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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number: 2009-015603-10 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | 358 subjects receive a two vaccination regimen with an LT patch |
|
| Placebo | Placebo Comparator | 358 subjects receive a two vaccination regimen with placebo patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD Vaccine System | Biological | TD Vaccine System containing heat labile enterotoxin of E. coli (LT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cases with vaccine preventable outcome | within 17 days after arrival in destination country |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of moderate/severe diarrhea | within 17 days after arrival in destination country |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Steffen, MD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belinger Centrum Reise & Tropenmedizin | Berlin | Germany | ||||
| Tropical Medicine and Bernhard-Nocht Ints |
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| TD Vaccine System | Biological | TD Vaccine System Containing Placebo Product |
|
| Hamburg |
| Germany |
| Dr. Tito's Health Care and Diagnostic Centre | Goā | 403516 | India |
| Prabhugaunker's Clinic | Goā | 403721 | India |
| Wellesley Medicentre | Kolkata | India |
| Pushpawati Singhania Research Institute | New Delhi | 110017 | India |
| Samvedna Hospital | Varanasi | India |
| Synexus | Reading | Berkshire | United Kingdom |
| Bio-Kinetic Europe Ltd | Belfast | Northern Ireland | BT2 7 BA | United Kingdom |
| Synexus Ltd | Chorley | United Kingdom |
| Guy's Drug Research Unit | London | United Kingdom |
| Hospital for Tropical Diseases | London | United Kingdom |