TyVAC Bangladesh: Typhoid Vaccine Trial

Phase 4

• Conditions: Blood culture confirmed typhoid fever; Prevention of typhoid fever (Salmonella typhi infection); Infections and Infestations

• Registration Number: ISRCTN11643110
• Lead Sponsor: niversity of Oxford

Brief Summary

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30845333/ protocol (added 29/05/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37090439/ (added 24/04/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-07
• Last Update Posted: 8 May 2023
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 32500

Inclusion Criteria

1. Parent/guardian is willing and competent to provide informed consent. If the participant is 11 to <16 years of age, informed assent will also be sought
2. Aged between 9 months (or eligible for measles vaccination according to local protocol) and <16 years (i.e. up to 15 years 364 days) at time of vaccination
3. Apparently healthy (no complaints of febrile illness) on the day of vaccination
4. Parent/guardian confirms that their child will be willing and be able to comply with study requirements including follow-up contact, according the schedule (Appendix B)
5. Living within the study catchment area at the time of vaccination

Exclusion Criteria

Current participant exclusion criteria as of 13/08/2018:
1. Has knowingly received a typhoid or Japanese encephalitis vaccine in the last three years
2. Known allergy to any of the vaccine components
3. Medical or social reasons that will prevent the participant from conforming to the study requirements as judged by a medical professional
4. Planning to move away from the catchment area within the next month
5. Pregnant at the time of vaccination, as confirmed by a urine test (urine pregnancy test will be done in girls who are married)

Temporary exclusion criteria:
1. Receipt of any other vaccines in the last 30 days
2. Current temperature of at least 38°C or reported fever within 24 hours prior to vaccination
3. Use of antipyretics within 4 hours prior to vaccination
4. Unmarried girls between the ages of =12 and <16 years old whose first day of their last menstrual period (LMP) is more than 28 days ago or who do not know the date they last menstruated upon presentation

Previous participant exclusion criteria:
1. Has knowingly received a typhoid or Japanese encephalitis vaccine in the last three years
2. Known allergy to any of the vaccine components
3. Medical or social reasons that will prevent the participant from conforming to the study requirements as judged by a medical professional
4. Planning to move away from the catchment area within the next month
5. Pregnant at the time of vaccination, as confirmed by a urine test (urine pregnancy test will be done in girls who are married)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy and rate reduction of the Vi-TCV in preventing blood culture-confirmed symptomatic infection caused by S. typhi, measured through the incidence of blood culture confirmed typhoid fever in vaccinees in intervention clusters compared to control clusters.