An Observational Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine

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.

NCT Number	NCT07009847
Lead Sponsor	Serum Institute of India Pvt. Ltd.
Conditions	Malaria,Falciparum, Morality
Enrollment	2,308 participants
Start Date	2025-06-16
Primary Completion	2026-10-30 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-13