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

NCT02391909 | Completed

• 1 other identifier: VIV-PASS-01
• Study Type: observational
• Target: 855
• Locations: 1 country
• Sites: 1

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.

Conditions

Typhoid Fever

Keywords

Vaccine

Outcome Measures

Primary Outcomes (1)

• The occurrence of any AE up to two weeks after the scheduled final vaccine dose

  Day 21

Secondary Outcomes (4)

• 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

Study Arms (2)

Group A

Vivotif 6.9-10.0 x109 CFU/capsule

Biological: Vivotif

Group B

Vivotif 4.0-6.8 x109 CFU/capsule

Biological: Vivotif

Interventions

Vivotif BIOLOGICAL

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Subjects are male or female aged ≥ 18 years at time of dosing
• Subjects are travelers attending travelers' vaccination clinics
• Subjects are eligible for typhoid vaccination, according to standard practice
• Subjects are expected to be able to provide follow-up information
• 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)
• Subjects must sign a written informed consent

You may not qualify if:

• Subjects with a known hypersensitivity to any component of the vaccine or the enteric coated capsule
• 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
• Subjects with an acute febrile illness
• Subjects with acute gastrointestinal (GI) illness
• Subjects who are receiving medications with antibacterial activity (including proguanil) at the time of enrollment
• Subjects with other contraindications as determined by the site investigator

Sponsors & Collaborators

• Bavarian Nordic: lead
• Emergent BioSolutions: collaborator

Study Sites (1)

Passport Health

Baltimore, Maryland, 21230, United States

Location

MeSH Terms

Conditions

Typhoid Fever

Interventions

Ty21a typhoid vaccine

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 18, 2015
• Study Start: August 26, 2015
• Primary Completion: October 6, 2016
• Study Completion: February 21, 2017
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

US (1)