At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 15,459 enrolled
Drug / intervention
Malaria Vaccine 257049 +4 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.
Efficacy of GSK Biologicals' Candidate Malaria Vaccine (257049) Against Malaria Disease Caused by P. Falciparum Infection in Infants and Children in Africa
In Brief
A Phase 3 clinical trial evaluating Malaria Vaccine 257049, Meningococcal C Conjugate Vaccine, and 3 other interventions for Malaria. Completed, enrolled 15,459 participants across 10 sites in 7 countries.
Detailed Summary
The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesBurkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Tanzania
CollaboratorsThe PATH Malaria Vaccine Initiative (MVI)
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2009
Enrollment StartMar 2009
Primary CompletionMar 2011
Study CompletionJan 2014
TodayJul 2026
First PostedMar 20, 2009
Enrollment StartMar 27, 2009
Primary CompletionMar 1, 2011
Study CompletionJan 31, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.3 years ago
Interventions
Malaria Vaccine 257049biological
administered intramuscularly into the left deltoid.
Meningococcal C Conjugate Vaccinebiological
administered intramuscularly into the left deltoid.
Cell-culture rabies vaccinebiological
administered intramuscularly into the left deltoid.
TritanrixHepB/Hibbiological
administered intramuscularly into the left deltoid.
Polio Sabin Oral Polio Vaccine (GSK)biological
administered orally.