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In a phase II trial of RTS,S/AS01E in children vaccinated at age 5 to 17 months in Kenya and Tanzania, efficacy against a first malaria episode was 46% at 15 months after the third vaccine dose. Investigators now provide 4-year efficacy data for one of the study sites (Kilifi, Kenya).
Participants in the extended follow-up study were limited to those randomized in the original study in Kilifi. The investigators calculated a malaria-exposure index based on the distance-weighted proportion of asymptomatic or symptomatic malaria cases within a 1-km radius of each child.
Three hundred twenty (71.6%) of the original participants completed 4 years of follow-up. Efficacy against first or only episodes of malaria was 29.9% in the intent-to-treat coho…