Status:
ACTIVE_NOT_RECRUITING
Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Conditions:
Typhoid
Eligibility:
All Genders
9-12 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy of a Typhoid conjugate vaccine (Vi-TCV) in Malawi, Africa among children age 9 months through 12 years. Participants will be randomized in a 1:1 ration to receive...
Detailed Description
This study is a double-blind, individually randomized, controlled, clinical efficacy trial with two vaccine groups: Vi-TCV (Typhoid conjugate) and MCV-A (meningococcal group A conjugate). This study w...
Eligibility Criteria
Inclusion
- Healthy male or female child between the ages of 9 months and 12 years/364 days at the time of study vaccination.
- A child whose parent or guardian resides primarily within the Ndirande or Zingwangwa study areas at the time of study vaccinations and who intends to be present in the area for the duration of the trial.
- A child whose parent or guardian has voluntarily given informed consent.
Exclusion
- History of documented hypersensitivity to any component of the vaccine
- Prior receipt of any typhoid vaccine in the past 3 years
- History of severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis
- Any condition determined by the investigator to be likely to interfere with evaluation of the vaccine or to be a significant potential health risk to the child or make it unlikely that the child would complete the study.
- Temporary
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
30000 Patients enrolled
Trial Details
Trial ID
NCT03299426
Start Date
February 21 2018
End Date
October 30 2025
Last Update
May 30 2025
Active Locations (1)
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1
Malawi Liverpool Wellcome Trust Clinical Research Programme, Queen Elizabeth Central Hospital College of Medicine
Blantyre, Malawi, P.O. Box 30096