CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 165 enrolled
Drug / intervention
Boostrixbiological
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/NCT01738477
NCT01738477Phase 3Completed
CompareCT.gov

Evaluation of Immunogenicity and Safety of GSK Biologicals' Tdap Booster Vaccine (Boostrix™) in Young Adults, Administered 10 Years After Previous Tdap Boosting

GlaxoSmithKline·interventional·Posted Nov 30, 2012·Updated Jun 6, 2018

In Brief

A Phase 3 clinical trial evaluating Boostrix for Tetanus and 2 related conditions. Completed, enrolled 165 participants across 20 sites.

Detailed Summary

The purpose of this follow-up study is to evaluate the persistence of antibodies against all the vaccine antigens 10 years after booster vaccination with either Tdap or Td, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study. This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00109330).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetanus, Acellular Pertussis, Diphtheria
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2012
Enrollment StartJan 31, 2013
Primary CompletionApr 2, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.6 years ago

Interventions

Boostrixbiological

Single dose intramuscular administration.