Clinical Trial: Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix (dTpa) Vaccine and the Chinese DT Vaccine, When Administered as Booster Vaccination in Healthy Children Aged 6-8 Years

Brief Summary: This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.

Original Primary Outcome: Same as current

Current Secondary Outcome: Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs

Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: March 26, 2007
Date Started: March 2007
Date Completion:
Last Updated: October 27, 2016
Last Verified: October 2016