CompletedPhase 2

Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

United States600 participantsStarted 2010-02

Plain-language summary

The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing

Who can participate

Age range18 Years – 64 Years

SexALL

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Inclusion criteria

✓. A female or male 18-64 (inclusive) years of age;
✓. In good health as determined by medical history and screening exam;
✓. 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

✕. Abnormalities at physical exam \[as determined by the Toxicity Grading Scale (Grade 1-4)\];
✕. Laboratory abnormalities \[as determined by the Toxicity Grading Scale (Grade 1 4)\] at screening;
✕. Participated in research involving investigational product within 30 days before planned date of first vaccination;
✕. Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd;
✕. Women who are pregnant or breastfeeding;
✕. Clinically significant underlying enteric, pulmonary, cardiac or renal disease;
✕. Current seizure disorder;
✕. Current use of immunosuppressive therapy (inhaled steroids are allowed);

What they're measuring

Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs

Timeframe: Day 0 to Day 180

Trial details

NCT IDNCT01067781

SponsorIntercell USA, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-09

Results submitted2014-01-30

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