Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso
NCT03614533 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 251
Last updated 2025-05-30
Summary
Typhoid fever is an illness that may cause mild effects in children, such as fever and feeling tired, or it may cause serious effects-- even death. A new typhoid vaccine has recently been recommended by the World Health Organization (WHO) to prevent typhoid in children. But this new typhoid vaccine has not been tested with all of the vaccines given to children in Burkina Faso. The investigators want to look at this new vaccine, and study how safe it is in children in Burkina Faso and how their immune systems respond to the vaccine when given with other vaccines, such as yellow fever and meningitis A vaccines.
The investigators plan to vaccinate 100 children between the ages of 9-11 months, and 150 children between the ages of 15 months and 2 years, in Ouagadougou, Burkina Faso, with either the typhoid vaccine or a vaccine against another illness called polio.
Children will have follow-up visits on days 3, 7, 28 and 180. One teaspoon of blood will be collected on days 0 and 28.
Conditions
- Typhoid
Interventions
- BIOLOGICAL
-
Vi-Typhoid Conjugate Vaccine (Vi-TCV)
Single 0.5-ml intramuscular injection
- BIOLOGICAL
-
Inactivated Poliovirus Vaccine (IPV)
Single 0.5-ml intramuscular injection
Sponsors & Collaborators
-
Bill and Melinda Gates Foundation
collaborator OTHER -
Groupe de Recherche Action en Sante
collaborator OTHER -
University of Maryland, Baltimore
lead OTHER
Principal Investigators
-
Laurens Matthew, MD · University of Maryland, Baltimore
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Months
- Max Age
- 23 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-12-03
- Primary Completion
- 2019-08-22
- Completion
- 2024-08-22
Countries
- Burkina Faso
Study Locations
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