NCT01629589

Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 423 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 11 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Tetanus
• Diphtheria
• Pertussis
• Whooping Cough

Interventions

Type	Name	Description
BIOLOGICAL	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)	0.5 mL, Intramuscular
BIOLOGICAL	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)	0.5 mL, Intramuscular

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2012-06-27
• Last updated: 2016-03-02
• Results posted: 2013-10-21

Locations

8 sites across 1 country: United States