At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 894 enrolled
Drug / intervention
GSK malaria vaccine 257049 Vaccine +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 Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS,S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya
In Brief
A Phase 2 clinical trial evaluating GSK malaria vaccine 257049 Vaccine and Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine for Malaria. Completed, enrolled 894 participants across 2 sites in 2 countries.
Detailed Summary
This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety. 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
CountriesKenya, Tanzania
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2006
Enrollment StartJan 2007
Primary CompletionAug 2008
Study CompletionNov 2008
TodayJul 2026
First PostedSep 26, 2006
Enrollment StartJan 3, 2007
Primary CompletionAug 15, 2008
Study CompletionNov 11, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.8 years ago
Interventions
GSK malaria vaccine 257049 Vaccinebiological
3 dose intramuscular injection
Sanofi-Pasteur's Human Diploid Cell Rabies Vaccinebiological
3 dose intramuscular injection