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Sponsored by: |
Intercell USA, Inc. |
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Information provided by: | Intercell USA, Inc. |
ClinicalTrials.gov Identifier: | NCT00751777 |
To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.
Condition | Intervention | Phase |
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Prevention of Travelers' Diarrhea |
Biological: heat-labile enterotoxin of E. coli (LT) Biological: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Two Vaccination Regimen With an LT Vaccine Patch in Healthy Adults |
Estimated Enrollment: | 120 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
80 subjects will receive a two vaccination regimen with a LT patch.
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Biological: heat-labile enterotoxin of E. coli (LT)
Travelers' Diarrhea Vaccine System
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2: Placebo Comparator
40 subjects will receive a two vaccination regimen with a placebo patch.
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Biological: Placebo
Travelers' Diarrhea Vaccine System
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Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Solano Clinical Research | |
Vallejo, California, United States, 94589 | |
United States, Florida | |
Miami Research Associates | |
South Miami, Florida, United States, 33143 | |
United States, Texas | |
Clinical Trials of Texas | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Eric Sheldon, MD | Miami Research Associates |
Responsible Party: | Intercell USA, Inc. ( Sarah Frech, Clinical Development Head ) |
Study ID Numbers: | ELT207 |
Study First Received: | September 11, 2008 |
Last Updated: | April 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00751777 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Protozoan Infections Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Giardiasis Healthy Intestinal Diseases |
Signs and Symptoms Digestive System Diseases Dysentery Parasitic Diseases Intestinal Diseases, Parasitic Gastroenteritis |
Protozoan Infections Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Mastigophora Infections Giardiasis Intestinal Diseases |
Signs and Symptoms Digestive System Diseases Dysentery Parasitic Diseases Sarcomastigophora Infections Intestinal Diseases, Parasitic Gastroenteritis |