NCT06700148

A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7 to 17 Year Olds

A Randomized, Blinded, Peer-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 7-17 Year Olds

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 840 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, blinded, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups, afterwards some subjects entered the immune persistence group.

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	MCV4	1 dose of MCV4 on Day 0
BIOLOGICAL	MPSV4	1 dose of MPSV4 on Day0

Timeline

• Start date: 2024-12-14
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2024-11-21
• Last updated: 2025-07-29

Locations

2 sites across 1 country: China