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Prevention study for Malaria Vaccine
Official title Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa
ClinicalTrials.gov ID: NCT06860178
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 59. Healthy volunteers may be eligible.
You may be able to join if
- 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 :
You likely can't join if
- History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;
- Any history of anaphylaxis in relation to vaccination;
- Known chronic illness;
- Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of...
- History of vaccination with another malaria vaccine. -
See the full eligibility 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.
- History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;
- Any history of anaphylaxis in relation to vaccination;
- Known chronic illness;
- 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...
- History of vaccination with another malaria vaccine. -
The study team makes the final eligibility decision.
Where it's taking place
- Ouagadougou, Burkina Faso
- Bamako, Mali
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 59 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ouagadougou, Burkina Faso; Bamako, Mali. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.