Meningitis Clinical Trial
Official title:
Safety and Immunogenicity of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine
The purpose of this trial is to describe the safety and antibody response to revaccination
with Menactra vaccine in persons who received their first dose at ≥11 years of age.
Primary Objective:
- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135,
measured by serum bactericidal assay using human complement (SBA-HC), induced by Menactra
vaccine in subjects who were first vaccinated with Menactra 4-6 years ago.
Secondary Objective:
- To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens
collected 6 days post-vaccination in a subset of study population.
Observational Objective:
- To describe the rates of immediate reactions, solicited injection-site and systemic
reactions, unsolicited adverse events and serious adverse events following vaccination.
All participants will receive one dose of Menactra vaccine at their first clinic visit. There will be a telephone safety follow-up contact at six months post-vaccination. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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