NCT06011200

A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a 4 to 6 Year-old Population

A Randomized, Blinded, Comparable Vaccine-controlled Phase IIIb Clinical Trial to Evaluate the Safety and Immunogenicity of Meningococcal Polysaccharide Conjugate Vaccine, Group ACYW135 (CRM197 Vector), in a 4 to 6 Year-old Population

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

The scientific name of meningococcus is Neisseria meningitidis (Nm), the causative agent of epidemic meningococcal meningitis (rheumatoid encephalitis), which colonizes the mucous membranes of the human nasopharynx or causes local infection and can cross the mucosal barrier to cause invasive bacteremia or epidemic meningococcal meningitis, meningococcus can often cause serious disease epidemics worldwide, the main clinical features of its infection are fever, rash and meningitis, the most common clinical manifestation is acute bacterial meningitis.

Detailed description

The preventive measures for influenza are based on strengthening personal protection, vaccination, strengthening surveillance, early detection of patients, and active isolation and treatment. The immune response to meningococcal polysaccharide vaccine is weak in infants under 2 years of age, and only a transient immune response is produced. Numerous experiments have shown that the immunogenicity of polysaccharides is enhanced by binding to protein carriers, and a significant booster effect is produced. Meningococcal polysaccharide conjugate vaccine induces a good immune response in infants and children under 2 years of age and produces immune memory, which enhances the immune effect of the vaccine and can eliminate the carrier state of infected patients.

Conditions

• Epidemic Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	MCV4	1 dose of MCV4 on Day 0
BIOLOGICAL	MSPV4	1 dose of MSPV4 on Day 0

Timeline

• Start date: 2023-09-16
• Primary completion: 2023-12-11
• Completion: 2024-05-11
• First posted: 2023-08-25
• Last updated: 2025-07-03

Locations

1 site across 1 country: China