Screening, enrolment and randomisation
DSS
Community sensitisation sessions were organised by the research team to engage the community in the trial. Participants were randomly drawn from the study area Demographic Surveillance System (DSS) and volunteers were invited to the clinical trial site for a screening visit. During the screening visit, after obtaining informed consent from adults, or the parent(s)/guardian(s), and assent from children aged 7 to 10 years, volunteers were assessed to determine if they were eligible to participate. Individuals were eligible for inclusion in the trial if they provided informed consent, were found to be healthy based on medical history and clinical examination, and indicated their intention to reside/stay within the Ouagadougou health region for the study duration (12 months) (The randomisation list was prepared by a statistician independent of the trial. Sequentially numbered opaque, sealed envelopes were provided to the unblinded pharmacy team to ensure treatment concealment. For each cohort, subjects were allocated sequentially to treatment in the order that they presented for vaccination.