Clinical Trial

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China

Active, Not Recruiting Phase 3
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Summary
This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China. Study details include: * The study duration will be approximately 180 days. * The vaccination visit will be Visit 1. * The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.
Protocol Amendment History 3 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-18
notable Primary completion moved earlier: 2026-06-05 -> 2026-04-27 2026-04-18
minor Completion moved earlier: 2026-11-02 -> 2026-09-23 2026-04-18
Trial Details
NCT Number NCT07135986
Lead Sponsor Sanofi
Conditions Meningococcal Infection, Healthy Volunteers
Enrollment 1,602 participants
Start Date 2025-09-26
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-09-23 (estimated)
Updated on ClinicalTrials.gov 2026-05-12