Phase 4 Study To Assess The Safety Of Vivotif At Differen... | NCT02391909

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

NCT02391909

Sponsor

Bavarian Nordic

Status

Completed

Last Update Posted

Jul 7, 2023Actual

Enrollment

855Actual

Phase

Not provided

Conditions

Typhoid Fever

Interventions

Vivotif

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 26, 2015Actual

Primary Completion Date

Oct 6, 2016Actual

Completion Date

Feb 21, 2017Actual

First Submitted Date

Mar 12, 2015

First Submission Date that Met QC Criteria

Mar 17, 2015

First Posted Date

Mar 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2023

Last Update Posted Date

Jul 7, 2023Actual

Name	Class
Emergent BioSolutions	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

855Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vivotif	Biological		Group A Group B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Passport Health		Baltimore	Maryland	21230	United States

Condition Browse Module

MeSH Terms

ID	Term
D014435	Typhoid Fever

Ancestor Terms

ID	Term
D012480	Salmonella Infections
D004756	Enterobacteriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections

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Browse Branches

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