NCT01040325

Brief Summary

The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
723

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2

Geographic Reach
3 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 14, 2012

Status Verified

January 1, 2012

Enrollment Period

6 months

First QC Date

December 25, 2009

Last Update Submit

March 13, 2012

Conditions

Traveler's Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Incidence of cases with vaccine preventable outcome

    within 17 days after arrival in destination country

Secondary Outcomes (1)

  • Incidence of moderate/severe diarrhea

    within 17 days after arrival in destination country

Study Arms (2)

Active

EXPERIMENTAL

358 subjects receive a two vaccination regimen with an LT patch

Biological: TD Vaccine System

Placebo

PLACEBO COMPARATOR

358 subjects receive a two vaccination regimen with placebo patch

Biological: TD Vaccine System

Interventions

TD Vaccine SystemBIOLOGICAL

TD Vaccine System containing heat labile enterotoxin of E. coli (LT)

Active

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age at date of first vaccination
  • Good health as determined by medical history and physical inspection
  • 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 study
  • Subject must be able to communicate in English

You may not qualify if:

  • Abnormalities as determined by the Investigator/clinician during physical inspection;
  • Participated in research involving investigational product within 30 days before planned date of first vaccination;
  • Ever received LT, ETEC, or cholera vaccine;
  • History of diarrhea while traveling in a developing country within the last year;
  • Women who are pregnant or breastfeeding;
  • Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease;
  • History of Irritable Bowel Syndrome;
  • Seizure disorder within the last year;
  • Current use of immunosuppressive therapy (excluding inhaled steroids) or immunodeficiency;
  • Known or suspected alcohol abuse or illicit drug use within the last year;
  • Medical history of HIV, HBV, or HCV;
  • An employee of a study site;
  • Known allergies to any component of the vaccine, including adhesives;
  • Planned use of antibiotics with known activity against gram negative facultative anaerobes;
  • Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar from two weeks prior to randomization through the surveillance phase of the study;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Belinger Centrum Reise & Tropenmedizin

Berlin, Germany

Location

Tropical Medicine and Bernhard-Nocht Ints

Hamburg, Germany

Location

Dr. Tito's Health Care and Diagnostic Centre

Goa, 403516, India

Location

Prabhugaunker's Clinic

Goa, 403721, India

Location

Wellesley Medicentre

Kolkata, India

Location

Pushpawati Singhania Research Institute

New Delhi, 110017, India

Location

Samvedna Hospital

Varanasi, India

Location

Synexus

Reading, Berkshire, United Kingdom

Location

Bio-Kinetic Europe Ltd

Belfast, Northern Ireland, BT2 7 BA, United Kingdom

Location

Synexus Ltd

Chorley, United Kingdom

Location

Guy's Drug Research Unit

London, United Kingdom

Location

Hospital for Tropical Diseases

London, United Kingdom

Location

Study Officials

  • Robert Steffen, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2009

First Posted

December 29, 2009

Study Start

December 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

March 14, 2012

Record last verified: 2012-01

Locations

GB(5)DE(2)IN(5)