Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Summary

The primary objective of this study is 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 6 to 7 months of age and 12 to 13 months of age.

The secondary objectives of the study are:

* To demonstrate the non-inferiority of the percentage of participants with antibody 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.
* 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®.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.
* 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®.

Conditions

• Healthy Volunteers (Meningococcal Infection)

Interventions

BIOLOGICAL

Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine

Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL

BIOLOGICAL

Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL

BIOLOGICAL

Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine

Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL

BIOLOGICAL

Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL

BIOLOGICAL

Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL

BIOLOGICAL

Haemophilus b Conjugate Vaccine

Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL

BIOLOGICAL

Rotavirus Vaccine, Live, Oral, Pentavalent

Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL

BIOLOGICAL

Hepatitis B Vaccine

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL

BIOLOGICAL

Measles, Mumps, and Rubella Virus Vaccine Live

Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL

BIOLOGICAL

Varicella Virus Vaccine Live

Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

19 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-04

Primary Completion

2023-10-20

Completion

2023-10-20

FDA Drug

Yes

Countries

• United States
• Puerto Rico

Study Locations