CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 180 enrolled
Drug / intervention
Boostrix™ +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01147900
NCT01147900Phase 4Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Jun 22, 2010·Updated Aug 20, 2018

In Brief

A Phase 4 clinical trial evaluating Boostrix™ and Boostrix™-US formulation for Acellular Pertussis and 2 related conditions. Completed, enrolled 180 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcellular Pertussis, Tetanus, Diphtheria
CountriesBelgium
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2010
Enrollment StartJun 15, 2010
Primary CompletionMay 8, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.0 years ago

Interventions

Boostrix™biological

Intramuscular, single dose

Boostrix™-US formulationbiological

Intramuscular, single dose