NCT01147900

Evaluation of Boostrix™10 Years After Previous Booster Vaccination

Evaluation of GSK Biologicals' Boostrix™ in Healthy Adults, 10 Years After Previous Booster Vaccination

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 28 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a dTpa (Boostrix™ vaccine) booster dose given 10 years after the previous vaccination with dTpa in GSK 263855/029 study. Only subjects who were part of the primary study will be invited to participate in this study.This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate study (see reference).

Detailed description

All subjects will receive a booster dose of the vaccine that they received in their primary study. Subjects who received the investigational vaccine formulation, will receive Boostrix™ in the present study.

Conditions

• Acellular Pertussis
• Tetanus
• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	Boostrix™	Intramuscular, single dose
BIOLOGICAL	Boostrix™-US formulation	Intramuscular, single dose

Timeline

• Start date: 2010-06-15
• Primary completion: 2012-05-08
• Completion: 2012-05-08
• First posted: 2010-06-22
• Last updated: 2018-08-20
• Results posted: 2013-10-08

Locations

3 sites across 1 country: Belgium