Meningitis Clinical Trial
Official title:
Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India
The purpose of this study is to assess the safety and immunogenicity of a single dose of
Menactra® vaccine to support registration.
Primary Objectives:
- To describe the antibody titers measured by serum bactericidal activity using baby
rabbit complement (SBA-BR) before and after Menactra® vaccination.
- To describe the safety profile of participants after one dose of Menactra®.
Participants will be enrolled in three age cohorts: Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age to receive a single dose of Menactra®. They will be followed for a duration of 30 days after vaccination. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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