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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2014-001995-71
    Sponsor's Protocol Code Number:PLATIG-1404
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-05-15
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-001995-71
    A.3Full title of the trial
    Open label multicenter prospective trial to assess the tetanus titer in subject of regular plasmapharesis
    Nyílt multicentrikus követéses klinikai vizsgálat a tetanus emlékeztető oltásban részesült, plazmaferezis donorok tetanusz antitest statuszának meghatározására
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open label multicenter prospective trial to assess the tetanus titer in subject of regular plasmapharesis
    klinikai vizsgálat a tetanus emlékeztető oltásban részesült, plazmaferezis donorok tetanusz antitest statuszának meghatározására
    A.4.1Sponsor's protocol code numberPLATIG-1404
    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 SponsorPlazmaferezis Állomás Közhasznú Nonprofit Kft
    B.1.3.4CountryHungary
    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 supportPlazmaferezis Állomás Közhasznú Nonprofit Kft
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHuman Biplazma Kft
    B.5.2Functional name of contact pointreguulatory dept
    B.5.3 Address:
    B.5.3.1Street AddressTancsics M 80
    B.5.3.2Town/ cityGödöllő
    B.5.3.3Post code2100
    B.5.3.4CountryHungary
    B.5.4Telephone number+3628532-248
    B.5.5Fax number+3628532201
    B.5.6E-mailj.juhasz@humanked.hu
    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 Tetanol pur vakcina fecskendőben
    D.2.1.1.2Name of the Marketing Authorisation holderPhoenix Pharma zrt.
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 nameTETANOL PUR
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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) No
    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
    healthy subjects eligible for tetanus booster vaccination
    egészséges donorok akik alkalmasak és megfelelnek a tetanus emlékeztető oltás kritériumainak
    E.1.1.1Medical condition in easily understood language
    Subject eligible and requires tetanus revaccination
    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
    Effect of plasmapheresis on tetanus titer by booster tetanus vaccination
    E.2.2Secondary objectives of the trial
    changes of tetanus titer during the repeated plasmadonation by course of the study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    21-65 years old
    eligible for plasmadonation
    at least 2 times given plasma
    eligible for Tetnus revacination
    accepted ICF
    - 21-65 éves egészséges önkéntesek
    - a plazmaferezisre való donor alkalmasság kritériumainak a teljesülése
    - korábbi, legalább 2 alkalommal önkéntes alapon történt plazmaferezis az elmúlt egy évben
    - a Tetanus emlékeztető oltásra alkalmas egészségi állapot és oltási státusz az Alkalmazási Előírásnak megfelelően
    - testsúly 50 kg felett
    - az immunizációra vonatkozó Önkéntes tájékoztatáson részt vett, a részvételt elfogadta és beleegyezési nyilatkozatot sajátkezűen aláírta
    E.4Principal exclusion criteria
    not eligible for regular plasmadonation
    suffer a serius medical condition such as CND, coagulatopathy, chronic diseases, diabetes, HCV, HB HIV, and others)
    E.5 End points
    E.5.1Primary end point(s)
    changes in tetanus antibody titer after regular palsma donation
    Az anitest titer változásának meghatározása aktív tetanusz immunizáláson átesett egészséges önkéntesek esetén, sorozatos plazmaferezis során.
    E.5.1.1Timepoint(s) of evaluation of this end point
    repeated in 1-3-6 months
    E.5.2Secondary end point(s)
    side effects
    adverse events during teh course of the study
    - a tanulmány ideje alatt a résztvevő önkéntesek esetében minden hónapban feljegyzésre kerülő, az emlékeztető oltással kapcsolatosan felmerülő mellékhatások, panaszok száma és változása.
    - a teljes időszak alatt regisztrálásra került a plazmadonorok egészségi állapotában történő változások összehasonlítása a csoportonként.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30-90 -120days
    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 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 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 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 concerned3
    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
    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 months6
    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: 480
    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 Yes
    F.3.2Patients No
    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 state480
    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 Decision2014-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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