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Travelers' Diarrhea (TD) Vaccine Pivotal 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.
 
ClinicalTrials.gov Identifier: NCT00993681
Recruitment Status : Completed
First Posted : October 12, 2009
Last Update Posted : March 14, 2012
Sponsor:
Information provided by (Responsible Party):
Intercell USA, Inc.

Brief Summary:
The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine System to actively immunize against Enterotoxigenic Escherichia coli disease in a field setting.

Condition or disease Intervention/treatment Phase
Travelers' Diarrhea Biological: TD Vaccine System Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2036 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System
Study Start Date : October 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: 1
900 subjects will receive a two vaccination regimen with an LT patch
Biological: TD Vaccine System
heat labile enterotoxin of E. coli (LT)

Placebo Comparator: 2
900 subjects will receive a two vaccination regimen with a placebo patch
Biological: TD Vaccine System
placebo




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

Secondary Outcome Measures :
  1. The incidence of moderate/severe diarrhea [ Time Frame: Day 17 (17 days after arrival in destination country) ]
  2. Total unformed stool frequency from diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ]
  3. Total duration of diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 vaccination in teh Country of Origin; females of child-bearing potential must agree not to become pregnant throughout the duration of the study
  • Subjects must have planned travel to an area within 3 hours traveling distance of Mexico City, Cuernavaca, Guadalajara, Oaxaca, or San Miguel de Allende, Mexico or Antigua, Quezaltenango, Guatemala City, or Solola, Guatemala for a minimum duration of stay 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 to 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 current 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 during 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 ClinicalTrials.gov identifier (NCT number): NCT00993681


Locations
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Sponsors and Collaborators
Intercell USA, Inc.
Investigators
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Principal Investigator: Herbert L Dupont, MD Center for Infectious Diseases, The University of Texas Health Sciences Center at Houston
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Intercell USA, Inc.
ClinicalTrials.gov Identifier: NCT00993681    
Other Study ID Numbers: ELT301
EudraCT Number: 2008-008726-75
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: March 2012
Keywords provided by Intercell USA, Inc.:
Prevention of Travelers' Diarrhea
Additional relevant MeSH terms:
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Dysentery
Diarrhea
Signs and Symptoms, Digestive
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs