R21/Matrix-M malaria vaccine: effectiveness and safety in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational case–control project enrolls children who meet case definitions for severe P. falciparum malaria, clinical malaria in high‑transmission perennial areas, or death (all causes) and compares their prior R21/Matrix‑M vaccination status to matched community controls. For severe malaria and death cases, four age‑ and neighborhood‑matched controls per case will be enrolled; clinical malaria cases in high‑transmission areas will have a 1:1 matched control. Cases are identified at hospitals, clinics, or community sites and vaccination and medical records are reviewed after parental or guardian consent. The study is conducted at multiple centers where R21/Matrix‑M has been deployed to estimate real‑world effectiveness and monitor all‑cause mortality.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

2\. Parent/legal guardian/ caregiver of the child willing to provide the 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 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.

Exclusion Criteria:

For Cases-

1. 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.
2. Child not meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).
3. Received one or more doses of RTS,S/AS01 vaccine in the past.

For Controls-

1. 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.
2. Child meeting any of the case definitions (Severe Malaria, Clinical Malaria).
3. Child having history suggestive of clinical malaria in past 30 days (applicable for clinical malaria and severe malaria case-control studies only).
4. Received one or more doses of RTS,S/AS01 vaccine/s in the past.

Where it's 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 Recruiting
• 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 Recruiting
• University of Ilorin Department of Pediatrics University of Ilorin Teaching Hospital, Ilorin, Nigeria
  Yenagoa, Bayesla, Nigeria Recruiting
• Infectious Diseases Research Collaboration (IDRC), Uganda
  Busia, Uganda, Uganda Recruiting
• Makerere University College of Health Sciences
  Mukono, Uganda Recruiting

Study contacts

• Study coordinator: Dr. Prasad Kulkarni, MD, FRCP
• Email: drpsk@seruminstitute.com
• Phone: +91-20-7194-6820

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.