NCT01067781

Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

A Phase 2, Gender-Stratified, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Two Vaccination Regimen With the Travelers' Diarrhea Vaccine System in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Intercell USA, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Conditions

• Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	Heat-Labile Enterotoxin of E. coli (LT)	Travelers' Diarrhea Vaccine System
BIOLOGICAL	Placebo	Travelers' Diarrhea Vaccine System

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-09-01
• Completion: 2012-03-01
• First posted: 2010-02-12
• Last updated: 2020-02-10
• Results posted: 2014-03-13

Locations

5 sites across 1 country: United States