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Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 4, 2026 (before its estimated May 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Oct 14, 2024 to May 15, 2026v5 Show 7 more changesShow less
    • Primary endpoints: 1 to 4
    • Trial status: Completed to Active, Not Recruiting
    • Study completion date: Jan 8, 2025 to Jul 15, 2026
    • Interventions: MCV4 (Biological), MCV4 (Biological) to MCV4 (Biological), MCV4 (Biological), MCV4 (Biological)
    • Eligibility criteria expanded, about 206 words
    • Secondary endpoints: 4 to 7
    • Study arms: 2 to 3
  2. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Jan 31, 2025 to Jan 8, 2025
    v4
  3. Primary completion date changed from estimate of Mar 1, 2024 to Oct 14, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Sep 1, 2024 to Jan 31, 2025
    • Site details revised
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 1, 2023 to Sep 20, 2023
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660 eligible participants aged 6 to 23 months, which has now been completed. Part 2 : Open Clinical Researchplans to enroll approximately 100 eligible participants from Part 1 who have completed immunopreservance blood sampling. Participants will receive a single booster dose of the ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector) at age 3 years (but not yet 4 years).
Trial Details
NCT Number NCT05935176
Lead Sponsor CanSino Biologics Inc.
Conditions
(from sponsor)		 Epidemic Meningitis
Related terms Meningitis, Meningococcal
Enrollment 660 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov