NCT06647407

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

A Parallel-group Prevention, Phase II, Partially Blinded, Multi-stage Study to Investigate the Immunogenicity and Safety of Pentavalent Meningococcal ABCYW Vaccine Formulations Compared With Licensed Meningococcal Vaccines When Administered Alone in Healthy Children (2 to 9 Years of Age) or Concomitantly With Routine Pediatric Vaccines in Toddlers (12 to 15 Months of Age) and Infants (2 Months of Age).

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 56 Days – 9 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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	Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
DRUG	Paracetamol	Pharmaceutical form:Suspension-Route of administration:oral
BIOLOGICAL	DTap-HepB-IPV-Hib vaccine	Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
BIOLOGICAL	DTap-HepB-IPV-Hib vaccine	Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
BIOLOGICAL	DTap-HepB-IPV-Hib vaccine	Pharmaceutical form: Oral solution in tube Route of administration: oral
BIOLOGICAL	Rotavirus vaccine	Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
BIOLOGICAL	Pneumococcal 13-valent conjugate vaccine	Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

Timeline

• Start date: 2024-11-05
• Primary completion: 2027-05-17
• Completion: 2027-05-17
• First posted: 2024-10-17
• Last updated: 2026-01-20

Locations

39 sites across 9 countries: Brazil, Czechia, Denmark, Finland, Germany, Honduras, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study