Vellore Typhoid Vaccine Impact Trial

NCT05500482 | Completed Phase 4 DMC

• 1 other identifier: 14247[INTERVEN]
• Study Type: interventional
• Target: 72,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Typhoid Fever

Keywords

typhoid conjugate vaccine; cluster randomised trial; Enteric Fever

Outcome Measures

Primary Outcomes (1)

• Total effect

  Number of blood culture confirmed typhoid fever episodes in vaccinated participants from vaccine clusters compared to the number of blood culture confirmed typhoid fever episodes in unvaccinated participants from non-vaccine clusters

  at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.

Secondary Outcomes (4)

• Overall effect

  at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.

• Effect in children 1 to 14 years

  at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.

• Effect on all febrile illness requiring healthcare visits

  at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.

• Safety outcomes

  Seven days after vaccine receipt

Other Outcomes (2)

• Indirect effect

  at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.

• Effect on hospitalised typhoid fever

  at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.

Study Arms (2)

Vaccinated arm

EXPERIMENTAL

Typhoid Conjugate Vaccine (TyphiBEV) 0.5 ml as a single dose given intramuscularly to consenting, eligible residents of vaccine clusters

Biological: Typhoid conjugate Vaccine

Control arm

NO INTERVENTION

No vaccination in the control clusters

Interventions

Typhoid conjugate Vaccine BIOLOGICAL

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.

Also known as: TyphiBEV

Vaccinated arm

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• For fever surveillance
• o Medical reasons that prevent the participant from complying with study requirements including follow up and testing during illness
• For vaccination
• Has received a typhoid vaccine in the previous three years
• Is known to have an allergy to any vaccine component
• Nursing mothers, Pregnancy or planning pregnancy around vaccination

Sponsors & Collaborators

• Christian Medical College, Vellore, India: lead
• Bill and Melinda Gates Foundation: collaborator
• University College, London: collaborator
• Imperial College London: collaborator

Study Sites (1)

Christian Medical College Vellore

Vellore, Tamil Nadu, 632002, India

Location

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jacob John, MD PhD

  Christian Medical College, Vellore, India

  PRINCIPAL INVESTIGATOR

• Gagandeep Kang, MD PhD

  Christian Medical College, Vellore, India

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The control arm will not receive a vaccine, however the investigator and the outcome assessors will be trained not to seek history of vaccination. The clusters selected for vaccination and their boundaries will not be accessible to the investigators and outcome assessors.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 15, 2022
• Study Start: May 1, 2023
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 6 months of data lock at the end of the trial and for a period of five years thereafter
• Access Criteria: Upon providing a draft hypothesis and analysis plan

Locations

IN (1)