Condition: Malaria,Falciparum · Morality · Sponsor: Serum Institute of India Pvt. Ltd.
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.
This description comes directly from the study's public registry record.
Dr. Prasad Kulkarni, MD, FRCP · +91-20-7194-6820 · drpsk@seruminstitute.com
Dr. Sandesh M Bharati, MD · +91- 20-7194-6825 · sandesh.bharati@seruminstitute.com
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT07009847