NCT05252715

Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 3 to 5 Months

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 3 Months – 5 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months.

Conditions

• Meningitis, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal ACYW135 Polysaccharide Conjugate Vaccine	Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 meningococcal polysaccharide combined with tetanus toxoid.
BIOLOGICAL	Meningococcal A and C Polysaccharide Conjugate Vaccine	Single intramuscular dose contains 10 µg each of Serogroup A and C meningococcal polysaccharide combined with tetanus toxoid.

Timeline

• Start date: 2021-12-18
• Primary completion: 2023-08-22
• Completion: 2024-09-18
• First posted: 2022-02-23
• Last updated: 2024-04-04

Locations

2 sites across 1 country: China