Tetanus Clinical Trial
Official title:
Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
The aim of this study is to describe immunogenicity of a single booster dose of Adacel
vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age.
Primary objective:
- To describe seroprotection rates against tetanus and diphtheria in subjects randomized
to receive either Adacel or Boostrix vaccine.
Observational objectives:
- To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean
antibody concentrations (GMCs) in subjects randomized to receive either Adacel or
Boostrix vaccine.
- To describe booster response rates against tetanus, diphtheria, and pertussis in
subjects randomized to receive either Adacel or Boostrix vaccine.
- To describe the rates of adverse events (AEs) immediately post-vaccination, and the
rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with
Adacel or Boostrix vaccine from Visit 1 through Visit 2.
Participants will be randomized in a 1:1 ratio to receive either Adacel or Boostrix vaccine.
Subjects will be monitored for immediate reactions for 15 minutes post-vaccination.
Unsolicited adverse events and serious adverse events will be collected from Visit 1 through
Visit 2.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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