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Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Study sites: 0 to 1
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 meningococcal conjugate vaccine in healthy children aged 2 to 6 years. The main questions it aims to answer are: Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine, as measured by serum antibody levels? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the control group (licensed ACYW135 polysaccharide vaccine) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile. Participants will: Receive a single dose of either the investigational vaccine or the control vaccine by intramuscular injection; Provide two blood samples (before vaccination and 30 days after) for antibody testing; Have their vaccination site and overall health monitored for AE/AR immediately after injection, for 7 days and for 30 days through diary card and follow-up contacts; Be followed for serious adverse events for 6 months after vaccination. A total of 660 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.
Trial Details
NCT Number NCT07505888
Lead Sponsor Sinovac Biotech Co., Ltd
Conditions
(from sponsor)		 Epidemic Meningitis, Meningococcal Vaccines
Related terms Meningitis, Meningococcal
Enrollment 660 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov