NCT06131554

A Clinical Trial to Evaluate the Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in Adults Aged 18 to 55 Years

A Multicenter, Randomized, Double-blinded, Positive-controlled Phase Ⅲ Clinical Trial to Evaluate Lot-to-lot Consistency, Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in Adults Aged 18 to 55 Years

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,480 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, randomized, double-blinded, positive controlled study to evaluate the lot-to-lot consistency, immunogenicity and safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in adults aged 18 to 55 years. Subjects will be randomized to receive investigational Lot 1, Lot 2, Lot 3 vaccine or control vaccine in a 1:1:1:1 ratio, with the subjects in experimental group randomly and equally assigned to three different batches of MCV4 for single-dose vaccination.

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4)	1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection
BIOLOGICAL	batch 2 of MCV4	1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection
BIOLOGICAL	batch 3 of MCV4	1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection
BIOLOGICAL	Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	1 dose of Menactra (0.5ml) on Day 0, Intramuscular injection

Timeline

• Start date: 2024-03-20
• Primary completion: 2024-07-12
• Completion: 2025-12-01
• First posted: 2023-11-14
• Last updated: 2025-04-03

Locations

1 site across 1 country: Indonesia