CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 657 enrolled
Drug / intervention
Infanrix hexa +2 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/NCT01453998
NCT01453998Phase 2Completed
CompareCT.gov

Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

GlaxoSmithKline·interventional·Posted Oct 18, 2011·Updated Jul 17, 2020

In Brief

A Phase 2 clinical trial evaluating Infanrix hexa, Prevenar 13, and 1 other intervention for Acellular Pertussis and 5 related conditions. Completed, enrolled 657 participants across 16 sites in 2 countries.

Detailed Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. All children in this booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948 (NCT01248884). No new subjects will be enrolled in this booster study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcellular Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Tetanus, Diphtheria, Poliomyelitis
CountriesDominican Republic, Finland
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2011
Enrollment StartOct 14, 2011
Primary CompletionNov 12, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.7 years ago

Interventions

Infanrix hexabiological

Single dose, licensed formulation, intramuscular into right thigh

Prevenar 13biological

Single co-administered dose, intramuscular into left thigh

GSK217744biological

Single dose, investigational formulation A or B, intramuscular into right thigh