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Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years

Healthy Population Clinical Trial

Official title:
A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 6 Months to 5 Years

Clinical Trial Summary

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

Clinical Trial Description

This is a Phase III, single center, randomized, blind, positive control clinical trial conducted in Hunan Province, China. The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old. A total of 2450 subjects were included, divided into three age groups: 6-11 months old (700 subjects), 12-23 months old (1050 subjects), and 2-5 years old (700 subjects). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06314685
Study type Interventional
Source Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Contact
Status Active, not recruiting
Phase Phase 3
Start date December 10, 2021
Completion date August 30, 2024
View Details
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