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

RTS,S + SMC extn

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.

2020-06-05

2022-03-31

2022-03-31

Completed

Early phase I

5098

Inclusion Criteria: * The child had been enrolled in the initial phase of the trial of seasonal vaccination with the RTS,S/AS01 vaccine * A parent or legally recognised guardian provides informed consent for the child's inclusion in the extension study * The child is a permanent resident of the study area and likely to remain a resident for the duration of the trial The child is under five years of age at the time of enrolment. Exclusion Criteria: * The child has had an allergic reaction to the study drugs or vaccines * The child had febrile convulsions on more than one occasion following vaccination * The child has developed a serious underlying illness such as severe malnutrition (weight for age or mid arm circumference Z scores \< 3 SD) which in view of the investigators might impair the response to vaccination * The child has been enrolled in another malaria vaccine or other experimental malaria intervention study

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2023-02-01