Assessing the impact of a Vi-Polysaccharide Conjugate Vaccine in preventing typhoid infection among Nepalese children – a Phase III trial

niversity of Oxford0 个研究点目标入组 20,019 人开始时间: 2017年9月26日最近更新: 2023年10月23日

适应症

试验速览

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)

•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

•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

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