At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 360 enrolled
Drug / intervention
Pneumococcal vaccine GSK1024850A +1 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 GlaxoSmithKline Biologicals' Pneumococcal Vaccine GSK1024850A Following Primary and Booster Vaccination of Healthy Japanese Children
In Brief
A Phase 3 clinical trial evaluating Pneumococcal vaccine GSK1024850A and DTPa for Infections, Streptococcal. Completed, enrolled 360 participants across 16 sites.
Detailed Summary
This study will aim to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedDec 2009
Primary CompletionAug 2010
Study CompletionSep 2011
TodayJul 2026
First PostedDec 9, 2009
Enrollment StartDec 8, 2009
Primary CompletionAug 13, 2010
Study CompletionSep 17, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.6 years ago
Interventions
Pneumococcal vaccine GSK1024850Abiological
Intramuscular injection, 4 doses
DTPabiological
Subcutaneous injection, 4 doses