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    Summary
    EudraCT Number:2014-001299-79
    Sponsor's Protocol Code Number:IMVX2014
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-07
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-001299-79
    A.3Full title of the trial
    Pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy
    Pneumokokvaccination af reumatologiske patienter i immunmodulerende behandling
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pnemococcal vaccination of rheumatoid arthritis patients in biological treatment
    Pneumokokvaccination af leddegigt patienter i biologisk behandling
    A.3.2Name or abbreviated title of the trial where available
    Immunovax_RA
    Immunovax_RA
    A.4.1Sponsor's protocol code numberIMVX2014
    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 SponsorDepartment of Infectious Diseases, Odense University Hospital
    B.1.3.4CountryDenmark
    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 supportDepartment of Infectious Diseases
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportUniversity of Southern Denmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion of Southern Denmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportFondation Idella
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Infectious Diseases
    B.5.2Functional name of contact pointA. Mai Nguyen
    B.5.3 Address:
    B.5.3.1Street AddressSdr. Boulevard 29, Indgang 18, 2. sal Penthouse
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4540259507
    B.5.6E-mailmai.nguyen@rsyd.dk
    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 Prevenar 13
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Suspension 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 INNpneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE
    D.3.9.4EV Substance CodeSUB129658
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30.8
    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.IMP: 2
    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 Pneumovax
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Suspension 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 INNpneumococcal polysaccharide serotype 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT)
    D.3.9.4EV Substance CodeSUB14922MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number575
    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
    Immunoresponse on pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy
    Immunrespons ved pneumokokvaccination hos reumatoid artrit patienter i immunmodulerende behandling
    E.1.1.1Medical condition in easily understood language
    The effect of pneumococcal vaccination of rheumatoid arthritis patients in biological treatment
    Effekten af pneumokokvaccination hos leddegigt patienter i biologisk behandling
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10069594
    E.1.2Term Pneumococcal immunization
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    A direct head-to-head comparison of the specific pneumococcal antibody level pre and post vaccination in the different study groups, for Prevenar and Pneumovax, independently of treatment for rheumatoid arthritis.
    De primære effektparametre er en direkte head-to-head sammenligning mellem de specifikke pneumokokantistofniveauer før og efter vaccination i de forskellige studiearme, for henholdsvis Prevenar og Pneumovax, uafhængigt af behandlingen for reumatoid artrit.
    E.2.2Secondary objectives of the trial
    A comparison of the specific pneumococcal antibody level pre and postvaccination (for Prevenar and Pneumovax) in the different treatment groups dependent on the treatment for rheumatoid arthritis.
    De sekundære effektparametre er sammenligning mellem det pneumokokspecifikke antistofniveau før og efter vaccination( med henholdsvis Prevenar og Pneumovax) i de forskellige studiearme afhængigt af behandlingen for reumatoid artrit.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosed with rheumatoid arthritis
    - Over 18 years old
    - Not pregnant
    - Receiving immunomodulatory therapy for rheumatoid arthritis (for randomized group)
    - Patient at theumatology outpatient clinic at Odense University Hospital or King Christian X's Hospital for Rheumatic Diseases
    - Diagnosticeret med reumatoid artrit
    - Over 18 år gammel
    - Ikke gravid
    - Modtager immunmodulerende behandling for reumatoid artrit (for randomiseret gruppe)
    - Følges i reumatologisk ambulatorie på Odense Universitetshospital eller Kong Christian X's Gigthospital
    E.4Principal exclusion criteria
    - Hypersensitivity to diphtheria toxoid, active substance or excipients in the vaccines.
    - Pneumovax vaccination within the last 12 months
    - Refuses to be vaccinated
    - Allergi overfor difteri toxoid, aktive stoffer eller tilsætningsstoffer i vaccinerne
    - Pneumovax vaccination indenfor de sidste 12 måneder
    - Afslår at blive vaccineret
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is a head-to-head comparison of the specifik pneumococcal antibody titer pre and post vaccination in the different study groups, independent of the treatment for rheumatoid arthritis.
    De primære effektparametre er en direkte head-to-head sammenligning mellem de specifikke pneumokokantistofniveauer før og efter vaccination for de to vacciner uafhængigt af behandlingen for reumatoid artrit.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Medio 2016
    Medio 2016
    E.5.2Secondary end point(s)
    A comparison of the specific pneumococcal antibody titer pre and post vaccination in the different study groups, dependent on the treatment for rheumatoid arthritis.
    De sekundære effektparametre er sammenligning mellem det pneumokokspecifikke antistofniveau før og efter vaccination i de foreskellige studiearme afhængigt af behandling for reumatoid artrit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Medio 2016
    Medio 2016
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Prevenar 13, Pneumovax
    Prevenar 13, Pneumovax
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 2
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 98
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    No different or new treatment.
    Ingen anderledes eller ny behandling.
    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 Decision2014-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-19
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