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Comparison of Two Strategies for Administering the R21-Matrix M Vaccine in a Context of Seasonal Malaria Transmission in Chad

RecruitingPhase 4Ages 6 Months - 59 MonthsAllEpicentre
NCT07038837 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a two-arm, cluster-randomised, phase IV trial conducted in Chad to assess the protective efficacy and impact in real-life conditions of a new strategy for administering the R21/MM malaria vaccine, synchronized within a seasonal malaria chemoprevention (SMC) campaign, among children living in areas of high seasonal malaria transmission. In this study, a cluster is defined as the catchment area of a primary care health centre. In Chad, each catchment area is known as a 'zone of responsibility' (French: Zone de Responsibilité' \[ZR\]). Twenty-six (26) of the total 27 ZRs in the districts of Moïssala and Dembo will be randomized in a 1:1 ratio to receive a 4-dose (3 primary doses + 1 booster) R21/MM schedule either (1) integrated into the routine EPI vaccination program (the "Routine" control arm), or (2) synchronized with an annual seasonal malaria chemoprevention (SMC) campaign (

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📋 Eligibility rules (as published)
Inclusion Criteria: * • Routine arm 1. Aged 6 to 11 months at the time of the first R21/MM vaccination (dose 1). 2. Residing in a village participating in the study and randomized to the routine arm. 3. Oral consent provided by the child's parent/guardian. * Synchronised arm <!-- --> 1. Aged 6 to 59 months at the time of the first R21/MM vaccination (dose 1) during the first 3 rounds of SMC (2025). 2. Residing in a village participating in the study and randomized to the synchronized arm. 3. Oral consent provided by the child's parent/guardian. Exclusion Criteria: * Exclusion criteria for both arms according to Chad national EPI guidelines Malaria vaccine is not recommended for children with known severe hypersensitivity: * To a previous dose of a malaria vaccine * To a previous dose of hepatitis B vaccine * One of the components of the R21/MM vaccine Mild illness - including respiratory tract infections, mild diarrhoea and fever below 38.5° C - is not a contraindication to R21/MM vaccination. Malnutrition and being HIV-seropositive are also not contraindications to R21/MM vaccination.
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What it tests

  • "Synchronised" arm (intervention)
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Where

1 site
Medecin sans Frontières
Moïssala, Chad
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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