CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 203 enrolled
Drug / intervention
Boostrix™biological
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/NCT00548171
NCT00548171Phase 4Completed
CompareCT.gov

Evaluation of GSK Biologicals' dTpa Booster Vaccine in Adults, Given 10 Years After Previous dTpa Boosting.

GlaxoSmithKline·interventional·Posted Oct 23, 2007·Updated Jan 13, 2020

In Brief

A Phase 4 clinical trial evaluating Boostrix™ for Acellular Pertussis and 3 related conditions. Completed, enrolled 203 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a previous clinical study (NCT01267058). Only subjects who received the booster vaccination in a previous clinical study are eligible for participation in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. No new recruitment will be performed in this booster phase (see inclusion criteria).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcellular Pertussis, Tetanus, Diphtheria, Diphtheria-Tetanus-acellular Pertussis Vaccines
CountriesAustralia
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 23, 2007
Enrollment StartNov 5, 2007
Primary CompletionApr 30, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.7 years ago

Interventions

Boostrix™biological

Intramuscular injection, 1 dose