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®) Versus Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) in Subjects 11 to 55 Years of Age in South Korea
The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in
support of registration of the vaccine in South Korea.
Primary Objective:
- To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y
and W-135, 28 days after a single dose of Menactra®.
Secondary objectives:
- To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion
rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine
- To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine.
- To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers
before and 28 days after a single dose of Menactra® or Adacel® vaccine.
All participants will receive a single dose of vaccine, and will be assessed for
immunogenicity at baseline (pre-vaccination) and at 28 days post-vaccination.
Safety data, including serious adverse events (SAEs) will be collected for Day 0 through Day
28 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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