1629589
Last Update Posted: 2016-03-02
Recruiting has ended
All Genders accepted | 11 Years-12 Years |
423 Estimated Participants | No Expanded Access |
Interventional Study | Accepts healthy volunteers |
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.
Eligibility
Relevant conditions:
Tetanus
Diphtheria
Pertussis
Whooping Cough
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
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Data sourced from ClinicalTrials.gov