Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Phase: PHASE3
Conditions: Healthy Volunteers (Meningococcal Infection)
Sponsor: Sanofi Pasteur, a Sanofi Company

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine 
Protocol Version 4.0 
Confidential/Proprietary Information 
Page 1 of 121 
Immunogenicity and Safety Study of an Investigational Quadrivalent 
Meningococcal Conjugate Vaccine Administered Concomitantly with Routine 
Pediatric Vaccines in Healthy Infants and Toddlers 
Phase III, modified double-blind, randomized, parallel group, active-controlled, multi-center 
study to compare the immunogenicity of MenACYW conjugate vaccine with that of 
MENVEO®, describe the immunogenicity of MenACYW conjugate vaccine and Menactra®, and 
describe the safety of MenACYW conjugate vaccine, MENVEO®, and Menactra® when 
administered in a 1 + 1 schedule concomitantly with routine pediatric vaccines to healthy 
infants and toddlers in the United States 
Clinical Study Protocol Amendment 2 
Health Authority File Number: 
BB-IND #:  14171 
WHO Universal Trial Number (UTN): U1111-1205-2836 
Study Code: 
MET61 
Development Phase: 
Phase III 
Sponsor: 
Sanofi Pasteur Inc. 
Discovery Drive, Swiftwater, PA 18370-0187, USA 
Investigational Product: 
MenACYW Conjugate Vaccine: Meningococcal Polysaccharide 
(Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine 
Form / Route: 
Liquid Solution / Intramuscular 
Indication For This Study: 
MenACYW conjugate vaccine administered as a 2-dose series to healthy 
infants and toddlers 
Manufacturer: 
Same as Sponsor 
Coordinating Investigator: 
Sponsor’s Responsible Medical 
Officer: 
Pharmacovigilance Global Safety 
Officer: 
Clinical Study Manager: 
Version and Date of the Protocol: 
Version 4.0 dated 12 May 2022 
Information contained in this publication is the property of Sanofi Pasteur and is confidential. This information may not be 
disclosed to third parties without written authorization from Sanofi Pasteur. This document may not be reproduced, stored in a 
retrieval system, or transmitted in any form or by any means–electronic, mechanical recording, or otherwise–without prior 
authorization from Sanofi Pasteur. This document must be returned to Sanofi Pasteur upon request. 
NCT03691610

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine 
Protocol Version 4.0 
Confidential/Proprietary Information 
Page 2 of 121 
History of Protocol Versions 
Version* 
Date 
Comments 
1.0 
31 May 2018 
Version not submitted to the IEC/IRB 
2.0 
06 June 2018 
Original study protocol (first version used in the 
study) 
3.0 
04 March 2021 
Protocol Amendment 1 
*Version in bold font have been approved by the Independent Ethics Committee(s) (IEC[s]) / Institutional Review
Board(s) (IRB[s]) and used in the study.

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 3 of 121 
Table of Contents  
History of Protocol Versions ........................................................................................................... 2 
List of Tables .................................................................................................................................... 9 
Synopsis .......................................................................................................................................... 10 
Table of Study Procedures – Group 1 and Group 2 ................................................................... 26 
Table of Study Procedures – Group 3 and Group 4 ................................................................... 29 
List of Abbreviations ..................................................................................................................... 31 
1 
Introduction ..................................................................................................................... 34 
1.1 
Background ..................................................................................................................... 34 
1.2 
Background of the Investigational Product ..................................................................... 35 
1.2.1 
Clinical .......................................................................................................................... 35 
1.2.1.1 
Study MET39 (Phase II) ............................................................................................ 36 
1.2.1.2 
Study MET54 (Phase II) ............................................................................................ 37 
1.3 
Potential Benefits and Risks ........................................................................................... 38 
1.3.1 
Potential Benefits to Subjects ....................................................................................... 38 
1.3.2 
Potential Risks to Subjects ........................................................................................... 38 
1.4 
Rationale for the Study ................................................................................................... 39 
2 
Study Objectives .............................................................................................................. 41 
2.1 
Primary Objective ........................................................................................................... 41 
2.2 
Secondary Objectives ...................................................................................................... 41 
2.3 
Observational Objectives ................................................................................................ 41 
3 
Investigators and Study Organization ........................................................................... 42 
4 
Independent Ethics Committee / Institutional Review Board .................................... 42 
5 
Investigational Plan ......................................................................................................... 43 
5.1 
Description of the Overall Study Design and Plan ......................................................... 43 
5.1.1 
Study Design ................................................................................................................. 43 
5.1.2 
Justification of the Study Design .................................................................................. 45 
5.1.3 
Study Plan ..................................................................................................................... 46 
5.1.4 
Visit Procedures ............................................................................................................ 48 
5.1.4.1 
Visit Procedures for Group 1 and Group 2 ................................................................ 48 
5.1.4.2 
Visit Procedures for Group 3 and Group 4 ................................................................ 53 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 4 of 121 
5.1.5 
Planned Study Calendar ................................................................................................ 57 
5.2 
Enrollment and Retention of Study Population .............................................................. 57 
5.2.1 
Recruitment Procedures ................................................................................................ 57 
5.2.2 
Informed Consent Procedures ...................................................................................... 57 
5.2.3 
Screening Criteria ......................................................................................................... 58 
5.2.4 
Inclusion Criteria .......................................................................................................... 58 
5.2.5 
Exclusion Criteria ......................................................................................................... 58 
5.2.6 
Medical History ............................................................................................................ 60 
5.2.7 
Contraindications for Subsequent Vaccinations ........................................................... 61 
5.2.7.1 
Temporary Contraindications ..................................................................................... 61 
5.2.7.2 
Definitive Contraindications ...................................................................................... 62 
5.2.7.3 
Warnings and Precautions to Vaccination ................................................................. 63 
5.2.8 
Conditions for Withdrawal ........................................................................................... 63 
5.2.9 
Lost to Follow-up Procedures ....................................................................................... 64 
5.2.10 
Classification of Subjects Who Discontinue the Study ................................................ 64 
5.2.11 
Follow-up of Discontinuations ..................................................................................... 65 
5.3 
Safety Emergency Call ................................................................................................... 65 
5.4 
Modification of the Study and Protocol .......................................................................... 65 
5.5 
Interruption of the Study ................................................................................................. 66 
6 
Vaccines Administered ................................................................................................... 66 
6.1 
Identity of the Investigational Products .......................................................................... 66 
6.1.1 
Identity of Study Products ............................................................................................ 66 
6.1.1.1 
Composition ............................................................................................................... 67 
6.1.1.2 
Preparation and Administration ................................................................................. 67 
6.1.1.3 
Dose Selection and Timing ........................................................................................ 67 
6.1.2 
Identity of Control Product 1 ........................................................................................ 68 
6.1.2.1 
Composition ............................................................................................................... 68 
6.1.2.2 
Preparation and Administration ................................................................................. 68 
6.1.2.3 
Dose Selection and Timing ........................................................................................ 68 
6.1.3 
Identity of Control Product 2 ........................................................................................ 68 
6.1.3.1 
Composition ............................................................................................................... 69 
6.1.3.2 
Preparation and Administration ................................................................................. 69 
6.2 
Identity of Other Products ............................................................................................... 69 
6.2.1 
Identity of Other Product 1 ........................................................................................... 69 
6.2.1.1 
Composition ............................................................................................................... 70 
6.2.1.2 
Preparation and Administration ................................................................................. 70 
6.2.1.3 
Dose Selection and Timing ........................................................................................ 70 
6.2.2 
Identity of Other Product 2 ........................................................................................... 71 
6.2.2.1 
Composition ............................................................................................................... 71 
6.2.2.2 
Preparation and Administration ................................................................................. 71 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 5 of 121 
6.2.2.3 
Dose Selection and Timing ........................................................................................ 72 
6.2.3 
Identity of Other Product 3 ........................................................................................... 72 
6.2.3.1 
Composition ............................................................................................................... 72 
6.2.3.2 
Preparation and Administration ................................................................................. 73 
6.2.3.3 
Dose Selection and Timing ........................................................................................ 73 
6.2.4 
Identity of Other Product 4 ........................................................................................... 74 
6.2.4.1 
Composition ............................................................................................................... 74 
6.2.4.2 
Preparation and Administration ................................................................................. 74 
6.2.4.3 
Dose Selection and Timing ........................................................................................ 74 
6.2.5 
Identity of Other Product 5 ........................................................................................... 74 
6.2.5.1 
Composition ............................................................................................................... 75 
6.2.5.2 
Preparation and Administration ................................................................................. 75 
6.2.5.3 
Dose Selection and Timing ........................................................................................ 75 
6.2.6 
Identity of Other Product 6 ........................................................................................... 75 
6.2.6.1 
Composition ............................................................................................................... 76 
6.2.6.2 
Preparation and Administration ................................................................................. 76 
6.2.6.3 
Dose Selection and Timing ........................................................................................ 76 
6.2.7 
Identity of Other Product 7 ........................................................................................... 76 
6.2.7.1 
Composition ............................................................................................................... 77 
6.2.7.2 
Preparation and Administration ................................................................................. 77 
6.2.7.3 
Dose Selection and Timing ........................................................................................ 77 
6.2.8 
Identity of Other Product 8 ........................................................................................... 77 
6.2.8.1 
Composition ............................................................................................................... 78 
6.2.8.2 
Preparation and Administration ................................................................................. 78 
6.2.8.3 
Dose Selection and Timing ........................................................................................ 78 
6.3 
Product Logistics ............................................................................................................ 78 
6.3.1 
Labeling and Packaging ................................................................................................ 79 
6.3.2 
Product Shipment, Storage, and Accountability ........................................................... 79 
6.3.2.1 
Product Shipment ....................................................................................................... 79 
6.3.2.2 
Product Storage .......................................................................................................... 79 
6.3.2.3 
Product Accountability ............................................................................................... 80 
6.3.3 
Replacement Doses ....................................................................................................... 80 
6.3.4 
Disposal of Unused Products ........................................................................................ 80 
6.3.5 
Recall of Products ......................................................................................................... 80 
6.4 
Blinding and Code-breaking Procedures ........................................................................ 80 
6.5 
Randomization and Allocation Procedures ..................................................................... 81 
6.6 
Treatment Compliance .................................................................................................... 82 
6.7 
Concomitant Medications and Other Therapies.............................................................. 82 
7 
Management of Samples ................................................................................................. 84 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 6 of 121 
7.1 
Sample Collection ........................................................................................................... 84 
7.2 
Sample Preparation ......................................................................................................... 85 
7.3 
Sample Storage and Shipment ........................................................................................ 85 
7.4 
Future Use of Stored Serum Samples for Research ........................................................ 86 
8 
Clinical Supplies .............................................................................................................. 86 
9 
Endpoints and Assessment Methods ............................................................................. 87 
9.1 
Primary Endpoints and Assessment Methods ................................................................. 87 
9.1.1 
Safety ............................................................................................................................ 87 
9.1.2 
Immunogenicity ............................................................................................................ 87 
9.1.2.1 
Immunogenicity Endpoint .......................................................................................... 87 
9.1.2.2 
Immunogenicity Assessment Methods....................................................................... 87 
9.1.3 
Efficacy ......................................................................................................................... 87 
9.2 
Secondary Endpoints and Assessment Methods ............................................................. 87 
9.2.1 
Safety ............................................................................................................................ 87 
9.2.2 
Immunogenicity ............................................................................................................ 88 
9.2.2.1 
Immunogenicity Endpoints ........................................................................................ 88 
9.2.2.2 
Immunogenicity Assessment Methods....................................................................... 89 
9.2.3 
Efficacy ......................................................................................................................... 89 
9.3 
Observational Endpoints and Assessment Methods ....................................................... 89 
9.3.1 
Immunogenicity ............................................................................................................ 89 
9.3.2 
Safety ............................................................................................................................ 89 
9.3.2.1 
Safety Definitions ....................................................................................................... 89 
9.3.2.2 
Safety Endpoints ........................................................................................................ 92 
9.3.2.3 
Safety Assessment Methods ....................................................................................... 93 
9.3.2.3.1 
Immediate Post-vaccination Observation Period ..................................................... 93 
9.3.2.3.2 
Reactogenicity (Solicited Reactions from Day 0 to Day 07 after Each 
Vaccination) ............................................................................................................. 93 
9.3.2.3.3 
Unsolicited Adverse Events ..................................................................................... 97 
9.3.2.3.4 
Adverse Events of Special Interest .......................................................................... 98 
9.3.2.3.5 
Medically-Attended Adverse Events ....................................................................... 99 
9.3.2.3.6 
Assessment of Causality .......................................................................................... 99 
9.3.3 
Efficacy ......................................................................................................................... 99 
10 
Reporting of Serious Adverse Events .......................................................................... 100 
10.1 
Initial Reporting by the Investigator ............................................................................. 100 
10.2 
Follow-up Reporting by the Investigator ...................................................................... 101 
10.3 
Reporting of SAEs Occurring After a Subject Has Completed the Study .................... 101 
10.4 
Assessment of Causality ............................................................................................... 101 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 7 of 121 
10.5 
Reporting SAEs to Health Authorities and IECs / IRBs ............................................... 101 
11 
Data Collection and Management ............................................................................... 102 
11.1 
Data Collection and CRB Completion .......................................................................... 102 
11.2 
Data Management ......................................................................................................... 103 
11.3 
Data Review .................................................................................................................. 103 
12 
Statistical Methods and Determination of Sample Size ............................................. 104 
12.1 
Statistical Methods ........................................................................................................ 104 
12.1.1 
Sensitivity analysis due to COVID-19 pandemic ....................................................... 104 
12.1.2 
Hypotheses and Statistical Methods for Primary Objective ....................................... 104 
12.1.2.1 
Hypotheses ............................................................................................................... 104 
12.1.3 
Hypotheses and Statistical Methods for Secondary Objective 1 ................................ 105 
12.1.3.1 
Hypotheses ............................................................................................................... 105 
12.1.4 
Statistical Methods for Observational Objectives ...................................................... 105 
12.2 
Analysis Sets ................................................................................................................. 106 
12.2.1 
Full Analysis Set ......................................................................................................... 106 
12.2.2 
Safety Analysis Set ..................................................................................................... 106 
12.2.2.1 
Overall Safety Analysis Set for Any Dose ............................................................... 106 
12.2.2.2 
Safety Analysis Set for Vaccination at 6 Months of Age ........................................ 107 
12.2.2.3 
Safety Analysis Set for Vaccination at 12 Months of Age ...................................... 107 
12.2.2.4 
Safety Analysis Set for Vaccination at 17 Months of Age ...................................... 107 
12.2.2.5 
Safety Analysis Set for Vaccination at 20 Months of Age ...................................... 107 
12.2.3 
Per-Protocol Analysis Set ........................................................................................... 108 
12.2.3.1 
Per-Protocol Analysis Set 1 (PPAS1) ...................................................................... 108 
12.2.3.2 
Per-Protocol Analysis Set 2 (PPAS2) ...................................................................... 109 
12.2.4 
Populations Used in Analyses .................................................................................... 110 
12.3 
Handling of Missing Data and Outliers ........................................................................ 110 
12.3.1 
Safety .......................................................................................................................... 110 
12.3.2 
Immunogenicity .......................................................................................................... 110 
12.4 
Interim Analysis ............................................................................................................ 110 
12.5 
Determination of Sample Size and Power Calculation ................................................. 111 
13 
Ethical and Legal Issues and Investigator / Sponsor Responsibilities ...................... 112 
13.1 
Ethical Conduct of the Study / Good Clinical Practice ................................................. 112 
13.2 
Source Data and Source Documents ............................................................................. 112 
13.3 
Confidentiality of Data and Access to Subject Records ............................................... 112 
13.4 
Monitoring, Auditing, and Archiving ........................................................................... 113 
13.4.1 
Monitoring .................................................................................................................. 113 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 8 of 121 
13.4.2 
Audits and Inspections ................................................................................................ 114 
13.4.3 
Archiving .................................................................................................................... 114 
13.5 
Financial Contract and Insurance Coverage ................................................................. 114 
13.6 
Stipends for Participation .............................................................................................. 114 
13.7 
Publication Policy ......................................................................................................... 115 
14 
Reference List ................................................................................................................ 116 
15 
Signature Page ............................................................................................................... 121 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 9 of 121 
List of Tables  
Table 5.1: Vaccination and blood sampling schedule - Group 1 and Group 2 ............................... 46 
Table 5.2: Vaccination and blood sampling schedule - Group 3 and Group 4 ............................... 47 
Table 9.1: Solicited injection site reactions: terminology, definitions, and intensity scales ........... 95 
Table 9.2: Solicited systemic reactions: terminology, definitions, and intensity scales* ............... 96 
Table 12.1: Power estimates to reject primary null hypothesis ..................................................... 111 
Table 12.2: Power estimates to reject the secondary null hypothesis ........................................... 111 
 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 10 of 121 
Synopsis  
Company: 
Sanofi Pasteur 
Investigational Product: 
MenACYW conjugate vaccine 
Active Substances: 
Capsular polysaccharide from meningococcal serogroups A, C, Y, and W 
conjugated to tetanus toxoid 
Title of the Study: 
Immunogenicity and Safety Study of an Investigational Quadrivalent 
Meningococcal Conjugate Vaccine Administered in Healthy Infants and 
Toddlers 
Development Phase: 
Phase III 
Coordinating Investigator: 
Dr. 
 
Study Sites: 
This will be a multi-center study conducted at approximately 30 sites in the 
United States (US). 
Investigators and sites are listed in the “List of Investigators and Centers 
Involved in the Trial” document. 
Planned Study Period: 
Q3 2018 to Q3 2023 
Study Design, Schedule of Study 
Procedures, and Methodology: 
A Phase III, randomized, parallel group, active-controlled, multi-center study 
to compare the immunogenicity and describe the safety of MenACYW 
conjugate vaccine and MENVEO® when administered in a 1 + 1 schedule and 
concomitantly with routine pediatric vaccines in healthy infants and toddlers 
in the US. This study will also describe the safety and immunogenicity of 
MenACYW conjugate vaccine and Menactra® when administered in a 1 + 1 
schedule to healthy toddlers in the US. For each age group at enrollment, the 
study will have a modified double-blind design, i.e., modified double-blind 
between Group 1 and Group 2, and between Group 3 and Group 4. 
 
Approximately 1070 subjects will be enrolled. Approximately 870 healthy 
infants 6 to 7 months of age will be randomized 1:1 to 2 groups, and 200 
healthy toddlers 17 to 19 months of age will be randomized 1:1 to 2 groups: 
• Group 1: MenACYW conjugate vaccine + routine pediatric vaccines at 
6 to 7 months of age and 12 to 13 months of age 
• Group 2 MENVEO® + routine pediatric vaccines at 6 to 7 months of age 
and 12 to 13 months of age 
• Group 3: MenACYW conjugate vaccine at 17 to 19 months of age and 
20 to 23 months of age 
• Group 4: Menactra® at 17 to 19 months of age and 20 to 23 months of age 
 
All subjects in Group 1 and Group 2 will receive a dose of either MenACYW 
conjugate vaccine or MENVEO® with the following routine pediatric vaccines 
to ensure compliance with the Advisory Committee on Immunization 
Practices (ACIP) recommendations: 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 11 of 121 
 
• Diphtheria, tetanus and acellular pertussis (DTaP) at 6 months of age 
• Inactivated poliovirus (IPV) at 6 months of age 
• Haemophilus influenzae type b (Hib) at 6 months of age* 
• Pneumococcal 13-valent conjugate (Prevnar 13®, PCV13) at 6 and 
13 months of age 
• Rotavirus (RotaTeq®) at 6 months of age 
• Hepatitis B at 6 months of age 
 
• Measles, mumps, and rubella (M-M-R®II) at 12 months of age 
• Varicella (Varivax®) at 12 months of age 
 
*In children immunized with PedvaxHIB® at 2 and 4 months of age, a third 
dose of Hib vaccine at 6 months of age is not required. The routine pediatric 
vaccines recommended at 6 months of age will be given as per standard of 
care during the first study visit (Visit 1) along with the corresponding study 
vaccine. The dose of Prevnar 13® and Hib (for children vaccinated with 
monovalent Hib vaccine at 2, 4, and 6 months of age) recommended in the 
second year of life may be given as per standard of care at the last study visit 
after completing all the study procedures (Visit 4). Routine pediatric vaccines 
recommended at 6 months of age and the dose of Prevnar 13® and Hib 
(for children vaccinated with monovalent Hib vaccine at 2, 4, and 6 months of 
age) recommended in the second year of life will not be provided by the 
Sponsor but procured by the sites as per their standard practices. 
 
Blood Sampling 
All subjects in Group 1 and Group 2 will provide 3 blood samples for 
immunogenicity assessment: 
• A blood sample before the first study vaccination at Visit 1 (all subjects) 
• A blood sample 30 days after administration of the first dose of 
MenACYW conjugate vaccine or MENVEO® at Visit 2 (only from 
approximately the first 50% of the subjects in Group 1 and Group 2) 
• A blood sample before the 12-month vaccination at Visit 3 (only from the 
remaining approximately 50% of subjects in Group 1 and Group 2, 
who did not have a blood draw at Visit 2) 
• A blood sample 30 days after administration of the second dose of 
MenACYW conjugate vaccine or MENVEO® at Visit 4 (all subjects in 
Group 1 and Group 2) 
 
All subjects in Group 3 and Group 4 will provide 2 blood samples for 
immunogenicity assessment: 
• A blood sample before the first study vaccination at Visit 1 
• A blood sample 30 days after administration of the second dose of 
MenACYW conjugate vaccine or Menactra® at Visit 3 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 12 of 121 
 
Collection of Safety Data 
All subjects will be followed for safety from Visit 1 to 6 months after the last 
vaccination. 
• Immediate unsolicited systemic adverse events (AEs) will be collected 
within 30 minutes after each vaccination. Solicited AEs will be collected 
from Day (D) 0 to D07 after each vaccination; unsolicited AEs will be 
collected from D0 after each vaccination to the next study visit; serious 
adverse events (SAEs) (including adverse events of special interest 
[AESIs]) and medically attended adverse events (MAAEs) will be 
collected throughout the study from Visit 1 (first vaccination visit) until 
the end of the 6-month follow up period after the last vaccinations. 
 
• All subjects will be observed for 30 minutes after each vaccination, and 
any unsolicited systemic AEs occurring during that time will be recorded 
as immediate unsolicited systemic AEs in the electronic case report book 
(CRB). 
• The subject’s parent / guardian will record information in a diary card 
about solicited reactions from D0 to D07 after each vaccination and 
unsolicited AEs from D0 after each vaccination to the next study visit. 
 
• SAEs (including AESIs) and MAAEs will be recorded throughout the 
study. For Groups 1 and 2, the subject’s parent/guardian will record 
information in a diary card about SAEs (including AESIs) and MAAEs 
from Visit 1 to Visit 2, from Visit 2 to Visit 3, and from Visit 3 to Visit 4. 
For Groups 1 and 2, SAEs (including AESIs) and MAAEs will also be 
recorded in a memory aid from Visit 4 until the 6-month follow up phone 
call. For Groups 3 and 4, the subject’s parent/ guardian will record 
information in a diary card about SAEs (including AESIs) and MAAEs 
from Visit 1 to Visit 2, and from Visit 2 to Visit 3. For Groups 3 and 4, 
SAEs (including AESIs) and MAAEs will also be recorded in a memory 
aid from Visit 3 until the 6-month follow up phone call. The subject’s 
parent/ guardian will be asked to notify the site immediately about any 
potential SAEs (including AESIs) at any time during the trial. 
• Staff will contact the subjects’ parent/ guardian by telephone 8 days 
(+2 days) after each vaccination visit to identify the occurrence of any 
SAEs (including AESIs) not yet reported and to remind them to complete 
the diary card after each vaccination visit and to bring it back at the 
subsequent visit. 
• The completed diary cards will be collected and reviewed with the 
subject’s parent/ guardian at the subsequent visit. 
• For Group 1 and Group 2: Staff will contact the subjects’ parent / 
guardian by telephone within 14 days before Visit 3 to remind them of 
the forthcoming study visit. If the subject’s participation in the study is 
discontinued, the information recorded on the diary card will be reviewed 
at this time and the subject’s parent /guardian will be asked to mail the 
diary card to the site. 
• Staff will contact the subjects’ parent / guardian by telephone at 6 months 
(+30 days) after the last vaccination visit to review the memory aid and 
identify the occurrence of any SAEs (including AESIs), as well as 
MAAEs that have not been reported. 
Interruption of the Study 
The study may be discontinued if new data about the investigational product 
resulting from this study or any other studies become available; or for 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 13 of 121 
administrative reasons; or on advice of the Sponsor, the Investigators, the 
IECs/IRBs, or the governing regulatory authorities in the country where the 
study is taking place. 
If the study is prematurely terminated or suspended, the Sponsor shall 
promptly inform the Investigators, the IECs/IRBs, the regulatory authorities, 
and any contract research organization(s) used in the study of the reason for 
termination or suspension, as specified by the applicable regulatory 
requirements. The Investigator shall promptly inform the subjects’ 
parents/guardians and should assure appropriate subject therapy and/or follow-
up. 
There will be an internal team at the level of the Sponsor (Safety Management 
Team, [SMT]), which will review the data being generated from all the 
ongoing studies with MenACYW conjugate vaccine at regular intervals for any 
new safety signals or safety concerns. The SMT is empowered to recommend a 
pause in both recruitment and / or further vaccination while it investigates any 
potential signal or concern. 
Primary Objective: 
To demonstrate the non-inferiority of the vaccine seroresponse* to 
meningococcal serogroups A, C, Y, and W following administration of 2 doses 
of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when 
given concomitantly with routine pediatric vaccines to infants and toddlers at 
6 to 7 months of age and 12 to 13 months of age. 
*Vaccine seroresponse is measured with the serum bactericidal assay using 
human complement (hSBA). hSBA vaccine seroresponse for serogroups 
A, C, Y, and W 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 ≥ 4-fold greater than the pre-vaccination titer 
Primary Endpoint: 
Meningococcal serogroups A, C, Y, and W antibody titers measured by hSBA, 
before the first study vaccination (Visit 1) and 30 days after the second dose of 
MenACYW conjugate vaccine or MENVEO® (Group 1 versus [vs] Group 2) 
Secondary Objectives: 
1) To demonstrate the non-inferiority of the percentage of subjects with 
hSBA titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following 
administration of 2 doses of MenACYW conjugate vaccine compared to 
2 doses of MENVEO® when given concomitantly with pediatric routine 
vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 
months of age 
2) To describe the antibody response against meningococcal serogroups A, C, 
Y, and W 30 days after the second vaccination at 12 to 13 months of age 
with MenACYW conjugate vaccine or MENVEO® 
3) To describe the antibody response against meningococcal serogroups A, C, 
Y, and W 30 days after the first vaccination at 6 to 7 months of age with 
MenACYW conjugate vaccine or MENVEO® (in a subset of subjects) 
4) To describe the antibody response against meningococcal serogroups A, C, 
Y, and W 6 months after the first vaccination at 6 to 7 months of age with 
MenACYW conjugate vaccine or MENVEO® (in a subset of subjects) 
5) To describe the antibody response against meningococcal serogroups A, C, 
Y, and W 30 days after the second vaccination at 20 to 23 months of age 
with MenACYW conjugate vaccine or Menactra® 
Secondary Endpoints: 
The following serological endpoints will be assessed. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 14 of 121 
1) 
Meningococcal serogroups A, C, Y, and W antibody titers ≥ 1:8 
measured by hSBA 30 days after the second dose of MenACYW 
conjugate vaccine or MENVEO® (Group 1 vs Group 2) 
2) 
30 days after the second vaccination at 12 to 13 months of age with 
MenACYW conjugate vaccine or MENVEO® (Group 1 and Group 2): 
• hSBA meningococcal serogroups A, C, Y, and W antibody titers 
• Geometric mean titers (GMTs) with 95% CI 
• Titer distribution and reverse cumulative distribution curves 
(RCDCs) 
• Percentage of subjects with titer ≥ 4-fold rise from pre-vaccination 
to post-vaccination and 95% CI 
3) 
30 days after the first vaccination at 6 to 7 months of age with 
MenACYW conjugate vaccine or MENVEO® (Group 1 and Group 2): 
• hSBA meningococcal serogroups A, C, Y, and W antibody titers 
• GMTs with 95% CI 
• Titer distribution and RCDCs 
• Percentage of subjects with titer ≥ 4-fold rise from pre-vaccination 
to post-vaccination and 95% CI 
• Percentage of subjects with hSBA vaccine seroresponse and  
95% CI 
4) 
6 months after the first vaccination at 6 to 7 months of age with 
MenACYW conjugate vaccine or MENVEO® (Group 1 and Group 2): 
• hSBA meningococcal serogroups A, C, Y, and W antibody titers 
• GMTs with 95% CI 
• Titer distribution and RCDCs 
• Percentage of subjects with titer ≥ 4-fold rise from pre-vaccination 
to post-vaccination and 95% CI 
• Percentage of subjects with hSBA vaccine seroresponse and  
95% CI 
5) 
30 days after the second vaccination at 20 to 23 months of age with 
MenACYW conjugate vaccine or Menactra® (Group 3 and Group 4): 
• hSBA meningococcal serogroups A, C, Y, and W antibody titers 
• GMTs with 95% CI 
• Titer distribution and RCDCs 
• Percentage of subjects with titer ≥ 4-fold rise from pre-vaccination 
to post-vaccination and 95% CI 
• Percentage of subjects with hSBA vaccine seroresponse and  
95% CI 
Observational Objectives: 
1) To describe the safety profile of MenACYW conjugate vaccine and 
MENVEO® when administered concomitantly with routine pediatric 
vaccines in healthy infants and toddlers 
2) To describe the safety profile of MenACYW conjugate vaccine and 
Menactra® administered in toddlers 
Observational Endpoints: 
The following endpoints will be used for all subjects: 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 15 of 121 
• Occurrence, nature (Medical Dictionary for Regulatory Activities 
[MedDRA] preferred term), duration, intensity, relationship to vaccination, 
and whether the event led to early termination from the study, of any 
unsolicited systemic AEs reported within 30 minutes after each 
vaccination. 
• Occurrence, time of onset, number of days of occurrence, intensity, action 
taken, and whether the reaction led to early termination from the study, of 
solicited (prelisted in the subject’s diary card and CRB) injection site 
reactions occurring up to D07 after each vaccination. 
• Occurrence, time of onset, number of days of occurrence, intensity, action 
taken, and whether the reaction led to early termination from the study, of 
solicited (prelisted in the subject’s diary card and CRB) systemic reactions 
occurring up to D07 after each vaccination. 
• Occurrence, nature (MedDRA preferred term), time of onset, duration, 
intensity, action taken, relationship to vaccination, and whether the event 
led to early termination from the study, of unsolicited AEs up to D30 after 
each vaccination. 
• Occurrence, nature (MedDRA preferred term), time of onset, duration, 
seriousness criteria, relationship to vaccination, outcome, and whether the 
event led to early termination from the study, of SAEs (including AESIs) 
throughout the trial from Visit 1 up to the 6 month follow-up contact after 
the last vaccination. 
• Occurrence, nature (MedDRA preferred term), time of onset, duration, 
intensity, action taken, relationship to vaccination, and whether the event 
led to early termination from the study for MAAEs throughout the trial 
from Visit 1 up to the 6 month follow-up contact after the last vaccination. 
Planned Sample Size: 
Approximately 1070 subjects are planned to be enrolled: 
• Group 1 (MenACYW conjugate vaccine and routine vaccines): 
n = 435 enrolled, at least 261 evaluable 
• Group 2 (MENVEO® and routine vaccines): n = 435 enrolled, at least 261 
evaluable 
• Group 3 (MenACYW conjugate vaccine): n = 100 enrolled 
• Group 4 (Menactra®): n = 100 enrolled 
Duration of Participation in the 
Study: 
For Group 1 and Group 2, the duration of each subject’s active participation in 
the study will be approximately 1 year including a safety follow-up contact at 
6 months after the last vaccinations. For Group 3 and Group 4, the duration of 
each subject’s active participation in the study will be approximately 
10 months, including a safety follow-up contact at 6 months after the last 
vaccinations. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 16 of 121 
Investigational Product: 
 
MenACYW conjugate vaccine: Meningococcal Polysaccharide 
(Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (Sanofi 
Pasteur Inc., Swiftwater, PA, USA) 
 Form: 
Liquid solution 
Composition: 
Each 0.5 milliliter (mL) dose of MenACYW conjugate vaccine is formulated 
in sodium acetate buffered saline solution to contain the following 
ingredients: 
Meningococcal capsular polysaccharides: 
Serogroup A .............................................................. 10 micrograms (µg) 
Serogroup C ..................................................................................... 10 µg 
Serogroup Y ..................................................................................... 10 µg 
Serogroup W .................................................................................... 10 µg 
Tetanus toxoid protein carrier ...................................... approximately 55 µg* 
* Tetanus toxoid protein quantity is approximate and dependent on the polysaccharide-
to-protein ratio for the conjugates used in each formulation. 
 Route: 
Intramuscular (IM) 
 Batch Number: 
To be determined 
Control Product 1: 
MENVEO®: Meningococcal (Groups A, C, Y and W-135) Oligosaccharide 
Diphtheria CRM197 Conjugate Vaccine (GSK Vaccines, Srl, Bellaria-Rosia 
53018, Sovicille [SI], Italy) 
 Form: 
Lyophilized powder and liquid components are combined to produce a 
solution for IM Injection 
 Composition: 
Each 0.5 mL dose of vaccine contains the following active ingredients: 
MenA oligosaccharide ...................................................................... 10 µg 
MenC oligosaccharide ........................................................................ 5 µg 
MenY oligosaccharide ........................................................................ 5 µg 
MenW-135 oligosaccharide ................................................................ 5 µg 
CRM197 protein .................................................................. 32.7 to 64.1 µg 
Other ingredients per 0.5 mL dose: residual formaldehyde ≤ 0.30 µg. 
 Route: 
IM 
 Batch Number: 
To be determined 
Control Product 2: 
Menactra®: Meningococcal (Groups A, C, Y and W-135) Polysaccharide 
Diphtheria Toxoid Conjugate Vaccine (Sanofi Pasteur Inc., Swiftwater, PA, 
USA) 
 Form: 
Liquid Solution 
 Composition: 
Each 0.5 mL dose of vaccine is formulated in sodium phosphate buffered 
isotonic sodium chloride solution to contain the following ingredients: 
Serogroup A ........................................................................................ 4 µg 
Serogroup C ........................................................................................ 4 µg 
Serogroup Y ........................................................................................ 4 µg 
Serogroup W-135 ............................................................................... 4 µg 
Diphtheria toxoid protein carrier .............................. approximately 48 µg 
 Route: 
IM 
 Batch Number: 
To be determined 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 17 of 121 
Other Product 1: 
Pentacel®: (Diphtheria and Tetanus Toxoids and Acellular Pertussis 
Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus 
Toxoid Conjugate) Vaccine (Sanofi Pasteur Ltd, Toronto, Ontario, Canada) 
 Form: 
Liquid DTaP-IPV used to reconstitute lyophilized ActHIB® 
 Composition: 
Each 0.5 mL dose contains: 
Diphtheria toxoid ............................................. 15 Limit of Flocculation (Lf) 
Tetanus toxoid ......................................................................................... 5 Lf 
Acellular pertussis antigens: 
  Pertussis toxin (PT) .............................................................................20 µg 
  Filamentous hemagglutinin (FHA) ......................................................20 µg 
  Pertactin (PRN) ......................................................................................3 µg 
Fimbriae Types 2 and 3 (FIM) .................................................................5 µg 
Inactivated polioviruses: 
  Type 1 (Mahoney) ................................................. 40 D-antigen units (DU) 
  Type 2 (MEF-1) ................................................................................... 8 DU 
  Type 3 (Saukett) ................................................................................ 32 DU 
H. influenzae type b (PRP) ....................................................................10 µg 
Tetanus toxoid (PRP-T) .........................................................................24 µg 
 
Excipients: 
Aluminum phosphate (0.33 mg aluminum) (adjuvant) ........................ 1.5 mg 
Polysorbate 80  ................................... approximately 10 ppm by calculation 
Sucrose .............................................................................................. 42.5 mg 
Residual formaldehyde ........................................................................ ≤ 5 µg 
Residual glutaraldehyde................................................. < 50 nanograms (ng) 
Residual bovine serum albumin .......................................................... ≤ 50 ng 
2-phenoxyethanol .............................................................. 3.3 mg (0.6% v/v) 
Neomycin ........................................................................ < 4 picograms (pg) 
Polymyxin B sulfate ............................................................................. < 4 pg 
Route: 
IM 
Batch Number: 
Commercial batches 
Other Product 2: 
Pediarix®: (Diphtheria and Tetanus Toxoids and Acellular Pertussis 
Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine) 
(GlaxoSmithKline Biologicals, Rixensart, Belgium) 
Form: 
Suspension for injection 
Composition: 
Each 0.5 mL dose contains: 
Diphtheria toxoid ................................................................................... 25 Lf 
Tetanus toxoid ....................................................................................... 10 Lf 
Acellular pertussis antigens: 
  Inactivated PT ......................................................................................25 µg 
  FHA .....................................................................................................25 µg 
  PRN .......................................................................................................8 µg 
HBsAg ...................................................................................................10 µg 
Inactivated polioviruses: 
  Type 1 (Mahoney) ............................................................................. 40 DU 
  Type 2 (MEF-1) ................................................................................... 8 DU 
  Type 3 (Saukett) ................................................................................ 32 DU 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 18 of 121 
 
Excipients: 
Aluminum salt (adjuvant) ............................ not more than 0.85 mg by assay 
Sodium chloride  .................................................................................. 4.5 mg 
Polysorbate 80  ................................................................................ ≤ 100 µg 
Residual formaldehyde .................................................................... ≤ 100 µg 
Neomycin ........................................................................................ ≤ 0.05 ng 
Polymyxin B ..................................................................................... ≤0.01 ng 
Route: 
IM 
Batch Number: 
Commercial batches 
Other Product 3: 
Haemophilus b conjugate vaccine: either ActHib®, Hiberix® or PedvaxHIB® 
ActHib®: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) 
(Sanofi Pasteur Inc., Swiftwater, PA, USA) 
Hiberix®: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) 
(GlaxoSmithKline Biologicals 441 Rixensart, Belgium) 
PedvaxHIB®: Haemophilus b Conjugate Vaccine (Meningococcal Protein 
Conjugate) (Merck &Co., Inc., West Point, PA, USA) 
Form: 
ActHib® and Hiberix®: lyophilized powder and liquid diluent are combined 
to produce a solution for IM injection 
PedvaxHIB®: Solution for IM injection 
Composition: 
ActHib®: After reconstitution, each 0.5 mL dose contains: 
Haemophilus influenzae type b polysaccharide…………………………10µg 
(polyribosylribitol phosphate, PRP) 
conjugated to tetanus toxoid as carrier protein………………………...24 µg 
Sucrose…………………………………………………………………. 8.5% 
 
Hiberix®: After reconstitution, each 0.5 mL dose contains: 
Haemophilus influenzae type b polysaccharide…………………………10µg 
(polyribosylribitol phosphate, PRP) 
conjugated to tetanus toxoid as carrier protein….……...approximately 25µg 
Lactose………………………………………………………………12.6 mg 
Residual formaldehyde………………………………………………<0.5 µg 
 
PedvaxHIB®: Each 0.5 mL dose contains: 
Haemophilus influenzae type b polysaccharide…………………………7.5µg 
(polyribosylribitol phosphate, PRP) 
Neisseria meningitidis outer membrane protein complex………………125µg 
Aluminum as amorphous aluminum hydroxyphosphate sulfate………225 µg 
Sodium chloride…………………………………………………………0.9% 
Route: 
IM 
Batch Number: 
Commercial batches 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 19 of 121 
Other Product 4: 
Prevnar 13®: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria 
CRM197 Protein) (Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer Inc, 
Philadelphia, PA, USA) 
 Form: 
Suspension for injection 
 Composition: 
Each 0.5 mL dose of the vaccine is formulated to contain 
Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 
19F, 23F saccharides ....................................... approximately 2.2 μg of each 
6B saccharides ...................................................................................... 4.4 μg 
CRM197 carrier protein ........................................................................... 34 μg 
Polysorbate 80 ..................................................................................... 100 μg 
Succinate buffer ................................................................................... 295 μg 
Aluminum as aluminum phosphate adjuvant ....................................... 125 μg 
 Route: 
IM 
 Batch Number: 
Commercial batches 
Other Product 5: 
RotaTeq®: (Rotavirus Vaccine, Live, Oral, Pentavalent) (Merck Sharp & 
Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, 
USA) 
 Form: 
Oral Solution 
 Composition: 
Each 2 mL dose contains the following 5 live reassortant rotaviruses: 
G1 serotype ..................................................... 2.2 x 106 infectious units (IU) 
G2 serotype ................................................................................. 2.8 x 106 IU 
G3 serotype ................................................................................. 2.2 x 106 IU 
G4 serotype .................................................................................. 2.0 x 106IU 
P1A(8) ......................................................................................... 2.3 x 106IU 
The reassortants are suspended in a buffered stabilizer solution. 
Each 2 mL vaccine dose also contains sucrose, sodium citrate, sodium 
phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell 
culture media, and trace amounts of fetal bovine serum. 
 Route: 
Oral 
 Batch Number: 
Commercial batches 
Other Product 6:  
Hepatitis B Vaccine: either ENGERIX-B® or Recombivax HB® 
Engerix-B®: (Hepatitis B Vaccine [Recombinant]) (GlaxoSmithKline 
Biologicals 441 Rixensart, Belgium) 
RecombivaxHB®: (Hepatitis B Vaccine [Recombinant]) (Merck Sharp & 
Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, 
USA) 
 Form: 
Suspension for injection 
 Composition: 
Engerix-B®: Each 0.5 mL pediatric/adolescent dose contains 10 µg of 
hepatitis B virus surface antigen (HBsAg) adsorbed on 0.25 mg aluminum as 
aluminum hydroxide. 
Excipients: 
Sodium chloride ............................................................................... 9 mg/mL 
Disodium phosphate dehydrate ................................................... 0.98 mg/mL 
Sodium dihydrogen phosphate dehydrate ................................... 0.71 mg/mL 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 20 of 121 
RecombivaxHB®: Each 0.5 mL pediatric/adolescent dose contains 5µg of 
HBsAg adsorbed onto approximately 0.5 mg of aluminum (provided as 
amorphous aluminum hydroxyphosphate sulphate) 
Excipient: 
Residual formaldehyde ............................................................... < 15 mg/mL 
 Route: 
IM 
 Batch Number: 
Commercial batches 
Other Product 7: 
M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live) (Merck 
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse 
Station, NJ, USA) 
 Form: 
Lyophilized live virus vaccine 
 Composition: 
Each 0.5 mL dose contains live, attenuated virus: 
Measles virus (derived from Ender’s Edmonston strain) propagated in chick 
embryo cell culture ............................................. not less than 1000 TCID50* 
Mumps virus (Jeryl Lynn™ [B level] strain) propagated in chick embryo 
cell culture ....................................................... not less than 12,500 TCID50* 
Rubella virus (Wistar RA 27/3 strain) propagated in WI-38 human diploid 
lung fibroblasts ................................................... not less than 1000 TCID50* 
*TCID50 = tissue culture infectious doses 50% 
Each 0.5 mL dose is calculated to contain sorbitol (14.5 mg), sodium 
phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), 
recombinant human albumin (≤ 0.3 mg), fetal bovine serum (< 1 ppm), other 
buffer and media ingredients and approximately 25 µg of neomycin. 
 Route: 
Subcutaneous (SC) 
 Batch Number: 
Commercial batches 
Other Product 8: 
Varivax®: Varicella Virus Vaccine Live (Merck Sharp & Dohme Corp., a 
subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA) 
 Form: 
Suspension for injection supplied as lyophilized vaccine to be reconstituted 
using the accompanying sterile diluent 
Composition: 
Each approximately 0.5 mL dose contains: 
Active: 
Oka/Merck varicella virus at least 1350 plaque-forming units (PFU) 
 
Excipients: 
Sucrose ................................................................................................. 25 mg 
Hydrolyzed gelatin ............................................................................ 12.5 mg 
Sodium chloride ................................................................................... 3.2 mg 
Monosodium L-glutamate ................................................................... 0.5 mg 
Sodium phosphate dibasic ................................................................. 0.45 mg 
Potassium phosphate monobasic ....................................................... 0.08 mg 
Potassium chloride ............................................................................. 0.08 mg 
The vaccine contains residual components of MRC-5 cells including DNA 
and protein and trace quantities of sodium phosphate monobasic, EDTA, 
neomycin, and fetal bovine serum. The product contains no preservative. 
Route: 
SC 
Batch Number: 
Commercial batches 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 21 of 121 
Inclusion Criteria: 
An individual must fulfill all of the following criteria to be eligible for study 
enrollment: 
1) Aged 6 to 7 months of age (168 to 224 days)* or 17 to 19 months of age 
on the day of the first visit 
*At Visit 1, subjects must be at least 24 weeks of age (168 days, the minimum 
age for the final dose of hepatitis B vaccine in the vaccine series), and no more 
than 32 weeks of age (224 days, the maximum age for the 3rd dose of rotavirus 
vaccine administration). 
3) Informed consent form has been signed and dated by the parent(s) or 
guardian and by an independent witness if required by local regulations 
4) Subject and parent/guardian are able to attend all scheduled visits and to 
comply with all trial procedures 
5) For subjects to be enrolled at 6 to 7 months of age (Group 1 and 
Group 2), documented history of having received 2 doses of DTaP, Hib, 
IPV, pneumococcal, hepatitis B (for children who received Pediarix® at 
2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and 
rotavirus (Rotateq®) vaccines 
6) For subjects to be enrolled at 17 to 19 months of age (Group 3 and 
Group 4), documented history of having received all routine pediatric 
vaccines recommended by ACIP up to the age of enrollment 
 
 
Exclusion Criteria: 
An individual fulfilling any of the following criteria is to be excluded from 
study enrollment: 
1) Participation at the time of study enrollment or in the 4 weeks preceding 
the first trial vaccination or planned participation during the present trial 
period in another clinical trial investigating a vaccine, drug, medical 
device, or medical procedure 
 
2) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination 
or planned receipt of any vaccine in the 4 weeks before and / or following 
any trial vaccination except for influenza vaccination, which may be 
received at least 2 weeks before or 2 weeks after any study vaccination. 
This exception includes monovalent pandemic influenza vaccines and 
multivalent influenza vaccines 
 
3) Previous vaccination against meningococcal disease with either the trial 
vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or 
conjugate meningococcal vaccine containing serogroups A, C, Y, or W; 
or meningococcal B serogroup-containing vaccine) 
4) For subjects to be enrolled at 6 to 7 months of age (Group 1 and 
Group 2), prior receipt of more than 2 doses of rotavirus vaccine 
(Rotateq), DTaP, Hib, IPV, pneumococcal, hepatitis B: for children who 
received Pediarix® at 2 and 4 months of age, prior receipt of more than 3 
doses of hepatitis B vaccine. 
5) For subjects to be enrolled at 6 to 7 months of age, receipt of 2 doses of 
rotavirus vaccine, Rotarix® at 2 and 4 months of age. 
6) Receipt of immune globulins, blood, or blood-derived products in the past 
3 months 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 22 of 121 
 
7) 
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 
8) 
Family history of congenital or hereditary immunodeficiency, until the 
immune competence of the potential vaccine recipient is demonstrated 
9) 
Individuals with blood dyscrasias, leukemia, lymphoma of any type, or 
other malignant neoplasms affecting the bone marrow or lymphatic 
systems 
 
10) Individuals with active tuberculosis 
11) History of any Neisseria meningitidis infection, confirmed either 
clinically, serologically, or microbiologically 
 
12) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, 
hepatitis A, measles, mumps, rubella, varicella; and Haemophilus 
influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection 
or disease 
13) At high risk for meningococcal infection during the trial (specifically,  
but not limited to, subjects with persistent complement deficiency, with 
anatomic or functional asplenia, or subjects travelling to countries with 
high endemic or epidemic disease) 
14) History of intussusception 
15) History of any neurologic disorders, including any seizures and 
progressive neurologic disorders 
16) History of Arthus-type hypersensitivity reaction after a previous dose of 
tetanus toxoid-containing vaccine 
17) History of Guillain-Barré syndrome 
18) Known systemic hypersensitivity to any of the vaccine components or 
to latex, or history of a life-threatening reaction to the vaccine(s) used in 
the trial or to a vaccine containing any of the same substances, including 
neomycin, gelatin, and yeast 
 
19) Verbal report of thrombocytopenia contraindicating intramuscular 
vaccination in the investigator’s opinion 
20) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding 
inclusion, contraindicating intramuscular vaccination in the 
investigator’s opinion 
 
21) Receipt of oral or injectable antibiotic therapy within 72 hours prior to 
the first blood draw 
22) Chronic illness that, in the opinion of the investigator, is at a stage 
where it might interfere with trial conduct or completion 
 
23) Any condition which, in the opinion of the investigator, might interfere 
with the evaluation of the study objectives 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 23 of 121 
 
24) Moderate or severe acute illness/infection (according to investigator 
judgment) on the day of vaccination or febrile illness (temperature 
≥ 38.0°C [≥ 100.4°F]). A prospective subject should not be included in 
the study until the condition has resolved or the febrile event has 
subsided 
25) Identified as a natural or adopted child of the investigator or employee 
with direct involvement in the proposed study 
Statistical Methods: 
Primary Objective 
Thirty days after receiving MenACYW conjugate vaccine at 12 months of 
age, the hSBA vaccine seroresponse* rates against meningococcal serogroups 
A, C, Y, and W in Group 1 is non-inferior to the corresponding hSBA vaccine 
seroresponse rates against meningococcal serogroups A, C, Y, and W in 
Group 2. 
Null hypothesis (H0): p(men, G1) - p(men, G2) ≤ -10% 
Alternative hypothesis (H1): p(men, G1) - p(men, G2) > -10%  
 
where p(men, G1) and p(men, G2) are the percentages of subjects who 
achieve hSBA vaccine seroresponse in Group 1 and Group 2, respectively. 
Each of the serogroups A, C, Y, and W will be tested separately. Assuming 
the difference between the 2 proportions is normally distributed, if the lower 
limit of the 2-sided 95% confidence interval (CI) of the difference between 
the 2 proportions is > -10%, the inferiority assumption will be rejected. For 
the non-inferiority hypotheses using the seroresponse rates, the CI of the 
difference in proportions is computed using the Wilson Score method without 
continuity correction. 
*hSBA vaccine seroresponse for serogroups A, C, Y and W 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 ≥ 4-fold greater than the pre-vaccination titer 
Refer to Table S1 for power estimates to reject the primary null hypothesis. 
 
Secondary Objective 
Thirty days after receiving MenACYW conjugate vaccine at 12 months of 
age, the hSBA vaccine seroprotection rates against meningococcal serogroups 
A, C, Y, and W in Group 1 is non-inferior to the corresponding hSBA vaccine 
seroprotection rates against meningococcal serogroups A, C, Y, and W in 
Group 2. 
Null hypothesis (H0): p(men, G1) - p(men, G2) ≤ -10% 
Alternative hypothesis (H1): p(men, G1) - p(men, G2) > -10%  
 
where p(men, G1) and p(men, G2) are the percentages of subjects who 
achieve hSBA vaccine seroprotection† in Group 1 and Group 2 respectively. 
Each of the serogroups A, C, Y, and W will be tested separately. Assuming 
the difference between the 2 proportions is normally distributed, if the lower 
limit of the 2-sided 95% CI of the difference between the 2 proportions is  
> -10%, the inferiority assumption will be rejected. The CI of the difference in 
proportions is computed using the Wilson Score method without continuity 
correction. 
 
†hSBA vaccine seroprotection for serogroups A, C, Y and W is defined as 
titers ≥ 1:8 
Refer to Table S2 for power estimates to reject the secondary null hypothesis. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 24 of 121 
 
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 
proportions. For GMTs and geometric mean concentrations (GMCs), 95% CIs 
of point estimates will be calculated using normal approximation assuming 
they are log-normally distributed. 
 
Observational Objective 
Safety 
Safety results will be described for subjects in all study groups. The main 
parameters for the safety endpoints will be described by 95% CIs (based on 
the Clopper-Pearson method). 
 
Calculation of Sample Size: 
Approximately 870 subjects will be enrolled in Group 1 and Group 2. An 
estimated around 20% to 30% and not higher than 40% of non-evaluable 
subjects will result in at least 522 subjects in the Per-Protocol population 
available for immunogenicity analyses. Group 1 will have 435 enrolled 
subjects and 261 evaluable subjects. Group 2 will have 435 enrolled subjects 
and 261 evaluable subjects. In addition, 200 subjects will be enrolled in Group 
3 and Group 4. 
 
For the Primary Objective: 
Thirty days after the month 12 vaccination (after the second dose vaccination) 
With at least 261 evaluable subjects in Group 1 and at least 261 evaluable 
subjects in Group 2, the study will have around 90.0% power by using 
Farrington and Manning’s method to declare the non-inferiority of Group 1 vs 
Group 2. 
 
Table S1: Power estimates to reject primary null hypothesis  
Antigen 
Endpoint 
Estimated 
response (%)* 
Non-inferiority 
margin 
Power 
(%) 
A 
Seroresponse 
Rate 
97.7 
10% 
100 
C 
Seroresponse 
Rate 
97.8 
10% 
100 
Y 
Seroresponse 
Rate 
93.3 
10% 
99.0 
W 
Seroresponse 
Rate 
86.7 
10% 
91.0 
Overall 
90.0 
Note: Evaluable subjects: Group 1 = 261 subjects; Group 2 = 261 subjects 
*Estimated responses are based on results observed in MET39 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 25 of 121 
 
For the Secondary Objective: 
Thirty days after the month 12 vaccination (after the second dose vaccination) 
With 261 evaluable subjects in Group 1 and 261 evaluable subjects in 
Group 2, the study will have 100% power by using Farrington and Manning’s 
method to declare the non-inferiority of Group 1 vs Group 2. 
 
Table S2: Power estimates to reject the secondary null hypothesis  
Antigen 
Endpoint 
Estimated 
response (%)* 
Non-inferiority 
margin 
Power 
(%) 
A 
% ≥1:8 
 
>99.9 
10% 
100 
C 
% ≥1:8 
 
>99.9 
10% 
100 
Y 
% ≥1:8 
 
97.8 
10% 
100 
W 
% ≥1:8 
97.8 
10% 
100 
Overall 
 
100 
Note: Evaluable subjects: Group 1 = 261 subjects; Group 2 = 261 subjects 
*Estimated responses are based on results observed in MET39 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 26 of 121 
Table of Study Procedures – Group 1 and Group 2  
Phase III Study, 4 Visits, 2 Vaccinations visits, 3 Blood Samples, 4 Telephone Calls and 12 Months Duration per Subject 
Visit (V) / Contact 
Visit 1 
Telephone 
Call (TC) 
1* 
Visit 2 
TC 2† 
Visit 3 
TC 3* 
Visit 4 
TC 4 Follow-
up contact‡ 
Approximate age of subjects 
6 to 7 
months§ 
 
7 to 8 
months 
11.5 to 12.5 
months 
12 to 13 
months 
 
13 to 14 
months 
18 to 19 
months 
Study timelines (days) 
D0 
Visit 1  
+8 days 
Visit 1  
+30 days  
Visit 3  
-14 days 
≥6 months 
post-Visit 1 
Visit 3  
+8 days 
Visit 3 
+30 days 
Visit 3  
+180 days 
Time windows (days) 
 
+2 days 
+21 days 
 
 
+2 days 
+21 days 
+30 days 
Informed consent 
X 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
 
 
 
Collection of demographic data 
X 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
Physical examination (including temperature measurement) 
** 
X 
 
 
 
X 
 
 
 
Contact interactive response technology (IRT) system for 
randomization/allocation of subject number/vaccine group 
assignment 
X 
 
 
 
 
 
 
 
Review of temporary contraindications for blood sampling†† 
X 
 
X 
 
X 
 
X 
 
Blood sampling (BL) (3 mL) 
BL0001‡‡ 
 
BL0002A§§ 
 
BL0002B‡‡*** 
 
BL0003 
 
Review of warning and precautions to vaccinations 
X 
 
 
 
X 
 
 
 
Review of contraindications to subsequent vaccinations and 
conditions for withdrawal††† 
 
 
 
 
X 
 
 
 
Contact IRT system for vaccine assignment 
X 
 
 
 
X 
 
 
 
Vaccination with MenACYW conjugate vaccine or 
MENVEO® 
X 
 
 
 
X 
 
 
 
Vaccination with routine pediatric vaccines‡‡‡ 
X§§§ 
 
 
 
X 
 
X**** 
 
Immediate surveillance (30 minutes) 
X 
 
 
 
X 
 
 
 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 27 of 121 
Visit (V) / Contact 
Visit 1 
Telephone 
Call (TC) 
1* 
Visit 2 
TC 2† 
Visit 3 
TC 3* 
Visit 4 
TC 4 Follow-
up contact‡ 
Approximate age of subjects 
6 to 7 
months§ 
 
7 to 8 
months 
11.5 to 12.5 
months 
12 to 13 
months 
 
13 to 14 
months 
18 to 19 
months 
Study timelines (days) 
D0 
Visit 1  
+8 days 
Visit 1  
+30 days  
Visit 3  
-14 days 
≥6 months 
post-Visit 1 
Visit 3  
+8 days 
Visit 3 
+30 days 
Visit 3  
+180 days 
Time windows (days) 
 
+2 days 
+21 days 
 
 
+2 days 
+21 days 
+30 days 
Diary card provided 
DC1 
 
DC2 
 
DC3 
 
 
 
Telephone Call 
 
X 
 
X 
 
X 
 
X 
Diary card reviewed and collected 
 
 
DC1 
 
DC2 
 
DC3 
 
Recording of solicited injection site and systemic reactions††††
X 
 
 
 
X 
 
 
 
Recording of unsolicited adverse events 
Recorded from D0 to D30 after each vaccination visit 
Reporting of SAEs (including AESIs) and MAAEs‡‡‡‡ 
To be reported throughout the study period 
Collection of reportable concomitant medications 
X 
 
X 
 
X 
 
X 
 
Memory Aid (MA) provided 
 
 
 
 
 
 
X§§§§ 
 
Completion at End of study 
 
 
 
 
 
 
X 
 
*This call will be made 8 days after the respective vaccinations. If day 8 falls on a weekend or holiday, the telephone call may be made on the following business day. During this telephone call, the staff 
will find out whether the subject experienced any SAE and/or MAAE not yet reported, and will remind the subject's parent / guardian to continue using the diary card, to bring the diary card to the 
study center at the next visit, and to confirm the date and time of the next visit. 
†Staff will contact the subjects’ parent / guardian by telephone within the 14 day time period before Visit 3 to remind them about the forthcoming study visit. If the subject’s participation in the study is 
discontinued, the information recorded on the diary card will be reviewed at this time and the diary card will be retrieved by the site. 
‡Staff will contact the subject’s parent/ guardian by telephone at 6 months (+ 30 days) after the last vaccination visit to identify the occurrence of any SAEs (including any AESIs) and MAAEs not yet 
reported 
§At Visit 1, subjects must be at least 24 weeks of age (168 days, the minimum age for the final dose of hepatitis B vaccine in the vaccine series) (1), and no more than 32 weeks of age (224 days, the 
maximum age for the 3rd dose of rotavirus vaccine administration). 
**Physical examination should be performed as per routine standard of care. Temperature should be measured before vaccination and recorded in the source documents. 
††Should a subject receive oral or injectable antibiotic therapy within 3 days prior to any blood draw, the investigator will postpone that blood draw until it has been 3 days since the subject last received 
oral or injectable antibiotic therapy. Postponement must still be within the timeframe for blood draw. If postponement would result in the sample collection falling outside of this timeframe, the blood 
sample should be collected without postponement, and it should be documented appropriately that the sample was taken less than 3 days after stopping antibiotic treatment. 
‡‡Blood sample will be drawn prior to vaccinations. 
§§Blood sample at Visit 2 is applicable only to approximately the first 50% of the subjects in Group 1 and Group 2. 
***Blood sample at Visit 3 is applicable only to the subjects in Group 1 and Group 2 who did not provide a blood sample at Visit 2 (approximately 50% of subjects in each group). 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 28 of 121 
†††Physical examination should be performed on the basis of relevant medical history at the time of the visit according to the investigator’s clinical judgment. Temperature should be measured before 
each vaccination and recorded in the source documents. 
‡‡‡In children immunized with PedvaxHIB® at 2 and 4 months of age, a third dose of Hib vaccine at 6 months of age is not required. 
§§§Routine pediatric vaccines recommended at this age are to be given as per standard of care, and will not be provided by the Sponsor. 
****PCV13 will not be provided by the Sponsor. PCV13 may be given as per standard of care outside of the study during the last study visit after completing all the study procedures (Visit 4). 
††††Solicited injection site and systemic reactions will be recorded from D0 through D07 after each vaccination 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. 
§§§§The memory aid will be used only for the recording of SAEs (including AESIs) and MAAEs from Visit 4 to the 6-month follow-up phone call (TC4). 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 29 of 121 
Table of Study Procedures – Group 3 and Group 4  
Phase III Study, 3 Visits, 2 Vaccination visits, 2 Blood Samples, 10-month Duration per Subject 
Visit / Contact 
Visit 1 
TC 1* 
Visit 2 
TC 2* 
Visit 3 
TC 3 
Follow-up 
contact† 
Approximate age of subjects 
17 to 19 
months 
 
20 to 23 
months 
 
21 to 24 
months 
27 to 30 
months 
Study timelines (days) 
D0 
Visit 1 
+8 
days 
≥3 
months 
post-
Visit 1 
Visit 2  
+8 days 
Visit 2  
+30 days 
Visit 2  
+180 days 
Time windows (days)  
 
+2 
days 
 
+2 days 
+21 days 
+30 days 
Informed consent 
X 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
 
 
 
 
 
Collection of demographic data 
X 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
Physical examination (including 
temperature)‡ 
X 
 
 
 
 
 
Randomization/allocation of subject 
number 
X 
 
 
 
 
 
Review of temporary contraindications 
for blood sampling§ 
X 
 
 
 
X 
 
Blood sampling (BL) (3 mL) 
BL0001** 
 
 
 
BL0002 
 
Review of warning and precautions to 
vaccinations 
X 
 
X 
 
 
 
Review of contraindications to 
subsequent vaccinations and conditions 
for withdrawal†† 
 
 
X 
 
 
 
Contact IRT system for vaccine 
assignment 
X 
 
X 
 
 
 
Vaccination with MenACYW conjugate 
vaccine or Menactra® 
X 
 
X 
 
 
 
Immediate surveillance (30 minutes) 
X 
 
X 
 
 
 
Diary card provided 
DC1 
 
DC2 
 
 
 
Telephone Call 
 
X 
 
X 
 
X 
Diary card reviewed and collected 
 
 
DC1 
 
DC2 
 
Recording of solicited injection site and 
systemic reactions‡‡ 
X 
 
X 
 
 
 
Recording of unsolicited adverse events 
Recorded from D0 to D30 after each vaccination visit 
Reporting of SAEs (including AESIs) and 
MAAEs§§ 
To be reported throughout the study period 
Collection of reportable concomitant 
medications 
X 
 
X 
 
X 
 
MA provided 
 
 
 
 
X 
 
Completion at End of study 
 
 
 
 
X 
 
*This call will be made 8 days after the respective vaccinations. If day 8 falls on a weekend or holiday, the telephone call may be 
made on the following business day. During this telephone call, the staff will find out whether the subject experienced any 
SAE and/or MAAE not yet reported, and will remind the subject's parent / guardian to continue using the diary card, to bring 
the diary card to the study center at the next visit, and to confirm the date and time of the next visit. 
†Staff will contact the subject’s parent / guardian by telephone at 6 months (+ 30 days) after the last vaccination visit to identify 
the occurrence of any SAEs (including any AESIs) and MAAEs not yet reported. 
‡Physical examination should be performed as per routine standard of care. Temperature should be measured before each 
vaccination and recorded in the source documents. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 30 of 121 
§Should a subject receive oral or injectable antibiotic therapy within 3 days prior to any blood draw, the investigator will postpone 
that blood draw until it has been 3 days since the subject last received oral or injectable antibiotic therapy. Postponement must 
still be within the timeframe for blood draw. If postponement would result in the sample collection falling outside of this 
timeframe, the blood sample should be collected without postponement, and it should be documented appropriately that the 
sample was taken less than 3 days after stopping antibiotic treatment. 
**Blood sample will be drawn prior to vaccinations. 
††Physical examination should be performed on the basis of relevant medical history at the time of the visit according to the 
investigator’s clinical judgment. Temperature should be measured before vaccination and recorded in the source documents. 
‡‡Solicited injection site and systemic reactions will be recorded from D0 through D07 after each vaccination 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. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 31 of 121 
List of Abbreviations  
AAP 
American Academy of Pediatrics 
ACIP 
Advisory Committee on Immunization Practices 
AE 
adverse event 
AESI 
adverse event of special interest 
AIDS 
acquired immune deficiency syndrome 
AR 
adverse reaction 
BL 
blood sampling 
CDM 
Clinical Data Management 
CI 
confidence interval 
CQA 
Clinical Quality Assessment 
CRA 
Clinical Research Associate 
CRB 
(electronic) case report book [all the case report forms for a subject] 
CRF 
(electronic) case report form 
CTA 
clinical trial agreement 
CTL 
Clinical Team Leader 
D 
day 
DC 
diary card 
DTaP 
diphtheria tetanus acellular pertussis vaccine 
DU 
D-antigen units 
EDC 
electronic data capture 
FAS 
full analysis set 
FDA 
Food and Drug Administration 
FHA 
filamentous hemagglutinin  
FIM 
fimbriae types 2 and 3 
FVFS 
first visit, first subject 
FVLS 
first visit, last subject 
GCI 
Global Clinical Immunology 
GCP 
Good Clinical Practice 
GMT 
geometric mean titer 
GPV 
Global Pharmacovigilance 
Hib 
Haemophilus influenza type b 
HIV 
human immunodeficiency virus 
hSBA 
serum bactericidal assay using human complement 
IATA 
International Air Transport Association 
ICF 
informed consent form 
ICH 
International Council for Harmonisation 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 32 of 121 
IEC 
Independent Ethics Committee 
IM 
intramuscular 
IMD 
invasive meningococcal disease 
IME 
important medical event 
IOM 
Institute of Medicine 
IPV 
poliovirus [inactivated] vaccine 
IRB 
Institutional Review Board 
IRT 
interactive response technology 
ITP 
idiopathic thrombocytopenic purpura 
IU 
international unit 
LCLS 
last contact, last subject 
Lf 
Limit of Flocculation 
LLOQ 
lower limit of quantification 
LLT 
lowest level term 
MA 
memory aid 
MAAE 
medically-attended adverse event 
MedDRA 
medical dictionary for regulatory activities 
MCV4 
quadrivalent meningococcal conjugate vaccine 
MMR 
measles, mumps, rubella 
NIMP 
non-investigational medicinal product 
NSAID 
non-steroidal anti-inflammatory drug 
PCV13 
pneumococcal 13-valent conjugate vaccine 
PFU 
plaque-forming unit 
PPAS 
per-protocol analysis set 
PRN 
pertactin 
PRP 
polyribosyl-ribitol phosphate 
PS 
polysaccharide 
PT 
pertussis toxoid / toxin 
PV 
Pharmacovigilance 
RCDC 
reverse cumulative distribution curve 
RMO 
Responsible Medical Officer 
RBM 
risk based monitoring 
rSBA 
serum bactericidal assay using baby rabbit complement 
SAE 
serious adverse event 
SafAS 
safety analysis set 
SAP 
statistical analysis plan 
SC 
subcutaneous 
SMT 
Safety Management Team 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 33 of 121 
SOC 
system organ class 
TBD 
to be determined 
TC 
telephone call 
TMF 
trial master file 
US 
United States 
vs 
versus 
WHO 
World Health Organization 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 34 of 121 
1 
Introduction  
1.1 
Background  
This study (MET61) will evaluate the safety and immunogenicity of MenACYW conjugate 
vaccine compared to the licensed comparator vaccine, MENVEO® [meningococcal (Groups A, C, 
Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine], when administered 
concomitantly with routine pediatric vaccines in infants and toddlers as a 2-dose series at 
6 to 7 months of age and 12 to 13 months of age in United States (US). MET61 will also evaluate 
the safety and immunogenicity of MenACYW conjugate vaccine compared to the licensed 
comparator vaccine, Menactra® (meningococcal [Groups A, C, Y and W-135] polysaccharide 
diphtheria toxoid conjugate vaccine), when administered in US toddlers as a 2-dose series at 
17 to 19 months of age and 20 to 23 months of age. 
Invasive meningococcal disease (IMD) is a serious illness caused by the bacterium Neisseria 
meningitidis (N. meningitidis), a Gram-negative diplococcus found exclusively in humans. 
Symptoms may include headache, fever, nausea, vomiting, photophobia, stiff neck, lethargy, 
myalgia, and a characteristic petechial rash (1). At least 12 different 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 remains the main cause of epidemics in the world and is especially 
dominant in Africa and Asia. Serogroup W has been observed in Africa, as well as the United 
Kingdom, 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), Brazil  
(14) (15), and other parts of the world. 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 the frequency with which it causes sporadic cases has 
gradually increased in the US and more recently in Canada and Europe (17) (18) (19). The 
Y serogroup is commonly associated with meningococcal pneumonia, particularly in older adults 
≥ 65 years of age (20). Outbreaks of serogroup B meningococcal disease have also been reported 
on college campuses in the US during the last five-year period: a prolonged outbreak of serogroup 
B on a university campus in Ohio from 2008 – 2010 and 2 universities in New Jersey and 
California in 2013 (21) (22). 
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 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 year old group. The highest incidence rate in Europe is 
caused by serogroup B, followed by C (23). 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 aged 65 years and above. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 35 of 121 
Surveillance data from England and Wales showed an increase in endemic meningococcal 
serogroup W disease across all age groups, accounting for 15% of all IMD cases in 2013 - 2014 
compared with an average of 1% to 2% of all IMD cases in earlier years (24). A gradual increase 
in serogroup Y IMD has also been recently reported in England and Wales between 2007 - 2009 
(25) and in Sweden during 2005 – 2012 (26) (27). Nearly 50% of all IMD in Sweden was caused 
by serogroup Y in 2012 (26). Similarly, an increase in the proportion of IMD caused by serogroup 
Y has been observed in other Nordic countries, accounting for 31% in Norway in 2009 – 2010 
(28) and 38% in Finland in 2010 (29). 
In the US, the incidence rate of IMD was 0.14 per 100,000 in all ages; 0.83 per 100,000 in infants 
less than 1 year; 0.62 per 100,000 in toddlers 1 year of age; 0.27 per 100,000 in children 2 to 
4 years of age; and 0.02 per 100,000 in children 5 to 17 years of age in 2013. The age specific 
incidence rate per 100,000 was 0.08 in adults 50 to 64 years of age, 0.03 in adults 65 to 74 years 
of age, 0.14 in adults 75 to 84 years of age, and 0.43 in adults 85 years of age and older in 2013 
(30). Serogroups B, C, and Y are the major causes of meningococcal disease in the US, each 
being responsible for approximately one-third of the overall cases. The proportion of cases caused 
by each serogroup varies by age group. Serogroups C, W, or Y, which are included in vaccines 
available in the US, cause 73% of all cases of meningococcal disease among persons 11 years of 
age or older (31). Approximately 60% of disease among children aged 0 through 59 months is 
caused by serogroup B, for which no conjugate vaccine is licensed or available in the US. More 
than 50% of meningococcal disease in children 0 to 6 months of age is caused by serogroup B; 
serogroup Y is also more prevalent in this age group (20). 
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 including children as young as 6 weeks of age, 
adolescents, and adults (including those 56 years of age and older). 
1.2 
Background of the Investigational Product  
1.2.1 
Clinical  
The MenACYW conjugate vaccine formulation was finalized based on data provided by 
2 studies: MET28, a Phase I study in infants, toddlers, and adults 18 to < 40 years of age; and 
MET32, a Phase I/II study in toddlers. 
The formulation has been evaluated in over 2000 subjects (infants, toddlers, adolescents, and 
adults > 56 years of age) in completed studies MET39, MET44, MET50, MET54, and MET56. 
MenACYW conjugate vaccine is also being evaluated in ongoing Phase III studies: MET51 and 
MET57 (toddlers 12 to 23 months of age); MET35 (children 2 to 9 years of age); MET43 
(adolescents and adults 15 to 55 years of age); and MET49 (older adults ≥ 56 years of age). 
MenACYW conjugate vaccine was found to be well tolerated and no unanticipated or new 
significant safety concerns have been identified in the clinical trials completed to date. 
The relevant Phase II studies are discussed below. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 36 of 121 
1.2.1.1 
Study MET39 (Phase II)  
MET39 was a Phase II, randomized, open-label, multi-center study conducted in the US for which 
580 healthy subjects from 2 to 15 months of age were enrolled. This study evaluated the optimal 
vaccination schedule in the infant/toddler population. Subjects in Group 1 through 
Group 4 received 1, 2, or 3 primary doses plus an additional dose of the MenACYW conjugate 
vaccine in the second year of life, concomitantly with routine pediatric vaccines at several 
different vaccination schedules. Subjects in Group 5 received 1 dose of the MenACYW conjugate 
vaccine concomitantly with routine pediatric vaccines. The routine pediatric vaccines given 
concomitantly with MenACYW conjugate vaccine at various schedules included Prevnar® 
(pneumococcal conjugate vaccine) or Prevnar 13® (pneumococcal 13-valent conjugate vaccine 
[PCV13]), Pentacel® (diphtheria, tetanus, pertussis [acellular, component]-poliovirus 
[inactivated]//Haemophilus influenzae type b [DTaP-IPV//Hib]), ROTARIX® (monovalent 
rotavirus vaccine [RV1]) or RotaTeq® (pentavalent rotavirus vaccine [RV5]), hepatitis B vaccine,  
M-M-R® II vaccine (measles, mumps, and rubella vaccine [MMR]), and VARIVAX® 
(varicella vaccine). 
Immunogenicity 
After the primary series consisting of 1, 2, or 3 doses of MenACYW conjugate vaccine, protective 
threshold antibody titers of ≥ 1:8 [serum bactericidal assay using human complement (hSBA)] 
were attained by > 88% of subjects for serogroup C and by 62% to 74% of subjects for 
serogroup A. For serogroups Y and W, ≥ 90% of subjects achieved the threshold titer after 
3 doses, 75% to 84% of subjects after 2 doses, but only 25% of subjects after a single dose 
administered at 6 months of age. 
After an additional dose of MenACYW conjugate vaccine in the second year of life (12 or 
15 months of age), between 91% and 100% of subjects achieved the protective threshold 
regardless of the number of doses they received in the first year of life. 
Safety 
MenACYW conjugate vaccine was well tolerated in infants and toddlers regardless of the 
immunization schedule and the number of doses administered. Safety results were comparable to 
those seen in control group subjects regardless of the immunization schedule and the number of 
doses administered. The safety profile of the licensed vaccines given concomitantly with 
MenACYW conjugate vaccine was similar to that of the licensed vaccines given concomitantly 
without MenACYW conjugate vaccine. 
No deaths occurred within 30 days. There were 2 subjects in Group 4 who died during the study, 
1 as a result of hypoxic ischemic encephalopathy which started 96 days after the 6-month 
vaccination and 1 as a result of non-accidental head trauma 36 days after the 12-month 
vaccination. These events were considered by the Investigator as unrelated to study vaccine. 
There were 2 other subjects who discontinued the study due to a serious adverse event (SAE) and 
the receipt of intravenous immunoglobulin treatment: 1 subject in Group 2 with Kawasaki 
disease, 106 days after the 6-month vaccination; and 1 subject in Group 3 with middle lobe 
pneumonia and Kawasaki disease, 50 and 52 days, respectively, after the 4-month vaccinations. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 37 of 121 
One other subject in Group 4 was discontinued due to a non-serious adverse event (AE) 
(viral rash 1 day after the 6-month vaccinations). None of these AEs leading to discontinuation 
were considered by the Investigator as related to the vaccine. There were no vaccine- related 
SAEs during this study. 
1.2.1.2 
Study MET54 (Phase II)  
MET54 was a Phase II, randomized, open-label, active-controlled, multi-center study conducted 
in Europe (Finland). This study evaluated the immunogenicity and safety profile of a single dose 
of MenACYW conjugate vaccine when given alone in healthy, meningococcal-vaccine naïve 
toddlers compared to that of the licensed vaccine Nimenrix®. A total of 188 meningococcal 
vaccine naïve subjects 12 to 23 months of age on the day of enrollment were randomized to 1 of 
2 groups. Group 1 received a single dose of MenACYW conjugate vaccine and Group 2 received 
a single dose of Nimenrix®. 
Immunogenicity 
Antibody responses to the antigens (serogroups A, C, Y, and W) were evaluated by serum 
bactericidal assay using baby rabbit complement (rSBA) and human complement (hSBA). 
MenACYW conjugate vaccine immune responses evaluated by rSBA and hSBA were generally 
comparable to Nimenrix® immune responses with some variation by serogroup. 
hSBA 
Most subjects in both groups had hSBA titers ≥ 1:8 at D30: the percentages after MenACYW 
conjugate vaccine for serogroups A, Y, and W (ranging from 97.8% [89/91] to 98.9% [90/91]) 
were comparable to those after Nimenrix® (ranging from 91.9% [79/86] to 100.0% [86/86]). 
The percentage of subjects with hSBA titers ≥ 1:8 for serogroup C was higher after MenACYW 
conjugate vaccine (100.0% [91/91]) than after Nimenrix® (89.5% [77/86]). At D30, most subjects 
in both groups demonstrated an hSBA vaccine seroresponse. The percentage of subjects with an 
hSBA vaccine seroresponse for serogroups A, Y, and W was comparable in both groups 
(ranging from 96.7% [87/90] to 98.9% [90/91] after MenACYW conjugate vaccine and from 
91.9% [79/86] to 98.8% [85/86] after Nimenrix®). The percentage of subjects with an hSBA 
vaccine seroresponse for serogroup C was higher after MenACYW conjugate vaccine (100.0% 
[91/91]) than after Nimenrix® (86.0% [74/86]). 
rSBA 
Most subjects had rSBA titers ≥ 1:128 at D30. The percentages after MenACYW conjugate 
vaccine were similar (100.0% [91/91] for serogroups A, Y, and W) or numerically higher 
(100.0% [91/91] for serogroup C) compared to Nimenrix® (100.0% [86/86] for serogroups A, Y, 
and W and 94.2% [81/86] for serogroup C). At D30, most subjects in both groups demonstrated 
an rSBA vaccine seroresponse as defined in the SAP and as defined in the protocol. 
The percentage of subjects with any rSBA vaccine seroresponse by either definition for 
serogroup A was numerically lower after MenACYW conjugate vaccine (91.2% [83/91]) than 
Nimenrix® (98.8% [85/86]) and the percentages of subjects with any rSBA vaccine seroresponse 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 38 of 121 
by either definition were similar or comparable between the 2 groups for serogroups C, Y, and W 
(all > 96%). 
Safety 
Overall, vaccination with MenACYW conjugate vaccine among toddlers 12 to 23 months of age 
was found to be safe with no safety concerns identified. The MenACYW conjugate vaccine was 
well tolerated with no immediate AEs or adverse reactions (ARs), no discontinuations due to an 
SAE or other AE, and no related SAEs. 
The safety profile of MenACYW conjugate vaccine was comparable to that of the licensed 
vaccine Nimenrix®. 
No new clinically important safety findings were identified with administration of the 
MenACYW conjugate vaccine. The MenACYW conjugate vaccine was well tolerated and 
immunogenic. Single dose of the MenACYW conjugate vaccine demonstrated excellent potential 
to be an alternative vaccine option for toddlers, receiving meningococcal vaccination for the first 
time. 
1.3 
Potential Benefits and Risks  
1.3.1 
Potential Benefits to Subjects  
MenACYW conjugate vaccine is an investigational vaccine that is undergoing active clinical 
investigation. There may be no direct benefit from receiving the MenACYW conjugate vaccine. 
However, based on the data generated from previous studies, the immunogenicity profile of the 
MenACYW conjugate vaccine in different age groups shows that the majority of subjects 
developed seroprotective levels of antibodies after vaccination. The safety evaluation indicates 
that the vaccine is well-tolerated, and no safety issues have been detected to date. In all, the data 
support further evaluation of the MenACYW conjugate vaccine in humans. 
Subjects who receive MENVEO® or Menactra® will likely be protected against meningococcal 
disease caused by N. meningitidis serogroups A, C, Y, and W. 
As with any vaccine, MenACYW conjugate vaccine, MENVEO®, and Menactra ® may not protect 
100% of individuals against the diseases they are designed to prevent. 
1.3.2 
Potential Risks to Subjects  
Like other vaccines, MenACYW conjugate vaccine, MENVEO®, or Menactra® may cause 
injection site reactions such as pain, swelling, and erythema, or certain systemic events such as 
fever, irritability, drowsiness, loss of appetite, abnormal crying, and vomiting when administered 
to infants / toddlers. There may be a rare possibility of an allergic reaction, which could be severe. 
There may also be a risk of febrile convulsion in some children who experience high fever. 
There may be other risks for MenACYW conjugate vaccine, MENVEO®, or Menactra® that are 
not yet known. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 39 of 121 
In a previous study with MenACYW conjugate vaccine (MET32), 1 SAE of reactive arthritis 
reported in a toddler was considered by the Investigator to be related to the investigational 
vaccine. The subject developed right knee inflammation the day after receiving MenACYW 
conjugate vaccine, given by IM injection in the right deltoid. The subject recovered after 
treatment with ibuprofen and antibiotics. Results of the reactive arthritis investigations performed 
as part of the workup were not indicative of any specific diagnosis. A point of further 
consideration was the monoarticular nature of the inflammation in this subject; reactive arthritis 
would typically be present clinically in a polyarticular fashion. Importantly, no similar cases have 
been reported following the administration of MenACYW conjugate vaccine in any other 
completed trials. 
Guillain-Barré syndrome has been reported mostly in persons aged 11 to 19 years who had 
symptom onset within 6 weeks of administration of a US licensed meningococcal conjugate 
vaccine (32). A retrospective cohort study carried out in the US using healthcare claims data 
found no evidence of increased Guillain-Barré syndrome risk associated with the use of that 
vaccine. The study was able to exclude all but relatively small incremental risks (33). 
A review by the Institute of Medicine (IOM) found inadequate evidence to accept or reject a 
causal relationship between tetanus toxoid containing vaccines and Guillain-Barré syndrome (34). 
The IOM found evidence for a causal relation between tetanus toxoid-containing vaccines and 
brachial neuritis (35). Arthus reactions are rarely reported after vaccination and can occur after 
tetanus toxoid-containing vaccines (36). 
No occurrences of Guillain-Barré syndrome, brachial neuritis, or Arthus reaction have been 
reported with the use of MenACYW conjugate vaccine in the completed clinical trials. 
The potential risks listed here are not exhaustive. Refer to the Investigator’s Brochure of the 
investigational vaccine, package inserts for MENVEO® (37),  Menactra® (38), and concomitant 
routine pediatric vaccines for additional information regarding potential risks. 
1.4 
Rationale for the Study  
The MenACYW conjugate vaccine is designed for the immunization of individuals of all ages 
(infants 6 weeks of age and older through and including older adults > 56 years of age) against 
IMD. The purpose of the vaccine is to provide broad coverage against circulating meningococcal 
strains from serogroups A, C, Y, and W. Compared to a previous Sanofi Pasteur meningococcal 
conjugate vaccine, Menactra®, the MenACYW conjugate vaccine is prepared using tetanus toxoid 
as the carrier protein. Conjugation of PS antigens to a protein carrier can induce T cell-dependent 
immune responses, which are anticipated to give rise to higher antibody titers, longer duration of 
the immune response, and enhanced immunologic memory that allows for a booster response. The 
program targets licensure of the MenACYW conjugate vaccine in many countries in North 
America, Europe, Latin America, Africa, the Middle East, and Asia Pacific. 
The MenACYW conjugate vaccine is designed to cover broader age groups than those covered by 
Menomune® -A/C/Y/W-135 and Menactra®. Menactra® has been very successful since its 
licensure in 2005; however, it is not licensed in Europe and is not indicated in persons 8 months 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 40 of 121 
of age or younger or 56 years of age and older. While Menomune® -A/C/Y/W-135 and Menactra® 
are currently licensed in different parts of the world, the MenACYW conjugate vaccine is being 
developed by Sanofi Pasteur to ultimately replace Menomune® -A/C/Y/W-135 and Menactra® in 
the global market as a quadrivalent meningococcal conjugate vaccine indicated in 
infants/toddlers, children, adolescents, adults, and older adults > 56 years of age. 
Meningococcal PS vaccines have two important limitations: a) the antibody response is age-
dependent, with infants giving the poorest response; and b) PSs alone are T-cell independent 
immunogens, and therefore no anamnestic response is seen. The immunogenicity of PS vaccines 
in infants and children has been shown to be improved by conjugating the PSs to protein carriers. 
Among the key advantages expected of the tetanus carrier is improved immunogenicity in infants 
and older adults. Pre-clinical studies using a mouse model and investigating different carriers, 
showed significant levels of PS-specific total immunoglobulin G (IgG) and bactericidal responses 
in response to the formulations with tetanus toxoid as a carrier. Early Phase I/II trials including 
those with the final formulation (MET39 and MET44) showed the potential of the candidate 
vaccine as a very good immunogen in all age groups, including young infants and older adults. 
The MenACYW conjugate vaccine was found to be immunogenic and well tolerated; it did not 
raise any safety concerns in the above or subsequent trials using the final formulation or in the 
earlier trials. 
MenACYW conjugate vaccine is being developed for the US infant/toddler population as a 4-dose 
(2, 4, 6, and 12 to 18 months of age) and 2-dose (6 to 7, and 12 to 13 months of age) series. 
Three Phase III studies (including MET61) will generate data to primarily support the licensing of 
the MenACYW conjugate vaccine in the US with an infant/toddler indication from 6 weeks of 
age. The purpose of the MET61 study is to evaluate the safety and immunogenicity of 
MenACYW conjugate vaccine and the comparator MENVEO® when administered in a 1 + 1 
schedule and concomitantly with routine pediatric vaccines in healthy infants and toddlers in the 
US. This study will also describe the safety and immunogenicity of MenACYW conjugate 
vaccine and Menactra® when administered in a 1 +1 schedule to healthy toddlers in the US. 
The MET61 study will generate data which will significantly contribute towards the overall safety 
database of the MenACYW conjugate vaccine in the US and in general. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 41 of 121 
2 
Study Objectives  
2.1 
Primary Objective  
To demonstrate the non-inferiority of the vaccine seroresponsea to meningococcal serogroups 
A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared 
to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and 
toddlers 6 to 7 months of age and 12 to 13 months of age 
The endpoint for the primary objective is presented in Section 9.1.2.1. 
2.2 
Secondary Objectives  
1) To demonstrate the non-inferiority of the percentage of subjects with hSBA titers to 
meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of 
MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given 
concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of 
age and 12 to 13 months of age 
2) To describe the antibody response against meningococcal serogroups A, C, Y, and W 
30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate 
vaccine or MENVEO®  
3) To describe the antibody response against meningococcal serogroups A, C, Y, and W 
30 days after the first vaccination at 6 to 7 months of age with MenACYW conjugate 
vaccine or MENVEO® (in a subset of subjects) 
4) To describe the antibody response against meningococcal serogroups A, C, Y, and W 
6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate 
vaccine or MENVEO® (in a subset of subjects) 
5) To describe the antibody response against meningococcal serogroups A, C, Y, and W 
30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate 
vaccine or Menactra® 
The endpoints for the secondary objectives are presented in Section 9.2.2.1. 
2.3 
Observational Objectives  
Safety 
                                                 
a  Vaccine seroresponse is measured with hSBA. hSBA vaccine seroresponse for serogroups A, C, Y, and W 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 ≥ 4-fold greater than the pre-
vaccination titer 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 42 of 121 
1) To describe the safety profile of MenACYW conjugate vaccine and MENVEO® when 
administered concomitantly with routine pediatric vaccines in healthy infants and toddlers 
2) To describe the safety profile of MenACYW conjugate vaccine and Menactra® administered 
in toddlers 
The endpoints for the observational objectives are presented in Section 9.3. 
3 
Investigators and Study Organization  
This study will be conducted in approximately 30 centers in the US. The Principal Investigators 
and any sub-investigators at the individual sites will be coordinated by 1 Coordinating 
Investigator. Details of the study centers, the Investigators at each center, and the Coordinating 
Investigator are provided in the “List of Investigators and Centers Involved in the Trial” 
document. 
An internal safety management team (SMT) will review the data being generated from all the 
ongoing studies with MenACYW conjugate vaccine at regular intervals for any new safety signals 
or safety concerns. 
The Sponsor’s Responsible Medical Officer (the RMO, the person authorized to sign this protocol 
and any amendments on behalf of the Sponsor) is 
 
4 
Independent Ethics Committee / Institutional Review Board  
Before the investigational product can be shipped to the investigational site and before the 
inclusion of the first subject, this protocol, the informed consent form (ICF), subject recruitment 
procedures, and any other written information to be provided to subjects must be approved by, 
and / or receive favorable opinion from the appropriate Independent Ethics Committee (IEC) or 
Institutional Review Board (IRB). 
In accordance with Good Clinical Practice (GCP) and local regulations, each Investigator and / or 
the Sponsor are responsible for obtaining this approval and / or favorable opinion before the start 
of the study. If the protocol is subsequently amended, approval must be re-obtained for each 
substantial amendment. Copies of these approvals, along with information on the type, version 
number, and date of document, and the date of approval, must be forwarded by the Investigator to 
the Sponsor together with the composition of the IEC / IRB (the names and qualifications of the 
members attending and voting at the meetings). 
The Investigator and Sponsor will submit written summaries of the status of the study to the IEC / 
IRB annually, or more frequently if requested. All SAEs occurring during the study that are 
related to the product administered will be reported by the Investigator to the IEC / IRB, 
according to the IEC / IRB policy. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 43 of 121 
5 
Investigational Plan  
5.1 
Description of the Overall Study Design and Plan  
5.1.1 
Study Design  
This is a Phase III, randomized, parallel group, active-controlled, multi-center study to compare 
the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® 
when administered in a 1 + 1 schedule and concomitantly with routine pediatric vaccines in 
healthy infants and toddlers in the US. This study will also describe the safety and 
immunogenicity of MenACYW conjugate vaccine and Menactra® when administered in a 1 +1 
schedule to healthy toddlers in the US. For each age group at enrollment, the study will have a 
modified double-blind design, i.e., modified double-blind between Group 1 and Group 2, and 
between Group 3 and Group 4. 
Approximately 1070 subjects will be enrolled. Approximately 870 healthy infants 6 to7 months of 
age will be randomized 1:1 to 2 groups, and 200 healthy toddlers 17 to 19 months of age will be 
randomized 1:1 to 2 groups: 
• 
Group 1: MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age 
and 12 to 13 months of age 
• 
Group 2: MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to13 months 
of age 
• 
Group 3: MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of 
age 
• 
Group 4: Menactra® at 17 to 19 months of age and 20 to 23 months of age 
The vaccination schedule and blood sampling is further detailed in Table 5.1 and Table 5.2. 
All subjects in Group 1 and Group 2 will receive a dose of either MenACYW conjugate vaccine 
or MENVEO® with the following routine pediatric vaccines to ensure compliance with the 
Advisory Committee on Immunization Practices (ACIP) recommendations: 
• 
Diphtheria, tetanus and acellular pertussis (DTaP) at 6 months of age 
• 
Inactivated poliovirus (IPV) at 6 months of age 
• 
Haemophilus influenzae type b (Hib) at 6 months of age. In children immunized with 
PedvaxHIB® at 2 and 4 months of age, a third dose of Hib vaccine at 6 months of age is not 
required. 
• 
Pneumococcal 13-valent conjugate (Prevnar 13®, PCV13) at 6 and 13 months of age 
• 
Rotavirus (RotaTeq®) at 6 months of age 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 44 of 121 
• 
Hepatitis B at 6 months of age 
• 
Measles, mumps, and rubella (M-M-R®II) at 12 months of age 
• 
Varicella (Varivax®) at 12 months of age. 
The routine pediatric vaccines recommended at 6 months of age will be given as per standard of 
care during the first study visit (Visit 1) along with the corresponding study vaccine. The dose of 
Prevnar 13® and Hib (for children vaccinated with monovalent Hib vaccine at 2 ,4, and 6 months 
of age) recommended in the second year of life may be given as per standard of care at the last 
study visit after completing all the study procedures (Visit 4). Routine pediatric vaccines 
recommended at 6 months of age and the dose of Prevnar 13® recommended in the second year of 
life will not be provided by the Sponsor but procured by the sites as per their standard practices. 
Blood Sampling 
All subjects in Group 1 and Group 2 will provide 3 blood samples for immunogenicity 
assessment: 
• 
A blood sample before the first study vaccination at Visit 1 (all subjects) 
• 
A blood sample 30 days after administration of the first dose of MenACYW conjugate 
vaccine or MENVEO® at Visit 2 (only from approximately the first 50% of the subjects in 
Group 1 and Group 2) 
• 
A blood sample before the 12-month vaccination at Visit 3 (only from the remaining 
approximately 50% of subjects in Group 1 and Group 2, who did not have a blood draw at 
Visit 2) 
• 
A blood sample 30 days after administration of the second dose of MenACYW conjugate 
vaccine or MENVEO® at Visit 4 (all subjects in Group 1 and Group 2) 
All subjects in Group 3 and Group 4 will provide 2 blood samples for immunogenicity 
assessment: 
• 
A blood sample before the first study vaccination at Visit 1 
• 
A blood sample 30 days after administration of the second dose of MenACYW conjugate 
vaccine or Menactra® at Visit 3 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 45 of 121 
Collection of Safety Data 
Immediate unsolicited systemic AEs will be collected within 30 minutes after each vaccination. 
Solicited AEs will be collected from Day (D) 0 to D07 after each vaccination; unsolicited AEs 
will be collected from D0 after each vaccination to the next study visit; SAEs (including adverse 
events of special interest [AESIs]) and medically attended adverse events (MAAEs) will be 
collected throughout the study from Visit 1 (first vaccination visit) until the end of the 6-month 
follow up period after the last vaccinations. 
5.1.2 
Justification of the Study Design  
The MET61 study is part of an ongoing development program that focuses on demonstrating that 
the safety profile of the MenACYW conjugate vaccine is acceptable and not different from that of 
licensed quadrivalent meningococcal conjugate vaccines (MCV4), and that the immunogenicity of 
the MenACYW conjugate vaccine is non-inferior to licensed comparators in direct comparison 
trials. MET61 is a pivotal Phase III immunogenicity and safety study in which the vaccine 
candidate will be evaluated in a 1 + 1 schedule in infants/toddlers receiving concomitantly 
licensed routine pediatric vaccines in the US. 
The primary objective of study MET61 is to describe and evaluate the safety and immunogenicity 
of MenACYW conjugate vaccine compared to the licensed comparator vaccine, MENVEO®, 
when administered concomitantly with routine pediatric vaccines in US infants and toddlers as a 
2-dose series administered at 6 to 7 months of age and 12 to 13 months of age. MET61 will also 
evaluate the safety and immunogenicity of MenACYW conjugate vaccine and the licensed control 
vaccine, Menactra®, when administered in US toddlers as a 2-dose series at 17 to 19 months of 
age and 20 to 23 months of age. 
The concomitant administration of standard of care pediatric vaccines together with 5 different 
administration schedules of the MenACYW conjugate vaccine has been assessed in 
infants/toddlers 2 to 15 months of age in the US in the MET39 study. The subjects received 
during, or prior to the study, a number of licensed recommended vaccines at 2, 4, and 6 months of 
age: Pentacel®, either Prevnar® or Prevnar 13®, RotaTeq® or ROTARIX®, and ENGERIX-B® or 
RECOMBIVAX HB®. All subjects received M-M-R® II and VARIVAX® at 12 months of age. 
A total of 457 subjects completed the study. The immunogenicity and safety profiles of selected 
licensed pediatric vaccines (Pentacel®, Prevnar® or Prevnar 13®, M-M-R® II, and VARIVAX®) 
were assessed when administered either concomitantly with or without MenACYW conjugate 
vaccine. There was no evidence of interference with the pediatric routine vaccines administered 
concomitantly with MenACYW conjugate vaccine and the vaccine was safe and well tolerated 
regardless of the number of doses administered during the first year of life. 
ACIP recommends routine administration of MCV4 for all persons aged 11 through 18 years. A 
single dose of vaccine should be administered at age 11 or 12 years, and a booster dose should be 
administered at age 16 years. In the US, meningococcal vaccination is not routinely recommended 
for children ≤ 10 years of age, however the vaccination is recommended for individuals at 
increased risk of disease. In infants at increased risk of disease starting vaccination at 8 weeks of 
age, the ACIP recommends a 4-dose series that includes doses at 2, 4, 6 and 12 months of age. In 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 46 of 121 
children at increased risk of disease who initiate vaccination at 7 through 23 months of age, a 2-
dose primary series with the second dose at least 12 weeks after the first dose and after the first 
birthday is recommended. Since MENVEO® is the only MCV4 licensed in US for use in infants 
as young as 2 months of age, the selection of MENVEO® as a comparator was considered most 
appropriate and aligned with the MET61 study design. 
Given that the meningococcal vaccines (investigational and control) used in this study have 
different appearances and preparation methods the study has a modified double blind design for 
each group at enrollment, i.e., modified double-blind between Group 1 and Group 2, and between 
Group 3 and Group 4, and thus, with the exception of the personnel administering the vaccine, 
everyone involved in study (participants, care provider, investigator, safety outcomes assessor, 
Sponsor) is blinded to avoid any bias. 
5.1.3 
Study Plan  
Vaccination and Blood Sampling 
A schedule of assessments, study vaccinations, and blood draws is provided in the Table of Study 
Procedures and Table 5.1 and Table 5.2. 
Table 5.1: Vaccination and blood sampling schedule - Group 1 and Group 2  
Age in months 
6 to 7 months 
7 to 8 months 
12 months 
13 months 
Visit # 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Procedure 
Blood 
Draw* 
Vaccines† 
Blood Draw‡ 
Blood 
Draw§ 
Vaccines 
Blood 
Draw 
Vaccines** 
Group 1 
X 
MenACYW 
DTaP 
IPV 
Hib 
PCV13 
Rotavirus 
HB 
X 
X 
MenACYW 
MMR 
Varicella 
X 
PCV13 
Hib 
Group 2 
X 
MENVEO 
DTaP 
IPV 
Hib 
PCV13 
Rotavirus 
HB 
X 
X 
MENVEO 
MMR 
Varicella 
X 
PCV13 
Hib 
* Blood will be drawn prior to vaccinations. 
† Routine pediatric vaccines recommended at this age are to be given as per standard of care, and will not be provided by the 
Sponsor. 
‡Blood sample at Visit 2 is applicable only to approximately the first 50% of the subjects in Group 1 and Group 2. 
§Blood sample at Visit 3 is applicable only to the subjects in Group 1 and Group 2 who did not provide a blood sample at Visit 2 
(approximately 50% in each group). 
** PCV13 and Hib may be given as per standard of care outside of the study during the last study visit after completing all the 
study procedures (Visit 4). PCV13 and Hib will not be provided by the Sponsor. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 47 of 121 
Table 5.2: Vaccination and blood sampling schedule - Group 3 and Group 4  
Age in months 
17-19 months 
20-23 months 
21-24 months 
Visit # 
Visit 1 
Visit 2 
Visit 3 
Procedure 
Blood Draw* 
Vaccine 
Vaccine 
Blood Draw 
Group 3 
X 
MenACYW 
MenACYW 
X 
Group 4 
X 
Menactra 
Menactra 
X 
*Blood will be drawn prior to vaccinations. 
 
Collection of Safety Data 
All subjects will be followed for safety from Visit 1 to 6 months after the last vaccination. 
• 
All subjects will be observed for 30 minutes after each vaccination, and any unsolicited 
systemic AEs occurring during that time will be recorded as immediate unsolicited systemic 
AEs in the electronic case report book (CRB). 
• 
The subject’s parent / guardian will record information in a diary card about solicited 
reactions from D0 to D07 after each vaccination and unsolicited AEs from D0 after each 
vaccination to the next study visit. 
• 
SAEs (including AESIs) and MAAEs will be recorded throughout the study. For Groups 1 and 
2, the subject’s parent/guardian will record information in a diary card about SAEs (including 
AESIs) and MAAEs from Visit 1 to Visit 2, from Visit 2 to Visit 3, and from Visit 3 to 
Visit 4. For Groups 1 and 2, SAEs (including AESIs) and MAAEs will also be recorded in a 
memory aid from Visit 4 until the 6-month follow up phone call. For Groups 3 and 4, the 
subject’s parent/ guardian will record information in a diary card about SAEs (including 
AESIs) and MAAEs from Visit 1 to Visit 2, and from Visit 2 to Visit 3. For Groups 3 and 4, 
SAEs (including AESIs) and MAAEs will also be recorded in a memory aid from Visit 3 until 
the 6-month follow up phone call. The subject’s parent/ guardian will be asked to notify the 
site immediately about any potential SAEs (including AESIs) at any time during the trial. 
• 
Staff will contact the subjects’ parent / guardian by telephone 8 days (+2 days) after each 
vaccination visit to identify the occurrence of any SAEs (including AESIs) not yet reported 
and to remind them to complete the diary card after each vaccination visit and to bring it back 
at the subsequent visit. 
• 
The completed diary cards will be collected and reviewed with the subject’s parent/ guardian 
at the subsequent visit. 
• 
Staff will contact the subjects’ parent/ guardian by telephone at 6 months (+30 days) after the 
last vaccination visit to review the memory aid and identify the occurrence of any SAEs 
(including AESIs), as well as MAAEs that have not been reported. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 48 of 121 
5.1.4 
Visit Procedures  
The visit procedures for Group 1 and Group 2 are described in Section 5.1.4.1 and the visit 
procedures for Group 3 and Group 4 are described in Section 5.1.4.2. The visits are listed 
separately because the age, vaccination schedule, and details of each visit vary for the 2 sets of 
groups. 
5.1.4.1 
Visit Procedures for Group 1 and Group 2  
Visit 1 (6 to 7 months of age): Inclusion, Randomization, Blood Sampling, and Vaccination 
1) 
Give the subject’s parent / guardian information about the study, obtain written informed 
consent, and provide a signed copy. 
2) 
Check inclusion and exclusion criteria for eligibility. 
3) 
Collect demographic data. 
4) 
Obtain and collect verbal medical history about the subject, including ongoing medication. 
5) 
Perform a physical examination, including, but not limited to, examination of the head 
(ear, nose, and throat), neck, heart, lungs, abdomen, and extremities. If a routine 
examination had been performed within the past week by a qualified health care provider, it 
does not need to be repeated unless there were changes in health status, in which case it 
may be limited to the affected area. 
6) 
Measure temperature. If the temperature is ≥38°C (≥ 100.4°F), postpone vaccination until 
the condition is resolved. 
7) 
Contact the interactive response technology (IRT) system for randomization, allocation of 
subject number, vaccine group assignment, and vaccine assignment. 
8) 
Review temporary contraindications for blood sampling. Ensure the subject has not had any 
antibiotics within the previous 72 hours (3 days). 
9) 
Collect 3 mL of blood (BL0001) (see Section 7 for detailed instructions regarding the 
handling of blood samples). If the blood sample cannot be obtained, the parent/guardian 
should be given the opportunity to bring the subject back to the study site for another 
attempt, as long as the subject continues to remain eligible for the trial. All attempts should 
be made to obtain a blood sample; however, if the attempts are unsuccessful, the subject 
could continue in the study with all the study procedures including vaccination. 
10) Review warnings and precautions to vaccinations. 
11) Administer the following study vaccines. Each vaccine should be administered in the 
assigned location (see Operating Guidelines) and documented appropriately: 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 49 of 121 
• Hepatitis B (or Haemophilus b conjugate vaccine if Pediarix® is used for 
DTaP/IPV/Hepatitis B immunization): inject IM into the anterolateral area of the thigh, 
preferably the right thigh 
• In children immunized with PedvaxHIB® at 2 and 4 months of age, a third dose of Hib 
vaccine at 6 months of age is not required 
• Diphtheria, tetanus and acellular pertussis vaccine (DTaP), inactivated poliovirus and 
Haemophilus influenzae type b (Hib) vaccine: inject IM into the anterolateral area of the 
left thigh (i.e., the opposite leg from that used for meningococcal vaccine administration) 
• Pneumococcal 13-valent conjugate (Prevnar 13®, PCV13): inject IM into the anterolateral 
area of the thigh, preferably the left thigh (i.e., the opposite leg from that used for 
meningococcal vaccine administration) 
• Rotavirus (RotaTeq®): administer orally per instructions in the package insert. 
When multiple vaccines are administered at a single visit, each vaccine should be administered at 
a different anatomic site. If vaccines are given in the same limb, the injection sites should be 
separated by 1 inch or more, so that any local reactions can be differentiated. 
Meningococcal vaccine and hepatitis B vaccine (Engerix-B® or RecombivaxHB) should be given 
in the same thigh. Do not administer DTaP vaccines or Prevnar 13® in the same thigh as the 
meningococcal vaccine. For details see Operating Guidelines. 
Failure to administer vaccines in the designated limb will not constitute a protocol deviation, but 
should be recorded as a comment in the case report form (CRF). 
12) Observe the subject for 30 minutes and record any AEs in the source document. In the event 
of a local reaction, indicate the associated vaccine. 
13) Give the parent / guardian a diary card (DC1), a thermometer, and a ruler, and go over the 
instructions for their use. Instruct the parent / guardian to retain the thermometer and ruler 
throughout the duration of the study. At each subsequent visit, confirm that the parent 
/guardian has retained the thermometer and ruler, replace only as necessary. 
14) Remind the parent / guardian to expect a telephone call 8 days after Visit 1 and to bring back 
the diary card when they return for Visit 2 at a specified date and time. 
15) Remind the parent / guardian to notify the site in case of an SAE. 
16) Complete the relevant CRFs for this visit. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 50 of 121 
Telephone Call 1 (8 days [+2 days] after Visit 1) 
Note: If Day 8 falls on a weekend or a holiday, the telephone call may be made on the following 
business day. 
1) Record relevant information concerning the subject’s health status on the telephone contact 
form. If an SAE (including AESI) occurred, follow the instructions in Section 10 for reporting 
it. 
2) Remind the parent / guardian to do the following: 
• 
Complete the D0 to D07 pages of the diary card. 
• 
Complete the remaining pages of the diary card, and bring them to the next visit. 
• 
Notify the site in case of an SAE. 
Visit 2 (30 [+21] days after Visit 1): Collection of Safety Information and Blood Sample 
1) 
Collect and review the diary card (DC1) with the parent / guardian, including any AEs, 
medications, or therapy that occurred since vaccination. If an SAE, including an AESI, has 
occurred, follow the instructions in Section 10 for reporting it. 
2) 
For subjects providing a blood sample at Visit 2 (50% of the subjects enrolled in Group 1 
and Group 2): 
• Review temporary contraindications for blood sampling. Ensure the subject has not had 
any antibiotics within the previous 72 hours (3 days). 
• Collect 3 mL of blood (BL0002A) (see Section 7 for detailed instructions regarding the 
handling of blood samples). 
3) 
Give the parent / guardian a diary card (DC2). 
4) 
Remind the parent / guardian to expect a telephone call within 14 days before Visit 3 and to 
bring back the diary card when they return for Visit 3 at a specified date and time. 
5) 
Remind the parent / guardian to notify the site in case of an SAE. 
6) 
Complete the relevant CRFs for this visit. 
Telephone Call 2 (within 14 days before Visit 3, at 11.5 to 12.5 months of age) 
1) Contact the subjects’ parent/ guardian by telephone within 14 days before Visit 3 to remind 
them about the forthcoming study visit. 
2) If the subject will not continue in the study: 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 51 of 121 
• 
Review the diary card. Ask the subject’s parent / guardian if the subject has experienced 
any SAE and / or MAAE in the time since vaccination that has not been reported to the 
study personnel. If an SAE, including an AESI, has occurred, follow the instructions in 
Section 10 for reporting it. 
• 
Request the subject’s parent / guardian to mail the diary card to the site. 
Visit 3 (6 months after Visit 1 [subjects must be 12 to 13 months of age]): Collection of 
Safety Information, Blood Sampling, and Vaccination 
1) Collect and review the diary card (DC2) with the parent / guardian, including any AEs, 
medications, or therapy that occurred since vaccination. If an SAE, including an AESI, has 
occurred, follow the instructions in Section 10 for reporting it. 
2) Perform a physical examination, including, but not limited to, examination of the head 
(ear, nose, and throat), neck, heart, lungs, abdomen, and extremities. If a routine examination 
had been performed within the past week by a qualified health care provider, it does not need 
to be repeated unless there were changes in health status, in which case it may be limited to 
the affected area. 
3) Measure temperature. If the temperature is ≥38°C (≥ 100.4°F), postpone vaccination until the 
condition is resolved. 
4) For subjects providing a blood sample at Visit 3 (50% of the subjects enrolled in Group 1 and 
Group 2): 
• 
Review temporary contraindications for blood sampling. Ensure the subject has not had 
any antibiotics within the previous 72 hours (3 days). 
• 
Collect 3 mL of blood (BL0002B) (see Section 7 for detailed instructions regarding the 
handling of blood samples). 
5) Review warnings and precautions to vaccinations. 
6) Review contraindications for subsequent vaccinations and conditions for withdrawal 
7) Contact IRT system for vaccine assignment. 
8) Administer the following study vaccines. Each vaccine should be administered in the 
assigned location (see Operating Guidelines) and documented appropriately: 
• 
Meningococcal vaccine (MenACYW conjugate vaccine or MENVEO®): inject IM into 
the anterolateral area of the thigh, preferably the right thigh. 
• 
Measles, mumps, and rubella (M-M-R®II): administer SC injection in the outer aspect of 
the upper arm. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 52 of 121 
• 
Varicella (Varivax®): administer SC injection in the outer aspect of the upper arm. 
When multiple vaccines are administered at a single visit, each vaccine should be administered at 
a different anatomic site. If vaccines are given in the same limb, the injection sites should be 
separated by 1 inch or more, so that any local reactions can be differentiated. 
Failure to administer vaccines in the designated limb will not constitute a protocol deviation, 
but should be recorded as a comment in the CRF. 
9) Observe the subject for 30 minutes and record any AEs in the source document. In the event 
of a local reaction, indicate the associated vaccine. 
10) Give the parent / guardian a diary card (DC3). 
11) Remind the parent / guardian to expect a telephone call 8 days after Visit 3 and to bring back 
the diary card when they return for Visit 4 at a specified date and time. 
12) Remind the parent / guardian to notify the site in case of an SAE. 
13) Complete the relevant CRFs for this visit. 
Telephone Call 3 (8 days [+2 days] after Visit 3) 
Refer to steps in Telephone Call 1. 
Visit 4 (30 [+21] days after Visit 3): Collection of Safety Information and Blood Sample 
1) Collect and review the diary card (DC3) with the parent / guardian, including any AEs, 
medications, or therapy that occurred since vaccination. If an SAE, including an AESI, has 
occurred, follow the instructions in Section 10 for reporting it. 
2) Review temporary contraindications for blood sampling. Ensure the subject has not had any 
antibiotics within the previous 72 hours (3 days). 
3) Collect 3 mL of blood (BL0003) (see Section 7 for detailed instructions regarding the 
handling of blood samples). 
4) Give the parent / guardian a memory aid to record SAE and MAAEs from Visit 4 until the 
6-month follow-up phone call. 
5) Remind the parent / guardian to notify the site in case of an SAE. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 53 of 121 
6) Complete the relevant CRFs for this visit and trial termination recorda. 
Safety Follow-up Telephone Call 4 (180 [+30] days after Visit 4): Collection of SAEs 
1) Ask the parent / guardian if the subject has experienced any SAE and / or MAAE since the 
last study visit. If an SAE, including an AESI, has occurred, follow the instructions in 
Section 10 for reporting it. 
2) Complete the relevant CRFs for this visit. 
This call must be made by a qualified person. 
A follow-up visit outside the scope of this study protocol can be arranged depending on the 
information recorded during the phone call. 
5.1.4.2 
Visit Procedures for Group 3 and Group 4  
Visit 1 (17 to 19 months of age): Inclusion, Randomization, Blood Sampling, and 
Vaccination 
1) Give the subject’s parent / guardian information about the study, obtain written informed 
consent, and provide a signed copy. 
2) Check inclusion and exclusion criteria for eligibility. 
3) Collect demographic data. 
4) Obtain and collect verbal medical history about the subject, including ongoing medication. 
5) Perform a physical examination, including, but not limited to, examination of the head 
(ear, nose, and throat), neck, heart, lungs, abdomen, and extremities. If a routine examination 
had been performed within the past week by a qualified health care provider, it does not need 
to be repeated unless there were changes in health status, in which case it may be limited to 
the affected area. 
6) Measure temperature. If the temperature is ≥38°C (≥ 100.4°F), postpone vaccination until the 
condition is resolved. 
7) Contact the IRT system for randomization, allocation of subject number, and vaccine 
assignment. 
                                                 
a  The dose of Prevnar 13® and Hib (for children vaccinated with monovalent Hib vaccine at 2, 4, and 6 months of 
age) recommended in the second year of life may be given as per standard of care at the last study visit after 
completing all the study procedures (Visit 4). As per standard of care, the correspondent contraindications and 
precautions to vaccination should be reviewed before administering each vaccine. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 54 of 121 
8) Review temporary contraindications for blood sampling. Ensure the subject has not had any 
antibiotics within the previous 72 hours (3 days). 
9) Collect 3 mL of blood (BL0001) (see Section 7 for detailed instructions regarding the 
handling of blood samples). If the blood sample cannot be obtained, the parent/guardian 
should be given the opportunity to bring the subject back to the study site for another attempt, 
as long as the subject continues to remain eligible for the trial. All attempts should be made to 
obtain a blood sample; however, if the attempts are unsuccessful, the subject could continue in 
the study with all the study procedures including vaccination. 
10) Review warnings and precautions to vaccinations. 
11) Administer the study vaccines. The vaccine should be administered in the assigned location 
(see Operating Guidelines) and documented appropriately: 
• 
Meningococcal vaccine (MenACYW conjugate vaccine or Menactra®): inject IM into the 
anterolateral area of the thigh, preferably the right thigh. 
12) Observe the subject for 30 minutes and record any AEs in the source document. 
13) Give the parent / guardian a diary card (DC1), a thermometer, and a ruler, and go over the 
instructions for their use. Instruct the parent / guardian to retain the thermometer and ruler 
throughout the duration of the study. At each subsequent visit, confirm that the parent 
/guardian has retained the thermometer and ruler, replace only as necessary. 
14) Remind the parent / guardian to expect a telephone call 8 days after Visit 1 and to bring back 
the diary card when they return for Visit 2 at a specified date and time. 
15) Remind the parent / guardian to notify the site in case of an SAE. 
16) Complete the relevant CRFs for this visit. 
Telephone Call 1 (8 days [+2 days] after Visit 1) 
Note: If Day 8 falls on a weekend or a holiday, the telephone call may be made on the following 
business day. 
1) Record relevant information concerning the subject’s health status on the telephone contact 
form. If an SAE (including AESI) occurred, follow the instructions in Section 10 for reporting 
it. 
2) Remind the parent / guardian to do the following: 
• 
Complete the D0 to D07 pages of the diary card. 
• 
Complete the remaining pages of the diary card, and bring them to the next visit. 
• 
Notify the site in case of an SAE. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 55 of 121 
Visit 2 (3 months after Visit 1 [at 20 to 23 months of age]): Collection of Safety Information 
and Vaccination 
1) Review the diary card (DC1) with the parent / guardian, including any AEs, medications, or 
therapy that occurred since vaccination. If an SAE, including an AESI, has occurred, follow 
the instructions in Section 10 for reporting it. 
2) Perform a physical examination, including, but not limited to, examination of the head 
(ear, nose, and throat), neck, heart, lungs, abdomen, and extremities. If a routine examination 
had been performed within the past week by a qualified health care provider, it does not need 
to be repeated unless there were changes in health status, in which case it may be limited to 
the affected area. 
3) Measure temperature. If the temperature is ≥ 38°C (≥ 100.4°F), postpone vaccination until the 
condition is resolved. 
4) Review warnings and precautions to vaccinations. 
5) Review contraindications for subsequent vaccinations and conditions for withdrawal 
6) Contact IRT system for vaccine assignment. 
7) Administer the study vaccines. The vaccine should be administered in the assigned location 
(see Operating Guidelines) and documented appropriately: 
• Meningococcal vaccine (MenACYW conjugate vaccine or Menactra®): inject IM into the 
anterolateral area of the thigh, preferably the right thigh. 
8) Observe the subject for 30 minutes and record any AEs in the source document. 
9) Give the parent / guardian a diary card (DC2). 
10) Remind the parent / guardian to expect a telephone call 8 days after Visit 2 and to bring back 
the diary card when they return for Visit 3 at a specified date and time. 
11) Remind the parent / guardian to notify the site in case of an SAE. 
12) Complete the relevant CRFs for this visit. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 56 of 121 
Telephone Call 2 (8 days [+2 days] after Visit 3) 
Refer to steps in Telephone Call 1. 
Visit 3 (30 [+21] days after Visit 2): Collection of Safety Information and Blood Sample 
1) Collect and review the diary card (DC2) with the parent / guardian, including any AEs, 
medications, or therapy that occurred since vaccination. If an SAE, including an AESI, has 
occurred, follow the instructions in Section 10 for reporting it. 
2) Review temporary contraindications for blood sampling. Ensure the subject has not had any 
antibiotics within the previous 72 hours (3 days). 
3) Collect 3 mL of blood (BL0002) (see Section 7 for detailed instructions regarding the 
handling of blood samples). 
4) Give the parent / guardian a memory aid to record SAE and MAAEs from Visit 3 until the 
6-month follow-up phone call. 
5) Remind the parent / guardian to notify the site in case of an SAE. 
6) Complete the relevant CRFs for this visit and trial termination record. 
Safety Follow-up Telephone Call 4 (180 [+30] days after Visit 4: Collection of SAEs 
1) Ask the parent / guardian if the subject has experienced any SAE and / or MAAE since the 
last study visit. If an SAE, including an AESI, has occurred, follow the instructions in 
Section 10 for reporting it. 
2) Complete the relevant CRFs for this visit. 
This call must be made by a qualified person. 
A follow-up visit outside the scope of this study protocol can be arranged depending on the 
information recorded during the phone call. 
Follow-up of subjects with Related AEs or with AEs That Led to Study/Vaccination 
Discontinuation: 
A subject 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 subject’s participation in the study) if either of the following is true: 
• 
The AE is considered by the Investigator to be related to the product administered. 
• 
The AE caused the discontinuation of the subject from the study or from vaccination. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 57 of 121 
5.1.5 
Planned Study Calendar  
The following dates are approximate. The actual dates may differ as, for example, the study will 
not start until all the appropriate regulatory and ethical approvals have been obtained. 
Planned study period - FVFS (first visit, first subject) to LCLS (last contact, last subject): 
04 October 2018 to 25 Aug 2023 
Planned inclusion period - FVFS to FVLS (first visit, last subject): 05 October 2018 to 31 Jan 
2022 
Planned end of study: 25 Aug 2023 
Planned date of final clinical study report: 1Q2024 
The 6-month follow- up telephone call (TC 4 for Group 1 and Group 2 and TC3 for Group 3 and 
Group 4) of the last subject in all groups is considered to be the end of the study. 
5.2 
Enrollment and Retention of Study Population  
5.2.1 
Recruitment Procedures  
Each site will be responsible for devising a recruitment plan for enrolling eligible subjects. 
Advertisements and other recruitment aids will be approved by Sanofi Pasteur and the site’s 
IRB/IEC prior to use by the clinical site. 
5.2.2 
Informed Consent Procedures  
Informed consent is the process by which a subject and / or parent / guardian voluntarily confirms 
his or her willingness to participate in a particular study. Informed consent must be obtained 
before any study procedures are performed. The process is documented by means of a written, 
signed, and dated ICF. 
In accordance with GCP, prior to signing and dating the consent form, the parent / guardian must be 
informed by appropriate study personnel about all aspects of the study that are relevant to making 
the decision to participate, and must have sufficient time and opportunity to ask any questions. 
The actual ICF 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 provided by the Sponsor. Any change to the content of the ICF 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 parent’s / guardian’s 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. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 58 of 121 
Informed consent forms will be provided in duplicate, or a photocopy of the signed consent will 
be made. The original will be kept by the Investigator, and the copy will be kept by the subject’s 
parent / guardian. 
Documentation of the consent process should be recorded in the source documents. 
5.2.3 
Screening Criteria  
There are no screening criteria other than the inclusion and exclusion criteria. 
5.2.4 
Inclusion Criteria  
An individual must fulfill all of the following criteria to be eligible for study enrollment: 
1) Aged 6 to 7 months (168 to 224 days)a or 17 to 19 months on the day of the first visitb 
3) Informed consent form has been signed and dated by the parent(s) or other guardian and by 
an independent witness if required by local regulations 
4) Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial 
procedures 
5) For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented history 
of having received 2 doses of DTaP, Hib, IPV, pneumococcal, hepatitis B (for children who 
received Pediarix® at 2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and 
rotavirus (Rotateq®) vaccines 
6) For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4), documented 
history of having received all routine pediatric vaccines recommended by ACIP up to the age 
of enrollment 
5.2.5 
Exclusion Criteria  
An individual fulfilling any of the following criteria is to be excluded from study enrollment: 
1) Participation at the time of study enrollment or in the 4 weeks preceding the first trial 
vaccination or planned participation during the present trial period in another clinical trial 
investigating a vaccine, drug, medical device, or medical procedure 
                                                 
a  At Visit 1, subjects must be at least 24 weeks of age (168 days, the minimum age for the final dose of hepatitis B 
vaccine in the vaccine series), and no more than 32 weeks of age (224 days, the maximum age for the 3rd dose of 
rotavirus vaccine administration). 
b  “6 to 7 months” means from the 6th month after birth to the day before the 8th month after birth. “168 to 
224 days” means from the 168th day after birth to the day before the 225th day after birth. “17 to 19 months” 
means from the 17th month after birth to the day before the 20th month after birth. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 59 of 121 
2) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt 
of any vaccine in the 4 weeks before and / or following any trial vaccination except for 
influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any 
study vaccination. This exception includes monovalent pandemic influenza vaccines and 
multivalent influenza vaccines 
3) Previous vaccination against meningococcal disease with either the trial vaccine or another 
vaccine (i.e., mono- or polyvalent, PS, or conjugate meningococcal vaccine containing 
serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine) 
4) For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), prior receipt of 
more than 2 doses of rotavirus vaccine (Rotateq), DTaP, Hib, IPV, pneumococcal, hepatitis 
B; for children who received Pediarix® at 2 and 4 months of age, prior receipt of more than 3 
doses of hepatitis B vaccine 
5) For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of 2 doses 
of rotavirus vaccine, Rotarix® at 2 and 4 months of age 
6) Receipt of immune globulins, blood, or blood-derived products in the past 3 months 
7) 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 
8) Family history of congenital or hereditary immunodeficiency, until the immune competence 
of the potential vaccine recipient is demonstrated 
9) Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant 
neoplasms affecting the bone marrow or lymphatic systems 
10) Individuals with active tuberculosis 
11) History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or 
microbiologically 
12) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, 
mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, 
and /or rotavirus infection or disease 
13) At high risk for meningococcal infection during the trial (specifically, but not limited to, 
subjects with persistent complement deficiency, with anatomic or functional asplenia, or 
subjects travelling to countries with high endemic or epidemic disease) 
14) History of intussusception 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 60 of 121 
15) History of any neurologic disorders, including any seizures and progressive neurologic 
disorders 
16) History of Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-
containing vaccine 
17) History of Guillain-Barré syndrome 
18) Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a 
life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of 
the same substances, including neomycin, gelatin, and yeasta 
19) Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the 
investigator’s opinion 
20) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 
contraindicating intramuscular vaccination in the investigator’s opinion 
21) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw 
22) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere 
with trial conduct or completionb 
23) Any condition which, in the opinion of the investigator, might interfere with the evaluation of 
the study objectives 
24) Moderate or severe acute illness/infection (according to investigator judgment) on the day of 
vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective subject 
should not be included in the study until the condition has resolved or the febrile event has 
subsided 
25) Identified as a natural or adopted child of the investigator or employee with direct 
involvement in the proposed study 
If the subject has a primary physician who is not the Investigator, the site must contact this 
physician with the parent’s / guardian’s consent to inform him / her of the subject’s participation 
in the study. In addition, the site should ask this primary physician to verify exclusion criteria 
relating to previous therapies, such as receipt of blood products or previous vaccines. 
5.2.6 
Medical History  
Prior to enrollment, subjects will be assessed for pre-existing conditions and illnesses, both past 
and ongoing. Any such conditions will be documented in the source document. Significant 
                                                 
a  The components of all study vaccines are listed in Section 6.1.1.1 and in the Investigator’s Brochure 
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. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 61 of 121 
(clinically relevant) medical history (reported as diagnosis) including conditions/illnesses for 
which the subject 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. 
5.2.7 
Contraindications for Subsequent Vaccinations  
5.2.7.1 
Temporary Contraindications  
Should a subject 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 Table of Study Procedures. 
• 
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. 
• 
Receipt of any vaccine (other than the study vaccines) in the 4 weeks preceding the first study 
vaccination or planned receipt of any vaccine in the 4 weeks before and / or following any 
study vaccination except for influenza vaccination, which may be received at least 2 weeks 
before or 2 weeks after study vaccination. This exception includes monovalent pandemic 
influenza vaccines and multivalent influenza vaccines. 
The following is a temporary contraindication to blood draw: 
• 
Receipt of oral or injected antibiotic therapy within the 72 hours (3 days) prior to a study 
blood draw. Note: if a subject receives oral or injectable antibiotic therapy within 3 days prior 
to a blood draw, the investigator will postpone that blood draw until it has been 3 days since 
the subject last received oral or injectable antibiotic therapy. Postponement must still be 
within the timeframe for blood draw. If postponement would result in the sample collection 
falling outside of this timeframe, the blood sample should be collected without postponement, 
and it should be documented appropriately that the sample was taken less than 3 days after 
stopping antibiotic treatment. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 62 of 121 
5.2.7.2 
Definitive Contraindications  
Prior to vaccination, check the complete list of contraindications for each individual vaccine to be 
administered. For the licensed vaccines refer to the individual current package inserts. For 
MenACYW conjugate vaccine refer to the Investigator’s Brochure. 
Should a subject experience an anaphylactic or other significant allergic reaction to the previous 
dose of vaccine(s), the Investigator will discontinue vaccination. 
The following AEs constitute absolute contraindications to subsequent vaccination with any of the 
study vaccines. If a subject should experience any of these events during the study, that subject is 
not to receive any additional study vaccines but should continue in the study and be followed up 
for safety only as per protocol up to 6 months after the last vaccinations received. 
Meningococcal vaccines (MenACYW conjugate vaccine, MENVEO® or Menactra®): 
1) History of Guillain-Barre syndrome within 6 weeks after vaccination with a tetanus 
toxoid-containing vaccine. 
2) History of an Arthus-like hypersensitivity reaction after vaccination with a tetanus 
toxoid-containing vaccine. 
3) Severe allergic reaction (e.g., anaphylaxis) after a previous dose of meningococcal capsular 
polysaccharide-, diphtheria toxoid- or CRM197 –containing vaccines or to any component of 
meningococcal vaccines. 
M-M-R®II (measles, mumps, and rubella vaccine): 
4) Hypersensitivity to any component of the vaccine, including gelatin. 
5) Anaphylactic or anaphylactoid reactions to neomycin. 
6) Patients receiving immunosuppressive therapy. This contraindication does not apply to 
patients who are receiving corticosteroids as replacement therapy, e.g., for Addison’s disease. 
7) Individuals with newly diagnosed (after inclusion in the study) blood dyscrasias, leukemia, 
lymphomas of any type, or other malignant neoplasms affecting the bone marrow or 
lymphatic systems. 
8) Newly diagnosed (after inclusion in the study) primary and acquired immunodeficiency states, 
including patients who are immunosuppressed in association with acquired immune 
deficiency syndrome (AIDS) or other clinical manifestations of infection with human 
immunodeficiency viruses; cellular immune deficiencies; and hypogammaglobulinemic and 
dysgammaglobulinemic states. 
9) Individuals with family members newly diagnosed (after a subject’s inclusion in the study) 
with congenital or hereditary immunodeficiency, unless immune competence of the potential 
vaccine recipient has been demonstrated. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 63 of 121 
Varivax® (varicella vaccine): 
10) History of severe allergic reaction to any component of the vaccine (including neomycin and 
gelatin) or to a previous dose of varicella vaccine. 
11) Newly diagnosed (after inclusion in the study) primary or acquired immunodeficiency states, 
leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic 
system, AIDS, or other clinical manifestations of infection with human immunodeficiency 
virus (HIV). 
12) Individuals receiving immunosuppressive therapy, including individuals receiving 
immunosuppressive doses of corticosteroids. A substantially immunosuppressive steroid dose 
is considered to be ≥ 2 weeks of daily receipt of 20 mg or 2 mg/kg body weight of prednisone 
or equivalent. For further information on contraindications to Varivax vaccination in persons 
receiving immunosuppressive therapies, consult the General Best Practices Guidelines for 
Immunization, the Recommendations of the Advisory Committee on Immunization Practices 
(ACIP), and the Pinkbook (39) (40) (41) 
13) Active untreated tuberculosis. 
Subjects with a definitive contraindication will continue to be followed up for the study-defined 
safety and immunogenicity assessments, as applicable. 
In the event of a local or national immunization program with a pandemic influenza vaccine, 
subjects who receive pandemic influenza vaccine at any time during the study will not be withdrawn 
from the study. 
5.2.7.3 
Warnings and Precautions to Vaccination  
Prior to vaccination, check the warnings and precautions for each individual vaccine to be 
administered. For the licensed vaccines, refer to the individual package inserts. For MenACYW 
conjugate vaccine, refer to the Investigator’s Brochure. 
5.2.8 
Conditions for Withdrawal  
Parents / guardians will be informed that they have the right to withdraw their child from the study 
at any time. 
A subject may be withdrawn from the study: 
• 
At the discretion of the Investigator or Sponsor due to safety concerns or significant 
non-compliance with the protocol (based on the Investigator’s judgment), without the 
subject’s permission (withdrawal) 
• 
At the request of the parent / guardian (dropout) 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 64 of 121 
The reason for a withdrawal or dropout should be clearly documented in the source documents 
and on the CRB. 
The Investigator must determine whether voluntary withdrawal is due to safety concerns 
(in which case, the reason for discontinuation will be noted as “Adverse Event”) or for another 
reason. 
Withdrawn subjects will not be replaced. 
5.2.9 
Lost to Follow-up Procedures  
In the case of subjects who fail to return for a follow-up examination, documented reasonable 
effort (i.e., documented telephone calls and certified mail) should be undertaken to locate or recall 
them, or at least to determine their health status while fully respecting their rights. These efforts 
should be documented in the CRB and in the source documents. 
5.2.10 Classification of Subjects Who Discontinue the Study  
For any subject who discontinues the study prior to completion, the most significant reason for 
early termination will be checked in the CRB. Reasons are listed below from the most significant 
to the least significant (refer to the CRB completion instructions for additional details and 
examples): 
Adverse Event 
To be used when the subject is permanently terminated from the study because of 
an AE (including an SAE), as defined in Section 9.3.2.1. 
This category also applies if the subject experiences a definitive contraindication 
that is an SAE or AE. 
Lost to Follow-up To be used when the subject cannot be found or contacted in spite of efforts to 
locate him/her before the date of his/her planned last visit, as outlined in 
Section 5.2.9. The certified letter was sent by the investigator and returned 
unsigned, and the parent/guardian did not give any other news and did not come to 
any following visit. 
Protocol 
Deviation 
To be used: 
• 
In case of significant noncompliance with the protocol (e.g., deviation of the 
Inclusion / Exclusion criteria, non-compliance with time windows, blood 
sampling or vaccination refusal, missed injection/treatment, or error in the 
vaccine/treatment administration). 
• 
If the subject experiences a definitive contraindication that is a protocol 
deviation. 
• 
The parent/guardian signed the certified letter sent by the investigator but did 
not give any other news and did not come to any following visit. 
Withdrawal by 
Parent / 
Guardian  
To be used: 
• 
When the subject or parent/guardian indicated unwillingness to continue in the 
study 
• 
When the parent/guardian made the decision to discontinue participation in the 
study for any personal reason other than an SAE/AE (e.g., subject is relocating, 
inform consent withdrawal, etc.) 
 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 65 of 121 
5.2.11 Follow-up of Discontinuations  
The site should complete all scheduled safety follow-ups and contact any subject who has 
prematurely terminated the study because of an AE, a protocol deviation, or loss of eligibility, 
including definitive contraindications. 
For subjects where the reason for early termination was lost to follow-up or if the subject 
withdrew informed consent and specified that they do not want to be contacted again and it is 
documented in the source document, the site will not attempt to obtain further safety information. 
If the subject’s status at the end of the study is “Withdrawal by Subject or Parent / Guardian / 
Legally Acceptable Representative”, the site will attempt to contact them for the 6-month 
follow-up except if they specified that they do not want to be contacted again and it is 
documented in the source document. 
For subjects where the reason for early termination is voluntary withdrawal, the site will attempt 
to contact them for the 6-month follow-up except if they specified that they do not want to be 
contacted again and it is documented in the source document. 
5.3 
Safety Emergency Call  
If, as per the Investigator’s judgment, a subject experiences a medical emergency, the Investigator 
may contact the Sponsor’s RMO for advice on 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 (Please refer to 
Section 10). 
In case of emergency code-breaking, the Investigator is required to follow the code-breaking 
procedures described in Section 6.4. 
5.4 
Modification of the Study and Protocol  
Any amendments to this study plan and protocol must be discussed with and approved by the 
Sponsor. If agreement is reached concerning the need for an amendment, it will be produced in 
writing by the Sponsor, and the amended version of the protocol will replace the earlier version. 
All substantial amendments (e.g., those that affect the conduct of the study or the safety of 
subjects) require IEC / IRB approval, and must also be forwarded to regulatory authorities. 
An administrative amendment to a protocol is one that modifies some administrative, logistical, or 
other aspect of the study but does not affect its scientific quality or have an impact on the 
subjects’ safety. The IECs / IRBs should only be notified, no formal approval is required. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 66 of 121 
The Investigator is responsible for ensuring that changes to an approved study, during the period 
for which IEC / IRB approval has already been given, are not initiated without IEC / IRB review 
and approval, except to eliminate apparent immediate hazards to subjects. 
5.5 
Interruption of the Study  
The study may be discontinued if new data about the investigational product resulting from this or 
any other studies become available; or for administrative reasons; or on advice of the Sponsor, the 
Investigators, the IECs/IRBs, or the governing regulatory authorities in the country where the 
study is taking place. 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
Investigators, the IECs/IRBs, the regulatory authorities, and any contract research organization(s) 
used in the study of the reason for termination or suspension, as specified by the applicable 
regulatory requirements. The Investigator shall promptly inform the subjects’ parents/guardians 
and should assure appropriate subject therapy and/or follow-up. 
There will be an internal team at the level of the Sponsor (SMT), which will review the data being 
generated from all the ongoing studies with MenACYW conjugate vaccine at regular intervals for 
any new safety signals or safety concerns. The SMT is empowered to recommend a pause in both 
recruitment and / or further vaccination while it investigates any potential signal or concern. 
6 
Vaccines Administered  
In the interest of the management, supply, and accountability of the products, MenACYW 
conjugate vaccine, MENVEO®, and Menactra® will be considered as Investigational Medicinal 
Products (IMP), MMR-II® and Varivax® will be considered as Non-Investigational Medicinal 
Products (NIMP) and all other vaccines will be classified as Other Products. 
6.1 
Identity of the Investigational Products  
6.1.1 
Identity of Study Products  
MenACYW conjugate vaccine: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) 
Tetanus Toxoid Conjugate Vaccine (Sanofi Pasteur Inc., Swiftwater, PA, USA) 
Form:  
 
Liquid solution 
Dose:  
 
0.5 milliliter (mL) 
Route: 
 
IM 
Batch number: 
To be determined (TBD) 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 67 of 121 
6.1.1.1 
Composition  
Each 0.5 mL dose of MenACYW conjugate vaccine is formulated in sodium acetate buffered 
saline solution to contain the following components: 
Meningococcal capsular polysaccharides: 
Serogroup A ............................................................................................................... 10 µg 
Serogroup C ............................................................................................................... 10 µg 
Serogroup Y ............................................................................................................... 10 µg 
Serogroup W .............................................................................................................. 10 µg 
Tetanus toxoid protein carrier ..................................................................... approximately 55 µga 
6.1.1.2 
Preparation and Administration  
MenACYW conjugate vaccine is supplied in single-dose vials (0.5 mL). 
Prior to administration, all study products must be inspected visually for cracks, broken seals, 
correct label content (see Section 6.3.1), and extraneous particulate matter and / or discoloration, 
whenever solution and container permit. If any of these conditions exists, 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. 
After vaccine administration, the used syringe and needle will be disposed of in accordance with 
currently established guidelines. 
Subjects must be kept under observation for 30 minutes after each vaccination to ensure their 
safety, and any reactions during this period will be documented in the CRB. 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. 
6.1.1.3 
Dose Selection and Timing  
• Subjects in Group 1 will receive 2 doses of MenACYW conjugate vaccine administered 
concomitantly with routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of 
age 
• Subjects in Group 3 will receive 2 doses of MenACYW conjugate vaccine administered at 
17 to 19 months of age and 20 to 23 months of age 
                                                 
a  Tetanus toxoid protein quantity is approximate and dependent on the PS-to-protein ratio for the conjugates used in 
each formulation. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 68 of 121 
6.1.2 
Identity of Control Product 1  
MENVEO®: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 
Conjugate Vaccine (GlaxoSmithKline Vaccines, Srl, Bellaria-Rosia 53018, Sovicille [SI], Italy) 
Form:  
 
Lyophilized powder and liquid components are combined to produce a 
Solution for Intramuscular Injection 
Dose:  
 
0.5 mL 
Route: 
 
IM 
Batch number: 
To be determined 
6.1.2.1 
Composition  
Each 0.5 mL dose of vaccine contains the following active ingredients: 
MenA oligosaccharide ............................................................................................... 10 µg 
MenC oligosaccharide ................................................................................................. 5 µg 
MenY oligosaccharide ................................................................................................. 5 µg 
MenW-135 oligosaccharide ......................................................................................... 5 µg 
CRM197 protein ...........................................................................................32.7 to 64.1 µg 
Other ingredients per 0.5 mL dose: residual formaldehyde  .......................................... ≤ 0.30 µg 
6.1.2.2 
Preparation and Administration  
MENVEO® is supplied in 2 vials, a lyophilized MenA conjugate vaccine component to be 
reconstituted with the accompanying MenCYW-135 liquid conjugate component. A single dose 
after reconstitution is 0.5 mL. See the MENVEO® package insert (37). 
The procedures for administering the control product are the same as those described for the study 
product in Section 6.1.1.2. Each 0.5 mL dose is to be injected IM as indicated in the Operating 
Guidelines and Section 5.1.4. 
6.1.2.3 
Dose Selection and Timing  
• Subjects in Group 2 will receive 2 doses of MENVEO® administered concomitantly with 
routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age 
6.1.3 
Identity of Control Product 2  
Menactra®: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid 
Conjugate Vaccine (Sanofi Pasteur Inc., Swiftwater, PA, USA) 
Form:  
 
Solution for injection 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 69 of 121 
Dose:  
 
0.5 mL 
Route: 
 
IM 
Batch number: 
To be determined 
6.1.3.1 
Composition  
Each 0.5 mL dose of vaccine is formulated in sodium phosphate buffered isotonic sodium 
chloride solution to contain the following ingredients: 
Serogroup A ............................................................................................................................. 4 µg 
Serogroup C ............................................................................................................................. 4 µg 
Serogroup Y ............................................................................................................................. 4 µg 
Serogroup W-135 .................................................................................................................... 4 µg 
Diphtheria toxoid protein carrier ...................................................................approximately 48 µg 
6.1.3.2 
Preparation and Administration  
Menactra® is supplied in single-dose (0.5 mL) vials. See the Menactra® package insert (38). 
The procedures for preparing and administering the control product are the same as those 
described for the study product in Section 6.1.1.2. Each 0.5 mL dose is to be injected IM as 
indicated in the Operating Guidelines and Section 5.1.4. 
6.2 
Identity of Other Products  
For each routine vaccine indication, all US licensed products are listed. Only one product per 
indication is to be used. As per ACIP guidelines, it is preferable that doses of vaccine in a series 
come from the same manufacturer. Hence, it is recommended that the 3rd dose of each routine 
vaccine (administered at 6 to 7 months of age as part of the study) come from the same 
manufacturer as the doses administered at 2- and 4- months of age. 
6.2.1 
Identity of Other Product 1  
Pentacel®: (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated 
Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine (Sanofi Pasteur 
Ltd, Toronto, Ontario, Canada) 
Form:  
 
Liquid DTaP-IPV used to reconstitute lyophilized ActHIB® 
Dose:  
 
0.5 mL 
Route: 
 
IM 
Batch number:  
Commercial batches 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 70 of 121 
6.2.1.1 
Composition  
Each 0.5 mL dose of vaccine contains: 
Diphtheria toxoid  ......................................................................................................... 15 Limit of 
Flocculation (Lf) 
Tetanus toxoid .............................................................................................................. 5 Lf 
Acellular pertussis antigens: 
  Pertussis toxin (PT) .................................................................................................... 20 µg 
  Filamentous hemagglutinin (FHA) ............................................................................. 20 µg 
  Pertactin (PRN) .......................................................................................................... 3 µg 
Fimbriae Types 2 and 3 (FIM) ..................................................................................... 5 µg 
Inactivated polioviruses: 
  Type 1 (Mahoney) ...................................................................................................... 40 D-antigen 
units (DU) 
  Type 2 (MEF-1) .......................................................................................................... 8 DU 
  Type 3 (Saukett) ......................................................................................................... 32 DU 
H. influenzae type b (PRP) ........................................................................................... 10 µg 
Tetanus toxoid (PRP-T) ................................................................................................ 24 µg 
Excipients: 
Aluminum phosphate (0.33 mg aluminum) (adjuvant) ................................. 1.5 mg 
Polysorbate 80  .............................................................................................. approximately 10 ppm 
by calculation 
Sucrose .......................................................................................................... 42.5 mg 
Residual formaldehyde .................................................................................. ≤ 5 µg 
Residual glutaraldehyde ................................................................................ < 50 nanograms (ng) 
Residual bovine serum albumin .................................................................... ≤ 50 ng 
2-phenoxyethanol .......................................................................................... 3.3 mg (0.6% v/v) 
Neomycin ...................................................................................................... < 4 picograms (pg) 
Polymyxin B sulfate ...................................................................................... < 4 pg 
6.2.1.2 
Preparation and Administration  
Pentacel® is supplied as a liquid vaccine component (DTaP-IPV component) that is combined 
through reconstitution with a lyophilized vaccine component (ActHIB vaccine), both in single 
dose vials. A single dose after reconstitution is 0.5 mL. See the Pentacel® package insert (42). 
The procedures for administering the product are the same as those described for the study 
product in Section 6.1.1.2. Each 0.5 mL dose is to be injected IM as indicated in the Operating 
Guidelines and Section 5.1.4. 
6.2.1.3 
Dose Selection and Timing  
• Subjects in Group 1and Group 2 will receive 1 dose of Pentacel® at 6 to 7 months of age as per 
the ACIP recommendations. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 71 of 121 
6.2.2 
Identity of Other Product 2  
Pediarix®: (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B 
(Recombinant) and Inactivated Poliovirus Vaccine) (GlaxoSmithKline Biologicals, Rixensart, 
Belgium) 
Form:  
 
Suspension for injection 
Dose:  
 
0.5 mL 
Route: 
 
IM 
Batch number:  
Commercial batches 
6.2.2.1 
Composition  
Each 0.5 mL dose of vaccine contains: 
Diphtheria toxoid ................................................................................. 25 Lf 
Tetanus toxoid ..................................................................................... 10 Lf 
Acellular pertussis antigens: 
  Inactivated PT ................................................................................... 25 µg 
  FHA .................................................................................................. 25 µg 
  PRN .................................................................................................... 8 µg 
HBsAg ................................................................................................ 10 µg 
Inactivated polioviruses: 
  Type 1 (Mahoney) ........................................................................... 40 DU 
  Type 2 (MEF-1) ................................................................................. 8 DU 
  Type 3 (Saukett) .............................................................................. 32 DU 
Excipients: 
Aluminum salt (adjuvant) ................................................................ not more than 0.85 mg by assay 
Sodium chloride ............................................................................... 4.5 mg 
Polysorbate 80  ................................................................................ ≤ 100 µg 
Residual formaldehyde .................................................................... ≤ 100 µg 
Neomycin ........................................................................................ ≤ 0.05 ng 
Polymyxin B sulfate ........................................................................ ≤ 0.01 ng 
6.2.2.2 
Preparation and Administration  
Pediarix® is supplied as a single-dose prefilled syringe containing 0.5 mL suspension for 
injection. See the Pediarix® package insert (43). 
The procedures for administering the product are the same as those described for the study 
product in Section 6.1.1.2. Each 0.5 mL dose is to be injected IM as indicated in the Operating 
Guidelines and Section 5.1.4. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 72 of 121 
6.2.2.3 
Dose Selection and Timing  
• Subjects in Group 1and Group 2 will receive 1 dose of Pediarix® at 6 to 7 months of age as per 
the ACIP recommendations. 
6.2.3 
Identity of Other Product 3  
Haemophilus b conjugate vaccines  
ActHIB®: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (Sanofi Pasteur Inc., 
Swiftwater, PA, USA) 
Form:  
 
Solution for injection: lyophilized powder to be reconstituted in supplied  
 
 
 
0.4% Sodium Chloride diluent 
Dose:  
 
0.5 mL 
Route: 
 
IM 
Batch number:  
Commercial batches 
Hiberix®: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (GlaxoSmithKline 
Biologicals 441 Rixensart, Belgium) 
Form:  
 
Solution for injection: supplied as a vial of lyophilized vaccine to be 
reconstituted with the accompanying vial of saline diluent 
Dose:  
 
0.5 mL 
Route: 
 
IM 
Batch number:  
Commercial batches 
PedvaxHIB®: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) 
(Merck & Co., Inc., West Point, PA, USA) 
Form:  
 
Solution for injection 
Dose:  
 
0.5 mL 
Route: 
 
IM 
Batch number:  
Commercial batches 
6.2.3.1 
Composition  
After reconstitution, each 0.5 mL dose of ActHIB® contains: 
Haemophilus influenzae type b polysaccharide 
(polyribosylribitol phosphate, PRP)  ............................................... 10 µg 
conjugated to tetanus toxoid as carrier protein ................................ 24 µg 
Sucrose 
8.5% 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 73 of 121 
After reconstitution, each 0.5 mL dose of Hiberix® contains: 
Haemophilus influenzae type b polysaccharide  
(polyribosylribitol phosphate, PRP) ................................................ 10 µg 
conjugated to tetanus toxoid as carrier protein ................................ approximately 25µg 
Lactose ............................................................................................. 12.6 mg 
Residual formaldehyde .................................................................... < 0.5 µg 
Each 0.5 mL dose of PevaxHIB® contains: 
Haemophilus influenzae type b polysaccharide 
(polyribosylribitol phosphate, PRP) ................................................ 7.5 µg 
Neisseria meningitidis outer membrane protein complex ............... 125 µg 
Aluminum as amorphous aluminum hydroxyphosphate sulfate ..... 225 µg 
Sodium chloride ............................................................................... 0.9% 
6.2.3.2 
Preparation and Administration  
ActHIB® is supplied as a lyophilized powder to be reconstituted in supplied 0.4% Sodium 
chloride diluent. A single dose after reconstitution is 0.5 mL. See the ActHIB® package insert 
(44). 
Hiberix® is supplied as a lyophilized vaccine to be reconstituted with the accompanying vial of 
saline diluent. A single dose after reconstitution is 0.5 mL. See the Hiberix® package insert (45). 
PevaxHIB® is supplied as a liquid vaccine. A single dose is 0.5 mL. See the PevaxHIB® package 
insert (46). 
The procedures for administering the product are the same as those described for the study 
product in Section 6.1.1.2. Each 0.5 mL dose is to be injected IM as indicated in the Operating 
Guidelines and Section 5.1.4. 
6.2.3.3 
Dose Selection and Timing  
• Subjects in Group 1 and Group 2 will receive 1 dosea,b of Haemophilus b conjugate vaccine at 
6 to 7 months of age 
                                                 
a  In children immunized with PedvaxHIB® at 2 and 4 months of age, a third dose of Hib vaccine at 6 months of age 
is not required. 
b  The dose of Hib (for children vaccinated with monovalent Hib vaccine at 2, 4, and 6 months of age)  
recommended in the second year of life may be given as per standard of care at the last study visit after 
completing all the study procedures (Visit 4). 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 74 of 121 
6.2.4 
Identity of Other Product 4  
Prevnar 13®: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) 
(Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer Inc., Philadelphia, PA, USA) 
Form:  
 
Suspension for injection 
Dose:  
 
0.5 mL 
Route: 
 
IM 
Batch number: 
Commercial batches 
6.2.4.1 
Composition  
Each 0.5 mL dose of the vaccine is formulated to contain: 
Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F 
saccharides .............................................................................. approximately 2.2 μg of each 
6B saccharides ............................................................................................................. 4.4 μg 
CRM197 carrier protein ................................................................................................. 34 μg 
Polysorbate 80 ............................................................................................................ 100 μg 
Succinate buffer .......................................................................................................... 295 μg 
Aluminum as aluminum phosphate adjuvant ............................................................. 125 μg 
6.2.4.2 
Preparation and Administration  
Prevnar 13® is supplied in a single-dose prefilled syringe. See the Prevnar 13® package insert 
(47). 
The procedures for administering the product are the same as those described for the study 
product in Section 6.1.1.2. Each 0.5 mL dose is to be injected IM as indicated in the Operating 
Guidelines and Section 5.1.4. 
6.2.4.3 
Dose Selection and Timing  
• Subjects in Group 1 and Group 2 will receive 1 dosea of Prevnar 13® at 6 to 7 months of age 
6.2.5 
Identity of Other Product 5  
RotaTeq®: (Rotavirus Vaccine, Live, Oral, Pentavalent) (Merck Sharp & Dohme Corp., a 
subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA) 
Form:  
 
Oral solution 
Dose:  
 
2 mL 
                                                 
a  The dose of Prevnar 13® recommended in the second year of life may be given as per standard of care at the last 
study visit after completing all the study procedures (Visit 4). 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 75 of 121 
Route: 
 
Oral 
Batch number: 
Commercial batches 
6.2.5.1 
Composition  
Each 2 mL dose contains the following 5 live reassortant rotaviruses: 
G1 serotype ............................................................................ 2.2 x 106 infectious units (IU) 
G2 serotype ........................................................................................................ 2.8 x 106 IU 
G3 serotype ........................................................................................................ 2.2 x 106 IU 
G4 serotype ........................................................................................................ 2.0 x 106 IU 
P1A(8) ............................................................................................................... 2.3 x 106 IU 
The reassortants are suspended in a buffered stabilizer solution. 
Each 2 mL vaccine dose also contains sucrose, sodium citrate, sodium phosphate monobasic 
monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal 
bovine serum. 
6.2.5.2 
Preparation and Administration  
RotaTeq® is supplied in a container consisting of a squeezable plastic dosing tube with a twist-off 
cap, allowing for direct oral administration. See the RotaTeq® package insert (48). 
Each 2 mL dose is to be administered orally, as indicated in the Operating Guidelines and 
Section 5.1.4. 
6.2.5.3 
Dose Selection and Timing  
• 
Subjects in Group 1 and Group 2 will receive 1 dose of RotaTeq® at 6 to 7 months of age 
6.2.6 
Identity of Other Product 6  
Hepatitis B vaccines 
ENGERIX-B®: (Hepatitis B Vaccine [Recombinant]) (GlaxoSmithKline Biologicals 441 
Rixensart, Belgium) 
Form:  
 
Suspension for injection 
Dose:  
 
0.5 mL 
Route: 
 
IM 
Batch number:  
Commercial batches 
RecombivaxHB®: (Hepatitis B Vaccine [Recombinant]) (Merck Sharp & Dohme Corp., a 
subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA) 
Form:  
 
Suspension for injection 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 76 of 121 
Dose:  
 
0.5 mL 
Route: 
 
IM 
Batch number:  
Commercial batches 
6.2.6.1 
Composition  
Each 0.5 mL pediatric/adolescent dose of ENGERIX® contains 10 µg of hepatitis B virus surface 
antigen (HBsAg) adsorbed on 0.25 mg aluminum as aluminum hydroxide. 
Excipients: 
Sodium chloride ...................................................................................................... 9 mg/mL 
Disodium phosphate dihydrate .......................................................................... 0.98 mg/mL 
Sodium dihydrogen phosphate dihydrate .......................................................... 0.71 mg/mL 
Each 0.5 mL pediatric/adolescent dose of RecombivaxHB® contains 5µg of HBsAg adsorbed onto 
approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate 
sulphate) 
Excipient: 
Residual formaldehyde ........................................................ < 15 mg/mL 
6.2.6.2 
Preparation and Administration  
ENGERIX-B® and RecombivaxHB® are supplied as 0.5 mL prefilled syringes. See the package 
inserts for ENGERIX-B® (49) and RecombivaxHB® (50). 
The procedures for administering the product are the same as those described for the study 
product in Section 6.1.1.2. Each 0.5 mL dose is to be injected IM, as indicated in the Operating 
Guidelines and Section 5.1.4. 
6.2.6.3 
Dose Selection and Timing  
• Subjects in Group 1 and Group 2 will receive 1 dose of hepatitis vaccine at 6 to 7 months of 
age 
6.2.7 
Identity of Other Product 7  
M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live) (Merck Sharp & Dohme Corp., a 
subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA) 
Form: 
Lyophilized live virus vaccine 
Dose:  
 
0.5 mL 
Route: 
 
Subcutaneous (SC) 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 77 of 121 
Batch number: 
Commercial batches 
6.2.7.1 
Composition  
Each 0.5 mL dose contains live attenuated virus: 
Measles virus (derived from Ender’s Edmonston strain) propagated in chick embryo cell 
culture ............................................................................................ not less than 1000 TCID50a 
Mumps virus (Jeryl Lynn™ [B level] strain) propagated in chick embryo cell culture 
 .................................................................................................... not less than 12,500 TCID50a 
Rubella virus (Wistar RA 27/3 strain) propagated in WI-38 human diploid lung fibroblasts 
 ....................................................................................................... not less than 1000 TCID50a 
Each 0.5 mL dose is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), 
sodium chloride, hydrolyzed gelatin (14.5 mg), recombinant human albumin (≤ 0.3 mg), fetal 
bovine serum (< 1 ppm), other buffer and media ingredients and approximately 25 µg of 
neomycin. 
6.2.7.2 
Preparation and Administration  
M-M-R® II is supplied as a lyophilized vaccine to be reconstituted using the accompanying sterile 
diluent. See the M-M-R® II package insert (51). 
The procedures for administering the product are the same as those described in Section 6.1.1.2. 
Each 0.5 mL dose is to be injected as indicated in the Operating Guidelines and Section 5.1.4. 
6.2.7.3 
Dose Selection and Timing  
• Subjects in Group 1 and Group 2 will receive a dose of M-M-R® II at 12 to 13 months of age. 
6.2.8 
Identity of Other Product 8  
VARIVAX®: Varicella Virus Vaccine Live (Merck Sharp & Dohme Corp., a subsidiary of Merck 
& Co., Inc., Whitehouse Station, NJ, USA) 
Form: Suspension for injection supplied as lyophilized vaccine to be reconstituted using the 
accompanying sterile diluent 
Dose:  
 
0.5 mL 
Route: 
 
SC 
Batch number: 
Commercial batches 
                                                 
a  TCID50 = tissue culture infectious doses 50% 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 78 of 121 
6.2.8.1 
Composition  
Each approximately 0.5 mL dose contains: 
Live, attenuated Oka/Merck varicella virus ........ at least 1350 plaque-forming units (PFU) 
Excipients: 
Sucrose ........................................................................................................................ 25 mg 
Hydrolyzed gelatin ................................................................................................... 12.5 mg 
Sodium chloride .......................................................................................................... 3.2 mg 
Monosodium L-glutamate .......................................................................................... 0.5 mg 
Sodium phosphate dibasic ........................................................................................ 0.45 mg 
Potassium phosphate monobasic .............................................................................. 0.08 mg 
Potassium chloride .................................................................................................... 0.08 mg 
The vaccine contains residual components of MRC-5 cells including DNA and protein and trace 
quantities of sodium phosphate monobasic, EDTA, neomycin, and fetal bovine serum. The 
vaccine contains no preservative. 
6.2.8.2 
Preparation and Administration  
VARIVAX® is supplied as a lyophilized vaccine to be reconstituted using the accompanying 
sterile diluent. See the VARIVAX® package insert (52). 
The procedures for administering the product are the same as those described in Section 6.1.1.2. 
Each 0.5 mL dose is to be injected as indicated in the Operating Guidelines Section 5.1.4. 
6.2.8.3 
Dose Selection and Timing  
• Subjects in Group 1 and Group 2 will receive a dose of VARIVAX® at 12 to 13 months of 
age. 
6.3 
Product Logistics  
The following products will be provided by the Sponsor: MenACYW conjugate vaccine, 
MENVEO®, Menactra®, MMR®-II, and Varivax®. 
The routine pediatric vaccines recommended at 6 months of age (DTaP-, IPV-, Hib-, 
hepatitis B- vaccines, PCV13 and RotaTeq®) will be procured by the sites and reimbursed by the 
Sponsor. 
The dose of PCV13 and Hib vaccine recommended in the second year of life are outside the scope 
of the study. These vaccines will be procured by the sites and will not be reimbursed by the 
Sponsor. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 79 of 121 
6.3.1 
Labeling and Packaging  
The investigational product, MenACYW conjugate vaccine (single-dose vials), and control 
products will be supplied with investigational labeling and packaging according to national 
regulations. Each single dose of investigational or control product will be identified by a unique 
number on the detachable label and on the outer carton label. The detachable label will be 
attached to the source documents by the sites. See the Operating Guidelines for additional label 
detail. 
The investigational and control products are blinded at the carton level but not at the vial level. 
To avoid any bias and ensure blinding is maintained, only the personnel administering the vaccine 
will be authorized to open the carton. 
All of the concomitant products (licensed routine vaccines) will retain original commercial 
labeling and packaging with no additional labels to be applied. 
The concomitant products (licensed routine vaccines) are not blinded. 
6.3.2 
Product Shipment, Storage, and Accountability  
6.3.2.1 
Product Shipment  
The Clinical Logistics Coordinator or designee will contact the Investigator or a designee to 
determine the dates and times of delivery of products. 
Each vaccine shipment will include a temperature-monitoring device to verify maintenance of the 
cold chain during transit. On delivery of the product to the site, the person in charge of product 
receipt will follow the instructions given in the Operating Guidelines including checking that the 
cold chain was maintained during shipment (i.e., verification of the temperature recorders). 
If there is an indication that the cold chain was broken, this person should immediately quarantine 
the product, alert the Sanofi Pasteur representative, and request authorization from Sanofi Pasteur 
to use the product. 
6.3.2.2 
Product Storage  
The Investigator will be personally responsible for product management or will designate a staff 
member to assume this responsibility. 
At the site, products must be kept in a secure place with restricted access. The study and control 
products (MenACYW conjugate vaccine, MENVEO®, and Menactra®) will be stored in a 
refrigerator at a temperature ranging from +2°C to +8°C and never frozen. All commercially 
labeled products should be stored according to the manufacturer's instructions. The temperature 
must be monitored and documented (see the Operating Guidelines) for the entire time that the 
vaccine is at the study site. In case of accidental freezing or disruption of the cold chain, vaccines 
must not be administered and must be quarantined, and the Investigator or authorized designee 
should contact the Sanofi Pasteur representative for further instructions. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 80 of 121 
6.3.2.3 
Product Accountability  
The person in charge of product management at the site will maintain records of product delivery 
to the study site, product inventory at the site, the dose(s) given to each subject, and the disposal 
of or return to the Sponsor of unused doses. 
The necessary information on the product labels is to be entered into the source document and the 
CRB. If applicable, information may also be entered into the subject’s vaccination card. 
The Sponsor’s monitoring staff will verify the study site’s product accountability records against 
the record of administered doses in the CRBs and the communication from the IRT system 
(if applicable). 
In case of any expected or potential shortage of product during the study, the Investigator or an 
authorized designee should alert the Sanofi Pasteur representative as soon as possible, so that a 
shipment of extra doses can be arranged. 
6.3.3 
Replacement Doses  
If a replacement dose is required (e.g., because the syringe broke or particulate matter was 
observed in the syringe), the site personnel must either contact the IRT system to receive the new 
dose allocation, or follow the instructions given in the Operating Guidelines. 
6.3.4 
Disposal of Unused Products  
Unused or wasted products provided by Sanofi Pasteur will be returned to the Sponsor in 
accordance with the instructions in the Operating Guidelines. Product accountability will be 
verified throughout the study period. 
6.3.5 
Recall of Products  
If the Sponsor makes a decision to launch a retrieval procedure, the Investigator(s) will be 
informed of what needs to be done. 
6.4 
Blinding and Code-breaking Procedures  
Given that the meningococcal vaccines (investigational and control) used in this study have 
different appearances, preparation methods, and vaccination schedules, the study has a modified 
double blind design for each group at enrollment, i.e., modified double-blind between Group 1 
and Group 2, and between Group 3 and Group 4, and thus, with the exception of the personnel 
administering the vaccine, everyone involved in study (participants, care provider, investigator, 
safety outcomes assessor, Sponsor) is blinded to avoid any bias. 
The code may be broken in the event of an AE only when the identification of the vaccine 
received could influence the treatment of the subject. Code-breaking should be limited to the 
subject(s) experiencing the AE. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine 
Protocol Version 4.0 
Confidential/Proprietary Information 
Page 81 of 121 
The blind can be broken by the Investigator or a delegate through the IRT system, as explained in 
the code-breaking procedures described in the Operating Guidelines. Once the emergency has 
been addressed by the site, the Investigator or a delegate must notify the Sanofi Pasteur RMO if a 
subject’s code was broken. All contact attempts with the Sponsor prior to unblinding are to be 
documented in the source documents, and the code breaking CRF is to be completed. 
A request for the code to be broken may also be made: 
•
by the GPV Department through an internal system for reporting to Health authorities in the
case of an SAE as described in ICH E2A.a In this case, the code will be broken only for the
subject(s) in question. The information resulting from code-breaking (i.e., the subject’s
vaccine or group assignment) will not be communicated to either the Investigator or the
immediate team working on the study, except for the GPV representative.
The IEC / IRB must be notified of the code-breaking. All documentation pertaining to the event 
must be retained in the site’s study records and in the Sanofi Pasteur files. Any intentional or 
unintentional code-breaking must be reported, documented, and explained, and the name of the 
person who requested it must be provided to the Sponsor. 
6.5 
Randomization and Allocation Procedures 
On the day of enrollment, subjects who meet the inclusion/exclusion criteria and whose parent / 
guardian signs the ICF will be randomly assigned to either Groups 1, 2 or Groups 3, 4 in a 1:1 
ratio depending on the age at recruitment. Approximately 870 healthy infants 6 to7 months of age 
will be randomized 1:1 to either Group 1 or Group 2, and 200 healthy toddlers 17 to 19 months of 
age will be randomized 1:1 to either Group 3 or Group 4. 
Site staff will connect to the IRT system, enter the identification and security information, and 
confirm a minimal amount of data in response to IRT system prompts. The IRT system will then 
provide the group assignment and have the site staff confirm it. The full detailed procedures for 
group allocation are described in the Operating Guidelines. If the subject is not eligible to 
participate in the study, then the information will only be recorded on the subject recruitment log. 
Subject numbers that are assigned by the IRT system will consist of a 12-digit string (a 3-digit 
country identifier, a 4-digit study center identifier, and a 5-digit subject identifier). For example, 
Subject 840000100005 is the fifth subject enrolled in Center Number 1 in the US (840 being the 
US country code). 
Subject numbers should not be reassigned for any reason. The randomization codes will be kept 
securely in the IRT system. 
a
All unexpected and related SAEs submitted to European Union competent authorities must be unblinded. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 82 of 121 
6.6 
Treatment Compliance  
The following measures will ensure that the vaccine doses administered comply with those planned, 
and that any non-compliance is documented so that it can be accounted for in the data analyses: 
• 
All vaccinations will be administered by qualified study personnel 
• 
The person in charge of product management at the site will maintain accountability records 
of product delivery to the study site, product inventory at the site, dose(s) given to each 
subject, and the disposal of unused or wasted doses 
6.7 
Concomitant Medications and Other Therapies  
At the time of enrollment, ongoing medications including, but not limited to, other therapies (e.g., 
blood products), should be recorded in the source documents. All new medications prescribed for 
new medical conditions / AEs during study participation should also be recorded in the source 
documents. 
Documentation in the CRB of concomitant medication(s) will be limited to specific categories of 
medication(s) (Categories 1, 2, and 3 as detailed below). Those will include Category 1, 2, and 3 
medications ongoing at the time of inclusion in the study, or started at any time during the 
subject’s participation in the trial. For category 3 medication, the period of reporting in CRB will 
be restricted to only 3 days (72 hours) prior to each blood sampling time point. 
Collection Period in Source Documents 
Reportable medications (Category 1, 2, and 3) will be collected in the source documents from the 
day of first vaccination to the end of the trial.a 
Categories of Reportable Medications and Reporting Period 
Reportable medications include medications that impact or may impact the consistency of the 
safety information collected after any vaccination and/or the immune response to vaccination. 
Category 1: Reportable medications with potential impact on the evaluation of the safety of the 
study vaccines. For example, antipyretics, analgesics, non-steroidal anti-inflammatory drugs 
(NSAIDs), systemic 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, otic, ophthalmic, nasal etc.) should not be captured or reported. 
Category 1 medications will be reported in the CRB from the day of first vaccination to the end of 
the solicited and unsolicited follow-up period after each vaccination. These medications will also 
be collected in the CRB for the 30-day period prior to the subsequent doses of the vaccine, 
                                                 
a  Subject’s parents will be required to document all medications received in the Diary Cards. The sites will focus on 
only recording the medications belonging to the 3 categories in the other source documents. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 83 of 121 
wherever applicable (second, third, fourth, etc., in case of a multi-dose schedule with more than a 
30-day interval between doses). 
• Category 2: Reportable medications with potential impact on immune response of the study 
vaccines 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 
• 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. 
• Immune globulins, blood or blood-derived products: used in the 3 months preceding 
the first blood draw and up to the last blood draw 
• Immunosuppressive therapy such as immune-suppressors, immune-modulators with 
immunosuppressive properties, long-term systemic corticosteroids therapy (prednisone 
or equivalent for more than 2 consecutive weeks) within past 3 months, anti-cancer 
chemotherapy, anti-proliferative drugs such as DNA synthesis inhibitors, or radiation 
therapy: used in the 6 months preceding the first trial vaccination, and up to the last 
blood draw. 
Category 2 medications will be reported in the CRB according to the collection period detailed 
above up to the last blood draw. 
• Category 3: Antibiotics that the subject received within 72 hours preceding each visit for 
blood draw related to IMP assessment (meningococcal vaccines) and used to define the PPAS. 
Category 3 medications will be reported in the CRB for the period of 3 days (72 hours) before 
each blood draw. 
Note: Topical antibiotics (inhaled, otic, ophthalmic, nasal, etc.) should not be captured or 
reported. 
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, will not be recorded. 
                                                 
a  Medication(s) prescribed for preventing AE occurrence (e.g. paracetamol to reduce the risk of fever) 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 84 of 121 
If the subject 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 to treat 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 prelisted categories. 
7 
Management of Samples  
Blood samples for the assessment of antibody responses will be collected at Visits 1, 2, 3 and 4 as 
follows: 
Group 1 and Group 2: 
• 
A blood sample before the first study vaccination at Visit 1 (all subjects) 
• 
A blood sample 30 days after administration of the first dose of MenACYW conjugate 
vaccine or MENVEO® at Visit 2 (only from approximately the first 50% of the subjects in 
Group 1 and Group 2) 
• 
A blood sample before the 12-month vaccination at Visit 3 (only from the remaining 50% of 
subjects in Group 1 and Group 2, who did not have a blood draw at Visit 2) 
• 
A blood sample 30 days after administration of the second dose of MenACYW conjugate 
vaccine or MENVEO® at Visit 4 (all subjects) 
Group 3 and Group 4: 
• 
A blood sample before the first study vaccination at Visit 1 
• 
A blood sample 30 days after administration of the second dose of MenACYW conjugate 
vaccine or Menactra® at Visit 3 
See the Table of Study Procedures and Section 5.1.3 for details of the sampling schedule. 
7.1 
Sample Collection  
At Visits that include a blood draw, 3 mL of blood will be collected in tubes provided by or 
recommended by the Sponsor. Immediately prior to the blood draw, the staff member performing 
the procedure will verify the subject’s identity; will write the assigned subject’s number on the 
pre-printed label that contains that subject’s number and the sampling stage; and will attach the 
label to the tube. If vaccination and blood sample collection occur at the same visit and vaccine is 
given only in one of the arms, blood is to be taken from the limb opposite to the one that will be 
used for vaccination. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 85 of 121 
Optional blood collection for routine screening tests (not part of study) 
The American Academy of Pediatrics (AAP) recommends blood lead screening as part of routine 
health supervision for children at 9 to 12 months of age and, if possible, again at 24 months of 
age. Further, the AAP recommends universal screening for anemia at approximately 12 months of 
age with determination of hemoglobin concentration and an assessment of risk factors associated 
with iron deficiency and iron deficient anemia (53). Children enrolled in this study will undergo 
routine screening outside of the study. Collection of blood for lead and anemia screening could be 
done at the same time as blood is drawn for the study immunologic assessment via the same 
venipuncture. This collection should be done in sample tubes which are not part of the study, and 
as per standard of care. The results of these tests will not be part of the study report. 
Blood collection for these screening tests could be done at any visit in the 2nd year of life, once 
for complete blood count (1 mL) and twice for lead blood levels (2 mL for each test). 
7.2 
Sample Preparation  
Detailed instructions on how to prepare blood samples for assessment of immune response are 
contained in the Operating Guidelines provided to the site. An overview of the procedures is 
provided here. 
Following the blood draw, the tubes are to be left undisturbed, positioned vertically and not 
shaken, for a minimum of 1 hour and a maximum of 24 hours to allow the blood to clot. 
Samples can be stored at room temperature for up to 2 hours; beyond 2 hours, they must be 
refrigerated at a temperature of +2°C to +8°C after the period of clotting at room temperature and 
must be centrifuged within a maximum of 24 hours. 
The samples are then centrifuged, and the serum is transferred to the appropriate number of 
aliquoting tubes. These tubes are pre-labeled with adhesive labels that identify the study code, the 
subject’s number and the sampling stage or visit number. 
The subject’s number and the date of sampling, the number of aliquots obtained, the date and time 
of preparation, and the subject’s consent for future use of his / her samples are to be specified on a 
sample identification list and recorded in the source document. Space is provided on this list for 
comments on the quality of samples. 
7.3 
Sample Storage and Shipment  
During storage, serum tubes are to be kept in a freezer whose temperature is set and maintained at 
-20°C or below. The temperature will be monitored and documented on the appropriate form 
during the entire study. If it rises above -10°C for any period of time, the Clinical Logistics 
Coordinator must be notified. See the Operating Guidelines for further details. 
Shipments to the laboratories will be made only after appropriate monitoring, and following 
notification of the Clinical Logistics Coordinator. Sera will be shipped frozen, using dry ice to 
maintain them in a frozen state, in the packaging container provided by the carrier. Again, 
temperatures will be monitored. Shipments must be compliant with the United Nations (UN) 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 86 of 121 
Class 6.2 specifications and the International Air Transport Association (IATA) 602 packaging 
instructions. 
Samples will be shipped to R&D Global Operations at Sanofi Pasteur. The address is provided in 
the Operating Guidelines. 
7.4 
Future Use of Stored Serum Samples for Research  
Any unused part of the serum samples will be securely stored at the Sanofi Pasteur R&D Global 
Operations for up to 25 years after the last license approval in the relevant market areas has been 
obtained for the vaccine being tested. 
Subjects’ parents / guardians will be asked to indicate in the ICF whether they will permit the 
future use of any unused stored serum samples for other tests. If they refuse permission, the 
samples will not be used for any testing other than that directly related to this study. If they agree 
to this use, they will not be paid for giving permission. Anonymity of samples will be ensured. 
The aim of any possible future research is unknown today, and may not be related to this 
particular study. It may be to improve the knowledge of vaccines or infectious diseases, or to 
improve existing tests or develop new tests to assess vaccines. Human genetic tests will never be 
performed on these samples without specific individual informed consent. 
8 
Clinical Supplies  
Sanofi Pasteur will supply the study sites with protocols, ICFs, CRBs, SAE reporting forms, diary 
cards, memory aids, and other study documents, as well as with the following study materials: all 
study vaccines, blood collection tubes, cryotubes, cryotube storage boxes, cryotube labels, 
temperature recorders, shipping containers, rulers, and digital thermometers. 
The means for performing Electronic Data Capture (EDC) will be defined by Sanofi Pasteur. If a 
computer is provided by Sanofi Pasteur, it will be retrieved at the end of the study. 
The Investigator will supply all vaccination supplies, phlebotomy, and centrifugation equipment, 
including biohazard and / or safety supplies. The biohazard and safety supplies include needles 
and syringes, examination gloves, laboratory coats, sharps disposal containers, and absorbent 
countertop paper. The site will ensure that all biohazard wastes are autoclaved and disposed of in 
accordance with local practices. The Investigator will also supply appropriate space in a 
temperature-monitored refrigerator for the storage of the products and for the blood samples, and 
appropriate space in a temperature-monitored freezer for serum aliquots. 
In the event that additional supplies are required, study staff must contact Sanofi Pasteur, 
indicating the quantity required. Contact information is provided in the Operating Guidelines. 
They must allow approximately 1 week for an order to be filled and to have the supplies sent to 
their site. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 87 of 121 
9 
Endpoints and Assessment Methods  
9.1 
Primary Endpoints and Assessment Methods  
9.1.1 
Safety  
There are no primary objectives for safety. 
9.1.2 
Immunogenicity  
9.1.2.1 
Immunogenicity Endpoint  
The primary endpoint for the evaluation of immunogenicity is: 
Meningococcal serogroups A, C, Y, and W antibody titers measured by hSBA, before the first 
study vaccination (Visit 1) and 30 days after the second dose of MenACYW conjugate vaccine or 
MENVEO® (Group 1 vs Group 2) 
9.1.2.2 
Immunogenicity Assessment Methods  
The hSBA testing will be performed at GCI, Swiftwater, PA or at a qualified contract laboratory 
for GCI. 
The assay method to be used is summarized below. Laboratory technicians conducting the 
immunogenicity assays will be blinded to the group to which each subject is assigned. 
Antibodies to meningococcal antigens (hSBA Method) 
Functional meningococcal antibody activity against serogroups A, C, Y, and W will be measured 
in hSBA. 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 quantitation (LLOQ) 
of the hSBA assay is a titer of 1:4. 
9.1.3 
Efficacy  
No clinical efficacy data will be obtained in the study. 
9.2 
Secondary Endpoints and Assessment Methods  
9.2.1 
Safety  
There are no secondary objectives for safety. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 88 of 121 
9.2.2 
Immunogenicity  
9.2.2.1 
Immunogenicity Endpoints  
The following serological endpoints will be assessed. 
1) Meningococcal serogroups A, C, Y, and W antibody titers ≥1:8 measured by hSBA 30 days 
after the second dose of MenACYW conjugate vaccine or MENVEO® (Group 1 vs Group 2) 
2) 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate 
vaccine or MENVEO® (Group 1 and Group 2): 
• 
hSBA meningococcal serogroups A, C, Y, and W antibody titers 
• 
Geometric mean titers (GMTs) with 95% CI 
• 
Titer distribution and reverse cumulative distribution curves (RCDCs) 
• 
Percentage of subjects with titer ≥ 4-fold rise from pre-vaccination to post-vaccination and 
95% CI 
3) 30 days after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine 
or MENVEO® (Group 1 and Group 2): 
• hSBA meningococcal serogroups A, C, Y, and W antibody titers 
• GMTs with 95% CI 
• Titer distribution and RCDCs 
• Percentage of subjects with titer ≥ 4-fold rise from pre-vaccination to post-vaccination and 
95% CI 
• Percentage of subjects with hSBA vaccine seroresponse and 95% CI 
4) 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate 
vaccine or MENVEO® (Group 1 and Group 2): 
• hSBA meningococcal serogroups A, C, Y, and W antibody titers 
• GMTs with 95% CI 
• Titer distribution and RCDCs 
• Percentage of subjects with titer ≥ 4-fold rise from pre-vaccination to post-vaccination and 
95% CI 
• Percentage of subjects with hSBA vaccine seroresponse and 95% CI 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 89 of 121 
5) 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate 
vaccine or Menactra® (Group 3 and Group 4): 
• hSBA meningococcal serogroups A, C, Y, and W antibody titers 
• GMTs with 95% CI 
• Titer distribution and RCDCs 
• Percentage of subjects with titer ≥ 4-fold rise from pre-vaccination to post-vaccination and 
95% CI 
• Percentage of subjects with hSBA vaccine seroresponse and 95% CI 
9.2.2.2 
Immunogenicity Assessment Methods  
The immunogenicity assessment methods for the secondary endpoints are the same as those 
presented in Section 9.1.2.2. 
9.2.3 
Efficacy  
No clinical efficacy data will be obtained in the study. 
9.3 
Observational Endpoints and Assessment Methods  
9.3.1 
Immunogenicity  
There are no observational objectives for immunogenicity in this study. 
9.3.2 
Safety  
9.3.2.1 
Safety Definitions  
The following definitions are taken from the ICH E2A Guideline for Clinical Safety Data 
Management: Definitions and Standards for Expedited Reporting. 
Adverse Event (AE): 
An AE is any untoward medical occurrence in a patient or in a clinical investigation subject 
administered a medicinal product and which does not necessarily have a causal relationship with 
this treatment. An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding, for example), symptom or disease temporally associated with the use 
of a medicinal product, whether or not considered related to the medicinal product. 
Therefore an AE may be: 
• 
A new illness 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 90 of 121 
• 
The worsening of a pre-existing condition 
• 
An effect of the vaccination, including the comparator 
• 
A combination of the above 
All AEs include serious and non-serious AEs. 
Surgical procedures are not AEs; they are the actions taken to treat a medical condition. It is the 
condition leading to the action taken that is the AE (if it occurs during the study period). 
Pre-existing medical conditions are not to be reported as AEs. However, if a pre-existing medical 
condition worsens following study interventions in frequency or intensity, or if according to the 
Investigator there is a change in its clinical significance, this change should be reported as an AE 
(exacerbation). This applies equally to recurring episodes of pre-existing conditions (e.g., asthma) 
if the frequency or intensity increases post-vaccination. 
Serious Adverse Event (SAE): 
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 
subject / event outcome or action criteria usually associated with events that pose a threat to a 
subject’s life or functioning. Seriousness, not severity, serves as a guide for defining regulatory 
reporting obligations. 
An SAE is any untoward medical occurrence that at any dose 
• 
Results in death 
• 
Is life-threateninga 
• 
Requires inpatient hospitalization or prolongation of existing hospitalizationb 
• 
Results in persistent or significant disability / incapacityc 
• 
Is a congenital anomaly / birth defect 
• 
Is an important medical event (IME) 
                                                 
a  The term “life-threatening” refers to an event in which the subject 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. 
b  All medical events leading to hospitalizations will be recorded and reported as SAEs, with the exception of: 
hospitalization planned before inclusion into the study or outpatient treatment with no hospitalization. 
c  “Persistent or significant disability or incapacity” means that there is a substantial disruption of a person’s ability 
to carry out normal life functions. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 91 of 121 
Medical and scientific judgment should be exercised in deciding whether expedited reporting is 
appropriate in other situations, such as IMEs that may not be immediately life-threatening or 
result in death or hospitalization but may jeopardize the health of the subject or may require 
intervention to prevent one of the other outcomes listed in the definition above. These IMEs 
should also usually be considered serious. Examples of such events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions 
that do not result in inpatient hospitalization, or the development of drug dependency or drug 
abuse, new-onset diabetes, or autoimmune disease. 
Adverse Reaction: 
All noxious and unintended responses to a medicinal product related to any dose should be 
considered adverse reactions (AR). 
(The phrase “responses to a medicinal product” means that a causal relationship between a 
medicinal product and an AE is at least a reasonable possibility) 
The following additional definitions are used by Sanofi Pasteur: 
Immediate Event/Reaction: 
Immediate events are recorded to capture medically relevant unsolicited systemic AEs (including 
those related to the product administered) that occur within the first 30 minutes after vaccination. 
Solicited Reaction: 
A solicited reaction is an “expected” adverse reaction (sign or symptom) observed and reported 
under the conditions (nature and onset) prelisted in the protocol and CRB (e.g., injection site 
tenderness or irritability occurring between D0 and D07 after vaccination). 
By definition, solicited reactions are to be considered as being related to the product administered. 
For injectable vaccines, solicited reactions can either be solicited injection site reactions or 
solicited systemic reactions. 
The assessment of these reactions by the investigator is mandatory. 
Unsolicited AE / AR: 
An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the CRB in 
terms of diagnosis and/or onset window post-vaccination. For example, if vomiting between D0 
and D07 is a solicited reaction (i.e., prelisted in the protocol and CRB), then a vomiting starting 
on D07 is a solicited reaction, whereas vomiting starting on D08 post-vaccination is an unsolicited 
AE. Unsolicited AEs includes both serious (SAEs) and non-serious unsolicited AEs. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 92 of 121 
Injection Site Reaction: 
An injection site reaction is an AR at and around the injection site. Injection site reactions are 
commonly inflammatory reactions. They are considered to be related to the product administered. 
Systemic AE: 
Systemic AEs are all AEs that are not injection or administration site reactions. They therefore, 
include systemic manifestations such as vomiting, fever, as well as localized or topical 
manifestations that are not associated with the vaccination or administration site (e.g., erythema 
that is localized but that is not occurring at the injection site). 
Adverse Event of Special Interest (AESI): 
An AESI is an event for which ongoing monitoring and rapid communication by the Investigator 
to the Sponsor must be done. 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 (e.g., regulators) might also be warranted. 
Medically-Attended Adverse Event (MAAE) 
An MAAE is defined, for the purpose of this study, as a new onset of a condition that prompts the 
subject or subject’s parent/guardian to seek unplanned medical advice at a health care provider’s 
office or Emergency Department. This definition excludes pre-planned medical office visits for 
routine pediatric check-ups or follow-up visits of chronic conditions with an onset prior to entry in 
the study. Health care provider contact made over the phone or by email will be considered a 
physician office visit for the purpose of MAAE collection. The outcome of the health care 
provider contact (whether it results in a prescription or not) will not be considered as a basis for 
reporting the event as an MAAE and all contacts should be reported. Sufficient data should be 
collected for the event to allow an assessment of the causality and diagnosis, if possible. 
9.3.2.2 
Safety Endpoints  
The following endpoints will be used for all subjects: 
• 
Occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), 
duration, intensity, relationship to vaccination, and whether the event led to early termination 
from the study, of any unsolicited systemic AEs reported within 30 minutes after each 
vaccination. 
• 
Occurrence, time of onset, number of days of occurrence, intensity, action taken, and whether 
the reaction led to early termination from the study, of solicited (prelisted in the subject’s 
diary card and CRB) injection site reactions occurring up to D07 after each vaccination. 
• 
Occurrence, time of onset, number of days of occurrence, intensity, action taken, and whether 
the reaction led to early termination from the study, of solicited (prelisted in the subject’s 
diary card and CRB) systemic reactions occurring up to D07 after each vaccination. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 93 of 121 
• 
Occurrence, nature (MedDRA preferred term), time of onset, duration, intensity, action taken, 
relationship to vaccination, and whether the event led to early termination from the study, of 
unsolicited AEs up to D30 after each vaccination. 
• 
Occurrence, nature (MedDRA preferred term), time of onset, duration, seriousness criteria, 
relationship to vaccination, outcome, and whether the event led to early termination from the 
study, of SAEs (including AESIs) throughout the trial from Visit 1 up to the 6 month follow-
up contact after the last vaccination. 
• 
Occurrence, nature (MedDRA preferred term), time of onset, duration, intensity, action taken, 
relationship to vaccination, and whether the event led to early termination from the study for 
MAAEs throughout the trial from Visit 1 up to the 6 month follow-up contact after the last 
vaccination. 
9.3.2.3 
Safety Assessment Methods  
At each visit, the Investigator or a delegate will perform a physical examination on the basis of 
relevant medical history according to the Investigator’s clinical judgement and will ask the parent 
/ guardian about any solicited reactions and unsolicited AEs recorded in the diary card, as well as 
about any other AEs that may have occurred since the previous visit. All relevant data will be 
transcribed into the CRB according to the instructions provided by the Sponsor. 
9.3.2.3.1 
Immediate Post-vaccination Observation Period  
Subjects will be kept under observation for 30 minutes after each vaccination to ensure their 
safety. The post-vaccination observation should be documented in the source document. Any AE 
that occurs during this period will be noted on the source document and recorded in the CRB, as 
follows: 
• 
Unsolicited systemic AEs will be recorded as immediate AEs in the CRB (presence marked as 
“yes” and details collected). 
• 
Solicited and unsolicited injection site reactions and solicited systemic reactions will be 
recorded in the CRB in the same way as any reactions starting on the day of vaccination. 
• 
SAEs will be recorded in the CRB and reported to the Sponsor in the same way as any other 
SAEs, according to the procedures described in Section 10. 
9.3.2.3.2 
Reactogenicity (Solicited Reactions from Day 0 to Day 07 after Each 
Vaccination)  
After each vaccination, parents / guardians will be provided with a diary card, a digital 
thermometer, and a flexible ruler, and will be instructed how to use them. The following items 
will be recorded by the subject’s parent / guardian in the diary card on the day of vaccination and 
for the next 7 days (i.e., D0 to D07) until resolution: 
• 
Daily temperature, with the route by which it was taken 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 94 of 121 
• 
Daily measurement or intensity grade of all other solicited injection site and systemic 
reactions 
• 
Action taken for each event (e.g., medication) 
The action(s) taken by the parent or guardian to treat and/or manage any solicited reactions 
will be classified in the CRB using the following list (all applicable items should be 
checked): 
• None 
• Medication 
• Health care provider contact 
• Hospitalized 
• Discontinuation of study vaccination 
Parents / guardians will be contacted by telephone 8 days after each vaccination to remind them to 
record all safety information in the diary card. 
If the timing of the telephone call should fall on a weekend or a holiday, the call should be made 
on the next business day. If contact is not made on the designated day, study staff will continue 
calling until contact is made. Every telephone attempt and its outcome will be documented in the 
source document. 
Table 9.1 and Table 9.2 present, respectively, the injection site reactions and systemic reactions 
that are prelisted in the diary cards and CRB, together with the intensity scales. 
 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 95 of 121 
Table 9.1: Solicited injection site reactions: terminology, definitions, and intensity scales  
CRB term 
(MedDRA lowest level term 
[LLT]) 
Injection site 
tenderness 
Injection site erythema 
Injection site swelling 
MedDRA preferred term 
Injection site pain 
Injection site erythema 
Injection site swelling 
Diary card term 
Tenderness 
Redness 
Swelling 
Definition 
Pain when the injection 
site is touched or 
injected limb mobilized 
Presence of a redness 
including the approximate 
point of needle entry 
Swelling at or near the 
injection site 
Swelling or edema is caused 
by a fluid infiltration in 
tissue or cavity and, 
depending on the space 
available for the fluid to 
disperse, swelling may be 
either soft (typically) or 
firm (less typical) to touch 
and thus can be best 
described by looking at the 
size of the swelling 
Intensity scale* 
Grade 1: 
Minor reaction when 
injection site is touched 
 
Grade 2: 
Cries or protests when 
injection site is touched 
 
Grade 3: 
Cries when injected limb 
is mobilized, or the 
movement of the 
injected limb is reduced 
Grade 1: > 0 to < 25 mm 
 
 
 
 
Grade 2: ≥ 25 to < 50 mm 
 
 
 
 
Grade 3: ≥ 50 mm 
Grade 1: > 0 to < 25 mm 
 
 
 
 
Grade 2: ≥ 25 to < 50 mm 
 
 
 
 
Grade 3: ≥ 50 mm 
*  For the subjective reaction of tenderness, parents /guardians will record the intensity level (Grade 1, 2, or 3) in the 
diary card. 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. Since all subjects will 
be vaccinated before the second birthday, the same intensity scales will be used for all subjects. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 96 of 121 
Table 9.2: Solicited systemic reactions: terminology, definitions, and intensity scales*  
CRB term (MedDRA 
LLT) 
Fever 
 
Vomiting 
Crying 
Abnormal 
Drowsiness 
Appetite Lost 
Irritability 
MedDRA preferred term 
Pyrexia 
Vomiting 
Crying 
Somnolence 
Decreased appetite 
Irritability 
Diary card term 
Temperature 
Vomiting 
Abnormal 
crying 
Drowsiness 
Loss of appetite 
Irritability 
Definition 
Elevation of temperature to 
≥°38.0°C (≥ 100.4°F) 
Vomiting does not include 
spitting up 
Inconsolable 
crying without 
a determined 
reason 
Reduced interest in 
surroundings, or 
increased sleeping 
See intensity scale 
An excessive 
response to stimuli: 
increased fussiness, 
whining, and 
fretfulness despite 
attempts to comfort 
the infant and 
despite caregiver 
responses that 
would normally be 
soothing 
Intensity scale† 
Grade 1:  
≥ 38.0°C to ≤ 38.5°C 
or ≥ 100.4°F to ≤ 101.3°F 
Grade 1: 1 episode per 
24 hours 
Grade 1: 
< 1 hour 
Grade 1: Sleepier than 
usual or less interested in 
surroundings 
Grade 1: Eating less 
than normal 
Grade 1: Easily 
consolable 
 
Grade 2: 
> 38.5°C to ≤ 39.5°C 
or > 101.3°F to ≤ 103.1°F 
Grade 2: 
2–5 episodes per 24 hours 
Grade 2: 
1–3 hours 
Grade 2: 
Not interested in 
surroundings or did not 
wake up for a feed / 
meal 
Grade 2: Missed 1 
or 2 feeds / meals 
completely 
Grade 2: Requiring 
increased attention 
 
Grade 3: 
> 39.5°C 
or > 103.1°F 
Grade 3: ≥ 6 episodes per 
24 hours or requiring 
parenteral hydration 
Grade 3: 
> 3 hours 
Grade 3: Sleeping most 
of the time or difficult to 
wake up 
Grade 3: Refuses ≥ 
3 feeds / meals or 
refuses most feeds / 
meals 
Grade 3: 
Inconsolable 
*Since all subjects will be vaccinated before the second birthday, the same intensity scales will be used for all subjects. 
†For all reactions but fever, parents / guardians will record the intensity level (Grade 1, 2, or 3) in the diary card. For fever, they will record the body temperature, and the 
classification as Grade 1, 2, or 3 will be assigned at the time of the statistical analysis based on the unit used to measure the temperature and the intensity scale. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 97 of 121 
Important notes for the accurate assessment of temperature: 
Parents / guardians 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 diary card, and the highest 
temperature will be recorded by the site in the CRB. The preferred route for this study is rectal. 
Pre-vaccination temperature is also systematically collected by the investigator on the source 
document. Tympanic thermometers must not be used. 
9.3.2.3.3 
Unsolicited Adverse Events  
In addition to recording solicited reactions, parents / guardians will be instructed to record any 
other medical events that may occur during the 30-day period after each vaccination. Space will 
be provided in the diary card for this purpose. 
Information on SAEs will be collected and assessed throughout the study, from Visit 1 until 
6 months after the last vaccinations. Any SAE occurring at any time during the study will be 
reported by the Investigator in the CRB according to the completion instructions provided by the 
Sponsor; this includes checking the “Serious” box on the AE CRF and completing the appropriate 
Safety Complementary Information CRF. All information concerning the SAE is to be reported 
either as part of the initial reporting or during follow-up reporting if relevant information became 
available later (e.g., outcome, medical history, results of investigations, copy of hospitalization 
reports. In case a subject experiences febrile convulsion (neurological event associating fever and 
seizure), the assessment will be performed according to the “Guideline for definition and 
collection of cases of febrile convulsion”, and this event will be considered an SAE. 
See Section 10 for further details on SAE reporting. 
For each unsolicited AE (whether serious or non-serious), the following information is to be 
recorded: 
• 
Start and stop datesa 
• 
Intensity of the event: 
For measurable unsolicited AEs that are part of the list of solicited reactions, the size of the 
AE as well as the temperature for fever will be collected and analyzed based on the 
corresponding scale used for solicited reactions (see Table 9.1 and Table 9.2). 
All other unsolicited AEs will be classified according to the following intensity scale: 
                                                 
a  The stop date of all related AEs will be actively solicited. For other events, the investigator will provide the stop 
date when it becomes available. AEs for which no stop date was obtained during the course of the study will be 
considered as ongoing at the end of the study. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 98 of 121 
• 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. 
• Whether the AE was related to the investigational product (for unsolicited systemic AEs) 
The Investigator will assess the causal relationship between the AE and the investigational 
product as either “Not related” or “Related,” as described in Section 9.3.2.3.6. 
• Action taken for each AE (e.g., medication) 
The action(s) taken by the parent or guardian to treat and/or manage any unsolicited AEs will 
be classified in the CRB using the following list (all applicable items should be checked): 
• None 
• Medication 
• Health care provider contact 
• Hospitalized 
• Discontinuation of study vaccination 
• 
Whether the AE was serious 
For each SAE, the investigator will complete all seriousness criteria that apply 
(outcome, elapsed time, and relationship to study procedures) 
• 
Whether the AE caused study discontinuation 
9.3.2.3.4 
Adverse Events of Special Interest  
An AESI is defined as an event for which ongoing monitoring and rapid communication by the 
Investigator to the Sponsor must be done. The following AEs will be captured as AESIs 
throughout the study: 
• 
Generalized seizures (febrile and non-febrile) (54) (55) 
• 
Kawasaki disease (55) (56) (57) 
• 
Guillain-Barré syndrome (56) 
• 
Idiopathic thrombocytopenic purpura (ITP) (57) (58) 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 99 of 121 
These events have been listed as AESIs based on the feedback received from the European Union 
regulators. 
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 and collected 
as SAEs and reported to the Sponsor according to the procedure described in Section 10. 
Further instructions on the data collection for these events and the relevant definitions will be 
provided in the Operating Guidelines. 
9.3.2.3.5 
Medically-Attended Adverse Events  
MAAE information will be collected throughout the study. MAAEs will be recorded as 
unsolicited AEs for up to D30 after each vaccination and as MAAEs until the next study visit on 
the appropriate diary cards. MAAEs that occur from D31 after the last vaccination visit until the 
6-month follow up phone call will be recorded in the appropriate memory aid. An MAAE that 
occurs within the study period but meets the definition of an SAE should be reported only on the 
SAE Reporting Form but not on the MAAE page of the CRB. The Investigator will assess the 
causal relationship between the MAAE and the investigational or study product as either “Not 
related” or “Related”, as described in Section 9.3.2.3.6. 
9.3.2.3.6 
Assessment of Causality  
The Investigator will assess the causal relationship between each unsolicited systemic AE and 
the investigational product administered 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 first vaccination (screening phase, if applicable) 
• 
Related – There is a “reasonable possibility” that the AE was caused by the product 
administered, meaning that there is evidence or arguments to suggest a causal relationship 
Note: 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 administered product and therefore 
are referred to as reactions and do not require the Investigator’s opinion on relatedness. 
Adverse events likely to be related to the product, 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 subject’s condition. The Investigator will inform the Sponsor of the date of 
final disappearance of the event or the date of “chronicity” establishment. 
9.3.3 
Efficacy  
There are no objectives for efficacy in this study. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 100 of 121 
10 Reporting of Serious Adverse Events  
To comply with current regulations on SAE reporting to health authorities, the Investigator must 
document all SAEs regardless of causal relationship, and notify the Sponsor and the Clinical 
Research Associate (CRA) within the notification timelines stated in the following sections. The 
Investigator will give access and provide the Sponsor and the CRA with all necessary information 
to allow the Sponsor to conduct a detailed analysis of the safety of the investigational product(s). 
It is the responsibility of the Investigator to request all necessary documentation (e.g., medical 
records, discharge summary) in order to provide comprehensive safety information. All relevant 
information must then be transcribed onto the AE CRF and the appropriate Safety 
Complementary Information CRFs. 
10.1 Initial Reporting by the Investigator  
Serious adverse events occurring during a subject’s participation in the study or experiment must 
be reported within 24 hours to the Sponsor’s GPV Department and to the CRA. Every SAE must 
be reported, even if the Investigator considers that it is not related to the vaccine. The investigator 
(licensed physician [M.D. or D.O.]) must validate the information entered on the AE CRF by 
completing the investigator validation form. 
The Investigator must indicate on the AE CRF that the event was serious and must complete the 
relevant SAE section of this form as well as the appropriate Safety Complementary Information 
CRFs. An e-mail alert will automatically be sent by the EDC system to the GPV mailbox, the 
CRA and the RMO with relevant SAE information details. 
If the EDC system is unavailable, the site must notify the Sponsor, using the paper version of the 
CRB, as described in the operating guidelines: 
The Investigator must complete the paper copies of the AE CRF and of the appropriate Safety 
Complementary Information CRFs and send them 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@sanofi.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 
When the EDC system becomes available, the Investigator must transcribe the information from 
the paper forms into the EDC system. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 101 of 121 
If there is need for urgent consultation, the Investigator is to contact the study RMO, 
, 
MD. If the RMO cannot be reached, the Investigator may contact the Call Center as described in 
Section 5.3. 
10.2 Follow-up Reporting by the Investigator  
The AE CRF completed initially must be updated within 24 hours after the Investigator has 
become aware of any new relevant information concerning the SAE (e.g., outcome, precise 
description of medical history, results of the investigation). All relevant information must be 
included directly in the AE CRF and the appropriate Safety Complementary Information CRFs. 
An e-mail alert will be sent automatically to the GPV Department and to the CRA. Copies of 
documents (e.g., medical records, discharge summary, autopsy) may be requested by the GPV 
Department. 
The anonymity of the subject must always be respected when forwarding this information. 
10.3 Reporting of SAEs Occurring After a Subject Has Completed the Study  
Any SAE that occurs after a subject has completed the study but that is likely to be related to the 
investigational product(s), other products (e.g., a benefit vaccine), or to the experiment must also 
be reported as soon as possible. In such a case, the reporting procedure to be followed is identical 
to that described in Section 10.1. 
10.4 Assessment of Causality  
The causal relationship between the SAE and the investigational product administered will be 
evaluated by the Investigator as described in Section 9.3.2.3.6. 
Following this, the Sponsor’s Pharmacovigilance (PV) Global Safety Officer will also assess the 
causal relationship to the product, based on the available information and current medical 
knowledge. 
The causal relationship to study procedures will be also assessed in the CRB. 
The decision to modify or discontinue the study may be made after mutual agreement between the 
Sponsor and the Investigator(s). 
10.5 Reporting SAEs to Health Authorities and IECs / IRBs  
The Sponsor will inform the relevant health authorities of any reportable SAEs according to the 
local regulatory requirements. Reporting to the health authorities will be according to the 
Sponsor’s standard operating procedures. 
The Sponsor’s RMO, 
, MD will notify the Investigators in writing of the occurrence 
of any reportable SAEs. The Investigators / Sponsor will be responsible for informing the IECs or 
IRBs that reviewed the study protocol. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 102 of 121 
11 Data Collection and Management  
11.1 Data Collection and CRB Completion  
Individual diary cards, specifically designed for this study by the Sponsor and provided to the 
study sites, will be given to study participants’ parent / guardian for the recording of daily safety 
information as described in Section 9.3.2.3. These diary cards will include prelisted terms and 
intensity scales (see Table 9.1 and Table 9.2) as well as areas for free text to capture additional 
safety information or other relevant details. Parents or guardians will also be provided with rulers 
for measuring the size of injection site reactions, and with standard digital thermometers for 
measuring daily temperatures. To ensure consistency of reporting, the study sites will instruct 
parents / guardians on how to correctly use these tools. 
The 6-month follow-up will be done by interviewing subjects’ parents / guardians over the 
telephone using a questionnaire to capture MAAEs, SAEs and AESIs, if applicable. A memory 
aid may be provided to the subjects’ parents / guardians at the preceding study visit to help them 
record information on events occurring between this visit and the 6-month follow-up. 
Relevant information will be transcribed into the AE CRF. Any SAEs captured during this 6-
month follow-up period will be reported and followed-up as per the normal process for reporting 
SAEs. 
At specified intervals, the Investigator or an authorized designee will interview the parents / 
guardians to collect the information recorded in the diary card, 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 diary card will first be captured in the source 
document and then reported electronically.) The CRB has been designed specifically for this 
study under the responsibility of the Sponsor, using a validated Electronic Records / Electronic 
Signature-compliant platform (21 CFR Part 11). 
To ensure the correct and consistent completion of the CRBs, the Sponsor or authorized 
representative will provide all necessary tools, instructions, and training to all site staff involved 
in data entry prior to study start. Additional instructional documents such as training manuals and 
completion instructions will be provided to assist with data entry during the course of the study. 
Upon completion of training, each user requiring access to the EDC system will be issued a 
unique username and password. In the event of a change in study personnel, each newly assigned 
individual will receive a unique username and password; the username and password of a 
previous user may not be reissued. If any study personnel leave the study, the Investigator is 
responsible for informing the Sponsor immediately so that their access is deactivated. An audit 
trail will be initiated in the EDC system at the time of the first data entry to track all modifications 
and ensure database integrity. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 103 of 121 
The Investigator is responsible for the timeliness, completeness, and accuracy of the information 
in the CRBs; must provide explanations for all missing information; and must sign the CRB using 
an e-signature. 
11.2 Data Management  
Management of SAE Data 
During the study, SAE data (reported on the AE and Safety Complementary Information CRFs) 
will be integrated into the Sponsor’s centralized GPV database upon receipt of these forms and 
after a duplicate check. Each case will be assigned a case identification number. Each case will be 
assessed by the case management platform or its delegate before being reported to the relevant 
authorities as necessary. The assessment of related cases will be done in collaboration with the PV 
Global Safety Officer and the RMO. Follow-up information concerning a completed case will be 
entered into the GPV database, and a new version of the case will be created. 
The information from the GPV database cases will be reconciled with that in the clinical database. 
Management of Clinical and Laboratory Data 
Clinical data, defined as all data reported in the CRB, and laboratory data will be handled by the 
Sponsor’s Clinical Data Management (CDM) platform or authorized representative. 
During the study, clinical data reported in the CRBs will be integrated into the clinical database 
under the responsibility of the Sanofi Pasteur CDM platform. Data monitoring at the sites and 
quality control in the form of computerized logic and / or consistency checks will be 
systematically applied to detect errors or omissions. In addition, data reviews may be performed 
several times by the Sponsor’s staff in the course of the study. Any questions pertaining to the 
reported clinical data will be submitted to the investigator for resolution using the EDC system. 
Each step of this process will be monitored through the implementation of individual passwords 
to maintain appropriate database access and to ensure database integrity. 
The validation of the immunogenicity data will be performed at the laboratory level following the 
laboratory’s procedures. Information from the laboratory will be checked for consistency before 
integration into the clinical Datawarehouse. 
After integration of all corrections in the complete set of data, and after the SAE information 
available from CDM and the GPV Department has been reconciled, the database will be released for 
statistical analysis. 
11.3 Data Review  
A blind review of the data is anticipated through the data review process led by Data Management 
before database lock. The safety of the investigational product will be continuously monitored by 
the Sponsor. Periodic safety data review will be performed by the Sponsor’s SMT. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 104 of 121 
12 Statistical Methods and Determination of Sample Size  
12.1 Statistical Methods  
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 under the 
responsibility of the Sponsor and all the conventions to be taken. 
Multiplicity adjustment is not required. Testing of the secondary hypotheses is dependent on 
successful rejection of the primary hypotheses. Within primary and secondary hypotheses, the 
intersection-union testing procedure (58) is being applied. 
12.1.1 Sensitivity analysis due to COVID-19 pandemic  
The impact of COVID-19 pandemic situation on study conduct will be summarized through 
impact on visit procedures, study completion and major/critical protocol deviations due to 
COVID-19. The subjects impacted by COVID-19 pandemic situation will be defined as the 
subjects with at least one major/critical protocol deviation due to COVID-19 or who did not 
complete the study due to COVID-19. If more than 10% of subjects are impacted as per this 
definition, baseline and demographic characteristics and the main immunogenicity and safety 
endpoints will also be summarized in  the subset of subjects impacted / not-impacted to assess the 
potential impact of COVID-19 situation on study outcome. 
12.1.2 Hypotheses and Statistical Methods for Primary Objective  
12.1.2.1 Hypotheses  
The primary objectives will be met if the following primary hypotheses are rejected: 
• Primary Hypothesis 1 (MenACYW vaccine seroresponse rate after 2nd dose): 
Thirty days after receiving MenACYW conjugate vaccine at 12 months of age, the hSBA vaccine 
seroresponsea rates against meningococcal serogroups A, C, Y, and W in Group 1 is non-inferior 
to the corresponding hSBA vaccine seroresponse rates against meningococcal serogroups A, C, Y, 
and W in Group 2. 
Null hypothesis (H0): p(men, G1) - p(men, G2) ≤ -10% 
                                                 
a  hSBA vaccine seroresponse for serogroups A, C, Y and W 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 ≥ 4-fold greater than the pre-
vaccination titer 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 105 of 121 
Alternative hypothesis (H1): p(men, G1) - p(men, G2) > -10%  
where p(men, G1) and p(men, G2) are the percentages of subjects who achieve hSBA vaccine 
seroresponse in Group 1 and Group 2, respectively. Each of the serogroups A, C, Y, and W will 
be tested separately. Assuming the difference between the 2 proportions is normally distributed, if 
the lower limit of the 2-sided 95% confidence interval (CI) of the difference between the 
2 proportions is > -10%, the inferiority assumption will be rejected. 
For the non-inferiority hypotheses using the seroresponse rates, the CI of the difference in 
proportions is computed using the Wilson Score method without continuity correction. 
12.1.3 Hypotheses and Statistical Methods for Secondary Objective 1  
12.1.3.1 Hypotheses  
Thirty days after receiving MenACYW conjugate vaccine at 12 months of age, the percentage of 
subjects that achieve hSBA titers ≥ 1:8 for meningococcal serogroups A, C, Y, and W in Group 1 
are non-inferior to the corresponding percentages in Group 2. 
Null hypothesis (H0): p(men, G1) - p(men, G2) ≤ -10% 
Alternative hypothesis (H1): p(men, G1) - p(men, G2) > -10% 
where p(men, G1) and p(men, G2) are the percentages of subjects who achieve hSBA ≥1:8 in 
Group 1 and Group 2 respectively. Each of the serogroups A, C, Y, and W will be tested 
separately. Assuming the difference between the 2 proportions is normally distributed, if the 
lower limit of the 2-sided 95% CI of the difference between the 2 proportions is > -10%, the 
inferiority assumption will be rejected. 
For the non-inferiority hypotheses using the seroprotection rates, the CI of the difference in 
proportions is computed using the Wilson Score method without continuity correction. 
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 proportions. For GMTs and GMCs, 95% CIs of point estimates will be calculated 
using normal approximation assuming they are log-normally distributed. 
For secondary objectives 2, 3, 4, and 5, no hypothesis will be tested, and descriptive statistics will 
be used. 
12.1.4 Statistical Methods for Observational Objectives  
No hypotheses will be tested. Descriptive statistics will be presented. 
Safety 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 106 of 121 
Safety results will be described for subjects in all study groups. The main parameters for the 
safety endpoints will be described by 95% CIs (based on the Clopper-Pearson method). 
12.2 Analysis Sets  
Three analysis sets will be used: the Full Analysis Set (FAS), the Per-Protocol Analysis Set 
(PPAS), and the SafAS. 
12.2.1 Full Analysis Set  
There will be 2 FAS for this study. 
FAS1 for infant vaccination: 
• 
The FAS1 is defined as the subset of all randomized subjects who received at least 1 dose of 
the study vaccine in infancy (< 12 months of age) and have a valid post vaccination serology 
result in infancy. All subjects will be analyzed according to the treatment group to which they 
were randomized. 
FAS2 for second year of life vaccination: 
• 
The FAS2 is defined as the subset of all randomized subjects who received at least 1 dose of 
the study vaccine in the second year of life (≥ 12 months of age) and have a valid 
post-vaccination serology result in the second year of life. All subjects will be analyzed 
according to the treatment group to which they were randomized. 
Immunogenicity analyses will be performed on the FAS for exploratory purposes. 
12.2.2 Safety Analysis Set  
The SafAS is defined as those subjects who have received at least 1 dose of the study vaccine(s)a, 
and have any safety data available. All subjects 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). 
12.2.2.1 Overall Safety Analysis Set for Any Dose  
The overall SafAS is defined as those subjects who have received at least one dose of the study 
vaccines and have any safety data available. All subjects will have their safety analyzed according 
to the vaccine they actually received at the first dose. 
                                                 
a  for which safety data are scheduled to be collected 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 107 of 121 
Safety data recorded for a vaccine received out of the protocol design will be excluded from the 
analysis (and listed separately). 
12.2.2.2 Safety Analysis Set for Vaccination at 6 Months of Age  
The SafAS 1 for vaccination at 6-7 months of age in Groups 1 and 2 is defined as those subjects 
who have received the study vaccine at Visit 1 (Groups 1 and 2) around 6-7 months of age and 
have any safety data available. 
All subjects in Group1 and Group 2 will have their safety analyzed after the Visit 1 dose 
according to the vaccines they actually received at Visit 1. 
Safety data recorded for a vaccine received out of the protocol design at Visit 1 will be excluded 
from the analysis (and listed separately). 
12.2.2.3 Safety Analysis Set for Vaccination at 12 Months of Age  
The SafAS 2 for vaccination at 12-13 months of age in Groups 1 and 2 is defined as those subjects 
who have received the study vaccine at Visit 3 (Groups 1 and 2) around 12-13 months of age and 
have any safety data available. 
All subjects in Group1 and Group 2 will have their safety analyzed after the Visit 3 dose 
according to the vaccines they actually received at Visit 3. 
Safety data recorded for a vaccine received out of the protocol design at Visit 3 will be excluded 
from the analysis (and listed separately). 
12.2.2.4 Safety Analysis Set for Vaccination at 17 Months of Age  
The SafAS 3 for vaccination at 17-19 months of age in Groups 3 and 4 is defined as those subjects 
who have received the study vaccine at Visit 1 (Groups 3 and 4) around 17-19 months of age and 
have any safety data available. 
All subjects in Group 3 and Group 4 will have their safety analyzed after the Visit 1 dose 
according to the vaccines they actually received at Visit 1. 
Safety data recorded for a vaccine received out of the protocol design at Visit 1 (Groups 3 and 4) 
will be excluded from the analysis (and listed separately). 
12.2.2.5 Safety Analysis Set for Vaccination at 20 Months of Age  
The SafAS 4 for vaccination at 20-23 months of age in Groups 3 and 4 is defined as those subjects 
who have received the study vaccine at Visit 2 (Groups 3 and 4) around 20-23 months of age and 
have any safety data available. 
All subjects in Group 3 and Group 4 will have their safety analyzed after the Visit 2 dose 
according to the vaccines they actually received at Visit 2. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 108 of 121 
Safety data recorded for a vaccine received out of the protocol design at Visit 2 (Groups 3 and 4) 
will be excluded from the analysis (and listed separately). 
12.2.3 Per-Protocol Analysis Set  
Immunogenicity analyses will primarily be performed on PPAS. The PPAS is a subset of the 
FAS. There will be 2 PPAS corresponding to the 2 FASs. 
• 
PPAS for infant vaccination (PPAS1) 
• 
PPAS for second year of life vaccination (PPAS2) 
12.2.3.1 Per-Protocol Analysis Set 1 (PPAS1)  
Serology obtained 30 days after the vaccination visit at 6 months of age for all antigens will be 
used for immunogenicity analyses of infant stage of study. 
PPAS1 will be a subset of FAS1. The subjects presenting with at least one of the following 
relevant protocol deviations will be excluded from the PPAS1: 
• Subject did not meet all protocol-specified inclusion criteria or met at least one of the 
protocol-specified exclusion criteria 
• Subject did not complete the vaccination schedule 
• Subject received a vaccine other than the one that he / she was randomized to receive 
• Preparation and / or administration of vaccine was not done as per-protocol 
• Subject did not receive vaccine in the proper time window 
• 
Group 1 and Group 2 
o Visit 1: 24 to 32 weeks of age 
• Subject did not provide a post-dose serology sample in the proper time window or a post-dose 
serology sample was not drawn 
• 
Group 1 and Group 2 
o Blood Sampling 0002A: Visit 1 + 30 days (±21 days) 
• Subject received a protocol-prohibited therapy / medication / vaccine (reportable concomitant 
medication of category 2 and / or category 3) 
• Subject had other protocol violations that affected the subject’s immune response, as 
determined by the clinical team before locking the database. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 109 of 121 
In addition to the reasons listed above, subjects will also be excluded from the PPAS1 if their 
serology sample did not produce a valid test result (i.e., results for all antigens are missing). 
Vaccine correctness required by the PPAS1 includes not only the dose of MenACYW conjugate 
vaccine or MENVEO® but also the concomitant vaccines (DTaP, IPV, Hib, PCV13, Rotavirus, 
hepatitis B) as scheduled. 
In the event of a local or national immunization program with a pandemic influenza or 
coronavirus vaccine, subjects who receive 1 or more doses of a pandemic influenza or coronavirus 
vaccine at any time during the study will not be withdrawn from the study. 
12.2.3.2 Per-Protocol Analysis Set 2 (PPAS2)  
During the second year of life, the immunogenicity analyses for various antigens will be 
performed on serology obtained 30 days after the given antigen administration if blood collection 
is planned at that time. 
PPAS2 will be a subset of FAS2. The subjects presenting with at least one of the following 
relevant protocol deviations will be excluded from the PPAS2: 
• Subject did not meet all protocol-specified inclusion criteria or met at least one of the 
protocol-specified exclusion criteria 
• Subject did not complete the vaccination schedule including the infant and the second year of 
the study: 
• 
Group 1 and Group 2: Up to 12-13 month vaccinations, including the infant schedule 
• 
Group 3 and Group 4: Up to 23 month vaccinations 
• Subject received a vaccine other than the one that he / she was randomized to receive 
• Preparation and / or administration of vaccine was not done as per-protocol 
• Subject did not receive vaccine in the proper time window 
• 
Group 1 and Group 2 
o Visit 3: 12 to 13 months of age 
• 
Group 3 and Group 4 
o Visit 1: 17 to 19 months of age 
o Visit 2: 20 to 23 months of age 
• Subject did not provide a post-dose serology sample in the proper time window or a post-dose 
serology sample was not drawn 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 110 of 121 
• 
Group 1 and Group 2 
o Blood Sampling 0003: Visit 4 (Visit 3 + 30 days [±21 days]) 
• 
Group 3 and Group 4 
o Blood Sampling 0002: Visit 3 (Visit 2 + 30 days [±21 days]) 
• Subject received a protocol-prohibited therapy / medication / vaccine (reportable concomitant 
medication of category 2 and / or category 3) 
• Subject had other protocol violations that affected the subject’s immune response, as 
determined by the clinical team before locking the database 
In addition to the reasons listed above, subjects will also be excluded from the PPAS if their 
serology sample did not produce a valid test result (i.e., results for all antigens are missing). 
Vaccine correctness required by the PPAS2 includes not only the 2 doses of MenACYW 
conjugate vaccine, MENVEO®, or Menactra® but also, for subjects in groups 1 and 2, the 
concomitant vaccines (MMR, Varicella) as scheduled in the second year of life. 
In the event of a local or national immunization program with a pandemic influenza vaccine, 
subjects who receive 1 or more doses of a pandemic influenza vaccine at any time during the 
study will not be withdrawn from the study. 
12.2.4 Populations Used in Analyses  
The primary immunogenicity analyses will be performed on the PPAS, including the PPAS1 and 
PPAS2. Additional immunogenicity analyses will be performed on the FAS for exploratory 
purposes, including FAS1 and FAS2, according to randomization group. The safety analysis will 
be performed on the SafAS (SafAS, and SafAS1 through SafAS4). 
12.3 Handling of Missing Data and Outliers  
12.3.1 Safety  
No replacement will be done. 
12.3.2 Immunogenicity  
Missing data will not be imputed. No test or search for outliers will be performed. 
12.4 Interim Analysis  
No interim analyses are planned. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 111 of 121 
12.5 Determination of Sample Size and Power Calculation  
Approximately 870 subjects will be enrolled in Group 1 and Group 2. An estimated around 20% 
to 30% and not higher than 40% of non-evaluable subjects will result in at least 522 subjects in 
the Per-Protocol population available for immunogenicity analyses. Group 1 will have 435 
enrolled subjects and 261 evaluable subjects. Group 2 will have 435 enrolled subjects and 261 
evaluable subjects. In addition, 200 subjects will be enrolled in Group 3 and Group 4. 
In case of unexpected situations or any study hold resulting in an unexpected number of 
unevaluable subjects, total sample size may be increased to replace withdrawn, or unevaluable 
subjects. 
For the Primary Objective: 
Thirty days after the month 12 vaccination (after the second dose vaccination) 
With at least 261 evaluable subjects in Group 1 and at least 261 evaluable subjects in Group 2, the 
study will have around 90.0% power by using Farrington and Manning’s method to declare the 
non-inferiority of Group 1 vs Group 2. 
Table 12.1: Power estimates to reject primary null hypothesis  
Antigen 
Endpoint 
Estimated response (%)* 
Non-inferiority margin 
Power (%) 
A 
Seroresponse Rate 
97.7 
10% 
100 
C 
Seroresponse Rate 
97.8 
10% 
100 
Y 
Seroresponse Rate 
93.3 
10% 
99.0 
W 
Seroresponse Rate 
86.7 
10% 
91.0 
Overall 
90.0 
Note: Evaluable subjects: Group 1 = 261 subjects; Group 2 = 261 subjects 
*Estimated responses are based on results observed in MET39 
For Secondary Objective 1: 
Thirty days after the month 12 vaccination (after the second dose vaccination) 
With 261 evaluable subjects in Group 1 and 261 evaluable subjects in Group 2, the study will 
have 100% power by using Farrington and Manning’s method to declare the non-inferiority of 
Group 1 vs Group 2. 
Table 12.2: Power estimates to reject the secondary null hypothesis  
Antigen 
Endpoint 
Estimated response (%)* 
Non-inferiority margin 
Power (%) 
A 
% ≥1:8 
>99.9 
10% 
100 
C 
% ≥1:8 
>99.9 
10% 
100 
Y 
% ≥1:8 
97.8 
10% 
100 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 112 of 121 
W 
% ≥1:8 
97.8 
10% 
100 
Overall 
 
100 
Note: Evaluable subjects: Group 1 = 261 subjects; Group 2 = 261 subjects 
*Estimated responses are based on results observed in MET39 
13 Ethical and Legal Issues and Investigator / Sponsor Responsibilities  
13.1 Ethical Conduct of the Study / Good Clinical Practice  
The conduct of this study will be consistent with the standards established by the Declaration of 
Helsinki and compliant with the ICH guidelines for GCP as well as with all local and / or national 
regulations and directives. 
13.2 Source Data and 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, diary cards, medical and 
hospital records, screening logs, informed consent / assent forms, telephone contact logs, and 
worksheets. The purpose of study source documents is to document the existence of subjects and 
to substantiate the integrity of the study data collected. Investigators must maintain source 
documents so that they are accurate, complete, legible, and up to date. 
For missing or discrepant data on a diary card, the study coordinator will obtain verbal clarification 
from the subject, enter the response into the “investigator’s comment” page of the diary card, and 
transfer the information to the CRB. 
The subject pre-screening log should list all individuals contacted by the Investigators to 
participate in the study, regardless of the outcome. 
The Investigator must printa any electronic records on an ongoing basis, sign and date them 
immediately after creation, and keep the printouts on file as source documents that can be verified 
by the Sponsor or an inspector against the electronic records. Any subsequent changes of an 
electronic record require the record to be re-printed, dated (with an indication of the date of 
change), and signed. Such records must also be kept together with the original printed copy. 
Good Documentation Practice should be followed by the Investigator and the site staff managing 
source documents. 
13.3 Confidentiality of Data and Access to Subject Records  
Prior to initiation of the study, the Investigator will sign a fully executed confidentiality 
agreement with Sanofi Pasteur. 
                                                 
a  Unless the electronic medical records are managed by validated computerized systems that are compliant with US 
21 CFR Part 11, in which case they are acceptable on their own. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 113 of 121 
Sanofi Pasteur personnel (or designates), the IECs / IRBs, and regulatory agencies, including the 
FDA, require direct access to all study records, and will treat these documents in a confidential 
manner. 
In the event a subject’s medical records are not at the investigational site, it is the responsibility of 
the investigator to obtain those records if needed. 
13.4 Monitoring, Auditing, and Archiving  
13.4.1 Monitoring  
Before the start of the study (i.e., before the inclusion of the first subject in the first center) the 
Investigators and the Sponsor’s staff or a representative will meet at the site-initiation visit to 
discuss the study protocol and the detailed study procedures. Emphasis will be placed on inclusion 
and exclusion criteria, visit timing, safety procedures, informed consent procedures, SAE 
reporting procedures, CRB completion, and the handling of samples and products. The Sponsor’s 
staff or a representative will ensure and document that all material to be used during the study has 
been received at the site; and that the study investigator team and local Sponsor/delegate staff 
have been properly informed about the study, GCP and regulatory requirements, and the 
Sponsor’s procedures. The trial will follow a Risk Based Monitoring (RBM) strategy in which site 
generated data will be source reviewed and verified through a combination of on-site monitoring 
visits and centralized monitoring. Specific training sessions for the study investigator team and 
the CRAs on these topics may be performed as necessary, and should be documented. 
The following instruction manuals will be provided: the CRB Completion Instructions for 
entering data into the CRB, and the Operating Guidelines for detailed study procedures such as 
the product management and sample-handling procedures. 
After the start of the study, the Sponsor’s staff or a representative will be in regular contact with 
the investigational team through telephone calls and regular follow-up visits. The Investigator or 
delegate must be available for these visits, and must allow the Sponsor/delegate staff direct access 
to subject medical files and CRBs. During these visits, the Sponsor/delegate staff will: 
• 
Evaluate the quality of the study progress (adherence to protocol and any study-specific 
guidelines, quality of data collection and document completion, signature of consent forms, 
occurrence of SAEs, sample and product management, cold-chain monitoring, archiving) 
• 
Source-verify completed CRBs and any corresponding answered queries. 
• 
Determine the number of complete or ongoing issues identified at monitoring visits (e.g., 
protocol deviations, SAEs). Any identified problems will be discussed with the Investigator, 
and corrective or preventive actions will be determined, as appropriate. 
• 
After all protocol procedures have been completed and the data have been entered into the 
CRB, the Investigator must still be available to answer any queries forwarded by the Sponsor. 
All data-related queries must be completed prior to database lock. 
At the end of the study, a close-out visit will be performed to ensure that: 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 114 of 121 
• 
The center has all the documents necessary for archiving. 
• 
All samples have been shipped to the appropriate laboratories. 
• 
All unused materials and products have been either destroyed or returned to the Sponsor. 
13.4.2 Audits and Inspections  
A quality assurance audit may be performed at any time by the Sponsor’s Clinical Quality 
Assessment department (CQA) or by independent auditors to verify that the study has been 
conducted according to the protocol, GCP and ICH requirements, and other applicable 
regulations. An inspection may be conducted by regulatory authorities. The Investigator must 
allow direct access to study documents during these inspections and audits. 
13.4.3 Archiving  
The Investigator must keep all study documents after the completion or discontinuation of the 
study, whatever the nature of the investigational center (private practice, hospital, or institution), 
for as long as required by applicable laws and regulations. In the absence of any applicable laws 
or regulations, study documents will be kept at a minimum for the duration indicated on the 
Clinical Trial Agreement (CTA). In no event, should study personnel destroy or permit the 
destruction of any study documents upon less than 90 days advance written notification to the 
Sponsor. In addition, study documents should continue to be stored, at Sponsor’s sole expense, in 
the event that the Sponsor requests in writing that such storage continues for a period of time that 
exceeds that required by any applicable law or regulation or the CTA. The Investigator will 
inform Sanofi Pasteur of any address change or if they will no longer be able to house the study 
documents. 
Archived data may be held on electronic records, provided that a back-up exists and that a hard 
copy can be obtained if required. The protocol, documentation, approvals, and all other 
documents related to the study will be kept by the Sponsor in the Trial Master File (TMF). Data 
on AEs are included in the TMF. All data and documents will be made available if requested by 
relevant authorities. 
13.5 Financial Contract and Insurance Coverage  
A Clinical Trial Agreement will be signed by all the parties involved in the study’s performance, 
if relevant. The Sponsor has an insurance policy to cover any liabilities that may arise from use of 
the product and / or the study protocol. 
13.6 Stipends for Participation  
The subject’s parent / guardian may be provided with a stipend according to local practice to 
compensate for the time and travel required for study visits and procedures, if any. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 115 of 121 
13.7 Publication Policy  
Data derived from this study are the exclusive property of Sanofi Pasteur. Any publication or 
presentation related to the study must be submitted to Sanofi Pasteur for review before submission 
of the manuscript. After publication of the results of the study, any participating center may 
publish or otherwise use its own data provided that any publication of data from the study gives 
recognition to the study group. In addition, Sanofi Pasteur shall be offered an association with all 
such publications, it being understood that Sanofi Pasteur is entitled to refuse the association. 
Sanofi Pasteur must have the opportunity to review all proposed abstracts, manuscripts, or 
presentations regarding this study at least 90 days prior to submission for publication / 
presentation. Any information identified by Sanofi Pasteur as confidential must be deleted prior to 
submission, it being understood that the results of this study are not to be considered confidential. 
Sanofi Pasteur’s review can be expedited to meet publication guidelines. 
 
 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 116 of 121 
14 Reference List  
 1 
Granoff DM, Harrison LH, Pelton S. Meningococcal vaccines. In: Plotkin SA, Orenstein 
WA, Offit PA, editors. Vaccines. 6th ed. Philadelphia (PA):Saunders (Elsevier);2013:388-
418. 
 2 
Borrow R, Alarcón P, Carlos J, et al. The Global Meningococcal Initiative: global 
epidemiology, the impact of vaccines on meningococcal disease and the importance of herd 
protection. Expert Rev Vaccines. 2017;16(4):313-28. 
 3 
Harrison OB, Claus H, Jiang Y, et al. Description and nomenclature of Neisseria 
meningitidis capsule locus. Emerg Infect Dis. 2013;19(4):566-73. 
 4 
Pollard AJ. Global epidemiology of meningococcal disease and vaccine efficacy. Pediatr 
Infect Dis J. 2004;23(12 Supp):S274-9. 
 5 
Kvalsvig AJ, Unsworth DJ. The immunopathogenesis of meningococcal disease. J Clin 
Pathol. 2003;56(6):417-22. 
 6 
Sidikou F, Djibo S, Taha MK, et al. Polymerase chain reaction assay and bacterial 
meningitis surveillance in remote areas, Niger. Emerg Infect Dis. 2003;9(11):1486-8. 
 7 
World Health Organization. Meningococcal disease, serogroup W135 (update). WER. 
2001;76(28):213-4. 
 8 
Sáfadi MA, O'Ryan M, Valenzuela Bravo MT, et al. The current situation of meningococcal 
disease in Latin America and updated Global Meningococcal Initiative (GMI) 
recommendations. Vaccine. 2015;33(48):6529-36. 
 9 
Ceyhan M, Yildirim I, Balmer P, et al. A prospective study of etiology of childhood acute 
bacterial meningitis, Turkey. Emerg Infect Dis. 2008;14(7):1089-96. 
 10 
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. 
 11 
Shao Z, Zhou H, Gao Y, et al. Neisseria meningitidis serogroup W135, China. Emerg Infect 
Dis. 2010;16(2):348-9. 
 12 
Zhou H, Liu W, Xu L, et al. Spread of Neisseria meningitidis serogroup W clone, China. 
Emerg Infect Dis. 2013;19(9):1496-9. 
 13 
Efron AM, Sorhouet C, Salcedo C, Abad R, Regueira M, Vasquez JA. W135 invasive 
meningococcal strains spreading in South America: significant increase in incidence rate in 
Argentina. J Clin Microbiol. 2009;47(6):1979-80. 
 14 
Weidlich L, Baethgen LF, Mayer LW, et al. High prevalence of Neisseria meningitidis 
hypervirulent lineages and emergence of W135:P1.5,2:ST-11 clone in southern Brazil. J 
Infect. 2008;57(4):324-31. 
 15 
Barroso DE, Rebelo MC. Recognition of the epidemiological significance of Neisseria 
meningitidis capsular serogroup W135 in the Rio de Janeiro region, Brazil. Mem Inst 
Oswaldo Crus. 2007;102(6):773-5. 
 16 
Boisier P, Nicholas P, Djibo S, et al. Meningococcal meningitis: unprecedented incidence of 
serogroup X-related cases in 2006 in Niger. Clin Infect Dis. 2007;44(5):657-63. 
 17 
Rosenstein NE, Perkins BA, Stephens DS, et al. The changing epidemiology of 
meningococcal disease in the United States, 1992-1996. J Infect Dis. 1999;180(6):1894-901. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 117 of 121 
 18 
Canadian Immunization Committee and Public Health Agency of Canada. Advice for 
consideration of quadrivalent (A, C, Y, W135) meningococcal conjugate vaccine, for use by 
provinces and territories. CCDR. 2010;36(S2):1-35. 
 19 
Bröker M, Jacobsson S, Kuusi M, et al. Meningococcal serogroup Y emergence in Europe: 
update 2011. Hum Vaccin Immunother. 2012;8(12):1907-11. 
 20 
Cohn AC, MacNeil JR, Harrison LH, et al. Changes in Neisseria meningitidis disease 
epidemiology in the United States, 1998-2007: implications for prevention of 
meningococcal disease. Clin Infect Dis. 2010;50(2):184-91. 
 21 
National Foundation for Infectious Diseases. Addressing the challenges of serogroup B 
meningococcal disease outbreaks on campuses: A report by the National Foundation for 
Infectious Diseases. May 2014. Available online: http://www.nfid.org/meningococcal-b. 
Accessed 14 November 2017. 
 22 
Centers for Disease Control and Prevention. Interim guidance for control of serogroup B 
meningococcal disease outbreaks in organizational settings. Available online: 
http://www.cdc.gov/meningococcal/downloads/interim-guidance.pdf. Accessed 14 
November 2017. 
 23 
European Centre for Disease Prevention and Control. Surveillance of invasive bacterial 
diseases in Europe 2008/2009. Stockholm: ECDC; 2011. Available at: 
https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/1107_SUR_IBD
_2008-09.pdf. Accessed on 14 November 2017. 
 24 
Public Health England. Increase in endemic meningococcal group W (MenW) ST-11 
complex associated with severe invasive disease in England and Wales. Health Protection 
Weekly Report. Vol 8 No 41 Published on: 24 October 2014. Available online: 
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/367588/hpr4
114.pdf. Accessed 14 November 2017. 
 25 
Ladhani S, Lucidarme J, Newbold LS, et al. Investigations into an increase in reported 
meningococcal serogroup Y disease in England and Wales in 2007-9. Presented at: The 
European Meningococcal Disease Society (EMGM). 11th EMGM Meeting, 18-20 May 
2011. Ljubljana Slovenia. Poster 035:107. 
 26 
Törös B, Thulin Hedberg S, Jacobsson S, Fredlund H, Olcén P, Mölling P. Surveillance of 
invasive Neisseria meningitidis with a serogroup Y update, Sweden 2010 to 2012. Euro 
Surveill. 2014;19(42):pii=20940. 
 27 
Thulin Hedberg S, Törös B, Fredlund H, Olcén P, Mölling P. Genetic characterisation of the 
emerging invasive Neisseria meningitidis serogroup Y in Sweden, 2000 to 2010. Euro 
Surveill. 2011;16(23):pii=19885. 
 28 
Caugant DA, Løvoll Ø, Blystad H. Meningococcal disease in Norway, 2009-2010: 
emergence of serogroup Y. Presented at: The European Meningococcal Disease Society 
(EMGM). 11th EMGM Meeting, 18-20 May 2011. Ljubljana Slovenia. Poster 040:117. 
 29 
Vainio A, Toropainen M, Kuusi M, Virolainen A. Characteristics of invasive 
meningococcal serogroup Y isolates in Finland, 1995-2010. Presented at: The European 
Meningococcal Disease Society (EMGM). 11th EMGM Meeting, 18-20 May 2011. 
Ljubljana Slovenia. Poster 037:110. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 118 of 121 
 30 
Centers for Disease Control and Prevention. Active Bacterial Core surveillance (ABCs) 
Report: Neisseria meningitidis, 2013. Available online: http://www.cdc.gov/abcs/reports-
findings/survreports/mening13.html. Accessed 14 November 2017. 
 31 
Centers for Disease Control and Prevention. Meningococcal disease. In: Hamborsky J, 
Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 
13th ed. Washington D.C. Public Health Foundation, 2015:231-45. 
 32 
Centers for Disease Control and Prevention. Update: Guillain-Barré syndrome among 
recipients of Menactra meningococcal conjugate vaccine--United States, June 2005-
September 2006. MMWR. 2006; 55(41):1120-4. 
 33 
Velentgas P, Amato AA, Bohn RL, et al. Risk of Guillain-Barré syndrome after 
meningococcal conjugate vaccination. Pharmacoepidemiol Drug Saf. 2012;21(12):1350-8. 
 34 
Institute of Medicine. Diphtheria toxoid, tetanus toxoid, and acellular pertussis-containing 
vaccines. In: Adverse effects of vaccines: evidence and causality. Washington, DC: The 
National Academies Press;2012:557-8. https://doi.org/10.17226/13164. 
 35 
Institute of Medicine. Diphtheria and tetanus toxoids. In: Adverse events associated with 
childhood vaccines: evidence bearing on causality. Washington, DC. The National 
Academies Press; 1994:67-117. https://doi.org/10.17226/2138. 
 36 
Centers for Disease Control and Prevention. General recommendations on immunization: 
recommendations of the Advisory Committee on Immunization Practices (ACIP):MMWR. 
2011;60(2):1-60. 
 37 
Menveo [package insert]. GSK Vaccines, Srl, Bellaria-Rosia 53018, Sovicille (SI), Italy. 
Available at: 
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Info
rmation/Menveo/pdf/MENVEO.PDF. Accessed 16 November 2017. 
 38 
Menactra®[package insert]: Sanofi Pasteur Inc., Swiftwater, PA, USA. Available at: 
https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UC
M131170.pdf. Accessed on 16 November 2017. 
 39 
Kroger AT, Duchin J, Vázquez M. General Best Practice Guidelines for Immunization. Best 
Practices Guidance of the  Advisory Committee on Immunization Practices (ACIP). 
Available from www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-
recs.pdf. Accessed 3 May 2018. 
 40 
Marin M, Güris Dalya, Chaves SS, et al, Recommendations of the Advisory Committee on 
Immunization Practices (ACIP), Division of Viral Diseases, National Center for 
Immunization and Respiratory Diseases, CDC. Available from 
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5604a1.htm. Accessed 3 May 2018. 
 41 
Centers for Disease Control and Prevention Epidemiology and Prevention of Vaccine-
Preventable Diseases, 13th Edition, April 2015. Available at 
https://www.cdc.gov/vaccines/pubs/pinkbook/varicella.html. Accessed 3 May 2018. 
 42 
Pentacel [package insert]. Sanofi Pasteur Ltd, Toronto, Ontario, Canada. Available at: 
https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm10
9810.pdf. Accessed 16 November 2017. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 119 of 121 
 43 
Pediarix [package insert]. GlaxoSmithKline Biologicals, Rixensart, Belgium. Available at: 
https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UC
M241874.pdf Accessed 16 November 2017. 
 44 
ActHIB®[package insert]: Sanofi Pasteur Inc., Swiftwater, PA, USA. Available at 
https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm10
9841.pdf. Accessed 16 November 2017 
 45 
Hiberix®[package insert]: GlaxoSmithKline Biologicals, Rixensart, Belgium. Available at 
https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm17
9530.pdf. Accessed 16 November 2017 
 46 
PedvaxHIB®[package insert]: Merck &Co., Inc., West Point, PA, USA. Available at 
https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UC
M253652.pdf. Accessed 16 November 2017. 
 47 
Prevnar 13® [package insert]. Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer Inc, 
Philadelphia, PA, USA. Available at: 
https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm20
1669.pdf. Accessed on 16 November 2017. 
 48 
RotaTeq® [package insert]. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., 
Inc., Whitehouse Station, NJ, USA. Available at: 
https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm14
2288.pdf. Accessed on 16 November 2017. 
 49 
ENGERIX-B® [package insert]. GlaxoSmithKline Biologicals 441 Rixensart, Belgium. 
Available at: 
https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm22
4503.pdf. Accessed on 16 November 2017. 
 50 
RecombivaxHB®[package insert]: Merck Sharp & Dohme Corp., a subsidiary of Merck & 
Co., Inc., Whitehouse Station, NJ, USA. Available at: 
https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm11
0114.pdf Accessed on 16 November 2017. 
 51 
M-M-R® II [package insert]. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., 
Inc., Whitehouse Station, NJ, USA. Available at: 
https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm12
3789.pdf. Accessed on 16 November 2017. 
 52 
VARIVAX® [package insert]. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., 
Inc., Whitehouse Station, NJ, USA. Available at: 
https://www.merck.com/product/usa/pi_circulars/v/varivax/varivax_pi.pdf. Accessed on 16 
November 2017. 
 53 
Lead Exposure in Children: Prevention, Detection, and Management. (2005). 
PEDIATRICS, 116(4), pp. 1036-1046 
 54 
Bonhoeffer J, Menkes J, Gold MS, et al. Generalized convulsive seizure as an adverse event 
following immunization: case definition and guidelines for data collection, analysis, and 
presentation. Vaccine. 2004;22:557-62. 

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 120 of 121 
 55 
Marcy SM, Kohl KS, Dagan R, et al. Fever as an adverse event following immunization: 
case definition and guidelines of data collection, analysis and presentation. Vaccine. 2004; 
22:551-556. 
 56 
Newburger JW, Takahashi M, Gerber MA, et al. Diagnosis, treatment, and long-term 
management of Kawasaki disease: a statement for health professionals from the Committee 
on Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular 
Disease in the Young, American Heart Association. Pediatrics. 2004;114(6):1708-33 
 57 
Centers for Disease Control and Prevention. Kawasaki Syndrome Case Report 2003. 
Available online: http://www.cdc.gov/kawasaki/pdf/ks_case_report-fillable.pdf. Accessed 
17 November 2017 
 58 
Chu YW, Korb J, Sakamoto M. Idiopathic thrombocytopenic purpura. Pediatr Rev. 
2000;21(3):95-104                                                                                                                              

Sanofi Pasteur 
MET61 
395 – MenACYW Conjugate Vaccine  
Protocol Version 4.0 
 
Confidential/Proprietary Information 
Page 121 of 121 
15 Signature Page