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Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa

NCT06860178 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40000

Last updated 2025-08-08

No results posted yet for this study

Summary

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.

Conditions

  • Malaria Vaccine

Interventions

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

Sponsors & Collaborators

  • R-Evolution Worldwide

    collaborator OTHER

  • CNRST Burkina Faso

    collaborator UNKNOWN

  • USTTB Mali

    collaborator UNKNOWN

  • Liverpool School of Tropical Medicine

    collaborator OTHER

  • Epicentre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2026-05-31
Completion
2027-12-31

Countries

  • Burkina Faso
  • Mali

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06860178 on ClinicalTrials.gov