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Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

Primary Purpose

Traveler's Diarrhea

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TD Vaccine System
TD Vaccine System
Sponsored by
Intercell USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Traveler's Diarrhea

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-64 years of age at date of first vaccination
  • Good health as determined by medical history and physical inspection
  • Females of child-bearing potential must have a negative pregnancy test prior to first and second vaccination in the country of origin; females of child-bearing potential must agree not to become pregnant throughout the duration of study
  • Subjects must have planned travel to DC, within 3 hours traveling distance of approved study site(s), for a minimum duration of stay of 7 days (no maximum stay is specified for inclusion).
  • Subject must be able to communicate in English

Exclusion Criteria:

  • Abnormalities as determined by the Investigator/clinician during physical inspection;
  • Participated in research involving investigational product within 30 days before planned date of first vaccination;
  • Ever received LT, ETEC, or cholera vaccine;
  • History of diarrhea while traveling in a developing country within the last year;
  • Women who are pregnant or breastfeeding;
  • Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease;
  • History of Irritable Bowel Syndrome;
  • Seizure disorder within the last year;
  • Current use of immunosuppressive therapy (excluding inhaled steroids) or immunodeficiency;
  • Known or suspected alcohol abuse or illicit drug use within the last year;
  • Medical history of HIV, HBV, or HCV;
  • An employee of a study site;
  • Known allergies to any component of the vaccine, including adhesives;
  • Planned use of antibiotics with known activity against gram negative facultative anaerobes;
  • Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar from two weeks prior to randomization through the surveillance phase of the study;
  • An employee of Intercell (global) or an immediate family member.

Sites / Locations

  • Belinger Centrum Reise & Tropenmedizin
  • Tropical Medicine and Bernhard-Nocht Ints
  • Dr. Tito's Health Care and Diagnostic Centre
  • Prabhugaunker's Clinic
  • Wellesley Medicentre
  • Pushpawati Singhania Research Institute
  • Samvedna Hospital
  • Synexus
  • Bio-Kinetic Europe Ltd
  • Synexus Ltd
  • Guy's Drug Research Unit
  • Hospital for Tropical Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

358 subjects receive a two vaccination regimen with an LT patch

358 subjects receive a two vaccination regimen with placebo patch

Outcomes

Primary Outcome Measures

Incidence of cases with vaccine preventable outcome

Secondary Outcome Measures

Incidence of moderate/severe diarrhea

Full Information

First Posted
December 25, 2009
Last Updated
March 13, 2012
Sponsor
Intercell USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01040325
Brief Title
Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study
Official Title
A Phase Two, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System in Travelers to Asia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intercell USA, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traveler's Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
723 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
358 subjects receive a two vaccination regimen with an LT patch
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
358 subjects receive a two vaccination regimen with placebo patch
Intervention Type
Biological
Intervention Name(s)
TD Vaccine System
Intervention Description
TD Vaccine System containing heat labile enterotoxin of E. coli (LT)
Intervention Type
Biological
Intervention Name(s)
TD Vaccine System
Intervention Description
TD Vaccine System Containing Placebo Product
Primary Outcome Measure Information:
Title
Incidence of cases with vaccine preventable outcome
Time Frame
within 17 days after arrival in destination country
Secondary Outcome Measure Information:
Title
Incidence of moderate/severe diarrhea
Time Frame
within 17 days after arrival in destination country

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-64 years of age at date of first vaccination Good health as determined by medical history and physical inspection Females of child-bearing potential must have a negative pregnancy test prior to first and second vaccination in the country of origin; females of child-bearing potential must agree not to become pregnant throughout the duration of study Subjects must have planned travel to DC, within 3 hours traveling distance of approved study site(s), for a minimum duration of stay of 7 days (no maximum stay is specified for inclusion). Subject must be able to communicate in English Exclusion Criteria: Abnormalities as determined by the Investigator/clinician during physical inspection; Participated in research involving investigational product within 30 days before planned date of first vaccination; Ever received LT, ETEC, or cholera vaccine; History of diarrhea while traveling in a developing country within the last year; Women who are pregnant or breastfeeding; Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease; History of Irritable Bowel Syndrome; Seizure disorder within the last year; Current use of immunosuppressive therapy (excluding inhaled steroids) or immunodeficiency; Known or suspected alcohol abuse or illicit drug use within the last year; Medical history of HIV, HBV, or HCV; An employee of a study site; Known allergies to any component of the vaccine, including adhesives; Planned use of antibiotics with known activity against gram negative facultative anaerobes; Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar from two weeks prior to randomization through the surveillance phase of the study; An employee of Intercell (global) or an immediate family member.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Steffen, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Belinger Centrum Reise & Tropenmedizin
City
Berlin
Country
Germany
Facility Name
Tropical Medicine and Bernhard-Nocht Ints
City
Hamburg
Country
Germany
Facility Name
Dr. Tito's Health Care and Diagnostic Centre
City
Goa
ZIP/Postal Code
403516
Country
India
Facility Name
Prabhugaunker's Clinic
City
Goa
ZIP/Postal Code
403721
Country
India
Facility Name
Wellesley Medicentre
City
Kolkata
Country
India
Facility Name
Pushpawati Singhania Research Institute
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Samvedna Hospital
City
Varanasi
Country
India
Facility Name
Synexus
City
Reading
State/Province
Berkshire
Country
United Kingdom
Facility Name
Bio-Kinetic Europe Ltd
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT2 7 BA
Country
United Kingdom
Facility Name
Synexus Ltd
City
Chorley
Country
United Kingdom
Facility Name
Guy's Drug Research Unit
City
London
Country
United Kingdom
Facility Name
Hospital for Tropical Diseases
City
London
Country
United Kingdom

12. IPD Sharing Statement

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Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

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