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    Summary
    EudraCT Number:2014-003573-42
    Sponsor's Protocol Code Number:232100-0131
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-09-29
    Trial 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 number2014-003573-42
    A.3Full title of the trial
    Antibody-mediated immune response after immunization with FSME-Immun(R) against Tick Borne Encephalitis(TBE) after hematopoietic autologous and allogeneic stem cell transplantation.
    Studie av antikroppsmedierat immunförsvar efter vaccination med FSME-Immun mot Tick Borne Encephalitis(TBE) hos patienter efter autolog och allogen stamcellstransplantation.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunity after Tick Borne Encephalitis vaccination in stem cell transplanted patients
    Immunitet mot Tick Borne Encephalitis efter vaccination till stamcellstransplanterade patienter
    A.4.1Sponsor's protocol code number232100-0131
    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 SponsorVästra Götalandsregionen
    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 supportLocal research funds
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDep of Clincial Research
    B.5.2Functional name of contact pointSahlgrenska University hospital
    B.5.3 Address:
    B.5.3.1Street AddressGröna Stråket 12
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code413 45
    B.5.3.4CountrySweden
    B.5.4Telephone number0046313421000
    B.5.6E-mailkaj.stenlof@vgregion.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 FSME-Immun
    D.2.1.1.2Name of the Marketing Authorisation holderMPA
    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.3.1Product nameFSME-immun
    D.3.2Product code J07BA01
    D.3.4Pharmaceutical form Suspension 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 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
    Patients have undergone allogeneic or autologous stem cell transplantation for hematological malignancies.
    Patienter som genomgått autolog eller allogen hematopoietisk stamcellstransplantation för malign blodsjukdom.
    E.1.1.1Medical condition in easily understood language
    As above.
    Var god se ovan.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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 quantify antibody-mediated immunity after TBE-vaccination in patients who have undergone allogeneic or autologous hematopoietic stem cell transplantation.
    Att mäta antikroppsmedierat svar på TBE-vaccination efter allogen eller autolog stamcellstransplantation.
    E.2.2Secondary objectives of the trial
    1.Safety.
    2. To evaluate differences between subgroups of patients; autoSCT vs alloSCT, ongoing immunosuppression vs not, older vs younger pts, earlier TBE-vaccination vs not.
    1. Säkerhet.
    2. Att analysera skillnader i immunsvar mellan undergrupper av patienter; auto SCT vs alloSCT, pågående vs avslutad immunosuppression, äldre vs yngre patienter eller tidigare TBE-vaccination vs ingen tidigare vaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 or above
    2.Informed consent

    FOR ALLO SCT PTS: myeloablative or reduced conditioning, sibling donor or matched unrelated donor, diagnosis of acute or chronic leukemia, lymphoma, myelofibrosis

    FOR AUTO SCT PTS: Pts with multiple myeloma, chronic lymphocytic leukemia, lymphoma or solid tumour with established indication
    1. Ålder 18 eller över
    2. Informerat samtycke

    FÖR ALLOSCT PATIENTER: myeloablativ eller reducerad konditionering, HLA-identisk syskondonator eller matchad obesläktad donator, grundsjukdom som är akut eller kronisk leukemi, lymfom eller myelofibros

    FÖR AUTOSCT PATIENTER: Patienter med myelom, lymfom, kronisk lymfatisk leukemi eller solid tumör med etablerad indikation
    E.4Principal exclusion criteria
    1. Relapse
    2. Ongoing infection
    3. Allergy to egg, hen protein or lathex
    4. Previous TBE-disease
    5. Pregnancy or wish to get pregnant
    6. Recent(3 months) treatment with iv or sc immunoglobulin

    FOR ALLOSCT PATIENTS: Patients transplanted with chord blood or from haploidentical donor
    1. Återfall i grundsjukdomen
    2.Pågående infektion
    3. Allergi mot hönsprotein, ägg eller latex
    4.Genomgången TBE-sjukdom
    5. Graviditet eller aktuell graviditetsönskan
    6.Behandling inom 3 månader före inklusion med IV eller SC immunglobulin

    FÖR ALLOSCT PATIENTER: Patienter som transplanterats från haploidentisk donator eller navelsträngsblod
    E.5 End points
    E.5.1Primary end point(s)
    Post immunization titers of TBE-specific antibodies.
    TBE-specifika antikroppstitrar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Titers as above will be assessed after each vaccination.
    Titrar enligt ovan tages efter varje vaccination.
    E.5.2Secondary end point(s)
    Safety.
    Säkerhet.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the last vaccination, approximately 13 months after inklusion.
    Efter sista vaccinationen, dvs ca 13 månader efter inklusion.
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    We are investigating an approved immunization scheme in pts not previously studied.
    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.8.2.4Number 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 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
    LVLS
    Vid sista deltagarens sista besök
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Transplanted pts might be suscetible to TBE infection, and may not respond adequately to vaccination
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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)
    None
    Inga
    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 Decision2014-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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