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Effectiveness of Malaria Vaccines in Reducing the Risk of Invasive Non-Typhoidal Salmonella Disease (VINS)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
SUMMARY

The goal of this observational study is to learn about the impact of malaria vaccination on the risk of invasive non-typhoidal Salmonella disease in children below the age of 5. Eligible participants residing in the Kisantu Health Zone (DRC) and presenting fever are enrolled in healthcare facilities and tested for malaria and iNTS. Using a case-control (test-negative) design, the researchers will look at the malaria vaccination status of participants with and without iNTS infection to determine if the malaria vaccine protects against iNTS.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR

• Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation

Locations
Other Locations
Democratic Republic of the Congo
Institut National de Recherche Biomedicale (INRB)
RECRUITING
Kinshasa
Contact Information
Primary
Birkneh Tadesse, MD, PHD
Birkneh.Tadesse@ivi.int
+821098041348
Backup
Camille Dauvergne, PharmD, M.S.c
Camille.Dauvergne@ivi.int
+821091480309
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2027-02
Participants
Target number of participants: 10000
Treatments
Age-eligible children who received the R21/Matrix-M Malaria Vaccine.
Depending on the study objective, participants who received at least the three primary doses of the R21/Matrix-M vaccine will be considered for analysis (complete vaccination - primary objective) or participants who received either the first or first two doses of R21/Matrix-M vaccine (incomplete vaccination - secondary objectives) shall be considered for analysis.
Age-eligible children who were not vaccinated against malaria.
Unvaccinated participants will be defined as not meeting the definitions for complete nor incomplete vaccination by time of enrollment.
Related Therapeutic Areas
Sponsors
Leads: International Vaccine Institute

This content was sourced from clinicaltrials.gov

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