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An Observational Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine
Sponsor: Serum Institute of India Pvt. Ltd.
Summary
This is an observational case-control study to assess the effectiveness of the R21/Matrix-M vaccine against severe malaria, clinical malaria (in high transmission perennial areas), and to assess if the R21 vaccine recipients are at an increased risk of deaths (all-cause). Clinical malaria, severe malaria and death (all-cause) cases will be enrolled in study. For each case (severe or death) 4 controls matched for age and neighborhood will be enrolled whereas for clinical malaria case, 1 matched control will be enrolled. 1. Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum. 2. Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases in high-transmission perennial areas caused by P. falciparum. 3. Proportion of vaccinated and unvaccinated children in cases of death (all cause) 4. Exploratory effectiveness endpoint: Proportion of vaccinated and unvaccinated children in the hospitalized clinical and severe malaria cases.
Official title: A Case Control Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine
Key Details
Gender
All
Age Range
5 Months - Any
Study Type
OBSERVATIONAL
Enrollment
2308
Start Date
2025-06-16
Completion Date
2026-12-31
Last Updated
2025-08-13
Healthy Volunteers
Yes
Conditions
Interventions
Case control study of clinical malaria
Case control study of clinical malaria
Case control study of severe malaria
Case control study of severe malaria
Case control study of death (all cause)
Case control study of death (all cause)
Locations (5)
Unité de Recherche Clinique de Nanoro (URCN), Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest (IRSS-DRCO), Bousse
Boussé, Burkina Faso, Burkina Faso
Centre de Recherche et de Lutte contre le Paludisme Institut National de Santé Publique, boulevard Nangui Abrogoua près État Major des Armées
Toumodi, Côte d’Ivoire
University of Ilorin Department of Pediatrics University of Ilorin Teaching Hospital, Ilorin, Nigeria
Yenagoa, Bayesla, Nigeria
Infectious Diseases Research Collaboration (IDRC), Uganda
Busia, Uganda, Uganda
Makerere University College of Health Sciences
Mukono, Uganda