Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
NCT ID: NCT00993681
Last Updated: 2012-03-14
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
PHASE3
2036 participants
INTERVENTIONAL
2009-10-31
2011-04-30
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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1
900 subjects will receive a two vaccination regimen with an LT patch
TD Vaccine System
heat labile enterotoxin of E. coli (LT)
2
900 subjects will receive a two vaccination regimen with a placebo patch
TD Vaccine System
placebo
Interventions
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TD Vaccine System
heat labile enterotoxin of E. coli (LT)
TD Vaccine System
placebo
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 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
* 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
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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Herbert L Dupont, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Infectious Diseases, The University of Texas Health Sciences Center at Houston
Locations
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University Medical Centre Hamburg-Eppendorf
Hamburg, City state of Hamburg, Germany
Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin
München, Munchen, Germany
Klinik for Gastroenterologie & Infektiologie
Potsdam, Potsdam, Germany
Berliner Centrum Reise & Tropenmedizin
Berlin, State of Berlin, Germany
Trek Study Antigua
Antigua, Departamento de Guatemala, Guatemala
Isthmian Medical Research Guatemala S.A.
Guatemala City, Departamento de Guatemala, Guatemala
SAMI-SSAPFORFAM Consultorio Privado
Sololá, Departamento de Sololá, Guatemala
Consultorio Privado
Quetzaltenango, Quezaltenango CP, Guatemala
Roberto Maxwell's Office
San Miguel de Allende, Guanajuato, Mexico
Consultorio Privado Torre Medica San Javier
Guadalajara, Jalisco, Mexico
Mexican Institute of Clinical Research (IMIC)
Mexico City, Mexico City, Mexico
Internal Medicine Trek Study Cuernavaca
Cuernavaca, Morelos, Mexico
Hospital Reforma
Oaxaca City, Oaxaca, Mexico
Synexus Thames Valley Clinical Research Center
Reading, Berkshire, United Kingdom
Synexus Midlands Clinical Research Center
Edgbaston, Birmingham, United Kingdom
Synexus Lancashire Clinical Research Center
Chorley, Lancashire, United Kingdom
Hospital for Tropical Diseases
London, London, United Kingdom
Guy's Drug Research Unit
London Bridge, London, United Kingdom
Bio-Kinetic Europe Ltd
Belfast, Northern Ireland, United Kingdom
Synexus Scotland Clinical Research Center
Glasgow, Scottland, United Kingdom
Countries
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References
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Behrens RH, Cramer JP, Jelinek T, Shaw H, von Sonnenburg F, Wilbraham D, Weinke T, Bell DJ, Asturias E, Pauwells HL, Maxwell R, Paredes-Paredes M, Glenn GM, Dewasthaly S, Stablein DM, Jiang ZD, DuPont HL. Efficacy and safety of a patch vaccine containing heat-labile toxin from Escherichia coli against travellers' diarrhoea: a phase 3, randomised, double-blind, placebo-controlled field trial in travellers from Europe to Mexico and Guatemala. Lancet Infect Dis. 2014 Mar;14(3):197-204. doi: 10.1016/S1473-3099(13)70297-4. Epub 2013 Nov 29.
Other Identifiers
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EudraCT Number: 2008-008726-75
Identifier Type: -
Identifier Source: secondary_id
ELT301
Identifier Type: -
Identifier Source: org_study_id
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