Seasonal R21 Mass Vaccination for Malaria Elimination
Recruiting
Phase 3
Interventional Study
Malaria
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
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
- 5 Months – 99
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 16,200 (estimated)
- Sponsor
- London School of Hygiene and Tropical Medicine · Other
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About This Trial
This is a cluster randomized trial to determine the impact of seasonal R21/MM mass vaccination (all ages) on malaria transmission and morbidity. Fifty-four villages (30 in The Gambia and 24 in Burkina Faso) will be randomized to either mass vaccination with R21 or no mass vaccination.
The primary objective is to compare in intervention and control clusters the prevalence of malaria (all age group…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age≥ 5 months.
2. Willingness to comply with trial procedures.
3. Individual written informed consent obtained at the beginning of the study.
Exclusion Criteria:
1. Pregnancy
2. History of allergic disease or reactions likely to be exacerbated by any component of the vaccin…
Contacts