At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 300 enrolled
Drug / intervention
GSK1024850A (Synflorix) +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.
Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Pneumococcal Vaccine 1024850A When Administered to Children Between 8 Weeks and 2 Years of Age
In Brief
A Phase 3 clinical trial evaluating GSK1024850A (Synflorix), Tritanrix-HepB/Hib, and 1 other intervention for Infections, Streptococcal. Completed, enrolled 300 participants across 1 site.
Detailed Summary
The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A. Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal
CountriesBurkina Faso
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartJun 2011
Primary CompletionJan 2013
Study CompletionMay 2013
TodayJul 2026
First PostedAug 4, 2010
Enrollment StartJun 1, 2011
Primary CompletionJan 17, 2013
Study CompletionMay 23, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.9 years ago
Interventions
GSK1024850A (Synflorix)biological
2, 3 or 4 intramuscular injection
Tritanrix-HepB/Hibbiological
Intramuscular injection, 4 doses
Polio Sabinbiological
4 oral doses