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    Summary
    EudraCT Number:2011-004771-36
    Sponsor's Protocol Code Number:IC43-202
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-06
    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 ConcernedSpain - AEMPS
    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.
    UN ESTUDIO EN FASE II/III CONFIRMATORIO PARA EVALUAR LA EFICACIA, INMUNOGENICIDAD Y SEGURIDAD DE LA VACUNA RECOMBINANTE IC43 CONTRA PSEUDOMONAS EN PACIENTES DE CUIDADOS INTENSIVOS.
    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
    Estudio clínico para evaluar eficacia, inmunogenicidad y seguridad de la vacuna de Pseudomonas (IC43) en pacientes de cuidados intensivos
    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 SponsorIntercell
    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 supportIntercell
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportNovartis
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntercell AG
    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 number431206201136
    B.5.5Fax number4312062081136
    B.5.6E-mailseder@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 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIC43
    D.3.9.2Current sponsor codeIC43
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Noscomial Pseudomonas aeruginosa infections in mechanically ventilated ICU patients
    Infecciones nosocomiales por Pseudomonas en pacientes de cuidados intensivos con ventilación mecánica
    E.1.1.1Medical condition in easily understood language
    Pseudomonas aeruginosa infections in mechanically ventilated ICU patients
    Infecciones por Pseudomonas aeruginosas en pacientes de cuidados intensivos con ventilación mecánica
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061471
    E.1.2Term Pseudomonas infection
    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
    To show the superiority of IC43 with regard to overall mortality on Day 28 after first vaccination in mechanically ventilated ICU patients.
    Demostrar la superioridad de IC43 respecto a la mortalidad general del Día 28 tras la primera vacunación, en pacientes en la UCI con ventilación mecánica
    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
    - 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
    Investigar el efecto de IC43 sobre la mortalidad general:
    - hasta 56 y 90 días después de la primera vacunación
    - los Días 14,28, 56 y 90 en pacientes que hayan sobrevivido el Día 3
    - los Días 28, 56 y 90 en pacientes que hayan sobrevivo el Día 14
    Investigator el efecto de IC43 en:
    - supervivencia global
    - mortalidad relacionada con septicemia
    - tasas de mortaliad hospitalaria
    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
    Pacientes de sexo masculino o femenino ingresados en una UCI, necesitando ventilación mecánica durante como mínimo 48 horas, de edades comprendidas entre 18 y 80 años en Visita 0

    Consentimiento Informado por escrito ( por ej., del/la paciente, familiar o de su representante legal autorizado)

    Imposibilidad de embarazo o prueba de embarazo negativa
    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
    SOFA < 4 el Día 0

    Patients < 6 meses tras trasplánte de algún órgano

    Plasmaféresis o inmunoadsorción esperadas

    Readmisión en la UCI durante la estancia en el hospital el Día 0

    Pacientes admitidos en la UCI dentro de las 48 horas posteriores a la cirugía o traumatismo en el Dia 0

    Cirugía electiva hasta el día 28 tras la primera vacunación
    E.5 End points
    E.5.1Primary end point(s)
    Day 28 all cause mortality in patients receiving IC43 or placebo
    Causa de mortalidad el Día 28 en patientes que han recibido IC43 o placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Día 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) Sepsis?related mortality at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo
    6) Sepsis?related survival in patients receiving IC43 or placebo
    7) In?ICU and in?hospital mortality in patients receiving IC43 or placebo until Day 14,28, 56, 90, 180
    8) 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 up to Day 56 after first vaccination
    9) Percentage of patients with P. aeruginosa respiratory tract infection (pneumonia or
    tracheobronchitis) or P. aeruginosa respiratory tract colonization in patients receivingIC43 or placebo up to Day 56 after first vaccination
    10) Organ function (Sequential Organ Failure Assessment [SOFA] scores) in patientsreceiving IC43 or placebo during ICU stay
    11) 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)
    Evaluación de la eficacia:
    1) Mortalidad por cualquier causa los días 14,56, 90 en pacientes que han recibido IC43 o placebo
    2) Mortalidad por cualquier causa los días 28,56 y 90 en pacientes que hayan sobrevivido el Días 14 y recibido IC43 o placebo
    3) Mortalidad por cualquier causa los días 14,28, 56 y 90 en pacientes que hayan sobrevivo el día 3 y recibido IC43 o placebo
    4) Supervivencia general en todos los pacientes y en pacientes que han sobrevivo el Día 14
    5) Mortalidad relacionada con septicemia los días 14,28,56 y 90 en pacientes que reciben IC43 o placebo
    6) Supervivencia relacionado con septicemia en pacientes que han recibido IC43 o placebo
    7) Mortalidad en la UCI y hospitalaria en pacientes que han recibido IC43 O PLACEBO HASTA EL DÍA 14,26, 36, 90 Y 180
    8) Porcentaje de pacientes con infección invasiva por P.aeruginosa como bacteriemia ( determinada como cultivo de sangre positivo) o infección de las vías urinarias en pacientes que han erecibido IC43 o placebo hasta el día 56 tras la primera vacunación
    9) Porcentaje de pacientes con infección del tracto respiratorio por P.aeruginosa (pneumonia o traqueobronquitis) o colonización de las vias respiratorias en pacientes que han recibido IC43 hasta el día 56 tras la primera vacunación
    10) Funcionamiento del órgano (sistema de puntuación SOFA ( Evaluación secuencial de la insuficiencia orgánica)) en pacientes que han recibido IC43 o placebo durante su estancia en la UCI
    11) Duración de la estancia en la UCI en pcientes a quienes han recibido IC43 o placebo

    Criterios de evaluación de inmunogenicidad:
    1) Inmunogenicidad el Día 7,14,28,56 y 180 determinada por el número de anticuerpos de IgG específicos de OprF/I, medido por ELISA en pcientes que reciben IC43 o placebo

    Criterios de evaluación de seguridad:
    1) Índice de acontecimientos adversos graves y no graves durante el periodo de vacunación hasta 180 días tras la primera vacunación
    2) Tolerabilidad sistémica (Signos Vitales, presión arterial, pulso, temperatura corporal)
    3) Tolerabilidad local ( reacción locales en el sitio de la inyección)
    4) Parámetros de laboratorio de seguridad ( hematología y bioquímica
    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 14, 28, 56 and 90
    6) Day 180
    7) Day 14, 28, 56, 90, 180
    7) Day 56
    8) Day 56
    9) Day 180
    10) 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
    Criterios de evaluación de eficacia
    1) Día 14, 56 y 90
    2) Día 28, 56 y 90
    3) Día 14, 28, 56 y 90
    4) Día 14
    5) Día 14, 28, 56 y 90
    6) Día 180
    7) Día 14, 28, 56, 90, 180
    7) Día 56
    8) Día 56
    9) Día 180
    10) 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
    Mortalidad e inmunogenicidad
    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 concerned6
    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
    A DMC will review safety data in the course of the futility analysis (i.e., after ~50% of patients enrolled) and will recommend on continuation/modification of the study in case of safety concerns. The DMC will review the Day 28 mortality data. Should the study be terminated pre-maturely, relevant Health Authority / Ethics Committee will be notified in writing according to local requirements. Adequate consideration will be given to the protection of patients' interests. Otherwise, EoS=LPLV.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months25
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months25
    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
    Pacientes ingresados en la UCI con ventilación mecánica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    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)
    -
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Assign Data Management & Biostatistics
    G.4.3.4Network Country Austria
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-29
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