NCT04689165

A Phase III Clinical Trial of the Group A Meningococcal Polysaccharide Vaccine

A Randomized, Double-Blind, Controlled, Non-inferiority Phase III Trial of a Group A Meningococcal Polysaccharide Vaccine in Healthy Infants Aged 6-15 Months

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,280 (estimated)
• Sponsor: Wei Cun · Unknown
• Sex: All
• Age: 6 Months – 50 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blinded, and controlled phase III clinical trial of the Group A meningococcal polysaccharide vaccine to evaluate the safety and immunogenicity of the vaccine in healthy infants aged 6-15 months.

Detailed description

This study was divided into two stages. The first stage study was an early safety assessment study among 80 subjects. The first stage study was conducted gradually in 20 subjects aged 18-50 years, 20 subjects aged 3-17 years, and 40 subjects aged 6-15 months. The second phase was a randomized, double-blind, controlled, non-inferiority phase III clinical trial in 1200 healthy infants aged 6-15 months, to evaluate the immunogenicity and safety of the experimental vaccine after two doses of immunization.

Conditions

• Meningitis, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Experimental Group A meningococcal polysaccharide vaccine	Two doses of Experimental Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12
BIOLOGICAL	Control Group A meningococcal polysaccharide vaccine	Two doses of Control Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12

Timeline

• Start date: 2020-09-14
• Primary completion: 2021-05-01
• Completion: 2021-12-01
• First posted: 2020-12-30
• Last updated: 2020-12-30

Locations

1 site across 1 country: China