Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants

NCT06647407 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2026-01-20

No results posted yet for this study

Summary

This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3).

Study details include:

The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.

Conditions

Meningococcal Immunization
Healthy Volunteers

Interventions

BIOLOGICAL

Pentavalent Meningococcal ABCYW vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

BIOLOGICAL

MenACYW conjugate vaccine

Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM)

BIOLOGICAL

MenACYW conjugate vaccine

Pharmaceutical form: Powder and solvent for injectable solution in a pre-filled syringe Route of administration: Intramuscular (IM)

BIOLOGICAL

Meningococcal group B vaccine