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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number: 2008-008726-75 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 900 subjects will receive a two vaccination regimen with an LT patch |
|
| 2 | Placebo Comparator | 900 subjects will receive a two vaccination regimen with a placebo patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD Vaccine System | Biological | heat labile enterotoxin of E. coli (LT) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cases with vaccine preventable outcome | Day 17 (17 days after arrival in destination country) |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of moderate/severe diarrhea | Day 17 (17 days after arrival in destination country) | |
| Total unformed stool frequency from diarrheal episodes | Day 17 (17 days after arrival in destination country) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert L Dupont, MD | Center for Infectious Diseases, The University of Texas Health Sciences Center at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20359 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24291168 | Derived | 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. |
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| TD Vaccine System |
| Biological |
placebo |
|
| Total duration of diarrheal episodes | Day 17 (17 days after arrival in destination country) |
| Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin |
| München |
| Munchen |
| 80802 |
| Germany |
| Klinik for Gastroenterologie & Infektiologie | Potsdam | Potsdam | 14467 | Germany |
| Berliner Centrum Reise & Tropenmedizin | Berlin | State of Berlin | 10117 | Germany |
| Trek Study Antigua | Antigua | Departamento de Guatemala | 03001 | Guatemala |
| Isthmian Medical Research Guatemala S.A. | Guatemala City | Departamento de Guatemala | 01015 | Guatemala |
| SAMI-SSAPFORFAM Consultorio Privado | Sololá | Departamento de Sololá | 07001 | Guatemala |
| Consultorio Privado | Quetzaltenango | Quezaltenango CP | 09001 | Guatemala |
| Roberto Maxwell's Office | San Miguel de Allende | Guanajuato | 37700 | Mexico |
| Consultorio Privado Torre Medica San Javier | Guadalajara | Jalisco | 44670 | Mexico |
| Mexican Institute of Clinical Research (IMIC) | Mexico City | Mexico City | 06700 | Mexico |
| Internal Medicine Trek Study Cuernavaca | Cuernavaca | Morelos | 62250 | Mexico |
| Hospital Reforma | Oaxaca City | Oaxaca | 68000 | Mexico |
| Synexus Thames Valley Clinical Research Center | Reading | Berkshire | RG2 0TG | United Kingdom |
| Synexus Midlands Clinical Research Center | Edgbaston | Birmingham | B15 2SQ | United Kingdom |
| Synexus Lancashire Clinical Research Center | Chorley | Lancashire | PR7 7NA | United Kingdom |
| Hospital for Tropical Diseases | London | London | WC1E 6JB | United Kingdom |
| Guy's Drug Research Unit | London Bridge | London | SE1 1YR | United Kingdom |
| Bio-Kinetic Europe Ltd | Belfast | Northern Ireland | BT2 7 BA | United Kingdom |
| Synexus Scotland Clinical Research Center | Glasgow | Scottland | G81 2DR | United Kingdom |