At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 540 enrolled
Drug / intervention
GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 +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.
A Partially-blind (Observer-blind) Study to Evaluate the Safety and Immunogenicity of 3 Different Vaccination Schedules With 2 GSK Biologicals' Candidate Plasmodium Falciparum Vaccines in Children Aged 5 to 17 Months Living in Ghana
In Brief
A Phase 2 clinical trial evaluating GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 and Rabipur for Malaria. Completed, enrolled 540 participants across 2 sites.
Detailed Summary
This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesGhana
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2006
Enrollment StartAug 2006
Primary CompletionAug 2007
Study CompletionMay 2008
TodayJul 2026
First PostedAug 4, 2006
Enrollment StartAug 30, 2006
Primary CompletionAug 25, 2007
Study CompletionMay 30, 2008
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 19.9 years ago
Interventions
GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049biological
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
Rabipurbiological
3-dose intramuscular injection.