Actively Recruiting
Study of Malaria Vaccine Impact on Invasive Non-Typhoidal Salmonella Disease Risk in Children Under 5 in Kisantu Health Zone
Led by International Vaccine Institute · Updated on 2026-02-18
10000
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying children under the age of 5 living in the Kisantu Health Zone of the Democratic Republic of Congo to understand how malaria vaccination affects the risk of invasive non-typhoidal Salmonella iNTS disease. This observational study aims to compare the malaria vaccination status of children with and without iNTS infection to see if the malaria vaccine offers protection against this serious bacterial infection. The study uses a case-control design to analyze these relationships. The intervention under study is the R21Matrix-M malaria vaccine, which was introduced in the Expanded Program on Immunizations on October 29, 2024. Children between 6 and 24 months old are eligible for vaccination, which includes four doses the first dose between 6 and 11 months of age, followed by a second dose one month later, a third dose one month after that, and a booster dose seven months after the third dose. Participants are grouped based on their vaccination status, including those who received all four doses, partial doses, or no vaccination. Participants presenting with fever at healthcare facilities are tested for malaria and iNTS using blood cultures, microscopic blood smears, rapid diagnostic tests, and PCR for confirmation. Those diagnosed with iNTS andor malaria receive treatment according to national guidelines and are monitored until recovery or up to 21 days after enrollment. The study measures include confirmed iNTS infection rates in vaccinated versus unvaccinated children and the severity of infections. Follow-up assessments track disease outcomes and resolution of symptoms.
CONDITIONS
Brief Title
Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-typhoidal Salmonella Disease
Research Team
B
Birkneh Tadesse, MD, PHD
C
Camille Dauvergne, PharmD, M.S.c
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