A Phase 4 interventional study of Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 months in Malaria Vaccine, sponsored by Epicentre. Recruiting at 2 sites in 2 countries. Open to participants aged 3 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Epicentre · Phase 4, Interventional, and Prevention
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.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 40,000 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Epicentre is the lead sponsor of 49 studies on the registry; 6 are open to participants now.
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Control arms :
Intervention arms :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children aged 5-36 months will receive R21 via routine EPI vaccination (Year round in Burkina faso, or prior to the malaria season and SMC delivery in Mali)
Children aged 3-59 months will receive 3-dose primary series aligned with SMC distribution in an annual campaign
Other: Annual campaign of the 3-dose primary series vaccine R21/Matrix-M aligned with SMC distribution in children aged 3-59 months
in the intenvention arm, the children will get the vaccine R21 Matrix M together with the CPS
Malaria Incidence on 5-36 months at 12 months
Malaria incidence among children aged 5-36 months over 12 months post first dose using routine surveillance activities for clinical malaria detection and reporting
Time frame: from enrollment to 12 months
Malaria incidence among children aged 5-36 months over 24 and 36 months
Malaria incidence among children aged 5-36 months over 24 and 36 months post first dose using routine surveillance activities for clinical malaria detection and reporting;
Time frame: From enrollment to 2 years after booster
Malaria incidence among children aged 3-59 months over 24 and 36 months
Malaria incidence among children aged 3-59 months over 24 and 36 months post first dose using routine surveillance activities for clinical malaria detection and reporting
Time frame: From enrollment to 2 years after booster
Malaria prevalence at peak transmission
Malaria prevalence at peak transmission in November after SMC campaigns in 2025 and 2026
Time frame: From enrollment to 2 years after booster dose
Vaccine coverage
Pourcentage of children who has received 3 or 4 doses at 24 months post 1st vaccination
Time frame: From enrollment to months 24
Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination;
Occurrence of adverse events (AEs) and serious adverse events (SAEs) following R21/Matrix-M vaccination
Time frame: From enrollment to months 4
Acceptability
Qualitative interviews and FGDs among policy makers, health managers, health providers and caregivers
Time frame: From 12 months after study start to 36 months
Stakeholder perceptions of the feasibility on the vaccine delivery strategy in each group
Acceptability and feasibility studies will use qualitative longitudinal study (QLS) research methods. We will apply an ecological framework approach with emphasis on the interplay and inter-dependency between individual, interpersonal, organizational, and policy levels. Qualitative data will be collected through ethnographic immersion, in-depth interviews, group interviews and focus group discussions. No quantitative measurements will be made.
Time frame: From enrollment to months 36
Contextual and behavioural factors impeding or facilitating R21/Matrix-M vaccine uptake
Interviews and FGD - will be explained in a parallel protocol
Time frame: From enrollment to months 24
Stakeholders and caregivers perceptions of the factors that enhance and/or constrain the succesful co,pletion of four doses of R21 and the key drivers of vaccination coverage
The study will cover a full, two-year R21/Matrix-M delivery cycle with data collection at two time points in each arm: soon after the primary series is delivered, and soon after the booster dose is provided a year later. This longitudinal approach will enable us to explore and chart dynamic processes as they occur, barriers and facilitators, and acceptability over time. It is inherently suitable for studying R21/Matrix-M introduction, requiring prolonged and repeated involvement by patients and providers. This approach is also necessary to explore the drivers of vaccine hesitancy which is not a static state; vaccine decision-making changes over time as caregivers experience different influences and nudges along the way. Qualitative data will be collected through ethnographic immersion, in-depth interviews, group interviews and focus group discussions to explore factors in the service delivery, household, and broader social environments that will lead to R21 adoption and adherence. A
Time frame: From enrollment to months 24 and 36
Incremental costs (per child vaccinated) and cost-effectiveness (per malaria case and separately, per DALY averted) of each vaccination strategy, calculated from a societal perspective
Costs associated with the different vaccination strategies will be estimated by collecting data on direct and indirect costs to health systems and opportunity costs to vaccinees and their caregivers (beneficiaries). Beneficiary costs will be collected during household surveys, via case report forms developed to collect data on direct costs (transport, food, medication) and indirect costs (time and income loss) incurred by their household related to each intervention arm. Provider costs will be collected using custom built spreadsheets structured to comprehensively capture the resources used for all intervention delivery related activities (excluding research activities) by cost category (person time, equipment, consumables including vaccines, storage, transport, overheads and other costs) by arm. Malaria incidence estimates (primary clinical outcome) will be used to calculate malaria cases and DALYs averted by arm, adjusted for intervention coverage (using the coverage survey data).
Time frame: From enrollment to months 36
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for May 2026, 11 months after the start.
Of 48 non-industry phase 4 interventional studies under Malaria, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's planned 11 months is below that.
Counting every sponsor, half of 49 studies reached it within 19 months; a quarter within 7 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
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