CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 302 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/NCT01988857
NCT01988857Phase 3Completed
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Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix™) in Healthy Vietnamese Children

GlaxoSmithKline·interventional·Posted Nov 20, 2013·Updated Aug 2, 2018

In Brief

A Phase 3 clinical trial evaluating Boostrix™ for Diphtheria and 2 related conditions. Completed, enrolled 302 participants across 1 site.

Detailed Summary

This study will evaluate the safety and reactogenicity of GSK Biologicals' combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old children. Data that are available globally on the age group from four to six years of age will be used to bridge the age gap in this study and aid in the registration of the vaccine for children from the age of four years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Tetanus, Acellular Pertussis
CountriesVietnam
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 20, 2013
Enrollment StartFeb 22, 2014
Primary CompletionMay 10, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.6 years ago

Interventions

Boostrix™biological

Single-dose administered intramuscularly in the deltoid region of non-dominant arm.