Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch
NCT ID: NCT01067781
Last Updated: 2020-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
600 participants
INTERVENTIONAL
2010-02-28
2012-03-31
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
TRIPLE
Study Groups
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1
Two vaccination regimen with an LT patch (no swabbing)
Heat-Labile Enterotoxin of E. coli (LT)
Travelers' Diarrhea Vaccine System
2
Two vaccination regimen with an LT patch (with swabbing)
Heat-Labile Enterotoxin of E. coli (LT)
Travelers' Diarrhea Vaccine System
3
Two vaccination regimen with a placebo patch (no swabbing)
Placebo
Travelers' Diarrhea Vaccine System
4
Two vaccination regimen with a placebo patch (with swabbing)
Placebo
Travelers' Diarrhea Vaccine System
Interventions
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Heat-Labile Enterotoxin of E. coli (LT)
Travelers' Diarrhea Vaccine System
Placebo
Travelers' Diarrhea Vaccine System
Eligibility Criteria
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Inclusion Criteria
2. In good health as determined by medical history and screening exam;
3. Females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at Day 0 and agree not to become pregnant for the duration of study.
Exclusion Criteria
2. Laboratory abnormalities \[as determined by the Toxicity Grading Scale (Grade 1 4)\] at screening;
3. Participated in research involving investigational product within 30 days before planned date of first vaccination;
4. Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd;
5. Women who are pregnant or breastfeeding;
6. Clinically significant underlying enteric, pulmonary, cardiac or renal disease;
7. Current seizure disorder;
8. Current use of immunosuppressive therapy (inhaled steroids are allowed);
9. Known or suspected alcohol abuse or illicit drug use within the last year;
10. Positive Serology for HIV-1, HIV-2, HbsAg, or HCV;
11. Known allergies to any component of the vaccine including adhesives;
12. An employee of the study site;
13. An employee of Intercell (global) or an immediate family member;
14. Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites;
15. Receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.
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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Eric Sheldon, MD
Role: PRINCIPAL_INVESTIGATOR
Miami Research Associates
Locations
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Advanced Clinical Research Institute
Anaheim, California, United States
Miami Research Associates
South Miami, Florida, United States
Johnson County Clinical Trials
Lenexa, Kansas, United States
Radiant Research
Cincinnati, Ohio, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Countries
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Related Links
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Intercell Home Page
Other Identifiers
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ELT208
Identifier Type: -
Identifier Source: org_study_id
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