CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 284 enrolled
Drug / intervention
GSK2197870A +4 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/NCT00871338
NCT00871338Phase 2Completed
CompareCT.gov

Study in Healthy Children of GSK Biologicals' DTPa-IPV/Hib-MenC-TT Vaccine, GSK2197870A, Co-administered With Prevenar™ as a Three-dose Primary Vaccination Course in Infancy Followed by a Booster Dose of Menitorix™ at 12 Months of Age

GlaxoSmithKline·interventional·Posted Mar 30, 2009·Updated Jun 6, 2018

In Brief

A Phase 2 clinical trial evaluating GSK2197870A, Prevenar™, and 3 other interventions for Neisseria Meningitidis and Haemophilus Influenzae Type b. Completed, enrolled 284 participants across 5 sites.

Detailed Summary

The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeisseria Meningitidis, Haemophilus Influenzae Type b
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2009
Enrollment StartJun 24, 2009
Primary CompletionMar 31, 2010
Study CompletionDec 9, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.3 years ago

Interventions

GSK2197870Abiological

3 doses given at 2, 3 and 4 months of age

Prevenar™biological

3 co-administered doses, intramuscular into right thigh

Menitorix™biological

1 booster dose at 12 months of age

Pediacel™biological

3 doses given at 2, 3 and 4 months of age

Menjugate™biological

2 doses given at 3 and 4 months of age