NCT06284915

Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers

A Parallel-group, Prevention, Phase III, Modified Double-blind, 2-arm, Study to Investigate the Immunogenicity and Describe the Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared With Nimenrix® When Administered in a 1+1 Schedule in Healthy Infants and Toddlers at 6 and 12 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 840 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 14 Months
• Healthy volunteers: Accepted

Summary

This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.

Detailed description

The study duration will be approximately 7 to 8.5 months (at least 7 months per participant).

Conditions

• Meningococcal Immunisation
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	MenACYW conjugate vaccine	Pharmaceutical form:Solution for injection (in a single-dose vial)-Route of administration:Intramuscular (IM) injection
BIOLOGICAL	MenACYW conjugate vaccine	Pharmaceutical form:Solution for injection (powder or cake in a single dose glass vial and a clear and colourless solvent in a pre filled syringe for reconstitution-Route of administration:Intramuscular (IM) injection

Timeline

• Start date: 2024-03-19
• Primary completion: 2025-11-14
• Completion: 2025-11-14
• First posted: 2024-02-29
• Last updated: 2025-12-02

Locations

45 sites across 6 countries: Czechia, Denmark, Finland, Germany, Poland, Romania

Regulatory

• FDA-regulated drug study