At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 327 enrolled
Drug / intervention
GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)biological
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.
Consistency of Immunogenicity and Non Inferiority of Three Production Lots of GSK Biologicals' Candidate Malaria Vaccine in Children
In Brief
A Phase 3 clinical trial evaluating GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049) for Malaria. Completed, enrolled 327 participants across 2 sites.
Detailed Summary
The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesNigeria
CollaboratorsThe PATH Malaria Vaccine Initiative (MVI)
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2011
Enrollment StartMay 2011
Primary CompletionNov 2011
Study CompletionMay 2012
TodayJul 2026
First PostedMar 28, 2011
Enrollment StartMay 16, 2011
Primary CompletionNov 22, 2011
Study CompletionMay 4, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.3 years ago
Interventions
GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)biological
4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process