A Phase Two, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System in Travelers to Asia - Pivotal Asia Efficacy Study

Intercell USA, Inc0 个研究点目标入组 716 人开始时间: 2009年9月25日最近更新: 2012年3月19日

研究概览

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•A subject may be included in the study if he/ she meets all the following inclusion criteria:
•1) 18-64 years of age at date of first vaccination
•2) Good health as determined by medical history and physical inspection
•3) Females of child-bearing potential must have a negative pregnancy test prior to first and second vaccination in the Country of Origin; females of child-bearing potential must agree not to become pregnant throughout the duration of the study
•4) Subjects must have planned travel to the Destination Country, within 3 hours travelling distance of approved study site(s), for a minimum duration of stay of 7 days
•5) Subjects must be able to communicate in English
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•A subject meeting any of the following criteria during the screening period is not eligible for participation in the study.
•1) Abnormalities as determined by the Investigator/ clinician during physical inspection
•2) Participated in research involving investigational product within 30 days before planned date of first vaccination
•3) Ever received heat labile Enterotoxin of E. Coli (LT), Enterotoxigenic Escherichia Coli (ETEC), or cholera vaccine
•4) History of diarrhea while travelling in a developing country within the last year
•5) Women who are pregnant or breastfeeding
•6) Clinically significant underlying entric, pulmonary, cardiac, liver or renal disease
•7) History of Irritable Bowel Syndrome
•8) Seizure disorder within last year
•9) Current use of immunosuppressive therapy (excluding inhaled steroids) or current immunodeficiency
•10) Known or suspected alcohol abuse or illicit drug use within the last year
•11) Medical history of HIV, HBV, or HCV
•12) An employee of the study site
•13) Known allergies to any component of the vaccine, including adhesives
•14) Planned use of antibiotics with known activity against gram negative facultative anaerobes
•15) Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar during the surveillance phase of the study
•16) An employee of Intercell (global) or an immediate family member

发起方