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    Summary
    EudraCT Number:2013-003403-19
    Sponsor's Protocol Code Number:HCK1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-02
    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 ConcernedSweden - MPA
    A.2EudraCT number2013-003403-19
    A.3Full title of the trial
    Study of T- and B-cell immunity after vaccination with a virosomebased influenza vaccine (Inflexal V) in patients who have undergone hematopoietic allogeneic stem cell transplantation.
    Studie av cell- och antikroppsmedierat svar efter vaccination med virosombaserat influensavaccin (Inflexal V) hos patienter som genomgått allogen stamcellstransplantation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of immune responses after vaccination with an influenza vaccine (Inflexal V) in patients who have undergone hematopoietic allogeneic stem cell transplantation.
    Studie av immunsvaret efter vaccination med influensavaccin (Inflexal V) hos patienter som genomgått allogen stamcellstransplantation
    A.4.1Sponsor's protocol code numberHCK1
    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 SponsorKarolinska University Hospital
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKarolinska University Hospital
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital
    B.5.2Functional name of contact pointDept. of Hematology
    B.5.3 Address:
    B.5.3.1Street AddressM54
    B.5.3.2Town/ cityStockholm
    B.5.3.4CountrySweden
    B.5.4Telephone number46858582507
    B.5.5Fax number4687748725
    B.5.6E-mailper.ljungman@ki.se
    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 Yes
    D.2.1.1.1Trade name Inflexal V
    D.2.1.1.2Name of the Marketing Authorisation holderCrucell Italy S.r.l
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Allogeneic stem cell transplantation
    Allogen stamcellstransplantation
    E.1.1.1Medical condition in easily understood language
    Stem cell transplantation
    Stamcellstransplantation
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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
    Analyze T-cell and B-cell immune response after influenzavaccination with Inflexal V.
    Att mäta T-cell och B-cell immunsvar efter influensavaccination med Inflexal V.
    E.2.2Secondary objectives of the trial
    Clinical efficacy and safety after vaccination with Inflexal V in allogeneic stem cell transplant patients.

    To analyze cellmediated and antibodymediated immune responses with additional techniques
    Att analysera klinisk effekt och säkerhet av Inflexal V hos allogena SCT patienter.

    Att mäta cellmedierat och antikroppsmedierat immunsvar med kompletterande tekniker
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult allogeneic stem cell transplant patients who has undergone transplant 3-24 months before transplantation and who shall get influenza vaccine according to national and international guidelines.
    1. Vuxna allogena SCT patienter (> 17 år) transplanterade mellan 3-24 månader innan vaccination och som skall ha influensavaccination med vaccin mot säsongsinfluensa enligt internationella och nationella rekommendationer.
    E.4Principal exclusion criteria
    1. Patients < 3 months and > 24 months after HSCT
    2. Patients who has been influenzavaccinated during the actual season.
    3. Patients who has been diagnosed with influenza during the actual season.
    4. Patients with severe acute GVHD (grade III-IV)
    5. Patienter with extensive or severe chronic GVHD treated with photopheresis or mesenchymal stem cells
    6. Patients treated with drugs produced by gene- or celltherapeutical techniques
    7. Patients with relapse of the original disease undergoing or planned to undergo chemotherapy
    8. Patients treated with iv or sc immune globulins
    9. Patients requiring platelet transfusions
    10. Patienter allergic to any of the in the vaccine included substances.
    11. Patients who are pregnant or nursing
    12. Patients not giving informed consent
    1. Patienter som är tidigare än 3 och senare än 24 månader efter SCT
    2. Patienter som under innevarande säsong erhållit influensavaccin.
    3. Patienter som under innevarande säsong diagnostiserats med influensa
    4. Patienter med svår akut GVHD (grad III-IV)
    5. Patienter med svår kronisk GVHD som behandlas med mesenkymala stamceller eller fotoferes
    6. Patienter behandlade med läkemedel tillverkade med gen- eller cellteurapetiska metoder.
    7. Patienter med återfall av den hematologiska grundsjukdomen som får eller förväntas få tumörbehandling
    8. Patienter som behandlas med intravenöst eller subkutant immunglobulin
    9. Patienter som är transfusionskrävande för trombocyter
    10. Patienter som är allergiska med någon i vaccinet ingående komponenter
    11. Kvinnliga patienter som är gravida eller ammar.
    12. Patienter som inte ger medgivande till studien.
    E.5 End points
    E.5.1Primary end point(s)
    B-cell response defined as a 4-fold increase in HI titer or achievement of ≥ 1:40 in HI after vaccination

    T-cell response defined as more than a 2-fold increase in the number of influenza-specific gamma-interferon producing T-cells after vaccination.
    B-cellssvar definierat som en fyrfaldig stegring i HI titer eller uppnående av ≥ 1:40 i HI efter vaccination
    T-cellsvar definierat som mer än en fördubbling av antalet influensaspecifika gamma-Interferon producerande T-celler efter vaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks after vaccination
    4 veckor efter vaccination
    E.5.2Secondary end point(s)
    Number of verified influensa cases after vaccination

    Side effects

    B-cell response defined as at least a two-fold increase in the number of influenza-specific antibodies analyzed by ELISA

    CD8+ T-cellresponse defined as more than a 2-fold increase in the number of influenza-specific Cd8+ cells analyzed by tetramertechnology
    Antalet verifierade influensafall hos vaccinerade patienter
    Biverkningar

    B-cellssvar definierat som minst fördubbling av influensaspecifika antikroppar efter vaccination analyserade med ELISA

    CD8+ T-cellssvar definierat som mer än en fördubbling av antalet influensaspecifika CD8+ T-celler analyserade med tetramerteknik
    E.5.2.1Timepoint(s) of evaluation of this end point
    Six months after vaccination for the clinical endpoints

    Four weeks after vaccination for the laboratory endpoints
    6 mån efter vaccination för kliniska parametrar

    4 veckor efter vaccination för laborotorieparametrar
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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
    Immune response to vaccination
    Immunsvar på vaccination
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    The study is closed when the last patient is 6 months after the vaccination or if a SUSAR is documented in included in the SmPC
    Studien avslutas när sista patienten är 6 månader efter vaccinationen eller om oväntade, allvarliga biverkningar (SUSAR) uppstår som ej finns angivna i SmPC för Inflexal V.
    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 months
    E.8.9.1In the Member State concerned days
    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: 25
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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)
    Routine medical care only
    Enligt gällande normala rutiner
    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 Decision2013-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-01
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