NCT01689324

Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents

Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) as a Booster in Japanese Adolescents

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 11 Years – 12 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose in adolescents in Japan. Primary Objective: * To assess the immunogenicity of Tdap (SP306) when administered as a single dose in Japanese adolescents Secondary Objective: * To assess the safety of Tdap vaccine when administered as a single dose in Japanese adolescents.

Detailed description

All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and undergo immunogenicity assessment from blood samples provided prior to, and 28 days post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination.

Conditions

• Pertussis
• Tetanus
• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	(ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis	0.5 mL, Intramuscular

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-11-01
• Completion: 2013-05-01
• First posted: 2012-09-21
• Last updated: 2014-02-21
• Results posted: 2014-02-21

Locations

3 sites across 1 country: Japan