NCT02391909

Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 855 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. The study will enroll 950 subjects who will be randomized at a ratio of 1:1 into two groups, A and B, of 475 subjects each. Group A will receive 6.9-10.0 x109 CFU/capsule and Group B will receive 4.0-6.8 x109 CFU/capsule, respectively. All subjects will receive four doses of Vivotif. One dose per subject will be administered on Days 1, 3, 5 and 7. Investigators, subjects and all personnel involved in running the study will not be aware of the actual release titer associated with the distributed lots. Blinding is maintained using the commercial packaging that does not include the actual value of the release titer.

Conditions

• Typhoid Fever

Interventions

Type	Name	Description
BIOLOGICAL	Vivotif

Timeline

• Start date: 2015-08-26
• Primary completion: 2016-10-06
• Completion: 2017-02-21
• First posted: 2015-03-18
• Last updated: 2023-07-07

Locations

1 site across 1 country: United States