NCT07505836

Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months

A Randomized, Double-Blind, Active Comparator-Controlled Phase Ⅲ Trial to Evaluate the Immunogenicity and Safety of the Group ACYW135 Meningococcal Conjugate Vaccine in Population Aged 12 to 23 Months

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,040 (estimated)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

Summary

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 12 to 23 months. 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? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the active comparator group (licensed ACYW135 meningococcal conjugate vaccine (CRM197 carrier), CanSinoBIO; hereinafter referred to as CanSinoBIO MCV-ACYW) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile. Participants will: Receive two doses of either the investigational vaccine or the control vaccine according to a 0,1-month schedule; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after completion of the primary immunization series; A total of 1040 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.

Conditions

• Epidemic Meningitis
• Meningococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	experimental vaccine	Group ACYW135 Meningococcal Conjugate Vaccine
BIOLOGICAL	Active Comparator vaccine	Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)

Timeline

• Start date: 2026-03-22
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2026-04-01
• Last updated: 2026-04-01