CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 576 enrolled
Drug / intervention
Pneumococcal vaccine GSK 2189242A (LD formulation 1) +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/NCT01204658
NCT01204658Phase 2Completed
CompareCT.gov

Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A When Co-administered With DTPa-HBV-IPV/Hib Vaccine in Healthy Infants

GlaxoSmithKline·interventional·Posted Sep 17, 2010·Updated May 29, 2019

In Brief

A Phase 2 clinical trial evaluating Pneumococcal vaccine GSK 2189242A (LD formulation 1), Pneumococcal vaccine GSK 2189242A (HD formulation 2), and 3 other interventions for Infections, Streptococcal. Completed, enrolled 576 participants across 24 sites in 4 countries.

Detailed Summary

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal
CountriesCzechia, Germany, Poland, Sweden
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 17, 2010
Enrollment StartSep 27, 2010
Primary CompletionNov 3, 2011
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.8 years ago

Interventions

Pneumococcal vaccine GSK 2189242A (LD formulation 1)biological

Intramuscular injection

Pneumococcal vaccine GSK 2189242A (HD formulation 2)biological

Intramuscular injection

Synflorixbiological

Intramuscular injection

Prevenar 13biological

Intramuscular injection

Infanrix Hexa (DTPa-HBV-IPV/Hib)biological

Intramuscular injection