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    Summary
    EudraCT Number:2011-004771-36
    Sponsor's Protocol Code Number:IC43-202
    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:2011-12-21
    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 number2011-004771-36
    A.3Full title of the trial
    A CONFIRMATORY PHASE II/III STUDY ASSESSING EFFICACY, IMMUNOGENICITY AND SAFETY OF IC43 RECOMBINANT PSEUDOMONAS VACCINE IN INTENSIVE CARE PATIENTS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study assessing efficacy, immunogenicity and safety of a Pseudomonas vaccine (IC43) in intensive care patients
    A.3.2Name or abbreviated title of the trial where available
    IC43-202
    A.4.1Sponsor's protocol code numberIC43-202
    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 SponsorValneva Austria GmbH
    B.1.3.4CountryAustria
    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 supportValneva Austria GmbH
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportGlaxoSmithKline Biologicals SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationValneva Austria GmbH
    B.5.2Functional name of contact pointHead of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressCampus Vienna Biocenter 3
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1030
    B.5.3.4CountryAustria
    B.5.4Telephone number0043120620
    B.5.5Fax number0043120620800
    B.5.6E-mailsusanne.eder-lingelbach@valneva.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 nameIC43
    D.3.2Product code IC43
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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 Yes
    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 placeboInjection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nosocomial Pseudomonas aeruginosa infections in mechanically
    ventilated ICU patients
    E.1.1.1Medical condition in easily understood language
    Pseudomonas aeruginosa infections in mechanically ventilated ICU
    patients
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To show the superiority of IC43 with regard to overall mortality on Day
    28 after first vaccination in mechanically ventilated ICU patients.
    E.2.2Secondary objectives of the trial
    To investigate the effect of IC43 on overall mortality
    - up to 56 and 90 days after first vaccination
    - on Day 14, 28, 56 and Day 90 in subjects surviving Day 3
    - on Day 28 , 56 and Day 90 in subjects surviving Day 14
    To investigate the effect of IC43 on
    - overall survival
    - patients with history of a hepatobiliary disorder: overall mortality on Day 28 and overall survival
    - sepsis‐related mortality
    - in-hospital mortality rates
    To analyze the impact of IC43 on sequential organ function assessments
    (SOFA) compared to placebo
    To compare incidence rates of
    - invasive P. aeruginosa (P.a.) infection in ICU patients receiving IC43 vs
    placebo
    - P. a. respiratory tract infection or colonization in ICU patients receiving
    IC43 vs placebo
    To investigate the
    - length of ICU stay in patients receiving IC43 vs placebo
    - immunogenicity of IC43 in mechanically ventilated ICU patients
    - safety and tolerability of IC43 during a period of up to 180 days after
    the first vaccination
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patients admitted to an ICU with need for mechanical
    ventilation for at least 48 hours, aged between 18 and 80 years at Visit 0
    Written informed consent (e.g., by the patient or his/her legally
    authorized representative) or waiver according to the national
    regulations
    No childbearing potential or negative pregnancy test
    E.4Principal exclusion criteria
    SOFA < 4 on Day 0
    Patients < 6 months post organ transplantation
    Expected plasmapheresis or immunoadsorption
    Readmission to ICU during the current total hospital stay on Day 0
    Patients admitted to ICU within 48 hours after surgery or due to trauma
    at Day 0
    Elective surgery until Day 28 after first vaccination
    E.5 End points
    E.5.1Primary end point(s)
    Day 28 all cause mortality in patients receiving IC43 or placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    Efficacy endpoints :
    1) Day 14,56 and 90 all cause mortality in patients receiving IC43 or
    placebo
    2) Day 28, 56 and 90 all cause mortality in patients surviving Day 14 and
    receiving IC43
    or placebo
    3) Day 14, 28, 56 and 90 all cause mortality in patients surviving Day 3
    and receiving
    IC43 or placebo
    4) Overall survival in all patients and in patients surviving Day 14
    5) Day 28 all cause mortality in patients with documented medical history of a hepatobiliary disorder receiving IC43 or placebo
    6) Overall survival in patients with documented medical history of a hepatobiliary disorder
    7) Sepsis‐related mortality at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo
    8) Sepsis‐related survival in patients receiving IC43 or placebo
    9) In‐ICU and in‐hospital mortality in patients receiving IC43 or placebo until Day 14, 28, 56, 90, 180
    10) Percentage of patients with invasive infection with P. aeruginosa, such as bacteremia (determined as positive blood culture) or P. aeruginosa urinary tract infection in patients receiving IC43 or placebo within 28 and 56, 90 and 180 days after first vaccination
    11) Percentage of patients with P. aeruginosa respiratory tract infection (pneumonia or tracheobronchitis) or P. aeruginosa respiratory tract colonization in patients receiving IC43 or placebo within 28 and 56, 90 and 180 days after first vaccination
    12) Organ function (Sequential Organ Failure Assessment [SOFA] scores) in patients receiving IC43 or placebo during ICU stay
    13) Length of ICU stay in patients receiving IC43 or placebo
    Immunogenicity endpoints:
    1) Immunogenicity at Day 7, 14, 28, 56 and 180 as determined by
    OprF/I specific IgG
    antibody titer measured by ELISA in patients receiving IC43 or placebo
    Safety endpoints:
    1) Rate of serious adverse events and adverse events during the
    vaccination period up
    to 180 days after the first vaccination
    2) Systemic tolerability (Vital signs: blood pressure, pulse, body
    temperature)
    3) Local tolerability (local injection site reactions)
    4) Safety laboratory parameters (hematology, serum chemistry)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints :
    1) Day 14, 56 and 90
    2) Day 28, 56 and 90
    3) Day 14, 28, 56 and 90
    4) Day 14
    5) Day 28
    6) Day 180
    7) Day 14, 28, 56 and 90
    8) Day 180
    9) Day 14, 28, 56, 90, 180
    10) Day 28, 56, 90, 180
    11) Day 28, 56, 90, 180
    12) Day 180
    13) Day 180
    Immunogenicity endpoints:
    1) Day 7, 14, 28, 56 and 180
    Safety endpoints:
    1) 180 days
    2) Day 180
    3) Day 180
    4) Day 180
    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 Yes
    E.6.13.1Other scope of the trial description
    Mortality, Immunogenicity
    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 No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 No
    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 trial2
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    EoS=LPLV.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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.1.1.1In 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: 520
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients admitted to ICU and mechanically ventilated
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    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 Decision2012-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-29
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