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    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2014-004344-35
    Sponsor's Protocol Code Number:50993
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-16
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-004344-35
    A.3Full title of the trial
    The effect of tetanus revaccination in patients with myasthenia gravis
    Het effect of tetanus revaccinatie in patienten met myasthenia gravis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of tetanus revaccination in patients with myasthenia gravis
    Het effect of tetanus revaccinatie in patienten met myasthenia gravis.
    A.3.2Name or abbreviated title of the trial where available
    Tetanus revaccination in patients with myasthenia gravis
    Tetanus revaccinatie in patienten met myasthenia gravis
    A.4.1Sponsor's protocol code number50993
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportFP7 EU project nr 110173
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointTetanus study contact
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715262118
    B.5.5Fax number0031715266671
    B.5.6E-mailmyasthenie@lumc.nl
    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 Tetanus vaccin
    D.2.1.1.2Name of the Marketing Authorisation holderBilthoven Biologicals B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameTetanus vaccin
    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 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
    Myasthenia gravis
    Lambert-Eaton myasthenic syndrome
    Myasthenia gravis
    Lambert-Eaton myastheen syndroom
    E.1.1.1Medical condition in easily understood language
    Myasthenia
    Lambert-Eaton myasthenic syndrome
    Myasthenie
    Lambert-Eaton myastheen syndroom
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effectiveness of the humeral and cellular immune response after tetanus revaccination in patients with AChR MG, MuSK MG, or LEMS.
    Het vaststellen van de effectiviteit van de humorale en cellulaire immunreactie na een tetanus revaccinatie in patienten met AChR MG, MuSK MG of LEMS.
    E.2.2Secondary objectives of the trial
    To determine if revaccination induces immunological or clinical exacerbation in patients with AChR MG, MuSK MG, or LEMS
    Het vaststellen of revaccinatie een immunologische of klinische exacerbatie induceert in patiënten met AChR MG, MuSK MG of LEMS.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The validation of the MG-QOL15 in Dutch
    Het valideren van de MG-QOL15 in het Nederlands
    E.3Principal inclusion criteria
    1. Males and females aged between 18 years and 65 years at the time of the injection.
    2. Patient with ocular or generalized AChR MG, MuSK MG or LEMS; and
    3. A positive serologic test for AChR antibodies > 3 nmol/l or MuSK antibodies >0.1 nmol/l or VGCC antibodies >20 fmol/l.
    4. Patient with prednisone dose lower than 30mg and stable (dose +/- 5mg) during the 3 months before participation; other immunosuppressive should be stable/unchanged.
    1. Mannen en vrouwen tussen de 18 en 65 jaar op het moment van injectie
    2. Patienten met oculaire of gegeneraliseerde AChR MG, MuSK MG of LEMS; en
    3. Een positieve serologie test voor AChR antistoffen >3 nmol/l of MuSK antistoffen >0.1 nmol/l of VGCC antistoffen >20 fmol/l.
    4. Patienten met prednisondosering lager dan 30mg en deze moet stabiel zijn (+/- 5mg) gedurende de 3 maanden voor deelname; andere immunosuppresiva moeten stabiel/onveranderd zijn.
    E.4Principal exclusion criteria
    1. Received no previous tetanus vaccination in the childhood age or received a revaccination in de past year.
    2. MG patients of Grade 4 or 5 based on MGFA classification.
    3. Myasthenic crisis in the last 3 months
    4. Presence of a thymoma.
    5. Planned thymectomy during the study period or within 12 months prior of the tetanus toxoid booster immunization.
    6. Any confirmed or suspected immunosuppressive or immunodeficient condition not related to the treatment of MG, including human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency.
    7. History or evidence of administration of immunoglobulins within 3 months prior to the tetanus revaccination.
    8. History or evidence of plasmapheresis within 3 months prior to the tetanus revaccination.
    9. At high risk for aspiration.
    10. Pulmonary: forced vital capacity reduced to less than 70% of predicted capacity.
    11. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    12. History of relevant chronic degenerative, psychiatric, or neurological disorder other than MG.
    13. Severe hepatic, renal or cardiac insufficiency.
    14. Major congenital defects or serious chronic illness other than MG.
    15. Positive pregnancy test or desire to become pregnant during the study.
    16. Influenza vaccination 1 month before the tetanus revaccination
    17. The use of vitamine K antagonist or new coagulantia (NOAC's)
    18. The patient is unable to fill out the study questionnaires or be interviewed in Dutch, or is unable to undergo the tests needed for the study, or is unable to give informed consent for participation in the study.
    19. The investigator can exclude patients for this trial which are deemed not suitable for any reason.
    1. Niet voor tetanus gevaccineerd op kinderleeftijd of nog binnen het afgelopen jaar een revaccinatie ontvangen.
    2. MG patiënten met graad 4 of 5 volgens de MGFA classificatie
    3. Myasthene crisis in de afgelopen 3 maanden
    4. Aanwezigheid van een thymoom.
    5. Geplande thymectomy gedurende de studie of binnen 12 maanden voor de tetanus revaccinatie.
    6. Een bevestigde of verdenking op een immunosuppresiva of immunodeficiente aandoening die niet gerelateerd is aan de behandeling voor MG, inclusief infectie met het human immunodeficiency virus (HIV), of een familaire voorgeschiedenis van congenitale of overerfbare immunodeficientie.
    7. Voorgeschiedenis of bewijs van toediening van immunoglobulines in de 3 maanden voor de tetanus revaccinatie.
    8. Voorgeschiedenis of bewijs van plasmaferese in de 3 maanden voor de tetanus revaccinatie.
    9. Verhoogd risico op aspiratie
    10. Pulmonaal: forced vital capacity afgenomen tot minder dan 70% van de verwachte capaciteit.
    11. Voorgeschiedenis van allergische ziekten/reacties die uitgelokt kunnen worden door een van de componenten van het vaccin
    12. Voorgeschiedenis van relevante chronisch degeneratieve, psychiatrische of neurologische aandoeningen anders dan MG
    13. Ernstige lever, nier of cardiale insufficiëntie
    14. Ernstige congenitale defecten of ernstige chronische ziekten anders dan MG.
    15. Positieve zwangerschapstest of het verlangen om zwanger te worden gedurende de studie.
    16. Griepvaccinatie 1 maand voor deelname aan de studie.
    17. Het gebruik van vitamine K antagonisten of nieuwe coagulantia (NOAC's)
    18. De patiënt is niet in staat om de vragenlijsten in het Nederlands in te vullen, of is niet in staat om de testen die voor de studie nodig zijn te ondergaan, of is niet in staat om informed consent te geven voor deelname aan de studie.
    19. De onderzoeker kan patiënten excluderen voor deze studie die voor welke reden dan ook niet geschikt zijn.
    E.5 End points
    E.5.1Primary end point(s)
    -Change in total tetanus specific serum IgG titer in patients with AChR MG, MuSK MG, or LEMS
    -Change in MG composite score at 4 weeks after revaccination
    - Verandering van de totaal tetanus specifieke serum IgG titer in patienten met AChR MG, MuSK MG of LEMS
    - Verandering in de MG composite score 4 weken na revaccinatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks after the revaccination
    4 weken na de revaccinatie
    E.5.2Secondary end point(s)
    - Change in MG composite score at 12 weeks after revaccination
    - Change in MG-ADL 4 and/or 12 weeks after revaccination
    - Increase in the dose of any of the immunosuppressive drugs for treatment of the MG or LEMS during the 12 weeks of the study
    - Change in tetanus specific serum IgG subclass titers in patients with AChR MG, MuSK MG, or LEMS
    -Change in autoimmune antibody titers against AChR, MuSK or VGCC at 4 weeks after revaccination
    -Change in tetanus specific T-cell immune response at 4 weeks after revaccination
    - Validation of the MG-QOL15 in Dutch
    - Verandering in MG composite score 12 weken na de revaccinatie
    - Verandering in de MG-ADL 4 en/of 12 weken na revaccinatie.
    - Verhoogde dosering van een van de immunosuppressieve medicatie voor de behandeling van de MG of LEMS gedurende de 12 weken van de studie
    - Verandering in de tetanus specifieke serum IgG sublclass titers in patienten met AChR MG, MuSK MG of LEMS.
    - Validatie van de MG-QOL15 in het Nederlands
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 and 12 weeks after the revaccination
    4 en 12 weken na de revaccinatie
    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 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
    12 weeks after the last subject is received the revaccination
    12 weken nadat de laatste proefpersoon de revaccinatie heeft gehad.
    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: 80
    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 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 state80
    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
    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 Decision2015-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-16
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