Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
This study has been completed.
Sponsor:
Intercell USA, Inc.
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT00993681
First received: October 8, 2009
Last updated: March 13, 2012
Last verified: March 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Travelers' Diarrhea |
Biological: TD Vaccine System |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Intercell USA, Inc.:
Primary Outcome Measures:
- Incidence of cases with vaccine preventable outcome [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The incidence of moderate/severe diarrhea [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]
- Total unformed stool frequency from diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]
- Total duration of diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]
| Enrollment: | 2036 |
| Study Start Date: | October 2009 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993681
Locations
| Germany | |
| Berliner Centrum Reise & Tropenmedizin | |
| Berlin, Germany, 10117 | |
| University Medical Centre Hamburg-Eppendorf | |
| Hamburg, Germany, 20359 | |
| Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin | |
| Munchen, Germany, 80802 | |
| Klinik for Gastroenterologie & Infektiologie | |
| Potsdam, Germany, 14467 | |
| Guatemala | |
| Consultorio Privado | |
| Quetzaltenango, Quezaltenango CP, Guatemala, 09001 | |
| Trek Study Antigua | |
| Antigua, Guatemala, 03001 | |
| Isthmian Medical Research Guatemala S.A. | |
| Guatemala, Guatemala, 01015 | |
| SAMI-SSAPFORFAM Consultorio Privado | |
| Solola, Guatemala, 07001 | |
| Mexico | |
| Roberto Maxwell's Office | |
| San Miguel de Allende, Guanajuato, Mexico, 37700 | |
| Consultorio Privado Torre Medica San Javier | |
| Guadalajara, Jalisco, Mexico, 44670 | |
| Mexican Institute of Clinical Research (IMIC) | |
| Mexico City, Mexico D.F., Mexico, 06700 | |
| Internal Medicine Trek Study Cuernavaca | |
| Cuernavaca, Morelos, Mexico, 62250 | |
| Hospital Reforma | |
| Oaxaca de Juarez, Oaxaca, Mexico, 68000 | |
| United Kingdom | |
| Synexus Thames Valley Clinical Research Center | |
| Reading, Berkshire, United Kingdom, RG2 0TG | |
| Synexus Midlands Clinical Research Center | |
| Edgbaston, Birmingham, United Kingdom, B15 2SQ | |
| Synexus Lancashire Clinical Research Center | |
| Chorley, Lancashire, United Kingdom, PR7 7NA | |
| Guy's Drug Research Unit | |
| London Bridge, London, United Kingdom, SE1 1YR | |
| Bio-Kinetic Europe Ltd | |
| Belfast, Northern Ireland, United Kingdom, BT2 7 BA | |
| Synexus Scotland Clinical Research Center | |
| Glasgow, Scottland, United Kingdom, G81 2DR | |
| Hospital for Tropical Diseases | |
| London, United Kingdom, WC1E 6JB | |
Sponsors and Collaborators
Intercell USA, Inc.
Investigators
| Principal Investigator: | Herbert L Dupont, MD | Center for Infectious Diseases, The University of Texas Health Sciences Center at Houston |
More Information
No publications provided
| Responsible Party: | Intercell USA, Inc. |
| ClinicalTrials.gov Identifier: | NCT00993681 History of Changes |
| Other Study ID Numbers: | ELT301, EudraCT Number: 2008-008726-75 |
| Study First Received: | October 8, 2009 |
| Last Updated: | March 13, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Ethics Commission Germany: Paul-Ehrlich-Institut Mexico: Ethics Committee Mexico: Ministry of Health Guatemala: Ethics Committee Guatemala: Ministry of Health |
Keywords provided by Intercell USA, Inc.:
|
Prevention of Travelers' Diarrhea |
Additional relevant MeSH terms:
|
Diarrhea Dysentery Signs and Symptoms, Digestive Signs and Symptoms |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013