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

StatusCompleted
PhasePhase 3
SponsorSanofi
Started

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Record History

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  1. Trial completed
    • Study completion date changed from estimate of Sep 23, 2026 to Sep 24, 2026
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 9 entries
  2. Primary completion date changed from estimate of Apr 27, 2026 to May 1, 2026v8
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion moved earlier from Jun 5, 2026 to Apr 27, 2026
    • Study completion moved earlier from Nov 2, 2026 to Sep 23, 2026
    • Study sites: 2 to 4
    v7
  4. Study sites: 1 to 2
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 8 to 9
    v6
  5. Study sites: 2 to 1
    • Primary completion date: Jan 28, 2026 to Jun 5, 2026
    • Study completion date: Jun 29, 2026 to Nov 2, 2026
    v5
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  1. Primary endpoints revised (6)v4 Show 4 more changesShow less
    • Enrollment target: 1504 to 1602
    • Study sites: 1 to 2
    • Interventions: MenAC conjugate vaccine (Biological), MenAC conjugate vaccine (Biological), MenACYW conjugate vaccine (Biological) to MenAC conjugate vaccine (Biological), MenACYW conjugate vaccine (Biological), MenACYW135 polysaccharide vaccine (Biological)
    • Secondary endpoints: 5 to 8
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  3. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
285 trials monitored
See 12 trials at risk
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.
Trial Details
NCT Number NCT07135986
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Meningococcal Infection, Healthy Volunteers
Related terms Meningococcal Infections
Enrollment 1,602 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov