Typhoid Fever Clinical Trial
— VEVACTOfficial title:
Vellore Typhoid Vaccine Impact Trial
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.
Status | Recruiting |
Enrollment | 72500 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 30 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
India | Christian Medical College Vellore | Vellore | Tamil Nadu |
Lead Sponsor | Collaborator |
---|---|
Christian Medical College, Vellore, India | Bill and Melinda Gates Foundation, Imperial College London, University College, London |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Indirect effect | The number of blood culture confirmed typhoid fever episodes in unvaccinated 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. | |
Other | Effect on hospitalised typhoid fever | The number of blood culture confirmed typhoid fever episodes in hospitalised participants who have been vaccinated compared to the number of blood culture confirmed typhoid fever episodes in hospitalised participants who have not been vaccinated | at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters. | |
Primary | 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 | Overall effect | The number of blood culture confirmed typhoid fever episodes in participants from vaccine clusters compared to the number of blood culture confirmed typhoid fever episodes in participants from non-vaccine clusters | at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters. | |
Secondary | Effect in children 1 to 14 years | The number of blood culture confirmed typhoid fever episodes in vaccinated children between 1 year and 14 years and 364 days from vaccine clusters compared to the number of blood culture confirmed typhoid fever episodes in unvaccinated children between 1 year and 14 years and 364 days from non-vaccine clusters | at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters. | |
Secondary | Effect on all febrile illness requiring healthcare visits | The number of febrile illness episodes where healthcare is sought among vaccinated participants from vaccine clusters compared to unvaccinated participants from non-vaccine clusters | at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters. | |
Secondary | Safety outcomes | The number and description of solicited and non-solicited adverse events reported within the first seven days after vaccination in the safety subset of vaccine recipients | Seven days after vaccine receipt |
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