RecruitingNCT07009847

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

A Case Control Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine


Sponsor

Serum Institute of India Pvt. Ltd.

Enrollment

2,308 participants

Start Date

Jun 16, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 5 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Case control study of clinical malaria, Case control study of death (all cause), and others for people with malaria,falciparum and morality. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCase control study of clinical malaria

Case control study of clinical malaria

OTHERCase control study of severe malaria

Case control study of severe malaria

OTHERCase control study of death (all cause)

Case control study of death (all cause)


Locations(5)

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

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

University of Ilorin Department of Pediatrics University of Ilorin Teaching Hospital, Ilorin, Nigeria

Yenagoa, Bayesla, Nigeria

Infectious Diseases Research Collaboration (IDRC), Uganda

Busia, Uganda, Uganda

Makerere University College of Health Sciences

Mukono, Uganda

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NCT07009847


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