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    Summary
    EudraCT Number:2008-008726-75
    Sponsor's Protocol Code Number:ELT301
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2008-008726-75
    A.3Full title of the trial
    A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
    to Evaluate the Efficacy of the Travelers’ Diarrhea Vaccine System
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System
    A.4.1Sponsor's protocol code numberELT301
    A.5.4Other Identifiers
    Name:TD Pivotal Efficacy TrialNumber:ELT301
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIntercell USA, Inc. (Intercell)
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIntercell USA, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntercell USA, Inc.
    B.5.2Functional name of contact pointRobert Dallimore, Vice President
    B.5.3 Address:
    B.5.3.1Street Address20 Firstfield Road
    B.5.3.2Town/ cityGaithersburg, Maryland
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1240-454-7247
    B.5.5Fax number+1301-556-4504
    B.5.6E-mailrdallimore@intercell.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTD Vaccine System
    D.3.2Product code TD Vaccine System
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeHeat Labile Enterotoxin of Escherichia Coli
    D.3.9.3Other descriptive nameLT
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Travelers' Diarrhea
    E.1.1.1Medical condition in easily understood language
    Travellers Diarrhea
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10044552
    E.1.2Term Traveller's diarrhea
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of the TD Vaccine System to prevent moderate to severe ETEC disease in a field setting.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study are to evaluate the efficacy of the TD Vaccine System to alleviate symptoms and characteristics associated with TD and to reduce the burden of gastrointestinal (GI) illness experienced, as well as to evaluate the safety and immunogenicity of the vaccine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject may be included in the study if he/she meets all of 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 childbearing potential must agree not to become pregnant throughout the duration of study
    4. Subjects must have planned travel to an area within 3 hours traveling distance of Mexico City, Cuernavaca, Guadalajara, Oaxaca, or San Miguel de Allende, Mexico or Antigua, Quetzaltenango, Guatemala City, or Solola, Guatemala for a minimum duration of stay of 7 days (no maximum stay is specified for inclusion)
    5. Subject must be able to communicate in English
    E.4Principal exclusion criteria
    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 LT, ETEC, or cholera vaccine;
    4. History of diarrhea while traveling in a developing country within the last year;
    5. Women who are pregnant or breastfeeding;
    6. Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease;
    7. History of Irritable Bowel Syndrome;
    8. Seizure disorder within the last year;
    9. Current use of immunosuppressive therapy (excluding inhaled steroids) or 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 a 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 from two weeks prior to randomization through the surveillance phase of the study.
    16. An employee of Intercell (global) or an immediate family member
    E.5 End points
    E.5.1Primary 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/ST or ST toxins (ETEC) are detected by either PCR or DNA hybridization (and no co-pathogen is detected) from diarrheal stool samples that are collected during first diarrheal episode
    E.5.1.1Timepoint(s) of evaluation of this end point
    Surveillance Period - through Day 17 visit
    E.5.2Secondary end point(s)
    1. The incidence of moderate/severe all-cause diarrheal episodes (i.e., with or without ETEC diagnosis) [first diarrheal episode experienced during the surveillance period]
    2. Total unformed stool frequency from all all-cause diarrheal episodes (mild, moderate or severe)
    experienced per subject during the surveillance period
    3. Total duration of all all-cause diarrheal episodes (mild, moderate or severe) experienced per subject during the surveillance period
    E.5.2.1Timepoint(s) of evaluation of this end point
    Surveillance Period - through Day 17 visit
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Administration to healthy volunteers
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    Guatemala
    Mexico
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    As provided in the protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2083
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2400
    F.4.2.2In the whole clinical trial 2400
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Refer to the protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-12
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