A Cluster-randomised Controlled Phase IV Trial Assessing the Impact of a Vi-Polysaccharide Conjugate Vaccine in Preventing Typhoid Infection in Asante Akim, Ghana (TyVEGHA)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA) with a primary endpoint of determining the total protection conferred by single-dose vaccination with Vi-TT against blood culture-confirmed symptomatic S. Typhi infection in the intervention vaccine clusters, compared with the control vaccine clusters.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9 months
Maximum Age: 15
Healthy Volunteers: t
View:

• Healthy participants aged 9 months to \<16 years (i.e., ≤15 years and 364 days) of age at the time of vaccination

• Participants/Parents/legally authorized representative (LAR) who have voluntarily given informed assent (sought from participants aged 12 years to \<16 years) and informed consent

• Participants/Parents/LAR living within study target area at the time of vaccination and willing to follow the study procedures and be available for the entire duration of the study

Locations
Other Locations
Ghana
Kwame Nkrumah University of Science and Technology
RECRUITING
Kumasi
Contact Information
Primary
Birkneh T Tadesse, PhD
birkneh.tadesse@ivi.int
+821098041348
Backup
Thaint Thaint Thwe, MBBS, MSc.
ThaintThaint.Thwe@ivi.int
+821037907535
Time Frame
Start Date: 2021-08-24
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 23000
Treatments
Experimental: Vi-TT Arm
A single dose of Vi-TT to children 9 months to 15 years of age.
Active_comparator: MCV-A arm
A single dose of MCV-A vaccine to the comparator group.
Related Therapeutic Areas
Sponsors
Collaborators: University of Maryland, Baltimore, University of Cambridge, International Centre for Diarrhoeal Disease Research, Bangladesh, Fondation Mérieux, Kwame Nkrumah University of Science and Technology
Leads: International Vaccine Institute

This content was sourced from clinicaltrials.gov