Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
NCT ID: NCT03276962 Phase: PHASE2 Status: COMPLETED Enrollment: 1500 Completion: 2022-11-14
Conditions
Malaria
Interventions
RTS,S/AS01E (Full dose), RTS,S/AS01E (1/5th dose), Rabies vaccine
Summary
The study intends to establish proof of concept for a fractional dose schedule under conditions of natural exposure in children 5-17 months old at first vaccination. The study also aims to establish the role of third dose spacing in a fractional dose schedule, describe the effect of an earlier full fourth dose at Month 14 and describe the effect of multiple fractional or full yearly doses.
Primary Outcome
Incidence of Clinical Malaria Meeting the Primary Case Definition