Status:
COMPLETED
A Baseline Study in Support of Clinical Evaluation of an Oral Shigella Vaccine Development in Africa
Lead Sponsor:
Centre for Infectious Disease Research in Zambia
Collaborating Sponsors:
European Vaccine Initiative
Groupe de Recherche Action en Sante
Conditions:
Diarrhea
Diarrhea Infectious
Eligibility:
All Genders
Up to 5 years
Brief Summary
This study aims to address the paucity of accurate incidence data of diarrheal diseases associated with Shigella in Zambia and Burkina Faso. Given the limited feasibility of the current complex diagno...
Detailed Description
This is an observational, cohort study to determine the incidence of Shigella in children under 5 years in Zambia and Burkina Faso. We will first identify the population at risk i.e children that wil...
Eligibility Criteria
Inclusion
- Children who are under five years, are resident in the catchment areas of participating health facilities and whose parents or guardians have no anticipated plan to leave the area for the next 12 months;
- Willing to submit child biological samples for testing and/or storage;
- Parent or guardian providing written informed consenting to the study.
Exclusion
- Any child born after the Census has taken place(Zambia) or whose household was not randomly selected from the database (Burkina Faso)
- Current participation in a research with the use of any drug or vaccine.
- Parent or guardian unwilling to provide consent
- Any confirmed or suspected immunosuppressive or immuniodeficiency condition based on medical history and physical examination (No testing will be done for HIV)
- A family history of congenital or hereditary immunodeficiency
- Major congenital defects
- Immunosuppresive therapy within 3 months prior to recruitment
Key Trial Info
Start Date :
September 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
1334 Patients enrolled
Trial Details
Trial ID
NCT04312906
Start Date
September 14 2020
End Date
November 30 2021
Last Update
July 20 2022
Active Locations (3)
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1
Schiphra Hospital
Ouagadougou, Burkina Faso
2
Arthur Davidson Childrens Hospital
Ndola, Copperbelt, Zambia, 10101
3
Chainda South Health Facility
Lusaka, Zambia, 10101