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

Completed

• Conditions: Typhoid Fever
• Interventions: Biological: Vivotif

• Registration Number: NCT02391909
• Lead Sponsor: Bavarian Nordic

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 Timeline

• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-18
• Study Start: 2015-08-26
• Primary Completion: 2016-10-06
• Study Completion: 2017-02-21
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 855

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	Vivotif	Vivotif 4.0-6.8 x109 CFU/capsule
Group A	Vivotif	Vivotif 6.9-10.0 x109 CFU/capsule

Primary Outcome Measures

Name	Time	Method
The occurrence of any AE up to two weeks after the scheduled final vaccine dose	Day 21

Secondary Outcome Measures

Name	Time	Method
The distribution of the solicited Adverse Reactions	Day 21
The occurrence of any SAE up to two weeks after the scheduled final vaccine dose	Day 21
The distribution of unsolicited Adverse Reactions	Day 21
The occurrence of any unsolicited adverse event up to two weeks after the scheduled final vaccine dose	Day 21

Trial Locations

Locations (1)

Passport Health; 🇺🇸 Baltimore, Maryland, United States