At a glance
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Seasonal Vaccination With the RTS,S/AS01 Malaria Vaccine Given With or Without Seasonal Malaria Chemoprevention: Extension of a Randomised, Double-blind Phase 3 Trial Until Children Reach the Age of Five Years
In Brief
A Phase 3 clinical trial evaluating Tetanus/diphtheria toxoids, SMC with SP+AQ, and 2 other interventions for Malaria,Falciparum and Child, Only. Completed, enrolled 5,098 participants across 2 sites in 2 countries.
Detailed Summary
A double-blind, individual randomised trial will be undertaken in children under five years of age living in areas of Burkina Faso or Mali where the transmission of malaria is intense and highly seasonal to determine whether administration of further doses of the malaria vaccine RTS,S/AS01 at the beginning of the malaria transmission until children reach the age of five years is (a) as effective as SMC with SP + AQ in preventing clinical malaria (b) provides additional, useful protection when given together with SMC. The primary trial end-point will be the incidence of clinical episodes of malaria detected by passive case detection. This is a two year extension of the current RTS,S/AS01 + SMC trial to continue the trial until the study children reach the age of five years, the current age at which SMC is recommended until.
Study Details
Timeline
Interventions
One dose of tetanus/diphtheria toxoids vaccine (June) in year 1 and year 2.
Year 1 and 2 (2020/21) Four cycles of SMC (SP+AQ) (July, August, September, October). One cycle of SMC consisting of sulphadoxine - pyrimethamine (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3.
One booster dose of RTSS/AS01 (June) in year 1 and 2.
Year 1 and 2 (2020/21) Four cycles of SMC placebo (July, August, September, October)