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Clinical trial

Vellore Typhoid Vaccine Impact Trial

ID
Name
14247[INTERVEN]
Description
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.
Trial arms
Trial start
2023-05-01
Estimated PCD
2025-06-30
Trial end
2025-12-31
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Vaccinated arm
Other names:
TyphiBEV
Size
72500
Primary endpoint
Total effect
at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Receipt of any other vaccine in the past 30 days (temporary exclusion) * Febrile illness in the 24 hours before vaccination (temporary exclusion)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 72500, 'type': 'ESTIMATED'}}
Updated at
2023-09-21

1 organization

1 product

1 indication

Organization
Christian Medical College
Product
Typhoid Conjugate Vaccine
Indication
Typhoid Fever