NCT05500482

Vellore Typhoid Vaccine Impact Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72,400 (actual)
• Sponsor: Christian Medical College, Vellore, India · Academic / Other
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Accepted

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.

Detailed description

TyphiBEV®, a typhoid conjugate vaccine from Biological E, has been licensed by the Central Drugs Standard Control Organaisation in India based on immunogenicity and safety data. A similar typhoid conjugate vaccine has been demonstrated in large clinical trials to provide 80% vaccine efficacy in Nepal and Bangladesh. The TyphiBEV® has not been similarly evaluated. The demonstration of the impact of a city-scale typhoid conjugate vaccine introduction on the burden of typhoid will aid policy decisions on the use of typhoid conjugate vaccines in the national immunisation program. After written informed consent, the investigators will establish stimulated passive surveillance in 72,000 individuals between 1 and 30 years of age within the Vellore Demographic Surveillance System to determine the incidence of blood-culture confirmed typhoid fever. Thirty-six thousand surveillance participants between 1 year and 30 years residing in the 30 clusters (areas) randomised to receive the vaccine will receive the vaccine at the beginning of the trial. Those in other areas will receive the same at the end of two years. Using a stimulated passive surveillance approach, those with acute febrile illness will be encouraged to visit study surveillance hospitals. Participants will be evaluated for blood-culture confirmed typhoid fever if they are eligible. The incidence of typhoid among those living in areas assigned to vaccination compared to those whose residence is in areas not designated for vaccination will be used to calculate the impact of the vaccine on disease burden.

Conditions

• Typhoid Fever

Interventions

Type	Name	Description
BIOLOGICAL	Typhoid conjugate Vaccine	TyphiBEV is a clear colourless monovalent vaccine containing 25 µg of Typhoid Vi polysaccharide manufactured using the Citrobacter freundii sensu lato3056 (Vi) and is conjugated to CRM 197 as a carrier protein. Sodium chloride and Phosphate buffer are used as a buffering agent in the vaccine formulation with 2-Phenoxyethanol as a preservative.

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-01-31
• Completion: 2026-02-28
• First posted: 2022-08-15
• Last updated: 2026-03-17

Locations

1 site across 1 country: India