CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,320 enrolled
Drug / intervention
Pneumococcal vaccine GSK 2189242A (LD formulation 1) +7 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/NCT01262872
NCT01262872Phase 2Completed
CompareCT.gov

Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety and Immunogenicity When Co-administered With Routine EPI Vaccines in Infants Following Safety Assessment in Children Aged 2-4 Years in The Gambia

GlaxoSmithKline·interventional·Posted Dec 17, 2010·Updated Jun 19, 2019

In Brief

A Phase 2 clinical trial evaluating Pneumococcal vaccine GSK 2189242A (LD formulation 1), Pneumococcal vaccine GSK 2189242A (HD formulation 2), and 6 other interventions for Infections, Streptococcal. Completed, enrolled 1,320 participants across 1 site.

Detailed Summary

This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal
CountriesThe Gambia
CollaboratorsPATH, Department of State for Health and Social Welfare, The Gambia, Medical Research Council Unit, The Gambia, London School of Hygiene and Tropical Medicine

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2010
Enrollment StartFeb 9, 2011
Primary CompletionMar 18, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.5 years ago

Interventions

Pneumococcal vaccine GSK 2189242A (LD formulation 1)biological

Intramuscular injection

Pneumococcal vaccine GSK 2189242A (HD formulation 2)biological

Intramuscular injection

Synflorix™biological

Intramuscular injection

Prevnar13™biological

Intramuscular injection

Tritanrix™-HepB/Hibbiological

Intramuscular injection

Polio Sabin™biological

Orally

M-Vac™biological

Intramuscular injection

Stamaril™biological

Intramuscular injection