Actively Recruiting
An Observational Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine
Led by Serum Institute of India Pvt. Ltd. · Updated on 2025-08-13
2308
Participants Needed
5
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Observational Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female child eligible to receive the R21/Matrix-M vaccine based on age
- Parent/legal guardian or caregiver willing to provide written informed consent for the child's participation
- Parent/legal guardian or caregiver willing to share vaccination and medical records with study personnel
- Resident of the R21/Matrix-M vaccine implementation area
- Child brought to study hospital, clinic, or sub-site with clinical complaints
- Child meeting case definitions for severe malaria, clinical malaria, or death due to any cause
- For controls: matched birth date within 60 days of the case
- Controls residing in the same neighborhood but not the same household as the respective case
- Controls would have sought treatment at the same hospital if symptoms developed
- Controls residing in the location for most days of the week for the past 6 months
You will not qualify if you...
- Parent/legal guardian or caregiver not consenting to participation or access to vaccination and medical records
- Child not meeting case definitions for severe malaria, clinical malaria, or death (cases)
- Child has received one or more doses of RTS,S/AS01 vaccine in the past
- Child meeting any case definitions (controls)
- Child with history suggestive of clinical malaria in past 30 days (for clinical and severe malaria studies only)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Unité de Recherche Clinique de Nanoro (URCN), Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest (IRSS-DRCO), Bousse
Bousse, Burkina Faso, Burkina Faso
Actively Recruiting
2
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
Actively Recruiting
3
University of Ilorin Department of Pediatrics University of Ilorin Teaching Hospital, Ilorin, Nigeria
Yenagoa, Bayesla, Nigeria
Actively Recruiting
4
Infectious Diseases Research Collaboration (IDRC), Uganda
Busia, Uganda, Uganda
Actively Recruiting
5
Makerere University College of Health Sciences
Mukono, Uganda
Actively Recruiting
Research Team
D
Dr. Prasad Kulkarni, MD, FRCP
CONTACT
D
Dr. Sandesh M Bharati, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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