Overview

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

Status:
RECRUITING

Trial end date:
2027-05-17

Target enrollment:

Participant gender:

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.

Phase:

PHASE1

Details

Lead Sponsor:

Sanofi Pasteur, a Sanofi Company

Treatments:

13-valent pneumococcal vaccine
4CMenB vaccine
Acetaminophen
diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine
DTaP-IPV-HB-PRP-T vaccine
Rotavirus Vaccines
Vaxelis