Condition: Malaria Vaccine · Sponsor: Epicentre
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. Effectiveness will be assessed in terms of clinical malaria, vaccine coverage, acceptability, feasibility, and cost-effectiveness. Malaria incidence will be determined using routine surveillance activities for clinical malaria detection and reporting in each country. Cross-sectional surveys will be conducted to determine the prevalence of parasitaemia in the communities. In addition, the acceptability, feasibility, coverage and cost-effectiveness of the different delivery systems of R21/Matrix-M will be assessed.
This description comes directly from the study's public registry record.
Valérie Briand · +331 40 21 55 55 · valerie.briand@epicentre.msf.org
Soazic Gardais · +331 40 21 55 55 · soazic.gardais@epicentre.msf.org
Always discuss trial participation with your own doctor first.
| Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest | Ouagadougou, Burkina Faso | Recruiting |
| University of Sciences Techniques and Technologies of Bamako | Bamako, Mali | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06860178