A Phase III Randomized, Double-Blind, Controlled Trial of the Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi
Who is this study for? Children up to age 12 at risk for typhoid fever
What treatments are being studied? Vi-Typhoid conjugate vaccine
Status: Active_not_recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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 the study vaccine or the control vaccine (meningococcal group A conjugate vaccine - MCV-A).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 9 months
Maximum Age: 12
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Malawi
Malawi Liverpool Wellcome Trust Clinical Research Programme, Queen Elizabeth Central Hospital College of Medicine
Blantyre
Time Frame
Start Date: 2018-02-21
Completion Date: 2025-10-30
Participants
Target number of participants: 30000
Treatments
Experimental: Vi-Typhoid Conjugate Vaccine (Vi-TCV)
Children will receive a single 0.5-ml dose of Vi-TCV administered by the intramuscular route.
Active_comparator: Meningococcal A Conjugate Vaccine (MCV-A)
Children will receive a single dose of MCV-A administered by the intramuscular route. Children 9-11 months will receive a 5µg/0.5ml dose. Children 12 months and older will receive a 10µg/0.5 ml dose.
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Bill and Melinda Gates Foundation, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Malawi, University College, London
Leads: University of Maryland, Baltimore