Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa
Recruiting
Phase 4
Interventional Study
Malaria Vaccine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 3 Months – 59 Months
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 40,000 (estimated)
- Sponsor
- Epicentre · Other
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About This Trial
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. …
Trial Locations
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Eligibility Criteria
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…
Contacts