Clinical Trial: Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents

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

Official Title: Immunogenicity and Safety Study of GSK Biologicals' Boostrix™ Vaccine Using a New Syringe Presentation in Healthy Adolescents Aged 10-15 Years

Brief Summary: The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years.

Detailed Summary:

The protocol has been updated following Protocol amendment 1 date 03 August 2011 leading to the update of the exclusion criteria to allow subjects in Mexico to receive the flu vaccine in accordance with the local standard of care.

The protocol has been updated following Protocol amendment 2 dated 14 December 2011 due to the recruitment constraints as a result of the DT/dTpa vaccination campaign in the countries. The inclusion and exclusion criteria were amended to allow the participation of those who have already received the 6th dose of the diphtheria, tetanus and/or pertussis containing vaccine.


Sponsor: GlaxoSmithKline

Current Primary Outcome: Immunogenicity with respect to the components of the study vaccine in terms of antibody concentrations [ Time Frame: One month after booster vaccination (Month 1) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Immunogenicity with respect to the components of the study vaccine in terms of number of seroprotected/seropositive subjects [ Time Frame: Prior to (Day 0) and one month after booster vaccination (Month 1) ]
  • Number of subjects with solicited local and general symptoms [ Time Frame: During the 4-day (Day 0- Day 3) follow-up period after booster vaccination ]
  • Number of subjects with unsolicited adverse events [ Time Frame: During the 31-day (Day 0- Day 30) follow-up period after booster vaccination ]
  • Number of subjects with serious adverse events [ Time Frame: From the booster dose up to study end (Day 0 to Month 1) ]
  • Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with a booster response [ Time Frame: One month after booster vaccination (Month 1) ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: May 19, 2011
Date Started: July 2011
Date Completion:
Last Updated: August 29, 2016
Last Verified: August 2016