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

Launched by SERUM INSTITUTE OF INDIA PVT. LTD. · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the R21/Matrix-M malaria vaccine to see how effective it is in preventing severe malaria and clinical malaria, especially in areas where malaria is common. The researchers want to find out if children who receive this vaccine are at a higher risk of dying from any cause compared to those who do not receive it. To do this, they will compare children who have severe malaria or have died with children of similar age and background who have not had these issues.

To be eligible for the study, children must be in an area where the R21 vaccine is given and meet certain health criteria. For example, they should either have severe malaria, clinical malaria, or have died from any cause. Their parents or caregivers must agree to let them participate and share their medical records. Children who have previously received another malaria vaccine, called RTS,S/AS01, cannot join the study. Participants will be monitored to understand the vaccine's safety and effectiveness better.

Gender

ALL

Eligibility criteria

• 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.