Phase 4 Observational Prospective Cohort Study to Assess the Safety of Vivotif at Different Release Titers Among Travelers

VIV-PASS-01

This is a multicenter (at travel clinics), phase 4 observational prospective cohort study in healthy adult male and female travelers for whom typhoid vaccination with Vivotif is recommended, as per standard practice.

2015-08-26

2016-10-06

2017-02-21

Completed

855

Inclusion Criteria: 1. Subjects are male or female aged ≥ 18 years at time of dosing 2. Subjects are travelers attending travelers' vaccination clinics 3. Subjects are eligible for typhoid vaccination, according to standard practice 4. Subjects are expected to be able to provide follow-up information 5. Subjects have an expected travel departure date more than 21 days after enrollment (to enhance follow-up by ensuring subjects remain in the US during the AE collection period) 6. Subjects must sign a written informed consent Exclusion Criteria: 1. Subjects with a known hypersensitivity to any component of the vaccine or the enteric coated capsule 2. Subjects deficient in their ability to mount a humoral or cell-mediated immune response due to either a congenital or acquired immunodeficient state including treatment with immune-suppressive or antimitotic drugs 3. Subjects with an acute febrile illness 4. Subjects with acute gastrointestinal (GI) illness 5. Subjects who are receiving medications with antibacterial activity (including proguanil) at the time of enrollment 6. Subjects with other contraindications as determined by the site investigator

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 855, 'type': 'ACTUAL'}}

2023-07-07