CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 551 enrolled
Drug / intervention
Infanrix hexabiological
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/NCT02853929
NCT02853929Phase 4Completed
CompareCT.gov

Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Infanrix Hexa™ (217744) in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery

GlaxoSmithKline·interventional·Posted Aug 3, 2016·Updated Jan 14, 2020

In Brief

A Phase 4 clinical trial evaluating Infanrix hexa for Diphtheria and 6 related conditions. Completed, enrolled 551 participants across 29 sites in 6 countries.

Detailed Summary

The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks. All infants in this booster study were born to pregnant women who participated in the study 116945 \[DTPA (BOOSTRIX)-047\] and having received the full primary vaccination series as per protocol requirement in study 201330 \[DTPA (BOOSTRIX)-048.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Tetanus, Poliomyelitis, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
CountriesAustralia, Canada, Czechia, Finland, Italy, Spain
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 3, 2016
Enrollment StartSep 19, 2016
Primary CompletionMar 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.9 years ago

Interventions

Infanrix hexabiological

All subjects will receive Infanrix hexa co-administered with Prevenar13 as a booster dose.