Actively Recruiting
A Case Control 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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational case-control study to evaluate the effectiveness and safety of the R21/Matrix-M vaccine in preventing severe malaria, clinical malaria in high transmission areas, and to assess if vaccinated children have an increased risk of death from any cause. The study focuses on children eligible for the vaccine, comparing vaccinated and unvaccinated groups to understand vaccine impact on malaria and mortality. Cases of severe malaria, clinical malaria, and death will be enrolled along with matched controls based on age and neighborhood. The study is carried out at multiple centers across countries where the R21/Matrix-M vaccine is approved and used. Cases are recruited from hospitals, clinics, or the community depending on the condition, while controls are matched from the same neighborhood but different households. For severe malaria and death cases, four controls per case are enrolled, and for clinical malaria cases, there is a one-to-one control ratio. Vaccination status is verified through records or caregiver history. Laboratory tests confirm malaria diagnosis as per specific case definitions. Participants will be children aged 5 months and older living in vaccine deployment areas. Researchers will collect medical and vaccination data, including hospital records and home visits when needed. The study will measure vaccine effectiveness against severe and clinical malaria caused by P. falciparum over about one year and assess the risk of death. Surveillance includes hospital and community case detection, with follow-up data collection from families and healthcare providers. The study aims to provide thorough monitoring of outcomes related to malaria and overall mortality.
CONDITIONS
Brief 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...
- Child eligible to have received R21/Matrix-M vaccine based on age (5 months or older)
- Parent/legal guardian/caregiver willing to provide written informed consent
- Parent/legal guardian/caregiver willing to share vaccination and medical data with study personnel
- Resident of the R21/Matrix-M vaccine implementation area
- Child meets the respective case definition (Severe Malaria, Clinical Malaria, or Death from any cause)
- For controls, matched to case by age within 60 days and living in the same neighborhood but not the same household
- Control child would have sought treatment at the same hospital if symptomatic
- Control child and family have lived in the area for most days over past 6 months
You will not qualify if you...
- Parent/legal guardian/caregiver not consenting to participate or share vaccination/medical data
- Child does not meet the respective case definitions for cases
- Child has received one or more doses of RTS,S/AS01 vaccine in the past
- For controls, child meets any case definitions of Severe or Clinical Malaria
- For controls, child had clinical malaria in the past 30 days (for clinical and severe malaria case-control studies only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Approximately 1 year
Participants are observed in their communities or healthcare settings to identify cases of clinical malaria, severe malaria, or death, and corresponding matched controls.
Visits to hospitals, clinics, or homes as needed for data collection and case identification
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
D
Dr. Sandesh M Bharati, MD
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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