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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03614533 on ClinicalTrials.gov