A Phase III, Open-label, Single-center Study to Describe the Immunogenicity and Safety of a Single Dose of MenACYW Conjugate Vaccine in Participants Aged 12 Months and Older in Vietnam
Phase: PHASE3
Conditions: Meningococcal Infection, Healthy Volunteers
Sponsor: Sanofi Pasteur, a Sanofi Company

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Title Page 
Protocol Title: 
A Phase III, open-label, single-center study to describe the immunogenicity and safety of a single 
dose of MenACYW Conjugate Vaccine in participants aged 12 months and older in Vietnam 
Study Code: MEQ00074 
Amendment Number: Not applicable 
Compound: MenACYW Conjugate Vaccine (MenQuadfiTM) 
Short Title: 
Study on a MenACYW Conjugate Vaccine administered as a single dose in participants aged 
12 months and older in Vietnam 
Study Phase: III 
Sponsor Name and Legal Registered Address: 
Sanofi Pasteur 
14 Espace Henry Vallée, 69007 Lyon, France 
Manufacturer: 
Sanofi Pasteur Inc. 
Discovery Drive, Swiftwater, PA 18370-0187, USA 
Regulatory Agency Identifier Number: 
EudraCT: 2021-001699-41 
WHO UTN: U1111-1256-9172 
Protocol Version Number: 1.0 
Approval Date: 29 March 2021 
Medical Monitor Name and Contact Information are provided in the Operating Guidelines. 
The study centers, the Investigators at each center, and the Coordinating Investigator are listed in 
a separate document. 
NCT:NCT06228586

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Document History  
Not applicable as this is the first version of the protocol. 
 
 

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Table of Contents  
Document History ............................................................................................................................ 2 
List of Tables .................................................................................................................................... 7 
List of Figures .................................................................................................................................. 8 
1 
Protocol Summary ............................................................................................................. 9 
1.1 
Synopsis ............................................................................................................................ 9 
1.2 
Schema ............................................................................................................................ 12 
1.3 
Schedule of Activities (SoA) .......................................................................................... 13 
2 
Introduction ..................................................................................................................... 15 
2.1 
Study Rationale ............................................................................................................... 15 
2.2 
Background ..................................................................................................................... 15 
2.3 
Benefit/Risk Assessment ................................................................................................ 16 
2.3.1 
Risks from Study Participation ..................................................................................... 16 
2.3.2 
Benefits from Study Participation ................................................................................ 18 
2.3.3 
Coronavirus Disease 2019 Risk Assessment ................................................................ 19 
2.3.4 
Overall Benefit-Risk Conclusion .................................................................................. 19 
3 
Objectives and Endpoints ............................................................................................... 19 
4 
Study Design .................................................................................................................... 21 
4.1 
Overall Design ................................................................................................................ 21 
4.2 
Scientific Rationale for Study Design ............................................................................. 22 
4.3 
Justification for Dose ...................................................................................................... 23 
4.4 
End of Study Definition .................................................................................................. 23 
5 
Study Population ............................................................................................................. 23 
5.1 
Inclusion Criteria ............................................................................................................ 23 
5.2 
Exclusion Criteria ........................................................................................................... 25 
5.3 
Lifestyle Considerations ................................................................................................. 28 
5.4 
Screen Failures ................................................................................................................ 28 
5.5 
Criterion for Temporarily Delaying Enrollment ............................................................. 28 
6 
Study Intervention and Concomitant Therapy ............................................................ 28 

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6.1 
Study Intervention Administered .................................................................................... 28 
6.2 
Preparation/Handling/Storage/Accountability ................................................................ 30 
6.3 
Measures to Minimize Bias: Randomization and Blinding ............................................ 30 
6.3.1 
Randomization and Allocation Procedures .................................................................. 30 
6.3.2 
Blinding and Code-breaking Procedures ...................................................................... 30 
6.4 
Study Intervention Compliance ...................................................................................... 30 
6.5 
Dose Modification .......................................................................................................... 30 
6.6 
Continued Access to Study Intervention After the End of the Study ............................. 31 
6.7 
Treatment of Overdose.................................................................................................... 31 
6.8 
Concomitant Therapy ...................................................................................................... 31 
6.8.1 
Rescue Medicine ........................................................................................................... 33 
6.8.2 
Coronavirus Disease 2019 Vaccine .............................................................................. 33 
7 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal .......................................................................................... 34 
7.1 
Discontinuation of Study Intervention ............................................................................ 34 
7.2 
Participant Discontinuation/Withdrawal from the Study ................................................ 34 
7.3 
Lost to Follow-up ............................................................................................................ 34 
8 
Study Assessments and Procedures ............................................................................... 35 
8.1 
Efficacy and Immunogenicity Assessments ................................................................... 35 
8.1.1 
Efficacy Assessments ................................................................................................... 35 
8.1.2 
Immunogenicity Assessments ...................................................................................... 36 
8.2 
Safety Assessments ......................................................................................................... 36 
8.2.1 
Medical History ............................................................................................................ 36 
8.2.2 
Physical Examinations .................................................................................................. 37 
8.2.3 
Vital Signs .................................................................................................................... 37 
8.2.4 
Pregnancy Testing ........................................................................................................ 37 
8.3 
Adverse Events (AEs), Serious Adverse Events, and Other Safety Reporting............... 37 
8.3.1 
Time Period and Frequency for Collecting Adverse Event and Serious Adverse 
Event Information ......................................................................................................... 37 
8.3.2 
Method of Detecting Adverse Events and Serious Adverse Events ............................. 38 
8.3.3 
Follow-up of Adverse Events and Serious Adverse Events ......................................... 39 
8.3.4 
Regulatory Reporting Requirements for Serious Adverse Events ............................... 39 
8.3.5 
Pregnancy ..................................................................................................................... 39 
8.3.6 
Adverse Events of Special Interest ............................................................................... 40 
8.4 
Pharmacokinetics ............................................................................................................ 41 
8.5 
Genetics ........................................................................................................................... 41 
8.6 
Biomarkers ...................................................................................................................... 41 

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8.7 
Immunogenicity Assessments ......................................................................................... 41 
8.8 
Medical Resource Utilization and Health Economics .................................................... 41 
8.9 
Leftover Biological Samples and Use of Data ................................................................ 41 
9 
Statistical Considerations ............................................................................................... 42 
9.1 
Statistical Hypotheses ..................................................................................................... 42 
9.2 
Sample Size Determination ............................................................................................. 43 
9.3 
Analysis Sets ................................................................................................................... 43 
9.4 
Statistical Analyses ......................................................................................................... 44 
9.4.1 
General Considerations ................................................................................................. 44 
9.4.2 
Immunogenicity Endpoint ............................................................................................ 44 
9.4.3 
Safety Endpoints ........................................................................................................... 45 
9.5 
Interim Analyses ............................................................................................................. 45 
9.6 
Data Monitoring Committee ........................................................................................... 45 
10 
Supporting Documentation and Operational Considerations .................................... 45 
10.1 
Appendix: Regulatory, Ethical, and Study Oversight Considerations ............................ 45 
10.1.1 
Regulatory and Ethical Considerations ........................................................................ 45 
10.1.2 
Financial Disclosure ..................................................................................................... 47 
10.1.3 
Informed Consent Process ............................................................................................ 47 
10.1.4 
Data Protection and Future Use of Stored Samples ..................................................... 48 
10.1.5 
Committees Structure ................................................................................................... 49 
10.1.6 
Dissemination of Clinical Study Data .......................................................................... 49 
10.1.7 
Data Quality Assurance ................................................................................................ 49 
10.1.8 
Source Documents ........................................................................................................ 50 
10.1.9 
Study and Site Start and Closure .................................................................................. 50 
10.1.10 
Publication Policy ......................................................................................................... 51 
10.2 
Appendix: Adverse Events and Serious Adverse Events: Definitions and 
Procedures for Recording, Evaluating, Follow-up, and Reporting ................................. 52 
10.2.1 
Definition of Adverse Event ......................................................................................... 52 
10.2.2 
Definition of Serious Adverse Event ............................................................................ 54 
10.2.3 
Recording and Follow-Up of Adverse Event and/or Serious Adverse Event .............. 55 
10.2.4 
Reporting of Serious Adverse Events ........................................................................... 57 
10.2.5 
Assessment of Intensity ................................................................................................ 58 
10.2.5.1 
Tables for Clinical Abnormalities .............................................................................. 58 
10.2.5.1.1 
Solicited AR Intensity Grading Scale ...................................................................... 58 
10.2.5.1.2 
Unsolicited AE Intensity Grading Scale .................................................................. 65 
10.3 
Appendix: Contraceptive and Barrier Guidance ............................................................. 65 
10.3.1 
Definitions .................................................................................................................... 65 
10.3.2 
Contraception Guidance ............................................................................................... 67 

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10.4 
Appendix: Risk-based Approach .................................................................................... 68 
10.5 
Appendix: Abbreviations ................................................................................................ 69 
11 
References ........................................................................................................................ 71 
12 
Sponsor Signature Page .................................................................................................. 73 
 
 
 

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List of Tables  
Table 1.1: Schedule of activities ................................................................................................... 13 
Table 2.1: Potential risks of clinical significance and risk management ...................................... 17 
Table 3.1: Objectives and endpoints ............................................................................................. 20 
Table 4.1: Overall design .............................................................................................................. 22 
Table 6.1: Identity of study intervention ....................................................................................... 29 
Table 10.1: Solicited injection site reactions: terminology, definitions, and intensity scales – 
Infants and toddlers aged ≤ 23 months .......................................................................................... 59 
Table 10.2: Solicited injection site reactions: terminology, definitions, and intensity scales – 
Children aged 2 through 11 years .................................................................................................. 60 
Table 10.3: Solicited injection site reactions: terminology, definitions, and intensity scales – 
Adolescents and adults aged ≥ 12 years ........................................................................................ 61 
Table 10.4: Solicited systemic reactions: terminology, definitions, and intensity scales – 
Infants and toddlers aged ≤ 23 months .......................................................................................... 62 
Table 10.5: Solicited systemic reactions: terminology, definitions, and intensity scales – 
Children aged 2 through 11 years, adolescents or adults aged ≥ 12 years .................................... 63 
 
 
 

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List of Figures  
Figure 1.1 – Graphical study design .............................................................................................. 12 
 
 
 

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1 
Protocol Summary  
1.1 
Synopsis  
Protocol Title: 
A Phase III, open-label, single-center study to describe the immunogenicity and safety of a single 
dose of MenACYW Conjugate Vaccine in participants aged 12 months and older in Vietnam 
Short Title: 
Study on a MenACYW Conjugate Vaccine administered as a single dose in participants aged 12 
months and older in Vietnam 
Rationale: 
The purpose of the MEQ00074 study will be to describe the immunogenicity and safety of a 
single dose of investigational quadrivalent Meningococcal Polysaccharide (serogroups A, C, W, 
and Y) Tetanus Toxoid Conjugate Vaccine (hereafter referred to as MenACYW conjugate 
vaccine) in participants aged 12 months and older. The MenACYW conjugate vaccine is designed 
to cover broader age groups than those covered by Menomune-A/C/Y/W-135 and Menactra® 
vaccines. Menactra® vaccine has been used in routine programs in several countries since its 
licensure in 2005; it has been approved in Vietnam on 03 October 2018. However, the 
MenACYW conjugate vaccine is being developed by Sanofi Pasteur to ultimately replace 
Menactra® vaccine in the global market as a quadrivalent meningococcal conjugate vaccine 
indicated in infants/toddlers, children, adolescents, and adults. 
Objectives and Endpoints: 
Objectives 
Endpoints 
Immunogenicity 
 
• 
To describe the antibody responses to 
meningococcal serogroups A, C, W, and Y 
before and 30 days after the administration 
of a single dose of MenACYW conjugate 
vaccine 
Antibody titers against meningococcal serogroups 
A, C, W, and Y measured by serum bactericidal 
assay using human complement (hSBA) will be 
assessed before and 30 days after vaccination with 
a single dose of MenACYW conjugate vaccine. 
Safety 
 
• 
To describe the safety profile of a single 
dose of MenACYW conjugate vaccine 
The safety profile will be evaluated within 30 days 
(+14 days) after vaccination. The following 
endpoints will be used for the evaluation of safety: 

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Objectives 
Endpoints 
• 
Presence of any unsolicited systemic 
adverse events (AEs) reported in the 30 
minutes after vaccination 
• 
Presence of solicited (prelisted in the 
participant’s diary card [DC] and case 
report form [CRF]) injection site and 
systemic reactions starting any time from 
the day of vaccination through 7 days after 
vaccination 
• 
Presence of unsolicited (recorded in a DC) 
non-serious AEs up to 30 days after 
vaccination; unsolicited non-serious AEs 
occurring after D31 will be presented in a 
specific listing 
• 
Presence of serious adverse events (SAEs) 
(including adverse events of special 
interest [AESIs]) throughout the study, ie 
from D01 (vaccination) to the last study 
day D31; SAEs occurring after D31 are 
also to be reported if they are considered 
related to vaccination with the 
investigational medicinal product (IMP) 
Depending on the items, the endpoints recorded or 
derived could include: nature (Medical Dictionary 
for Regulatory Activities [MedDRA] preferred 
term), time of onset, duration/number of days of 
occurrence, intensity, relationship to the vaccine, 
whether the AE led to early termination from the 
study, outcome, and seriousness criterion 
Overall Design 
This is a Phase III, open-label, single-center study to describe the immunogenicity and safety of a 
single dose of MenACYW conjugate vaccine in participants aged 12 months and older in 
Vietnam. 
Participants aged 18 years and above on the day of inclusion (adults), 10 to 17 years on the day of 
inclusion (adolescents), 2 to 9 years on the day of inclusion (children), and aged 12 to 23 months 
on the day of the inclusion (toddlers) will be eligible for enrollment in study MEQ00074. 
All participants will receive a single dose of MenACYW conjugate vaccine on D01. 

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All participants will provide blood samples for immunogenicity assessments at baseline (pre-
vaccination, Visit 1 on D01) and 1 month post vaccination on Visit 2 (D31 [+14 days]). 
Solicited AE information will be collected for 7 days after vaccination (D01-D08); unsolicited AE 
information will be collected from Visit 1 (D01) to Visit 2 (D31 [+14 days]), and SAE 
information (including AESIs) will be collected throughout the study period. 
 
Type of design 
Single group, single-center 
Phase 
III 
Control method 
Uncontrolled 
Study population 
Meningococcal vaccination naïve, healthy 
toddlers, children, adolescents, adults and older 
adults aged 12 months and above 
Country 
Vietnam 
Level and method of blinding 
Open-label 
Study intervention assignment method 
Not applicable 
Disclosure Statement: 
This is a single group open-label study. 
Number of Participants: 
A total of 446 participants are expected to be enrolled with the aim to obtain a total of 
400 evaluable participants: 
• 223 participants will be 12-23 months of age 
• 223 participants will be 24 months of age and above. To ensure all sub-groups are 
represented, a minimum of 20 participants will be enrolled from each of the sub-groups 
mentioned below: 
• 
Children 2 to 9 years of age 
• Adolescents 10 to 17 years of age 
• Adults 18 to 55 years of age 
• Older adults 56 years and above 
Intervention Groups and Duration: 
All eligible participants will receive a single intramuscular injection of MenACYW conjugate 
vaccine. 
The duration of study participation for each participant will be approximately 30 to 44 days. 

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Data Monitoring/Other Committee: 
Not applicable 
1.2 
Schema  
The graphical design of MEQ000074 study is presented in Figure 1.1. 
Figure 1.1 – Graphical study design  
 
BL: blood sample; TC: telephone call; VAC: vaccination 
 

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1.3 
Schedule of Activities (SoA)  
Visit procedures are detailed in the Operating Guidelines. 
Table 1.1: Schedule of activities  
Phase III Study, 2 Visits, 2 Telephone calls, 1 Vaccination, 2 Blood Samples, 30 to 
44 Days’ Duration Per Participant 
Visit/Contact 
Collection 
of 
information 
in the CRF 
Visit 1 
TC1 
TC2 
Visit 2 
Study timelines (days) 
 
D01 
D04 
Visit 1 
+ 3 days 
D09 
Visit 1 
+ 8 days 
D31 
Visit 1 
+ 30 days 
Time windows (days) 
 
- 
+2 days 
+2 days 
+14 days 
Visit procedures: 
 
 
 
 
 
Informed consent/assent* 
X 
X 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
Collection of demographic data 
X 
X 
 
 
 
Urine pregnancy test 
(if applicable) 
 
X 
 
 
 
Collection of significant medical 
history 
X 
X 
 
 
 
Physical examination (including 
pre-vaccination temperature)** 
  
X 
 
 
 
Review of temporary 
contraindications for blood 
sampling † 
X 
 
 
 
X 
Blood sampling (BL) ‡ [3 mL] 
X 
BL0001 
 
 
BL0002 
Vaccination 
X 
X 
 
 
 
Immediate surveillance (30 min) 
X 
X 
 
 
 
Information on DC provided 
 
X 
 
 
 
Telephone call (TC) § 
X 
 
X 
X 
 
Collection of solicited injection 
site and systemic reactions** 
X 
Day 1 to 
Day 8 
 
 
 
Collection of unsolicited AEs 
X 
Visit 1 to Visit 2 
DC reviewed and information 
collected 
 
 
 
 
X 

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Visit/Contact 
Collection 
of 
information 
in the CRF 
Visit 1 
TC1 
TC2 
Visit 2 
Study timelines (days) 
 
D01 
D04 
Visit 1 
+ 3 days 
D09 
Visit 1 
+ 8 days 
D31 
Visit 1 
+ 30 days 
Time windows (days) 
 
- 
+2 days 
+2 days 
+14 days 
Visit procedures: 
 
 
 
 
 
Collection of reportable 
concomitant medications 
X 
X 
 
 
X 
Collection of SAEs, including 
AESIs †† 
X 
To be reported at any time during the study period 
Collection of pregnancies 
X 
To be reported at any time during the study period 
End of study participation 
record ‡‡ 
X 
 
 
 
X 
Abbreviations: AE: adverse event; AESI: adverse events of special interest; BL: blood sampling; CRF: case report 
form; DC: diary card; SAE: serious adverse event; TC: telephone call 
* Assent required for participants aged 12 to 15 years. 
**Physical examination should be performed as per standard of care. If a routine examination had been performed 
within the last week by the Investigator, a sub-Investigator, or a licensed nurse practitioner, it does not need to be 
repeated unless there were some changes in health status, in which case it may be limited to the affected area. 
Temperature needs to be measured before vaccination and daily during the 7 days after vaccination and recorded in 
the DC. 
†Should a participant receive oral or injectable antibiotic therapy within 3 days prior to any blood draw, the 
Investigator will postpone that blood draw until it has been 3 days since the participant last received oral or injectable 
antibiotic therapy. Postponement must still be within the timeframe for blood draw. If postponement would result in 
the sample collection falling outside of this timeframe, the blood sample should be collected without postponement, 
and it should be appropriately documented that the sample was taken less than 3 days after stopping antibiotic 
treatment. 
‡Blood sample at Visit 1 to be drawn before administration of the vaccine. 
§The first telephone call will be made 3 days to 5 days after the vaccination. The second telephone call will be made 
8 days to 10 days after the vaccination. If Day 04 (+ 2 days) and Day 09 (+2 days) fall on a weekend or holiday, the 
telephone call may be made on the following business day. During this telephone call, the staff will find out whether 
the participant experienced any SAE (including any AESI) not yet reported, and will remind the 
participant/participant’s parent/legally acceptable representative to continue using the DC, bring the DC to the study 
center at the next visit, and confirm the date and time of the next visit. 
** Solicited injection site and systemic reactions will be recorded from the day of vaccination through 7 days after 
vaccination. 
††AESI will be collected throughout the study as SAEs to ensure that the events are communicated to the Sponsor in 
an expedited manner and followed up until the end of the follow-up period or resolution, as per the assigned causal 
relationship 
‡‡ In case of participant discontinuation at a visit, the entire visit will be completed. 

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2 
Introduction  
The investigational quadrivalent Meningococcal Polysaccharide (serogroups A, C, W, and Y) 
Tetanus Toxoid Conjugate Vaccine (hereafter referred to as MenACYW conjugate vaccine) was 
designed for the immunization of individuals of all ages (infants 6 weeks of age and older through 
and including older adults ≥ 56 years of age) against invasive meningococcal disease (IMD). 
Compared to a previous Sanofi Pasteur meningococcal conjugate vaccine, Menactra®, the 
MenACYW conjugate vaccine is prepared using tetanus toxoid as the carrier protein. Conjugation 
of polysaccharide antigens to a protein carrier can induce T-cell-dependent immune responses, 
which are anticipated to give rise to higher antibody titers, longer duration of the immune 
response, and enhanced immunologic memory that allows for a booster response. 
The clinical development program targets licensure of the MenACYW conjugate vaccine in many 
countries in North America, Europe, Latin America, Africa, the Middle East, and Asia Pacific. It 
has been licensed for active immunization of individuals from 2 years of age in the United States 
(US) since April 2020, and for active immunization of individuals from 12 months of age in 
Canada and Australia since October 2020 and in the European Union (EU) since November 2020, 
under the brand name of MenQuadfiTM. The MenACYW conjugate vaccine has also been recently 
approved in Brazil in individuals from 12 months of age. 
MenACYW conjugate vaccine has been evaluated in over 7500 participants (infants, toddlers, 
adolescents, and adults) in completed Phase II and Phase III studies. In these studies, MenACYW 
conjugate vaccine was found to be well tolerated and did not reveal any apparent safety concerns 
with good immune responses non-inferior to comparators, for all 4 serogroups. 
2.1 
Study Rationale  
According to regulations in Vietnam, local clinical trial data must be generated in order to obtain 
licensure in this country. MEQ00074 study will therefore generate immunogenicity and safety 
data of MenACYW conjugate vaccine in order to support registration in individuals 12 months of 
age and older in Vietnam. 
MEQ00074 study will assess the immunogenicity and safety of a single dose of MenACYW 
conjugate vaccine administered to participants 12 months of age and older. 
2.2 
Background  
IMD is a serious illness caused by the bacterium Neisseria meningitidis (N. meningitidis), a Gram-
negative diplococcus found exclusively in humans. Symptoms may include intense headache, 
fever, nausea, vomiting, photophobia, stiff neck, lethargy, myalgia, and a characteristic petechial 
rash (1). Some age groups are disproportionately affected by IMD, with major peaks of IMD 
incidence occurring in infants, adolescents and young adults. 
The epidemiology of N. meningitidis can be described as complex, unpredictable, geographically 
variable, and changing over time. IMD occurs worldwide in both endemic and epidemic forms 
with seasonal variation. 

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Clinical studies are ongoing to support an extension of the licensure in individuals from 6 weeks 
of age and older. 
Although a surveillance and reporting system is in place in Vietnam, there is a paucity of IMD 
data. A serogroup C epidemic occurred in the Southern provinces of the country between 1977 
and 1979. The overall incidence rate of meningococcal disease during the epidemic rose from 
< 5/100,000 in the preceding years to > 20/100,000. The mortality rate was between 27.4% and 
34.7%. Seventy percent of cases occurred in children aged between 3 and 15 years. Four 
prospective studies of meningitis have been conducted since the 1977 epidemic covering the years 
1993 to 2005. Between 2000 and 2002, the estimated incidence of meningococcal meningitis in 
Hanoi, Vietnam, was 21.8/100,000 (95% confidence interval [CI] 5.0–94.4) in children aged 7 to 
11 months and 2.6/100,000 in children aged < 5 years (95% CI 0.8–8.5) (2). There have been 
sporadic serogroup C cases in Ho Chi Minh City (in 2006 and 2012). Serogroup B has been 
detected in IMD cases since 2012. A carriage study among military personnel in 2015 indicated 
carriage rates of 30-40% for serogroups B and C (3). Data are limited in Vietnam with regards to 
other serogroups. 
2.3 
Benefit/Risk Assessment  
More detailed information about the known and expected benefits and risks, reasonably expected 
adverse events (AEs), the potential risks, and uncertainties of MenACYW conjugate vaccine may 
be found in the Investigator’s Brochure (IB), Participant Information Leaflet, Package Insert, or 
Summary of Product Characteristics. 
2.3.1 
Risks from Study Participation  
The potential risks of clinical significance and risk management are summarized in Table 2.1. 

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Table 2.1: Potential risks of clinical significance and risk management  
Potential Risk of Clinical 
Significance 
Summary of Data/Rationale 
for Risk 
Risk Management 
Investigated Vaccine: MenACYW conjugate vaccine 
Anaphylaxis 
Known important risk occurring 
at a low frequency (very rare) 
based on what would be 
common for any vaccine. 
 
One case of anaphylaxis was 
reported 10 minutes after 
receiving the second dose of 
MenQuadfiTM given alone in 
study MET52. While temporal 
relationship was consistent with 
causal association to MenACYW 
conjugate vaccine and 
anaphylaxis has been reported 
with association to immunization 
in general, causality was 
assessed as related. 
Observation period after 
vaccination for early detection 
and treatment. 
 
Exclusion criteria: Known 
systemic hypersensitivity to any 
of the study intervention 
components, or history of a life-
threatening reaction to the study 
intervention used in the study or 
to a product containing any of 
the same substances. 
Guillain-Barré syndrome 
Important potential risk-based on 
post-marketing experience for 
other quadrivalent 
meningococcal conjugate 
vaccines occurring with a low 
frequency (very rare) with no 
definite evidence of excess risk 
identified in population based 
study (4) (5) (6). A review by the 
Institute of Medicine found 
inadequate evidence to accept or 
reject a causal relationship 
between tetanus toxoid-
containing vaccines and 
Guillain-Barré syndrome (7). 
No cases with MenACYW 
conjugate vaccine in the 
completed studies. 
Exclusion criteria: Personal 
history of Guillain-Barré 
syndrome 
Bell’s palsy 
 
Refer to IB Section 6 for more 
information regarding potential 
risks 
Important potential risk-based on 
post-marketing experience for 
other quadrivalent 
meningococcal conjugate 
vaccines occurring at a low 
frequency (very rare).  
No risk mitigation actions 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale 
for Risk 
Risk Management 
A post-marketing observational 
safety study conducted in a US 
health maintenance organization 
found a statistically significant 
association with Bell’s palsy 
when a licensed quadrivalent 
meningococcal conjugate 
vaccine (MCV4-CRM 
[Menveo®]) was administered 
concomitantly with other 
vaccines (tetanus, diphtheria, and 
acellular pertussis [Tdap], 
human papillomavirus [HPV], 
and/or influenza vaccine), while 
no association was found when 
the vaccine was administered 
alone (8). This study used a 
longer risk interval than used in 
previous studies, beyond the 
biologically plausible and widely 
accepted risk interval of 42 days. 
No cases with MenACYW 
conjugate vaccine within 42 days 
of vaccination in the completed 
studies. 
Study Procedures 
Vasovagal reactions (fainting) 
Syncope can occur following, or 
even before, any vaccination or 
blood draw as a psychogenic 
response to the needle injection, 
most commonly in the 
adolescent age group (9). 
Cases of vasovagal-like response 
(eg, dizziness) or syncope have 
been observed infrequently in 
adolescent or young adult study 
participants within 30 minutes of 
vaccination with MenACYW 
conjugate vaccine. 
Observation period after 
vaccination for early detection 
and treatment. Procedures should 
be in place to prevent falling 
injury and manage syncopal 
reactions. 
2.3.2 
Benefits from Study Participation  
There might be no direct benefit from receiving MenACYW conjugate vaccine. However, based 
on the data from previous studies, evaluation of the immunogenicity profile of MenACYW 

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conjugate vaccine in different age groups shows that the majority of participants develop 
seroprotective levels of antibodies after vaccination. The safety evaluation indicates that the 
vaccine is well-tolerated, and no safety issues have been detected to date. In all, the data support 
the further evaluation of MenACYW conjugate vaccine in humans. 
As with any vaccine, MenACYW conjugate vaccine may not protect 100% of individuals against 
the disease they are designed to prevent. 
2.3.3 
Coronavirus Disease 2019 Risk Assessment  
MenACYW conjugate vaccine is a vaccine against IMD. MenACYW conjugate vaccine would 
not cause immune suppression. Therefore, the risk that a participant in this study will contract 
COVID-19 solely due to the administration of the study vaccine will be similar to the risk that a 
person not participating in this study will contract COVID-19. However, the risk of exposure to 
infected people cannot be completely excluded as the participants may need to be exposed to 
public areas (eg, commute to the site and at the site). 
Risk mitigation for participants: 
• Not start the study until the local confinement measures or other safety restrictions linked 
to the COVID-19 pandemic are lifted by the local Authorities. 
• Continued risk assessment by the Investigator and Sponsor before deciding to start the 
study. 
• Reduce the public exposure while ambulatory when possible. 
• In order to limit the participant visits to the hospital, visits (blood draw, physical 
examination, safety assessments) may be conducted at the site (site visit) or at the 
participant’s home (home visit). Implementation of home visits will be assessed based on 
the country situation, case-by-case situation and operational feasibility. 
Risk mitigation for study management: 
Remote source data verification and monitoring can be planned. 
2.3.4 
Overall Benefit-Risk Conclusion  
Considering the measures taken to minimize risk to participants enrolled in this study, the 
potential risks that may result from study participation are balanced by the anticipated benefits 
that may be afforded to participants. 
3 
Objectives and Endpoints  
The study objectives and the corresponding endpoints are described in Table 3.1. 

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Table 3.1: Objectives and endpoints  
Objectives 
Endpoints 
Immunogenicity 
 
• 
To describe the antibody responses to 
meningococcal serogroups A, C, W, and Y 
before and 30 days after the administration 
of a single dose of MenACYW conjugate 
vaccine 
Antibody titers against meningococcal serogroups 
A, C, W, and Y measured by serum bactericidal 
assay using human complement (hSBA) will be 
assessed before and 30 days after vaccination with 
a single dose of MenACYW conjugate vaccine. 
Safety 
 
• 
To describe the safety profile of a single 
dose of MenACYW conjugate vaccine 
The safety profile will be evaluated within 30 days 
(+14 days) after vaccination. The following 
endpoints will be used for the evaluation of safety: 
• 
Presence of any unsolicited systemic 
adverse events (AEs) reported in the 30 
minutes after vaccination 
• 
Presence of solicited (prelisted in the 
participant’s diary card [DC] and case 
report form [CRF]) injection site and 
systemic reactions starting any time from 
the day of vaccination through 7 days after 
vaccination 
• 
Presence of unsolicited (recorded in a DC) 
non-serious AEs up to 30 days after 
vaccination; unsolicited non-serious AEs 
occurring after D31 will be presented in a 
specific listing 
• 
Presence of serious adverse events (SAEs) 
(including adverse events of special 
interest [AESIs]) throughout the study, ie 
from D01 (vaccination) to the last study 
day D31; SAEs occurring after D31 are 
also to be reported if they are considered 
related to vaccination with the 
investigational medicinal product (IMP) 
Depending on the items, the endpoints recorded or 
derived could include: nature (Medical Dictionary 
for Regulatory Activities [MedDRA] preferred 
term), time of onset, duration/number of days of 
occurrence, intensity, relationship to the vaccine, 
whether the AE led to early termination from the 
study, outcome, and seriousness criterion 

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4 
Study Design  
4.1 
Overall Design  
This is a Phase III, open-label, single-center study to describe the immunogenicity and safety of a 
single dose of MenACYW conjugate vaccine in participants aged 12 months and older in 
Vietnam. 
Participants aged 18 years and above on the day of inclusion (adults), 10 to 17 years on the day of 
inclusion (adolescents), 2 to 9 years on the day of inclusion (children), and aged 12 to 23 months 
on the day of inclusion (toddlers) will be eligible for enrollment in study MEQ00074. 
All participants will receive a single dose of MenACYW conjugate vaccine on D01. 
All participants will provide blood samples for immunogenicity assessments at baseline (pre-
vaccination, Visit 1 on D01) and 1 month post vaccination on Visit 2 (D31 [+14 days]). 
Solicited AE information will be collected for 7 days after vaccination (D01-D08); unsolicited AE 
information will be collected from Visit 1 (D01) to Visit 2 (D31 [+14 days]), and SAE 
information (including AESIs) will be collected throughout the study period. 
The design of the study is summarized in Table 4.1. 

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Table 4.1: Overall design  
Type of design 
Single group, single-center 
Phase 
III 
Control method 
Uncontrolled 
Study population 
Meningococcal vaccination naïve, healthy toddlers, 
children, adolescents, adults and older adults aged 
12 months and above 
Level and method of blinding 
Open-label 
Study intervention assignment method 
Not applicable 
Number of participants 
A total of 446 participants are expected to be 
enrolled with the aim to obtain a total of 
400 evaluable participants: 
• 223 participants will be 12-23 months of age 
• 223 participants will be 24 months of age 
and above. To ensure all sub-groups are 
represented, a minimum of 20 participants 
will be enrolled from each of the sub-groups 
mentioned below: 
• Children 2 to 9 years of age 
• Adolescents 10 to 17 years of age 
• Adults 18 to 55 years of age 
• Older adults 56 years and above 
Intervention groups 
All eligible participants will receive a single 
intramuscular injection of MenACYW conjugate 
vaccine 
Total duration of study participation 
The duration of each participant’s participation will 
be approximately 30 to 44 days 
Country 
Vietnam 
Use of an Independent Data Monitoring 
Committee, Dose Escalation 
Committee, or similar review group 
No 
4.2 
Scientific Rationale for Study Design  
The clinical development of MenACYW conjugate vaccine has started in 2006 with the objective 
to provide protection against 4 serogroups (A, C, Y, and W) that cause IMD, in all population age 

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groups, including infant as young as 6 weeks of age and including adults 56 years of age and 
older. 
The initial licensures of this vaccine cover age 2 years and above in the US and age 12 months 
and above in Europe, Canada, Australia and Brazil, with a single injection. Studies are ongoing to 
support the extension of indication from 6 weeks of age. 
The clinical studies supporting the first licensure were designed to demonstrate the ability of 
MenACYW conjugate vaccine to safely elicit a robust immune response. Studies were conducted 
to demonstrate efficacy through the non-inferiority of MenACYW conjugate vaccine compared to 
licensed meningococcal standard of care vaccines. 
According to regulations in Vietnam, local clinical trial data must be generated in order to obtain 
licensure in this country. 
4.3 
Justification for Dose  
All participants will receive a single dose of MenACYW conjugate vaccine on D01 as per the 
current/intended indication in this age group for quadrivalent meningococcal conjugate vaccines. 
4.4 
End of Study Definition  
A participant is considered to have completed the study if he/she has completed the last visit 
planned in the SoA. 
The end of the study is defined as the date of the last visit of the last participant in the study. 
However, for periodic safety reports, the study is considered completed when the clinical study 
report is finalized. 
5 
Study Population  
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1 
Inclusion Criteria  
Participants are eligible for the study only if all of the following criteria are met: 
I01: 
Aged 12 months and above on the day of inclusion 

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Adults (aged 18 and above on the day of inclusion): 
I02: 
A female participant is eligible to participate if she is not pregnant or breastfeeding 
and one of the following conditions applies: 
• Is of non-childbearing potential. To be considered of non-childbearing potential, a 
female must be pre-menarchea or post-menopausal for at least 1 year, or surgically 
sterile. 
OR 
• Is of childbearing potential and agrees to use an effective contraceptive method or 
abstinence from at least 4 weeks prior to study intervention administration until at 
least 4 weeks after study intervention administration. 
A female participant of childbearing potential must have a negative highly sensitive 
pregnancy test (urine) within 1 week before the dose of study intervention. 
I03: 
Informed consent form has been signed and dated 
I04: 
Able to attend all scheduled visits and to comply with all study procedures 
Adolescents (aged 10 to 17 years on the day of inclusionb): 
I05: 
A female participant is eligible to participate if she is not pregnant or breastfeeding 
and one of the following conditions applies: 
• Is of non-childbearing potential. To be considered of non-childbearing potential, a 
female must be pre-menarchec. 
OR 
• Is of childbearing potential and agrees to use an effective contraceptive method or 
abstinence from at least 4 weeks prior to study intervention administration until at 
least 4 weeks after study intervention administration. 
A female participant of childbearing potential must have a negative highly sensitive 
pregnancy test (urine) within 1 week before the dose of study intervention. 
I06: 
Informed consent form has been signed and dated by both the participant (if aged 16 
to 18 years) and the parent(s) or another legally acceptable representative and by an 
independent witness, if required by local regulations 
                                                 
a  Pre-menarche females will declare by themselves that they have not yet started menstruation. If a young female 
participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential 
from that time forward 
b  “10 to 17 years” means from the day of the 10th birthday to the day before the 18th birthday 
c  Pre-menarche females will declare by themselves that they have not yet started menstruation. If a young female 
participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential 
from that time forward 

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Assent form has been signed and dated by the participant (assent form required for 
participants aged 12 to 15 years) or verbal consent has been obtained (for participants 
aged 10 to 11 years), and informed consent form has been signed and dated by the 
parent(s) or another legally acceptable representative and by an independent witness, 
if required by local regulations 
I07: 
Participant and parent/legally acceptable representative are able to attend all scheduled 
visits and to comply with all study procedures 
Children (aged 2 to 9 years on the day of inclusiona): 
I08: 
Verbal consent has been obtained (for participants aged 7 to 9 years), and informed 
consent form has been signed and dated by the parent(s) or another legally acceptable 
representative and by an independent witness, if required by local regulations  
I09: 
Participant and parent/legally acceptable representative are able to attend all scheduled 
visits and to comply with all study procedures 
Toddlers (aged 12 to 23 months on the day of inclusionb) 
I10: 
Informed consent form has been signed and dated by the parent(s) or other legally 
acceptable representative and by an independent witness if required by local 
regulations 
I11: 
Participant and parent/legally acceptable representative are able to attend all scheduled 
visits and to comply with all study procedures 
5.2 
Exclusion Criteria  
Participants are not eligible for the study if any of the following criteria are met: 
Adults (aged 18 years and above), Adolescents (aged 10 to 17 years), Children (aged 2 to 
9 years) and Toddlers (aged 12 to 23 months) 
E01: 
Participation at the time of study enrollment (or in the 4 weeks preceding the study 
intervention administration) or planned participation during the present trial period in 
another clinical study investigating a vaccine, drug, medical device, or medical 
procedure 
E02: 
Receipt of any vaccine in the 4 weeks preceding the study intervention administration 
or planned receipt of any vaccine in the 4 weeks following study intervention 
administration except for influenza vaccination, which may be received at least 2 
                                                 
a  “2 to 9 years” means from the day of the 2nd birthday to the day before the 10th birthday 
b  “12 to 23 months” means from the 12th month after birth to the day before the 25th month after birth 

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weeks before or after study vaccine. This exception includes monovalent pandemic 
influenza vaccines and multivalent influenza vaccines. 
E03: 
Previous vaccination against meningococcal disease with either the study vaccine or 
another vaccine (ie, polysaccharide, or conjugate meningococcal vaccine containing 
serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine)  
E04: 
Receipt of immune globulins, blood or blood-derived products in the past 3 months 
E05: 
History of any N. meningitidis infection, confirmed either clinically, serologically, or 
microbiologically 
E06: 
At high risk for meningococcal disease during the study (specifically but not limited to 
participants with persistent complement deficiency, with anatomic or functional 
asplenia, or participants traveling to countries with high endemic or epidemic disease) 
E07: 
Known systemic hypersensitivity to any of the study intervention components, or 
history of a life-threatening reaction to the study intervention used in the study or to a 
product containing any of the same substancesa 
E08: 
Personal history of Guillain-Barré syndrome 
E09: 
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 
contraindicating intramuscular injection 
E10: 
Deprived of freedom by an administrative or court order, or in an emergency setting, 
or hospitalized involuntarily 
E11: 
Chronic illness that, in the opinion of the Investigator, is at a stage where it might 
interfere with study conduct or completionb 
E12: 
Moderate or severe acute illness/infection (according to Investigator judgment) on the 
day of vaccination or febrile illness (axillary temperature ≥ 37.5°C) or hypothermia 
(axillary temperature ≤ 35.5°C) on the day of vaccination. A prospective participant 
should not be included in the study until the condition has resolved or the febrile event 
has subsided 
E13: 
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood 
draw 
Adults (aged 18 years and above) and Adolescents (aged 10 to 17 years) 
E14: 
Known or suspected congenital or acquired immunodeficiency; or receipt of 
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, 
within the preceding 6 months; or long-term systemic corticosteroid therapy 
                                                 
a  The components of MenACYW conjugate vaccine are listed in Section 6.1, and in Section 3 of the IB. 
b  Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, 
diabetes, psychiatric disorders or chronic infection 

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(prednisone or equivalent for more than 2 consecutive weeks within the past 
3 months) 
E15: 
Personal history of an Arthus-like reaction after vaccination with a tetanus 
toxoid-containing vaccine within at least 10 years of the proposed study vaccination 
E16: 
Self-reported thrombocytopenia, contraindicating intramuscular injection 
E17: 
Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, 
might interfere with the study conduct or completion 
E18: 
Identified as an Investigator or employee of the Investigator or study center with direct 
involvement in the proposed study, or identified as an immediate family member (ie, 
parent, spouse, natural or adopted child) of the Investigator or employee with direct 
involvement in the proposed study 
Children (aged 2 to 9 years) 
E19: 
Known or suspected congenital or acquired immunodeficiency; or receipt of 
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, 
within the preceding 6 months; or long-term systemic corticosteroid therapy 
(prednisone or equivalent for more than 2 consecutive weeks within the past 
3 months) 
E20: 
Personal history of an Arthus-like reaction after vaccination with a tetanus 
toxoid-containing vaccine 
E21: 
Thrombocytopenia as reported by the parent/legally acceptable representative, or 
suspected thrombocytopenia contraindicating intramuscular injection 
E22: 
Identified as a natural or adopted child of the Investigator or employee with direct 
involvement in the proposed study 
Toddlers (aged 12 to 23 months) 
E23: 
Known or suspected congenital or acquired immunodeficiency; or receipt of 
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, 
within the preceding 6 months; or long-term systemic corticosteroid therapy 
(prednisone or equivalent for more than 2 consecutive weeks since birth) 
E24: 
Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-
containing vaccine 
E25: 
Thrombocytopenia as reported by the parent/legally acceptable representative, or 
suspected thrombocytopenia contraindicating intramuscular injection 
E26: 
Identified as a natural or adopted child of the Investigator or employee with direct 
involvement in the proposed study 
If the participant has a primary physician who is not the Investigator, the site is recommended to 

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contact this physician with the participant’s consent to inform him/her of the participant’s 
participation in the study. In addition, the site may ask this primary physician to verify exclusion 
criteria relating to previous therapies, such as receipt of blood products or previous vaccines. 
5.3 
Lifestyle Considerations  
No other restrictions than the ones listed in the exclusion criteria or in the contraindications for the 
subsequent blood sample (on Visit 2) are required. 
5.4 
Screen Failures  
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently assigned to study intervention. Screening information is recorded in the source 
documents. 
5.5 
Criterion for Temporarily Delaying Enrollment  
The reactogenicity of any of the COVID-19 vaccines available to date will occur during the first 
few days post-immunization. As immunogenicity interactions with other vaccines have not been 
studied, if the first dose of a COVID-19 vaccination is received before the participant is enrolled 
in the study, it is recommended to postpone enrollment at least 4 weeks after the last COVID-19 
vaccine dose. 
6 
Study Intervention and Concomitant Therapy  
Study intervention is defined as any investigational intervention(s), marketed product(s), placebo, 
or medical device(s) intended to be administered to a study participant according to the study 
protocol. 
Note: Vaccines or products administered outside of study protocol are not considered as study 
interventions and are reported in the CRF as reportable medications (see Section 6.8). Study 
procedures (eg, blood sampling) are also not considered as study interventions. 
6.1 
Study Intervention Administered  
Study interventions are described in Table 6.1. 

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Table 6.1: Identity of study intervention  
Intervention Name 
MenACYW conjugate vaccine: Meningococcal Polysaccharide 
(Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine 
(Sanofi Pasteur Inc., Swiftwater, PA, USA) 
Use 
Investigational 
IMP and NIMP 
IMP 
Type 
Vaccine 
Dose Formulation 
Liquid solution 
Unit Dose Strength(s) 
Each dose of MenACYW conjugate vaccine contains the 
following components: 
Meningococcal capsular polysaccharides: 
• 
Serogroup A*: 10 µg 
• 
Serogroup C*: 10 µg 
• 
Serogroup Y*: 10 µg 
• 
Serogroup W*: 10 µg 
* Conjugated to tetanus toxoid protein carrier: 55 µg** 
**Tetanus toxoid protein quantity is approximate and dependent on the 
polysaccharide-to-protein ratio for the conjugates used in each 
formulation 
Excipients/Diluent 
Sodium acetate buffered saline solution 
Dosage Level 
0.5 mL per dose 
Number of Doses / Dosing 
Interval 
1 dose  
Route of Administration 
Intramuscular injection  
Site of Administration 
Anterolateral area of the thigh or deltoid muscle  
Sourcing 
Provided by the Sponsor  
Packaging and Labeling 
MenACYW conjugate vaccine (single-dose vial) will be supplied 
with investigational labeling and packaging according to national 
regulations. Each single dose of study interventions will be 
identified by a unique number on the detachable label and on the 
outer carton label. The detachable label is for the sites to attach to 
the source documents. See the Operating Guidelines for additional 
label detail. 
Current/Former Name or 
Alias 
MenQuadfi™ 
Batch Number 
TBD 
Storage Conditions 
Study interventions will be stored in a refrigerator at a temperature 
ranging from +2°C to +8°C. The study interventions must not be 
frozen. 
IMP: investigational medicinal product; NIMP: non-investigational medicinal product; TBD: to be determined 

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6.2 
Preparation/Handling/Storage/Accountability  
Detailed guidance and information are provided in the Operating Guidelines. 
1) The Investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study intervention received and any discrepancies are 
reported and resolved before use of the study intervention. 
2) Only participants enrolled in the study may receive study intervention and only authorized 
site staff may supply or administer study intervention. All study intervention must be stored 
in a secure, environmentally controlled, and monitored (manual or automated) area in 
accordance with the labeled storage conditions with access limited to the Investigator and 
authorized site staff. 
3) The Investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance (ie, 
receipt, reconciliation, and final disposition records). 
4) Further guidance and information for the final disposition of unused study interventions are 
provided in the Operating Guidelines. 
6.3 
Measures to Minimize Bias: Randomization and Blinding  
6.3.1 
Randomization and Allocation Procedures  
Participants will not be randomized. 
6.3.2 
Blinding and Code-breaking Procedures  
This is a single-arm study that is not blinded. 
6.4 
Study Intervention Compliance  
The following measures will ensure that the study intervention is administered as planned (see 
Table 6.1), and that any non-compliance is documented so that it can be accounted for in the data 
analyses: 
• All study interventions will be administered by qualified and trained study personnel 
• The person in charge of study intervention management at the site will maintain 
accountability records of study intervention delivery to the study site, study intervention 
inventory at the site, dose(s) given to each participant, and unused or wasted doses 
6.5 
Dose Modification  
Not applicable. 

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6.6 
Continued Access to Study Intervention After the End of the Study  
Not applicable. 
6.7 
Treatment of Overdose  
Since the study intervention is administered by a health care professional, it is unlikely that 
overdose by injection occurs. 
However, in the event of an overdose, the Investigator should: 
1) Contact the Medical Monitor immediately 
2) Closely monitor the participant for any AE/SAE 
3) Document the quantity of the excess of the overdose in the source documents 
6.8 
Concomitant Therapy  
At the time of enrollment, ongoing medications and other therapies (eg, blood products) should be 
recorded in the source document as well as new medications prescribed for new medical 
conditions/AEs during study participation. 
Documentation in the CRF of ongoing concomitant medication(s) will be limited to specific 
categories of medication(s) of interest beginning on the day of vaccination. This may include 
medications of interest that were started prior to the day of vaccination. 
Reportable medications include medications that may affect the interpretation of safety data (eg, an 
antipyretic or analgesic that could have reduced the intensity or frequency of an adverse event) or may 
interfere with the development or measurement of the immune response (eg, the use of immune-
suppressors, immune-modulators, or some antibiotics that can affect certain bioassays). Some 
medications such as steroids can affect both the evaluation of the safety and the immune response to a 
vaccine. 
This may include medications of interest that were started prior to the day of vaccination, and even 
stopped prior to enrollment if there is a reasonable possibility that they may have an impact on safety 
and/or immune assessment during study participation. 
The following reportable medications are defined: 
• Category 1: medications impacting or that may have an impact on the evaluation of the 
safety (eg, antipyretics, analgesics, and non-steroidal anti-inflammatory drugs [NSAIDs], 
systemic steroids/corticosteroids [therapy duration less than 2 weeks] and other immune-
modulators) Category 1 medications do not define the per-protocol analysis set (PPAS). 
Note: Topical analgesics should NOT be applied at the injection site of study intervention; 
however, if they are applied inadvertently, they should be recorded. 
Note: Topical steroids (inhaled, optic, ophthalmic, nasal, etc.) should not be captured or 
reported. 
Category 1 medications will be reported in the CRF from the day of vaccination to the end 
of the solicited and unsolicited follow-up period. 

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• Category 2: medications impacting or that may have an impact on the immune response 
and used to define the PPAS; for example: 
• Flu vaccines administered 14 days (2 weeks) pre or post study intervention 
administration, including the day of the study vaccination visit. 
• Any vaccine other than the study vaccine and flu vaccines within the 4 weeks 
preceding or after the study vaccination, including the day of the study vaccination 
visit. 
• Immune globulins, blood or blood-derived products: used in the 3 months preceding 
the first blood draw and up to the last blood draw 
• Immunosuppressive therapy such as immune-suppressors, immune-modulators with 
immunosuppressive properties, long-term systemic corticosteroids therapy (prednisone 
or equivalent for more than 2 consecutive weeks) used in the 3 months preceding the 
study vaccination and up to the last blood draw, anti-cancer chemotherapy, anti-
proliferative drugs such as deoxyribonucleic acid (DNA) synthesis inhibitors, or 
radiation therapy: used in the 6 months preceding the study vaccination, and up to the 
last blood draw 
Category 2 medications will be reported in the CRF according to the collection period 
detailed above up to the last blood draw. 
• Category 3: medications impacting or that may have an impact on both the safety and the 
immune response: systemic (oral or injectable) antibiotics, received within 72 hours 
preceding each visit for blood draw related to investigational medicinal product (IMP) 
assessment (MenACYW conjugate vaccine) and used to define the PPAS, as they may 
interfere with bioassays used for antibody testing when taken before a blood draw 
Category 3 medications will be reported in the CRF for the period of 3 days (72 hours) 
before each blood draw. 
Note: Topical antibiotics (inhaled, optic, ophthalmic, nasal, etc.) should not be captured 
or reported. 
Reportable medications (Category 1, 2, and 3) will be collected in the source document from the 
day of vaccination to the end of the study and in the CRF as per the instructions given below for 
each category. 
The information reported in the CRF for each reported medication will be limited to: 
• Trade name 
• Rationale for the origin of prescription: Whether it was a prophylactica medication? 
Prophylactic medications will be recorded in the Action Taken section of the AE 
collection tables 
• Medication category (1, 2, or 3) 
• Start and stop dates 
                                                 
a Medication prescribed for preventing AE occurrence (eg, paracetamol to reduce the risk of fever) 

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Dosage and administration route, homeopathic medication, topical and inhaled steroids, as well as 
topical, ophthalmic, and ear treatments will not be recorded (except topical analgesics applied at the 
injection site of study intervention). 
If the participant has received medications other than those listed in Categories 1, 2, and 3, the detailed 
information will be collected in the source documents only. 
Medications given in response to an AE will be captured in the “Action Taken” section of the AE 
CRF only. No details will be recorded in the concomitant medication CRF unless the medication(s) 
received belongs to one of the pre-listed categories. Medications will not be coded. 
6.8.1 
Rescue Medicine  
Appropriate medical equipment and emergency medications, including epinephrine (1:1000), 
must be available at the study site in the event of an anaphylactic, vasovagal, or other immediate 
allergic reaction. 
6.8.2 
Coronavirus Disease 2019 Vaccine  
If after study initiation coronavirus disease 2019 (COVID-19) vaccines become available for the 
population under study, the highest priority will be that study participants get their immunizations 
as per country recommendations.  
Refer to Section 5.5 for the criterion for temporarily delaying enrollment in case of receipt of 
COVID-19 vaccine. 
If a COVID-19 vaccine dose is received during one IMP solicited reactogenicity period it would 
not be possible to differentiate systemic reactions between the two. Likewise, if the vaccine is 
received between an IMP dose and the collection of blood, it will not be possible (at this point) to 
rule out an immunogenicity interaction. Therefore, in any of those two situations it is 
recommended that the participant be pulled out of the per protocol (PP) population but should 
continue in the trial within the intent-to-treat (ITT) population. 
If the above observations would not apply, the participant could continue as PP.  
The kind of COVID-19 vaccine received (including tradename) and the date time of its 
administration(s) should be documented in the concomitant medications CRF. 
Wherever possible the site of injection of the IMP should be in the limb separate from the limb in 
which COVID-19 vaccine is administered (if it has already been administered). Likewise, and if 
on the control of the study site, any COVID-19 vaccine scheduled to be received after 
administration of the IMP should not be received in the same limb as the IMP. Where it is not 
possible to have the IMP and COVID-19 vaccine administered in separate limbs, a distance of at 
least 3.8 to 5.1 centimeters (1.5 to 2 inches) should be maintained between the two administration 
sites. 

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7 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal  
7.1 
Discontinuation of Study Intervention  
Not applicable as there is only one vaccination. 
7.2 
Participant Discontinuation/Withdrawal from the Study  
• Parents/legally acceptable representatives will be informed that they have the right to 
withdraw their child from the study at any time. 
• A participant may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the Investigator for safety, behavioral, or 
compliance reasons. This is expected to be uncommon. 
• The reason for withdrawal should be clearly documented in the source documents and in 
the CRF: Adverse Event, Lost to Follow-up, Protocol Deviation, or Withdrawal by 
Participant or Parent/Legally Acceptable Representative. 
• The participant will be permanently discontinued both from the study intervention and 
from the study at that time. 
• If the participant withdraws consent for disclosure of future information, the Sponsor may 
retain and continue to use any data collected before such a withdrawal of consent. 
• If a participant withdraws consent, he/she may request destruction of any biological 
samples taken (unless local law requires not to destroy them), and the Investigator must 
document this in the site study records. 
• Withdrawn participants will not be replaced. 
Follow-up of Discontinuations 
For participants who have prematurely terminated the study, the site should attempt to contact 
them and complete all scheduled safety follow-ups, except if they specified that they do not want 
to be contacted again and it is documented in the source document. 
For participants where the reason for early termination is lost to follow-up, the site will not 
attempt to obtain further safety information. See Section 7.3 for definition of “lost to follow-up”. 
7.3 
Lost to Follow-up  
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the site for a required study 
visit or cannot be contacted as planned in the SoA: 

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• 
The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible and counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain whether or not the participant wishes to and/or should continue in 
the study. 
• 
Before a participant is deemed lost to follow-up, the Investigator or designee must make 
every effort to regain contact with the participant (where possible, 3 telephone calls and, 
if necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
medical record. 
• 
Should the participant continue to be unreachable, he/she will be considered lost to 
follow-up. 
Discontinuation of specific sites or of the study as a whole are handled as part of Appendix 10.1. 
8 
Study Assessments and Procedures  
• Study procedures and their timing are summarized in the SoA (Section 1.3). Protocol 
waivers or exemptions are not allowed. 
• Immediate safety concerns should be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or discontinue 
study intervention. 
• Adherence to the study design requirements, including those specified in the SoA, is 
essential and required for study conduct. 
• All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The Investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
Blood samples will be collected as described in the SoA table (Section 1.3). At Visit 1 (BL0001) 
and Visit 2 (BL0002), 3 mL of blood will be collected in tubes provided by or recommended by 
the Sponsor. 
Guidance and information for the sample collection, preparation, storage, and shipment are 
provided in the Operating Guidelines. 
8.1 
Efficacy and Immunogenicity Assessments  
8.1.1 
Efficacy Assessments  
No clinical efficacy data will be obtained in the study. 

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8.1.2 
Immunogenicity Assessments  
Functional meningococcal antibody activity against serogroups A, C, Y, and W will be measured 
in a serum bactericidal assay utilizing the human complement (hSBA). Results will be expressed 
as antibody titer, geometric mean titers (GMTs), seroprotection and hSBA vaccine seroresponse. 
hSBA vaccine seroresponse for serogroups A, C, W, and Y is defined as: 
•  For a participant with a pre-vaccination titer < 1:8, the post-vaccination titer must be 
≥ 1:16 
• For a participant with a pre-vaccination titer ≥ 1:8, the post-vaccination titer must be at 
least 4-fold greater than the pre-vaccination titer 
Two-fold dilutions of test sera are prepared in sterile 96-well microtiter plates. Serogroup-specific 
meningococcal bacteria along with human complement are added to the serum dilutions and 
allowed to incubate. After this incubation period, an agar overlay medium is added to the 
serum/complement/bacteria mixture, allowed to harden, and then incubated overnight at 37°C 
with 5% carbon dioxide (CO2). Bacterial colonies present in the wells are then counted. The 
endpoint titer is determined by the reciprocal serum dilution yielding ≥ 50% killing as compared 
to the mean of the complement control wells. The lower limit of quantification (LLOQ) of the 
hSBA assay is a titer of 1:4. 
Assays will be performed at Global Clinical Immunology (GCI), Swiftwater, Pennsylvania, USA. 
8.2 
Safety Assessments  
This section presents safety assessments other than AEs which are presented in Section 8.3. 
Planned time points for all safety assessments are provided in the SoA (Section 1.3). 
8.2.1 
Medical History  
Prior to enrollment, participants will be assessed for pre-existing conditions and illnesses, both 
past and ongoing. Any such conditions will be documented in the source document. Significant 
(clinically relevant) medical history (reported as diagnosis) including conditions/illnesses for 
which the participant is or has been followed by a physician or conditions/illnesses that could 
resume during the course of the study or lead to an SAE or to a repetitive outpatient care will be 
collected in the CRF. The significant medical history section of the CRF contains a core list of 
body systems and disorders that could be used to prompt comprehensive reporting, as well as 
space for the reporting of specific conditions and illnesses. 
For each condition, the data collected will be limited to: 
• Diagnosis (this is preferable to reporting signs and symptoms) 
• Presence or absence of the condition at enrollment 
The reporting of signs and symptoms in lieu of a diagnosis is strongly discouraged. 

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Dates, medications, and body systems are not to be recorded, and the information collected will 
not be coded. Its purpose is to assist in the later interpretation of safety data collected during the 
study.  
8.2.2 
Physical Examinations  
At Visit 1, the Investigator or a designee will perform a physical examination as per standard of 
care. Information will be recorded in the source document. 
If a routine examination had been performed within the last week by the Investigator, a sub-
Investigator, or a licensed nurse practitioner, it does not need to be repeated unless there were 
some changes in health status, in which case it may be limited to the affected area.  
8.2.3 
Vital Signs  
Pre-vaccination temperature will be systematically collected by the Investigator on the source 
document by axillary route. Tympanic, skin, and temporal artery thermometers must not be used. 
8.2.4 
Pregnancy Testing  
Urine pregnancy testing will be performed in women of childbearing potential at Visit 1 before 
vaccination. 
8.3 
Adverse Events (AEs), Serious Adverse Events, and Other Safety Reporting  
The definitions of an AE, SAE, and the different categories of AEs can be found in 
Appendix 10.2. 
AEs will be reported by the participants/participants’ parents/legally acceptable representatives to 
the Investigator, then by the Investigator to the Sponsor. 
The Investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible for following 
up AEs that are serious, considered related to the study intervention or study procedures, or that 
caused the participant to discontinue the study (see Section 7). 
The method of recording, evaluating, and assessing causality of AEs and SAEs and the procedures 
for completing and transmitting SAE reports are provided in Appendix 10.2. 
8.3.1 
Time Period and Frequency for Collecting Adverse Event and Serious Adverse 
Event Information  
Immediate Post-vaccination Observation Period 
Participants will be kept under observation for 30 minutes after vaccination to ensure their safety. 
The post-vaccination observation should be documented in the source document. 
Reactogenicity 
Solicited injection site reactions will be collected from D01 to D08 after vaccination. 

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Solicited systemic reactions will be collected from D01 to D08 after vaccination. 
The solicited injection site reactions and systemic reactions that are pre-listed in the DCs and 
CRF, together with the intensity scales, are presented in Appendix 10.2.5.1.1. 
Unsolicited Non-serious Adverse Events 
Unsolicited non-serious AEs will be collected from D01 to D31 after vaccination. Unsolicited 
non-serious AEs occurring after D31 will be presented in a specific listing. 
The intensity grading scale for unsolicited non-serious AEs is presented in Appendix 10.2.5.1.2. 
Adverse Events of Special Interest (AESIs) 
AESIs will be collected throughout the study period, from D01 to D31 after vaccination. 
See Section 8.3.6 for the list of AESIs. 
Serious Adverse Events 
Information on SAEs will be collected and assessed throughout the study, from D01 until 30 days 
after vaccination. However, before the first study intervention administration, only SAEs related 
to study procedures are to be collected in the CRF. In addition, SAEs occurring after D31 are also 
to be reported if they are considered related to vaccination with the IMP. 
Medical occurrences that begin before the start of study intervention but after obtaining informed 
consent will not be recorded on the AE section of the CRF. 
All SAEs will be recorded and reported to the Sponsor or designee immediately and under no 
circumstance should this exceed 24 hours, as indicated in Appendix 10.2. The Investigator will 
submit any updated SAE data to the Sponsor within 24 hours of it being available. 
Investigators are not obligated to actively seek information on AEs or SAEs after conclusion of 
the study participation. However, if the Investigator learns of any SAE, including a death, at any 
time after a participant has been discharged from the study, and he/she considers the event to be 
reasonably related to the study intervention or study participation, the Investigator must promptly 
notify the Sponsor. 
8.3.2 
Method of Detecting Adverse Events and Serious Adverse Events  
Individual DCs, specifically designed for this study by the Sponsor and provided to the study 
sites, will be given to study participants for the recording of daily safety information. These DCs 
will include pre-listed terms and intensity scales as well as areas for free text to capture additional 
safety information or other relevant details. Participants/participants’ parents/legally acceptable 
representatives will also be provided with rulers for measuring the size of injection site reactions, 
and with standard digital thermometers for measuring daily temperatures. To ensure consistency 
of reporting, the study sites will instruct participants/participants’ parents/legally acceptable 
representatives] on how to correctly use these tools. 
At specified intervals, the Investigator or a designee will interview the participants/participants’ 
parents/legally acceptable representatives to collect the information recorded in the DC, and will 
attempt to clarify anything that is incomplete or unclear. All clinical study information gathered 
by the study site will be reported electronically by the Investigator or designee using a web-based 

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CRF. Any information that was not documented in the DC will first be captured in the source 
document and then reported electronically. 
The method of recording, evaluating, and assessing causal relationship of AE and SAE and the 
procedures for completing and transmitting SAE reports are provided in Appendix 10.2. 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
non-leading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences. 
8.3.3 
Follow-up of Adverse Events and Serious Adverse Events  
After the initial AE/SAE report, the Investigator is required to proactively follow each participant 
at subsequent visits/contacts, unless a participant or parents/legally acceptable representatives 
refuses further contact. All AEs that are considered by the Investigator as serious, or related to the 
study intervention administered, or that led to study or vaccination discontinuation, or AESIs (as 
defined in Section 8.3.6), will be followed during the conduct of the study until resolution, 
stabilization, or the participant is lost to follow-up (as defined in Section 7.3). For related SAEs 
ongoing at last study visit, such follow-up may need to continue after the end of the study.  
Further information on follow-up procedures is provided in Appendix 10.2. 
8.3.4 
Regulatory Reporting Requirements for Serious Adverse Events  
• Prompt notification by the Investigator to the Sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a 
study intervention under clinical investigation are met. 
• The Sponsor has a legal responsibility to notify both the local regulatory authority and 
other regulatory agencies about the safety of a study intervention under clinical 
investigation. The Sponsor will comply with country-specific regulatory requirements 
relating to safety reporting to the regulatory authority, Institutional Review Board 
(IRB)/Independent Ethics Committee (IEC), and Investigators. 
• An Investigator who receives an investigator safety report describing a SAE or other 
specific safety information (eg, summary or listing of SAEs) from the Sponsor will review 
and then file it and will notify the IRB/IEC, if appropriate according to local requirements. 
• Investigator safety reports must be prepared for suspected unexpected serious adverse 
reactions (SUSARs) according to local regulatory requirements and Sponsor policy and 
forwarded to Investigators as necessary. 
8.3.5 
Pregnancy  
Pregnant women are not eligible to participate in the study and women of childbearing potential 
agree to use an effective contraceptive method, as defined in the inclusion criteria. However, a 
participant could potentially become pregnant during her participation. 
• Details of all pregnancies in female participants will be collected after the start of study 
intervention and until delivery, by the Investigator, and recorded in the Pregnancy CRF. 

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Any data collected after CRF lock will be transmitted to the pharmacovigilance 
department on the paper form. 
• If a pregnancy is reported, the Investigator should promptly inform the Sponsor and will 
record pregnancy information together with the contraceptive method on the appropriate 
form and submit it to the Sponsor within 1 month of learning of the pregnancy. 
• While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication 
or elective termination of a pregnancy for medical reasons will be reported as an AE or 
SAE. 
• Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, ectopic pregnancy) are considered SAEs and will be reported as such. 
• The participant will be followed to determine the outcome of the pregnancy. The 
Investigator will collect follow-up information on the participant and the neonate and the 
information will be forwarded to the Sponsor. Generally, follow-up will not be required 
for longer than 1 month beyond the estimated delivery date, but will be in accordance with 
local regulations. Any termination of pregnancy will be reported, regardless of fetal status 
(presence or absence of anomalies) or indication for the procedure. 
• Any post-study pregnancy-related SAE considered reasonably related to the study 
intervention by the Investigator will be reported to the Sponsor as described in 
Section 8.3.4. While the Investigator is not obligated to actively seek this information in 
former study participants, he or she may learn of an SAE through spontaneous reporting. 
• Any female participant who becomes pregnant while participating in the study will be 
followed for safety assessment (and may be followed for immunogenicity assessment, if 
applicable). 
8.3.6 
Adverse Events of Special Interest  
An AESI is an event for which ongoing monitoring and rapid communication by the Investigator 
to the Sponsor must be done. The following SAEs will be captured as serious AESIs throughout 
the study: 
• Generalized seizures (febrile and non-febrile) (10)  
• Kawasaki disease (11) (12) (13)  
• Guillain-Barré syndrome (14)  
• Idiopathic thrombocytopenic purpura (ITP) (15)  
These events have been listed as AESIs based on the feedback received from the European Union 
regulators for the MenACYW conjugate vaccine. 
No safety concerns relating to these AESIs have been identified with the use of MenACYW 
conjugate vaccine in the completed clinical trials. 
Because of their medical importance and to ensure expedited communication to the Sponsor, these 
AESIs are to be considered as SAEs and reported to the Sponsor according to the procedure 

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described in Appendix 10.2.4. Further instructions on the data collection for these events and the 
relevant definitions will be provided in the Operating Guidelines. 
8.4 
Pharmacokinetics  
Pharmacokinetics parameters are not evaluated in this study. 
8.5 
Genetics  
Genetics are not evaluated in this study. 
8.6 
Biomarkers  
No other biomarkers than those described in the immunogenicity assessments section 
(Section 8.1.2) are evaluated in this study. 
8.7 
Immunogenicity Assessments  
See Section 8.1.2. 
8.8 
Medical Resource Utilization and Health Economics  
Medical Resource Utilization and Health Economics parameters are not evaluated in this study. 
8.9 
Leftover Biological Samples and Use of Data  
Any unused part of the biological samples collected for this study (blood samples) are being 
retained in long-term storage to support answers to regulatory questions related to the product’s 
licensure and the potential revalidation of the study results. 
In addition, participants/participants’ parents/legally acceptable representatives will be asked to 
indicate in the ICF whether they will permit the future use of any unused stored biological 
samples for other tests, unless prohibited by local laws or IRBs/IECs (in such case, consent for 
future use of any unused biological samples will not be included in the site-specific ICF). If they 
refuse permission, the biological samples will not be used for any testing other than that directly 
related to this study. If they agree to this future use, they will not be paid for giving permission. 
The aim of any possible future research is unknown today, and may not be related to this 
particular study. It may be to improve the knowledge of vaccines and their mechanism of action, 
the knowledge of infectious diseases, or to improve existing tests or develop new tests to assess 
vaccines, or to help identify new vaccine targets or biomarkers that predict participant response to 
the vaccine. Such research may also include, but is not limited to, performing assessments on 
DNA, ribonucleic acid (RNA), proteins or metabolites. If future research on genetic material is 
performed, a specific individual consent will be obtained. 

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Data and samples will be used in compliance with the information provided to 
participants/participants’ parents/legally acceptable representatives in the ICF Part 2 (future 
research). In the event future research is conducted for other purposes, the study participants will 
be informed of those purposes and will be given means to object to the use of their biological 
samples or data for those research projects. 
All study participant data and biological samples will be coded such that no direct identifiers will 
be linked to participants. Coded data and biological samples may be transferred to a Sponsor site 
(or a subcontractor site), which may be located outside of the country where the study is 
conducted. The Sponsor adopts safeguards for protecting participant confidentiality and personal 
data (see Section 10.1.4). 
The biological samples will be securely stored at the Sponsor’s facilities (R&D Global 
Operations, Swiftwater, Pennsylvania, USA) up to 25 years after the end of the study. Any 
samples remaining at the end of retention period will be destroyed. If a participant/participants’ 
parents/legally acceptable representatives request(s) destruction of the participant’s samples 
before the end of the retention period, the Investigator must notify the Sponsor (or its contract 
organization) in writing. In such case, samples will be destroyed and sample related coded data 
will be anonymized unless otherwise required by applicable laws. 
Study participant coded data will be stored for future research for up to 25 years after the end of 
the study. If data are still considered of important scientific value after this period, coded data 
already available will be anonymized unless otherwise required by applicable laws (the same will 
apply to the data of a study participant who has requested the destruction of his/her samples). 
Participant’s coded data sets provided to researchers for a specific research project will be 
available to the researchers for a maximum of 2 years after the end of their specific project (end of 
project is defined by publication of the results or finalization of the future research project report). 
Note: The other biological samples collected to qualify the participant for inclusion in the study or 
to monitor his/her health during the study are dedicated for immediate use. If any of these 
biological samples are not completely used up, they will be destroyed at the latest at the end of the 
study or after the time requested by local law. 
9 
Statistical Considerations  
Clinical data will be analyzed under the responsibility of the Biostatistics Platform of the Sponsor. 
A statistical analysis plan (SAP) will be written and peer reviewed before any analyses. In 
accordance with the protocol, the SAP will describe all analyses to be performed by the Sponsor 
and all the conventions to be taken. 
9.1 
Statistical Hypotheses  
No statistical hypotheses will be tested. Descriptive statistics will be presented. 
Details on statistical methods are provided in Section 9.4. 

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9.2 
Sample Size Determination  
There are no statistically powered hypotheses in this study. No formal sample size calculations 
were performed.  
A total of 446 participants will be enrolled in the study, 223 participants will be enrolled in age 
category 12 months to 23 months, 223 participants will be enrolled in age category 24 months and 
above. An estimated 10% non-adherence rate from enrollment will result in approximately 
400 evaluable participants in total, and 200 evaluable participants in each age category (12 months 
– 23 months, ≥ 24 months). 
The overall evaluable study cohort (N=400) will provide a probability of approximately 95% of 
observing any AE (at least 1 occurrence) with a true incidence of 0.75%. 
For participants aged 12 to 23 months, 200 participants will provide a probability of 
approximately 95% of observing any AE (at least 1 occurrence) with a true incidence of 1.5%. 
For participants aged 24 months and above, 200 participants will provide a probability of 
approximately 95% of observing any AE (at least 1 occurrence) with a true incidence of 1.5%. 
9.3 
Analysis Sets  
The following populations are defined for immunogenicity and safety analyses: 
 
Analysis Set 
Description 
Full analysis set 
(FAS) 
Participants who received the study vaccine and had a valid post-vaccination 
serology result. 
Per-protocol analysis 
set (PPAS) 
Subset of the FAS. Participants presenting with at least one of the following 
relevant protocol deviations will be excluded from the PPAS: 
• 
Participants did not meet all protocol-specified inclusion criteria or met at 
least one of the protocol-specified exclusion criteria 
• 
Participant did not receive vaccine 
• 
Preparation and / or administration of vaccine was not done as per-protocol 
• 
Participants did not provide the post-dose serology sample at Visit 2 in the 
proper time window or a post-dose serology sample was not drawn 
• 
Participants received a category 2 or 3 protocol-prohibited therapy / 
medication / vaccine 
• 
Participants had other protocol violations that affected the participant’s 
immune response, as determined by the clinical team before locking the 
database. 
In addition to the reasons listed above, participants will also be excluded from 
the PPAS if their Visit 2 serology sample did not produce a valid test result. 
In the event of a local or national immunization program with a pandemic 
COVID-19 vaccine, participants who receive COVID-19 vaccine between an 
IMP dose and the collection of blood will not be withdrawn from the study, but 
will be excluded from PPAS. 
Safety analysis set 
(SafAS) 
Participants who have received the study vaccine and have any safety data 
available. 

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9.4 
Statistical Analyses  
The SAP will be finalized prior to database lock and it will include a more technical and detailed 
description of the statistical analyses than described in this section. This section is a summary of 
the planned statistical analyses of the most important endpoints. 
9.4.1 
General Considerations  
Immunogenicity and safety parameters will be analyzed in specified analysis sets in the overall 
population, as well as by age categories (12 months – 23 months, ≥ 24 months). 
The impact of COVID-19 pandemic situation on study conduct will be summarized through 
impact on visit procedures, study completion and major/critical protocol deviations due to 
COVID-19. The participants impacted by COVID-19 pandemic situation will be defined as the 
participants with at least one major/critical protocol deviation due to COVID-19 or who did not 
complete the study due to COVID-19. If more than 10% of participants are impacted as per this 
definition, the main immunogenicity and safety endpoints will also be summarized in these 
participants to assess the impact of COVID-19 situation on study outcome. 
9.4.2 
Immunogenicity Endpoint  
No statistical hypotheses will be tested. Descriptive statistics will be provided for the antibody 
titers against meningococcal serogroups A, C, W, and Y by using hSBA before and 30 days after 
a single dose of meningococcal conjugate vaccine. 
All immunogenicity analyses will be performed on the PPAS. Additional immunogenicity 
analyses will be performed for exploratory purposes on the FAS. 
In general, categorical variables will be summarized and presented by frequency counts, 
percentages, and CIs. The 95% CIs of point estimates will be calculated using the normal 
approximation for quantitative data and the exact binomial distribution (Clopper-Pearson method) 
for percentages (16). For GMTs, 95% CIs of point estimates will be calculated using normal 
approximation assuming they are log10-normally distributed. 
Descriptive analyses of antibody responses to A, C, W, and Y serogroups using hSBA will 
include but not be limited to: 
• GMTs and 95% CI.  
• Titer distribution and reverse cumulative distribution curves (RCDCs) 
• Percentage of participants with titers ≥ 4-fold rise from pre-vaccination to post-
vaccination, and 95% CI 
• Percentage of participants with hSBA titers ≥ 1:4 and ≥ 1:8, and 95% CI 
• Percentage of participants with hSBA vaccine seroresponse, and 95% CI 
Note: hSBA vaccine seroresponse for serogroups A, C, W, and Y is defined as: 
o For a participant with a pre-vaccination titer < 1:8, the post-vaccination titer must be 
≥ 1:16 
o For a participant with a pre-vaccination titer ≥ 1:8, the post-vaccination titer must be at 
least 4-fold greater than the pre-vaccination titer 

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9.4.3 
Safety Endpoints  
No statistical hypotheses will be tested. 
Safety results will be described for participants in the study. The main parameters for the safety 
endpoints will be described by 95% CIs (based on the Clopper-Pearson method). 
 
Depending on the items, the endpoints recorded or derived could include: nature (Medical 
Dictionary for Regulatory Activities [MedDRA] preferred term), time of onset, duration/number 
of days of occurrence, intensity, relationship to the vaccine, whether the AE led to early 
termination from the study, outcome, and seriousness criterion. 
All safety analyses will be performed on the SafAS. 
9.5 
Interim Analyses  
No analyses are planned to be performed prior to the formal completion of the study. 
9.6 
Data Monitoring Committee  
Not applicable. 
10 Supporting Documentation and Operational Considerations  
10.1 Appendix: Regulatory, Ethical, and Study Oversight Considerations  
Note: The term “participant” is used throughout this protocol. However, the term “subject” will be 
used in the CRF in order to comply with the Clinical Data Interchange Standards Consortium 
(CDISC) requirements. Similarly, “legally acceptable representative” is used in the protocol 
whereas “guardian” is used in the CRF. 
10.1.1 Regulatory and Ethical Considerations  
• This study will be conducted in accordance with the protocol and with the following: 
• Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines 
• Applicable International Council for Harmonisation (ICH) Good Clinical Practice 
(GCP) Guidelines 
• Applicable laws and regulations (eg, data protection law as General Data Protection 
Regulation [GDPR]) 

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• The protocol, protocol amendments, ICF, IB, and other relevant documents (eg, 
advertisements) must be submitted to an IRB/IEC by the Investigator or the Sponsor 
(according to local regulations) and reviewed and approved by the IRB/IEC before the 
study is initiated 
• Any amendments to the protocol will require IRB/IEC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants 
• Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate hazard 
to study participants. 
• The Investigator will be responsible for the following: 
• Providing written summaries of the status of the study to the IRB/IEC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/IEC [(in addition to summaries required from the Sponsor)] 
• Determining whether an incidental finding (as per Sanofi policy) should be returned to 
a participant and, if it meets the appropriate criteria, to ensure the finding is returned 
(an incidental finding is a previously undiagnosed medical condition that is discovered 
unintentionally and is unrelated to the aims of the study for which the tests are being 
performed). The following should be considered when determining the return of an 
incidental finding: 
• The return of such information to the study participant (and/or his/her designated 
healthcare professional, if so designated by the participant) is consistent with all 
applicable national, state, or regional laws and regulations in the country where the 
study is being conducted, and 
• The finding reveals a substantial risk of a serious health condition or has 
reproductive importance, AND has analytical validity, AND has clinical validity.  
• The participant in a clinical study has the right to opt out of being notified by the 
Investigator of such incidental findings. In the event that the participant has opted out 
of being notified and the finding has consequences for other individuals, eg, the 
finding relates to a communicable disease, Investigators should seek independent 
ethical advice before determining next steps. 
• In case the participant has decided to opt out, the Investigator must record in the 
site medical files that she/he does not want to know about such findings. 
• Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures 
• Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 536/2014 
for clinical studies (if applicable), European Medical Device Regulation 2017/745 for 
clinical device research (if applicable), and all other applicable local regulations 

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10.1.2 Financial Disclosure  
Information related to financial disclosure is described in the Investigator’s contract. 
10.1.3 Informed Consent Process  
• The Investigator or his/her representative will explain the nature of the study to the 
participant or his/her parent(s)/legally acceptable representative(s) and answer all 
questions regarding the study 
• Participants must be informed that their participation is voluntary. Participants and their 
parents/legally acceptable representatives will be required to sign a statement of informed 
consent that meets the requirements of 21 CFR 50, local regulations, ICH guidelines, 
Health Insurance Portability and Accountability Act (HIPAA) requirements, where 
applicable, and the IRB/IEC or study center 
• ICF may have to be signed and dated by an independent witness, if required by local 
regulations 
• Participants aged 12 to 15 years will be required to sign an assent 
• The medical record must include a statement that written informed consent/assent was 
obtained before the participant was enrolled in the study and the date the written 
consent/assent was obtained. The authorized person obtaining the informed consent/assent 
must also sign the ICF or AF. 
• The actual ICF or AF used at each center may differ, depending on local regulations and 
IEC/IRB requirements. However, all versions must contain the standard information found 
in the sample ICF or AF provided by the Sponsor. Any change to the content of the ICF or 
AF must be approved by the Sponsor and the IEC/IRB prior to the form being used. 
• If new information becomes available that may be relevant to the participant’s or 
parents’/legally acceptable representatives’ willingness to continue participation in the 
study, this will be communicated to him/her in a timely manner. Such information will be 
provided via a revised ICF or AF or an addendum to the original ICF or AF. 
• Participants and their parents/legally acceptable representatives must be re-consented to 
the most current version of the ICF or AF during their participation in the study. 
• A copy of the ICF or AF must be provided to the participant or their parents/legally 
acceptable representatives. 
Rationale for Including Participants Unable to Give Consent: 
MEQ00074 is a study to be conducted in participants aged 12 months and older; its aim is to 
obtain immunogenicity and safety data in participants who are meningococcal vaccination naïve. 
Since minor participants are unable to give their consent, written informed consent must be 
obtained from the parent(s) or legally acceptable representative in accordance with local practices 
before participation in the study and before any study-related procedure is done. The signature on 
the ICF must be dated by the parent(s)/legally acceptable representative in accordance with local 

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practices. The parent/legally acceptable representative should be able to consent for their child. 
The child of minor parents must not be included in the study. 
Recruitment Procedure 
An appropriate pool of potential participants (independent of the Investigator and investigational 
team) will be approached during their routine visit to the investigational site. The 
Investigator/investigational team at the study site will take the responsibility of participant 
recruitment. The site will ensure that any advertisements used to recruit participants (letters, 
pamphlets, posters, etc.) are submitted to the IEC/IRB for approval. 
10.1.4 Data Protection and Future Use of Stored Samples  
• All personal data collected and/or processed in relation to this study will be handled in 
compliance with all applicable Privacy & Data Protection laws and regulations, including 
the GDPR. Data collected must be adequate, relevant and not excessive, in relation to the 
purposes for which they are collected. Each category of data must be properly justified and 
in line with the study objective. 
• Participants will be assigned a unique identifier by the Sponsor. Any participant records or 
datasets that are transferred to the Sponsor or its service providers will be identifiable only 
by the unique identifier; participant names or any information which would make the 
participant identifiable will not be transferred to the Sponsor. 
• The participant/parent(s)/legally acceptable representative must be informed that the 
participant’s personal study-related data will be used by the Sponsor in accordance with 
applicable data protection law. The level of disclosure must also be explained to the 
participant as described in the informed consent. 
• The participant/parent(s)/legally acceptable representative must be informed that the 
participant’s medical records may be examined by Clinical Quality Assurance auditors or 
other authorized personnel appointed by the Sponsor, by appropriate IRB/IEC members, 
and by inspectors from regulatory authorities. 
• When archiving or processing personal data pertaining to the Investigator and/or to the 
participants, the Sponsor shall take all appropriate measures to safeguard and prevent 
access to this data by any unauthorized third party. 
• Participant data will be used for this study and in support of the whole drug development 
program for the Investigational Product, including negotiations with payers and 
publication of results. 
• Any unused part of the serum samples will be securely stored at the Sanofi Pasteur 
serology laboratory (GCI) up to 25 years after the end of the study. These samples are 
being retained in long-term storage to support answers to regulatory questions related to 
the product’s licensure and the potential revalidation of the study results. 

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The other biological samples collected to qualify the participant for inclusion in the study 
or to monitor his/her health are dedicated for immediate use. In case they are not 
completely used up, they will be destroyed at the latest at the end of the study or after the 
time requested by local law. 
In addition, parent(s)/legally acceptable representative will be asked to indicate in the ICF 
whether they will permit the future use of any unused stored serum samples for other tests. 
If they refuse permission, the samples will not be used for any testing other than that 
directly related to this study. If they agree to this use, they will not be paid for giving 
permission. Anonymity of samples will be ensured. The aim of any possible future 
research is unknown today, and may not be related to this particular study. It may be to 
improve the knowledge of vaccines or infectious diseases, or to improve existing tests or 
develop new tests to assess vaccines. Human genetic tests will never be performed on 
these samples without specific individual informed consent. 
10.1.5 Committees Structure  
This study will not include an early safety data review. 
10.1.6 Dissemination of Clinical Study Data  
Sanofi shares information about clinical trials and results on publicly accessible websites, based 
on company commitments, international and local legal and regulatory requirements, and other 
clinical trial disclosure commitments established by pharmaceutical industry associations. These 
websites include clinicaltrials.gov, EU clinicaltrialregister (eu.ctr), and sanofi.com, as well as 
some national registries. 
In addition, results from clinical trials in patients are required to be submitted to peer-reviewed 
journals following internal company review for accuracy, fair balance, and intellectual property. 
For those journals that request sharing of the analyzable data sets that are reported in the 
publication, interested researchers are directed to submit their request to 
clinicalstudydatarequest.com. 
Individual participant data and supporting clinical documents are available for request at 
clinicalstudydatarequest.com. While making information available we continue to protect the 
privacy of participants in our clinical trials. Details on data sharing criteria and process for 
requesting access can be found at this web address: clinicalstudydatarequest.com. 
10.1.7 Data Quality Assurance  
• All participant data relating to the study will be recorded on electronic CRF unless 
transmitted to the Sponsor or designee electronically (eg, laboratory data). The 
Investigator is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the CRF. 
• The Investigator must maintain accurate documentation (source data) that supports the 
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• The Investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents. 
• Monitoring details describing strategy (eg, risk-based initiatives in operations and quality 
such as Risk Management and Mitigation Strategies and Analytical Risk-Based 
Monitoring), methods, responsibilities and requirements, including handling of 
noncompliance issues and monitoring techniques (central, remote, or on-site monitoring) 
are provided in the Monitoring Plan. 
• The Sponsor or designee is responsible for the data management of this study including 
quality checking of the data. 
• The Sponsor assumes accountability for actions delegated to other individuals (eg, 
Contract Research Organizations [CROs]). 
• Study monitors will perform ongoing source data verification to confirm that data entered 
into the CRF by authorized site personnel are accurate, complete, and verifiable from 
source documents; that the safety and rights of participants are being protected; and that 
the study is being conducted in accordance with the currently approved protocol and any 
other study agreements, ICH GCP, and all applicable regulatory requirements. Remote site 
visits may be planned in case the COVID-19 pandemic situation does not allow to go on 
site. 
• Records and documents, including signed ICFs and AFs, pertaining to the conduct of this 
study must be retained by the Investigator for 25 years after the signature of the final study 
report unless local regulations or institutional policies require a longer retention period. No 
records may be destroyed during the retention period without the written approval of the 
Sponsor. No records may be transferred to another location or party without written 
notification to the Sponsor. 
10.1.8 Source Documents  
 “Source data” are the data contained in source documents. Source documents are original 
documents or certified copies, and include, but are not limited to, DCs, medical and hospital 
records, screening logs, ICFs or AFs, telephone contact logs, and worksheets. 
• Source documents provide evidence for the existence of the participant and substantiate 
the integrity of the data collected. Source documents are filed at the Investigator’s site. 
• Data entered in the CRF that are transcribed from source documents must be consistent 
with the source documents or the discrepancies must be explained. The Investigator may 
need to request previous medical records or transfer records, depending on the study. Also, 
current medical records must be available. 
Detailed guidance and information are provided in the Operating Guidelines. 
10.1.9 Study and Site Start and Closure  
Details on which clinical supplies are provided by the Sponsor or the site are described in the 
Operating Guidelines. 

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The study start date is considered the date of the first visit planned in the SoA of the first 
participant. The study end date is considered as the site closure date. 
The Sponsor or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the Sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been either destroyed or returned to the Sponsor, all samples are shipped to the appropriate 
laboratories, the center study-site has all the documents necessary for archiving and a study-site 
closure visit has been performed along with a Site Close Out Form submitted to the IRB, as 
required. 
The Investigator may initiate study-site closure at any time, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the Sponsor or Investigator may include but are 
not limited to: 
• Failure of the Investigator to comply with the protocol, the requirements of the IRB/IEC or 
local health authorities, the Sponsor's procedures, or GCP guidelines 
• Inadequate or no recruitment of participants by the Investigator 
• Discontinuation of further study intervention development 
• Total number of participants included earlier than expected 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
Investigators, the IECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of the 
reason for termination or suspension, as specified by the applicable regulatory requirements. The 
Investigator shall promptly inform the participant/parent(s)/legally acceptable representative and 
should assure appropriate participant therapy and/or follow-up. 
10.1.10 Publication Policy  
Information related to publication policy is described in the Investigator’s contract. 

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10.2 Appendix: Adverse Events and Serious Adverse Events: Definitions and 
Procedures for Recording, Evaluating, Follow-up, and Reporting  
10.2.1 Definition of Adverse Event  
Adverse Event Definition 
• An AE is any untoward medical occurrence in a clinical study participant, temporally 
associated with the use of study intervention, whether or not considered related to the study 
intervention. 
• NOTE: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study intervention. 
 
Events Meeting the Adverse Event Definition 
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or other 
safety assessments (eg, electrocardiogram [ECG], radiological scans, vital signs 
measurements), including those that worsen from baseline, considered clinically significant 
in the medical and scientific judgment of the Investigator (ie, not related to progression of 
underlying disease). 
• Exacerbation of a chronic or intermittent pre-existing condition including either an increase 
in frequency and/or intensity of the condition. 
• New conditions detected or diagnosed after study intervention administration even though it 
may have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected intervention-intervention 
interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming 
intent. Such overdoses should be reported regardless of sequelae. 
 
Events NOT Meeting the Adverse Event Definition 
• Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
Investigator to be more severe than expected for the participant’s condition. 
• Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads to 
the procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or 
detected at the start of the study that do not worsen. 
 

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Other Definitions 
Adverse Reaction: 
All noxious and unintended responses to a study intervention related to any dose should be 
considered adverse reactions (ARs). 
(The phrase “responses to a study intervention” means that a causal relationship between a 
study intervention and an AE is at least a reasonable possibility) 
Immediate Event/Reaction: 
Immediate events are recorded to capture medically relevant unsolicited systemic AEs 
(including those related to the study intervention administered) which occur within the first 
30 minutes after vaccination. 
Injection Site Reaction/Administration Site Reaction: 
An injection/administration site reaction is an AR at and around the injection/administration 
site. Injection/administration site reactions are commonly inflammatory reactions. They are 
considered to be related to the study intervention administered. 
Systemic Adverse Event/Adverse Reaction: 
Systemic ARs are all ARs that are not injection or administration site reactions. They therefore 
include systemic manifestations such as headache, fever, as well as localized or topical 
manifestations that are not associated with the injection or administration site (eg, erythema that 
is localized but that is not occurring at the injection site). 
Systemic AEs assessed as related to study intervention are referred as systemic ARs. 
Adverse Event of Special Interest: 
An AESI (serious or non-serious) is one of scientific and medical concern specific to the 
Sponsor’s study intervention or program, for which ongoing monitoring and rapid 
communication by the Investigator to the Sponsor can be appropriate. Such an event might 
warrant further investigation in order to characterize and understand it. Depending on the nature 
of the event, rapid communication by the study Sponsor to other parties (eg, regulators) might 
also be warranted. 
Reactogenicity / Solicited Reactions 
A solicited reaction is an “expected” AR (sign or symptom) observed and reported under the 
conditions (nature and onset) pre-listed in the protocol and CRF. 
By definition, solicited reactions are considered as being related to the study intervention 
administered. 
For injectable vaccines, solicited reactions can either be solicited injection/administration site 
reactions or solicited systemic reactions. 

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Unsolicited Adverse Event/Adverse Reaction: 
An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, 
ie, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination. For example, 
varicella or a solicited term such as headache starting after the solicited observation period (eg, 
headache starting on Day 10 post-vaccination in the case where headache occurring between the 
day of vaccination and the next 7 days is pre-listed in the protocol and CRF as a solicited 
reaction). 
An unsolicited AR is an unsolicited AE that is considered related to the study intervention 
administered.  
Unsolicited AEs includes both serious (SAEs) and non-serious unsolicited AEs. 
10.2.2 Definition of Serious Adverse Event  
If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met (eg, hospitalization for signs/symptoms of the disease under study, death due to 
progression of disease). 
An Serious Adverse Event is defined as any adverse event that, at any dose: 
a. Results in death 
b. Is life-threatening 
The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant 
was at risk of death at the time of the event. It does not refer to an event, which hypothetically 
might have caused death, if it were more severe. 
c. 
Requires inpatient hospitalization or prolongation of existing hospitalization 
• In general, hospitalization signifies that the participant has been admitted (usually involving 
at least an overnight stay) at the hospital or emergency ward for observation and/or 
treatment that would not have been appropriate in the physician’s office or outpatient 
setting. Complications that occur during hospitalization are AEs. If a complication prolongs 
hospitalization or fulfills any other serious criteria, the event is serious. When in doubt as to 
whether “hospitalization” occurred or was necessary, the AE should be considered serious. 
• Hospitalization for elective treatment of a pre-existing condition that did not worsen from 
baseline is not considered an AE. 
d. Results in persistent or significant disability/incapacity 
• The term disability means a substantial disruption of a person’s ability to conduct normal 
life functions. 
• This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and 
accidental trauma (eg, sprained ankle) which may interfere with or prevent everyday life 
functions but do not constitute a substantial disruption. 
e. 
Is a congenital anomaly/birth defect 

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f. 
Is other medically important event 
• Medical or scientific judgment should be exercised by the Investigator in deciding whether 
expedited reporting is appropriate in other situations such as significant medical events that 
may jeopardize the health of the participant or may require intervention to prevent one of 
the other outcomes listed in the above definition. These important medical events should 
also usually be considered serious. These include generalized seizures (febrile and non-
febrile), Kawasaki disease, Guillain-Barré syndrome, and ITP (see Section 8.3.6). 
• 
Examples of such events are intensive treatment in an emergency room or at home for 
allergic bronchospasm, blood dyscrasias, convulsions that do not result in hospitalization, or 
development of drug dependency or intervention abuse, new-onset diabetes or autoimmune 
disease. 
Note: Serious and severe are not synonymous. The term severe is often used to describe the 
intensity of a specific event as corresponding to Grade 3. This is not the same as serious, which is 
based on participant / event outcome or action criteria usually associated with events that pose a 
threat to a participant’s life or functioning. 
10.2.3 Recording and Follow-Up of Adverse Event and/or Serious Adverse Event  
Adverse Event and Serious Adverse Event Recording 
• When an AE/SAE occurs, it is the responsibility of the Investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostics reports) 
related to the event. 
• The Investigator will then record all relevant AE/SAE information in the CRF. 
• It is not acceptable for the Investigator to send photocopies of the participant’s medical 
records to the Sponsor in lieu of completion of the CRF pages. 
• There may be instances when copies of medical records for certain cases are requested by 
the Sponsor. In this case, all participant identifiers, with the exception of the participant 
number, will be redacted on the copies of the medical records before submission to the 
Sponsor. 
• The Investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not the 
individual signs/symptoms) will be documented as the AE/SAE. 
 
Assessment of Causal Relationship 
By convention, all AEs reported at the injection site (either solicited or unsolicited) and all 
solicited systemic AEs are considered to be related to the study intervention (see definition in 
Section 6) and therefore are referred to as reactions and do not require the Investigator’s 
opinion on relatedness. 
• Causal relationship of unsolicited systemic AEs and SAEs will be recorded as follows: 
• For non-serious unsolicited systemic AEs (except for non-serious AESIs), relationship to 
study intervention will usually be assessed by the Investigator only. 

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• For SAEs and non-serious AESIs, relationship to study intervention will be assessed by 
both the Investigator and the Sponsor. Sponsor assessment is entered in the Global 
Pharmacovigilance (GPV) database only. 
• For SAEs only, the causal relationship to study procedures (related/not related to study 
procedures) will be assessed by both the Investigator and the Sponsor. Sponsor assessment 
is entered in the GPV database only. 
• The Investigator will assess the causal relationship between each unsolicited systemic AE 
and the study intervention administereda a as either not related or related, based on the 
following definitions: 
• Not related – The AE is clearly / most probably caused by other etiologies such as 
participants’ underlying condition, therapeutic intervention, or concomitant therapy; or the 
delay between vaccination and the onset of the AE is incompatible with a causal 
relationship; or the AE started before the vaccination (screening phase, if applicable) 
• Related – There is a “reasonable possibility” that the AE was caused by the study 
intervention administered, meaning that there are facts (evidence) or arguments to suggest 
a causal relationship 
• The Investigator will use clinical judgment to determine the relationship. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention administration 
will be considered and investigated. 
• The Investigator will also consult the IB and/or Product Information, for marketed products, 
in his/her assessment. 
• For each AE/SAE, the Investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causal relationship. 
• There may be situations in which an SAE has occurred and the Investigator has minimal 
information to include in the initial report to the Sponsor. However, it is very important that 
the Investigator always makes an assessment of causal relationship for every event before 
the initial transmission of the SAE data to the Sponsor. 
• The Investigator may change his/her opinion of causal relationship in light of follow-up 
information and send an SAE follow-up report with the updated causal relationship 
assessment. 
• The causal relationship assessment is one of the criteria used when determining regulatory 
reporting requirements. 
 
                                                 
a Study intervention administered can correspond to either the investigational product or other products when no 
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Follow-up of Adverse Events and Serious Adverse Events 
• The Investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the Sponsor to 
elucidate the nature and/or causal relationship of the AE or SAE as fully as possible. This 
may include additional laboratory tests or investigations, histopathological examinations, or 
consultation with other health care professionals. 
• If a participant dies during participation in the study or during a recognized follow-up 
period, when available the Investigator will provide the Sponsor with a copy of any 
post-mortem findings including histopathology. 
• New or updated information will be recorded in the originally completed CRF. 
• The Investigator will submit any updated SAE data to the Sponsor within 24 hours of 
receipt of the information. 
• AEs likely to be related to the study intervention, whether serious or not, that persist at the 
end of the study will be followed up by the Investigator until their complete disappearance 
or the stabilization of the participant’s condition. The Investigator will inform the Sponsor 
of the date of final disappearance of the event or the date of “chronicity” establishment. 
10.2.4 Reporting of Serious Adverse Events  
Serious Adverse Event Reporting to the Sponsor via an Electronic Data Collection Tool 
• The primary mechanism for reporting an SAE to the Sponsor will be the electronic data 
collection tool. 
• If the electronic system is unavailable, then the site will use the paper SAE data collection 
tool (see next section) to report the event within 24 hours. The site will enter the SAE data 
into the electronic system as soon as it becomes available. 
• After the study is completed at a given site, the electronic data collection tool will be taken 
off-line to prevent the entry of new data or changes to existing data. 
• If a site receives a report of a new SAE from a study participant or receives updated data on 
a previously reported SAE after the electronic data collection tool has been taken off-line, 
then the site can report this information on a paper SAE form (see next section). 
• Details regarding SAE reporting can be found in the Operating Guidelines. 
 
Serious Adverse Event Reporting to the Sponsor via Paper Case Report Form 
The SAE paper CRF can be sent to the Sponsor by one of the following means: 
• By fax, to the following number: 001-570-957-3172 
• In PDF format to the following e-mail address, using a method of transmission that includes 
password protection: PV.outsourcing@sanofi.com (see the Operating Guidelines for 
directions on how to send a password-protected e-mail). 

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• By express mail, to the following address: 
Sanofi Pasteur Inc. 
Reception and Triage – Case Management 
Global Pharmacovigilance 
Mail Drop: 45D38 
Discovery Drive 
Swiftwater, PA 18370, USA 
 
Safety Emergency Call 
If, as per the Investigator's judgment, a participant experiences a medical emergency, the 
Investigator may contact the Sponsor’s RMO for advice on how to address any study-related 
medical question or problem. If the RMO is not available, then the Investigator may contact the 
Call Center—available 24 hours a day, 7 days a week—that will forward all safety emergency 
calls to the appropriate primary or back-up Sanofi Pasteur contact, as needed. The toll-free 
contact information for the Call Center is provided in the Operating Guidelines. 
This process does not replace the need to report an SAE. The Investigator is still required to 
follow the protocol-defined process for reporting SAEs to the GPV Department. 
10.2.5 Assessment of Intensity  
The Investigator will make an assessment of intensity for each AE reported during the study. An 
intensity grade will be assigned to each AE. The intensity grading scales used in this study are 
adapted from the “Food and Drug Administration (FDA) Guidance for Industry: Toxicity Grading 
Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials, September 2007”. 
10.2.5.1 Tables for Clinical Abnormalities  
10.2.5.1.1 Solicited AR Intensity Grading Scale  

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Table 10.1: Solicited injection site reactions: terminology, definitions, and intensity scales – Infants and toddlers aged ≤ 23 months  
CRF term 
(MedDRA lowest 
level term [LLT]) 
Injection site tenderness 
Injection site erythema 
Injection site swelling 
Diary card term 
Tenderness 
Redness 
Swelling 
Definition 
Pain when the injection site is touched or 
injected limb mobilized 
Presence of a redness including the 
approximate point of needle entry 
Swelling at or near the injection site 
Swelling or edema is caused by a fluid infiltration in 
tissue or cavity and, depending on the space available 
for the fluid to disperse, swelling may be either soft 
(typically) or firm (less typical) to touch and thus can 
be best described by looking at the size of the 
swelling 
Intensity scale* 
 
Grade 1: Minor reaction when injection site is 
touched 
Grade 2: Cries or protests when injection site is 
touched 
Grade 3 (CRF): Cries when injected limb is 
mobilized, or the movement of the injected 
limb is reduced 
Grade 3 (diary card): Cries when injected limb 
is moved or the movement of the injected limb 
is reduced 
Grade 1: > 0 to < 25 mm 
Grade 2: ≥ 25 to < 50 mm 
Grade 3: ≥ 50 mm 
Grade 1: > 0 to < 25 mm 
Grade 2: ≥ 25 to < 50 mm 
Grade 3: ≥ 50 mm 
MedDRA: Medical Dictionary for Regulatory Activities 
* For tenderness, the scale will be provided in the CRF and the intensity will be transcribed from the diary card. For other injection site reactions (erythema and swelling), the 
classification as Grade 1, 2, or 3 will be applied at the time of statistical analysis; the scale is provided for information purposes only. The actual size of the reaction will be reported in 
the CRF. 

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Table 10.2: Solicited injection site reactions: terminology, definitions, and intensity scales – Children aged 2 through 11 years  
CRF term 
(MedDRA lowest 
level term [LLT]) 
Injection site pain 
Injection site 
erythema 
Injection site swelling  
Diary card term 
Pain 
Redness 
Swelling 
Definition 
Pain either present spontaneously or when the 
injection site is touched or injected limb is 
mobilized 
Presence of a redness 
including the 
approximate point of 
needle entry 
Swelling at or near the injection site 
Swelling or edema is caused by a fluid infiltration in tissue or 
cavity and, depending on the space available for the fluid to 
disperse, swelling may be either soft (typically) or firm (less 
typical) to touch and thus can be best described by looking at 
the size of the swelling 
Intensity scale* 
 
CRF: 
Grade 1: Easily tolerated 
Grade 2: Sufficiently discomforting to interfere 
with normal behavior or activities 
Grade 3: Incapacitating, unable to perform usual 
activities 
Diary card: 
Grade 1: No interference with usual activities 
Grade 2: Some interference with usual activities 
Grade 3: Significant; prevents usual activities 
Grade 1: > 0 to 
< 25 mm 
Grade 2: ≥ 25 to 
< 50 mm 
Grade 3: ≥ 50 mm 
Grade 1: > 0 to < 25 mm 
Grade 2: ≥ 25 to < 50 mm 
Grade 3: ≥ 50 mm 
MedDRA: Medical Dictionary for Regulatory Activities 
* For pain, the scale will be provided in the CRF and the intensity will be transcribed from the diary card. For other injection site reactions (erythema and swelling), the classification as 
Grades 1, 2, or 3 will be applied at the time of statistical analysis; the scale is provided for information purposes only. The actual size of the reaction will be reported in the CRF. 

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Table 10.3: Solicited injection site reactions: terminology, definitions, and intensity scales – Adolescents and adults aged ≥ 12 years  
CRF term 
(MedDRA lowest 
level term [LLT]) 
Injection site pain 
Injection site 
erythema 
Injection site swelling  
Diary card term 
Pain 
Redness 
Swelling 
Definition 
Pain either present spontaneously or when the injection site is touched 
or injected limb is mobilized 
Presence of a 
redness including 
the approximate 
point of needle entry 
Swelling at or near the injection site 
Swelling or edema is caused by a fluid 
infiltration in tissue or cavity and, depending 
on the space available for the fluid to 
disperse, swelling may be either soft 
(typically) or firm (less typical) to touch and 
thus can be best described by looking at the 
size of the swelling 
Intensity scale* 
 
CRF: 
Grade 1: A type of adverse event that is usually transient and may 
require only minimal treatment or therapeutic intervention. The event 
does not generally interfere with usual activities of daily living. 
Grade 2: A type of adverse event that is usually alleviated with 
additional therapeutic intervention. The event interferes with usual 
activities of daily living, causing discomfort but poses no significant 
or permanent risk of harm to the research participant. 
Grade 3: A type of adverse event that interrupts usual activities of 
daily living, or significantly affects clinical status, or may require 
intensive therapeutic intervention. 
Diary card: 
Grade 1: No interference with usual activities 
Grade 2: Some interference with usual activities 
Grade 3: Significant; prevents usual activities 
Grade 1: ≥ 25 to 
≤ 50 mm 
Grade 2: ≥ 51 to 
≤ 100 mm 
Grade 3: > 100 mm 
Grade 1: ≥ 25 to ≤ 50 mm 
Grade 2: ≥ 51 to ≤ 100 mm 
Grade 3: > 100 mm 
MedDRA: Medical Dictionary for Regulatory Activities 
* For pain, the scale will be provided in the CRF and the intensity will be transcribed from the diary card. For other injection site reactions (erythema and swelling), the classification as 
Grades 1, 2, or 3 will be applied at the time of statistical analysis; the scale is provided for information purposes only. The actual size of the reaction will be reported in the CRF. 

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Table 10.4: Solicited systemic reactions: terminology, definitions, and intensity scales – Infants and toddlers aged ≤ 23 months  
CRF term (MedDRA 
lowest level term 
[LLT]) 
Fever 
Vomiting 
Crying abnormal  
Drowsiness 
Appetite lost 
Irritability 
Diary card term 
Temperature 
Vomiting 
Abnormal crying 
Drowsiness 
Loss of appetite 
Irritability 
Definition 
Elevation of 
temperature to ≥ 38.0°C 
Vomiting does not 
include spitting up 
Inconsolable crying 
without a determined 
reason 
Reduced interest in 
surroundings, or 
increased sleeping 
See intensity scale 
An excessive response to 
stimuli: increased 
fussiness, whining, and 
fretfulness despite 
attempts to comfort the 
infant and despite 
caregiver responses that 
would normally be 
soothing 
Intensity scale* 
Grade 1:  
≥ 38.0°C to ≤ 38.5°C 
Grade 1: 1 episode per 
24 hours 
Grade 1: < 1 hour 
Grade 1: Sleepier than 
usual or less interested 
in surroundings 
Grade 1: Eating less 
than normal 
Grade 1: Easily 
consolable 
 
Grade 2: 
> 38.5°C to ≤ 39.5°C 
 
Grade 2: 2–5 episodes 
per 24 hours 
Grade 2: 1–3 hours  
Grade 2: Not interested 
in surroundings or did 
not wake up for a feed / 
meal 
Grade 2: Missed 1 or 2 
feeds / meals 
completely 
Grade 2: Requiring 
increased attention 
 
Grade 3: > 39.5°C 
Grade 3: ≥ 6 episodes 
per 24 hours or 
requiring parenteral 
hydration 
Grade 3: > 3 hours 
Grade 3: Sleeping most 
of the time or difficult 
to wake up 
Grade 3: Refuses ≥ 3 
feeds / meals or refuses 
most feeds / meals 
Grade 3: Inconsolable 
MedDRA: Medical Dictionary for Regulatory Activities 
* For all reactions (except fever), the scale will be provided in the CRF and the intensity will be transcribed from the diary card. For fever, the body temperature will be recorded, and the 
classification as Grade 1, 2, or 3 will be assigned at the time of the statistical analysis based on the unit used to measure the temperature and the intensity scale. 

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Table 10.5: Solicited systemic reactions: terminology, definitions, and intensity scales – Children aged 2 through 11 years, adolescents or adults 
aged ≥ 12 years  
CRF term (MedDRA 
lowest level term 
[LLT]) 
Fever 
Headache 
Malaise 
Myalgia 
Diary card term 
Temperature 
Headache 
Feeling unwell 
Muscle aches and pains 
Definition 
Elevation of temperature to 
≥°38.0°C 
Pain or discomfort in the head or 
scalp. Does not include migraine. 
General ill feeling. 
Malaise is a generalized feeling of 
discomfort, illness, or lack of well-
being that can be associated with a 
disease state. It can be accompanied 
by a sensation of exhaustion or 
inadequate energy to accomplish 
usual activities. 
Muscle aches and pains are 
common and can involve more than 
one muscle at the same time. 
Muscle pain can also involve the 
soft tissues that surround muscles. 
These structures, which are often 
referred to as connective tissues, 
include ligaments, tendons, and 
fascia (thick bands of tendons). 
Does not apply to muscle pain at 
the injection site which should be 
reported as injection site pain. 
Intensity scale* 
Grade 1: ≥ 38.0°C to ≤ 38.4°C 
CRF: 
Grade 1: A type of adverse event 
that is usually transient and may 
require only minimal treatment or 
therapeutic intervention. The event 
does not generally interfere with 
usual activities of daily living. 
CRF: 
Grade 1: A type of adverse event 
that is usually transient and may 
require only minimal treatment or 
therapeutic intervention. The event 
does not generally interfere with 
usual activities of daily living. 
CRF: 
Grade 1: A type of adverse event 
that is usually transient and may 
require only minimal treatment or 
therapeutic intervention. The event 
does not generally interfere with 
usual activities of daily living. 

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CRF term (MedDRA 
lowest level term 
[LLT]) 
Fever 
Headache 
Malaise 
Myalgia 
 
Grade 2: ≥ 38.5°C to ≤ 38.9°C 
Grade 2: A type of adverse event 
that is usually alleviated with 
additional therapeutic intervention. 
The event interferes with usual 
activities of daily living, causing 
discomfort but poses no significant 
or permanent risk of harm to the 
research participant. 
Grade 2: A type of adverse event 
that is usually alleviated with 
additional therapeutic intervention. 
The event interferes with usual 
activities of daily living, causing 
discomfort but poses no significant 
or permanent risk of harm to the 
research participant. 
Grade 2: A type of adverse event 
that is usually alleviated with 
additional therapeutic intervention. 
The event interferes with usual 
activities of daily living, causing 
discomfort but poses no significant 
or permanent risk of harm to the 
research participant. 
 
Grade 3: ≥ 39.0°C 
Grade 3: A type of adverse event 
that interrupts usual activities of 
daily living, or significantly affects 
clinical status, or may require 
intensive therapeutic intervention. 
Diary card: 
Grade 1: No interference with usual 
activities 
Grade 2: Some interference with 
usual activities 
Grade 3: Significant; prevents usual 
activities 
Grade 3: A type of adverse event 
that interrupts usual activities of 
daily living, or significantly affects 
clinical status, or may require 
intensive therapeutic intervention. 
Diary card: 
Grade 1: No interference with usual 
activities 
Grade 2: Some interference with 
usual activities 
Grade 3: Significant; prevents usual 
activities 
Grade 3: A type of adverse event 
that interrupts usual activities of 
daily living, or significantly affects 
clinical status, or may require 
intensive therapeutic intervention. 
Diary card: 
Grade 1: No interference with usual 
activities 
Grade 2: Some interference with 
usual activities 
Grade 3: Significant; prevents usual 
activities 
MedDRA: Medical Dictionary for Regulatory Activities 
* For all reactions (except fever), the scale will be provided in the CRF and the intensity will be transcribed from the diary card. For fever, the body temperature will be recorded, and 
the classification as Grade 1, 2, or 3 will be assigned at the time of the statistical analysis based on the unit used to measure the temperature and the intensity scale. 
 

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Important notes for the accurate assessment of temperature: 
Participants or participants’ parents/legally acceptable representatives are to measure body 
temperature once per day, preferably always at the same time. The optimal time for measurement 
is the evening, when body temperature is the highest. Temperature is also to be measured at the 
time of any apparent fever. The observed daily temperature and the route of measurement are to 
be recorded in the DC, and the highest temperature will be recorded by the site in the CRF. The 
preferred route for this study is axillary. 
10.2.5.1.2 Unsolicited AE Intensity Grading Scale  
For measurable unsolicited AEs that are part of the list of solicited reactions, the corresponding 
scale for solicited reactions will be used (see Section 10.2.5.1.1). 
All other unsolicited AEs will be classified according to the following intensity scale: 
• Grade 1 
• CRF: A type of adverse event that is usually transient and may require only minimal 
treatment or therapeutic intervention. The event does not generally interfere with usual 
activities of daily living. 
• DC: No interference with usual activities. 
• Grade 2 
• CRF: A type of adverse event that is usually alleviated with additional therapeutic 
intervention. The event interferes with usual activities of daily living, causing 
discomfort but poses no significant or permanent risk of harm to the research 
participant. 
• DC: Some interference with usual activities. 
• Grade 3 
• CRF: A type of adverse event that interrupts usual activities of daily living, or 
significantly affects clinical status, or may require intensive therapeutic intervention. 
• DC: Significant; prevents usual activities. 
10.3 Appendix: Contraceptive and Barrier Guidance  
10.3.1 Definitions  
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below). 
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot be 
confirmed before first dose of study intervention, additional evaluation should be considered. 

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Women in the following categories are not considered WOCBP 
1) Premenarchal 
2) Premenopausal female with 1 of the following: 
• Documented hysterectomy 
• Documented bilateral salpingectomy 
• Documented bilateral oophorectomy 
For individuals with permanent infertility due to an alternate medical cause other than the 
above, (eg, mullerian agenesis, androgen insensitivity), Investigator discretion should be 
applied to determining study entry. 
Note: Documentation can come from the site personnel’s: review of the participant’s medical 
records, medical examination, or medical history interview. 
3) Postmenopausal female 
• A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 
• A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used 
to confirm a postmenopausal state in women not using hormonal contraception or 
hormonal replacement therapy (HRT). However, in the absence of 12 months of 
amenorrhea, confirmation with more than one FSH measurement is required. 
• Females on HRT and whose menopausal status is in doubt will be required to use one of 
the non-estrogen hormonal highly effective contraception methods if they wish to continue 
their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation 
of postmenopausal status before study enrollment. 

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10.3.2 
Contraception Guidance  
CONTRACEPTIVESa ALLOWED DURING THE STUDY INCLUDE: 
Highly Effective Methodsb That Have Low User Dependency Failure rate of <1% per year when used 
consistently and correctly. 
• Implantable progestogen-only hormone contraception associated with inhibition of ovulationb 
• Intrauterine device (IUD) 
• Intrauterine hormone-releasing system (IUS) b 
• Bilateral tubal occlusion 
• Azoospermic partner (vasectomized or due to a medical cause) 
Azoospermia is a highly effective contraceptive method provided that the partner is the sole sexual partner of 
the woman of childbearing potential and the absence of sperm has been confirmed. If not, an additional 
highly effective method of contraception should be used. 
Note: documentation of azoospermia for a male participant can come from the site personnel’s review of the 
participant’s medical records, medical examination, or medical history interview. 
Highly Effective Methodsb That Are User Dependent Failure rate of <1% per year when used consistently 
and correctly. 
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of 
ovulationc 
− oral 
− intravaginal 
− transdermal 
− injectable 
• Progestogen-only hormone contraception associated with inhibition of ovulationc 
− oral 
− injectable 
• Sexual abstinence 
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual 
intercourse during the entire period of risk associated with the study intervention. The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle 
of the participant. 
Effective Methodsd That Are Not Considered Highly Effective Failure rate of ≥ 1% per year when used 
consistently and correctly. 
• Progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of 
action 
• Male or female condom with or without spermicide 
• Cervical cap, diaphragm, or sponge with spermicide 
• A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double-
barrier methods)c 
a) Contraceptive use by men or women should be consistent with local regulations regarding the use of 
contraceptive methods for those participating in clinical studies. 
b) Failure rate of <1% per year when used consistently and correctly. Typical use failure rates differ from those 
when used consistently and correctly. 
c) [Male condoms must be used in addition to hormonal contraception]. 
d) Considered effective, but not highly effective - failure rate of ≥1% per year. Periodic abstinence (calendar, 
symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational 
amenorrhea method (LAM) are not acceptable methods of contraception.  
e) Male condom and female condom should not be used together (due to risk of failure from friction). 

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10.4 Appendix: Risk-based Approach  
ICH E6-R2 guideline for GCP is introducing the « risk-based approach » concept which permits 
to focus efforts on what is critical for a study and most specifically on Critical Data and Critical 
Processes. Critical data and processes are defined for the study with associated risks in the Study 
Risk Management Plan. 

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10.5 Appendix: Abbreviations  
AE 
 
Adverse event 
AF 
 
Assent form 
AESI  
Adverse event of special interest 
AR 
 
Adverse reaction 
BL 
 
Blood sample 
CDISC 
Clinical Data Interchange Standards Consortium 
CI 
 
Confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences 
COVID-19 
Coronavirus disease 2019 
CRF  
Case report form 
CRO  
Contract Research Organization 
DC 
 
Diary card 
DNA  
Deoxyribonucleic acid 
EU 
 
European Union 
FAS 
 
Full analysis set 
FSH 
 
Follicle-stimulating hormone 
GCI 
 
Global Clinical Immunology 
GCP  
Good Clinical Practice 
GDPR  
General Data Protection Regulation 
GMT  
Geometric mean titer 
GPV  
Global Pharmacovigilance 
HIPAA 
Health Insurance Portability and Accountability Act 
HPV  
human papillomavirus 
HRT  
Hormonal replacement therapy 
hSBA  
Serum bactericidal assay using human complement 
IB 
 
Investigator’s Brochure 
ICF 
 
Informed consent form 
ICH 
 
International Council for Harmonisation 
IEC 
 
Independent Ethics Committee 
IMD  
Invasive meningococcal disease 

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IMP 
 
Investigational medicinal product 
IRB 
 
Institutional Review Board 
ITP 
 
Idiopathic thrombocytopenic purpura 
ITT 
 
Intent-to-treat 
LLOQ  
Lower limit of quantification 
MCV4-CRM Meningococcal conjugate vaccine quadrivalent 
MedDRA 
Medical Dictionary for Regulatory Activities 
NIMP  
Non-investigational medicinal product 
NSAID 
Non-steroidal anti-inflammatory drug 
PP 
 
Per protocol 
PPAS  
Per-protocol analysis set 
RCDC  
Reverse cumulative distribution curve 
RMO  
Responsible Medical Officer 
RNA  
Ribonucleic acid 
SAE  
Serious adverse event 
SafAS  
Safety analysis set 
SAP 
 
Statistical analysis plan 
SoA 
 
Schedule of activities 
SUSAR 
Suspected unexpected serious adverse reaction 
TC 
 
Telephone call 
Tdap  
tetanus, diphtheria, and acellular pertussis 
US(A)  
United States (of America) 
WOCBP 
Woman of Childbearing Potential 

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11 References  
1. 
Harrison L, Granoff D, Pollard A. Meningococcal capsular group A, C, W, and Y 
conjugate vaccines. [ed.] Orenstein WA, Offit PA, Edwards KM Plotkin SA. Vaccines. 7. 
Philadelphia (PA): Elsevier; 2018. p. 619-43. 
2. 
Vyse A, Wolter JM, Chen J, Ng T, Soriano-Gabarro M. Meningococcal disease in Asia: an 
under-recognized public health burden. Epidemiology & Infection. 2011 Jul;139(7):967-85. 
3. 
Aye AM, Bai X, Borrow R, Bory S, Carlos J, Caugant DA, et al. Meningococcal disease 
surveillance in the Asia–Pacific region (2020): the Global Meningococcal Initiative. Journal of 
Infection. 2020 Jul 27. 
4. 
Velentgas P, Amato AA, Bohn RL, Chan KA, Cochrane T, Funch DP, et al. Risk of 
Guillain-Barre syndrome after meningococcal conjugate vaccination. Pharmacoepidemiol Drug 
Saf. 2012;21(12):1350-8. 
5. 
Yih WK, Weintraub E, Kulldorff M. No risk of Guillain-Barre syndrome found after 
meningococcal conjugate vaccination in two large cohort studies. Pharmacoepidemiol Drug Saf. 
2012;21(12):1359-60. 
6. 
Update: Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate 
vaccine--United States, June 2005-September 2006. MMWR Morb Mortal Wkly Rep. 
2006;55(41):1120-4. 
7. 
Institute of Medicine. Diphtheria toxoid, tetanus toxoid, and acellular pertussis-containing 
vaccines. In: Stratton K, Ford A, Rusch E, Clayton EW, editors. Adverse Effects of Vaccines: 
Evidence and Causality. Washington, DC: The National Academies Press; 2012. p. 557-8. 
8. 
Tseng HF, Sy LS, Ackerson BK, Hechter RC, Tartof SY, Haag M, et al. Safety of 
Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds. Pediatrics. 2017;139(1). 
9. 
Centers for Disease Control and Prevention. Syncope after vaccination--United States, 
January 2005-July 2007. MMWR Morb Mortal Wkly Rep. 2008;57(17):457-60. 
10. 
Bonhoeffer J, Menkes J, Gold MS, de Souza-Brito G, Fisher MC, Halsey N, et al. 
Generalized convulsive seizure as an adverse event following immunization: case definition and 
guidelines for data collection, analysis, and presentation. Vaccine. 2004;22(5-6):557-62. 
11. 
Newburger JW, Takahashi M, Gerber MA, Gewitz MH, Tani LY, Burns JC, et al. 
Diagnosis, treatment, and long-term management of Kawasaki disease: a statement for health 
professionals from the Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease, 
Council on Cardiovascular Disease in the Young, American Heart Association. Pediatrics. 
2004;114(6):1708-33. 
12. 
Centers for Disease Control and Prevention. Kawasaki Syndrome Case Report. 2003. 
13. 
Phuong LK, Bonetto C, Buttery J, Pernus YB, Chandler R, Goldenthal KL, et al. Kawasaki 
disease and immunisation: Standardised case definition & guidelines for data collection, analysis. 
Vaccine. 2016;34(51):6582-96. 

Sanofi Pasteur 
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14. 
Sejvar JJ, Kohl KS, Gidudu J, Amato A, Bakshi N, Baxter R, et al. Guillain-Barre 
syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and 
presentation of immunization safety data. Vaccine. 2011;29(3):599-612. 
15. 
Wise RP, Bonhoeffer J, Beeler J, Donato H, Downie P, Matthews D, et al. 
Thrombocytopenia: case definition and guidelines for collection, analysis, and presentation of 
immunization safety data. Vaccine. 2007;25(31):5717-24. 
16. 
Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of 
seven methods. Stat Med. 1998;17(8):857-72. 

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12 Sponsor Signature Page  
 

Signature Page for VV-CLIN-0607397 v1.0
MenQuadTT-MEQ00074-protocol-version1.0
Approve & eSign
Clinical
01-Apr-2021 02:11:40 GMT+0000
VV-CLIN-0607397 1.0