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Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01040325
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : March 14, 2012
Information provided by (Responsible Party):
Intercell USA, Inc.

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.

Condition or disease Intervention/treatment Phase
Traveler's Diarrhea Biological: TD Vaccine System Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 723 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : December 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active
358 subjects receive a two vaccination regimen with an LT patch
Biological: TD Vaccine System
TD Vaccine System containing heat labile enterotoxin of E. coli (LT)

Placebo Comparator: Placebo
358 subjects receive a two vaccination regimen with placebo patch
Biological: TD Vaccine System
TD Vaccine System Containing Placebo Product

Primary Outcome Measures :
  1. Incidence of cases with vaccine preventable outcome [ Time Frame: within 17 days after arrival in destination country ]

Secondary Outcome Measures :
  1. Incidence of moderate/severe diarrhea [ Time Frame: within 17 days after arrival in destination country ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01040325

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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, 403516
Prabhugaunker's Clinic
Goa, India, 403721
Wellesley Medicentre
Kolkata, India
Pushpawati Singhania Research Institute
New Delhi, India, 110017
Samvedna Hospital
Varanasi, India
United Kingdom
Reading, Berkshire, United Kingdom
Bio-Kinetic Europe Ltd
Belfast, Northern Ireland, United Kingdom, BT2 7 BA
Synexus Ltd
Chorley, United Kingdom
Guy's Drug Research Unit
London, United Kingdom
Hospital for Tropical Diseases
London, United Kingdom
Sponsors and Collaborators
Intercell USA, Inc.
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Principal Investigator: Robert Steffen, MD University of Zurich
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Responsible Party: Intercell USA, Inc. Identifier: NCT01040325    
Other Study ID Numbers: ELT209
EudraCT Number: 2009-015603-10
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunologic Factors
Physiological Effects of Drugs