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

Recruiting now

Conditions studied: Malaria,Falciparum, Morality

In brief

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.

Key facts

Study ID

NCT07009847

Run by

Serum Institute of India Pvt. Ltd.

People needed

2308

Starts

2025-06-16

Expected to finish

2026-12-31

Last updated by the study team

2025-08-13

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For Cases- A male or female child eligible to have received R21/Matrix-M Vaccine based on age. 2 Parent/legal guardian/ caregiver of the child willing to provide the written informed consent for their child's participation in the study.
• 3 Parent/legal guardian/ caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel.
• 4 Resident of the R21/Matrix-M vaccine implementation area and brought to the study hospital /clinic or sub-site with clinical complaints. 5 Child meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).
• For Controls- A male or female child eligible to have received R21/Matrix-M Vaccine based on age. The matched control should have a date of birth within 60 days of that of the case.
• Parent/legal guardian/ caregiver of the child willing to provide the informed consent for their child's participation in the study.
• Parent/ legal guardian/ caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel 4. Resident of the R21/Matrix-M vaccine implementation area and who would have sought treatment at the same hospital if they had developed symptoms. Resident will be defined as child and/or child's parents/ guardian/caregiver eating and sleeping in a household in the location for most days of the week from past 6 months. The matched control should be residing in the same neighborhood as the respective case, but not from the same household.

You may not qualify if…

• For Cases-
• Parent/legal guardian/ caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.
• Child not meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).
• Received one or more doses of RTS,S/AS01 vaccine in the past.
• For Controls-
• Parent/legal guardian/ caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.
• Child meeting any of the case definitions (Severe Malaria, Clinical Malaria).
• Child having history suggestive of clinical malaria in past 30 days (applicable for clinical malaria and severe malaria case-control studies only).
• Received one or more doses of RTS,S/AS01 vaccine/s in the past.

Where it is running

• 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 (enrolling)
• 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 (enrolling)
• University of Ilorin Department of Pediatrics University of Ilorin Teaching Hospital, Ilorin, Nigeria — Yenagoa, Bayesla, Nigeria (enrolling)
• Infectious Diseases Research Collaboration (IDRC), Uganda — Busia, Uganda, Uganda (enrolling)
• Makerere University College of Health Sciences — Mukono, Uganda (enrolling)

Full record on ClinicalTrials.gov

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