Meningitis Clinical Trial
Official title:
Safety and Immunogenicity of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine Versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine in Children 2-6 Years of Age in China
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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