Condition: Malaria · Sponsor: London School of Hygiene and Tropical Medicine
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 groups) at peak transmission after seasonal mass vaccination with R21 (3 monthly doses). Secondary objectives are: 1. To assess the safety and tolerability of R21 through spontaneously reported adverse events. 2. To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following seasonal mass vaccination with R21 (3 monthly doses). 3. To compare in intervention and control clusters the incidence of clinical malaria (all age groups) after seasonal mass vaccination with R21 (3 monthly doses). 4. To compare in intervention and control clusters the prevalence of malaria (all age groups) at peak transmission after one booster dose of R21. 5. To compare in intervention and control clusters the incidence of malaria infection (all age groups) during the malaria transmission season following one booster dose of R21. 6. To compare in intervention and control clusters the incidence of clinical malaria (all age groups), after one booster dose of R21. 7. To determine the coverage of seasonal mass vaccination with R21 (…
This description comes directly from the study's public registry record.
Umberto D'Alessandro, MD, DHTM, MSc, PhD · +220449544 · Umberto.Dalessandro@lshtm.ac.uk
Anette Erhart, MD, MSs, PhD · Annette.Erhart@lshtm.ac.uk
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| Clinical Research Unit of Nanoro, Burkina Faso | Nanoro, Burkina Faso | Recruiting |
| MRC Unit The Gambia at LSHTM | Fajara, The Gambia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06578572