TyVAC Nepal: typhoid vaccine study

Phase 3

Completed

• Conditions: Blood culture confirmed typhoid fever; Infections and Infestations; Typhoid fever

• Registration Number: ISRCTN43385161
• Lead Sponsor: niversity of Oxford

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30845329 protocol (added 08/03/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31800986 results (added 06/12/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34678198/ (added 26/10/2021) 2020 Results article in https://doi.org/10.1371/journal.pntd.0007805 Under-detection of blood culture-positive enteric fever cases: The impact of missing data and methods for adjusting incidence estimates (added 11/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-26
• Study Completion: 2020-08-01
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20019

Inclusion Criteria

1. Parent/legal guardian is willing and competent to provide informed consent. If the participant is 12 years of age or older, 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. In good health on the day of vaccination
4. Parent/legal guardian confirms that their child will be wiling and be able to comply with study requirements including follow-up contact, according the trial schedule
5. Live within the study catchment area at the time of vaccination

Exclusion Criteria

The participant will not be enrolled if any of the following criteria apply:
1. They have knowingly received a typhoid vaccine in the last three years
2. They have a known allergy to any of the vaccine components
3. Any medical or social reasons that will prevent the participant from conforming to the study requirements as judged by a medical professional
4. They are planning to move away from the catchment area within the next 6 months

Participants will be temporarily excluded from being vaccinated if, at point of vaccination, any of the following apply:
1. Reported fever within 24 hours prior to vaccination
2. Use of anti-pyretics within 4 hours prior to vaccination
If these apply, the participant will be temporarily excluded for vaccination until 48 hours has passed. A re-assessment will be conducted to ensure these temporary exclusion criteria no longer exist

Study & Design

• Study Type: Interventional
• Study Design: Not specified