Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

Summary

This open label randomized study will be conducted to evaluate and/or describe the immunogenicity and describe the safety of MenACYW conjugate vaccine when administered in infants and toddlers.

It will be conducted in India and the RSA in 2 cohorts:

* Cohort I: Infants and toddlers 6 months to 16 months of age (Cohort I)
* Cohort II: Infants and toddlers 6 weeks to 15 months of age (Cohort II) In Cohort I, eligible participants will be randomized in a 1:1 ratio to receive 2 intramuscular (IM) injections (1+1 vaccination schedule) of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines.

In Cohort II, eligible participants will be randomized in a 2:1 ratio to receive either 3 IM injections (2+1 vaccination schedule) of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7) or routine pediatric vaccines only (Groups 6 and 8).

The primary objectives of this study are:

* To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in terms of serum bactericidal assay using human complement (hSBA) seroprotection (titers ≥ 1:8) in India and the Republic of South Africa (RSA)
* To demonstrate the vaccine immune sufficiency of 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in terms of hSBA seroprotection (titers ≥ 1:8) in India and the RSA

The secondary objectives of this study are:

* To describe the antibody titers to the meningococcal serogroups A, C, Y, and W:

* before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* before and after 30 days post each dose of MenACYW conjugate vaccine or Menactra vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* To describe the antibody responses against the antigens of the other age-recommended vaccines when administered concomitantly with MenACYW conjugate vaccine:

* in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA.
* in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA.
* To describe the safety profile of MenACYW conjugate vaccine and that of licensed Menactra vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* To describe the safety profile of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* To describe the safety profile of age-recommended vaccines:

* in infants 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.
* in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.

The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.

Conditions

• Meningococcal Immunisation
• Healthy Volunteers

Interventions

BIOLOGICAL

Typhoid conjugate vaccine (TCV)

Suspension for injection - intramuscular

BIOLOGICAL

Measles vaccine

Freeze-dried powder for reconstitution and injection - subcutaneous

BIOLOGICAL

Varicella vaccine live

Sterile powder and diluent for injection - subcutaneous

BIOLOGICAL

Varicella vaccine live

Lyophilized powder for injection - subcutaneous

BIOLOGICAL

Measles, Mumps, and Rubella Vaccine live (MMR)

Lyophilized powder for injection - subcutaneous

BIOLOGICAL

Hepatitis A vaccine

Suspension for injection - intramuscular

BIOLOGICAL

DTaP-IPV-Hib-HepB vaccine

Liquid solution - intramuscular

BIOLOGICAL

Hepatitis A vaccine

Lyophilized powder for injection - subcutaneous

BIOLOGICAL

Rotavirus vaccine

Oral solution - oral

BIOLOGICAL

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

Liquid solution - intramuscular

BIOLOGICAL

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

Liquid solution - intramuscular

BIOLOGICAL

Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV)

Oral suspension - oral

BIOLOGICAL

Pneumoccocal Vaccine

Suspension for injection - intramuscular

BIOLOGICAL

Measles, Mumps, and Rubella Vaccine live (MMR)

Lyophilized powder for injection - subcutaneous

BIOLOGICAL

DTwP-HepB-Hib-IPV vaccine

Suspension - intramuscular

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

NONE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Max Age

6 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-27

Primary Completion

2025-11-15

Completion

2025-11-15

Countries

• India
• South Africa

Study Locations