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

Typhoid Fever Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02391909
Study type Observational
Source Bavarian Nordic
Contact
Status Completed
Phase
Start date August 26, 2015
Completion date February 21, 2017
View Details
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