Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico

Summary

Primary Objective:

1. To describe the vaccine seroprotection (antibody titer greater than or equal to \[\>=\] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico.
2. To describe the vaccine seroprotection (antibody titer \>=1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation.

Secondary Objective:

1. To describe hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) 30 days after the last vaccination of the infant series, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico and Russian Federation (RF).
2. To describe immunogenicity profile of routine pediatric vaccines when administered concomitantly with MenACYW Conjugate vaccine or Menveo®; or when administered alone.
3. To describe hSBA antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW Conjugate vaccine and Menveo® are administered concomitantly with routine pediatric vaccines in Mexico and RF.
4. To describe antibody titers to the antigens present in MenACYW Conjugate vaccine and Menveo®, before the first vaccination and 30 days after the last vaccination of the infant series and in the second year of life, when administered concomitantly with routine pediatric vaccines in a subset of participants in Mexico and RF.

Conditions

• Healthy Volunteers (Meningococcal Infection)

Interventions

BIOLOGICAL

Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine

Pharmaceutical form: Liquid solution Route of administration : Intramuscular

BIOLOGICAL

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

Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular

BIOLOGICAL

Measles, Mumps, and Rubella Virus Vaccine Live

Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine

Pharmaceutical form: Powder and suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Hepatitis B Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Rotavirus Vaccine, Live, Pentavalent

Pharmaceutical form: Oral solution Route of administration: Oral

BIOLOGICAL

Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

12 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-17

Primary Completion

2022-02-18

Completion

2022-02-18

FDA Drug

Yes

Countries

• Mexico
• Russia

Study Locations