A Cluster-randomised Controlled Phase IV Trial Assessing the Impact of a Vi-Polysaccharide Conjugate Vaccine in Preventing Typhoid Infection in Asante Akim, Ghana (TyVEGHA)

TyVEGHA2020

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) with a primary endpoint of determining the total protection conferred by single-dose vaccination with Vi-TT against blood culture-confirmed symptomatic S. Typhi infection in the intervention vaccine clusters, compared with the control vaccine clusters.

2021-08-24

2024-12-31

2024-12-31

Recruiting

Early phase I

23000

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet the following criteria: * Healthy participants aged 9 months to \<16 years (i.e., ≤15 years and 364 days) of age at the time of vaccination * Participants/Parents/legally authorized 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 Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this 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 the 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 the 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participant- and observer-blinded, cluster-randomised controlled Phase IV trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 23000, 'type': 'ESTIMATED'}}

2024-03-08