Clinical Trial

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

Active, Not Recruiting Phase 4
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.
Summary
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).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-07-05; most recent amendment 2026-03-02.
Status change: Completed → Active, Not Recruiting 2026-03-02
Status change: Active, Not Recruiting → Completed 2025-07-31
Status change: Recruiting → Active, Not Recruiting 2024-12-02
Status change: Not Yet Recruiting → Recruiting 2023-09-25
Trial Details
NCT Number NCT05935176
Lead Sponsor CanSino Biologics Inc.
Conditions Epidemic Meningitis
Enrollment 660 participants
Start Date 2023-09-20
Primary Completion 2026-05-15 (estimated)
Study Completion 2026-07-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-04