Safety, Immunogenicity and Efficacy of R21 Matrix-M in 5-17 Month Old Children in Nanoro, Burkina Faso
NCT03896724 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 450
Last updated 2025-07-11
Summary
This is a double blind randomised controlled clinical trial to evaluate the efficacy of R21 adjuvanted with Matrix-M in healthy 5-17 month old children in a malaria endemic area.
Conditions
- Malaria,Falciparum
Interventions
- BIOLOGICAL
-
R21 adjuvanted with 25mcg Matrix-M
Vaccine
- BIOLOGICAL
-
Rabies Vaccine
Vaccine
- BIOLOGICAL
-
R21 adjuvanted with 50mcg Matrix-M
vaccine
Sponsors & Collaborators
-
Institut de Recherche en Sciences de la Sante, Burkina Faso
collaborator OTHER_GOV -
European and Developing Countries Clinical Trials Partnership (EDCTP)
collaborator OTHER_GOV -
University of Oxford
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Months
- Max Age
- 17 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-05-07
- Primary Completion
- 2023-07-07
- Completion
- 2023-07-07
Countries
- Burkina Faso
Study Locations
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