Vellore Typhoid Vaccine Impact Trial
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This cluster randomised trial will examine the impact of introducing TyphiBEV, a typhoid conjugate vaccine licensed in India, on the incidence of typhoid fever in a high burden urban setting in South India.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 30
Healthy Volunteers: t
View:
• Consent
‣ For adults, 18 years and over - they must be willing and competent to provide informed consent
⁃ For those aged under 18 years, the parent/guardian is willing and competent to provide informed consent, and if the participant is 11 to 18 years of age, informed assent will also be sought,
• Age:
‣ Between 1 and 30 years (i.e., up to 29 years 364 days) at time of recruitment into the surveillance
⁃ Currently living within the study catchment area with no plans to leave the study area in the next 24 months
Locations
Other Locations
India
Christian Medical College Vellore
RECRUITING
Vellore
Contact Information
Primary
Jacob John, MD PhD
jebu@cmcvellore.ac.in
00919442631628
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 72500
Treatments
Experimental: Vaccinated arm
Typhoid Conjugate Vaccine (TyphiBEV) 0.5 ml as a single dose given intramuscularly to consenting, eligible residents of vaccine clusters
No_intervention: Control arm
No vaccination in the control clusters
Related Therapeutic Areas
Sponsors
Collaborators: Bill and Melinda Gates Foundation, Imperial College London, University College, London
Leads: Christian Medical College, Vellore, India