A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA)

International Vaccine Institute0 个研究点目标入组 23,000 人开始时间: 2020年11月26日最近更新: 2023年5月29日

适应症

试验速览

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•Healthy participants aged 9 months to <16 years (i.e. =15 years and 364 days) of age at time of vaccination
•Participants/Parents/legally authorised representative (LAR) who have voluntarily given informed assent (sought from participants aged 12 years to <16 years)) and informed consent
•Participants/Parents/LAR living within study target area at the time of vaccination and willing to follow the study procedures and be available for the entire duration of the study

•Known allergy to any vaccine component
•Self-reported ongoing acute and/or chronic illness
•Any self-reported coagulopathies
•Any medical or social compelling reasons in the judgment of a clinical physician
•Self-reported pregnancy/Positive urine pregnancy test or lactating
•Previous typhoid vaccination in the last 5 years (proven by presentation of a vaccine card or self-reporting).
•Temporary exclusion criteria
•Self-reported fever (elevated tympanic (=38°C) or axillary temperature (=37.5°C)) within 24 hours of vaccination
•Self-reported use of antipyretics within 4hours prior to vaccination
•Any other vaccination during the last 4 weeks (proven by presentation of a vaccine card or self-reporting)
•Girls =11 years of age with self-reported irregular menstruation or who do not know their last menstruation date

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