Brief Title
Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers
Official Title
Phase 4 Observational Prospective Cohort Study to Assess the Safety of Vivotif at Different Release Titers Among Travelers
Brief 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.
Study Type
Observational
Primary Outcome
The occurrence of any AE up to two weeks after the scheduled final vaccine dose
Secondary Outcome
The distribution of the solicited Adverse Reactions
Condition
Typhoid Fever
Intervention
Vivotif
Study Arms / Comparison Groups
Group A
Description: Vivotif 6.9-10.0 x109 CFU/capsule
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
855
Start Date
August 26, 2015
Completion Date
February 21, 2017
Primary Completion Date
October 6, 2016
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02391909
Organization ID
VIV-PASS-01
Responsible Party
Sponsor
Study Sponsor
Emergent BioSolutions
Study Sponsor
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Verification Date
March 2020