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Clinical Trial Summary

This study is part of the post-licensure commitment to evaluate the safety and immunogenicity of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age.

Primary Objective:

To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30 days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine.

Secondary Objective:

- To describe the immunogenicity for serogroups A and C, 30 days after administration of the study vaccines given as a single dose.

- To describe the full reactogenicity profile after administration of the study vaccines given as a single dose.


Clinical Trial Description

Eligible participants will receive one injection of either Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine or Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine and will be monitored for safety and immunogenicity for up to 30 days post-vaccination. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01430611
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 4
Start date August 2011
Completion date November 2012

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