R21 malaria vaccine plus seasonal malaria chemoprevention for young children in West Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-site, phase-4, cluster-randomised non-inferiority trial in Burkina Faso and Mali where health centre catchment areas are randomised to different vaccine delivery strategies. One arm delivers the 3-dose R21/Matrix-M primary series aligned with seasonal malaria chemoprevention (SMC) for children aged 3–59 months, while the comparator arm uses country-specific routine EPI or pre-SMC campaign delivery for children aged 5–36 months. Effectiveness will be measured by clinical malaria incidence as well as vaccine coverage, acceptability, and operational feasibility under real-world conditions. Clusters are followed through the malaria season to compare health and programmatic outcomes between the integrated and routine delivery approaches.

Why it matters

Who can join: the full rules

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. -

Where it's running

• 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

Study contacts

• Study coordinator: Valérie Briand
• Email: valerie.briand@epicentre.msf.org
• Phone: +331 40 21 55 55

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Do malaria vaccines lower the risk of invasive non-typhoidal Salmonella in young children?

  This study will see if the R21/Matrix-M malaria vaccine lowers the chance of invasive non-typhoidal Salmonella disease in children under 5 who come to health facilities with fever in the Kisantu Health Zone (DRC).

  Recruiting International Vaccine Institute · Kinshasa · NCT07416461

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.