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
- Conditions
- Travelers DiarrheaMedDRA version: 12.0Level: LLTClassification code 10044552Term: Traveller's diarrhea
- Registration Number
- EUCTR2009-015603-10-GB
- Lead Sponsor
- Intercell USA, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 716
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to evaluate the efficacy of TD Vaccine System to prevent moderate to severe ETEC disease in travelers to India. ;Secondary Objective: The secondary objectives of the study are to: 1) estimate travelers' diarrhea disease frequency including ETEC disease (classified by subtypes); 2) evaluate the impact of the TD Vaccine System on disease severity, the need for medical assistance, and the interference with daily activites; 3) to evaluate the immunogenicity of the vaccine; and 4) to evaluate the safety of the vaccine.;Primary end point(s): The incidence of cases with vaccine preventable outcome (VPO) reported during the surveillance period; VPO is all moderate/ severe diarrheal cases in which LT , LT/ heat stable toxin (ST) or ST toxins (ETEC) are detected by either PCR or DNA hybridisation (and no co-pathogen is detected) from diarrheal stool samples that are collected during the first diarrheal episode
- Secondary Outcome Measures
Name Time Method