Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
723 participants
INTERVENTIONAL
2009-12-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Active
358 subjects receive a two vaccination regimen with an LT patch
TD Vaccine System
TD Vaccine System containing heat labile enterotoxin of E. coli (LT)
Placebo
358 subjects receive a two vaccination regimen with placebo patch
TD Vaccine System
TD Vaccine System Containing Placebo Product
Interventions
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TD Vaccine System
TD Vaccine System containing heat labile enterotoxin of E. coli (LT)
TD Vaccine System
TD Vaccine System Containing Placebo Product
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
64 Years
ALL
Yes
Sponsors
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Intercell USA, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Steffen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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Belinger Centrum Reise & Tropenmedizin
Berlin, , Germany
Tropical Medicine and Bernhard-Nocht Ints
Hamburg, , Germany
Dr. Tito's Health Care and Diagnostic Centre
Goa, , India
Prabhugaunker's Clinic
Goa, , India
Wellesley Medicentre
Kolkata, , India
Pushpawati Singhania Research Institute
New Delhi, , India
Samvedna Hospital
Varanasi, , India
Synexus
Reading, Berkshire, United Kingdom
Bio-Kinetic Europe Ltd
Belfast, Northern Ireland, United Kingdom
Synexus Ltd
Chorley, , United Kingdom
Guy's Drug Research Unit
London, , United Kingdom
Hospital for Tropical Diseases
London, , United Kingdom
Countries
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Other Identifiers
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EudraCT Number: 2009-015603-10
Identifier Type: -
Identifier Source: secondary_id
ELT209
Identifier Type: -
Identifier Source: org_study_id
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