Status:
RECRUITING
Seasonal R21 Mass Vaccination for Malaria Elimination
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
National Malaria Control Programme, The Gambia
Conditions:
Malaria
Eligibility:
All Genders
5-99 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
This is a cluster-randomized controlled trial. 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. Therefore,15...
Eligibility Criteria
Inclusion
- Age≥ 5 months.
- Willingness to comply with trial procedures.
- Individual written informed consent obtained at the beginning of the study.
Exclusion
- Pregnancy
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g., Kathon, neomycin, betapropiolactone.
- 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 the participant's ability to participate in the trial.
Key Trial Info
Start Date :
May 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
16200 Patients enrolled
Trial Details
Trial ID
NCT06578572
Start Date
May 30 2024
End Date
December 31 2025
Last Update
August 29 2024
Active Locations (2)
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1
Clinical Research Unit of Nanoro, Burkina Faso
Nanoro, Burkina Faso
2
MRC Unit The Gambia at LSHTM
Fajara, The Gambia, 273