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

NCT07009847 | Recruiting

• 1 other identifier: R21-PMS-01
• Study Type: observational
• Target: 2,308
• Locations: 4 countries
• Sites: 5

Brief 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. 1.Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.
2. 2.Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases in high-transmission perennial areas caused by P. falciparum.
3. 3.Proportion of vaccinated and unvaccinated children in cases of death (all cause)
4. 4.Exploratory effectiveness endpoint: Proportion of vaccinated and unvaccinated children in the hospitalized clinical and severe malaria cases.

Conditions

Malaria,Falciparum; Morality

Keywords

clinical malaria; severe malaria; death (all cause)

Outcome Measures

Primary Outcomes (3)

• Vaccine Effectiveness against Severe Malaria caused by P. falciparum

  Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.

  through study, an average of one year

• Vaccine Effectiveness against clinical malaria caused by P. falciparum in high perennial transmission areas

  Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases caused by P. falciparum.

  through study, an average of one year

• Risk of death (all cause) due to R21-vaccination

  Proportion of vaccinated and unvaccinated children in cases of death

  through study, an average of one year

Study Arms (3)

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.

Other: Case control study of clinical malaria

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.

Other: Case control study of severe malaria

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.

Other: Case control study of death (all cause)

Interventions

Case control study of clinical malaria OTHER

Case control study of clinical malaria

Case control study of Clinical malaria

Case control study of severe malaria OTHER

Case control study of severe malaria

Case control study of Severe malaria

Case control study of death (all cause) OTHER

Case control study of death (all cause)

Case control study of death (all cause)

Eligibility Criteria

• Age: 5 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise children aged 5 months and above who live in R21-Malaria vaccine implementation areas in Uganda, Burkina Faso, Nigeria, Cote d'ivoire and who were eligible to have received R21-malaria vaccine based on their date of birth and age

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.
• 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.
• 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.

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.: lead

Study Sites (5)

Unité de Recherche Clinique de Nanoro (URCN), Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest (IRSS-DRCO), Bousse

Boussé, 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

MeSH Terms

Conditions

Malaria, Falciparum; Malaria; Death

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr. Prasad Kulkarni, MD, FRCP

CONTACT

+91-20-7194-6820; drpsk@seruminstitute.com

Dr. Sandesh M Bharati, MD

CONTACT

+91- 20-7194-6825; sandesh.bharati@seruminstitute.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: June 8, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

CÔ (1); UG (2); BU (1); NG (1)