Meningitis Clinical Trial
Official title:
Immunogenicity and Safety of a Single Dose of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects
This study is designed to assess the safety and immunogenicity of a single dose of
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
(SP284) to support registration of the product in Japan.
Primary Objective:
- To describe the seroprotection rate [% of subjects with serum bactericidal assay using
baby rabbit complement (SBA-BR) ≥1:128] to meningococcal antigens (serogroups A, C, Y
and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of
age
Secondary Objectives:
- To describe the safety following receipt of SP284 vaccine in subjects 2 through 55
years of age
- To describe the immune responses to meningococcal antigens (serogroups A, C, Y and
W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.
All participants will receive a single injection of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine on Day 0 and undergo immunogenicity assessment and safety monitoring post-vaccination. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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