CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 585 enrolled
Drug / intervention
Infanrix hexa +8 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/NCT02096263
NCT02096263Phase 3Completed
CompareCT.gov

Immunogenicity and Safety Study of GSK Biologicals' Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

GlaxoSmithKline·interventional·Posted Mar 26, 2014·Updated Nov 27, 2019

In Brief

A Phase 3 clinical trial evaluating Infanrix hexa, Pediarix, and 7 other interventions for Poliomyelitis and 5 related conditions. Completed, enrolled 585 participants across 43 sites.

Detailed Summary

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis, Diphtheria, Haemophilus Influenzae Type b, Tetanus, Acellular Pertussis, Hepatitis B
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 26, 2014
Enrollment StartApr 16, 2014
Primary CompletionFeb 6, 2015
Study CompletionNov 13, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.3 years ago

Interventions

Infanrix hexabiological

3 doses administered intramuscularly in the right thigh.

Pediarixbiological

3 doses administered intramuscularly in the right thigh

ActHIBbiological

4 doses administered intramuscularly in the upper left thigh

Pentacelbiological

4 doses administered intramuscularly in the right thigh

Engerix-Bbiological

2 or 3 doses administered intramuscularly in the upper left thigh

Infanrixbiological

1 dose administered intramuscularly in the right thigh

Hiberixbiological

1 dose administered intramuscularly in the left thigh

Prevnar13biological

3 doses administered intramuscularly in the lower left thigh

Rotarixbiological

2 doses administered orally