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Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa

RecruitingPhase 4Ages 3 Months - 59 MonthsAllEpicentre
NCT06860178 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a multi-site, multi-disciplinary, Phase-4 two-arm cluster-randomised non-inferiority trial in Burkina Faso and Mali to evaluate the effectiveness and real-life impact of a novel integrated delivery strategy of the R21 malaria vaccine alongside SMC among children in areas with highly seasonal malaria transmission. In this study, a cluster is defined as the catchment area of a health centre. Clusters will be randomised to receive either year-round age-based routine EPI vaccination for children aged 5-36 months ("Routine EPI Vaccination") in Burkina Faso or an annual campaign of the 3-dose primary series in children aged 5-36 months prior to the malaria season and SMC delivery (''Routine Pre-SMC vaccination'') in Mali versus an annual campaign of the 3-dose primary series aligned with SMC distribution in children aged 3-59 months ("Integrated SMC Vaccination") in each country. Effecti

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📋 Eligibility rules (as published)
Inclusion criteria: Control arms : * Children aged 5-36 months in Burkina Faso and Mali at the time of first study vaccination; * Resident in the catchment area of a health centre assigned to the control arm; * Willingness to comply with the study procedures; * Written informed consent from Parent/Guardian. Intervention arms : * Children aged 3-59 months at the time of first study vaccination; * Resident in the catchment area of a health centre assigned to the intervention arm; * Willingness to comply with the study procedures; * Written informed consent from Parent/Guardian. Exclusion Criteria: 1. History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines; 2. Any history of anaphylaxis in relation to vaccination; 3. Known chronic illness; 4. Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial; 5. History of vaccination with another malaria vaccine. -
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What it tests

  • Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 months
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Where

2 sites
Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest
Ouagadougou, Burkina Faso
University of Sciences Techniques and Technologies of Bamako
Bamako, Mali
🤝 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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