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

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

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.

Study Overview

• Status: Completed
• Conditions: Typhoid Fever
• Intervention / Treatment: Biological: Vivotif

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
• Enrollment (Actual): 855

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21230
      • Passport Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Travelers attending travelers' vaccination clinics, and for whom typhoid vaccination with Vivotif is recommended, according to standard practice

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Vivotif 6.9-10.0 x109 CFU/capsule	Biological: Vivotif
Group B; Vivotif 4.0-6.8 x109 CFU/capsule	Biological: Vivotif

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The occurrence of any AE up to two weeks after the scheduled final vaccine dose	Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
The distribution of the solicited Adverse Reactions	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
The occurrence of any SAE up to two weeks after the scheduled final vaccine dose	Day 21

Collaborators and Investigators

• Sponsor: Bavarian Nordic
• Collaborators: Emergent BioSolutions

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2015
• Primary Completion (Actual): October 6, 2016
• Study Completion (Actual): February 21, 2017

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimated): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Vaccine
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Salmonella Infections; Typhoid Fever
• Other Study ID Numbers: VIV-PASS-01