CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 688 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/NCT02377349
NCT02377349Phase 4Completed
CompareCT.gov

Immunogenicity and Safety Study of GSK Biologicals' dTpa Vaccine, Boostrix™ (263855) in Pregnant Women

GlaxoSmithKline·interventional·Posted Mar 3, 2015·Updated Jan 28, 2020

In Brief

A Phase 4 clinical trial evaluating Boostrix™ and Saline placebo for Diphtheria-Tetanus-acellular Pertussis Vaccines. Completed, enrolled 688 participants across 35 sites in 6 countries.

Detailed Summary

The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45 years. Infants born to mothers enrolled in this study will be followed-up in two separate clinical studies: 201330 \[DTPA (BOOSTRIX)-048 PRI\] and 201334 \[DTPA (BOOSTRIX)-049 BST: 048\].

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria-Tetanus-acellular Pertussis Vaccines
CountriesAustralia, Canada, Czechia, Finland, Italy, Spain
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 3, 2015
Enrollment StartOct 14, 2015
Primary CompletionAug 14, 2017
Study CompletionOct 24, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.3 years ago

Interventions

Boostrix™biological

One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.

Saline placebodrug

One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.