...................................... 18 
1. 
BACKGROUND AND RATIONALE .................................................................... 20 
1.1 
Background .......................................................................................................... 20 
1.2 
Rationale .............................................................................................................. 21 
1.3 
Potential Risks and Benefits ................................................................................ 22 
2. 
OBJECTIVES ........................................................................................................... 23 
2.1 
Primary Objective(s) ............................................................................................ 23 
2.2 
Secondary Objective(s) ........................................................................................ 23 
2.3 
Exploratory Objective(s) ..................................................................................... 23 
3. 
STUDY DESIGN ..................................................................................................... 24 
3.1 
Overview of Study Design ................................................................................... 24 
3.2 
Study Period ......................................................................................................... 25 
3.3 
Blinding Procedures ............................................................................................. 26 
3.4 
Data Collection .................................................................................................... 26 
3.4.1 Data Collected from Subjects .......................................................................... 26 
3.4.2 Tools Used for Data Collection .................................................................... 27 
3.5 
Collection of Clinical Specimens ........................................................................ 28 
3.6 
Stopping/Pausing Guidelines ............................................................................... 29 
3.7 
Independent Data Monitoring Committee ........................................................... 29 
3.8 
Premature Withdrawal from Study ...................................................................... 29 
3.9 
End of Study ........................................................................................................ 31 
4. 
SELECTION OF STUDY POPULATION .............................................................. 33 
4.1 
Inclusion Criteria ................................................................................................. 33 
4.2 
Exclusion Criteria ................................................................................................ 33 

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4.3 
Criteria for Delay of Vaccination ........................................................................ 35 
4.4 
Criteria for Repeat Vaccination in the Study ....................................................... 35 
5. 
STUDY PROCEDURES .......................................................................................... 37 
Table 5: Study Procedures ........................................................................................ 37 
5.1 
Pre-vaccination Clinic Visit(s) ............................................................................ 37 
5.1.1 Informed Consent/Assent ............................................................................. 37 
5.1.2 Screening ...................................................................................................... 38 
5.1.3 Enrolment ..................................................................................................... 40 
5.1.4 Randomization .............................................................................................. 40 
5.1.5 Blood draw.................................................................................................... 41 
5.2 
Vaccination Clinic Visit(s) .................................................................................. 41 
5.2.1 Post-vaccination Procedures ......................................................................... 42 
5.2.2 Post-vaccination Reminders ......................................................................... 43 
5.3 
Post-vaccination Visit(s) ...................................................................................... 43 
5.3.1 Follow-up Clinic Visit(s) .............................................................................. 43 
5.3.2 Safety Follow-up Calls ................................................................................. 44 
5.4 
Unscheduled Visits .............................................................................................. 45 
5.5 
Study Termination Visit ...................................................................................... 45 
5.5.1 Early Termination Visit ................................................................................ 45 
6. 
TREATMENT OF SUBJECTS ................................................................................ 47 
6.1 
Study Vaccine(s) .................................................................................................. 47 
Table 6.1: H5N1 HA and MF59 content of the 6 vaccine formulations. ................. 47 
Table 6.2: Full composition of the active vaccine components. .............................. 48 
6.2 
Non-Study Vaccines ............................................................................................ 48 
6.3 
Vaccine Preparation and Administration ............................................................. 49 
6.4 
Vaccine Administration Error or Overdose of Vaccine ...................................... 50 
6.5 
Prior and Concomitant Medications and Vaccines .............................................. 50 
6.6 
Vaccine Supply, Labeling, Storage and Tracking ............................................... 51 
7. 
ASSESSMENTS ...................................................................................................... 54 

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7.1 
Safety Assessment ............................................................................................... 54 
7.1.1 Solicited Adverse Events ................................................................................. 54 
7.1.2 Unsolicited Adverse Events .......................................................................... 57 
7.1.3 Evaluation of Adverse Events ...................................................................... 57 
7.1.4 Serious Adverse Events ................................................................................ 59 
7.1.5 Methods for Recording Adverse Events and Serious Adverse Events ......... 61 
7.1.6 Pregnancies ................................................................................................... 62 
7.1.7 Safety Laboratory Measurements ................................................................. 62 
7.2 
Efficacy Assessment ............................................................................................ 62 
7.3 
Immunogenicity Assessment ............................................................................... 62 
8. 
STATISTICAL CONSIDERATIONS ..................................................................... 64 
8.1 
Endpoints ............................................................................................................. 64 
8.1.1 Primary Endpoint(s)...................................................................................... 64 
8.1.2 Secondary Endpoint(s).................................................................................. 65 
8.1.3 Exploratory Endpoint(s) ............................................................................... 66 
8.2 
Success Criteria ................................................................................................... 66 
8.2.1 Success Criteria for Primary Objective(s) .................................................... 66 
8.2.2 Success Criteria for Secondary Objective(s) ................................................ 67 
8.3 
Analysis Sets ........................................................................................................ 67 
8.3.1 All Enrolled Set ............................................................................................ 67 
8.3.2 All Exposed Set ............................................................................................ 67 
8.3.3 Safety Set ...................................................................................................... 67 
8.3.4 Full Analysis Set (FAS) Efficacy/Immunogenicity Set................................ 68 
8.3.5 Per Protocol Set (PPS) Efficacy/Immunogenicity Set .................................. 68 
8.3.6 Other Analysis Sets....................................................................................... 69 
8.3.7 Subgroups ..................................................................................................... 69 
8.3.8 Protocol Deviations ...................................................................................... 69 
8.4 
Statistical Analysis Plan ...................................................................................... 69 
8.4.1 Analysis of Demographic and Baseline Characteristics ............................... 69 

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8.4.1.1 Subject Disposition ....................................................................................... 70 
8.4.1.2 Concomitant Medications ............................................................................. 70 
8.4.2 Analysis of Primary Objective(s) ................................................................. 70 
8.4.3 Analysis of Secondary Objective(s) ............................................................. 73 
8.4.4 Analysis of Exploratory Objectives .............................................................. 75 
8.5 
Sample Size and Power Considerations of Primary  Objective ........................... 75 
8.6 
Interim Analysis ................................................................................................... 76 
9. 
SOURCE DOCUMENTATION, STUDY MONITORING AND AUDITING ...... 77 
9.1 
Source Documentation ......................................................................................... 77 
9.2 
Study Monitoring, Auditing and Source Data Verification ................................. 78 
10. 
DATA MANAGEMENT ......................................................................................... 79 
10.1 Data Entry and Management ............................................................................... 79 
10.2 Data Clarification ................................................................................................. 79 
10.3 Data Protection .................................................................................................... 79 
11. 
RECORD RETENTION .......................................................................................... 80 
12. 
USE OF INFORMATION AND PUBLICATION .................................................. 81 
13. 
ETHICAL CONSIDERATIONS ............................................................................. 82 
13.1 Regulatory and Ethical Compliance .................................................................... 82 
13.2 Informed Consent Procedures .............................................................................. 82 
13.3 Responsibilities of the Investigator and IRB/EC ................................................. 83 
13.4 Protocol Amendments ......................................................................................... 84 
14. 
REFERENCE LIST .................................................................................................. 85 
Appendix A: Adverse Events of Special Interest .......................................................... 87 
 

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PROTOCOL SYNOPSIS V87_30  
Name of sponsor:  
Seqirus UK Ltd. 
Protocol number:  
V87_30 
Generic name of study vaccine(s): 
H5N1 Pandemic influenza vaccine 
(surface antigen, inactivated, 
adjuvanted) 
Title of Study:  
A Phase II, Randomized, Observer-Blind, Multicenter Study to Evaluate the 
Immunogenicity and Safety of Several Doses of Antigen and MF59 Adjuvant Content in 
a Monovalent H5N1 Pandemic Influenza Vaccine in Healthy Pediatric Subjects 6 
Months to < 9 Years of Age 
Study Period: 
Each subject is expected to participate in the 
study for approximately 12 months 
Clinical Phase:  
2 
Background and Rationale: 
The purpose/aim of this study is to evaluate responses to vaccination with different 
adjuvanted pandemic influenza vaccine formulations in pediatric subjects. The data from 
this study are intended to provide information for health authorities to determine the best 
formulation for protection of children during the pandemic phase of a pandemic of a 
novel pandemic influenza strain (World Health Organization (WHO) 2013). Although 
the criteria for formulation selection for use in children are still under discussion with 
health authorities such as European Medicines Agency (EMA), it is expected that the 
results from this study will provide enough information for individual health authorities 
to select the appropriate formulation in the situation of an actual pandemic. 
Pandemic influenza differs from seasonal influenza by representing a novel influenza 
strain, to which humans are immunologically naive, and has the potential for heavily 
impacting a young otherwise healthy population. If sustained human-to-human 
transmission were to occur with a pandemic influenza strain, global spread is likely, and 
morbidity and mortality could be staggering if efforts to contain the spread were not 
implemented quickly. Vaccination is the best option by which spread of a pandemic 
virus could be minimized or prevented. Vaccination efforts would be further enhanced 
by identification of the fewest number of vaccinations and lowest antigen dose needed 
for protection of segments of the population. The present study design will evaluate 
different pandemic influenza vaccine formulations in children after 2 doses of vaccine. 
The formulations proposed are based on prior experience with pandemic influenza A 

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Name of sponsor:  
Seqirus UK Ltd. 
Protocol number:  
V87_30 
Generic name of study vaccine(s): 
H5N1 Pandemic influenza vaccine 
(surface antigen, inactivated, 
adjuvanted) 
strains evaluated with and without MF59C.1 (hereafter referred to as MF59) adjuvant at 
varying antigen doses. MF59 adjuvant has been safely combined with influenza antigens 
given to children in clinical trials and use during the 2009 pandemic, and offers an 
important option for lowering the required antigenic dose for priming of 
immunologically naive individuals. As dose sparing is a key attribute of pandemic 
influenza vaccine candidates and as MF59 has been included in other licensed pandemic 
influenza vaccines administered to children (Focetria and Celtura), this study will not 
include non-adjuvanted comparator vaccine arms. In addition, as immune responses to 
MF59 adjuvanted influenza vaccine in children over 9 years of age appear to be similar 
to responses seen in adolescents and adults (Vesikari et al. 2010, Chotpitayasunondh et 
al. 2008), this trial will focus on the response seen in younger children, and will enroll 
children in age cohorts of 6 months to <36 months and 3 to <9 years. 
The aH5N1 vaccine is an MF59-adjuvanted influenza vaccine that has been approved for 
active immunization against the H5N1 subtype of influenza A virus in adults and elderly 
(ages 18 years and older). The current study is designed to evaluate the safety and 
immunogenicity of two vaccinations of aH5N1 in healthy subjects aged 6 months to 
<9 years. 
The study is designed to obtain safety and immunogenicity data with the formulations 
gauged likely to be most successful against the pandemic strain. Endpoints used in other 
trials of pandemic and seasonal influenza trials that examine responses in 
haemagglutination inhibition (HI) and microneutralization (MN) assays, respectively 
according to titers of 40 or greater and 4-fold or higher increases in titer, are included in 
the design to allow for maximum flexibility in selecting the antigen formulation for use 
in children.  
 
 

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Study Objectives:  
Primary Safety Objective:  
• To evaluate the safety in each study vaccine group from Day 1 through Day 387, 
by total population and by age cohort. 
Primary Immunogenicity Objective:  
• To assess by total population and by age cohort, the antibody responses to each 
of the study vaccines prior to (Day 1) and at 3 weeks after the first or second 
vaccination (Day 22 or Day 43), as measured by HI and MN assays.  
Secondary Immunogenicity Objectives: 
• To evaluate in each study vaccine group, by total population and by age cohort, 
the persistence of antibody responses to the H5N1 vaccine strain 6 months after 
the second vaccination (Day 202) as measured by HI and MN assays. 
Exploratory Objectives: 
• To further evaluate the antibody responses to seasonal and/or homologous and/or 
heterologous pandemic influenza strain(s), as measured by the HI, MN or SRH 
assays (depending on availability of adequate sera and on assay availability). 
Study Design: 
This randomized, observer blind, multi-center clinical trial evaluates the immunogenicity 
in healthy children 6 months to < 9 years of age utilizing 6 different aH5N1 vaccine 
formulations, in order to describe the possible impact of decreasing the quantities of 
antigen and/or adjuvant dosage on the antibody responses. In addition, levels of antibody 
persistence (at Day 202) and the safety profile of each vaccine regimen will be assessed. 
Eligible subjects will be stratified by age at the time of enrollment into one of 2 age 
cohorts and within each age cohort will be randomly assigned (equally) to 1 of 6 study 
vaccine groups. Subjects in each study vaccine group will be scheduled to receive 2 
injections of aH5N1 vaccine 3 weeks apart.  
The vaccine regimens are: 
A. Lowest-dose, less-adjuvanted vaccine = 1.875 μg H5N1 antigen + 0.125 mL 
MF59 adjuvant, with 2 consecutive administrations: dose 1 at Day 1 and dose 2  
at Day 22  

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B. Low-dose, less-adjuvanted vaccine = 3.75 μg H5N1antigen + 0.125 mL MF59 
adjuvant, with 2 consecutive administrations: dose 1 at Day 1 and dose 2 at  
Day 22  
C. Mid-dose, less-adjuvanted vaccine = 7.5 μg H5N1 antigen + 0.125 mL MF59 
adjuvant, with 2 consecutive administrations: dose 1 at Day 1 and dose 2 at  
Day 22  
D. Lowest-dose, adjuvanted vaccine = 1.875 μg H5N1 antigen + 0.25 mL MF59 
adjuvant, with 2 consecutive administrations: dose 1 at Day 1 and dose 2 at  
Day 22  
E. Low-dose, adjuvanted vaccine = 3.75 μg H5N1 antigen + 0.25 mL MF59 
adjuvant, with 2 consecutive administrations: dose 1 at Day 1 and dose 2  
at Day 22  
F. Mid-dose, adjuvanted vaccine = 7.5 μg H5N1 antigen + 0.25 mL MF59 
adjuvant, with 2 consecutive administrations: dose 1 at Day 1 and dose 2 at Day 
22  
Immunogenicity will be measured by HI and MN assays. Blood samples for serology 
assessments will be collected from each subject on Day 1 (before vaccination), and Day 
22 (before vaccination), Day 43, and Day 202.  
For all subjects, study participation includes a total of 4 clinic visits, 2 reminder calls, 
and 3 safety calls through the treatment and follow-up periods (a total study duration of 
approximately 12 months). 
Treatment period (Day 1 through Day 43): 3 clinic visits and 2 diary completion 
reminder calls. 
Follow-up period (Day 44 through Day 387): 1 clinic visit and 3 safety calls. 
Vaccine administration will be performed intramuscularly (IM), anterolateral thigh for 
children ages < 2 years; deltoid for children ages ≥ 2 years, unless insufficient deltoid 
mass. Each vaccine administration will be performed in an observer-blind manner (ie, 
efforts should be taken to shield the subject/parent/legally acceptable representative and 
blinded study team members from the view of the vaccine administration). To maintain 
the observer-blind design of the study, the roles and responsibilities of “blinded” and 
“unblinded” team members will be defined and maintained in a site-specific blinding 

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plan. Safety assessments and study-related procedures and monitoring thereof must be 
performed by “blinded” team members. 
After each vaccination, all subjects will remain under medical supervision at the study 
site for at least 30 minutes to be monitored and evaluated for adverse events (AEs). 
Subject Diary Cards will be provided to subjects for recording of local and systemic 
reactions for 7 consecutive days after each vaccination.  
The Subject Diary Cards will collect solicited AEs, and associated medications from 
Day 1 to Day 7 (inclusive) and from Day 22 to Day 28 (inclusive). Solicited AEs that 
continue beyond Day 7 and 28 respectively, and medications given to treat them, will be 
collected in the Subject Diary Card until the time of return to the clinic on Day 22 and 
43, respectively, must be recorded as unsolicited AEs. In addition, during the treatment 
period (Day 1 through Day 43), all AEs, serious adverse events (SAEs), all adverse 
events of special interest (AESI), new onset of chronic disease (NOCD), AEs leading to 
vaccine/study withdrawal, associated concomitant medications for any of these events, 
and all vaccinations will be collected. These data will be captured by interview of the 
parent(s)/legally acceptable representative (s)(LARs), and if available by review of 
medical records. 
During the follow-up period (Day 44 through Day 387), only a subset of unsolicited AEs 
and the medications/vaccinations used to treat these will be collected and included in the 
subjects eCRFs: all SAEs, NOCDs, AEs leading to vaccine and/or study withdrawal 
and/or delay, and AESIs (as described in section 7.1 of the current protocol). These data 
will be captured by interviewing the parent(s)/ LAR(s) and/or by reviewing the available 
medical records. 
Number of Subjects planned:  
A total of 420 subjects between 6 months and less than 9 years of age, are planned to be 
enrolled. Allocation to each of 6 vaccine regimens will be randomized in an equal ratio 
(1:1:1:1:1:1) stratified by age 6 months through < 36 months and 3 years through 
< 9 years of age. Approximately 35 subjects will be randomized per vaccine group in 
each age cohort. 
Study Population and Subject Characteristics: 
This study will enroll pediatric subjects 6 months <9 years of age in good health as 
determined by medical history, physical assessments, and clinical judgment of the 
investigator, if the parent(s) or LAR(s) have given consent, are able to follow all the 
required study procedures for the whole period of the study, and a baseline blood sample 
has been collected.  

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Subjects will be excluded when suffering from progressive, unstable or uncontrolled 
clinical conditions; hypersensitivity, including allergy, to any component of vaccines, 
medicinal products or medical equipment whose use is foreseen in this study; clinical 
conditions representing a contraindication to intramuscular vaccination or blood draws; 
experienced a body temperature ≥ 38.0°C within 3 days before intended study 
vaccination; clinical suspicion of pandemic influenza illness within the past six months; 
abnormal function of the immune system resulting from clinical conditions or systemic 
administration of corticosteroids (per os [PO]/intravenously [IV]/IM) for more than 14 
consecutive days or administration of antineoplastic and immunomodulation agents or 
radiotherapy, prior to each study vaccination. 
The list of inclusion and exclusion criteria is included in protocol section 4, Selection of 
Study Population. 
Study Procedures: 
Written informed consent (and assent if applicable) must be obtained prior to the 
conduct of any study-related procedures. The informed consent process may be 
conducted up to 10 days before day of vaccination (Day 1) or may be conducted on the 
day of vaccination (Day 1). Pre-vaccination study procedures will include: baseline 
physical examination, height and weight; review of medical history and concomitant 
medications; body temperature measurement; determination of eligibility; baseline blood 
draw and randomization. Prior to the second study vaccine administration (Day 22), 
review of eligibility, the Subject Diary Card, concomitant medication and body 
temperature measurement will be repeated, as well as blood sampling as described 
below. 
Blood samples for serology (approximately 6 mL for HI and MN antibody responses) 
will be drawn after temperature measurement, ie, confirmation subject does not have 
fever (body temperature ≥ 38.0°C) on Day 1 (before randomization), Day 22 (before 
study vaccine administration), Day 43, and on Day 202. 
Post-vaccination study procedures will include a 30 min safety assessment (vaccination 
visits only), safety data collection via the 7-day Subject Diary Card, periodic safety 
telephone calls, and interviews at clinic visits, to obtain safety data as described in the 
endpoints section. Each clinic visit will include a symptom-directed physical exam. As 
much safety data as possible should be collected at early termination visits, such as 
collection of the Subject Diary Card (if applicable) and interview, and blood sampling 
for serology, if applicable. 

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Study Vaccines: 
Six different formulations including per dose either 1.875, 3.75, or 7.5 µg hemagglutinin 
antigen (HA) of pandemic H5N1 influenza strain combined with either 0.125 mL or 0.25 
mL MF59, in two IM injections. Note that 7.5 µg HA of H5N1 influenza strain 
combined with 0.25 mL MF59 in a total injection volume of 0.5 mL is the currently 
licensed adult formulation for aH5N1 and seasonal influenza vaccines contain 15 µg HA 
per influenza strain. Vaccination schedule of the study vaccine for the 6 vaccine group 
assignments is shown in Table 1. 
Table 1: Vaccination schedule 
Arm* Description 
Day 1 
Day 22 
A 
1.875 µg + 50% MF59 0.25 mL 
1.875 μg 
1.875 μg 
B 
3.75 µg + 50% MF59 0.25 mL 
3.75 μg 
3.75 μg 
C 
7.5 µg + 50% MF59 0.25 mL 
7.5 μg 
7.5 μg 
D 
1.875 µg + 100% MF59 0. 5 mL 
1.875 μg 
1.875 μg 
E 
3.75 µg + 100% MF59 0.5 mL 
3.75 μg 
3.75 μg 
F 
7.5 µg + 100% MF59 0.5 mL 
7.5 μg 
7.5 μg 
*Approximately 70 subjects will be randomized per treatment arm, ie, 35 subjects in each age cohort. 
Primary Endpoints: 
Safety Endpoints: 
The measures for assessing safety are as follows: 
• Percentages of subjects with solicited local and systemic AEs1 that occur within 
7 days following each vaccination and calculated for 4 time intervals after 
vaccination: 30 minutes, 1 through 3 days, 4 through 7 days, and 1 through 7 
days 
• Percentages of subjects with any unsolicited AEs reported within 21 days after 
each vaccination within each vaccine group 
                                                 
1 Including the use of antipyretics/analgesics. 

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• Percentages of subjects reporting SAEs, NOCDs, AESIs, AEs leading to vaccine 
and/or study withdrawal as collected from Day 1 through Day 387 
Primary Immunogenicity Endpoints: 
The measures of immunogenicity, as determined by the HI and MN assay against the 
H5N1 antigen include the following: 
• Geometric mean titers on Day 1 and Day 22 (3 weeks after the first vaccination) 
or Day 43 (3 weeks after the second vaccination), as determined by HI and MN 
assays against the homologous H5N1 pandemic influenza strain; 
• Geometric mean ratios calculated as follows: Day 22/Day 1 or Day 43/Day 1 as 
determined by HI and MN assays against the homologous H5N1 pandemic 
influenza strain; 
• Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-
fold increase from a detectable Day 1 titer) on Day 22 or 43; 
• Percentage of subjects achieving seroconversion with a titer ≥ 1:40 on Days 1, 
22, or 432. 
Secondary Immunogenicity Endpoints: 
• Geometric mean titers on Day 1 and Day 202 (6 months after the second 
vaccination) as determined by HI and MN assays; 
• Geometric mean ratios calculated as follows: Day 202/Day 1 as determined by 
HI and MN assays; 
• Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-
fold increase from a detectable Day 1 titer) on Day 202; 
• Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 2023; 
Exploratory Immunogenicity Endpoint(s): 
Exploratory endpoints of seasonal and homologous and/or heterologous strain testing 
will be described in the SAP. 
                                                 
2 Percentage of subjects achieving a titer ≥1:40 on Days 1, 22, or 43 
3 Percentage of subjects achieving a titer ≥1:40 on Day 202 

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Statistical Analyses:  
There are no statistical (null) hypothesis associated with the immunogenicity and safety 
objectives, and all data will be analyzed descriptively. Statistical analyses of the 
immunogenicity endpoints will include point estimates and the associated 95% 
confidence intervals (CIs). As the decision on objectives does not involve testing 
procedures, adjustment for multiplicity is not applicable.  
Interim Analysis:  
No interim analysis is planned.  
Independent Data Monitoring Committee:  
An independent data monitoring committee (IDMC) will not be utilized for this study. 

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Table 2: Time and Events Table  
 
 
Treatment period 
Follow-up period 
 
Visit Type 
clinic 
visit 
Diary 
reminder 
phone call 
clinic 
visit 
Diary 
reminder 
phone call 
clinic 
visit* 
safety 
phone call 
safety 
phone call 
clinic 
visit* 
safety phone 
call 
 
Study Daya 
1 
V1 + 4 
V1 + 21 
V2 + 4 
V2 + 21 
V2 + 70 
V2 + 130 
V2 + 180 
V2+ 365 
 
Visit Window (days) 
-10/0 
-1/+1 
-1 to +7 
-1/+1 
-1 to +7 
-7 to +7 
-7 to +7 
-7 to +7 
-7 to +7 
 
Visit Number 
V1 
n/a 
V2 
n/a 
V3 
V4 
V5 
V6 
V7 
Study event 
references 
 
study treatment 
vaccination  
section 5.2 
X 
 
X 
 
 
 
 
 
 
screening and safety 
informed consentb 
section 5.1.1 
X 
 
 
 
 
 
 
 
 
demographicsc 
section 5.1.2  
X 
 
 
 
 
 
 
 
 
review of systemsc 
section 5.1.2 
X 
 
X 
 
X 
 
 
X 
 
clinical signsc 
section 5.1.2 
X 
 
Xd 
 
 
 
 
 
 
medical historyc, e 
section 5.1.2 
X 
 
 
 
 
 
 
 
 
physical examc, f 
sections 5.1.2 and 
5.3.1 
X 
 
X 
 
X 
 
 
X 
 
exclusion/inclusion 
criteriag 
section 4 
X 
 
X 
 
 
 
 
 
 
randomizationh 
section 5.1.4 
X 
 
 
 
 
 
 
 
 

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Treatment period 
Follow-up period 
 
Visit Type 
clinic 
visit 
Diary 
reminder 
phone call 
clinic 
visit 
Diary 
reminder 
phone call 
clinic 
visit* 
safety 
phone call 
safety 
phone call 
clinic 
visit* 
safety phone 
call 
 
Study Daya 
1 
V1 + 4 
V1 + 21 
V2 + 4 
V2 + 21 
V2 + 70 
V2 + 130 
V2 + 180 
V2+ 365 
 
Visit Window (days) 
-10/0 
-1/+1 
-1 to +7 
-1/+1 
-1 to +7 
-7 to +7 
-7 to +7 
-7 to +7 
-7 to +7 
 
Visit Number 
V1 
n/a 
V2 
n/a 
V3 
V4 
V5 
V6 
V7 
Study event 
references 
 
30 minutes post 
injection assessment 
section 5.2.1 
X 
 
X 
 
 
 
 
 
 
Subject Diary Card 
dispensed with training 
section 5.2.1 
X 
 
X 
 
 
 
 
 
 
Subject Diary Card 
reminder calli 
section 5.2.2 
 
X 
 
X 
 
 
 
 
 
Subject Diary Card 
reviewed and collectedj 
section 5.3.1 
 
 
X 
 
X 
 
 
 
 
assess all AEs 
section 7.1 
X 
 
X 
 
X 
 
 
 
 
assess SAEs 
section 7.1.4 
X 
 
X 
 
X 
X 
X 
X 
X 
assess NOCDs, AEs 
leading to withdrawal, 
AESIs 
sections 7.1.4.1 and 
7.1.3 
X 
 
X 
 
X 
X 
X 
X 
X 
assess relevant 
medicationsk 
sections 5.1.2 and 6.5 
X 
 
X 
 
X 
X 
X 
X 
X 
Immunogenicity 
serology blood drawl 
section 3.5 
Xm 
 
X 
 
X 
 
 
X 
 

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Treatment period 
Follow-up period 
 
Visit Type 
clinic 
visit 
Diary 
reminder 
phone call 
clinic 
visit 
Diary 
reminder 
phone call 
clinic 
visit* 
safety 
phone call 
safety 
phone call 
clinic 
visit* 
safety phone 
call 
 
Study Daya 
1 
V1 + 4 
V1 + 21 
V2 + 4 
V2 + 21 
V2 + 70 
V2 + 130 
V2 + 180 
V2+ 365 
 
Visit Window (days) 
-10/0 
-1/+1 
-1 to +7 
-1/+1 
-1 to +7 
-7 to +7 
-7 to +7 
-7 to +7 
-7 to +7 
 
Visit Number 
V1 
n/a 
V2 
n/a 
V3 
V4 
V5 
V6 
V7 
Study event 
references 
 
Study termination/completion 
Study completionn 
section 5.5 
 
 
 
 
 
 
 
 
X 
Notes: * In the exceptional case that a clinic visit is not possible due to the site being closed, with appropriate sponsor approvals a home visit may be considered. 
a Visit 1 (vaccination visit) is the baseline for calculating visit 2 and 3; Visit 2 is the baseline for calculation of all following visits; b Confirm consent form (and if applicable 
assent form) signed prior to any procedures. The informed consent process may be conducted earlier, but within 10 days prior to Day 1. c Pre-vaccination procedures may 
occur within 10 days prior to or within the Day 1 visit, if procedures are performed prior to Day 1 inclusion/exclusion criteria have to be rechecked, and the subject’s 
eligibility must be confirmed prior to the Day 1 vaccination; d clinical signs includes weight, height and temperature measurement before the 1st vaccination, and only 
temperature measurement before 2nd vaccination; e Including prior and concomitant medications. f A physical examination will be based on a review of systems, ie, a 
structured interview for complaints for each organ system; g.To be checked prior to each vaccination; h Randomization only to be done if baseline blood sample has been 
collected. i A reminder call after each vaccination should occur between 3 to 5 days following vaccination; j If a clinic visit is not possible, review should be completed upon 
return of the Subject Diary card. k 24 hours prior to vaccination antipyretic medication is not allowed; l Blood sample for serology to be taken after temperature measurement, 
but prior to vaccination; m Subjects must provide a baseline blood sample after informed consent, but before randomization, up to 10 days prior to the 1st vaccination. n 
Subjects who terminate the study early should complete an early termination visit when possible, see section 5.5.1, Early Termination Visit. 
 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
AE 
Adverse Event 
AESI 
Adverse Events of Special Interest 
aH5N1 
Monovalent H5N1 Influenza Vaccine Including MF59C.1 Adjuvant 
CI 
Confidence Interval 
CPMP 
Committee of Proprietary Medicinal Products 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EMA 
European Medicine Agency  
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GMR 
Geometric Mean Ratio 
GMT 
Geometric Mean Titer 
HA 
Hemagglutinin Antigen 
HI 
Hemagglutination Inhibition 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
ID 
Identification 
IDMC 
Independent Data Monitoring Committee 
IM 
Intramuscular(ly) 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
ISF 
Investigator Study File 
IV 
Intravenous(ly) 
LAR 
Legally acceptable representative 
LLD 
Lower Limit of Detection 
MedDRA 
Medical Dictionary for Regulatory Activities  
MCAR 
Missing Completely and Random  
MN 
Microneutralization 
NOCD 
New-Onset Chronic Disease 
PI 
Principal Investigator 
PPS 
Per Protocol Set 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SDA 
Source Document Agreement 

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SUSAR 
Suspected Unexpected Serious Adverse Reaction 
WHO 
World Health Organization 
 
Follow-up period 
The follow-up period for subjects starts 21 days after the second 
vaccination and continues for up to study completion 
Legally Acceptable An individual or juridical or other body authorized under  
Representative(s) 
applicable law to consent, on behalf of a prospective subject, to the 
subject’s participation in the clinical trial (see ICH-GCP, ICH E6 
(R2)) 
Qualified health care Any licensed health care professional who is permitted by 
Professional 
institutional policy to perform clinical interventions and assessments 
such as physical examinations, is trained on the study procedure(s) 
and who is identified within the site signature and delegation log. 
Trained health care Any health care professional who is permitted by institutional 
Professional 
policy, trained to perform delegated tasks, is trained on the study 
procedure(s) and who is identified within the site signature and 
delegation log. 
Treatment period 
Per protocol treatment period begins at the time of vaccination 
(Day 1) and ends 21 days after the second vaccination. 
 
 
 

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1. 
BACKGROUND AND RATIONALE 
1.1 
Background 
aH5N1 is a pandemic4 vaccine for prophylaxis of avian H5N1 influenza. aH5N1 is an 
inactivated, surface antigen, A/H5N1 Influenza (flu) Vaccine, with International 
Nonproprietary Name (INN) Pandemic Influenza Vaccine H5N1 (surface antigen, 
inactivated, adjuvanted), produced in embryonated hen eggs and formulated with 
MF59C.1 adjuvant (MF59). For clarity, the term aH5N1 will be used in the remainder of 
this document to refer to Pandemic Influenza Vaccine H5N1 (surface antigen, inactivated, 
adjuvanted). 
Nonclinical studies assessed the immunogenicity (mice, rabbits, ferrets), efficacy (mice, 
ferrets), and toxicity (rabbits) of aH5N1 formulations. In these studies, vaccine 
formulations were immunogenic and protective, and there was no evidence of local or 
systemic toxicity. In rabbits, vaccination did not cause maternal or embryofetal toxicity, 
was not teratogenic, and had no effects on post-natal development. These studies support 
the clinical use of aH5N1. 
Inactivated influenza vaccines from the applicant, including aH5N1and aH1N1, are 
manufactured from the same manufacturing process but differ only in terms of antigen 
and adjuvant content. These vaccines are based on replication, inactivation, and 
purification of proteins from selected influenza viruses and each is formulated with MF59 
adjuvant, which allows for administration of lower antigen doses. HA and neuraminidase 
(NA) proteins are included in all three vaccines. The mechanism of action of inactivated 
influenza vaccines is based on induction of antibodies against the purified viral HA. 
Production of antibodies to HA is thought to prevent viral attachment to human 
respiratory epithelial cells. Although there is no established correlate of protection against 
pandemic influenza strains, HI antibody levels have been regarded as both a sign of 
vaccine activity and post-vaccination HI titer ≥ 1:40 has been associated with protection 
against seasonal influenza in adults.  
Influenza antigen doses used to immunize against seasonal influenza have been well 
established for inactivated influenza vaccines (15 µg HA per influenza strain per dose in 
individuals 3 to 18 years of age, and 7.5 µg HA per influenza strain per dose in 
individuals 6 to <36 months of age, for most inactivated influenza vaccines). 
                                                 
4 Throughout this study protocol ‘pandemic’ vaccine is used for the aH5N1 vaccine, however this study is 
also in support of the corresponding zoonotic vaccine. 

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However recent experience with pandemic influenza strains has indicated that different 
pandemic influenza strains may require different amounts of antigen to achieve similar 
antibody responses. Experiences with non-adjuvanted pandemic influenza strains in 
adults have demonstrated that two separate doses of 90 µg HA of A/H5N1 are necessary 
to achieve 4-fold increases in antibodies in just over 50% of adult subjects (Treanor 
2006).  
During the A(H1N1)pdm09 influenza pandemic, a dose-ranging trials in adults (including 
elderly) and children was performed as soon as formulations were available. Ultimately, 
these trials established that the addition of MF59 adjuvant to A(H1N1)pdm2009 antigen 
allowed for administration of lower doses of antigen (7.5 µg, dose of Focetria) to achieve 
high seroconversion rates by HI and MN assay. Moderate seroconversion rates were also 
observed with even lower antigen doses (3.75 µg) when MF59 adjuvant was added (60% 
by HI assay). Seroconversion rates were also high in children after a single dose of 3.75 
µg HA A(H1N1)pdm09 with 0.125 mL MF59 dose: 91%, 97%, 95%, and 91% in 
children ages 6 to 11 months, 12 to 35 months, 3 to 8 years, and 9 to 17 years, 
respectively. 
A clinical study with still another pandemic influenza strain (A/H7N9) demonstrated that 
15 µg HA antigen with 0.25 mL MF59 dose given as 2 doses was needed to achieve HI 
titers ≥ 1:40 in adults (Bart 2014). 
These experiences illustrate that for novel influenza strains, a range of doses may need to 
be evaluated in order to understand how much antigen and adjuvant is needed to 
demonstrate desirable antibody levels, and children may not demonstrate the same 
responses as adults to the doses given.  
1.2 
Rationale 
The present study is a post authorization commitment in Europe. The purpose of this 
study is to provide additional clinical data on aH5N1 in children in anticipation of an 
avian influenza pandemic, as agreed in the pediatric investigational plan with 
EMA/Pediatric Committee. This is a pediatric dose-ranging study for aH5N1 to dosages 
with decreased content of HA antigen and/or MF59 adjuvant (versus the licensed dosage 
for adults). The study is designed to evaluate the safety and immunogenicity of two 
vaccinations using three different amounts of aH5N1 and two different dosages of MF59 
adjuvant, administered 3 weeks apart. 
The study will be conducted according to the protocol and in compliance with Good 
Clinical Practice, as defined by the International Council on Harmonisation, the principles 
outlined in the Declaration of Helsinki and all applicable federal and local regulations. 

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1.3 
Potential Risks and Benefits 
Based upon clinical studies with the aH5N1 vaccine, the following local and systemic 
adverse events may occur after vaccination: 
Immediate hypersensitivity type reactions including anaphylaxis.  
Vaccination-related anxiety symptoms such as syncope and pre-syncope.  
Local reactions: erythema, induration, and pain at the injection site. 
Systemic reactions: fever, (defined as body temperature ≥38.0°C), shivering (chills), 
irritability, diarrhea, vomiting, sleepiness, and change in eating habits 
Most of these reactions usually disappear within 1-2 days without treatment. As this 
vaccine has only been administered to a limited number of humans, there may be other 
yet unforeseen adverse events or reactions that may be associated with administration of 
this vaccine. 
The aH5N1 vaccine has a good immunogenicity and a safety profile. The benefit-risk 
relationship for aH5N1 is positive for the prevention of infection from A/H5N1 virus. 
When blood samples are taken, there is a risk of bruising at the injection site, soreness, 
possibly bleeding. Sometimes a person may become dizzy or faint for a short period of 
time. There is a rare possibility of infection or of nerve injury. Details of study 
procedures can be found in Section 3. 
More detailed information about the known and expected benefits and risks and 
reasonably expected adverse events of the aH5N1 vaccine may be found in the 
Investigators’ Brochure and the participant information leaflet.

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2. 
OBJECTIVES 
The purpose of this study is to assess the safety and immunogenicity of 6 different 
formulations including either 1.875, 3.75, or 7.5 µg HA of pandemic H5N1 influenza 
strain combined with either 0.125 mL or 0.25 mL MF59, in two IM injections 
administered three weeks apart. 
2.1 
Primary Objective(s) 
Primary Safety Objective:  
• To evaluate the safety in each study vaccine group from Day 1 through Day 387, 
by total population and by age cohort. 
Primary Immunogenicity Objective:  
• To assess by total population and by age cohort, the antibody responses to each of 
the study vaccines prior to (Day 1) and at 3 weeks after the first or second 
vaccination (Day 22 or Day 43), as measured by HI and MN assays. 
2.2 
Secondary Objective(s) 
Secondary Immunogenicity Objectives: 
• To evaluate in each study vaccine group, by total population and by age cohort, 
the persistence of antibody responses to the H5N1 vaccine strain 6 months after 
the second vaccination (Day 202) as measured by HI and MN assays. 
2.3 
Exploratory Objective(s) 
• To further evaluate the antibody responses to seasonal, and/or homologous and/or 
heterologous pandemic influenza strain(s) by vaccine group on Days 1, 22, 43, 
and 202, as measured by HI, MN, or SRH assays (depending on availability of 
adequate sera and on assay availability). 
 

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3. 
STUDY DESIGN 
3.1 
Overview of Study Design 
This randomized, observer blind, multi-center clinical trial evaluates the immunogenicity 
in healthy children ages 6 months to <9 years of 6 vaccine regimens utilizing 6 different 
formulations including either 1.875, 3.75, or 7.5 µg HA of pandemic H5N1 influenza 
strain combined with either 0.125 mL or 0.25 mL MF59, in two IM injections 
administered three weeks apart, in order to describe the possible impact of decreasing the 
quantities of antigen and/or adjuvant dosage. Levels of antibody persistence and the 
safety profile of each vaccine regimen will also be assessed. 
A total number of 420 subjects will be enrolled to assure at least 150 evaluable subjects 
per age cohort. 
Eligible subjects will be stratified by age at the time of enrollment into one of 2 age 
cohorts and within each age cohort will be randomly assigned (equally) to 1 of 6 study 
vaccine groups. Randomization will be equal (1:1:1:1:1:1) for each of 6 vaccine groups, 
and stratified by age cohort as follows: 6 months through <36 months of age, and 3 years 
through <9 years of age. Approximately 35 subjects will be randomized per vaccine 
group in each age cohort.  
Subjects in each study vaccine group will be scheduled to receive 2 injections of aH5N1 
vaccine 3 weeks apart.  
The study groups are described in Table 1.  
Immunogenicity will be measured by HI and MN assays.  
• Blood samples for serology assessments will be collected from each subject on 
Day 1 (before randomization), Day 22 (before vaccination), Day 43, and Day 202.  
• Each subject will be followed for a period of 12 months after receipt of the second 
study vaccine. After informed consent is signed by the subject’s parent(s) or 
LAR(s), and if applicable assent form is signed by the subject, eligibility is 
confirmed, and the Day 1 blood sample is collected, subjects will be randomized 
receive a single vaccination followed by a second vaccination after three weeks 
(Day 22). For all subjects, study participation includes a total of 4 clinic visits, 2 
diary completion reminder calls, and 3 safety calls through the treatment and 
follow-up periods (a total duration of approximately 13 months). 
• Treatment period (Day 1 through Day 43): 3 clinic visits and 2 reminder calls 
• Follow-up period (Day 44 through Day 387): 1 clinic visit and 3 safety calls 

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Vaccine administration will be performed IM, anterolateral thigh for children ages 
< 2 years; deltoid for children ages ≥ 2 years, unless insufficient deltoid mass. Each 
vaccine administration will be performed in an observer-blind manner (ie, efforts should 
be taken to shield the subject/parent(s)/LAR(s) and blinded study team members from the 
view of the vaccine administration). To maintain the observer-blind design of the study, 
the roles and responsibilities of “blinded” and “unblinded” team members will be defined 
and maintained. Safety assessments and study-related procedures and monitoring thereof 
must be performed by “blinded” team members. 
After each vaccination, all subjects will remain under medical supervision at the study 
site for at least 30 minutes to be monitored and evaluated for AEs. 
Subject Diary Cards will be provided to subjects for recording of local and systemic 
reactions for 7 consecutive days after each vaccination.  
• From Day 1 through Day 7, and from Day 22 through Day 28, all solicited AEs, 
all unsolicited AEs (including SAEs, NOCDs, AEs leading to vaccine and/or 
study withdrawal, and AESIs), and associated concomitant medications for any of 
these events and vaccinations given within these periods will be recorded in the 
subject’s eCRFs.  
• From Day 8 through Day 22 (before vaccination), and from Day 29 through Day 
43 all unsolicited AEs (including SAEs, NOCDs, AEs leading to vaccine and/or 
study withdrawal, AESIs), solicited AEs that continue beyond Day 7 or Day 28 , 
respectively, and associated concomitant medications and all vaccinations given 
within these intervals will be recorded in the subject’s eCRF until the time of 
return to the clinic on Day 22, and Day 43,respectively in the subject’s eCRFs. 
In the follow-up period (Day 44 through Day 387), only the following subset of 
unsolicited AEs and the associated concomitant medications/vaccinations will be 
collected and documented in the subject’s eCRFs: all SAEs, NOCDs, AEs leading to 
vaccine and/or study withdrawal, and AESIs (as described in section 7.1 of the current 
protocol). These data will be captured by interviewing the subject’s parent(s)/LAR(s) 
and/or by reviewing the available medical records. 
3.2 
Study Period 
Each subject should expect to participate in the study for approximately 12 months, from 
the time of enrolment through the last study visit. 

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3.3 
Blinding Procedures 
This is a phase 2, stratified, randomized, observer-blind, multicenter study. As such it is 
important to ensure that the subject and parent(s)/LAR(s) are not advised of the treatment 
assignment in this study. 
Vaccine preparation and administration should be completed by the designated unblinded 
team members. Any other subject related assessments should be performed by the 
principal investigator (PI) and/or blinded staff members as applicable. 
Except in the case of medical necessity, a subject’s treatment should not be unblinded 
without the approval of the sponsor. In such instance of medical emergency, every effort 
should be made to contact the sponsor prior to unblinding. If unblinding should occur (by 
either accidental unblinding or emergency unblinding for a serious adverse event) prior to 
completion of the study, the investigator must promptly contact the sponsor and document 
the circumstances on the appropriate forms. Instructions regarding emergency unblinding 
will be provided to the investigator. 
3.4 
Data Collection 
3.4.1 Data Collected from Subjects 
The following data will be collected from each subject over the duration of their study 
participation: 
• Informed Consent 
• demographic information 
• physical examination5 and clinical signs information 
• adverse events 
• relevant medical history 
• relevant concomitant medications 
• vaccination history (including influenza vaccination) 
• serology results 
                                                 
5 A review of systems, ie, a structured interview for complaints for each organ system, will be used to guide 
a physical examination. 

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All data collected must only be identified using the sponsor’s subject ID, as described in 
section 5.1.4, Randomization. 
3.4.2 Tools Used for Data Collection 
Electronic Data Capture system and paper diary cards will be used to collect data for this 
study. Data will be collected in the Subject Diary Card by subject’s parent(s) /LAR(s) or 
caregiver and recorded in electronic case report forms (eCRFs) by site staff. 
Subject Diary Card 
Paper diaries, hereafter referred to as Subject Diary Cards, will be the only source 
document allowed for solicited local and systemic adverse events (including body 
temperature measurements), starting after the initial 30-minute post-vaccination period at 
the clinic to 7 consecutive days after each vaccination. The following additional rules 
apply to documentation of safety information collected in the Subject Diary Card. 
The Subject Diary Card will be completed by the parent(s) or LAR(s) or caregiver.  
The investigator or delegated staff should monitor the Subject’s Diary Card status 
throughout the study for compliance and any solicited local and systemic adverse events 
that were of concern to the subject. 
1. No corrections or additions to the information recorded by the 
parent(s)/LAR(s)/caregiver within the Subject Diary Card will be allowed after it is 
delivered to the site. 
2. Any blank or illegible fields on the Subject Diary Card must be described as missing, 
unknown or not done in the eCRF. 
The following additional rules apply to documentation of Subject Diary Card information 
collected in the eCRFs: 
– The site must enter all readable entries in the Subject Diary Card into the eCRF, 
including those values that may be biologically implausible (eg, body temperature: 
400°C). 
– Any illegible or implausible data should be reviewed with the 
parent(s)/LAR(s)/caregiver. If an underlying solicited or unsolicited adverse event 
is described on review with the subject’s parent(s)/LAR(s)/caregiver, this should 
be documented in the source document and reported as an unsolicited adverse 
event in the adverse event eCRF (eg, if the subject’s parent(s)/LAR(s)/caregiver 
confirms a body temperature of 40°C on the day in which body temperature: 

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400°C was written into his/her Subject Diary Card, this fever of 40°C should be 
recorded in the adverse event eCRF). No correction should be made on diary card. 
– Any newly described safety information (including a solicited adverse event) must 
not be written into the Subject Diary Card, but must be documented in the source 
document as a verbally reported adverse event. Any adverse event reported in this 
fashion must be documented as an unsolicited adverse event and therefore entered 
on the adverse event eCRF. 
Case Report Forms 
This study utilizes eCRFs to collect study-related data from each subject. A qualified site 
staff member(s) is required to enter subject data in the eCRFs in English based on the 
medical information available in each subject’s source record. 
Data should be entered into the eCRF in a timely fashion following each subject’s clinic 
visit, study procedure, or phone call. Each subject’s eCRF casebook will be compared 
with the subject’s source records by a sponsor-approved study monitor (or delegate) over 
the duration of the study in order to ensure data collection accuracy. 
3.5 
Collection of Clinical Specimens 
In this study the only clinical specimens required to be collected from each subject are 
blood samples on Day 1 (baseline)6, Day 22, Day 43, and Day 202. Processing of each 
specimen should be completed by a qualified site member (or sponsor approved 
designee7) and in accordance with the study-specific clinical specimen laboratory manual. 
Testing of clinical specimens will be performed by the sponsor or designated laboratory. 
Refer to the study-specific clinical specimen laboratory manual for additional details. 
Blood Specimens 
Approximately 6 mL of blood will be drawn from all subjects at visit 1 (Day 1) before 
randomization, and at visit 2 (Day 22) before vaccination, visit 3 (Day 43), and visit 6 
(Day 202). The blood volume must be approximately 6 mL at each time point in order to 
provide the necessary serum volume (approximately half of the blood draw volume) for 
the serology assays.  
                                                 
6 Note: the baseline blood sample must be collected prior to randomization of the subject. If a baseline 
blood sample is not obtained, the subject is not eligible for the study. 
7 In the exceptional case that a clinic visit is not possible, and a home visit is conducted due to COVID19 
restrictions. 

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The blood will be used for immunological assays. See section 7, Assessments for 
additional details. 
The total maximum amount of blood collected over the study period per subject will be 
24 mL. 
 
3.6 
Stopping/Pausing Guidelines 
There are no predetermined stopping rules in this study. Subjects may be withdrawn from 
the study according to investigator discretion as described in Section 3.8 Premature 
Withdrawal from Study. 
The Sponsor can halt the study at any time. If the study is halted, the Sponsor will 
promptly notify the health authorities and investigators, who will promptly inform the 
parent(s)/LAR of study subjects and Institutional Review Board(s) (IRBs)/Ethics 
Committee(s) (ECs) as per local regulations. Further enrollment will only occur after 
written authorization is provided by the Sponsor in consultation with the health 
authorities and IRB(s)/EC(s), as appropriate. 
3.7 
Independent Data Monitoring Committee 
An IDMC will not be utilized for the study.  
3.8 
Premature Withdrawal from Study 
Subjects may withdraw at any time, or be dropped from the study at the discretion of the 
investigator should any untoward effects occur and/or for safety reasons. In addition, a 
subject may be withdrawn by the investigator or the sponsor or delegate if he/she violates 
the study plan or for administrative reasons. The investigator or study coordinator must 
notify the sponsor or delegate immediately when a subject has been withdrawn due to an 
adverse event. 
The circumstances above are referred to as premature withdrawal from the study, and the 
reason for premature withdrawal should be clearly documented and detailed in the source 
documentation. The investigator should make every attempt to evaluate the subject’s 
safety, including resolution of ongoing AEs, at the time of premature withdrawal. If a 
subject’s parent(s)/LAR(s) wants to withdraw from the study before all doses are 
administered or prior to the last planned study visit, the subject’s parent(s)/LAR will be 
asked if his/her/their child can be followed for safety for the duration of the study. When 
a subject withdraws, or is withdrawn, from the study, the procedures described in section 
5.5.1, Early Termination Visit should be completed if possible. 

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The reasons for premature withdrawal from the study include: adverse event, death, 
withdrawal of consent, lost to follow-up, study terminated by sponsor, protocol deviation, 
and other. These reasons are described in greater detail below. 
 
Adverse Event 
For any subject withdrawn from study participation prior to the planned study termination 
visit, it is important to determine if an AE was associated with the reason for 
discontinuing the study. This AE must be identified on the AE eCRF page by indicating 
“withdrawn from study due to AE”. Any ongoing AEs at the time of study withdrawal 
must be followed until resolution or stabilization. 
Subjects who develop a serious adverse event (SAE) judged to be possibly or probably 
related to the study vaccine (first dose), including fever (>40 °C), febrile convulsion and 
hypersensitivity type reactions, should not receive subsequent vaccination (second dose). 
Death 
For any subject withdrawn from study participation due to death, this should be noted on 
the Study Termination eCRF page and the associated SAE that led to the death must be 
reported on the AE eCRF page. 
Withdrawal of consent 
The subject’s parent(s)/LAR(s) can withdraw consent for participation in the study at any 
time without penalty or loss of benefit to which the subject is otherwise entitled. Reason 
for early termination should be deemed as “withdrawal of consent” if the subject’s 
parent(s)/LAR(s) withdraws from participation due to a non-medical reason (i.e., reason 
other than AE). If the subject’s parent(s)/LAR (s) intends to withdraw consent from the 
study, the investigator should clarify if the subject’s parent(s)/LAR (s)will withdraw 
completely from the study or if the subject will continue study participation for safety, or 
a subset of other study procedures. If the subject’s parent(s)/LAR (s) requests complete 
withdrawal from the study, no further study interventions and assessments will be 
performed with the subject. 
Lost to Follow-Up 
For parent(s)/LAR (s) who fail to show up with his/her/their child for final visits (clinic or 
telephone calls), study staff are must make at least three documented attempts to contact 
the parent(s)/LAR (s) by telephone and at least one documented written attempt to contact 
the parent(s)/LAR(s) to encourage the completion of study termination procedures. These 

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efforts to contact the parent(s)/LAR (s) should be recorded in the source document. The 
termination date for the subject to be captured on the study termination eCRF page is the 
date of the last successful contact (clinic visit or telephone) with the subject’s 
parent(s)/LAR. 
Study Terminated by Sponsor 
If the clinical study is prematurely terminated by the Sponsor, the investigator is to 
promptly inform the study subjects and IRB/EC and should assure appropriate therapy 
and follow up for the subjects. All procedures and requirements pertaining to the 
archiving of study documents should be followed. All other study materials (study 
medication/vaccines, etc.) must be returned to the Sponsor. 
Protocol Deviation 
A protocol deviation is any change, divergence, or departure from the study design or 
procedures of a study protocol. In general, subjects associated with protocol deviations 
may remain in the study unless continuation in the study jeopardizes the subject’s health, 
safety, or rights. 
Investigators will apply due diligence to avoid protocol deviations. Under no 
circumstances should the investigator contact the sponsor or delegate, monitoring the 
study to request approval of a protocol deviation, as no authorized deviations are 
permitted. If the investigator feels a change to the protocol would improve the conduct of 
the study this must be considered a protocol amendment, and unless such an amendment 
is agreed upon by the sponsor and approved by the IRB/EC and health authorities it 
cannot be implemented.  
Other 
Examples for subjects withdrawn from the study due to other reasons can include: 
Sponsor decision to terminate the study, subject discontinuation for insurance issues, 
moving, no time, etc. This reason should be noted in the Study Completion eCRF page 
and any ongoing AE’s at the time of study withdrawal must be followed until 
resolution/stabilization. 
3.9 
End of Study 
Most clinical trials intended to support the efficacy/immunogenicity and safety of an 
investigational product proceed to full completion of planned sample size accrual. 
Evaluation of the primary and/or secondary immunogenicity/efficacy objectives requires 
the testing of biological samples from the study subjects, which can only be completed 

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after all samples are collected. The last samples for the analysis of the primary and/or 
secondary objectives will be taken at visit 6. For the purpose of this protocol, end of study 
is defined as the completion of the Last Subject Last Visit (LSLV), i.e., the last subject’s 
Day 387 safety assessment call, or completion of testing of biological samples, to be 
achieved no later than 8 months after LSLV, whichever is longer. 
Evaluation of the exploratory objectives also requires the testing of biological samples, 
which can only be completed after all samples are collected. If this testing will take 
longer than the time frame indicated above, these results may be reported in a clinical 
study report addendum. 

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4. 
SELECTION OF STUDY POPULATION 
4.1 
Inclusion Criteria 
Pediatric subjects in good health as determined by medical history, physical assessments, 
and clinical judgment of the investigator will be enrolled if the parent(s) or LAR(s) have 
given consent and are able to follow all the required study procedures for the whole 
period of the study.  
In order to participate in this study, all subjects must meet ALL of the inclusion criteria 
described. 
1. Healthy male and female subjects of 6 months through <9 years of age on the day of 
informed consent/assent. 
2. Documented consent provided by the subject’s parent(s)/LAR(s) have voluntarily 
given written informed consent/assent after the nature of the study has been explained 
according to local regulatory requirements, prior to study entry. 
3. Subject’s parent(s)/LAR(s) able to comprehend and comply with all study procedures, 
and available for all clinic visits and telephone contacts scheduled in the study. 
4. Subjects must provide a baseline blood sample within 10 days prior to the Day 1 
vaccination. 
Prior to receipt of the second vaccination, subjects must be re-evaluated to confirm that 
they are eligible for subsequent vaccination. If subjects do not meet any of the original 
inclusion criteria listed above, they should not receive additional vaccinations. 
4.2 
Exclusion Criteria 
Each subject must not have: 
1. Progressive, unstable or uncontrolled clinical conditions. 
2. Hypersensitivity, including allergy, to any component of vaccines, medicinal 
products or medical equipment whose use is foreseen in this study. 
3. Clinical conditions representing a contraindication to intramuscular vaccination 
and blood draws, ie, 
a. Subjects who have had a fever (body temperature measurement ≥ 38°C) 
within three days prior to vaccination. The subject may return for 
vaccination after they have been free of fever for three days. 
b. History of epilepsy or convulsions (excluding febrile convulsions). 

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c. A subject who has any medical condition meeting the definition of AESI 
defined for the purposes of this trial (see appendix A). 
d. Subjects who have received antipyretic medication within the past 24 
hours prior to vaccination. The subject may return for vaccination after a 
period of 24 hours has passed since the administration of an antipyretic. 
4. Abnormal function of the immune system resulting from: 
a. Clinical conditions. 
b. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 
consecutive days within 90 days prior to informed consent/assent. Topical, 
inhaled and intranasal corticosteroids are permitted. Intermittent use (one 
dose in 30 days) of intra-articular corticosteroids are also permitted. 
c. Administration of antineoplastic and immunomodulating agents or 
radiotherapy from within 90 days prior to informed consent/assent. 
5. Suspicion of pandemic influenza illness within past six months or have ever 
received previous pandemic H5N1 flu vaccination. 
6. Received immunoglobulins or any blood products within 180 days prior to 
informed consent/assent. 
7. Received an investigational or non-registered medicinal within 30 days prior to 
informed consent/assent.  
8. Children of study site staff (this includes research or clinic staff) or children who 
are otherwise related to study site staff or have household members who are study 
site staff. Study site staff are employees with direct or indirect contact with study 
subjects and/or have access to any study documents containing subject 
information. This would include receptionists, persons scheduling appointments or 
making screening calls, regulatory specialists, laboratory technicians, medical 
assistants, document scanners, etc. study personnel as an immediate family or 
household member. 
9. Any other clinical condition that, in the opinion of the investigator, might interfere 
with the results of the study or pose additional risk to the subject due to 
participation in the study. 
10. Individuals who received any other vaccines within 14 days (for inactivated 
vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are 
planning to receive any vaccine prior to day 43. Following day 43 other vaccines 
may be administered, including seasonal flu. 
Prior to receipt of the second vaccination, subjects must be re-evaluated to confirm that 
they are eligible for subsequent vaccination. If subjects meet any of the original exclusion 

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criteria listed above, they should not receive the second vaccination. These subjects will 
be requested to fulfill all the scheduled clinic visits and calls for safety follow-up. No 
further blood samples will have to be taken. This review of eligibility should be 
documented in the source document and the reason for not administrating a scheduled 
study vaccine should be documented in the eCRF. 
4.3 
Criteria for Delay of Vaccination 
After enrollment, subjects may encounter clinical circumstances that warrant a delay in 
subsequent study vaccination. These situations are listed below. In the event that a subject 
meets a criterion for delay of vaccination, the subject may receive study vaccination once 
the window for delay has passed as long as the subject is otherwise eligible for study 
participation. 
• Acute moderate or severe infection with or without fever within 3 days of 
intended study vaccination. 
• Fever is defined as body temperature ≥38.0°C (100.4°F) within 3 days of intended 
study vaccination. 
• Administration of any vaccine not foreseen by the study protocol within 7 days 
prior to intended study vaccination. 
There are also circumstances under which repeat vaccination is a contraindication in this 
study. These circumstances are presented in section 4.4. 
There may be instances when individuals meet all eligibility criteria for vaccination yet 
have a transient clinical circumstance which may warrant delay of vaccination: body 
temperature elevation (≥38.0° C (100.4°F) within 3 days prior to intended study 
vaccination), or acute use of antipyretics and/or analgesic medications within 24 hours 
prior to vaccination. Under such circumstances, a subject may be considered eligible for 
study enrolment or next study vaccination after the appropriate window for delay has 
passed and inclusion/exclusion criteria have been rechecked, and if the subject is 
confirmed to be eligible. 
4.4 
Criteria for Repeat Vaccination in the Study 
Prior to receipt of the second study vaccination, subjects must be evaluated to confirm 
that they are eligible for subsequent vaccination. If subjects meet any of the criteria listed 
below, they should not receive additional vaccinations. 

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• Has experienced any immediate allergic reaction after the previous study 
vaccination 
• Has experienced any serious adverse event judged to be possibly or probably 
related to study vaccination, including hypersensitivity reactions. 
• Has developed any clinically significant medical condition which, in the opinion 
of the investigator, may pose additional risk to the subject if he/she continues to 
participate in the study. 
Subjects who meet any of these criteria must not receive further study vaccinations. 
However, the subject’s parent(s)/LAR(s) should be encouraged to continue study 
participation of the subject. 

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5. 
STUDY PROCEDURES 
The sections that follow provide an overview of the procedures that are to be followed in 
enrolling, evaluating, and following subjects who participate in this clinical study. Visits 
can be either clinic visits or safety follow-up telephone calls, as specified in the table 
below and in the Time and Events Table. 
Table 5: Study Procedures 
visit category 
procedures 
pre-vaccination clinic visit(s) 
Section 5.1 describes procedures to be followed 
prior to first study vaccination: informed 
consent/assent, screening, enrolment, and 
randomization 
vaccination clinic visit(s) 
Section 5.2 describes procedures to be followed 
during each clinic visit involving vaccination: 
vaccination, post-vaccination procedures, and post-
vaccination reminders  
post-vaccination visit(s)  
Section 5.3 describes follow-up clinic visits and 
safety follow-up calls 
unscheduled visit(s) 
Section 5.4 describes possible procedures to be 
followed at unscheduled clinic visit 
study termination visit 
Section 5.5 describes procedures to be followed at 
the last study visit for a subject (may include early 
termination visit) 
 
5.1 
Pre-vaccination Clinic Visit(s) 
This section describes the procedures that must be performed for each potential subject 
prior to first vaccination, including obtaining informed consent/assent, screening, 
enrolment and randomization. 
5.1.1 Informed Consent/Assent 
"Informed consent" is the voluntary agreement of an individual or his/her 
parent(s)/LAR(s) to participate in research. Consent must be given with free will of 
choice, and without undue inducement. The individual must have sufficient knowledge 
and understanding of the nature of the proposed research, the anticipated risks and 
potential benefits, and the requirements of the research to be able to make an informed 
decision. 

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"Assent" is a term used to express willingness to participate in research by persons who 
are by definition too young to give informed consent but who are old enough to 
understand the proposed research in general, its expected risks and possible benefits, and 
the activities expected of them as subjects. Assent by itself is not sufficient, however. If 
assent is given, informed consent must still be obtained from the subject's parent(s) or 
LAR(s). 
Informed consent of the parent(s)/LAR(s) and assent of subject following local IRB/EC 
guidance must be obtained before conducting any study-specific procedures (ie, all of the 
procedures described in the protocol). The process of obtaining informed consent and 
assent should be documented in the subject source document in addition to maintaining a 
copy of the signed and dated informed consent and assent. Additional specifics regarding 
the informed consent and assent processes are located in section 13.2, Informed Consent 
Procedures. 
If a subject and/or parent(s)/LAR(s) is unable to read, an impartial witness should be 
present during the entire informed consent and assent discussion. An impartial witness is 
defined as a person who is independent from study conduct, who cannot be unfairly 
influenced by those involved with the study, who attends the informed consent and assent 
process if the subject or the subject's parent(s)/LAR(s) cannot read, and who reads the 
informed consent form (ICF), assent and any other written information supplied to the 
subject. After the written ICF/assent and any other written information to be provided to 
subjects, is read and explained to the subject and/or parent(s)/LAR(s) and after the subject 
and/or parent(s)/LAR(s) has verbally consented to the subject’s participation in the study 
and, if capable of doing so, has signed and personally dated the ICF/assent, the witness 
should sign and personally date the consent form. By signing the consent form, the 
witness attests that the information in the consent form and any other written information 
was accurately explained to, and apparently understood by, the subject and/or 
parent(s)/LAR (s) and that informed consent was freely given by the subject and/or 
parent(s)/LAR (s). 
The informed consent process may be conducted within 10 days prior to Day 1. 
5.1.2 Screening 
After an individual has consented to participate in the study and informed consent/assent 
is signed, that individual will be given a unique screening number manually created by 
the investigator. The subject’s unique screening number will be documented in the 
screening and enrolment log. The eligibility of the subject will be determined based on 
the inclusion and exclusion criteria listed in section 4, Selection of Study Population and 
evaluated during this screening procedure. 

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Screening procedures will include the following: 
1. Demographic data will be collected from the subject, including: age and/or Date 
of Birth, sex, race, ethnicity). 
2. Relevant Medical history will also be collected, including but not limited to any 
medical history that may be relevant to subject eligibility for study participation 
such as prior vaccinations, concomitant medications, and previous and ongoing 
illnesses or injuries. Relevant medical history can also include any medical history 
that contributes to the understanding of an adverse event that occurs during study 
participation, if it represents an exacerbation of an underlying disease/pre-existing 
problem. 
3. Review of systems is a structured interview that queries the subject and/or 
parent(s)/LAR(s) as to any complaints the subject has experienced across each 
organ system. This will be performed before enrolment and used to guide physical 
examination. A general physical examination is to be performed by a qualified 
health care practitioner. “Qualified health care practitioner” refers to any licensed 
health care professional who is permitted by institutional policy to perform 
physical examinations and who is identified within the study staff signature log. 
4. If applicable, prior and concomitant medications or vaccinations taken prior to 
start of study, including influenza vaccinations in the past 2 years, should be 
collected (refer to section 6.5, Prior and Concomitant Medications and Vaccines 
for further details). 
5. Collection of clinical signs is to be performed: weight, height and body 
temperature. If body temperature is ≥38.0°C (≥100.4°F) at the time of screening, 
blood draw and/or vaccination must be postponed until 3 days after the fever has 
resolved (see section 4.3, Criteria for Delay of Vaccination). 
6. The use of antipyretics and/or analgesic medications within 24 hours prior to 
vaccination must be identified and the reason for their use (prophylaxis versus 
treatment) must be described in the source document and Concomitant 
Medications eCRF. The use of antipyretics/analgesics within 24 hours prior to 
vaccine administration is a reason to delay study vaccination (see section 4.3, 
Criteria for Delay of Vaccination, and section 6.5, Prior and Concomitant 
Medications and Vaccines). 
7. Collection of a baseline blood sample (approximately 6 mL) must be performed 
prior to randomization, and can be done after obtaining informed consent, within 

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10 days prior to the first vaccination. Note: if a baseline blood sample is not 
obtained, the subject is not eligible for the study. 
These data will be written in the source document (see section 9.1, Source 
Documentation). Should the physical assessment reveal any abnormal values or events, 
these must be documented in the eCRF adverse events form. 
In the event that the individual is determined ineligible for study participation, he/she is 
considered a screen failure. The reason for screen failure must be documented in the 
screening and enrolment log, eg, baseline blood sample not obtained. If the individual is 
determined to be eligible for the study, he/she will be enrolled into the study. 
5.1.3 Enrolment 
After signing the informed consent/assent form, if an individual is determined to be 
eligible for study participation, the investigator or delegate will enroll the subject and 
enter the subject information and stratification information into the Electronic Data 
Capture system (EDC). The EDC system is integrated with interactive response 
technology (IRT) system for randomization. 
5.1.4 Randomization 
Enrolled subjects will be assigned a unique Subject ID manually entered in EDC. Subject 
information and stratification information (ie, age) are automatically transferred to the 
IRT system for randomization in a 1:1:1:1:1:1 ratio into 6 treatment groups and 
automatically assigned a unique pack ID. The subject ID will be the subject’s unique 
identification number for all eCRFs and associated study documentation that will be used 
for duration of the study. After randomization, the screening number ceases to be used 
and remains in the screening and enrolment log only. The list of randomization 
assignments is produced by the IRT service provider and approved by the sponsor or 
delegate prior to study start. 
Randomization will be stratified by age (cohorts of 6 months through <36 months, and 3 
years through <9 years) and by site. The age cohorts will be of equal size. Once an age 
cohort attains its planned size (ie, half of the planned study sample size) the 
randomization in this age cohort will be blocked. 
If for any reason, after signing the ICF/assent, the subject who is eligible and enrolled 
fails to be randomized, this is called a randomization failure. The reason for all 
randomization failures should be recorded in the screening and enrolment log and in the 
source document as specified in the source data agreement (SDA). The information on 

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subjects who are randomization failures should be kept distinct from subjects who are 
screen failures, as described in section 5.1.2, Screening. 
If for any reason, after randomization the subject fails to undergo treatment, this is an 
early termination and the reason should be recorded in source document as specified in 
the SDA. The information on these early termination subjects should be kept distinct in 
the source documentation from randomization failures. 
5.1.5  Blood draw  
The baseline blood draw must be performed after obtaining informed consent, but prior to 
randomization. Note: if a baseline blood sample is not obtained, the subject is not eligible 
for the study. The following volumes of blood will be withdrawn: approximately 6 mL 
per blood draw for subjects. Details regarding the volume of blood and testing to be 
performed are in section 3.5, Collection of Clinical Specimens. These data will be written 
in the source document (see Section 9.1, Source Documentation) and must be 
documented in the eCRF. 
A topical analgesic/anesthetic/icepack may be used for the blood draw. However, the 
topical analgesic/anesthetic/icepack used for the blood draw should not be applied to the 
area of vaccination. 
In the exceptional situation in which a clinic visit is not possible, such as in the case when 
a site is not able to see study subjects at the clinic due to local regulations related to the 
coronavirus pandemic, a home visit (only at Day 43 or 202) may be considered. The site 
must get approval from the sponsor to conduct home visits. The site must also have 
sponsored approved Standard Operating Procedures/Instructions for conducting home 
visits and the collection of blood samples in the home setting, prior to the home visit 
occuring. These procedures may also need to be approved by the site’s IRB/EC 
depending on local and country regulations. 
5.2 
Vaccination Clinic Visit(s) 
Vaccination will be performed on Day 1, and Day 22.  
Ensure the Day 1 and Day 22 blood samples are taken prior to each vaccination. 
After completing the pre-vaccination procedures on Day 1, administer the vaccine to the 
subject according to the procedures described in section 6.3, Vaccine Preparation and 
Administration. Observe the blinding procedures described in section 3.3, Blinding 
Procedures. 

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Prior to administration of the second vaccination at Day 22 confirm that the subject is 
eligible for additional study vaccinations and does not meet any criteria for delaying 
additional or stopping study vaccinations as described in section 4, Selection of Study 
Population. 
5.2.1 Post-vaccination Procedures 
The following post-vaccination procedures will be performed on Day 1 and Day 22. 
After vaccination, the subject will be observed for at least 30 minutes including 
observation for unsolicited adverse events, solicited adverse events, and body temperature 
measurement. Record all safety data collected during this time in the subject’s source 
document and eCRF. 
A Subject Diary Card will be used in this study to document solicited adverse events. The 
Subject Diary Card is the only source for collection of these data; therefore, it is critical 
that the parent(s)/LAR(s) completes the Subject Diary Card correctly. The 
parent(s)/LAR(s) should be trained on how and when to complete each field of the 
Subject Diary Card. 
The parent(s)/LAR(s) should be trained on how to self-measure local solicited adverse 
events and body temperature. The measurement of solicited local adverse events is to be 
performed using the ruler provided by the site. 
The parent(s)/LAR(s) should be instructed how to perform body temperature 
measurement using the thermometer provided by the site. If the subject feels unusually 
hot or cold during the day, the parent(s)/LAR(s) should check body temperature. If the 
subject has fever, the highest body temperature observed that day should be recorded in 
the Subject Diary Card. 
Subject Diary Card training should be directed at the individual(s) who will perform the 
measurements of adverse events and who will enter the information into the Subject Diary 
Card. This individual may not be the parent(s)/LAR(s), but if a person other than the 
parent(s)/LAR(s) enters information into the Subject Diary Card, this person’s identity 
must be documented in the Subject Diary Card and subject’s source record. Any 
individual that makes entries into the Subject Diary Card must receive training on 
completion of the Subject Diary Card prior to entering data at visit 1 (Day 1) and visit 2 
(Day 22). This training must be documented in the subject’s source record. 
The same individual (preferably) should complete the Subject Diary Card throughout the 
course of the study. 

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The site should schedule the next study activity with the subject’s parent(s)/LAR(s). It is 
recommended for the site to already schedule in advance the remaining upcoming study 
activities. 
The subject’s parent(s)/LAR(s) should be reminded of the next planned study activity. 
The parent(s)/LAR(s) will be reminded to complete the Subject Diary Card and to contact 
the site if there are any questions, and to contact the site immediately (or as soon as the 
subject is medically stable) if the subject has a medical condition that leads to a 
hospitalization or an emergency room visit or to a visit to/by a doctor or is of concern. 
5.2.2 Post-vaccination Reminders 
Reminder calls or alerts are not intended to be an interview for collection of safety data. If 
the subject’s parent(s)/LAR (s) wishes to describe safety information, this information 
should only be collected by a trained health care professional at the site, and the safety 
data described must be written down in the subject’s medical chart. 
 
Subject Diary Reminder Calls  
Subject Diary Card reminder calls will be performed on Day 5, and on Day 26. The 
purpose of this call is to remind the subject’s parent(s)/LAR(s) about completion of the 
Subject Diary Card. The call follows the Subject Diary Card reminder telephone call 
script provided to the site. The subject’s parent(s)/LAR(s) should be reminded to contact 
the site via the telephone number provided in the informed consent to discuss medical 
questions. 
5.3 
Post-vaccination Visit(s) 
Post-vaccination clinic visits will be performed on Day 22, Day 43, and Day 202. 
5.3.1 Follow-up Clinic Visit(s) 
Safety follow-up clinic visits will be performed on Day 22, Day 43, and Day 202. 
During the follow-up clinic visit 2 and 5 (Days 22 and 43), the Subject Diary Card8 will 
be reviewed. No changes to the information recorded within the Subject Diary Card are 
permissible. For details on the Subject Diary Card see sections 3.4.2, Tools Used for Data 
Collection and 5.2.1, Post-vaccination Procedures. The parent(s)/LAR (s) will be 
interviewed to determine if any unsolicited adverse events occurred and if any associated 
                                                 
8 In case a clinic visit is not possible, subjects should be instructed on how to return the Subject’s Diary 
Card. 

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concomitant medications or vaccines were taken/ received in the time since the last clinic 
visit. This interview will follow a script which will facilitate the collection of relevant 
safety information. The qualified health care professional reviewing these data will 
discuss the symptoms (if any) reported by the subject’s parent(s)/LAR(s) and will 
determine if any additional diagnoses and/or adverse events are present. All adverse 
events reported by the parent(s)/LAR(s) at the follow-up clinic visits on Day 22 and Day 
43 must be recorded in the subject's source document and on an Adverse Events eCRF, as 
specified in section 7.1, Safety Assessment, and not written on the script used for the 
interview. During the Day 202 safety follow-up clinic visit, only the following subset of 
unsolicited AEs and the associated concomitant medications/vaccinations will be 
documented in the subject’s eCRFs: all SAEs, NOCDs, AEs leading to vaccine and/or 
study withdrawal, and AESIs. 
Perform a brief symptom-directed physical examination if necessary according to 
symptoms the subject has reported. This is a physical examination that will include an 
examination of organ systems that are relevant to the investigator based on review of the 
subject’s reported adverse events and concomitant medication use. The physical 
assessment must be performed by the investigator or designee of the investigator, who is 
qualified to perform a physical assessment in accordance with their institutional policy. 
Corresponding information is documented in the subject’s source document and eCRF(s). 
The site should schedule the next study activity: safety call with the subject’s 
parent(s)/LAR(s). The subject’s parent(s)/LAR(s) will receive a written reminder of the 
next planned study activity. The subject’s parent(s)/LAR(s) will be reminded to contact 
the site if there are any questions and to contact the site immediately (or as soon as the 
subject is medically stable) if the subject has a medical condition that leads to a 
hospitalization or an emergency room visit. 
5.3.2 Safety Follow-up Calls 
Safety follow-up calls will be performed on Days 92, 152 and 387. 
Safety follow-up calls are calls made to the subject by a qualified health care professional 
designated on the site’s roles and responsibilities log. These calls will follow a script 
which will facilitate the collection of relevant safety information. The subject’s 
parent(s)/LAR (s) will be interviewed according to the script, and information relating to 
the following unsolicited adverse events: SAEs, AESIs, AEs leading to withdrawal, 
and/or NOCD and associated concomitant medications or vaccinations. All safety 
information described by the subject must be written down in a designated location within 
the source document and not written on the script used for the telephone call. 
The site should schedule the next study activity: clinic visit or safety call with the 
subject’s parent(s)/LAR(s). 

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The parent(s)/LAR(s) will be reminded to contact the site if there are any questions and to 
contact the site immediately (or as soon as the subject is medically stable) if the subject 
has a medical condition that leads to a hospitalization or an emergency room visit. 
5.4 
Unscheduled Visits 
An unscheduled visit describes a non-routine study visit triggered by a specific event. 
These could include anticipated or unanticipated adverse events or interventions. 
Unscheduled visits may include, but are not limited to, review of Subject Diary Card data, 
review of systems, symptom directed physical examination, and blood sampling for 
safety, and should be documented in the subject’s source documentation. 
5.5 
Study Termination Visit 
The study termination visit (ie, safety phone call) will occur on Day 387. The date of 
termination is the date of the last contact (clinic visit or telephone call) in which the 
subject’s health status was assessed or, in cases where the subject does not agree to any 
further safety follow-up, it is the date consent is withdrawn. This date should be recorded 
on the termination eCRF page. For visit procedures to be performed for a subject whose 
planned study participation ends prematurely, please see section 5.5.1, Early Termination 
Visit.  
During the telephone call, the following procedures will be performed if applicable: 
review of Subject Diary Card, collection of Subject Diary Card, review of systems, 
interview of the subject’s parent(s)/LAR (s) to collect unsolicited AEs, AEs leading to 
withdrawal, SAEs, AESIs, and NOCD, interview of subject and/or parent(s)/LAR (s) to 
collect associated concomitant medications/ vaccinations, symptom-directed physical 
assessment, and blood sampling for immunogenicity. 
The site will review with the subject’s parent(s)/LAR(s) the plan of when information 
relating to the subject’s participation in the study may be available (eg, study results, 
treatment assignments). It will also be discussed how information relating to the subject’s 
participation in the study will be shared with the subject’s health care provider, if the 
subject’s parent(s)/LAR(s) chooses to share this information. 
The site will complete the termination eCRF page and this will mark the completion of 
the subject’s participation in the study. 
5.5.1 Early Termination Visit 
When a subject is withdrawn from treatment or withdraws from the study, the investigator 
will notify the sponsor or delegate and, when possible, will perform the procedures listed 
below. The reason(s) for the early termination will be included in the subject’s source 

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documentation. If the early termination visit is a telephone call, collect as much 
information as possible. Early termination visits include subjects who were randomized 
but not treated. 
At the clinic visit or during the telephone call, the following procedures will be performed 
as during the study termination visit, see section 5.5 Study Termination Visit, if possible. 
In addition, the following procedures will be performed:  
• Collect and review Subject Diary Card, if applicable.9 
• Review the subject’s safety data (if collection of these was in progress at the time of 
study completion). 
The site will review with the subject’s parent(s)/LAR (s) the plan of when information 
relating to the subject’s participation in the study may be available (eg, study results, 
treatment assignments). It will also be discussed how information relating to the subject’s 
participation in the study will be shared with the subject’s health care provider, if the 
subject’s parent(s)/LAR(s) chooses to share this information. 
The site will complete the termination eCRF page and this will mark the completion of 
the subject’s participation in the study. 
                                                 
9 In case a clinic visit is not possible, subjects should be instructed on how to return the Subject’s Diary 
Card. 

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6. 
TREATMENT OF SUBJECTS 
All vaccines associated with this study are to be stored separately from other vaccines and 
medications in a secure location under appropriate storage conditions with temperature 
monitoring. All vaccines associated with this study must be checked for expiration 
date prior to use. Expired vaccines must not be administered to subjects. 
6.1 
Study Vaccine(s) 
The term ‘study vaccine’ refers to those vaccines provided by the sponsor, which will be 
evaluated as part of the study objectives. The study vaccines specific to this study are 
described below. 
Investigational vaccine: aH5N1 
Six different formulations of the aH5N1 vaccine in 6 different HA/MF59 combinations 
will be tested in this study, see Table 6.1. The full composition of the active vaccine 
components of the currently licensed adult formulation for aH5N1 (7.5 µg HA of H5N1 
influenza strain combined with 0.25 mL MF59) is reported in Table 6.2.  
Table 6.1: H5N1 HA and MF59 content of the 6 vaccine formulations. 
Arm* 
H5N1 HA content 
MF59 content** 
Injection volume 
A 
1.875 µg 
50% MF59 
0.25 mL 
B 
3.75 µg 
50% MF59 
0.25 mL 
C 
7.5 µg 
50% MF59 
0.25 mL 
D 
1.875 µg 
100% MF59 
0.5 mL 
E 
3.75 µg 
100% MF59 
0.5 mL 
F 
7.5 µg 
100% MF59 
0.5 mL 
*Approximately 70 subjects will be randomized per treatment arm, ie, 35 subjects in each age cohort. 
**50% MF59 refers to half the standard MF59 content of the licensed adult formulation for H5N1. 
 

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Table 6.2: Full composition of the active vaccine components. 
Composition of the active vaccine components 
Component 
7.5 g + 100% MF59 per 0.5 mL 
Influenza virus surface antigens (HA and NA) 
A/turkey/Turkey/1/2005 (H5N1)-like (NIBRG-23) 
~7.5-µg HA 
% MF59 content relative to commercial vaccine 
100% 
Squalene 
9.75 mg 
Polysorbate 80 
1.175 mg 
Sorbitan trioleate 
1.175 mg 
Sodium citrate dihydrate 
0.66 mg 
Citric acid monohydrate 
0.04 mg 
Sodium chloride 
 
Potassium chloride 
 
Potassium dihydrogen phosphate 
 
Disodium phosphate dihydrate 
 
Magnesium chloride hexahydrate 
 
Calcium chloride dihydrate 
 
Water for injection 
Up to 0.5 mL 
Vaccine Presentation 
Prefilled syringe 
Volume of Component 
~0.5 mL 
Subjects will be randomized to receive 2 doses of study vaccine, 3 weeks apart, according 
to the vaccine group assignments shown in Table 1.  
6.2 
Non-Study Vaccines 
The term ‘non-study vaccine’ refers to those vaccines which will be intentionally given to 
study subjects but not formally included in the analysis of study objectives. No “non-
study vaccines” will be given as part of this study.  
Subjects are not prohibited from receiving other vaccinations during the course of the trial 
as long as these are not an influenza vaccination administered prior to visit 3 (Day 43). 
Please see section 6.5 for further details. Following Day 43 other vaccines may be 
administered, including seasonal flu. 

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6.3 
Vaccine Preparation and Administration 
The investigator or designee will be responsible for oversight of the administration of 
vaccine to subjects enrolled in the study according to the procedures stipulated in this 
study protocol. The study vaccines will be administered only by unblinded personnel who 
are qualified to perform that function under applicable local laws and regulations for the 
specific study site.  
The study vaccines will be supplied in kits (per subjects/per visit) containing the required 
materials to administer the specific formulation at the site. The kits may contain the 
following components, depending on the dose regimen: 
• PFS, adjuvanted (50% MF59) H5N1 A/turkey/Turkey/1/2005 1.9 µg/0.25 mL 
• PFS, adjuvanted (100% MF59) H5N1 A/turkey/Turkey/1/2005 1.9 µg/0.5 mL 
• PFS, adjuvanted H5N1 (50% MF59) A/turkey/Turkey/1/2005 3.75 µg/0.25 mL 
• PFS, adjuvanted (100% MF59) H5N1 A/turkey/Turkey/1/2005 3.75 µg/0.5 mL 
• PFS, adjuvanted H5N1 (50% MF59) A/turkey/Turkey/1/2005 7.5 µg/0.25 mL 
• PFS, adjuvanted (100%) H5N1 A/turkey/Turkey/1/2005 7.5 µg/0.5 mL 
All formulations will be supplied as PFSs, depending on the treatment allocation 0.25 mL 
or 0.5 mL will be administered. 
For detailed vaccine preparation and administration instructions unblinded personnel 
should refer to the IMP handling instructions. 
PRECAUTIONS TO BE OBSERVED IN ADMINISTERING STUDY VACCINE: 
Prior to vaccination, subjects must be determined to be eligible for study vaccination and 
it must be clinically appropriate in the judgment of the investigator to vaccinate. 
Eligibility for vaccination prior to first study vaccine administration is determined by 
evaluating the entry criteria outlined in protocol sections 4.1, Inclusion Criteria and 4.2, 
Exclusion Criteria. 
Eligibility for subsequent study vaccination is determined by following the criteria 
outlined in section 4.3, Criteria for Delay of Vaccination. 

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Eligibility for non-study vaccines should be determined by the investigator, pending the 
review of the package insert of the relevant vaccine and the guidelines described in 
section 6.2, Non-Study Vaccines. 
Study vaccines should not be administered to individuals with known hypersensitivity to 
any component of the vaccines. 
Vaccine administration will be performed intramuscularly, anterolateral thigh for children 
ages <2 years; deltoid for children ages ≥2 years, unless insufficient deltoid mass. 
Standard immunization practices are to be observed and care should be taken to 
administer the injection intramuscularly. Before administering vaccine, the vaccination 
site is to be disinfected with a skin disinfectant (eg, 70% alcohol). Allow the skin to dry. 
DO NOT inject intravascularly. 
As with all injectable vaccines, trained medical personnel and appropriate medical 
treatment should be readily available in case of anaphylactic reactions following vaccine 
administration. For example, epinephrine 1:1000, diphenhydramine, and/or other 
medications for treating anaphylaxis should be available. 
6.4 
Vaccine Administration Error or Overdose of Vaccine 
Vaccine administration error is defined as receiving a dose of study vaccine that was not 
reconstituted as instructed or administered by a different route from the intended route of 
administration. An overdose of study vaccine (whether accidental or intentional) is 
defined when a dosage higher than the recommended dosage is administered in one dose 
of study aH5N1 vaccine. 
An overdose would also occur if two doses of the study vaccine are administered within 
half the time of the recommended interval between doses, as defined in the protocol. 
Any vaccine administration error or overdose of study vaccine detailed in this protocol 
must be reported as an adverse event, and if the vaccine administration error or overdose 
is associated with a serious adverse event, it must be reported as such within 24 hours to 
the sponsor or delegate. 
6.5 
Prior and Concomitant Medications and Vaccines 
All medications, vaccines, including influenza vaccines (within the last 2 years), and 
blood products taken or received by the subject within 3 months prior to the start of the 
study are to be recorded on the prior and concomitant medications eCRF. See the 
exclusion criteria in section 4.2, Exclusion Criteria for details on medication that is not 
allowed prior and during the study.  

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The use of antipyretics and/or analgesic medications within 24 hours prior to vaccination 
must be identified and the reason for their use (prophylaxis versus treatment) must be 
described in the source document and concomitant medications eCRF. The use of 
antipyretics/analgesics within 24 hours prior to vaccine administration is a reason to delay 
study vaccination (see section 4.3, Criteria for Delay of Vaccination). 
Medications taken for prophylaxis are those intended to prevent the onset of symptoms. 
Medications taken for treatment are intended to reduce or eliminate the presence of 
symptoms that are present. 
Concomitant medications include all medications (including vaccines) taken 
by/administered to the subject at and after enrolment and must be documented on the 
concomitant medications eCRF. From Day 1 to Day 43 all concomitant medications 
should be recorded in the eCRF. In the follow-up period (Day 44 through Day 387), only 
concomitant medications associated with SAEs, NOCDs, AEs leading to vaccine and/or 
study withdrawal, and AESIs should be recorded in the eCRF.  
When recording concomitant medications/vaccines, they should be checked against the 
study entry and continuation criteria in section 4, Selection of Study Population to ensure 
that the subject should be enrolled/continue in the study. 
6.6 
Vaccine Supply, Labeling, Storage and Tracking 
The sponsor will ensure the following: 
• Supply of the study vaccine(s). 
• Appropriate labeling of all study vaccines provided that these comply with the legal 
requirements of each country where the study is to be performed. 
The investigator must ensure the following: 
• Acknowledge receipt of the study vaccines by a designated staff member at the site, 
including: 
- 
Confirmation that the vaccines were received in good condition 
- 
Confirmation to the sponsor or delegate of the temperature range during shipment 
from the sponsor to the investigator’s designated storage location 
- 
In case of temperature excursions during shipment: Confirmation by the sponsor 
or delegate that the vaccines are authorized for use. 
• Proper storage of the study vaccines, including: 
- 
Storage in a secure, locked, temperature-controlled location. 

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- 
Proper storage according to the instructions specified on the labels. 
- 
Appropriate record keeping and inventory of the study vaccines, including regular 
documentation of adequate storage temperature. 
• Appropriate use of the study vaccines, including: 
- 
Use only in accordance with the approved protocol. 
- 
Proper handling, including confirmation that the vaccine has not expired prior to 
administration. 
- 
Appropriate documentation of administration of vaccines to study subjects 
including: 
▪ 
Date, dosage, batch/lot numbers, expiration dates, unique identifying numbers 
assigned to subjects and study vaccines, and time of vaccine administration. 
This information will be maintained on the Vaccine Administration log that 
will be reviewed by the site monitor. 
▪ 
Reconciliation of all vaccines received from the sponsor. Reconciliation is 
defined as maintaining records of which and how many vaccines were 
received, which vaccines and the volume administered to subjects, which 
vaccines were destroyed at the site, and which vaccines were returned to the 
sponsor , as applicable. 
• Proper adherence to the local institutional policy with respect to destruction of study 
vaccines upon approval from the sponsor. 
• Complete record keeping of vaccine use, wastage, return or destruction, including 
documentation of: 
- 
Copy of the site’s procedure for destruction of hazardous material. 
- 
Number of doses destroyed, date of destruction, destruction code (if available), 
method of destruction, and name of individual performing destruction upon 
approval from the sponsor. 
Vaccines that have been stored differently from the manufacturer’s indications must not 
be used unless the sponsor provides written authorization for use. In the event that the use 
cannot be authorized, the sponsor will make every effort to replace the vaccine supply. 
All vaccines used in conjunction with this protocol must be stored separately from normal 
hospital/practice stocks to prevent unintentional use of study vaccines outside of the 
clinical study setting. 
Monitoring of vaccine accountability will be performed by the study monitor during site 
visits and at the completion of the study. 

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At the conclusion of the study, and as appropriate during the course of the study, the 
investigator must ensure that all unused study vaccines are destroyed locally (upon 
approval from sponsor) or returned to the sponsor. 

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7. 
ASSESSMENTS 
7.1 
Safety Assessment 
The measures of safety used in this study are routine clinical procedures. They include a 
close vigilance for, and stringent reporting of, selected local and systemic adverse events 
routinely monitored in vaccine clinical studies as indicators of reactogenicity. 
An AE is defined as any untoward medical occurrence in a subject or clinical 
investigation subject administered a pharmaceutical product at any dose that does not 
necessarily have to have a causal relationship with this treatment. Therefore, an AE can 
be any unfavorable and unintended sign (including an abnormal laboratory finding, for 
example), symptom, or disease temporally associated with the use of an investigational 
product, whether or not considered related to the investigational product. This definition 
includes intercurrent illnesses or injuries and exacerbation of pre-existing conditions. 
The period of observation for AEs extends from the time the subject signs informed 
consent /assent until he or she completes the specified safety follow-up period visit 7 
(Day 387) or terminates the study early (whichever comes first). AEs occurring after the 
ICF/assent is signed but prior to receiving study vaccine/product will be documented as 
an adverse event in EDC and recorded within the source document. However, any AEs 
occurring prior to receipt of any study vaccine will be analyzed separately from 
“treatment emergent” AEs (AEs occurring after administration of the first study vaccine). 
AEs are collected as either solicited or unsolicited adverse events. Solicited events are 
derived from organized data collection systems, such as subject diaries or interview. 
7.1.1 Solicited Adverse Events 
The term “reactogenicity” refers to solicited signs and symptoms (“solicited adverse 
events”) occurring in the hours and days following a vaccination, to be collected by the 
subject’s parent(s)/LAR(s)/caregiver for 7 consecutive days, using a pre-defined Subject 
Diary Card. In this study there will be 2 versions of the Subject Diary Card; one version 
for children <3 years and one version for children ages 3 years and older. 
The following solicited adverse events are included in the Subject Diary Card. Each 
adverse event is to be assessed according to defined severity grading scales. 
For children ages 6 months through <3 years, solicited local AEs will include injection-
site erythema, injection-site induration, injection-site ecchymosis, and injection-site 
tenderness; solicited systemic AEs will include change in eating habits, shivering, 
sleepiness, irritability, vomiting, diarrhea, and body temperature ≥38.0°C.  

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For children ages 3 years and older, solicited local AEs will include injection-site 
erythema, injection-site induration, injection-site ecchymosis, and injection-site pain; 
solicited systemic AEs will include loss of appetite, nausea, fatigue, malaise, generalized 
myalgia, generalized arthralgia, headache, shivering/chills, vomiting, diarrhea, and body 
temperature ≥38.0°C. 
Solicited local or systemic adverse event continuing beyond Day 7 after vaccination, must 
also be recorded as an unsolicited AE on the AE eCRF. 
Other Indicators of Reactogenicity 
The use of analgesics/antipyretics will be captured as “absent” or “present” and will also 
be summarized by “for treatment” or “for prophylaxis”. 
Instructions for Temperature Collection 
Temperature should preferably be measured using the thermometer provided to the 
parent(s)/LAR(s) by the site staff. Ideally the subject’s temperature should be taken 
orally, however if for some reason it cannot be taken in this way, the alternate route of 
administration should be recorded on the Subject Diary Card. 
The parent(s)/LAR(s) should be advised to begin measuring the subject’s temperature 
approximately 6 hours after the vaccination or prior to the subject going to bed if this is 
before. For the next 6 days following vaccination, the subject‘s temperature should be 
measured at least once a day, preferably in the evening and at the same time each day. If 
the subject feels warm or unusually cold at any time during the 7 day post vaccination 
reporting period, the parent(s)/LAR(s) should be advised to record an additional 
temperature. If multiple temperatures are collected on any given day, only the highest 
temperature measured that day should be recorded. 
If the subject’s temperature is below 35.5°C the parent(s)/LAR(s) should be advised to 
take a repeat measurement to ensure the temperature is correct. If the subject’s 
temperature is 38.0°C or higher at day 7, the parent(s)/LAR(s) should continue to 
measure the subject’s temperature each day until it returns below 38.0°C. The date of the 
last day that the subject’s temperature was above 38.0 °C should be recorded on the 
Subject Diary Card. 
If the subject’s temperature is ≥38.0°C and is accompanied by one or more of the 
following symptoms: cough, sore throat, nasal congestion or runny nose, the 
parent(s)/LAR(s) should be advised to contact the study site immediately. 
Instructions for Recording Injection Site Reactions 
It is important to advise the parent(s)/LAR(s) that they should record both when an 
injection site reaction was observed as well as when one was not by checking the 

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appropriate tick box on the Subject Diary Card. The parent(s)/LAR(s) should be advised 
to complete their assessments at approximately the same time each day, preferably in the 
evening. 
When a measurable reaction is observed such as hardness, bruising or redness the 
parent(s)/LAR(s) making the assessment should use the ruler provided by the site to 
measure the size in mm of the affected area. This information should be recorded by the 
parent(s)/LAR(s) on the Subject Diary Card. 
When tenderness at the reaction site is noticed the parent(s)/LAR(s) should monitor the 
monitor the symptoms throughout the day and enter the most severe status that was 
observed (ie, mild, moderate or severe). If a reaction continues past day 7 the subject’s 
parent(s)/LAR(s) should be advised to record the last day that the reaction was observed. 
Instructions for Recording General Symptoms (changes in eating habits, sleepiness, 
vomiting, diarrhea, irritability and shivering) 
 When general symptoms are observed by the subject’s parent(s)/LAR(s) they should be 
monitored throughout the day and the most severe status observed (mild, moderate or 
severe) should be recorded on the Subject Diary Card. Definitions of these categories for 
each the general symptoms inquired about can be found in the diary. It is important to 
advise the parent(s)/LAR(s) that they should record both when a reaction was observed as 
well as when one wasn’t by checking the appropriate tick box on the Subject Diary Card. 
If a symptom is still present at Day 7, the date of the last day the symptom was present 
should be recorded. 
Instructions for Recording Medicines Taken for Reactions and General Symptoms 
on the Day of Vaccination and/or on the First 6 days after Vaccination 
The subject’s parent(s)/LAR(s) should be advised to report any medications that were 
taken to treat any of the reactions or symptoms which occurred following the vaccination 
administration and for the next 3 weeks. With a tick box this should be recorded on the 
diary for the first 6 days after vaccination. 
Other Solicited Adverse Events  
The study staff must review the data entered into the Subject Diary Card as described in 
section 3.4.2, Tools Used for Data Collection and section 5.3.1, Follow-up Clinic Visit(s). 
Note: Any solicited AE that meets any of the following criteria must be entered into 
subjects’ source document (see section 9.1, Source Documentation) and also as an 
adverse event on the adverse event eCRF: 
• Solicited local or systemic AE that leads to a visit to a health care provider (see 
section 7.1.3, Evaluation of Adverse Events). 

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• Solicited local or systemic AE leading to the subject withdrawing from the study 
or the subject being withdrawn from the study by the investigator (AE leading to 
withdrawal, see section 7.1.3, Evaluation of Adverse Events). 
• Solicited local or systemic AE that otherwise meets the definition of a SAE (see 
section 7.1.4, Serious Adverse Events). 
7.1.2 Unsolicited Adverse Events 
An unsolicited AE is an AE that was not solicited using a subject diary and that was 
spontaneously communicated by a subject and/or parent(s)/LAR(s) who has signed the 
informed consent. 
The period of observation for AEs extends from the time of informed consent until the 
subject either completes the specified safety follow-up period (Day 387) or at early 
termination. Adverse events that occur after the ICF is signed but prior to receiving study 
vaccine are to be documented as an AE and recorded within the source document. All 
AEs that start during the treatment period (Day 1 to Day 43) are to be recorded in the 
eCRF. During the safety follow-up period (Day 44 to Day 387), only AEs that meet any 
of the following criteria are to be recorded in the eCRF: SAE, AESI, NOCD, or AE 
leading to withdrawal. Potential unsolicited AEs may be medically attended (defined as 
symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a 
health care provider), or were of concern to the subject and/or parent(s)/LAR(s). In case 
of such events occur during the first 3 weeks after the study vaccine administration, 
subject’s parent(s)/LAR(s) will be instructed to contact the site as soon as possible to 
report the event(s). The detailed information about the reported unsolicited AEs will be 
collected by the qualified site personnel during the interview and will be documented in 
the subject’s records. 
Unsolicited AEs that are not medically attended nor perceived as a concern by the 
subject’s parent(s)/LAR(s) will be collected during interview with the subject’s 
parent(s)/LAR(s) and by review of available medical records at the next visit (see section 
5.3, Post-vaccination Visit(s)). 
7.1.3 Evaluation of Adverse Events 
Every effort should be made by the investigator to evaluate safety information reported by 
a subject for an underlying diagnosis and to capture this diagnosis as the event on the AE 
page. In other words, the practice of reporting only symptoms (eg, “cough” or “ear pain”) 
are better reported according to the underlying cause (eg, “asthma exacerbation” or “otitis 
media”). 
The severity of events reported on the adverse events eCRF will be determined by the 
investigator as: 

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Mild: 
transient with no limitation in normal daily activity. 
Moderate: 
some limitation in normal daily activity. 
Severe: 
unable to perform normal daily activity. 
The relationship of the study treatment to an AE will be determined by the investigator 
based on the following definitions: 
1. Not Related 
The AE is not related to an investigational vaccine if there is evidence that clearly 
indicates an alternative explanation. If the subject has not received the vaccine, the timing 
of the exposure to the vaccine and the onset of the AE are not reasonably related in time, 
or other facts, evidence or arguments exist that reasonably suggest an alternative 
explanation, then the AE is not related. 
2. Possibly Related 
The administration of the investigational vaccine and AE are considered reasonably 
related in time and the AE could be explained by exposure to the investigational vaccine 
or by other causes. 
3. Probably Related 
Exposure to the investigational vaccine and AE are reasonably related in time and no 
alternative explanation has been identified. 
The relationship of the study treatment to an unsolicited AE will be determined by the 
investigator.  
Note: all solicited AEs from Day 1 to Day 7 will be considered Adverse Drug Reactions 
(ADRs). Grading for severity of solicited local and systemic AEs is described in section 
7.1.1, Solicited Adverse Events. 
Adverse events will also be evaluated by the investigator for the co-existence of any of 
the other following conditions: 
• “New Onset of Chronic Disease”: an AE that represents a new diagnosis of a 
chronic medical condition that was not present or suspected in a subject prior to 
study enrolment. 
• Adverse events leading to withdrawal: AEs leading to study or vaccine 
withdrawal. 

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If solicited or unsolicited adverse events have been reported and the subject’s 
parent(s)/LAR(s) indicated that the symptoms required medical attendance or were of 
concern, the subject’s parent(s)/LAR(s) must be contacted for further information. 
When the subject’s parent(s)/LAR(s) are contacted for any of these reasons, the contact 
must be documented in the subject’s source documentation. 
All AEs, regardless of severity, will be monitored until resolution or until the investigator 
assesses them as chronic or stable. All subjects experiencing AEs - whether considered 
associated with the use of the study vaccine or not - must be monitored until symptoms 
subside and any abnormal laboratory values have returned to baseline, or until there is a 
satisfactory explanation for the changes observed, or until death, in which case a full 
pathologist’s report should be supplied, if possible. The investigator’s assessment of 
ongoing AEs at the time of each subject’s last visit should be documented in the subject’s 
medical chart/source document. 
7.1.4 Serious Adverse Events 
An SAE is defined as any untoward medical occurrence that at any dose results in one or 
more of the following: 
• Death. 
• Is life-threatening (ie, the subject was, in the opinion of the investigator, at 
immediate risk of death from the event as it occurred); it does not refer to an event 
which hypothetically might have caused death if it were more severe. 
• Required or prolonged hospitalization. 
• Persistent or significant disability/incapacity (ie, the event causes a substantial 
disruption of a person’s ability to conduct normal life functions). 
• Congenital anomaly/or birth defect. 
• An important and significant medical event that may not be immediately life 
threatening or resulting in death or hospitalization but, based upon appropriate 
medical judgment, may jeopardize the subject or may require intervention to 
prevent one of the other outcomes listed above. 
Adverse events which do not fall into these categories are defined as non-serious. 
It should be noted that a severe adverse event need not be serious in nature and that a 
serious adverse event need not, by definition, be severe. 

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Serious AEs will be captured on the Adverse Events eCRF. All SAEs will be evaluated 
by the investigator for relationship of the event to study vaccine. SAEs that are judged to 
be possibly or probably related to the study vaccine should be reported to the sponsor as 
related/suspected events. 
The relationship of the study treatment to an SAE will be determined by the investigator 
based on the following definitions: 
1. Related/suspected 
The SAE is judged by the investigator to be possibly or probably related to the study 
vaccine on the AE eCRF page (see section 7.1.3, Evaluation of Adverse Events). 
2. Not Related 
The SAE is not related if exposure to the study vaccine has not occurred, or the 
occurrence of the SAE is not reasonably related in time, or the SAE is considered 
unlikely to be related to use of the study vaccine, ie, there are no facts (evidence) or 
arguments to suggest a causal relationship. 
The relationship of the study vaccine to an SAE will be determined by the investigator. 
In addition, SAEs will be evaluated by the sponsor or delegate for “expectedness.” An 
unexpected AE is one that is not listed in the current summary of product characteristics 
or the Investigator’s Brochure or an event that is by nature more specific or more severe 
than a listed event. 
In addition, a pre-existing event or condition that results in hospitalization should be 
recorded on the medical history eCRF. If the onset of an event occurred before the subject 
entered the study (eg, any pre-planned hospitalization for conditions like cosmetic 
treatments or for non-emergency routine visits for a pre-existing condition), the 
hospitalization would not lead to an AE being classified as serious unless, in the view of 
the investigator, hospitalization was prolonged as a result of participation in the clinical 
study or was necessary due to a worsening of the pre-existing condition. 
7.1.4.1 
Adverse Events of Special Interest 
The investigator will be provided with a list of AESIs prior to study start (Appendix A: 
Adverse Events of Special Interest).  
Subjects will be assessed at each clinic visit for any new medical events or signs or 
symptoms that could possibly indicate an AESI. The subject’s parent(s)/LAR(s) will be 
asked whether any new diagnosis has been given to the subject through a review of recent 

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medical history. The subject’s parent(s)/LAR(s) will be instructed, prior to the visit, to 
bring any medical records/documentation of any new medical diagnosis or medical 
problem. The medical records/documentation will be thoroughly reviewed by the site 
staff and recorded into the subject’s medical chart/source documents. A review of organ 
systems and a targeted physical examination of the subject will also take place. A 
qualified health care practitioner listed on the site’s responsibilities and delegation logs 
are required to evaluate subjects. Should a qualified health care practitioner who is not the 
investigator suspect a potential AESI, she/he should promptly inform the investigator. A 
diagnosis of an AESI should be categorized as an SAE and must be documented on the 
AE eCRF within 24 hours of the site becoming aware of an AESI diagnosis. If the eCRF 
is not available, then the study site must complete the paper SAE Report Form and email 
the Seqirus Pharmacovigilance and Risk Management (PVRM) (or delegate) 
at ae.reporting@seqirus.com within 24 hours of becoming aware. Once the eCRF is 
available, the AESI should be documented on the AE eCRF as soon as possible. 
The AESI diagnosis will also be recorded in the medical chart/source document. This is 
also applicable to any medication(s) used to treat the condition. 
7.1.4.2 New Onset of Chronic Disease  
NOCD is defined as an illness that starts during the course of the study that did not exist 
prior to enrollment into the study and is likely to persist throughout the lifetime of the 
subject. A chronic disease is one that can be treated but for which no cure exists. For 
example, a new onset of asthma (occurs for the first time during the study and has been 
evaluated longitudinally to ensure that a diagnosis of asthma is appropriate) is classified 
as a NOCD. This is applicable for any chronic disease affecting any organ class that 
arises during the study that is likely to persist throughout the subject’s lifetime (even if in 
remission). Infectious diseases, such as Hepatitis C Virus or tuberculosis, are not 
considered NOCDs as there are antibiotics and antivirals that are potentially able to cure 
such diseases (this is a generalizable cure and not specific to the subject). In case of 
doubt, diagnoses of NOCD should be discussed with the study medical monitor. Of note, 
a NOCD may be a condition listed in AESI.  
7.1.5 Methods for Recording Adverse Events and Serious Adverse Events 
Findings regarding AEs must be reported on an AE eCRF, as specified in section 7.1.1, 
Solicited Adverse Events. All findings in subjects experiencing AEs must also be reported 
in the subject's source document. 
All SAEs which occur during the course of the study, whether considered to be associated 
with the study vaccination or not, must be documented on the AE eCRF within 24 hours 
of the site becoming aware of the event. If the eCRF is not available, then the study site 

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must complete the paper SAE Report Form and email the Seqirus PVRM (or delegate) 
at ae.reporting@seqirus.com within 24 hours of becoming aware. Once the eCRF is 
available, the SAE should be documented on the AE eCRF as soon as possible. 
Any medication or other therapeutic measures used to treat the AE will be recorded on the 
appropriate eCRF(s) in addition to the outcome of the AE. 
After receipt of the initial report, Seqirus PVRM or delegate will contact the investigator 
if it is necessary to obtain further information for assessment of the event. 
All SAEs must be reported by the investigator to his/her corresponding EC/IRB 
applicable regulatory authorities in accordance with institutional policy/regulatory 
requirements and adequate documentation of this notification must be provided to the 
sponsor or its delegate. 
Seqirus or delegate must also comply with the applicable regulatory requirement(s) 
related to the reporting of suspected unexpected serious adverse vaccine reactions (also 
known as SUSARs) to the regulatory authority(ies) and the IRB/EC. If a SUSAR or other 
safety signal relating to use of one of the study vaccines is reported to the sponsor or 
delegate, the sponsor will communicate the information to the investigator and the 
investigator will be responsible for submitting this information to the EC/IRB and other 
relevant authorities. 
7.1.5.1 
Post-Study Events 
For this study no post-study follow-up will be defined. A 12 months’ follow-up period 
after the vaccinations is already included in the study design.  
7.1.6 Pregnancies 
Not applicable. 
7.1.7 Safety Laboratory Measurements 
Not applicable. 
7.2 
Efficacy Assessment 
Not applicable. 
7.3 
Immunogenicity Assessment 
The measures of immunogenicity used in this study are standard, ie, widely used and 
generally recognized as reliable, accurate, and relevant (able to describe the quality and 
extent of the immune response). 

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The measures of immunogenicity used in this study have been described/adopted in 
guidance/based on scientific consensus/other and have been deemed appropriate to 
describe the immune response against A/H5N1 in this study. 
Immunological responses to the different doses of antigens and adjuvant contained in the 
vaccine (A/H5N1) will be evaluated using HI and MN assays (and SRH assay if sufficient 
serum if available). Blood samples will be obtained prior to the first vaccination on Day 
1, on Day 22, 3 weeks after the first vaccination, on Day 43, 3 weeks after the second 
vaccination, and on Day 202, 6 months after the second vaccination. 
Measuring HI and MN antibody titers on Days 22 and 43, approximately 21 days after 
first and second study vaccination, is the typical timing to evaluate the antibody response 
of subjects. These titers will be compared against baseline antibody titers (Day 1, prior to 
vaccination) and will be used to evaluate immunogenicity. 
Testing will be conducted by the sponsor designated laboratory (ies) in a blinded manner 
to the treatment arm and the visit. Please see the laboratory manual for name(s) and other 
details. 
 

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8. 
STATISTICAL CONSIDERATIONS 
A complete description of the statistical analyses and methods will be available in the 
Statistical Analysis Plan, which will be finalized before the database is locked. 
This study will evaluate the safety and immunogenicity endpoints related to different 
formulations of the vaccine. The statistical analysis will be mainly descriptive in nature 
without any pre-specified inferential analyses. 
8.1 
Endpoints 
8.1.1 Primary Endpoint(s) 
8.1.1.1 
Primary Safety Endpoint(s) 
The measures for assessing safety and reactogenicity are as follows: 
• Percentages of subjects with solicited local and systemic AEs10 that occur within 7 
days following each vaccination and calculated for 4 time intervals after 
vaccination: 30 minutes, 1 through 3 days, 4 through 7 days, and 1 through 7 days.  
• Percentages of subjects with any unsolicited AEs reported within 21 days after 
each vaccination within each vaccine group.  
• Percentages of subjects reporting SAEs, NOCDs, AESIs, and AEs leading to 
vaccine and/or study withdrawal , as collected from Day 1 through Day 387.  
8.1.1.2 
Primary Efficacy Endpoint(s) 
This study does not have primary efficacy endpoint(s). 
8.1.1.3 
Primary Immunogenicity Endpoint(s) 
The measures of immunogenicity, as determined by the HI and MN assay against the 
H5N1 pandemic influenza homologous strain include the following:  
• Geometric mean titers (GMTs) on Day 1 and Day 22 (3 weeks after the first 
vaccination) or Day 43 (3 weeks after the second vaccination) as determined by 
HI and MN assays against the homologous H5N1 pandemic influenza strain;  
                                                 
10 Including the use of antipyretics/analgesics 

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• Geometric mean ratios (GMRs) calculated as follows: Day 22/Day 1 or Day 
43/Day 1 as determined by HI and MN assays against the homologous H5N1 
pandemic influenza strain;  
• Percentage of subjects achieving seroconversion (non-detectable to ≥ 1:40 , or 4-
fold increase from a detectable Day 1 titer) on Day 22 or 43;  
• Percentage of subjects achieving seroconversion with a titer ≥ 1:40 on Days 1, 22 
or 4311.  
All primary immunogenicity endpoints will be described by treatment group, overall and 
by age cohort. 
In addition, reverse cumulative distribution functions for HI and MN titers will be 
computed on Days 1, 22, 43, and 202 (as applicable) and presented graphically and/or in 
tabulated form. 
8.1.2 Secondary Endpoint(s) 
8.1.2.1 
Secondary Safety Endpoint(s) 
This study does not have secondary safety endpoint(s). 
8.1.2.2 
Secondary Efficacy Endpoint(s) 
This study does not have secondary efficacy endpoint(s). 
8.1.2.3 
Secondary Immunogenicity Endpoint(s) 
All secondary immunogenicity endpoints will be described by treatment group and by age 
cohort. 
The measures of persistence of antibody responses on Day 202 to study vaccine after 
primary vaccinations, as determined by the HI and MN assays against the H5N1 
pandemic influenza homologous strain: 
• Geometric mean titers on Day 1 and Day 202 (6 months after the second 
vaccination) as determined by HI and MN assays;  
• Geometric mean ratios calculated as follows: Day 202/Day 1 as determined by HI 
and MN assays;  
                                                 
11 Percentage of subjects achieving a titer ≥1:40 on Days 1, 22, or 43 

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• Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-
fold increase from a detectable Day 1 titer) on Day 202;  
• Percentage of subjects achieving seroconversion with a titer of ≥1:40 on Day 
20212  
8.1.3 Exploratory Endpoint(s) 
8.1.3.1 
Exploratory Safety Endpoint(s) 
This study does not have exploratory safety endpoint(s). 
8.1.3.2 
Exploratory Efficacy Endpoint(s) 
This study does not have exploratory efficacy endpoint(s). 
8.1.3.3 
Exploratory Immunogenicity Endpoint(s) 
If adequate sera will be available and depending on assay availability, antibody responses 
and their persistence to seasonal and/or homologous and/or heterologous pandemic 
influenza strains as measured by HI, MN and SRH assays may be described at Days 1, 22, 
43, and 202 in the same manner as for primary and secondary immunogenicity endpoints. 
Other exploratory immunogenicity analyses may be described in the SAP or in an 
addendum to such a plan. 
8.2 
Success Criteria 
There is no pre-defined success criterion in this study. 
8.2.1 Success Criteria for Primary Objective(s) 
There is no pre-defined success criterion for primary objectives. 
8.2.1.1 
Success Criteria for Primary Safety Objective(s) 
There is no pre-defined success criterion for safety objectives. 
8.2.1.2 
Success Criteria for Primary Efficacy Objective(s) 
Not applicable to this study. 
                                                 
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8.2.1.3 
Success Criteria for Primary Immunogenicity Objective(s) 
There is no pre-defined success criterion for immunogenicity objectives. 
8.2.2 Success Criteria for Secondary Objective(s) 
8.2.2.1 
Success Criteria for Secondary Safety Objective(s) 
Not applicable to this study. 
8.2.2.2 
Success Criteria for Secondary Efficacy Objective(s) 
Not applicable to this study. 
8.2.2.3 
Success Criteria for Secondary Immunogenicity Objective(s) 
There is no pre-defined success criterion for secondary immunogenicity objectives. 
8.3 
Analysis Sets 
8.3.1 All Enrolled Set 
All screened subjects who provide informed consent/assent and provide demographic 
and/or baseline screening assessments, regardless of the subject’s randomization and 
treatment status in the study, and receive a subject ID. 
8.3.2 All Exposed Set 
All subjects in the enrolled set who receive at least one or a partial dose of study 
vaccination. 
8.3.3 Safety Set 
Solicited Safety Set (solicited local and systemic adverse events and other solicited 
adverse events) 
All subjects in the exposed set with any solicited adverse event data and/or indicators of 
solicited adverse events. 
Subjects with a confirmation of no indicators of solicited adverse event (for example 
vomiting is none or injection site-induration is 0 mm [none]) will be included in this 
population as well. 
Unsolicited Safety Set (unsolicited adverse events) 

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All subjects in the exposed set with unsolicited adverse event data. 
Subjects with a confirmation of no unsolicited adverse event will be included in this 
population as well. 
Overall Safety Set 
All subjects who are in the solicited safety set and/or unsolicited safety set. 
Subjects will be analyzed “as treated” (ie, according to the vaccine formulation a subject 
received, rather than the vaccine formulation to which the subject may have been 
randomized). 
Subjects randomized in the wrong age stratum will be reassigned to the correct age 
stratum and will be analyzed using corrected stratum for all safety sets (ie, solicited safety 
set, unsolicited safety set and overall safety set). If a subject is unblinded during the 
study, he/she will be included in all the safety sets. 
8.3.4 Full Analysis Set (FAS) Efficacy/Immunogenicity Set 
Full Analysis Set Efficacy  
Not applicable to this study. 
Full Analysis Set Immunogenicity 
All subjects in the all enrolled set who are randomized, receive at least one study 
vaccination and provide immunogenicity data at any time point.  
In case of vaccination error, subjects in the FAS sets will be analyzed “as randomized” 
(ie, according to the vaccine a subject was designated to receive, which may be different 
from the vaccine the subject actually received). 
8.3.5 Per Protocol Set (PPS) Efficacy/Immunogenicity Set 
Per Protocol Set Efficacy 
Not applicable to this study. 
Per Protocol Set Immunogenicity 
All subjects in the FAS immunogenicity who: 
• Correctly receive the vaccine (ie, receive the vaccine to which the subject is 
randomized and at the scheduled time points). 

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• Provide at least the baseline and one post-baseline blood sample, with evaluable 
immunogenicity data. 
• Have no protocol deviations leading to exclusion (see section 8.3.8, Protocol 
Deviations) as defined prior to unblinding / analysis. 
• Are not excluded due to other reasons defined prior to unblinding or analysis (see 
section 8.3.8, Protocol Deviations). Examples for subjects excluded due to other 
reasons than protocol deviations are subjects who withdrew informed consent/assent. 
Note that missing immunogenicity data at some time points following vaccination will 
not be considered a reason to exclude the subject from PPS Immunogenicity.  
8.3.6 Other Analysis Sets 
Not applicable to this study. 
8.3.7 Subgroups 
Age cohort (6 months to <36 months and 3 to <9 years based on the actual age) will be 
used as a subgroup for all study primary and secondary endpoints. 
8.3.8 Protocol Deviations 
A protocol deviation is any change, divergence, or departure from the study design or 
procedures of a study protocol. A protocol deviation may be a reason to remove data from 
an analysis set at the time of analysis. Clinical study report-reportable protocol deviations 
will be defined as exclusionary from the analysis according to protocol objectives and 
endpoints, which will be specified in the SAP. In some cases, exclusion of data may be 
due to a reason other than a protocol deviation, eg, early termination. 
8.4 
Statistical Analysis Plan 
A complete description of the statistical analyses and methods will be available in the 
Statistical Analysis Plan (SAP), which will be finalized prior to unblinding. 
8.4.1 Analysis of Demographic and Baseline Characteristics 
Descriptive statistics (mean, SD, median, minimum and maximum) for age, height, 
weight, and BMI at enrolment will be calculated overall, by vaccine group and age 
cohort. 
Distributions of subjects by sex, race, ethnicity, country and previous influenza 
vaccination status will be summarized overall, by vaccine group and age cohort. 

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8.4.1.1 Subject Disposition 
The number of subjects enrolled into the study and completed the study, will be presented 
in summary tables by treatment group, overall and by age cohort. The number in the 
Enrolled population will be used as the denominator. The primary reason for withdrawal 
from the study vaccination or from the study will summarized overall, by vaccine group, 
and age cohort. All data will be listed by subject. 
8.4.1.2 Concomitant Medications 
Use of concomitant medication will be presented by treatment, age cohort, therapeutic 
area, and preferred drug name. 
Concomitant medications are all medications taken during the study period, including 
those started before but ongoing at vaccination. 
If a start date for a medication is partially or fully missing, and it is unclear as to whether 
the medication is prior or concomitant, it will be assumed that it is concomitant. 
Medications will be coded using the WHO Drug dictionary. 
8.4.2 Analysis of Primary Objective(s) 
8.4.2.1 
Analysis of Primary Safety Objective(s) 
8.4.2.1.1 Analysis of Extent of Exposure 
The number of subjects actually receiving the first and second vaccination will be 
summarized by vaccine group. 
8.4.2.1.2 Analysis of Solicited Local, Systemic and Other Adverse Events 
Frequencies and percentages of subjects experiencing each AE occurring after first study 
vaccination, will be presented for each symptom overall and by maximum severity. 
Summary tables showing the occurrence of any local or systemic AE overall and at each 
time point will also be presented. 
Post-vaccination solicited AEs reported from Day 1 to Day 7 will be summarized for the 
intervals Day 1-3, Day 4-7, Day 1-7 by maximal severity and by vaccine group, excluding 
the 30 minute measurement, which will be summarized separately.  
The severity of solicited local AEs including injection-site erythema, injection-site 
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ages 6 months through <3 year) or injection-site pain (for children 3 years and older). 
Injection-site erythema, induration and ecchymosis will be summarized according to 
categories: 1 to 10 mm, 11 to 25 mm, 26 to 50 mm, >50 mm. Injection site 
pain/tenderness and systemic AEs (except fever) occurring up to 7 days after each 
vaccination will be summarized according to “mild”, “moderate” or “severe”. 
Body temperature will be summarized by 0.5 °C and 1.0 °C increments from 36.0°C up to 
≥ 40°C and will be broken down according by route of measurement. Fever, ie, body 
temperature ≥38°C will also be categorized as mild (38.0-38.4°C), moderate (38.5-
38.9°C), severe (39.0-40.0°C), and potentially life threatening (≥40.0°C). 
Each solicited local and systemic AE will also be further summarized as “none” versus 
“any”. 
Implausible measurements (for further definition see the SAP) will be left out of the 
analysis. 
Use of antipyretics and analgesics will be summarized by frequency: by type of use 
(prophylactic versus treatment) and percentage of subjects reporting use. 
8.4.2.1.3 Analysis of Unsolicited Adverse Events 
This analysis applies to all AEs occurring during the study, judged either as probably 
related, possibly related, or not related to vaccination by the investigator, recorded in AE 
eCRF, with a start date on or after the date of first vaccination. This analysis will include 
solicited AEs continuing beyond Day 7, which will be considered as possibly related AEs. 
AE starting prior to the first vaccination will only be listed. The original verbatim terms 
used by investigators to identify AEs in the eCRFs will be mapped to preferred terms 
using the Medical Dictionary for Regulatory Activities (MedDRA) dictionary. The AEs 
will then be grouped by MedDRA preferred terms into frequency tables according to 
system organ class. 
All reported AEs, as well as AEs judged by the investigator as at least possibly related to 
study vaccine, will be summarized according to system organ class and preferred term 
within system organ class. These summaries will be presented by vaccination group. 
When an adverse event occurs more than once for a subject, the maximal severity and 
strongest relationship to the vaccine group will be counted. 
Separate summaries will be produced for the following categories: 
• SAEs  
• AEs that are possibly or probably related to vaccine 

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• AEs of special interest 
• New onset of chronic disease 
• AEs leading to withdrawal from the study or the second vaccination 
Data listings of all AEs will be provided by subject. In addition, AEs in the categories 
above will be provided as listed data. 
8.4.2.1.4 Analysis of Safety Laboratory Values 
Not applicable for this study. 
8.4.2.2 
Analysis of Primary Efficacy Objective(s) 
Not applicable for this study. 
8.4.2.2.1 Statistical Hypotheses 
This study does not have statistical hypotheses. 
8.4.2.2.2 Analysis Sets 
All immunogenicity analyses (primary, secondary, and exploratory) will be performed on 
the PPS Immunogenicity. The primary immunogenicity analyses will be also performed 
based on the FAS Immunogenicity if the percentage of subjects excluded from the PPS 
immunogenicity is greater than 5%. All solicited safety analyses will be performed in 
solicited safety set. All unsolicited safety analyses will be performed ontheunsolicited 
safety set. Further details are given in section 8.3, Analysis Sets. 
8.4.2.2.3 Statistical Methods 
8.4.2.3 
Analysis of Primary Immunogenicity Objective(s) 
The antibody titers below lower limit of detection (LLD) will be coded as half of LLD 
(for example, 5 if LLD is 10). Missing immunogenicity data will be excluded from 
analysis of immunogenicity endpoints. Imputation methods will therefore not be applied. 
Sensitivity analyses may be considered to assess the impact of missing data in case of 
substantial missing data. 
For analysis requiring quantitative summarization of antibody titers (such as GMT or 
GMR) all antibody titers will be log10-transformed. Geometric mean ratios with 95% CIs 
will be calculated by estimating arithmetic means and 95% CIs for a normal variate on 

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log10-transformed scale, then back-transformation of these statistics using exponentiation 
at the base of 10. 
For analysis of binary data (ie, percentage of subjects with seroconversion and percentage 
of subjects with titer ≥1:40), the counts and percentages will be determined, the CIs will 
be calculated using Clopper-Pearson method.  
Seroconversion will be defined as either of the two conditions: subjects with a baseline 
titer <1:10 by either HI or MN assay with a post-vaccination titer ≥1:40 OR subjects with 
baseline titer ≥1:10 by either HI or MN assay with a 4-fold or higher increase in post-
vaccination titer. 
No formal statistical hypothesis will be tested.  
8.4.2.3.1 Statistical Hypotheses 
This study does not have statistical hypotheses. 
8.4.2.3.2 Analysis Sets 
See section 8.4.2.2.2, Analysis Sets 
8.4.2.3.3 Statistical Methods 
See section 8.4.2.2.3, Statistical Methods. 
8.4.3 Analysis of Secondary Objective(s) 
All secondary immunogenicity endpoints will be analyzed in the same manner as primary 
immunogenicity endpoints. 
8.4.3.1 
Analysis of Secondary Safety Objective(s) 
8.4.3.1.1 Analysis of Extent of Exposure 
Not applicable to this study as all safety objectives are considered primary. 
8.4.3.1.2 Analysis of Solicited Local, Systemic and Other Adverse Events 
Not applicable to this study as all safety objectives are considered primary. 
8.4.3.1.3 Analysis of Unsolicited Adverse Events 
Not applicable to this study as all safety objectives are considered primary. 

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8.4.3.1.4 Statistical Hypotheses 
Not applicable to this study as all safety objectives are considered primary. 
8.4.3.1.5 Analysis Sets 
Not applicable to this study as all safety objectives are considered primary. 
8.4.3.1.6 Statistical Methods 
Not applicable to this study as all safety objectives are considered primary. 
8.4.3.2 
Analysis of Secondary Efficacy Objective(s) 
Not applicable to this study. 
8.4.3.2.1 Statistical Hypotheses 
Not applicable to this study. 
8.4.3.2.2 Analysis Sets 
Not applicable to this study. 
8.4.3.2.3 Statistical Methods 
Not applicable to this study. 
8.4.3.3 
Analysis of Secondary Immunogenicity Objective(s) 
Secondary immunogenicity endpoints will be analyzed in the same manner as primary 
immunogenicity endpoints. 
8.4.3.3.1 Statistical Hypotheses 
Not applicable to this study. 
8.4.3.3.2 Analysis Sets 
See section 8.4.3.2.2, Analysis Sets. 
8.4.3.3.3 Statistical Methods 
See section 8.4.2.2.3, Statistical Methods. 

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8.4.4 Analysis of Exploratory Objectives 
8.4.4.1 
Analysis of Exploratory Safety Objective(s) 
Not applicable to this study. 
8.4.4.2 
Analysis of Exploratory Efficacy Objective(s) 
Not applicable to this study. 
8.4.4.3 
Analysis of Exploratory Immunogenicity Objective(s) 
Exploratory immunogenicity endpoints related to evaluation antibody responses to 
seasonal and/or homologous and/or heterologous pandemic influenza strain(s) will be 
analyzed in the same manner as primary and secondary immunogenicity endpoints. 
As an additional exploratory analysis, an analysis of co-variance will be conducted on log 
transformed (base ten) Day 22 or Day 43 HI (or MN) titers as the outcome variables and 
terms for covariates: age cohort, dose of MF59 adjuvant, amount of antigen and – where 
applicable – the Day 1 prevaccination HI (or MN) titer. Potential covariate interaction 
effects will also be examined in this model. 
The SAP may specify additional exploratory analyses of immunogenicity data. 
8.5 
Sample Size and Power Considerations of Primary Objective 
This is a dose-ranging study without inferential hypothesis testing. The total sample size 
to be randomized is 420 subjects equally divided for two age cohorts. This number of 
subjects should provide sufficiently accurate estimates of the GMT to evaluate the 
pediatric dose. Assuming an exclusion rate of up to 14% of subjects from the analysis, 
around 180 subjects per age cohort will be included in the analysis. With equal allocation 
to one of six vaccine groups, we expect at least 60 subjects per vaccine group and at least 
30 per vaccine group and age cohort to be evaluable for the statistical analysis. No formal 
power calculations have been done. However, the accuracy of the estimates of the GMT’s 
can be illustrated by the length of the 95% confidence intervals. Assuming a SD of log10-
transformed HI titers as 0.7 (based on studies V87_25 and V87_26 in healthy elderly): 
- 
With n=30 per dose group per age cohort; the 95% CI will be from 0.56 to 1.78 
times the GMT estimate 
- 
With n=60 per dose group; the 95% CI will be from 0.67 to 1.50 times from the 
GMT estimate. 

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In pairwise dose-group comparisons with n=60 per dose group it would be feasible to 
detect a difference of 2.5 in the GMT ratio with statistical power of 80% with the two 
sample T-test at significance level of 0.05.  
8.6 
Interim Analysis 
No interim analysis is planned for this study.   
 

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9. 
SOURCE DOCUMENTATION, STUDY MONITORING AND AUDITING 
In order to ensure consistency across sites, study monitoring and auditing will be 
standardized and performed in accordance with the sponsor’s or delegated contract 
research organization’s (CRO) standard operating procedures and applicable regulatory 
requirements (eg, Food and Drug Administration (FDA), EMA, and ICH guidelines). 
Prior to enrolment of the first study subject, the sponsor or delegate will train 
investigators and/or their study staff on the study protocol, all applicable study 
procedures, documentation practices and all electronic systems. eCRFs supplied by the 
sponsor or delegate must be completed for each enrolled subject (see section 8.3.1, All 
Enrolled Set for definition of enrolled subject). Documentation of screened but not 
enrolled subjects must be maintained at the site and made available for review by the site 
monitor. Data and documents will be checked by the sponsor and/or monitor. 
9.1 
Source Documentation 
Prior to the start of the study, the site staff participating in the study conduct will be 
instructed on what documents will be required for review as source documents. The kinds 
of documents that will serve as source documents will be agreed between sponsor or 
delegate and investigator and designees and specified in the SDA prior to subject 
enrolment. 
In addition, source documentation must include all of the following: subject identification 
(on each page), eligibility and participation, proper informed consent/assent procedures, 
dates of visits, adherence to protocol procedures, adequate reporting and follow-up of 
adverse events, documentation of prior/concomitant medication/vaccines, study vaccine 
receipt/dispensing/return records, study vaccine administration information, any data 
collected by a telephone conversation with the subject’s parent(s)/LAR(s) and date of 
completion and reason. 
The subject’s parent(s)/LAR(s) must also allow access to the subject’s medical records. 
Each subject and/or parent(s)/LAR(s) must be informed of this prior to the start of the 
study and consent for access to medical records may be required in accordance with local 
regulations. 
All safety data reported by subject’s parent(s)/ LAR(s) must be written down in source 
documents prior to entry of the data into eCRFs. If there are multiple sources of 
information (eg, Subject Diary Card, verbal report of the subject, telephone contact 
details, medical chart) supporting the diagnosis of an adverse event, these sources must be 
identified in the source documents, discrepancies between sources clarified, the ultimate 
diagnosis must be justified and written in the source documents, and this diagnosis must 
be captured in the adverse event eCRF (AE eCRF). The AE eCRF must also capture 

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which source(s) of information were used to determine the adverse event (eg, subject 
recall, medical chart, Subject Diary Card). 
9.2 
Study Monitoring, Auditing and Source Data Verification 
Prior to enrolment of the first study subject, the sponsor or delegate (eg, a CRO) will 
develop a Clinical Monitoring Plan to specify how centralized and/or on-site monitoring, 
including clinical specimens reconciliation, will be performed for the study. Study 
progress will be monitored by the sponsor or delegate as frequently as necessary to 
ensure: 
• that the rights and well-being of human subjects are protected, 
• the reported study data are accurate, complete, and verifiable from the source 
documents and 
• the conduct of the study is in compliance with the current approved 
protocol/amendment(s), good clinical practice (GCP) and applicable regulatory 
requirements. 
Contact details for the sponsor team or its designee involved in study monitoring will be 
provided to the investigator. Study data recorded on eCRFs will be verified by checking 
the eCRF entries against source documents in order to ensure data completeness and 
accuracy as required by study protocol. 
The investigator and/or site staff must make source documents of subjects enrolled in this 
study available for inspection by the sponsor or delegate at the time of each monitoring 
visit and sponsor audits, when applicable. These documents must also be available for 
inspection, verification and copying, as required by regulations, by officials of the 
regulatory health authorities (eg, FDA, EMA and others) and/or ECs/IRBs. The 
investigator and study site staff must comply with applicable privacy, data protection and 
medical confidentiality laws for use and disclosure of information related to the study and 
enrolled subjects. 

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10. 
DATA MANAGEMENT 
10.1 
Data Entry and Management 
In this study, all clinical data (including, but not limited to, AE/SAEs, concomitant 
medications, medical history, and physical assessments) and safety data, data will be 
entered onto eCRFs in a timely fashion by the investigator and/or the investigator’s 
dedicated site staff. Data entered onto eCRFs are stored on a secure server. The data 
collected on this secure website are assimilated into an EDC system, which is compliant 
with Title 21 Part 11 policies of the Code of Federal Regulations (FDA 1997). The data 
system includes password protection and internal quality checks. The EDC system will be 
designed and validated by the sponsor or delegate prior to activation for data entry by 
sites. The investigator or designated delegate must review data entered and electronically 
sign the eCRFs to verify their accuracy. 
Access to the EDC system for data entry or review will require training and distinct 
individual access code assignments to those site staff members who will be entering study 
data and those involved in study oversight who may review study data. Data are collected 
within the EDC system, to which the sponsor and site monitors have “read only” access. 
10.2 
Data Clarification 
As part of the conduct of the trial, the sponsor or delegate may have questions about the 
data entered by the site, referred to as queries. The monitors and the sponsor or delegate 
are the only parties that can generate a query. All corrections and clarifications will be 
entered into the EDC system and will be identified by the person entering the information, 
the reason for the change, as well as the time of the changes made. If changes are made to 
a previously and electronically signed eCRF, the investigator must confirm and endorse 
the changes. 
10.3 
Data Protection 
The sponsor respects the subjects’ rights to privacy and will ensure the confidentiality of 
their medical information in accordance with all applicable laws and regulations. 
The sponsor as Data Controller according to the General Data Protection Regulation 
(“GDPR”) on the protection of individuals with regard to the processing of personal data 
and on the free movement of such data  confirms herewith compliance to GDPR in all 
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11. 
RECORD RETENTION 
Investigators must retain all study records required by the sponsor and by the applicable 
regulations in a secure and safe facility. The investigator must consult a sponsor 
representative before disposal of any study records, and must notify the sponsor of any 
change in the location, disposition, or custody of the study files. 
The sponsor specific essential documents should be retained until at least 2-years after the 
last approval of a marketing application in an ICH region and until there are no pending 
or contemplated marketing applications in an ICH region or at least 2-years have elapsed 
since the formal discontinuation of clinical development of the investigational product. 
These documents should be retained for a longer period however if required by the 
applicable regulatory requirement(s) or if needed by the sponsor (ICH E6 (R2)).  
“Essential documents” are defined as documents that individually and collectively permit 
evaluation of the conduct of a study and the quality of the data produced. These 
documents should be retained for a longer period, however, if required by the applicable 
national regulatory or institutional requirements. (ICH E6 (R2)). 
The sponsor should inform the investigator(s)/institution(s) in writing of the need for 
record retention and should notify the investigator(s)/institution(s) in writing when the 
trial related records are no longer needed (ICH E6 (R2)). 
The principles of record retention will also be applied to the storage of laboratory 
samples, provided that the integrity of the stored sample permits testing. These laboratory 
samples will be securely stored for future testing at a global sponsor or sponsor 
controlled/contracted facility for up to 15 years and then destroyed, for purposes to 
conduct additional analyses needed related to the study, or ultimately for future analysis 
to further understand the immune response to the vaccine or to influenza disease. Only 
laboratory staff performing the testing will have access to these samples. By signing the 
ICF, the subject’s parent(s)/LAR(s) agrees that samples will be retained for use limited to 
additional analyses related to this study. If the parent(s)/LAR(s) also agrees to have the 
subject’s samples stored for future testing after the study is completed, this can be 
indicated on the ICF. 

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12. 
USE OF INFORMATION AND PUBLICATION 
The sponsor assures that the key design elements of this protocol will be posted in a 
publicly accessible database such as clinicaltrials.gov, and in compliance with current 
regulations. 
The sponsor also assures that key results of this clinical study will be posted in a publicly 
accessible database within the required time-frame from the end of study as defined in 
section 3.9, End of Study. 
In accordance with standard editorial, ethical practices and current guidelines of Good 
Publication Practice (Graf 2009), the sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual center data. In this case, a 
coordinating investigator will be designated by mutual agreement prior to the start of the 
study. The coordinating investigator will also sign the clinical study report on behalf of 
the principal investigators (Committee of Proprietary Medicinal Products 
(CPMP)/Efficacy Working Party (EWP)/2747/00). Authorship will be determined by 
mutual agreement and in line with International Committee of Medical Journal Editors 
authorship requirements. Any formal publication of the study in which contribution of 
sponsor personnel exceeded that of conventional monitoring will be considered as a joint 
publication by the investigator and the appropriate sponsor personnel. 
The sponsor must be notified of any intent to publish data collected from the study and 
prior approval from the sponsor must be obtained prior to submission for publication. 

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13. 
ETHICAL CONSIDERATIONS 
13.1 
Regulatory and Ethical Compliance 
The study will be conducted in compliance with the protocol, GCP and applicable 
regulatory requirement(s). 
This clinical study was designed and shall be implemented and reported in accordance 
with the ICH Harmonized Tripartite Guidelines for GCP, with applicable local 
regulations: including, including European Directive 2001/20/EC, US Code of Federal 
Regulations Title 21, ICH E6 (R2), and Japanese Ministry of Health, Labor, and Welfare, 
the sponsor codes on protection of human rights, and with the ethical principles laid down 
in the Declaration of Helsinki (European Council 2001, US Code of Federal Regulations, 
ICH 1997). 
13.2 
Informed Consent Procedures 
Eligible subjects may only be included in the study after providing written informed 
consent or assent, as described in section 5.1.1, Informed Consent/Assent. Before the start 
of the study, the investigator will have the informed consent/assent and any other 
materials that will be provided to the subjects reviewed and approved by the IRB/EC. 
This review and approval will be documented and stored with other study documents. The 
investigator or designee must fully inform the subject’s parent(s)/LAR(s) of all pertinent 
aspects of the study. A copy of the written informed consent/assent will be given to the 
subject’s parent(s)/LAR(s). The subject’s parent(s)/LAR(s) must be allowed ample time 
to ask about the details of the study and to make a decision as to whether or not to 
participate in the study. The subject’s parent(s)/LAR(s) must sign the consent form 
indicating their agreement to participate in the study before any study-related procedures 
are conducted. The informed consent/assent process may be conducted up to 10 days 
prior to vaccination on Day 1. If the subject’s parent(s)/LAR(s) is unable to read and 
write, a witness must be present during the informed consent/assent discussion and at the 
time of informed consent/assent signature. 
Prior to the start of the study, the sponsor will provide to investigators a proposed 
ICF/assent that complies with the ICH GCP guideline and regulatory requirements and is 
considered appropriate for this study. Any changes to the proposed consent form 
suggested by the investigator must be agreed to by the sponsor before submission to the 
IRB/EC and a copy of the approved version must be provided to the sponsor or delegate 
monitor after IRB/EC approval. 
Before the start of the study, the investigator will have the informed assent, the informed 
consent, and any other materials that will be provided to the subject’s parent(s)/LAR(s) 
reviewed and approved by the IRB/EC. This review and approval will be documented and 

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stored with other study documents. The investigator or designee must fully inform the 
subject’s parent(s)/LAR(s) of all pertinent aspects of the study. A copy of the written 
informed consent and informed assent will be given to the subject’s parent(s)/LAR(s). 
In addition, the investigator or designee should explain pertinent aspects of the study in an 
age appropriate manner to pediatric subjects who are eligible for informed assent in 
accordance with local policies. The subject’s parent(s)/LAR(s) must be allowed ample 
time to ask about the details of the study and to make a decision as to whether or not to 
participate in the study. The subject/parent(s)/LAR(s) must sign the consent/assent forms 
indicating their agreement to participate in the study before any study-related procedures 
are conducted. If the subject’s parent(s)/LAR(s) are unable to read and write, a witness 
must be present during the informed consent/assent discussion and at the time of informed 
consent/assent signature. 
13.3 
Responsibilities of the Investigator and IRB/EC 
The protocol and the proposed ICF/assent must be reviewed and approved by a properly 
constituted IRB/EC before study start. Properly constituted IRB/EC is defined in the 
integrated addendum to ICH E6: ICH Guideline for Good Clinical Practice E6 (R2). A 
signed and dated statement that the protocol and informed consent/assent have been 
approved by the IRB/EC must be given to the sponsor or delegate before study initiation. 
Prior to study start and at any time the protocol is amended during study conduct, the 
investigator is required to sign a protocol signature page confirming his/her agreement to 
conduct the study in accordance with these documents and all of the instructions and 
procedures found in this protocol and to give access to all relevant data and records to 
sponsor monitors, auditors, the sponsor clinical quality assurance representatives, 
designated agents of the sponsor, IRBs/ECs, and regulatory authorities as required. If an 
inspection of the clinical site is requested by a regulatory authority, the investigator must 
inform the sponsor or delegate immediately that this request has been made. 
The investigator is also responsible for the following: 
• Maintaining a list of appropriately qualified persons to whom the investigator has 
delegated significant study-related duties. 
• Demonstrating the capability of recruiting the required number of suitable subjects 
within the recruitment period. 
• Demonstrating sufficient time and staffing to properly conduct and complete the 
study within the agreed study period. 
• Ensuring that all persons assisting with the study are adequately informed about 
the protocol, the investigational product(s), and their study-related duties and 
functions. 

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• Ensuring that appropriately trained or qualified health care professionals are 
responsible for all study-related medical decisions and for ensuring appropriate 
medical care of subjects experiencing any adverse event related to the study. 
• If permission to do so is given by the subject’s parent(s)/LAR(s), ensuring that the 
subject’s primary health care provider is informed of the subject’s participation in 
the study. 
The investigator should not implement any deviation from, or changes of the protocol 
without agreement by the sponsor and prior review and documented approval/favorable 
opinion from the IRB/IEC of an amendment, except where necessary to eliminate an 
immediate hazard(s) to study subjects, or when the change(s) involves only logistical or 
administrative aspects of the study (eg, change in monitor(s), change of telephone 
number[s]). In addition, the investigator, or person designated by the investigator, should 
document and explain any deviation from the approved protocol. 
The investigator may implement a deviation from, or a change of the protocol to eliminate 
an immediate hazard(s) to study subjects without prior IRB/IEC approval/favorable 
opinion. As soon as possible, the implemented deviation or change, the reasons for it, and, 
if appropriate, the proposed protocol amendment(s) should be submitted: 
(a) to the IRB/IEC for review and approval/favorable opinion, 
(b) to the sponsor for agreement and, if required, 
(c) to the regulatory authority(ies). 
13.4 
Protocol Amendments 
An amendment is a written description of change(s) to or formal clarification of a study 
protocol which may impact on the conduct of the clinical study, potential benefit of the 
clinical study, or may affect subject safety, including changes of study objectives, study 
design, subject population, sample sizes, study procedures, or significant administrative 
aspects. An administrative change (non-substantial amendment) of a study protocol is a 
minor correction or clarification that has no significant impact on the way the clinical 
study is to be conducted and no effect on subject safety (eg, change of telephone 
number(s), logistical changes). Protocol amendments must be approved by the sponsor, 
health authorities where required, and the IRB/EC. In cases when the amendment is 
required in order to protect the subject safety, the amendment can be implemented prior to 
IRB/EC approval. Notwithstanding, the need for formal approval of a protocol 
amendment, the investigator is expected to take any immediate action required for the 
safety of any subject included in this study, even if this action represents a deviation from 
the protocol. In such cases, the sponsor should be notified of this action, the IRB/EC at 
the study site, and, if required by local regulations, the relevant health authority) should 
be informed within 10 working days. 

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14. 
REFERENCE LIST 
1. WHO Pandemic Influenza Risk Management WHO Interim Guidance; 2013. 
http://www.who.int/influenza/preparedness/pandemic/GIP_Pandemic Influenza Risk 
Management Interim Guidance_Jun2013. 
2. Vesikari T, Karvonen A, Tilman S, Borkowski A ,Montomoli E, Banzhoff A, 
Clemens R. Immunogenicity and Safety of MF59-Adjuvanted H5N1 Influenza 
Vaccine From Infancy to Adolescence. Pediatrics 2010;126:e762–e770 
3. Chotpitayasunondh T, Thisyakorn U, Pancharoen C, Pepin S, Nougarede N. (2008) 
Safety, humoral and cell mediated immune responses to two formulations of an 
inactivated, split-virion influenza A/H5N1 vaccine in children. PloS ONE 
(3)12:e4028 
4. Treanor, J. J., Campbell, J. D., Zangwill, K. M., Rowe, T., & Wolff, M. 2006, 
"Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) 
vaccine", N.Engl J Med, vol. 354, no. 13, pp. 1343-1351. 
5. Bart SA, Hohenboken M, Della Cioppa G,Narasimhan V,Dormitzer PR, and 
Nanesa-thasan K,  A Cell Culture–Derived MF59-Adjuvanted Pandemic A/H7N9 
Vaccine Is Immunogenic in Adults. www.ScienceTranslationalMedicine.org Vol 6 
Issue 234 234ra55 30 April 2014. 
6. Code of Federal Regulations (1997): Food and Drug Administration, U.S. 
Department of Health and Human Services: Title 21, Part 11: Electronic Records 
Electronic Signatures. Federal Register 62: 13464. 
7. European Parliament (1995): Directive 95/46/EC of the European Parliament and of 
the Council of 4 April 2001. Official Journal of the European Communities. L 
281/31-39. 
8. Graf C, Battisti WP, Bridges D (2009). Good publication practice for 
communicating company Sponsored medical research: the GPP2 guidelines. BMJ; 
339: b4330. 
9. Committee for proprietary medicinal products (CPMP), European Agency for the 
Evaluation of Medicinal Products. (2001) Note for guidance on coordinating 
investigator signature of clinical study reports. London, UK. 
10. Committee for proprietary medicinal products (CPMP), European Agency for the 
Evaluation of Medicinal Products. (2016) Guideline on influenza vaccines, Non-
clinical and clinical Module. EMA/CHMP/VWP/457259/2014. 

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11. ICH E6 (R2) (2016) ICH Harmonised Tripartite ICH Guideline for Good Clinical 
Practices E6 (R2). EMA/CHMP/ICH/135/1995. 
12. ICH (1998) ICH Harmonised Tripartite ICH Guideline for Statistical principles for 
Clinical Trials E9. Federal Register, 63 (179): 49583. 
 
 

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Appendix A: Adverse Events of Special Interest 
AEs of special interest (AESI) will include those listed in below. The AESIs will be 
defined according to the following MedDRA preferred terms. 
Gastrointestinal disorders: Celiac disease, Crohn’s disease, Ulcerative colitis, 
Ulcerative proctitis 
Liver disorders: Autoimmune cholangitis, Autoimmune hepatitis, Primary biliary 
cirrhosis, Primary sclerosing cholangitis 
Metabolic diseases: Addison’s disease, Autoimmune thyroiditis (including Hashimoto 
thyroiditis), Diabetes mellitus type I, Grave's or Basedow’s disease 
Musculoskeletal disorders: Antisynthetase syndrome, Dermatomyositis, Juvenile 
chronic arthritis, (including Still’s disease), Mixed connective tissue disorder, 
Polymyalgia rheumatic, Polymyositis, Psoriatic arthropathy, Relapsing polychondritis, 
Rheumatoid arthritis, Scleroderma, including diffuse systemic form and CREST 
syndrome, Spondyloarthritis, including ankylosing spondylitis, reactive arthritis (Reiter's 
Syndrome) and undifferentiated spondyloarthritis, Systemic lupus erythematosus, 
Systemic sclerosis 
Neuroinflammatory disorders: Acute disseminated encephalomyelitis, including site 
specific variants: eg, non-infectious encephalitis, encephalomyelitis, myelitis, 
myeloradiculomyelitis, Cranial nerve disorders, including paralyses/paresis (eg, Bell’s 
palsy), Guillain-Barré syndrome, including Miller Fisher syndrome and other variants, 
Immune-mediated peripheral neuropathies and plexopathies,(including chronic 
inflammatory demyelinating polyneuropathy, multifocal motor neuropathy and 
polyneuropathies associated with monoclonal gammopathy), Multiple sclerosis, 
Narcolepsy, Optic neuritis, Transverse Myelitis 
Skin disorders: Alopecia areata, Autoimmune bullous skin diseases (including 
pemphigus, pemphigoid and dermatitis herpetiformis), Cutaneous lupus erythematosus, 
Erythema nodosum, Morphoea, Lichen planus, Psoriasis, Sweet’s syndrome, Vitiligo 
Vasculitides: Large vessels vasculitis including: giant cell arteritis such as Takayasu's 
arteritis and temporal arteritis. Medium sized and/or small vessels vasculitis including: 
polyarteritis nodosa, Kawasaki's disease, microscopic polyangiitis, Wegener's 
granulomatosis, Churg–Strauss syndrome (allergic granulomatous angiitis), Buerger’s 
disease thromboangiitis obliterans), necrotizing vasculitis and anti-neutrophil cytoplasmic 
antibody (ANCA) positive vasculitis (type unspecified), Henoch- Schonlein purpura, 
Behcet's syndrome, leukocytoclastic vasculitis. 
Others: Antiphospholipid syndrome, Autoimmune hemolytic anemia, Autoimmune 
glomerulonephritis (including IgA nephropathy, glomerulonephritis rapidly progressive, 

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membranous glomerulonephritis, membranoproliferative glomerulonephritis, and 
mesangioproliferative glomerulonephritis), Autoimmune myocarditis/cardiomyopathy, 
Autoimmune thrombocytopenia, Goodpasture syndrome, Idiopathic pulmonary fibrosis, 
Pernicious anemia, Raynaud’s phenomenon, Sarcoidosis, Sjögren’s syndrome, Stevens-
johnson syndrome, Uveitis.