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.
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 Type
OBSERVATIONAL
Enrollment
855
Passport Health
Baltimore, Maryland, United States
The occurrence of any AE up to two weeks after the scheduled final vaccine dose
Time frame: Day 21
The distribution of the solicited Adverse Reactions
Time frame: Day 21
The distribution of unsolicited Adverse Reactions
Time frame: Day 21
The occurrence of any unsolicited adverse event up to two weeks after the scheduled final vaccine dose
Time frame: Day 21
The occurrence of any SAE up to two weeks after the scheduled final vaccine dose
Time frame: Day 21
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