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

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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

, ,

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

, ,

Verification Date

March 2020