A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a Booster Dose and Describe the Immune Persistence of MenACYW Conjugate Vaccine With 5- and/or 10-year Booster Doses in Children and Adolescents Who Had Been Primed With MenACYW Conjugate Vaccine as Toddlers.
Phase: PHASE3
Conditions: Meningococcal Immunisation, Healthy Volunteers
Sponsor: Sanofi Pasteur, a Sanofi Company

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Title Page 
Protocol Title: 
A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a 
Booster Dose and Describe the Immune Persistence of MenACYW Conjugate Vaccine with 5- 
and/or 10-year Booster Doses in Children and Adolescents who had been Primed with 
MenACYW Conjugate Vaccine as Toddlers  
Study Code: MEQ00073 
Protocol Version Number: 2.0 
Amendment Number: 1.0 
Compound: MenQuadfi® 
Study Phase: IIIb 
Short Title: 
Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW 
Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Dose in Children and 
Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers 
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: 2021-000104-38 
Approval Date: 16-Feb-2022 
Responsible medical officer (RMO) [and designee(s)], and pharmacovigilance (PV) 
representative names and contact Information are provided in the Operating Guidelines. 
The study centers and the Coordinating Investigators at each center are listed in a separate 
document. 
NCT04936685

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Document History 
DOCUMENT HISTORY 
Document 
Date 
Amendment 1.0 
16-Feb-2022
Original Protocol 
08-Feb-2021
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union.  
Overall Rationale for the Amendment: 
The purpose of Amendment 1.0 is to add a study arm in order to describe the immunogenicity and 
safety of a booster dose and the persistence of a priming dose of MenACYW conjugate vaccine 
(MenQuadfi®) in adolescents who had been vaccinated with MenACYW conjugate vaccine 
approximately 10 years earlier as toddlers as part of the MET51 study. It is also to increase the 
study duration in the initial study arm to describe the immunogenicity and safety of a second 
booster dose (as adolescents approximately 5 years after the first booster dose) and the persistence 
of a first booster dose of MenACYW conjugate vaccine in adolescents who had been primed with 
MenACYW conjugate vaccine as toddlers as part of the MET51 study and had received a first 
booster dose as children approximately 5 years after the priming dose. 

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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 ............................................................................................................................ 14 
1.3 
Schedule of Activities (SoA) .......................................................................................... 16 
2 
Introduction ..................................................................................................................... 22 
2.1 
Study Rationale ............................................................................................................... 22 
2.2 
Background ..................................................................................................................... 28 
2.3 
Benefit/Risk Assessment ................................................................................................ 30 
2.3.1 
Risks from Study Participation ..................................................................................... 30 
2.3.2 
Benefits from Study Participation ................................................................................ 33 
2.3.3 
COVID-19 Risk Assessment ........................................................................................ 33 
2.3.4 
Overall Benefit-Risk Conclusion .................................................................................. 34 
3 
Objectives and Endpoints ............................................................................................... 34 
4 
Study Design .................................................................................................................... 38 
4.1 
Overall Design ................................................................................................................ 38 
4.2 
Scientific Rationale for Study Design ............................................................................. 40 
4.3 
Justification for Dose ...................................................................................................... 41 
4.4 
End of Study Definition .................................................................................................. 42 
5 
Study Population ............................................................................................................. 42 
5.1 
Inclusion Criteria ............................................................................................................ 42 
5.2 
Exclusion Criteria ........................................................................................................... 42 
5.3 
Lifestyle Considerations ................................................................................................. 44 
5.4 
Screen Failures ................................................................................................................ 44 
6 
Study Intervention ........................................................................................................... 44 

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6.1 
Study Intervention Administered .................................................................................... 44 
6.2 
Preparation/Handling/Storage/Accountability ................................................................ 46 
6.3 
Measures to Minimize Bias: Randomization and Blinding ............................................ 47 
6.3.1 
Randomization and Allocation Procedures .................................................................. 47 
6.3.2 
Blinding and Code-breaking Procedures ...................................................................... 47 
6.4 
Study Intervention Compliance ...................................................................................... 47 
6.5 
Concomitant Therapy ...................................................................................................... 47 
6.5.1 
Rescue Medicine ........................................................................................................... 49 
6.6 
Dose Modification .......................................................................................................... 49 
6.7 
Intervention After the End of the Study .......................................................................... 49 
7 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal .......................................................................................... 50 
7.1 
Discontinuation of Study Intervention ............................................................................ 50 
7.1.1 
Temporary Contraindications for Vaccination ............................................................. 50 
7.1.2 
Temporary Contraindications for Blood Sample .......................................................... 50 
7.1.3 
Definitive Contraindication .......................................................................................... 50 
7.2 
Participant Discontinuation/Withdrawal from the Study ................................................ 52 
7.3 
Lost to Follow-up ............................................................................................................ 52 
8 
Study Assessments and Procedures ............................................................................... 53 
8.1 
Efficacy and Immunogenicity Assessments ................................................................... 53 
8.1.1 
Efficacy Assessments ................................................................................................... 53 
8.1.2 
Immunogenicity Assessments ...................................................................................... 53 
8.2 
Safety Assessments ......................................................................................................... 55 
8.2.1 
Medical History ............................................................................................................ 55 
8.2.2 
Physical Examinations .................................................................................................. 55 
8.2.3 
Vital Signs .................................................................................................................... 56 
8.3 
Adverse Events and Serious Adverse Events ................................................................. 56 
8.3.1 
Time Period and Frequency for Collecting Adverse Event and Serious Adverse 
Event Information ......................................................................................................... 56 
8.3.2 
Method of Detecting Adverse Events and Serious Adverse Events ............................. 57 
8.3.3 
Follow-up of Adverse Events and Serious Adverse Events ......................................... 57 
8.3.4 
Regulatory Reporting Requirements for Serious Adverse Events ............................... 58 
8.3.5 
Pregnancy ..................................................................................................................... 58 
8.3.6 
Adverse Events of Special Interest ............................................................................... 59 
8.4 
Treatment of Overdose.................................................................................................... 59 
8.5 
Pharmacokinetics ............................................................................................................ 60 
8.6 
Pharmacodynamics ......................................................................................................... 60 

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8.7 
Genetics ........................................................................................................................... 60 
8.8 
Biomarkers ...................................................................................................................... 60 
8.9 
Immunogenicity Assessments ......................................................................................... 60 
8.10 
Medical Resource Utilization and Health Economics .................................................... 60 
9 
Statistical Considerations ............................................................................................... 60 
9.1 
Statistical Hypotheses ..................................................................................................... 60 
9.2 
Sample Size Determination ............................................................................................. 61 
9.3 
Populations for Analyses ................................................................................................ 62 
9.4 
Statistical Analyses ......................................................................................................... 63 
9.4.1 
General Considerations ................................................................................................. 63 
9.4.2 
Primary Endpoint .......................................................................................................... 64 
9.4.3 
Secondary Endpoints .................................................................................................... 64 
9.4.3.1 
Immunogenicity ......................................................................................................... 64 
9.4.3.2 
Safety .......................................................................................................................... 66 
9.4.4 
Other Safety Analyses .................................................................................................. 66 
9.4.5 
Other Analyses ............................................................................................................. 66 
9.5 
Interim Analyses ............................................................................................................. 66 
9.6 
Data Monitoring Committee (DMC) .............................................................................. 66 
10 
Supporting Documentation and Operational Considerations .................................... 66 
10.1 
Appendix: Regulatory, Ethical, and Study Oversight Considerations ............................ 66 
10.1.1 
Regulatory and Ethical Considerations ........................................................................ 67 
10.1.2 
Financial Disclosure ..................................................................................................... 68 
10.1.3 
Informed Consent Process ............................................................................................ 68 
10.1.4 
Data Protection and Future Use of Stored Samples ..................................................... 69 
10.1.5 
Committees Structure ................................................................................................... 71 
10.1.6 
Dissemination of Clinical Study Data .......................................................................... 71 
10.1.7 
Data Quality Assurance ................................................................................................ 72 
10.1.8 
Source Documents ........................................................................................................ 73 
10.1.9 
Study and Site Start and Closure .................................................................................. 73 
10.1.10 
Publication Policy ......................................................................................................... 74 
10.2 
Appendix: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting ............................................................................ 74 
10.2.1 
Definition of Adverse Event ......................................................................................... 74 
10.2.2 
Definition of Serious Adverse Event ............................................................................ 76 
10.2.3 
Recording and Follow-Up of Adverse Event and/or Serious Adverse Event .............. 77 
10.2.4 
Reporting of Serious Adverse Events ........................................................................... 80 
10.2.5 
Assessment of Intensity ................................................................................................ 81 
10.2.5.1 
Tables for Clinical Abnormalities .............................................................................. 81 

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10.2.5.1.1 
Solicited Adverse Reaction Intensity Grading Scale ............................................... 81 
10.2.5.1.2 
Unsolicited Adverse Event Intensity Grading Scale ................................................ 84 
10.3 
Appendix: Risk-based Approach .................................................................................... 84 
10.4 
Appendix: Abbreviations ................................................................................................ 85 
11 
Reference List .................................................................................................................. 88 
12 
Sponsor Signature Page .................................................................................................. 91 
 
 
 
 

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List of Tables  
Table 1.1: Schedule of activities, Group 1 .................................................................................... 16 
Table 1.2: Schedule of activities, Group 2 .................................................................................... 19 
Table 2.1: Comparison of bactericidal antibody responses to MenACYW conjugate vaccine 
and Nimenrix Vaccine Reported in MET51 .................................................................................. 24 
Table 2.2: Potential risks of clinical significance and risk management ...................................... 30 
Table 3.1: Objectives and endpoints ............................................................................................. 34 
Table 4.1: Overall design .............................................................................................................. 39 
Table 6.1: Identity of study intervention ....................................................................................... 45 
Table 9.1: Power of the study based on the primary objective ..................................................... 61 
Table 10.1: Solicited injection site reactions: terminology, definitions, and intensity scales – 
Children at V2 (Group 1) .............................................................................................................. 82 
Table 10.2: Solicited injection site reactions: terminology, definitions, and intensity scales – 
Adolescents and adults aged ≥ 10 years at V4 (Group 1) and V3 (Group 2) ................................ 83 
 
 
 

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List of Figures  
Figure 1.1 – Graphical study design .............................................................................................. 15 
 

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1 
Protocol Summary  
1.1 
Synopsis  
Protocol Title: 
A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a 
Booster Dose and Describe the Immune Persistence of MenACYW Conjugate Vaccine with 5- 
and/or 10-year Booster Doses in Children and Adolescents who had been Primed with 
MenACYW Conjugate Vaccine as Toddlers 
Short Title: 
Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW 
Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Dose in Children and 
Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers 
Rationale: 
The purpose of Amendment 1.0 is to add a study arm in order to describe the immunogenicity and 
safety of a booster dose and the persistence of a priming dose of MenACYW conjugate vaccine 
(MenQuadfi®) in adolescents who had been vaccinated with MenACYW conjugate vaccine 
approximately 10 years earlier as toddlers as part of the MET51 study. It is also to increase the 
study duration in the initial study arm to describe the immunogenicity and safety of a second 
booster dose (as adolescents approximately 5 years after the first booster dose) and the persistence 
of a first booster dose of MenACYW conjugate vaccine in adolescents who had been primed with 
MenACYW conjugate vaccine as toddlers as part of the MET51 study and had received a first 
booster dose as children approximately 5 years after the priming dose. 
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
 
• To demonstrate the vaccine seroresponse 
sufficiency of meningococcal serogroups A, 
C, W, and Y after the administration of a 
booster dose of MenACYW conjugate 
vaccine in children who received 1 dose of 
MenACYW conjugate vaccine 
approximately 5 years earlier as toddlers 
(Group 1) 
• Vaccine seroresponse1 against meningococcal 
serogroups A, C, W, and Y measured by serum 
bactericidal assay using human complement 
(hSBA) assessed at Visit (V)1 (baseline) and at 
V2 (30 days after the administration of a 
booster dose of MenACYW conjugate vaccine) 
(Group 1) 
1 Seroresponse is defined as the proportions of 
participants with an hSBA pre-vaccination titer 
< 1:8 who achieved a post-vaccination titer ≥ 1:16 or 
participants with a pre-vaccination titer ≥ 1:8 who 

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achieved a post-vaccination titer at least 4-fold 
greater than the pre-vaccination titer 
Key Secondary  
 
Immunogenicity 
• To describe the antibody persistence of 
meningococcal serogroups A, C, W, and Y 
in children who received MenACYW 
conjugate vaccine approximately 5 years 
earlier as toddlers (Groups 1 and 2) 
• To describe the antibody persistence of 
meningococcal serogroups A, C, W, and Y 
in adolescents who received MenACYW 
conjugate vaccine approximately 10 years 
earlier as toddlers (Group 2) 
• To describe the antibody persistence of 
meningococcal serogroups A, C, W, and Y 
in adolescents who received a booster as 
children approximately 5 years after the 
primary dose of MenACYW conjugate 
vaccine as toddlers (Group 1) 
• To describe the antibody responses to 
meningococcal serogroups A, C, W, and Y 
before and 30 days after the administration 
of a booster dose of MenACYW conjugate 
vaccine in children who received 
MenACYW conjugate vaccine 
approximately 5  years earlier as toddlers 
(Group 1) 
• To describe the antibody responses to 
meningococcal serogroups A, C, W, and Y 
before and 30 days after the administration 
of a booster dose of MenACYW conjugate 
vaccine in adolescents who received 
MenACYW conjugate vaccine 
approximately 10 years earlier as toddlers 
(Group 2) 
Immunogenicity 
• 
Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by hSBA 
and serum bactericidal assay using baby rabbit 
complement (rSBA) at V1 for Group 1 and 
Group 2  
 
• 
Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by hSBA 
and rSBA at V2 (Group 2)  
 
• 
Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by hSBA 
and rSBA at V3 (Group 1)  
 
 
• 
Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by hSBA 
and rSBA at V1 (baseline) and V2 (30 days 
after the administration of a booster dose of 
MenACYW conjugate vaccine) (Group 1) 
 
 
• 
Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by hSBA 
and rSBA at V2 and V3 (30 days after the 
administration of a booster dose of MenACYW 
conjugate vaccine) (Group 2) 
 

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• To describe the antibody responses to 
meningococcal serogroups A, C, W, and Y 
before and 30 days after the administration of 
a booster dose of MenACYW conjugate 
vaccine in adolescents who received a 
booster as children approximately 5 years 
after the primary dose of MenACYW 
conjugate vaccine as toddlers (Group 1) 
• To describe the antibody responses to tetanus 
toxoid before and 30 days after the 
administration of each booster dose of 
MenACYW conjugate vaccine in children 
(Group 1) and adolescents (Group 2) who 
received MenACYW conjugate vaccine 
approximately 5 or 10 years earlier as 
toddlers and in children who received a 
booster approximately 5 years after the 
primary dose of MenACYW conjugate 
vaccine as toddlers (Group 1)  
• To describe the antibody responses to 
meningococcal serogroup C before and 
30 days after the administration of a booster 
dose of MenACYW conjugate vaccine 
o In children who received MenACYW 
conjugate vaccine approximately 
5  years earlier as meningococcal 
vaccine naïve toddlers (MET51 
Group 1) (Group 1) 
o In children who received MenACYW 
conjugate vaccine approximately 
5 years earlier as meningococcal C 
(MenC)-primed toddlers (MET51 
Group 3) (Group 1) 
o In adolescents who received 
MenACYW conjugate vaccine 
approximately 10  years earlier as 
meningococcal vaccine naïve toddlers 
(MET51 Group 1) (Group 2) 
 
• 
Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by hSBA 
and rSBA at V3 and V4 (30 days after the 
administration of a booster dose of MenACYW 
conjugate vaccine) (Group 1) 
 
• 
Antibody concentrations against tetanus toxoid 
at V1 (baseline) and V2 (30 days after the 
administration of a 5-year booster dose of 
MenACYW conjugate vaccine) (Group 1) 
• 
Antibody concentrations against tetanus toxoid 
at V3 and V4 (30 days after administration of 
the second booster dose of MenACYW 
conjugate vaccine) (Group 1) 
• 
Antibody concentrations against tetanus toxoid 
at V2 and V3 (30 days after administration of a 
10-year booster dose of MenACYW conjugate 
vaccine) (Group 2) 
• 
Antibody titers2 against meningococcal 
serogroup C measured by hSBA and rSBA at 
V1 (baseline) and V2 (30 days after the 
administration of a 5-year booster dose of 
MenACYW conjugate vaccine) (Group 1) 
• 
Antibody titers2 against meningococcal 
serogroup C measured by hSBA and rSBA at 
V3 and V4 (30 days after the administration of 
the second booster dose of MenACYW 
conjugate vaccine) (Group 1) 
• 
Antibody titers2 against meningococcal 
serogroup C measured by hSBA and rSBA at 
V2 and V3 (30 days after the administration of 
a 10-year booster dose of MenACYW 
conjugate vaccine) (Group 2) 

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o In adolescents who received 
MenACYW conjugate vaccine 
approximately 10 years earlier as 
MenC-primed toddlers (MET51 
Group 3) (Group 2) 
o In adolescents who received 
MenACYW conjugate vaccine booster 
as children approximately 5 years after 
receiving the primary dose of 
MenACYW conjugate vaccine as 
meningococcal vaccine naïve toddlers 
(MET51 Group 1) (Group 1) 
o In adolescents who received 
MenACYW conjugate vaccine booster 
as children approximately 5 years after 
receiving the primary dose of 
MenACYW conjugate vaccine as 
MenC-primed toddlers (MET51 
Group 3) (Group 1) 
 
2 Results will be expressed as vaccine 
seroresponse, seorprotection, and GMTs 
Safety 
To describe the safety profile of a booster dose of 
MenACYW conjugate vaccine: 
• 
in children who received MenACYW 
conjugate vaccine approximately 5 years 
earlier as toddlers in MET51 (Group 1)  
• 
in adolescents who received 
MenACYW conjugate vaccine 
approximately 10 years earlier as 
toddlers in MET51 (Group 2)  
• 
in adolescents who received a booster 
dose as children approximately 5 years 
after the primary dose of MenACYW 
conjugate vaccine as toddlers (Group 1) 
Safety 
The safety profile will be evaluated within 30 days 
(+14 days) after vaccination. The following 
endpoints will be used for the evaluation of safety: 
• Unsolicited systemic adverse events (AEs) 
reported within 30 minutes after vaccination 
• Solicited (prelisted in the participant’s diary card 
[DC] and [electronic] case report book [CRB]) 
injection site and systemic reactions starting any 
time from the day of vaccination through 7 days 
after vaccination 
• Unsolicited (recorded in a DC) non-serious AEs 
reported within 30 days after vaccination(s)  
• Serious adverse events (SAEs) (including adverse 
events of special interest [AESIs]) reported 
throughout the study  

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Overall Design 
This is a Phase IIIb, open-label, multi-center study to evaluate the immunogenicity and safety of a 
booster dose and describe the immune persistence of a priming dose of MenACYW conjugate 
vaccine in children and adolescents in Finland, Germany, Spain, and Hungary who had been 
vaccinated with MenACYW conjugate vaccine approximately 5 or 10 years earlier as toddlers as 
part of the MET51 study, and to describe the immunogenicity and safety of a second booster dose 
and the persistence of a first booster dose of MenACYW conjugate vaccine in adolescents who 
had been vaccinated with MenACYW conjugate vaccine approximately 5 years earlier as 
children. 
Participants who were vaccinated with MenACYW conjugate vaccine approximately 5 years 
earlier at 12 to 23 months of age in study MET51 will be eligible for enrollment in study 
MEQ00073. Eligible participants will be stratified to 1 of 2 groups based on country and MenC 
status (primed [Hungary, Spain] or naïve [Finland, Germany]). Participants in Group 1 will 
receive a first booster dose of MenACYW conjugate vaccine on D01 (V1) (at child age 
approximately 5 years post priming dose as toddlers in study MET51) and a second booster dose 
of MenACYW conjugate vaccine at Year 5 of study MEQ00073 (at adolescent age approximately 
5 years post booster dose as children in study MEQ00073). Participants in Group 2 will receive a 
single booster dose of MenACYW conjugate vaccine at Year 5 of study MEQ00073 
(approximately 10 years post priming dose as toddlers in study MET51).  
All participants will provide blood samples (BL) for antibody persistence and immunogenicity 
assessments at V1 (pre-vaccination for Group 1 [D01]); participants in Group 1 will also provide a 
BL at V2 (D31 +14 days), 30 days post-first booster vaccination. Participants in both groups will 
provide a BL at Year 5 (V3 for Group 1, Visit 2 for Group 2) for antibody persistence and 
immunogenicity assessments prior to receiving a booster vaccination of MenACYW conjugate 
vaccine, and another BL 30 days post-booster vaccination (V4 for Group 1, V3 for Group 2).  
Solicited AE information will be collected for 7 days after each vaccination; unsolicited AE 
information will be collected for 30 days (+14 days) after each vaccination. Serious AE 
information (including AESIs) will be collected throughout the study period. 

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Type of design 
open-label, multi-center and multi-country 
Phase 
IIIb 
Control method 
uncontrolled 
Study population 
Healthy children approximately 6 to 7 years of age 
at the time of enrollment who were vaccinated 
with MenACYW conjugate vaccine approximately 
5 years earlier as toddlers (12 to 23 months of age) 
in the MET51 study (Group 1 [naïve] and Group 3 
[MenC-primed]) 
Countries 
Finland, Germany, Hungary, Spain 
Level and method of blinding 
open-label 
Study intervention assignment method 
randomly selected 
Disclosure Statement: 
This is an open-label study.  
Number of Participants: 
All available and eligible participants, who participated in and completed the MET51 study and 
received a single dose of MenACYW conjugate vaccine as a part of the study, can be enrolled. 
Participants from MET51 will be invited to participate in MEQ00073, with around 
250 participants each in Group 1 and in Group 2 (maximum estimate).  
Intervention Groups and Duration: 
Participants in Group 1 will receive a first booster dose of MenACYW conjugate vaccine at D01 
and a second booster dose of MenACYW conjugate vaccine at Year 5 of study MEQ00073. 
Participants in Group 2 will receive a single booster dose of MenACYW conjugate vaccine at 
Year 5 of study MEQ00073.  
The duration of each participant’s participation will be approximately 5.5 years. 
Data Monitoring Committee: 
Not applicable 
1.2 
Schema  
The graphical design of study MEQ00073 is presented in Figure 1.1. 

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Figure 1.1 – Graphical study design  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Group 1 
V1 (D01) 
5Y after MET51 D01 
TC* (D09) 
D31* 
AE: adverse event; D: day; N/A: not applicable; SAE: serious AE; TC: telephone call; V: visit; Y: year 
 
*The TC at D09 and the D31 visit (V2, Group 1) are applicable only to Group 1 participants 
† This TC is applicable to both groups, and will be done approximately 8 days after V3 (Group 1) / V2 (Group 2)  
 
BL2 
Group 2 
Annual TCs 
 
All participants in Group 1 
and Group 2 will be 
contacted annually to 
follow-up for any SAEs  
Group 1 
V3 (Group 1) /  
V2 (Group 2) 
V1 + 5Y 
V4 (Group 1) /
V3 (Group 2)  
V2 or V3 + 30D 
 
Group 2 
Y10 booster 
– Group 1 
Y10 booster 
– Group 2 
V2* (Group 1) 
V1 + 30D 
N/A 
 
 
Y5 booster 
– Group 1 
TC† 
N/A 
 

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1.3 
Schedule of Activities (SoA)  
Visits procedures are detailed in the Operating Guidelines. 
Table 1.1: Schedule of activities, Group 1   
Phase IIIb Study, 4 Visits (V), 6 Telephone Calls (TC), 2 Vaccinations, 4 Blood Samples (BLs), 5.5 Years Duration per Participant 
Visit/Contact 
Collection of 
information 
in the CRF 
Visit 1 
(V1) 
TC1 
Visit 2 
(V2) 
TC2 
TC3 
TC4 
TC5 
Visit 3 
(V3) 
TC6 
Visit 4 
(V4) 
Trial timelines (days) 
 
Day 01 
(D01) 
Day 09 
(D09) 
V1 + 8d 
Day 31 
(D31) 
V1 + 30d 
Year 1 
V1 + 12m 
Year 2 
V1 + 24m 
Year 3 
V1 + 36m 
Year 4  
V1 + 48m 
Year 5  
V1 + 60m  
Year 5 
Day 09  
V3 + 8d 
Year 5 
Day 31  
V3 + 30d 
Time windows (days) 
 
- 
+2d 
+14d 
+14d 
+14d 
+14d 
+14d 
+14d 
+2d 
+14d 
Informed consent form 
(ICF)/Assent form (AF) 
(As applicable and if required by 
country regulation, a new AF 
will be signed by the adolescent 
aged participant at V3) 
X 
X 
 
 
 
 
 
 
X 
 
 
Inclusion/exclusion criteria* 
X 
X 
 
 
 
 
 
 
 
 
 
Collection of demographic data 
X 
X 
 
 
 
 
 
 
 
 
 
Collection of medical history 
X 
X 
 
 
 
 
 
 
 
 
 
Collection of vaccination history 
X 
X 
 
 
 
 
 
 
 
 
 
Physical examination 
 
X 
 
 
 
 
 
 
X 
 
 

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Visit/Contact 
Collection of 
information 
in the CRF 
Visit 1 
(V1) 
TC1 
Visit 2 
(V2) 
TC2 
TC3 
TC4 
TC5 
Visit 3 
(V3) 
TC6 
Visit 4 
(V4) 
Trial timelines (days) 
 
Day 01 
(D01) 
Day 09 
(D09) 
V1 + 8d 
Day 31 
(D31) 
V1 + 30d 
Year 1 
V1 + 12m 
Year 2 
V1 + 24m 
Year 3 
V1 + 36m 
Year 4  
V1 + 48m 
Year 5  
V1 + 60m  
Year 5 
Day 09  
V3 + 8d 
Year 5 
Day 31  
V3 + 30d 
Time windows (days) 
 
- 
+2d 
+14d 
+14d 
+14d 
+14d 
+14d 
+14d 
+2d 
+14d 
Urine pregnancy test (if 
applicable) 
 
 
 
 
 
 
 
 
X 
 
 
Review warnings and 
precautions and / or 
contraindications for vaccination 
X 
X 
 
 
 
 
 
 
X 
 
 
Review of temporary 
contraindications for blood 
sampling† 
X 
X 
 
X 
 
 
 
 
X 
 
X 
Blood sample (BL), 5 mL‡ 
 
BL1 
 
BL2 
 
 
 
 
BL3 
 
BL4 
Randomization/stratification of 
participant number 
X 
X 
 
 
 
 
 
 
 
 
 
Study Vaccination 
 
X 
 
 
 
 
 
 
X 
 
 
Immediate surveillance post 
vaccination (30 minutes) 
X 
X 
 
 
 
 
 
 
X 
 
 
Diary card (DC) provided 
 
DC1 
 
DC for 
safety 
 
 
 
 
DC2 
 
 
Telephone call (TC) 
 
 
X§ 
 
X 
X 
X 
X 
 
X§ 
 
Recording of solicited injection 
site & systemic reactions 
X 
Day 01 
to 
Day 08 
 
 
 
 
 
 
V3 to 7d 
post-V3 
 
 

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Visit/Contact 
Collection of 
information 
in the CRF 
Visit 1 
(V1) 
TC1 
Visit 2 
(V2) 
TC2 
TC3 
TC4 
TC5 
Visit 3 
(V3) 
TC6 
Visit 4 
(V4) 
Trial timelines (days) 
 
Day 01 
(D01) 
Day 09 
(D09) 
V1 + 8d 
Day 31 
(D31) 
V1 + 30d 
Year 1 
V1 + 12m 
Year 2 
V1 + 24m 
Year 3 
V1 + 36m 
Year 4  
V1 + 48m 
Year 5  
V1 + 60m  
Year 5 
Day 09  
V3 + 8d 
Year 5 
Day 31  
V3 + 30d 
Time windows (days) 
 
- 
+2d 
+14d 
+14d 
+14d 
+14d 
+14d 
+14d 
+2d 
+14d 
Recording of unsolicited AEs (to 
be collected up to 30d after 
vaccination) 
X 
 
 
X 
 
 
 
 
 
 
X 
Reporting of SAEs (including 
AESIs**) 
X 
To be reported throughout the study period 
DC collected 
 
 
 
DC1 
 
 
 
 
 
 
DC2 
Collection of reportable 
concomitant medications 
X 
X 
 
X 
 
 
 
 
X 
 
X 
Termination record 
X 
 
 
 
 
 
 
 
 
 
X 
AE: adverse event; AESI: adverse event of special interest; AF: assent form; AR: adverse reaction; BL: blood sample; CRF: case report form; D, d: day(s); DC: diary card: ICF: informed consent form; 
m: month(s); mL: milliliter; SAE: serious adverse event; TC: telephone call; V: visit  
* Temperature to be measured by oral, rectal, or axillary route (axillary preferred) using a certified standard digital thermometer and recorded in the source document. 
† Should a participant receive oral or injectable antibiotic therapy within 3 days prior to each 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 is still to be within the timeframe for blood draw (30 to 44 days after vaccination at D01). If postponement will result in the sample collection 
falling outside of the appropriate timeframe, the blood sample should be collected without postponement, and it should be documented appropriately that the sample was taken less than 3 days after 
stopping antibiotic treatment. 
‡ Blood samples at V1 (BL1) and V3 (BL3) are to be drawn before administration of the vaccine. 
§ This call is to be made 8 to 10 days after the vaccination visit. If the contact date (+2 days) falls on a weekend or holiday, the TC may be made on the following business day. During this TC, the staff 
will find out whether the participant experienced any SAEs, including AESIs, not yet reported, and are to remind the participant’s parent/legally acceptable representative (LAR) to continue using the 
DC up to the next visit, to bring the DC to the study center at the next visit, and to confirm the date and time of the next visit. 
** AESIs will be collected throughout the trial 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 causality.  
 

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Table 1.2: Schedule of activities, Group 2  
Phase IIIb Study, 3 Visits (V), 5 Telephone Calls (TC), 1 Vaccination, 3 Blood Samples (BLs), 5.5 Years Duration per Participant 
Visit/Contact 
Collection of 
information 
in the CRF 
Visit 1 (V1) 
TC1 
TC2 
TC3 
TC4 
Visit 2 (V2) 
TC5 
Visit 3 (V3) 
Trial timelines (days) 
 
Day 01 
(D01) 
Year 1 
V1 + 12m 
Year 2 
V1 + 24m 
Year 3 
V1 + 36m 
Year 4  
V1 + 48m 
Year 5  
V1 + 60m  
Year 5 
Day 09  
V2 + 8d 
Year 5 
Day 31  
V2 + 30d 
Time windows (days) 
 
- 
+14d 
+14d 
+14d 
+14d 
+14d 
+2d 
+14d 
Informed consent form 
(ICF)/Assent form (AF) 
(As applicable and if required by 
country regulation, a new AF 
will be signed by the adolescent 
aged participant at V3) 
X 
X 
 
 
 
 
X 
 
 
Inclusion/exclusion criteria* 
X 
X 
 
 
 
 
 
 
 
Collection of demographic data 
X 
X 
 
 
 
 
 
 
 
Collection of medical history 
X 
X 
 
 
 
 
X 
 
 
Collection of vaccination history 
X 
X 
 
 
 
 
 
 
 
Physical examination 
 
X 
 
 
 
 
 
 
 
Urine pregnancy test (if 
applicable) 
 
 
 
 
 
 
X 
 
 
Review warnings and 
precautions and / or 
contraindications for vaccination 
X 
 
 
 
 
 
X 
 
 

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Visit/Contact 
Collection of 
information 
in the CRF 
Visit 1 (V1) 
TC1 
TC2 
TC3 
TC4 
Visit 2 (V2) 
TC5 
Visit 3 (V3) 
Trial timelines (days) 
 
Day 01 
(D01) 
Year 1 
V1 + 12m 
Year 2 
V1 + 24m 
Year 3 
V1 + 36m 
Year 4  
V1 + 48m 
Year 5  
V1 + 60m  
Year 5 
Day 09  
V2 + 8d 
Year 5 
Day 31  
V2 + 30d 
Time windows (days) 
 
- 
+14d 
+14d 
+14d 
+14d 
+14d 
+2d 
+14d 
Review of temporary 
contraindications for blood 
sampling† 
X 
X 
 
 
 
 
X 
 
X 
Blood sample (BL), 5 mL 
 
BL1 
 
 
 
 
BL2‡ 
 
BL3 
Randomization/stratification of 
participant number 
X 
X 
 
 
 
 
 
 
 
Study Vaccination 
 
 
 
 
 
 
X 
 
 
Immediate surveillance post 
vaccination (30 minutes) 
X 
 
 
 
 
 
X 
 
 
Diary card (DC) provided 
 
DC for 
safety 
 
 
 
 
DC1 
 
 
Telephone call (TC) 
 
 
X 
X 
X 
X 
 
X§ 
 
Recording of solicited injection 
site & systemic reactions 
X 
 
 
 
 
 
V2 to 7d 
post-V2 
 
 
Recording of unsolicited AEs (to 
be collected up to 30d after 
vaccination) 
X 
 
 
 
 
 
 
 
X 
Reporting of SAEs (including 
AESIs**) 
X 
 
To be reported throughout the study period 
DC collected 
 
 
 
 
 
 
 
 
DC1 

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Visit/Contact 
Collection of 
information 
in the CRF 
Visit 1 (V1) 
TC1 
TC2 
TC3 
TC4 
Visit 2 (V2) 
TC5 
Visit 3 (V3) 
Trial timelines (days) 
 
Day 01 
(D01) 
Year 1 
V1 + 12m 
Year 2 
V1 + 24m 
Year 3 
V1 + 36m 
Year 4  
V1 + 48m 
Year 5  
V1 + 60m  
Year 5 
Day 09  
V2 + 8d 
Year 5 
Day 31  
V2 + 30d 
Time windows (days) 
 
- 
+14d 
+14d 
+14d 
+14d 
+14d 
+2d 
+14d 
Collection of reportable 
concomitant medications 
X 
X 
 
 
 
 
X 
 
X 
Termination record 
X 
 
 
 
 
 
 
 
X 
AE: adverse event; AESI: adverse event of special interest; AF: assent form; AR: adverse reaction; BL: blood sample; CRF: case report form; D, d: day(s); DC: diary card: ICF: informed consent form; 
m: month(s); mL: milliliter; SAE: serious adverse event; TC: telephone call; V: visit  
* Temperature to be measured by oral, rectal, or axillary route (axillary preferred) using a certified standard digital thermometer and recorded in the source document. 
† Should a participant receive oral or injectable antibiotic therapy within 3 days prior to each 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 is still to be within the timeframe for blood draw (30 to 44 days after vaccination at D01). If postponement will result in the sample collection 
falling outside of the appropriate timeframe, the blood sample should be collected without postponement, and it should be documented appropriately that the sample was taken less than 3 days after 
stopping antibiotic treatment. 
‡ Blood sample at V2 (BL2) is to be drawn before administration of the vaccine.   
§ This call is to be made 8 to 10 days after the vaccination visit. If the contact date (+2 days) falls on a weekend or holiday, the TC may be made on the following business day. During this TC, the staff 
will find out whether the participant experienced any SAEs, including AESIs, not yet reported, and are to remind the participant’s parent/legally acceptable representative (LAR) to continue using the 
DC up to the next visit, to bring the DC to the study center at the next visit, and to confirm the date and time of the next visit. 
** AESIs will be collected throughout the trial 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 causality. Before the first booster vaccination at V2, only SAEs related to study procedures are to be collected for Group 2. 
 

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2 
Introduction  
The MenACYW conjugate vaccine (MenQuadfi®) was designed for the immunization of 
individuals of all ages (children as young as 6 weeks of age, adolescents, and adults including 
those 56 years of age and older) against invasive meningococcal disease (IMD). The purpose of 
the vaccine is to provide broad coverage against circulating meningococcal strains from 
serogroups A, C, W, and Y.  
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 in the 
European Union (EU) since November 2020, and some other countries under the brand name of 
MenQuadfi®. 
MenACYW conjugate vaccine has been evaluated in over 7500 participants (infants, toddlers, 
adolescents, and adults, including those > 56 years of age) 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. Phase III studies are ongoing to investigate the vaccine in 
infants from 6 weeks of age. 
2.1 
Study Rationale  
The MEQ00073 study will assess the immunogenicity and safety of a booster dose in children 
who had been vaccinated with MenACYW conjugate vaccine approximately 5 years earlier as 
toddlers as part of the MET51 study; it will describe the persistence of a priming dose in children 
and adolescents who had been vaccinated with MenACYW conjugate vaccine approximately 
5 years or 10 years earlier as toddlers as part of the MET51 study, the immunogenicity and safety 
of a booster dose in adolescents who had been primed with MenACYW conjugate vaccine as 
toddlers as part of the MET51 study, and the immunogenicity and safety of a second booster dose 
in adolescents approximately 5 years after a first booster dose as children approximately 5 years 
after the priming dose as toddlers. 
MET51 
MET51, entitled “Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal 
Conjugate Vaccine in Toddlers 12 to 23 Months of Age”, was a Phase III modified, double blind 
randomized, parallel group, active-controlled, multi-center study conducted in Spain, Hungary, 
Finland, and Germany. This study focused on evaluating the immunogenicity and safety profiles 
of a single dose of MenACYW conjugate vaccine compared to those of the licensed quadrivalent 
meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine (Nimenrix®) among 
toddlers 12 to 23 months of age in the EU who were either meningococcal vaccine naïve (Finland 
and Germany) or had received meningococcal C (MenC) vaccination (Spain and Hungary) during 
infancy. 

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A total of 918 participants 12 to 23 months of age were enrolled and randomly allocated to one of 
the following 4 groups: 
Meningococcal vaccine-naïve participants were randomized in a 1:1 ratio to the following 
2 groups: 
• Group 1: MenACYW conjugate vaccine (306 participants) 
• Group 2: Nimenrix vaccine (306 participants) 
MenC-primed participants were randomized in a 2:1 ratio to the following 2 groups: 
• Group 3: MenACYW conjugate vaccine (203 participants) 
• Group 4: Nimenrix vaccine (103 participants) 
All meningococcal vaccine-naïve participants (Groups 1 and 2) were enrolled in Finland 
(356 [38.8%] participants) and Germany (256 [27.9%] participants), and all MenC-primed 
participants (Groups 3 and 4) were enrolled in Hungary (145 [15.8%] participants) and Spain 
(161 [17.5%] participants). 
In MenC-primed toddlers vaccinated with MenACYW conjugate vaccine (Group 3), 151 (74.4%) 
and 52 (25.6%) participants were MenC-TT- and MenC-CRM-primed, respectively. In 
MenC-primed toddlers vaccinated with the Nimenrix vaccine (Group 4), 77 (74.8%) and 
26 (25.2%) participants were MenC-TT- and MenC-CRM-primed, respectively. 
Overall, vaccination with MenACYW conjugate vaccine among toddlers 12 to 23 months of age 
was found to be well-tolerated, with no safety concerns identified, no immediate hypersensitivity 
reactions, no discontinuations due to a serious adverse event (SAE) or other adverse event (AE), 
and no related SAEs. 
The 2 co-primary objectives were met: 
• Non-inferiority of immune response, based on percentage of participants achieving a 
post-vaccination titer ≥ 1:8 (seroprotection) at Day (D)30 regardless of their meningococcal 
vaccine background, was demonstrated for MenACYW conjugate vaccine versus Nimenrix 
vaccine for all serogroups 
• Non-inferiority of immune response, based on percentage of participants achieving a 
post-vaccination titer ≥ 1:8 (seroprotection) at D30 in meningococcal vaccine-naïve toddlers, 
was demonstrated for MenACYW conjugate vaccine versus Nimenrix vaccine for all 
serogroups 
As well as the secondary objectives and observational objectives:  
At D30, the percentage of participants with a seroresponse to serogroup C, based on serum 
bactericidal assay using human complement (hSBA), was higher in MenACYW conjugate 
vaccine recipients than in Nimenrix vaccine recipients. For the other serogroups, percentages were 
similar between MenACYW conjugate vaccine recipients and Nimenrix vaccine recipients. 

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Antibody Responses (hSBA Geometric Mean Titers [GMTs]) at D30 
Toddlers who either were meningococcal vaccine naïve or had received monovalent MenC 
vaccination during infancy 
The geometric mean titer ratios (GMTRs) (stratified on priming vaccination background) were 
7.59, 1.32, and 1.28 for serogroups C, W, and Y, respectively, with the lower bound of the 95% 
confidence interval (CI) greater than 1.0; and the GMTR (stratified on priming vaccination 
background) was 0.819 for serogroup A, with the upper bound of the 95% CI lower than 1.0.  
Meningococcal vaccine-naïve toddlers  
The GMTRs were 1.03 and 1.18 (with the lower bound of the 95% CI below 1.0) for serogroups 
A and Y, respectively, and 16.5 and 1.34 (with the lower bound of the 95% CI greater than 1.0) 
for serogroups C and W, respectively. 
Table 2.1 shows a comparison of the bactericidal antibody responses to MenACYW conjugate 
vaccine and Nimenrix vaccine 30 days after the vaccination of meningococcal vaccine naïve 
subjects only or combined (naïve + MenC-primed) subjects 12 through 23 months of age. 
Table 2.1: Comparison of bactericidal antibody responses to MenACYW conjugate vaccine 
and Nimenrix Vaccine Reported in MET51  
Endpoint by 
Serogroup 
MenACYW 
(95% CI) 
Naïve  
Nimenrix 
vaccine 
(95% CI) 
Naïve  
MenACYW 
(95% CI) 
Combined 
(Naïve + MenC 
Primed)  
Nimenrix 
vaccine 
(95% CI) 
Combined 
(Naïve + MenC 
Primed) 
A 
N=293 
N=295 
N=490 
N=393-394 
% ≥ 1:8 
(Seroprotection)** 
90.8 
(86.9; 93.8) 
89.5 
(85.4; 92.7) 
90.4 
(87.4; 92.9) 
91.6 
(88.4; 94.2) 
% Seroresponse 
76.8 
(71.5; 81.5) 
72.5 
(67.1; 77.6) 
76.5 
(72.5; 80.2) 
77.1 
(72.6; 81.2) 
hSBA GMT 
28.7  
(25.2; 32.6) 
28.0  
(24.4; 32.1)  
29.9 
(26.9; 33.2) 
34.5 
(30.5; 39.0) 
C 
N=293 
N=295 
N=489 
N=393-394 
% ≥ 1:8 
(Seroprotection)** 
99.3 
 (97.6; 99.9) 
81.4 
(76.4; 85.6) 
99.2 
(97.9; 99.8) 
85.5 
(81.7; 88.9) 
% Seroresponse 
98.3 
(96.1; 99.4) 
71.5 
(66.0; 76.6) 
97.1 
(95.2; 98.4) 
77.4 
(72.9; 81.4) 
hSBA GMT 
436 
(380; 500) 
26.4  
(22.5; 31.0) 
880 
(748; 1035) 
77.1 
(60.7; 98.0) 

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Endpoint by 
Serogroup 
MenACYW 
(95% CI) 
Naïve  
Nimenrix 
vaccine 
(95% CI) 
Naïve  
MenACYW 
(95% CI) 
Combined 
(Naïve + MenC 
Primed)  
Nimenrix 
vaccine 
(95% CI) 
Combined 
(Naïve + MenC 
Primed) 
W 
N=293 
N=296 
N=489 
N=393-394 
% ≥ 1:8 
(Seroprotection)** 
83.6 
(78.9; 87.7) 
83.4 
(78.7; 87.5) 
84.9 
(81.4; 87.9) 
84.0 
(80.0; 87.5) 
% Seroresponse 
67.6  
(61.9; 72.9) 
66.6  
(60.9; 71.9) 
70.8 
(66.5; 74.8) 
68.4 
(63.6; 73.0) 
hSBA GMT 
22.0 
(18.9; 25.5) 
16.4 
(14.4; 18.6) 
24.4 
(21.8; 27.5) 
17.7 
(15.8; 19.8) 
Y 
N=293 
N=296 
N=488-490 
N=394-395 
% ≥ 1:8 
(Seroprotection)** 
93.2 
(89.7; 95.8) 
91.6 
(87.8; 94.5) 
94.3 
(91.8; 96.2) 
91.6 
(88.5; 94.2) 
% Seroresponse 
81.9 
(77.0; 86.1) 
79.1  
(74.0; 83.5) 
84.8 
(81.3; 87.9) 
78.9 
(74.6; 82.9) 
hSBA GMT 
38.0 
(33.0; 43.9) 
32.2 
(28.0; 37.0) 
41.7 
(37.5; 46.5) 
31.9 
(28.4; 36.0) 
N: number of subjects in the per-protocol analysis set  
95% CI of the single proportion calculated from the exact binomial method. 
** Non-inferiority criterion met 
Toddlers who received monovalent MenC vaccination during infancy 
The GMTRs were 0.496 (with the upper bound of the 95% CI lower than 1.0) for serogroup A, 
1.34 and 1.29 (with the lower bound of the 95% CI below 1.0) for serogroups C and W, 
respectively, and 1.53 (with the lower bound of the 95% CI greater than 1.0) for serogroup Y. 
Response in toddlers previously vaccinated with MenC conjugate vaccines in their first year of 
life 
The majority of monovalent MenC-primed toddlers (12 to 23 months of age) in study MET51 
(NCT02955797) had hSBA titers ≥ 1:8 in the MenQuadfi group (N=198) (≥ 86.7%) and in 
MenACWY-TT group (N=99) (≥ 85.7%) at D30 post-vaccination. These toddlers received during 
their infancy MenC-TT or MenC-CRM vaccines. Post-vaccination seroprotection rates were 
comparable between MenQuadfi and MenACWY-TT for all serogroups regardless of the priming 
background. 
In MenC-CRM-primed toddlers, the GMTs for serogroup A were lower in the MenQuadfi group 
(n=49) than in the MenACWY-TT group (n=25) (12.0 [8.23; 17.5] vs 42.2 [25.9; 68.8]). After 
administration of MenQuadfi, seroprotection rates (hSBA titers ≥ 1:8) for toddlers primed with 
MenC-CRM were lower but still comparable for serogroups A, Y and W compared with those in 
the MenACWY-TT group (A: 68.8% [53.7; 81.3] vs 96.0% [79.6; 99.9]; Y: 95.8% [85.7; 99.5] vs 

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80.0% [59.3; 93.2]; W: 68.1% [52.9; 80.9] vs 79.2% [57.8; 92.9]). The rates for serogroup C were 
comparable in both groups (95.7% [85.5; 99.5] vs 92.0% [74.0; 99.0]). The clinical relevance of 
these results is unknown. This aspect might be considered for individuals at high risk for MenA 
infection who received MenC-CRM vaccine in their first year of life. 
Antibody Responses (serum bactericidal assay using baby rabbit complement [rSBA] GMTs and 
Titers ≥ 1:8) at D30 
Toddlers who either were meningococcal vaccine naïve or had received monovalent MenC 
vaccination during infancy 
At D30, meningococcal rSBA GMTs were lower in MenACYW recipients than in Nimenrix 
vaccine recipients for serogroup A (1382 and 4882, respectively), and higher in MenACYW 
recipients than in Nimenrix vaccine recipients for serogroup C (2150 and 686, respectively).  
Thirty days after vaccination, the percentages of participants with rSBA antibody titers ≥ 1:8 were 
high and comparable between MenACYW and Nimenrix vaccine recipients ranging from 97.3% 
to 100.0% for all serogroups. 
Other relevant Phase II and Phase III studies that concern the toddler populations are discussed 
below. 
MET62 
MET62 entitled, “Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal 
Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as 
Toddlers”, was a Phase III, open-label, multi-center trial to describe the immune persistence of the 
priming dose and describe the immunogenicity and safety of a booster dose of MenACYW 
conjugate vaccine in children 4 to 5 years of age in Finland who had been vaccinated 3 years 
earlier as toddlers with either MenACYW conjugate vaccine or Nimenrix vaccine as part of the 
MET54 clinical trial. MET54 was a Phase II randomized, open-label, active-controlled study 
conducted to describe the safety and immunogenicity of MenACYW conjugate vaccine compared 
to Nimenrix vaccine in meningococcal vaccine naïve toddlers 12 to 23 months of age. A total of 
188 participants were enrolled. 
A total of 91 participants were enrolled in the MET62 clinical trial. 
• Group 1 (MenACYW primed – MenACYW booster): 42 
• Group 2 (Nimenrix vaccine primed – MenACYW booster): 49 
Vaccination with MenACYW conjugate vaccine given as a booster in children vaccinated 3 years 
earlier with either MenACYW conjugate vaccine or Nimenrix vaccine was found to be 
well-tolerated with no safety concerns identified. The safety profile of a booster dose of 
MenACYW conjugate vaccine in MenACYW conjugate vaccine-primed participants was 
comparable to that in Nimenrix vaccine-primed participants. No SAEs, adverse events of special 
interest (AESIs) or cases of death were reported during the study. 

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Antibody Responses to Meningococcal Serogroups A, C, W, and Y at Baseline (D0) and D30 
Measured by rSBA 
rSBA GMTs 
Meningococcal rSBA GMTs were higher at D30 than at baseline for all 4 serogroups in both 
study groups. The rSBA GMT immune response in Group 1 was comparable for serogroups A, 
W, and Y (4240, 16103, and 5499, respectively) and higher for serogroup C (8629) compared to 
those in Group 2 (5702, 4871, 19793, and 7814, respectively for serogroups A, C, W, and Y). 
Proportion of Participants with rSBA Antibody Titers ≥ 1:8 and ≥ 1:128 30 Days After 
Vaccination 
All participants in both study groups had rSBA titers ≥ 1:8 at D30. For all serogroups, the 
percentages of participants were 100% for both study groups. 
All participants in both study groups had rSBA titers ≥ 1:128 at D30. For all serogroups, the 
percentages of participants were 100% for both study groups. 
Fold Rise in rSBA Antibody Titers 
Most participants in both study groups had a ≥ 4-fold rise in rSBA antibody titers at D30. The 
percentages of participants with a ≥ 4-fold rise in rSBA antibody titers 30 days after vaccination 
in Group 1 (92.3%, 94.9%, 100%, and 100%, respectively for serogroups A, C, W, and Y) were 
comparable to those in Group 2 (81.8%, 97.7%, 100%, and 100%, respectively for serogroups A, 
C, W, and Y). 
rSBA Vaccine Seroresponse 
Most participants in both study groups demonstrated an rSBA vaccine seroresponse at D30. The 
percentages of participants with an hSBA vaccine seroresponse were comparable in Group 1 
(ranging from 92.3% to 100%) to those in Group 2 (ranging from 81.8% to 100%). 
Overall, the MenACYW conjugate vaccine had comparable immune response in both study 
groups across all 4 serogroups. 
This provides evidence that the MenACYW conjugate vaccine can boost MenACYW conjugate 
vaccine-primed children as well as Nimenrix vaccine-primed children. 
In addition to the studies MET51 and MET62 described above, the relevant Phase III (MET35) 
study in children population (2 to 9 years of age) is discussed in the Investigator’s Brochure (IB) 
Section 5. 
Current Study MEQ00073 
The MET51 study enrollment period was February 2017 to September 2017. There is now the 
opportunity to generate persistence and booster data approximately 5 and 10 years after 
vaccination with MenACYW conjugate vaccine in toddlers. Therefore, this MEQ00073 study will 
provide longer persistence data than in the MET62 study, with a larger sample size. It also is 
intended to further confirm that the MenACYW conjugate vaccine can boost MenACYW 
conjugate vaccine-primed children and adolescents. The boostability of MenACYW conjugate 
vaccine in children who were MenACYW conjugate vaccine-primed as toddlers will be 
determined by sufficiency of the seroresponse measured using hSBA 30 days post-booster in 

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Group 1. With this amendment, the boostability of MenACYW conjugate vaccine will also be 
described in adolescents primed with MenACYW conjugate vaccine approximately 10 years 
earlier as toddlers (Group 2) and in adolescents boosted as children approximately 5 years earlier 
(after priming at toddler age [Group 1]). The persistence of the immune response against 
meningococcal serogroups A, C, W, and Y in adolescents approximately 10 years after the 
primary vaccination as toddlers (Group 2) and in adolescents approximately 5 years after a 
booster dose administered as children (approximately 5 years after priming at toddler age 
[Group 1]) will be described. 
MenC titers will also be described according to the priming status in infancy before receiving the 
toddler dose in MET51 study (meningococcal vaccine naïve or MenC-primed). 
2.2 
Background  
IMD is a serious illness caused by the bacterium Neisseria meningitidis (N meningitidis), a 
Gram-negative diplococcus found exclusively in humans. It is associated with high morbidity and 
mortality. Symptoms may include intense headache, fever, nausea, vomiting, photophobia, stiff 
neck, lethargy, myalgia, and a characteristic petechial rash (1). IMD usually results in septicemia 
(~35%–40% of cases), meningitis (~50% of cases), or both. Bacteremic pneumonia is less 
common (~9% of cases). At least 12 distinct meningococcal serogroups have been classified 
based on the immunochemistry of the capsular polysaccharides (PS). Some strains are more likely 
than others to cause infection (1) (2) (3). Worldwide, most cases of meningococcal disease are 
caused by serogroups A, B, C, X, Y, and W (2) (3) (4). Serogroup B is responsible for endemic 
disease and some outbreaks, while serogroup C is responsible for large outbreaks (5). Serogroup 
A is the main cause of epidemics in the world, and is especially dominant in Africa and Asia but 
is only minor in Europe. Serogroup W has been seen in Africa, as well as in the United Kingdom 
(UK) in residents who participated in the Hajj pilgrimage to the Kingdom of Saudi Arabia (4) (6) 
(7) and more recently in Chile (8), Turkey (9) (10), China (11) (12), Argentina (13), and Brazil 
(14) (15) and in other parts of the world. An increasing trend of the notification rate of 
serogroup W is seen in Europe. Serogroup X causes substantial meningococcal disease in parts of 
Africa but rarely causes disease in other parts of the world (2) (16). Serogroup Y has not been 
associated with outbreaks, but its frequency as a cause of sporadic cases has gradually increased 
in the US and more recently in Canada and Europe (17) (18) (19). This serogroup is commonly 
associated with meningococcal pneumonia, particularly in older adults > 65 years of age (20).  
The epidemiology of N meningitidis can be described as complex, unpredictable, geographically 
variable, and changing over time. Meningococcal disease occurs worldwide in both endemic and 
epidemic forms with seasonal variation.  
In Europe, the European Center for Disease Prevention and Control (ECDC) annually publishes 
an epidemiological report on IMD, based on data retrieved from the European Surveillance 
System (TESSy) which is used to collect, analyze, and disseminate data on communicable 
diseases. The last report has been published in April 2019, based on 2017 data. As per this report, 
in 2017, the overall notification rate of IMD in EU/European Economic Area (EEA) countries was 
0.6 per 100 000 population, similar to the notification rate for previous years. IMD remains rare in 
EU/EEA countries, but is a severe and life-threatening disease. The greatest burden is in infants 
and young children: case fatality is relatively high and up to one fifth of all survivors suffer from 

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long-term sequelae (21). There was a notification rate of 8.2 confirmed cases per 100 000 
population in children under 1 year of age, and 2.5 confirmed cases per 100 000 population in 
children 1 to 4 years of age. There was a second peak in people 15 to 24 years of age, with a rate 
of 1.0 per 100 000. Infants were the most affected age group in the majority of Member States, 
with county-specific rates varying from 0–36.2 cases per 100 000. 
In 2017, 3221 confirmed cases of IMD were reported in 30 EU/EEA countries. Four countries 
(France, Germany, Spain, and the UK) accounted for 58% of all confirmed cases. In the countries 
involved in the MEQ00073 study, the incidence per 100 000 was 0.3 in Finland and in Germany, 
0.4 in Hungary and 0.6 in Spain. 
The majority of IMD cases belonged to serogroup B (51%), followed by W and C (17% and 16%, 
respectively). Serogroup B caused the highest proportion of cases in all age groups below 65 years 
of age and accounted for 70% of IMD in children under the age of 5 years, but only 24% of cases 
concerned adults 65 years of age and above. Serogroup C was most prominent in adults 25 to 
49 years of age, accounting for 27% of cases in this age group. Serogroups W and Y were most 
prominent in adults 65 years of age and above, causing 30% and 26% of IMD cases, respectively, 
in this age group. Notifications of serogroup B decreased from 0.42 cases per 100 000 in 2013 to 
0.30 cases in 2017). The decrease was most pronounced in children, where rates diminished from 
10.4 to 5.4 per 100 000 in children < 1 year of age, and from 2.6 to 1.7 per 100 000 in children 1 
to 4 years of age, from 2013 to 2017. A 3-fold increase of serogroup W was observed between 
2013 and 2017 (from 0.03 to 0.10 per 100 000). The increase was most pronounced among young 
children and adults above 50 years of age. The incidence per 100 000 in 2013 and 2017 were 0.6 
and 1.2 in children < 1 year of age, 0.09 and 0.31 in children 1 to 4 years of age, 0.03 and 0.10 in 
adults 50 to 64 years of age and 0.06 and 0.20 in adults 65 years of age or above, respectively. 
The notification rates of serogroups C and Y have fluctuated between 0.08–0.10 and 0.05–0.07 
per 100 000 respectively during the last 5 years. 
In Europe, the incidence rate of IMD has remained stable over the last 5 to 10 years, with the 
highest peak occurring in the population less than 4 years of age and a smaller peak in the 15 to 
19 years of age group. The highest incidence rate in Europe is caused by serogroup B, followed by 
C and W (21). The highest proportion of meningococcal cases was due to serogroup B in the 
population under 5 years of age. The highest proportion of serogroup C cases was observed in the 
population 25 to 44 years of age while the proportion of serogroup Y cases was highest in the 
population 65 years of age and above. 
In this context of increasing trends for serogroups W and Y, several EU countries have introduced 
or consider to introduce the quadrivalent conjugate vaccine MenACYW into their routine 
vaccination schedules, predominantly as booster doses for adolescents, but also in some countries 
targeting toddlers, switching from MenC to MenACYW vaccination. The goal for MenACYW 
conjugate vaccine is to provide broad protection against IMD caused by serogroups A, C, Y, and 
W in all age groups: children as young as 6 weeks of age, adolescents, and adults including those 
56 years of age and older. 

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2.3 
Benefit/Risk Assessment  
More detailed information about the known and expected benefits and risks, reasonably expected 
AEs, the potential risks, and uncertainties of the MenACYW conjugate vaccine may be found in 
the IB, Participant Information Leaflet, Package Insert, or Summary of Product Characteristics 
(SmPC) (22). 
2.3.1 
Risks from Study Participation  
The potential risks of clinical significance and risk management are summarized in Table 2.2. 
Table 2.2: 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 
MenQuadfi 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 vaccine 
components, or history of a 
life-threatening reaction to the 
vaccines used in the study or 
to a vaccine containing any of 
the same substances. 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale 
for Risk 
Risk Management 
Guillain-Barré syndrome 
(GBS) 
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 (23) (24) (25). A 
review by the Institute of 
Medicine found inadequate 
evidence to accept or reject a 
causal relationship between 
tetanus toxoid-containing 
vaccines and GBS (26). 
No cases with MenACYW 
conjugate vaccine in the 
completed studies. 
Exclusion criteria: Personal 
history of GBS 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale 
for Risk 
Risk Management 
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). 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 (27). 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. 
No risk mitigation actions 

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Potential Risk of Clinical 
Significance 
Summary of Data/Rationale 
for Risk 
Risk Management 
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 (28). 
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 
conjugate vaccine in different age groups shows that the majority of subjects develop 
seroprotective levels of antibodies after vaccination. Participants may experience additional 
protection after administration of a booster dose(s) approximately 5 and/or 10 years after primary 
vaccination in the MET51 study. 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 
COVID-19 Risk Assessment  
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 expose to public area (eg, commute to the site and at the site). 

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Risk Mitigation: 
• 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) except for V1 (Group 1 and Group 2), V3 (Group 1), and V2 (Group 2) that must be 
conducted at the investigational site. 
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. 
Table 3.1: Objectives and endpoints  
Objectives 
Endpoints 
Primary 
 
• To demonstrate the vaccine 
seroresponse sufficiency of 
meningococcal serogroups A, C, W, 
and Y after the administration of a 
booster dose of MenACYW conjugate 
vaccine in children who received 1 dose 
of MenACYW conjugate vaccine 
approximately 5 years earlier as 
toddlers (Group 1)  
• Vaccine seroresponse1 against 
meningococcal serogroups A, C, W, and 
Y measured by hSBA assessed at Visit 
(V)1 (baseline) and at V2 (30 days after 
the administration of a booster dose of 
MenACYW conjugate vaccine) 
(Group 1) 
1 Seroresponse is defined as the proportions of 
participants with an hSBA pre-vaccination 
titer < 1:8 who achieved a post-vaccination 
titer ≥ 1:16 or participants with a pre-
vaccination titer ≥ 1:8 who achieved a post-
vaccination titer at least 4-fold greater than 
the pre-vaccination titer 

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Objectives 
Endpoints 
Secondary  
 
Immunogenicity 
• To describe the antibody persistence of 
meningococcal serogroups A, C, W, and 
Y in children who received MenACYW 
conjugate vaccine approximately 5 years 
earlier as toddlers (Groups 1 and 2) 
• To describe the antibody persistence of 
meningococcal serogroups A, C, W, and 
Y in adolescents who received 
MenACYW conjugate vaccine 
approximately 10 years earlier as 
toddlers (Group 2) 
• To describe the antibody persistence of 
meningococcal serogroups A, C, W, and 
Y in adolescents who received a booster 
as children approximately 5 years after 
the primary dose of MenACYW 
conjugate vaccine as toddlers (Group 1) 
• To describe the antibody responses to 
meningococcal serogroups A, C, W, and 
Y before and 30 days after the 
administration of a booster dose of 
MenACYW conjugate vaccine in 
children who received MenACYW 
conjugate vaccine approximately 
5  years earlier as toddlers (Group 1) 
• To describe the antibody responses to 
meningococcal serogroups A, C, W, and 
Y before and 30 days after the 
administration of a booster dose of 
MenACYW conjugate vaccine in 
adolescents who received MenACYW 
Immunogenicity 
• Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by 
hSBA and rSBA at V1 (baseline) for 
Group 1 and Group 2  
• Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by 
hSBA and rSBA at V2 (Group 2)  
• Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by 
SBA and rSBA at V3 (Group 1)  
• Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by 
hSBA and rSBA at V1 (baseline) and V2 
(30 days after the administration of a 
booster dose of MenACYW conjugate 
vaccine) (Group 1) 
• 
Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by 
hSBA and rSBA at V2 and V3 (30 days 
after the administration of a booster dose of 
MenACYW conjugate vaccine) (Group 2) 
• 
Antibody titers2 against meningococcal 
serogroups A, C, W, and Y measured by 
hSBA and rSBA at V3 and V4 (30 days 
after the administration of a booster dose of 
MenACYW conjugate vaccine) (Group 1) 
• Antibody concentrations against tetanus 
toxoid at V1 (baseline) and V2 (30 days 
after the administration of a 5-year booster 
dose of MenACYW conjugate vaccine) 
(Group 1) 

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Objectives 
Endpoints 
conjugate vaccine approximately 
10 years earlier as toddlers (Group 2) 
• To describe the antibody responses to 
meningococcal serogroups A, C, W, and 
Y before and 30 days after the 
administration of a booster dose of 
MenACYW conjugate vaccine in 
adolescents who received a booster as 
children approximately 5 years after the 
primary dose of MenACYW conjugate 
vaccine as toddlers (Group 1) 
• To describe the antibody responses to 
tetanus toxoid before and 30 days after 
the administration of each booster dose 
of MenACYW conjugate vaccine in 
children (Group 1) and adolescents 
(Group 2) who received MenACYW 
conjugate vaccine approximately 5 or 
10 years earlier as toddlers and in 
children who received a booster 
approximately 5 years after the primary 
dose of MenACYW conjugate vaccine 
as toddlers (Group 1)  
• To describe the antibody responses to 
meningococcal serogroup C before and 
30 days after the administration of a 
booster dose of MenACYW conjugate 
vaccine 
o In children who received 
MenACYW conjugate vaccine 
approximately 5  years earlier as 
meningococcal vaccine naïve 
toddlers (MET51 Group 1) 
(Group 1) 
o In children who received 
MenACYW conjugate vaccine 
approximately 5 years earlier as 
• Antibody concentrations against tetanus 
toxoid at V3 and V4 (30 days after 
administration of the second booster dose 
of MenACYW conjugate vaccine) 
(Group 1) 
• Antibody concentrations against tetanus 
toxoid at V2 and V3 (30 days after 
administration of a 10-year booster dose of 
MenACYW conjugate vaccine) (Group 2) 
• Antibody titers2 against meningococcal 
serogroup C measured by hSBA and rSBA 
at V1 (baseline) and V2 (30 days after the 
administration of a 5-year booster dose of 
MenACYW conjugate vaccine) (Group 1) 
• Antibody titers2 against meningococcal 
serogroup C measured by hSBA and rSBA 
at V3 and V4 (30 days after the 
administration of the second booster dose 
of MenACYW conjugate vaccine) 
(Group 1) 
• Antibody titers2 against meningococcal 
serogroup C measured by hSBA and rSBA 
at V2 and V3 (30 days after the 
administration of a 10-year booster dose of 
MenACYW conjugate vaccine) (Group 2) 
2 Results will be expressed as vaccine seroresponse, 
seorprotection, and GMTs 

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Objectives 
Endpoints 
meningococcal C (MenC)-primed 
toddlers (MET51 Group 3) 
(Group 1) 
o In adolescents who received 
MenACYW conjugate vaccine 
approximately 10  years earlier as 
meningococcal vaccine naïve 
toddlers (MET51 Group 1) 
(Group 2) 
o In adolescents who received 
MenACYW conjugate vaccine 
approximately 10 years earlier as 
MenC-primed toddlers (MET51 
Group 3) (Group 2) 
o In adolescents who received 
MenACYW conjugate vaccine 
booster as children approximately 
5 years after receiving the primary 
dose of MenACYW conjugate 
vaccine as meningococcal vaccine 
naïve toddlers (MET51 Group 1) 
(Group 1) 
o In adolescents who received 
MenACYW conjugate vaccine 
booster as children approximately 
5 years after receiving the primary 
dose of MenACYW conjugate 
vaccine as MenC-primed toddlers 
(MET51 Group 3) (Group 1) 
Safety 
To describe the safety profile of a booster 
dose of MenACYW conjugate vaccine: 
• in children who received MenACYW 
conjugate vaccine approximately 
Safety 
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 
5 years earlier as toddlers in MET51 
(Group 1)  
• in adolescents who received 
MenACYW conjugate vaccine 
approximately 10 years earlier as 
toddlers in MET51 (Group 2)  
• 
in adolescents who received a booster 
dose as children approximately 5 years 
after the primary dose of MenACYW 
conjugate vaccine as toddlers (Group 1) 
• Unsolicited systemic AEs reported within 
30 minutes after vaccination. 
• Solicited (prelisted in the participant’s diary 
card [DC] and [electronic] case report book 
[CRB]) injection site and systemic reactions 
starting any time from the day of vaccination 
through 7 days after vaccination. 
• Unsolicited (recorded in a DC) non-serious 
AEs reported within 30 days after 
vaccination(s).  
• SAEs (including AESIs) reported throughout 
the study  
4 
Study Design  
4.1 
Overall Design  
This is a Phase IIIb, open-label, multi-center study to evaluate the immunogenicity and safety of a 
booster dose and describe the immune persistence of a priming dose of MenACYW conjugate 
vaccine in children and adolescents in Finland, Germany, Spain, and Hungary who had been 
vaccinated with MenACYW conjugate vaccine approximately 5 or 10 years earlier as toddlers as 
part of the MET51 study, and to describe the immunogenicity and safety of a second booster dose 
and the persistence of a first booster dose of MenACYW conjugate vaccine in adolescents who 
had been vaccinated with MenACYW conjugate vaccine approximately 5 years earlier as 
children. 
Participants who were vaccinated with MenACYW conjugate vaccine approximately 5 years 
earlier at 12 to 23 months of age in study MET51 will be eligible for enrollment in study 
MEQ00073. Eligible participants will be stratified to 1 of 2 groups based on country and MenC 
status (primed [Hungary, Spain] or naïve [Finland, Germany]). Participants in Group 1 will 
receive a first booster dose of MenACYW conjugate vaccine on D01 (V1) (at child age 
approximately 5 years post priming dose as toddlers in study MET51) and a second booster dose 
of MenACYW conjugate vaccine at Year 5 of study MEQ00073 (at adolescent age approximately 
5 years post booster dose as children in study MEQ00073). Participants in Group 2 will receive a 
single booster dose of MenACYW conjugate vaccine at Year 5 of study MEQ00073 
(approximately 10 years post priming dose as toddlers in study MET51).  
All participants will provide blood samples (BL) for antibody persistence and immunogenicity 
assessments at V1 (pre-vaccination for Group 1 [D01]); participants in Group 1 will also provide a 

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BL at V2 (D31 +14 days), 30 days post-first booster vaccination. Participants in both groups will 
provide a BL at Year 5 (V3 for Group 1, V2 for Group 2) for antibody persistence and 
immunogenicity assessments prior to receiving a booster vaccination of MenACYW conjugate 
vaccine, and another BL 30 days post-booster vaccination (V4 for Group 1, V3 for Group 2). 
Solicited AE information will be collected for 7 days after each vaccination; unsolicited AE 
information will be collected for 30 days (+14 days) after each vaccination. Serious AE 
information (including AESIs) will be collected throughout the study period, however for Group 2 
before the first study intervention is administered at V2, only SAEs related to study procedures 
are to be collected. 
The design of the study is summarized in Table 4.1. 
Table 4.1: Overall design  
Type of design 
open-label, multi-center and multi-country 
Phase 
IIIb 
Control method 
uncontrolled 
Study population 
Healthy children approximately 6 to 7 years of age 
at the time of enrollment who were vaccinated with 
MenACYW conjugate vaccine approximately 
5 years earlier as toddlers (12 to 23 months of age) 
in the MET51 study (Group 1 [naïve] and Group 3 
[MenC-primed]) 
Level and method of blinding 
open-label 
Study intervention assignment method 
randomly selected 
Number of participants 
All available and eligible participants, who 
participated in and completed the MET51 study and 
received a single dose of MenACYW conjugate 
vaccine as a part of the study, can be enrolled. The 
total maximum number of children expected for 
enrollment is around 500 participants (MET51 
participants who received MenACYW conjugate 
vaccine approximately 5 years earlier), with 
approximately 250 participants each in Group 1 and 
Group 2 

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Intervention groups 
Participants in Group 1 will receive a dose of 
MenACYW conjugate vaccine at D01 (V1) and a 
dose of MenACYW conjugate vaccine at Year 5 
(V3). Participants in Group 2 will receive a single 
dose of MenACYW conjugate vaccine at Year 5 
(V2) 
Total duration of study participation 
The duration of each participant’s participation will 
be approximately 5.5 years 
Countries 
Finland, Germany, Hungary, Spain 
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 
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 and other countries, 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. The potential impact of concomitant 
administration of MenACYW conjugate vaccine with routine licensed vaccines in toddlers and 
adolescents and the suitability of MenACYW conjugate vaccine administered as a booster dose 
were assessed as well. 
At the time of initial licensure, limited data were available regarding booster vaccination. Primed 
subjects have only been included in 2 studies: study MET56 included adolescent and adult 
subjects (15 to 55 years of age) previously vaccinated with a meningococcal quadrivalent 
conjugate vaccine and study MET51 included toddlers who received a monovalent MenC 
vaccination during infancy. No data for MenQuadfi vaccine are available from MenC-primed 
adolescents or adults.  
Results are presented in the IB and MenQuadfi SmPC. 
No data were available for MenQuadfi vaccine to boost itself. 

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Therefore, long-term persistence of immunogenicity beyond 30 days as well as the ability of 
MenQuadfi vaccine to boost itself were to be further investigated. 
To assess the long-term immunogenicity of priming dose and safety and immunogenicity of 
booster in individuals primed with the MenACYW conjugate vaccine, the following studies have 
been conducted or are ongoing: 
• Study MET62, an immunogenicity and safety study of a booster dose of MenACYW 
conjugate vaccine assessed antibody persistence in children 3 years after prior receipt of 
MenACYW conjugate vaccine as toddlers in study MET54. 
The results are presented in the IB and in this protocol. 
• Study MET59, an immunogenicity and safety study of a booster dose of MenACYW 
conjugate vaccine that also assessed antibody persistence in adolescents and adults 3 to 
6 years after prior receipt of MenACYW conjugate vaccine in study MET50. Individuals 
≥ 13 to < 26 years of age at enrollment in MET59 study.  
• Study MEQ00066, an immunogenicity and safety study of a booster dose of MenACYW 
conjugate vaccine that will also assess antibody persistence in older adults and elderly 3 to 
7 years after prior receipt of MenACYW conjugate vaccine in studies MET44 and MET49. 
This study is ongoing in the US. 
In Europe, a lifelong approach for meningococcal prevention with, in addition to the toddler and 
adolescent vaccination, a MenACYW preschool booster dose is recommended by some scientific 
societies as presented in the Calendario per la Vita developed conjointly by the Società Italiana di 
Pediatria, the Societa Italianadi Igiene, the Federazione Italiana Medici Pediatri, and the 
Federazione Italina Medici di Famiglia (29). It is already implemented in Italy, in the Tuscany 
region, with a booster dose given at 6-9 years of age (30). 
In this context, generating boostability data approximately 5 and 10 years after a toddler dose, as 
well as immune persistence is of interest for Health Authorities.  
The MEQ00073 study will evaluate the boostability of MenACYW conjugate vaccine in 
MenACYW conjugate vaccine-primed participants, and will provide longer persistence data than 
in the MET62 study, with a larger sample size (refer to Section 2.1). 
MenACYW conjugate vaccine has been developed using titers measured by hSBA for the primary 
endpoints; titers measured by rSBA were also used as secondary endpoints in a subset of 
participants. Therefore, similar assays will be used in this study. The boostability will be 
determined by sufficiency for the primary objective of the study in children (who received 1 dose 
of MenACYW conjugate vaccine approximately 5 years earlier as toddlers) with the seroresponse 
measured using hSBA 30 days post booster dose administration in Group 1.  
Since MenACYW conjugate vaccine has been evaluated in infants, toddlers, and adults without 
raising any safety concerns, safety assessment will be done up to 30 days after vaccination. 
4.3 
Justification for Dose  
Participants in Group 1 will receive a first booster dose of MenACYW conjugate vaccine on D01 
(V1) (at child age approximately 5 years post priming dose as toddlers in MET51) and a second 

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booster dose of MenACYW conjugate vaccine at Year 5 (V3) (at adolescent age approximately 
5 years post booster dose as children in study MEQ00073). Participants in Group 2 will receive a 
single booster dose of MenACYW conjugate vaccine at Year 5 (V2) (approximately 10 years post 
priming dose as toddlers in study MET51) 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. 
There are no screening criteria other than the inclusion and exclusion criteria. 
5.1 
Inclusion Criteria  
Participants are eligible for the study only if all of the following criteria are met: 
I01: 
Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the 
study (attended V2) 
I02: 
Assent form (AF) has been signed and dated by the participant (if applicable) and 
informed consent form (ICF) has been signed and dated by the parent(s) or another 
legally acceptable representative (LAR) and by an independent witness, if required by 
local regulations 
I03: 
Participant and parent/LAR are able to attend all scheduled visits and to comply with 
all trial procedures 
I04: 
Covered by health insurance, if required by local regulations 
5.2 
Exclusion Criteria  
Participants are not eligible for the study if any of the following criteria are met: 
E01: 
Participation at the time of study enrollment (or in the 4 weeks preceding the trial 
vaccination) or planned participation during the present trial period in another clinical 
trial investigating a vaccine, drug, medical device, or medical procedure 
E02: 
Previous vaccination against meningococcal disease with either the trial vaccine or 
another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal 

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vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC 
vaccination received during infancy (MET51 Group 3), of the single dose of 
meningococcal vaccine administered as part of study MET51 (Groups 1 and 3) and of 
Meningococcal B vaccine 
E03: 
Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned 
receipt of any vaccine in the 4 weeks following trial vaccination except for influenza 
vaccination, which may be received at least 2 weeks before or after study vaccines. 
This exception includes monovalent pandemic influenza vaccines and multivalent 
influenza vaccines 
E04: 
Receipt of immune globulins, blood or blood-derived products in the past 3 months 
E05: 
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) 
E06: 
History of meningococcal infection, confirmed either clinically, serologically, or 
microbiologically 
E07: 
At high risk for meningococcal infection during the trial (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) 
E08: 
Personal history of GBS 
E09: 
Personal history of an Arthus-like reaction after vaccination with a tetanus 
toxoid-containing vaccine 
E10: 
Known systemic hypersensitivity to any of the vaccine components, or history of a 
life-threatening reaction to the vaccines used in the trial or to a vaccine containing any 
of the same substancesa 
E11: 
Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, 
contraindicating IM vaccination 
E12: 
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 
contraindicating IM vaccination 
E13: 
Deprived of freedom by an administrative or court order, or in an emergency setting, 
or hospitalized involuntarily 
E14: 
Chronic illnessb that, in the opinion of the Investigator, is at a stage where it might 
interfere with trial conduct or completion 
E15: 
Moderate or severe acute illness/infection (according to Investigator judgment) on the 
day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant 
                                                 
a The components of the MenACYW conjugate vaccine are listed in Section 6.1 and in the IB. 
b Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, 
diabetes, psychomotor diseases, and known congenital or genetic diseases. 

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should not be included in the study until the condition has resolved or the febrile event 
has subsided 
E16: 
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood 
draw 
E17: 
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 may contact this 
physician (with the parent’s/LAR’s consent) to inform him/her of the participant’s participation in 
the study. In addition, the site could 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 
subsequent vaccinations are required. 
5.4 
Screen Failures  
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently enrolled. Screening information is recorded in the source documents. 
Individuals who do not meet the criteria for participation in this study (screen failure) can be 
rescreened when the condition excluding them from participation is resolved (eg, fever, antibiotics 
received within 72 hours, etc). 
6 
Study Intervention  
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: routine vaccines administered outside of study protocol are 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 (MenQuadfi®): 
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 Strengths 
Each dose of MenACYW conjugate vaccine contains the 
following components: 
Meningococcal capsular polysaccharides: 
• Serogroup A1: 10 µg 
• Serogroup C1: 10 µg 
• Serogroup W1: 10 µg 
• Serogroup Y1: 10 µg 
1 Conjugated to Tetanus toxoid protein carrier: 55 µg2 
2 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 
IM injection 
Site of Administration 
Deltoid muscle in the upper arm for children 3-17 years of 
age 
Sourcing 
Provided by the Sponsor  

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Packaging and Labeling 
MenACYW conjugate vaccine (single-dose vial) will be 
supplied as an individual commercial box without 
repackaging. There will be no overlabel for primary 
packaging and a multilingual booklet label with clear tape 
on the outer box will be added. See the Operating 
Guidelines for additional label detail. 
Current/Former Name or Alias Brand name: MenQuadfi® 
Batch Number 
TBD 
IMP: Investigational Medicinal Product; NIMP: Non-Investigational Medicinal Product; TBD: to be determined 
6.2 
Preparation/Handling/Storage/Accountability  
MenACYW conjugate vaccine is supplied in single-dose (0.5 mL) vials. 
It will be administered intramuscularly in the deltoid muscle of arm.  
The site of injection should be prepared with a suitable antiseptic. After administration of the 
vaccine, the used syringe and needles will be disposed of in accordance with currently established 
guidelines.  
Prior to administration, all study products must be inspected visually for cracks, broken seals, 
correct label content, and extraneous particulate matter and/or discoloration, whenever solution 
and container permit. If any of these conditions exist, the vaccine must not be administered. A 
replacement dose is to be used, and the event is to be reported to the Sponsor. The rubber stopper 
should not be removed from any of the vaccine vials. 
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. 

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6.3 
Measures to Minimize Bias: Randomization and Blinding  
6.3.1 
Randomization and Allocation Procedures  
At V1, participants will be randomly selected with a balanced distribution between Groups 1 and 
2 using SAS® software, Version 9.4 or above (SAS Institute, Cary, North Carolina, USA) to 
receive the same vaccine (MenACYW conjugate vaccine) at different timepoints. 
Participant numbers will consist of a 12-digit string (a 3-digit country identifier, a 4-digit 
study center identifier, and a 5-digit participant identifier). The 5-digit participant identified will 
correspond to the chronological order of enrollment in the center. For example, 
Subject 246000100005 is the fifth subject enrolled in Center Number 1 in Finland (246 being the 
country code for Finland). 
Participant numbers should not be reassigned for any reason. 
The Biostatistics platform of the Sponsor will generate a list of participants randomly selected 
(1 per site).  
6.3.2 
Blinding and Code-breaking Procedures  
This is an open-label study.  
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 noncompliance is documented so that it can be accounted for in the data 
analyses: 
• All vaccinations 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 
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 CRB 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 (Category 1, 2, and 3) will be collected in the source document from the 
day of first vaccination to the end of the study and in the CRB as per the instructions given below 
for each category.  

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Reportable medications include medications that impact or may impact the consistency of the safety 
information collected after vaccination and/or the immune response to vaccination. Three standard 
categories of 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 steroids (inhaled, optic, ophthalmic, nasal, etc.) should not be captured or 
reported. 
Category 1 medications will be reported in the CRB from the day of each vaccination to the 
end of the solicited and unsolicited follow-up period after each vaccination. 
• 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 within 14 days pre or post each trial vaccination, 
including the day of the study vaccination visit and up to the last blood draw. 
• 
Any vaccine other than study vaccines (vaccines non-described in the Protocol) 
within the 28 days (4 weeks) preceding or after the trial vaccination, including the 
day of the study vaccination visit and up to the last blood draw. 
• 
Immune globulins, blood or blood-derived products: used in the 3 months preceding 
each blood draw between BL1 to BL2 and BL3 to BL4 (Group 1) or between BL2 to 
BL3 (Group 2). 
• 
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, 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 between BL1 to BL2 and BL3 to 
BL4 (Group 1) and between BL2 to BL3 (Group 2). 
Category 2 medications will be reported in the CRB according to the collection period detailed 
above. 
• Category 3: systemic (oral or injectable) antibiotics, received within 72 hours preceding each 
visit for blood draw related to IMP assessment (meningococcal vaccines) 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. 

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The information reported in the CRB 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 
Dosage and administration route, homeopathic medication, topical and inhaled steroids, as well as 
topical, ophthalmic, and ear treatments will not be recorded. Topical analgesics should not be 
applied at the site of vaccination; however, if they are applied inadvertently to the vaccination site, 
they should be recorded as a Category 1 medication in this specific instance. 
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 
CRB only. No details will be recorded in the concomitant medication CRB unless the medication(s) 
received belongs to one of the pre-listed categories. Medications will not be coded. 
6.5.1 
Rescue Medicine  
Appropriate medical equipment and emergency medications, including epinephrine (1:1000), 
must be available on site in the event of an anaphylactic, vasovagal, or other immediate allergic 
reaction. 
6.6 
Dose Modification  
Not applicable. 
6.7 
Intervention After the End of the Study  
Not applicable. 
                                                 
a Medication prescribed for preventing AE occurrence (eg, paracetamol to reduce the risk of fever) 

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7 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal  
7.1 
Discontinuation of Study Intervention  
7.1.1 
Temporary Contraindications for Vaccination  
Should a participant experience one of the conditions listed below, the Investigator will postpone 
further vaccination until the condition is resolved. Postponement must still be within the 
timeframe for vaccination indicated in the SoA. 
TCI01: 
Febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) or moderate or severe acute illness 
/ infection on the day of vaccination, according to Investigator judgment  
TCI02: 
Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned 
receipt of any vaccine in the 4 weeks following trial vaccination except for influenza 
vaccination, which may be received at least 2 weeks before or after study vaccines. 
This exception includes monovalent pandemic influenza vaccines and multivalent 
influenza vaccines 
TCI03: 
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood draw 
TCI04: 
Receipt of immune globulins, blood or blood-derived products in the past 3 months 
7.1.2 
Temporary Contraindications for Blood Sample  
Should a participant receive oral or injectable antibiotic therapy within 3 days (72 hours) prior to a 
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 
the appropriate timeframe, the blood sample should be collected without postponement, and it 
should be documented appropriately that the sample was taken less than 3 days after stopping 
antibiotic treatment. 
7.1.3 
Definitive Contraindication  
Participants will permanently discontinue (definitive discontinuation) study intervention for the 
reasons listed below. These participants must not receive any additional dose of study intervention 
but should continue to be followed for safety and immunogenicity. Additional unscheduled visits 
may be performed for safety reasons and information will be reported in the source documents.  
Should a participant experience at least one of the conditions listed below, the Investigator will 
discontinue vaccination: 
DCI01: 
Pregnancy, as indicated by a positive urine test  
DCI02: 
An anaphylactic or other significant allergic reaction to the previous dose of vaccine 

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DCI03: 
SAE assessed as related to the study vaccine following the previous dose of vaccine, 
based on Investigator’s judgment. 
DCI04: 
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding vaccination. 
DCI05: 
Receipt of immune globulins, blood or blood-derived products in the 3 months 
preceding vaccination 
DCI06: 
Previous vaccination against meningococcal disease with either the trial vaccine or 
another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal 
vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC 
vaccination received during infancy (MET51 Group 3), of the single dose of 
meningococcal vaccine administered as part of study MET51 (Groups 1 and 3) and of 
Meningococcal B vaccine 
DCI07: 
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 3 months 
preceding vaccination) 
DCI08: 
New history of meningococcal infection, confirmed either clinically, serologically, or 
microbiologically 
DCI09: 
At high risk for meningococcal infection during the trial (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) 
DCI10: 
New personal history of GBS 
DCI11: 
New personal history of an Arthus-like reaction after vaccination with a tetanus 
toxoid-containing vaccine 
DCI12: 
Known systemic hypersensitivity to any of the vaccine components, or history of a 
life-threatening reaction to the vaccines used in the trial or to a vaccine containing any 
of the same substancesa 
DCI13: 
Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, 
contraindicating IM vaccination 
DCI14: 
Chronic illnessb that, in the opinion of the Investigator, is at a stage where it might 
interfere with trial conduct or completion 
In the event of a local or national immunization program with any other vaccine as needed, 
participants who receive such a vaccine at any time during the study will not be withdrawn from 
the study. 
                                                 
a The components of the MenACYW conjugate vaccine are listed in Section 6.1 and in the IB. 
b Chronic illness may include, but is not limited to, cardiac disorders, renal disorders, auto-immune disorders, 
diabetes, psychomotor diseases, and known congenital or genetic diseases. 

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7.2 
Participant Discontinuation/Withdrawal from the Study  
• 
Parents/LARs 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, compliance, 
or administrative reasons. This is expected to be uncommon. 
• 
The reason for withdrawal should be clearly documented in the source documents and in the 
CRB: Adverse Event, Lost to Follow-up, Protocol Deviation, or Withdrawal by Participant or 
Parent/LAR. 
• 
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 samples taken and 
not tested, 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: 
• 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), or at least to determine his/her health status while fully respecting his/her rights. 
These contact attempts should be documented in the participant’s medical record. 
• Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 

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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. 
• 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 
• Exceptional situations (eg, COVID-19) may prevent access to the clinical trial sites. In these 
situations, site visits may be replaced by home visits where blood draw, physical examination 
and safety assessments will be performed by home nurses except for V1 (Group 1 and 
Group 2), V3 (Group 1), and V2 (Group 2), which will be conducted at the investigational 
site. 
Blood samples will be collected as described in the SoA tables (Section 1.3). At V1 for all 
participants, 5 mL of blood will be collected in tubes provided by or recommended by the 
Sponsor. At V2, only participants in Group 1 who received study vaccination at V1 will provide a 
5 mL blood sample. All participants are required to provide a blood sample at the Year 5 visit (V3 
for Group 1, and V2 for Group 2) prior to receiving vaccination, and another blood sample 
30 days post vaccination (V4 for Group 1 and V3 for Group 2). 
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. 
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) and the baby rabbit 
complement (rSBA). The results will be expressed as vaccine seroresponse, seroprotection, and 
GMTs. 

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Antibodies to Meningococcal Antigens (hSBA Method) 
Functional meningococcal antibody activity against serogroups A, C, Y, and W will be measured 
in a serum bactericidal assay utilizing human complement. 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. 
The hSBA testing will be performed at 
 
  
Antibodies to Meningococcal Antigens (rSBA Method) 
Functional meningococcal antibody activity against serogroups A, C, Y, and W will be measured 
in a SBA using a rabbit complement. Two-fold dilutions of test sera are prepared in sterile 96-well 
microtiter plates. Serogroup-specific meningococcal bacteria along with baby rabbit complement 
are added to the serum dilutions and allowed to incubate. After this incubation period, 10 µL of 
the serum/complement/bacteria mixture is removed and added to a blood agar plate using the tilt 
method, and then incubated overnight at 37°C with 5% CO2. Bacterial colonies present on the 
blood agar plate are then counted. The bactericidal titer of each sample is expressed as the final 
reciprocal dilution yielding ≥ 50% killing as compared to the T60 (average number of bacteria in 
each control well after incubation) colony-forming unit (CFU). To report a titer greater than 1:4, 
clear bactericidal activity must be noted and the next dilution must have a CFU count less than the 
calculated 20% T60. The LLOQ of the rSBA assay is a titer of 1:4.  
The rSBA testing will be performed at 
 
 
Antibody concentrations against tetanus toxoid contained in MenACYW conjugate vaccine as a 
carrier protein will be determined in children who received MenACYW conjugate vaccine 
approximately 5 or 10 years earlier as toddlers. The results will be expressed as percentage of 
participants with antibody concentrations to tetanus toxoid ≥ 0.01 international units (IU)/mL and 
≥ 0.1 IU/mL, and geometric mean concentrations (GMCs). 
Tetanus (diphtheria, tetanus, pertussis multiplexed electrochemiluminescent [DTP-ECL] assay) 
Anti-tetanus antibodies will be measured by DTP-ECL assay, a multiplexed serological assay 
which allows for the simultaneous quantification of human antibodies to 6 specific antigens 
including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous 
haemagglutinin, fimbriae and pertactin. 
In this assay, each well of a 96-well microtiter plate is pre-coated in precise positions with the 
6 different antigens in a multi-spot fashion. Following incubation with serum samples, antigen 
specific antibodies bind to the respective antigens. The captured antibodies are then detected using 
a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate. Electrical stimulation of the 
conjugate in the presence of a chemiluminescent substrate results in the generation of a light 
signal from each specific spot that is captured by a camera in relative light units. The signal 

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generated is directly proportional to the amount of antibodies present in the sample, which is 
quantified using software and based on an established reference standard sample curve. For this 
study, only tetanus results will be calculated. 
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 at V1 (Groups 1 and 2) and before administration of the booster vaccination at 
V2 (Group 2) / V3 (Group 1), 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 CRB. The significant medical history section of 
the CRB 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. 
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  
A physical examination as per standard of care (physical examination, including, but not limited 
to, general examination of the main body systems of interest [heart, lungs, skin, neurologic, 
muscular-skeletal, lymphatic system, etc]) will be performed at V1 for both groups, and at V2 
(Group 2) / V3 (Group 1) by the Investigator or a delegate. 
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. 

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8.2.3 
Vital Signs  
Oral, rectal, or axillary route (axillary preferred) pre-vaccination temperature using a certified 
standard digital thermometer will be systematically collected by the Investigator on the source 
document (including the route of measurement). Other types of thermometer (tympanic scan, 
temporal artery scan and infrared skin scan) are not allowed. 
8.3 
Adverse Events and Serious Adverse Events  
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/parents/LARs 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). 
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. 
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 
CRB, 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. 
The intensity grading scale for unsolicited non-serious AEs is presented in Appendix 10.2.5.1.2. 
Adverse Events of Special Interest 
AESIs will be collected throughout the study. 
See Section 8.3.6 for the list of AESIs. 
Serious Adverse Events 
Information on SAEs will be collected and assessed throughout the study for both groups. 
However, for Group 2 before the first study intervention administration at V2, only SAEs related 
to study procedures (eg, blood sampling) are to be collected. 

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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 CRB. 
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 AE or SAE 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’ parents/LARs 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’ parents/LARs 
will also be provided with rulers for measuring the size of injection site reactions, and with 
certified standard digital thermometers for measuring daily temperatures. To ensure consistency 
of reporting, the study sites will instruct participants’ parents/LARs on how to correctly use these 
tools. 
At specified intervals, the Investigator or an authorized designee will interview the participants’ 
parents/LARs 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 authorized designee using a web-based CRB. 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 participants’ parents/LARs is the preferred method to 
inquire about AE occurrences. 
8.3.3 
Follow-up of Adverse Events and Serious Adverse Events  
Unless a participants’ parents/LARs refuses further contact, each participant who experiences an 
AE (whether serious or non-serious) during the study must be followed until the condition 
resolves, becomes stable, or becomes chronic (even after the end of the participant’s participation 
in the study) if either of the following is true: 
• The AE is considered by the Investigator to be related to the study intervention administered. 
• The AE caused the discontinuation of the participant from the study or from vaccination. 

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The Investigator will inform the Sponsor of the date of final disappearance of the event or the date 
of “chronicity” establishment. 
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. 
• For all studies except those investigating medical devices, 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. 
• An Investigator who receives an Investigator safety report describing an 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. 
8.3.5 
Pregnancy  
Pregnancy and/or the absence of the use of effective contraceptive methods, if required, will 
exclude vaccination at V3 (Group 1) / V2 (Group 2). However, a participant could potentially 
become pregnant during her participation.  
Urine pregnancy testing will be performed, as applicable, before the V2 (Group 2) / V3 (Group 1) 
vaccination. 
Details of all pregnancies in female participants will be collected after the start of study 
intervention and until delivery, and recorded in the Pregnancy CRF. 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 [6 to 
8 weeks] beyond the estimated delivery date, but will be in accordance with local regulations. 

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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 discontinue 
study intervention until delivery or until delivery and end of lactation. However, the participant 
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) (31) 
• Kawasaki disease (32) (33) (34) 
• GBS (35) 
• Idiopathic thrombocytopenic purpura (ITP) (36) 
These events have been listed as AESIs based on the feedback received from the EU 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 
described in Appendix 10.2.4. Further instructions on the data collection for these events and the 
relevant definitions will be provided in the CRB Completion Instructions. 
8.4 
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 

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8.5 
Pharmacokinetics  
Pharmacokinetics parameters are not evaluated in this study. 
8.6 
Pharmacodynamics  
Pharmacodynamic parameters are not evaluated in this study. 
8.7 
Genetics  
Genetics are not evaluated in this study. 
8.8 
Biomarkers  
No other biomarkers than those described in the immunogenicity assessments section 
(Section 8.1.2) are evaluated in this study. 
8.9 
Immunogenicity Assessments  
See Section 8.1.2. 
8.10 Medical Resource Utilization and Health Economics  
Medical Resource Utilization and Health Economics parameters are not evaluated in this study. 
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  
Primary objective 
Thirty days after the administration of MenACYW conjugate vaccine at V1, the sufficiency of the 
percentages of participants in Group 1 who achieve an hSBA vaccine seroresponse for 
meningococcal serogroups A, C, W, and Y will be tested.  
Details on statistical methods are provided in Section 9.4. 

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Secondary objectives 
Immunogenicity: No hypotheses will be tested. The analyses will be descriptive. 
Safety: The main parameters for the safety endpoints will be described by 95% CIs (based on the 
Clopper-Pearson method). 
9.2 
Sample Size Determination  
All available and eligible participants, who participated in and completed the MET51 study 
(Groups 1 and 3) and received MenACYW conjugate vaccine as a part of the study, can be 
enrolled (approximately 500 participants), with approximately 250 participants each in 
MEQ00073 Group 1 and Group 2 (maximum estimate). 
A sample size of 84 achieves at least 90.0% power to detect that the lower bound of the 1-sided 
97.5% CI is greater than 0.75 (proportion under the null hypothesis) for the vaccine seroresponse 
to each serogroup using a 1-sided exact test with a significance level (alpha) of 0.025. 
Table 9.1: Power of the study based on the primary objective  
Antigen 
Endpoint 
Estimates* for 
MenACYW 
Power (%) 
A 
Seroresponse 
0.95 
> 99.9 
C 
Seroresponse 
0.90 
92.6 
Y 
Seroresponse 
0.95 
> 99.9 
W 
Seroresponse 
0.925 
99.0 
Global Power 
 
 
> 90 
*Estimated responses are based on the results of MET62 Group 1 that received 1 dose of MenACYW conjugate vaccine (estimates 
of MET62 minus 5%). 

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9.3 
Populations for Analyses  
The following populations are defined: 
Population 
Description 
Safety Analysis Set 
(SafAS) 
• SafAS 1: Participants who have received the study vaccine 
5 years after priming vaccination (at V1) and have any safety 
data available (Group 1).  
• SafAS 2: Participants who have received the study vaccine 
10 years after priming vaccination at V3 (Group 1) / V2 
(Group 2) and have any safety data available.  
All participants will have their safety analyzed according to the 
vaccine they actually received. 
Safety data recorded for a vaccine received out of the protocol 
design will be excluded from the analysis (and listed separately). 
Full analysis set (FAS) 
The FAS will be duplicated for each FAS defined below: 1 each 
for hSBA and rSBA measurements. 
• FAS1: Subset of participants who received the study vaccine 
and had a valid post-vaccination serology result 5 years after 
priming vaccination at V1 (Group 1). Participants will be 
analyzed according to the intervention they received. 
• FAS2: Subset of participants who received the study vaccine 
and had a valid post-vaccination serology result 10 years after 
priming vaccination at V3 (Group 1) / V2 (Group 2). 
Participants will be analyzed according to the intervention 
they received. 
• FAS3: For persistence includes participants who have a valid 
serology result for at least 1 serogroup from a pre-vaccination 
blood sample (5-year antibody persistence, Group 1 and 
Group 2) 
• FAS4: For persistence includes participants who have a valid 
serology result for at least 1 serogroup from a pre-vaccination 
blood sample (10-year antibody persistence, Group 1 and 
Group 2) 
PPAS 
The PPAS will be duplicated for each PPAS defined below: 
1 each for hSBA and rSBA measurements. 
The PPAS is a subset of the FAS. PPAS1 and PPAS2 will be 
defined: PPAS1 for Group 1 V1, and PPAS2 for Group 1 and 
Group 2 V3 and V2, respectively. Participants presenting with at 

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least 1 of the following relevant protocol deviations will be 
excluded from the PPAS1 or PPAS2 as applicable. 
• Participant did not meet all protocol-specified inclusion 
criteria or met at least one of the protocol-specified exclusion 
criteria 
• Participant did not receive vaccine 
• Participant received a vaccine other than MenACYW 
conjugate vaccine  
• Preparation and/or administration of vaccine was not done as 
per-protocol 
• Participant did not receive vaccine in the proper time window 
• Participant did not provide post-dose serology sample in the 
proper time window or a post-dose serology sample was not 
drawn 
• Participant received a protocol-prohibited Category 2 or 
Category 3 therapy/medication/vaccine  
• Participant’s serology sample did not produce a valid test 
result (ie, results for all meningococcal antigens are missing) 
• Participant had other protocol deviations that affected the 
participant’s immune response, as determined by the clinical 
team before locking the database  
• Participant’s serology sample did not produce a valid test 
result (ie, results for all meningococcal antigens are missing) 
• Participant had other protocol deviations that affected the 
participant’s immune response, as determined by the clinical 
team before locking the database  
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 described in this section. This section is a summary of the 
planned statistical analyses of the most important endpoints including primary and key secondary 
endpoints. 
9.4.1 
General Considerations  
All immunogenicity analyses will be performed on the PPAS and on the FAS. All safety analyses 
will be performed on the SafAS. 

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9.4.2 
Primary Endpoint  
Thirty days after the administration of the MenACYW conjugate vaccine (approximately 5 years 
after priming as toddlers), the sufficiency of the percentages of participants in Group 1 who 
achieve an hSBA vaccine seroresponse (see definition below) for meningococcal serogroups A, C, 
W, and Y will be tested.  
Seroresponse will be considered sufficient if lower limit of the 1-sided 97.5% CI calculated using 
the Exact method (Clopper-Pearson method) for percentage of participants with hSBA 
seroresponse against serogroups A, C, W and Y is greater than 75%. 
This is equivalent to testing H0: p ≤ 0.75 against H1: p > 0.75, where p is the observed proportion 
of subjects with hSBA seroresponse against serogroups A, C, W and Y. The CI for the single 
proportion will be calculated using the exact method (Clopper-Pearson method). 
Note: hSBA vaccine seroresponse for serogroups A, C, W, and Y is defined as: 
• For a subject with a pre-vaccination titer < 1:8, the post-vaccination titer must be ≥ 1:16 
• For a subject with a pre-vaccination titer ≥ 1:8, the post-vaccination titer must be at least 
4-fold greater than the pre-vaccination titer 
9.4.3 
Secondary Endpoints  
9.4.3.1 
Immunogenicity  
All analyses for the secondary endpoints will be descriptive; no hypotheses will be tested. 
Descriptive statistics will be provided for the hSBA and rSBA antibody titers against 
meningococcal serogroups (A, C, W, and Y) and for antibody concentrations against tetanus 
toxoid contained in MenACYW conjugate vaccine as a carrier protein. The results will be 
expressed as vaccine seroresponse, seroprotection, and GMTs. 
In general, categorical variables will be summarized and presented by frequency counts,  
proportion 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. For GMTs, 95% CIs of point estimates will be calculated using normal 
approximation assuming they are log-normally distributed. 
Reverse cumulative distribution curve (RCDC) figures will be provided for the antibody titers 
against meningococcal serogroups and the antibody concentrations against tetanus toxoid 
contained in MenACYW conjugate vaccine. 
In summary, descriptive analyses of antibody responses to A, C, W, and Y serogroups for Group 1 
(at V1 [baseline], V2 [30 days after the administration of a booster dose of MenACYW conjugate 
vaccine], and at V3 before the administration of a booster dose), V4 (30 days after the 
administration of a booster dose of MenACYW conjugate vaccine), and for Group 2 at V2 before 
the administration of a booster dose of MenACYW conjugate vaccine and at V3 (30 days after the 
administration of a booster dose of MenACYW conjugate vaccine) will include but not be limited 
to: 
• hSBA and rSBA seroprotection rate (titer ≥ 1:8) and 95% CI 

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• hSBA and rSBA GMTs and 95% CI 
• hSBA and rSBA titer distribution and RCDC 
• Percentage of participants with hSBA titer ≥ 1:4 and ≥ 1:8 and 95% CI 
• Percentage of participants with rSBA titer ≥ 1:8 and ≥ 1:128 and 95% CI 
• Percentage of participants with hSBA and rSBA titer ≥4-fold rise from pre-vaccination to 
post-vaccination, and 95% CI 
• Percentage of participants with hSBA and rSBA vaccine seroresponse rate and 95% CI 
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 
rSBA vaccine seroresponse is defined as: 
• 
A post-vaccination rSBA titer ≥ 1:32 for participants with pre-vaccination rSBA titer 
< 1:8, or  
• 
A post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with 
pre-vaccination rSBA titer ≥ 1:8 
The hSBA and rSBA antibody titers against serogroup C will also be described for Group 1 at V1 
(baseline) and V2 (30 days after the administration of a 5-year booster dose of MenACYW 
conjugate vaccine, and at V3 and V4 (30 days after administration of the second booster dose of 
MenACYW conjugate vaccine), and for Group 2 at V2 and V3 (30 days after administration of a 
10-year booster dose of MenACYW conjugate vaccine) according to the priming status in infancy 
before receiving the toddler dose in MET51 study (meningococcal vaccine naïve or MenC-
primed). 
In addition, descriptive analyses on anti-tetanus antibody concentrations for Group 1 at V1 
(baseline) and V2 (30 days after the administration of a 5-year booster dose of MenACYW 
conjugate vaccine, and at V3 and V4 (30 days after administration of the second booster dose of 
MenACYW conjugate vaccine, and for Group 2 at V2 and V3 (30 days after administration of a 
10-year booster dose of MenACYW conjugate vaccine) will include but not be limited to: 
• GMCs and 95% CI 
• The percentage of participants with antibody concentrations to tetanus toxoid ≥ 0.01 IU/mL 
and ≥ 0.1 IU/mL and 95% CI 
Data from MET51 and MEQ00073 will also be combined and paired to evaluate antibody 
persistence and overall trends over 5 and 10 years. 

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9.4.3.2 
Safety  
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. 
9.4.4 
Other Safety Analyses  
Not applicable. 
9.4.5 
Other Analyses  
Not applicable. 
9.5 
Interim Analyses  
This study will not include an early safety data review. However, participant safety will be 
continuously monitored by the Sponsor’s internal safety review committee which includes safety 
signal detection at any time during the study. 
This study will include an interim analysis. A first statistical analysis of the immunogenicity and 
safety data collected up to V2 (Day 31) (Group 1) and V1 (Group 2), 5 years after priming dose in 
the MET51 study, will be performed once data are available and an interim database lock has been 
conducted. A final report will be prepared at the end of the entire study period.  
9.6 
Data Monitoring Committee (DMC)  
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 CRB in order to comply with the Clinical Data Interchange Standards Consortium 
(CDISC) requirements. 

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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]). 
• The protocol, protocol amendments, ICF, AF (if applicable), 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. 
• 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 

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• 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), and all other applicable local regulations. 
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 
and his/her parent/LAR and answer all questions regarding the study. 
• Participants and their parents/LARs must be informed that their participation is voluntary. 
Participant’s parents/LAR 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. 
• An AF will be signed and dated by the participant (if applicable) at enrollment (V1) and again 
after 5 years (V3 for Group 1 / V2 for Group 2) if required by local regulation. This form is to 
be used in addition to, not in place of, the ICF that is signed by the participant’s parents/LARs. 
• ICF may have to be signed and dated by an independent witness, if required by local 
regulations. 
• The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date the written consent was obtained. 
The authorized person obtaining the informed consent must also sign the ICF and AF (if 
applicable). 
• The actual ICF and 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 and AF provided by the Sponsor. Any change to the content of the ICF and 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 and 
participant’s parents’/LARs’ 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 an addendum to the original ICF and via a revised AF or an addendum to the original 
AF (if applicable). 
• Participants and their parents/LARs must be re-consented to the most current version of the 
ICF and AF during their participation in the study. 
• A copy of the ICF and AF must be provided to the participants and their parents/LARs. 

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• The ICF will contain a specific section, if applicable, that addresses the use of remaining 
mandatory samples for optional exploratory research. The Investigator or authorized designee 
will explain to each participant and their parent/LAR the objectives of the exploratory 
research. Participants and their parents/LARs will be told that they are free to refuse to 
participate and may withdraw their consent at any time and for any reason during the storage 
period. 
Rationale for Including Participants Unable to Give Consent: 
MEQ00073 is a study to be conducted in children approximately 6 to 7 years of age at enrollment 
(V1) and adolescents approximately 11 to 12 years of age at V2 (Group 2) or V3 (Group 1) to 
obtain immunogenicity and safety data in participants who were vaccinated with the MenACYW 
conjugate vaccine approximately 5 or 10 years earlier as toddlers (12 to 23 months of age) in the 
MET51 study (Group 1 and Group 3) and participants vaccinated with a booster dose of 
MenACYW conjugate vaccine approximately 5 years earlier as children in MEQ00073 study 
(Group 1). 
Since these participants are unable to give their consent, written informed consent must be 
obtained from the parent or LAR 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/LAR in accordance with local practices. The parent/LAR should be able to consent for 
their child. The child of minor parents must not be included in the study. 
The participants will be asked to date and sign an AF (if applicable). 
Recruitment Procedures 
Before the start of the trial, the Investigator or sub-investigator may contact the parents/LARs of 
an appropriate pool of potential participants (Group 1 and Group 3 of study MET51) and invite 
them to participate in the trial. The site will ensure that any advertisements used to recruit 
participants (eg, letters, pamphlets, posters) are submitted to Sanofi Pasteur before submission to 
the IEC/IRB for approval. 
As this is a multi-center, multi-country study, the recruitment procedures will be described in a 
separate “Recruitment and consent process form” in each site. In such a case, the form will be 
archived on-site. 
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 (General 
Data Protection Regulation). The study Sponsor is the Sanofi company responsible for ensuring 
compliance with this matter, when processing data from any individual who may be included in 
the Sanofi databases, including Investigators, nurses, experts, service providers, Ethics Committee 
members, etc.  
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 
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Protection of participant data 
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’ race and ethnicity will be collected in this study because these characteristics 
may influence the immune response to the vaccine. 
• Participants will be assigned a unique identifier by the Sponsor. Any participant records or 
datasets that are transferred to the Sponsor will contain the identifier only; participant names 
or any information which would make the participant identifiable will not be transferred to the 
Sponsor. 
• The participant’s parent/LAR must be informed that the participant’s personal study-related 
data will be used by the Sponsor in accordance with local data protection law. The level of 
disclosure must also be explained to the participant/parent/LAR as described in the informed 
consent. 
• The participant’s parent/LAR 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. 
• The participant’s parent/LAR must be informed that their study-related data will be used for 
the whole “drug development program”, ie, for this trial as well as for the following steps 
necessary for the development of the investigational product, including to support negotiations 
with payers and publication of results.  
Protection of data related to professionals involved in the study  
• Personal data (eg, contact details, affiliation(s) details, job title and related professional 
information, role in the study, professional resume, training records) are necessary to allow 
Sanofi to manage involvement in the study and/or the related contractual or pre-contractual 
relationship. They may be communicated to any company of the Sanofi group (“Sanofi”) or to 
Sanofi service providers, where needed. 
• Personal data can be processed for other studies and projects.  
• In case of refusal to the processing of personal data by or on behalf of Sanofi, it will be 
impossible to involve the professionals in any Sanofi study. In case the professionals have 
already been involved in a Sanofi study, they will not be able to object to the processing of 
their personal data as long as they are required to be processed by applicable regulations. The 
same rule applies in case the professionals are listed on a regulatory agencies disqualification 
list. 
• Personal data can be communicated to the following recipients:  
• Personnel within Sanofi or partners or service providers involved in the study  
• Judicial, administrative and regulatory authorities, in order to comply with legal or 
regulatory requirements and/or to respond to specific requests or orders in the 

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framework of judicial or administrative procedures. Contact details and identity may 
also be published on public websites in the interest of scientific research transparency 
• Personal data may be transferred towards entities located outside the Economic European 
Area, in countries where the legislation does not necessarily offer the same level of data 
protection or in countries not recognized by the European Commission as offering an adequate 
level of protection. Those transfers are safeguarded by Sanofi in accordance with the 
requirement of European law including, notably:  
• The standard contractual clauses of the European Commission for transfers towards 
our partners and service providers, 
• Sanofi’s Binding Corporate Rules for intra-group transfers.  
• Professionals have the possibility to lodge a complaint with Sanofi leading Supervisory 
Authority, the “Commission Nationale de l’Informatique et des Libertés” (CNIL) or with any 
competent local regulatory authority. 
• Personal data of professionals will be retained by Sanofi for up to thirty (30) years, unless 
further retention is required by applicable regulations. 
• In order to facilitate the maintenance of Investigators personal data, especially if they 
contribute to studies sponsored by several pharmaceuticals companies, Sanofi participates in 
the Shared Investigator Platform (SIP) and in the Transcelerate Investigator Registry (IR) 
project (https://transceleratebiopharmainc.com/initiatives/investigator-registry/). Therefore, 
personal data will be securely shared by Sanofi with other pharmaceutical company members 
of the Transcelerate project. This sharing allows Investigators to keep their data up-to-date 
once for all across pharmaceutical companies participating in the project, with the right to 
object to the transfer of the data to the Transcelerate project.  
• Professionals have the right to object to the processing, to request for access to and the 
rectification of their personal data, as well as their erasure (where applicable) by contacting 
the Sanofi Data Protection Officer: Sanofi DPO - 54 rue La Boétie - 75008 PARIS - France (to 
contact Sanofi by email, visit https://www.sanofi.com/en/our-responsibility/sanofi-global-
privacy-policy/contact). 
  
10.1.5 Committees Structure  
There will be no DMC. This study will not include an early safety data review. However, 
participant safety will be continuously monitored by the Sponsor’s internal safety review 
committee which includes safety signal detection at any time during the study. 
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 

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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 CRB 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 CRB. 
• The Investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRB. 
• 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 CRB 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. 
• 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 

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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/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 CRB 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. 
The study start date is considered the date of the first visit planned in the SoA of the first 
participant. 
The Sponsor 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 recruitment of participants by the Investigator. 
• Discontinuation of further study intervention development. 
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 

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Investigator shall promptly inform the participant/parent/LAR 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. 
10.2 Appendix: 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 patient or 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 drug-drug 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. 

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• 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. 
 
Other Definitions 
Adverse Reaction: 
All noxious and unintended responses to a study intervention related to any dose should be 
considered adverse reactions (AR). 
(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) that occur within the first 30 
minutes after vaccination. 
Injection Site Reaction/Administration Site Reactions: 
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 AEs are all AEs 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 vaccination 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. 

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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 CRB. 
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. 
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 CRB in terms of diagnosis and/or onset window post-vaccination. For 
example, varicella or a solicited term such as headache starting after the solicited observation 
period (headache starting on D10 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 CRB as a 
solicited reaction). 
An unsolicited AR is an unsolicited AE that is considered related to study intervention. 
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). 
A Serious Adverse Event is defined as any untoward medical occurrence 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 detained (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. 

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d. Results in persistent 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 
f. 
Other important medical event 
• Medical or scientific judgment should be exercised in deciding whether expedited reporting 
is appropriate in other situations such as important medical events that may not be 
immediately life-threatening or result in death or hospitalization but 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, GBS and ITP (Section 8.3.6). 
• 
Examples of such events are intensive treatment in an emergency room or at home for 
allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, 
or development of drug dependency or drug 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 CRB. 
• 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 CRB 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. 

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• 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 (whether 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. 
• 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 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 an 
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 is evidence or arguments to suggest a 
causal relationship. 
                                                 
a Study intervention administered can correspond to either the investigational product or other products when no 
investigational product is administered at the visit 

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• 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 make 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 a 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. 
 
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 CRB. 
• 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. 

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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) in order 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 Book 
• The SAE paper CRB can be sent to the Sponsor by one of the following means: 
• By fax, to the following number: (570) 957 - 2782 
• In PDF format to the following e-mail address, using a method of transmission that 
includes password protection: PV.outsourcing@sanofipasteur.com.  
• 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 
 
Safety Emergency Call 
If, as per the Investigator's judgment, a participant experiences a medical emergency, the 
Investigator may contact the Sponsor's Responsible Medical Officer (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. 

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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 Adverse Reaction Intensity Grading Scale  
 

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Table 10.1: Solicited injection site reactions: terminology, definitions, and intensity scales – Children at V2 (Group 1)  
CRB term 
(MedDRA lowest 
level term [LLT]) 
Injection site pain 
Injection site erythema 
Injection site swelling  
DC 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* 
CRB: 
Grade 1: Easily tolerated 
Grade 2: Sufficiently discomforting to interfere with 
normal behavior or activities 
Grade 3: Incapacitating, unable to perform usual 
activities 
DC: 
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 
Abbreviations: DC, diary card; MedDRA, Medical Dictionary for Regulatory Activities 
* For the subjective reaction of pain, participants or parents/LARs will record the intensity level (Grade 1, 2, or 3) in the DC. For the measurable reactions of redness and swelling, they will record just the size 
of the reaction, and the classification as Grade 1, 2, or 3 will be assigned at the time of the statistical analysis. 
Note: This table is to be used for Group 1 at V2. 
 
 

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Table 10.2: Solicited injection site reactions: terminology, definitions, and intensity scales – Adolescents and adults aged ≥ 10 years at V4 
(Group 1) and V3 (Group 2)  
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 activity 
Grade 2: Some interference with activity 
Grade 3: Significant; prevents daily activity 
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. 
Note: This table is to be used for Group 1 at V4 and for Group 2 at V3. 
 
 

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Important notes for the accurate assessment of temperature: 
Participants or parents/LARs 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 CRB. The preferred route for this study is axillary 
(rectal or oral may be also used). A certified standard digital thermometer should be used. Other 
types of thermometer (tympanic scan, temporal artery scan and infrared skin scan) are not 
allowed. 
10.2.5.1.2 Unsolicited Adverse Event 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 Appendix 10.2.5.1.1). 
All other unsolicited AEs will be classified according to the following intensity scale: 
• Grade 1 
• CRB: A type of AE 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 activity. 
• Grade 2 
• CRB: A type of AE 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 activity. 
• Grade 3 
• CRB: A type of AE that interrupts usual activities of daily living, or significantly affects 
clinical status, or may require intensive therapeutic intervention. 
• DC: Significant; prevents daily activity. 
10.3 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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10.4 Appendix: Abbreviations  
AE 
 
adverse event 
AESI  
adverse event of special interest 
AF 
 
assent form 
AR 
 
adverse reaction 
BL 
 
blood sample 
CDISC 
Clinical Data Interchange Standards Consortium  
CFU  
colony-forming unit  
CI 
 
confidence interval 
CIOMS 
Council for International Organizations of Medical Sciences 
CO2 
 
carbon dioxide 
CRB  
case report book 
CRO  
Contract Research Organization 
D 
 
Day 
DC 
 
diary card 
DMC  
Data Monitoring Committee 
DNA  
deoxyribonucleic acid 
DTP-ECL 
diphtheria, tetanus, pertussis multiplexed electrochemiluminescent 
ECG  
electrocardiogram 
ECDC  
European Center for Disease Prevention and Control  
EEA  
European Economic Area  
EU 
 
European Union 
FAS 
 
Full Analysis Set 
FDA  
Food and Drug Administration 
GBS  
Guillain-Barré syndrome 
 
 
 
GCP  
Good Clinical Practice 
GDPR  
General Data Protection Regulation 
GMC  
geometric mean concentration 
GMT  
geometric mean titer 
GMTR 
geometric mean titer ratio 

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GPV  
Global Pharmacovigilance 
HIPAA 
Health Insurance Portability and Accountability Act 
HPV  
human papillomavirus 
hSBA  
serum bactericidal assay using human complement  
IB 
 
Investigator’s Brochure 
ICF 
 
informed consent form 
ICH 
 
International Council for Harmonisation 
IEC 
 
Independent Ethics Committee 
Ig 
 
immunoglobulin 
IM 
 
intramuscular 
IMD  
invasive meningococcal disease  
IMP 
 
investigational medicinal product 
IRB 
 
Institutional Review Board 
ITP 
 
idiopathic thrombocytopenic purpura 
IU 
 
international unit 
LAR  
legally acceptable representative  
LLOQ  
lower limit of quantification  
LLT 
 
lowest level term 
MCV4-CRM meningococcal conjugate vaccine quadrivalent 
MedDRA 
Medical Dictionary for Regulatory Activities 
MenC  
meningococcal C 
NIMP  
non-investigational medicinal product 
NSAID 
non-steroidal anti-inflammatory drug 
PPAS  
Per-protocol Analysis Set 
PS 
 
polysaccharide 
RCDC  
Reverse cumulative distribution curve 
RMO  
Responsible Medical Officer 
rSBA  
serum bactericidal assay using baby rabbit complement 
SAE  
serious adverse event 
SafAS  
Safety Analysis Set 
SAP 
 
statistical analysis plan 
SmPC  
Summary of Product Characteristics 

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SoA 
 
schedule of activities 
SUSAR 
suspected unexpected serious adverse reaction 
TBD  
to be determined 
TC 
 
telephone call 
Tdap  
tetanus, diphtheria, and acellular pertussis 
TESSy  
The European Surveillance System 
 
 

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11 Reference List  
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Harrison LH, Trotter CL, Ramsay ME. Global epidemiology of meningococcal disease. 
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Harrison OB, Claus H, Jiang Y, Bennett JS, Bratcher HB, Jolley KA, et al. Description and 
nomenclature of Neisseria meningitidis capsule locus. Emerg Infect Dis. 2013;19(4):566-73. 
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Pollard AJ. Global epidemiology of meningococcal disease and vaccine efficacy. Pediatr 
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Ceyhan M, Yildirim I, Balmer P, Borrow R, Dikici B, Turgut M, et al. A prospective study 
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Kilic A, Urwin R, Li H, Saracli MA, Stratton CW, Tang YW. Clonal spread of serogroup 
W135 meningococcal disease in Turkey. J Clin Microbiol. 2006;44(1):222-4. 
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W135, China. Emerg Infect Dis. 2010;16;348-9. 
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Barroso DE, Rebelo MC. Recognition of the epidemiological significance of Neisseria 
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Boisier P, Nicolas P, Djibo S, Taha MK, Jeanne I, Maïnassara HB, et al. Meningococcal 
meningitis: unprecedented incidence of serogroup X-related cases in Niger. Clin Infect Dis 
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Bröker M, Jacobsson S, Kuusi M, Pace D, Simões MJ, Skoczynska A, et al. Meningococcal 
serogroup Y emergence in Europe: update 2011. Hum Vaccin Immunother. 
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European Medicines Agency. MenQuadfi Summary of product characteristics. 2020. 
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information/menquadfi-epar-product-information_en.pdf. Accessed 01 February 2021. 
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Velentgas P, Amato AA, Bohn RL, Chan KA, Cochrane T, Funch DP, et al. Risk of 
Guillain-Barre syndrome after meningococcal conjugate vaccination. Pharmacoepidemiol 
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Yih WK, Weintraub E, Kulldorff M. No risk of Guillain-Barre syndrome found after 
meningococcal conjugate vaccination in two large cohort studies. Pharmacoepidemiol Drug 
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Update: Guillain-Barre syndrome among recipients of Menactra meningococcal conjugate 
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Medicine Io. 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. 
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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. 
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Centers for Disease Control and Prevention. Syncope after vaccination--United States, 
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Società Italiana di Pediatria, Societa Italianadi Igiene, Federazione Italiana Medici Pediatri, 
Federazione Italina Medici di Famiglia. Calendario per la Vita. 4 EDIZIONE 2019. 
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http://www301.regione.toscana.it/bancadati/atti/Contenuto.xml?id=5208701&nomeFile=De
libera_n.193_del_18-02-2019-Allegato-A. Accessed 02 December 2020.  
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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. 
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Newburger JW, Takahashi M, Gerber MA, Gewitz MH, Tani LY, Burns JC, et al. 
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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. 
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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. 
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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. 
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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. 
                                                                                                                                                                          

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12 Sponsor Signature Page  
 
 
 

Signature Page for VV-CLIN-0605405 v2.0
VV-TMF-1720568 MEQ00073 protocol v1.0
Approve & eSign
VV-CLIN-0605405 2.0