A Case Control Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Burkina Faso
Unité de Recherche Clinique de Nanoro (URCN), Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest (IRSS-DRCO), Bousse
RECRUITING
Boussé
Nigeria
University of Ilorin Department of Pediatrics University of Ilorin Teaching Hospital, Ilorin, Nigeria
RECRUITING
Yenagoa
Uganda
Infectious Diseases Research Collaboration (IDRC), Uganda
RECRUITING
Busia
Makerere University College of Health Sciences
RECRUITING
Mukono
Contact Information
Primary
Dr. Prasad Kulkarni, MD, FRCP
drpsk@seruminstitute.com
+91-20-7194-6820
Backup
Dr. Sandesh M Bharati, MD
sandesh.bharati@seruminstitute.com
+91- 20-7194-6825
Time Frame
Start Date:2025-06-16
Estimated Completion Date:2026-12-31
Participants
Target number of participants:2308
Treatments
Case control study of Clinical malaria
Clinical Malaria case definition: Presence of axillary temperature ≥ 37.5°C and/ or history of fever within the last 48 hours before the diagnosis is made AND P. falciparum asexual parasitaemia \>5000 parasites/μL detected by microscopy.~This is a case-control study to assess the effectiveness of the R21/Matrix-M Vaccine against clinical malaria in children aged ≥ 5 months of age.~Surveillance and detection of cases: Cases qualifying the case definitions of clinical, cases will be recruited from the hospitals, clinics or the sub-sites as per the respective case definitions. The required laboratory investigations will be conducted if not already done to ensure the child meets the respective case definition example: e.g. microscopy with parasite density will be conducted in the suspected cases of clinical malaria.~For clinical malaria cases in high-transmission perennial areas, the ratio of case: control will be 1:1. Controls will be matched for age and neighborhood.
Case control study of Severe malaria
Severe Malaria case definition: Presence of P. falciparum parasitaemia detected by microscopy AND one or more of the disease severity criteria.~This is a case-control study to assess the effectiveness of the R21/Matrix-M Vaccine against severe malaria in children aged ≥ 5 months of age. Surveillance and detection of cases: Cases qualifying the case definitions of severe malaria, cases will be recruited from the hospitals, clinics or the sub-sites as per the respective case definitions. The required laboratory investigations will be conducted if not already done to ensure the child meets the respective case definition. For severe malaria cases, the ratio of case: control will be 1:4. Controls will be matched for age and neighborhood.
Case control study of death (all cause)
Death (all-cause) case definition: Children who died, of any cause excluding trauma or elective surgery, who were eligible to have received the R21/Matrix-M vaccine based on their date of birth.~This is a case-control study to assess if the R21 vaccine recipients are at an increased risk due to (all cause) mortality in children aged ≥ 5 months of age. Surveillance and detection of cases: For deaths, cases will be recruited from the hospital or the community (house visits). Cause of death can be ascertained from hospital or available medical records as well as discussions with family or healthcare professionals who may have been involved. For death (all cause) cases, the ratio of case: control will be 1:4. living controls will be enrolled and matched for age and neighborhood.