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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

855 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-26

Study Completion Date

2017-02-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Blood Donor CVD 5000

NCT03971669

Risk Reduction

RECRUITING PHASE4

Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)

NCT01193907

Typhoid Fever

COMPLETED PHASE2

CVD 909 Vi Prime Boost Study

NCT00326443

Typhoid Fever

COMPLETED PHASE1

Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants

NCT01229176

Typhoid Fever

COMPLETED PHASE2

Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine

NCT02645032

Typhoid

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Typhoid Fever

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Vivotif 6.9-10.0 x109 CFU/capsule

Vivotif

Intervention Type BIOLOGICAL

Group B

Vivotif 4.0-6.8 x109 CFU/capsule

Vivotif

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vivotif

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes