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    Summary
    EudraCT Number:2011-003672-36
    Sponsor's Protocol Code Number:115231
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-20
    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 ConcernedEstonia - SAM
    A.2EudraCT number2011-003672-36
    A.3Full title of the trial
    A Phase IIIA, observer-blind, randomized study to evaluate non-inferiority of a second dose of GSK Biologicals’ measles-mumps-rubella vaccine vs. a second dose of Merck & Co., Inc.’s MMR vaccine when administered to healthy subjects seven years of age and older
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety study of GSK Biologicals’ combined measles-mumps-rubella vaccine in subjects seven years of age and older (209762).
    A.3.2Name or abbreviated title of the trial where available
    MMR-159
    A.4.1Sponsor's protocol code number115231
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02058563
    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 SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de I'Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    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 Priorix® (GSK Biologicals’ measles, mumps, and rubella vaccine live)
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Biologicals
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namePriorix
    D.3.2Product code 209762
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated measles virus (Schwarz strain)
    D.3.9.3Other descriptive nameMEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB25680
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated mumps virus (RIT4385 strain)
    D.3.9.3Other descriptive nameMUMPS VIRUS VACCINE LIVE (JERYL LYNN)
    D.3.9.4EV Substance CodeSUB21041
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.7
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated rubella virus (Wistar RA 27/3 strain)
    D.3.9.3Other descriptive nameRUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB21610
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.0
    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 RoleComparator
    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 M-M-R VAXPRO
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameM-M-R VAXPRO
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEASLES VIRUS ENDERS' EDMONSTON STRAIN (LIVE, ATTENUATED)
    D.3.9.3Other descriptive nameMEASLES VIRUS ENDERS' EDMONSTON STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS
    D.3.9.4EV Substance CodeSUB25310
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated mumps virus (Jeryl Lynn™ (level B) strain)
    D.3.9.3Other descriptive nameMUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS
    D.3.9.4EV Substance CodeSUB25309
    D.3.10 Strength
    D.3.10.1Concentration unit CCID50/dose cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number12500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRubella virus Wistar RA 27/3 strain (live, attenuated)
    D.3.9.3Other descriptive nameRUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN WI-38 HUMAN DIPLOID LUNG FIBROBLASTS
    D.3.9.4EV Substance CodeSUB25308
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.0
    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
    Healthy volunteers (Active immunization against measles, mumps and rubella diseases of healthy subjects, 7 years of age and older).
    E.1.1.1Medical condition in easily understood language
    measles, mumps and rubella diseases
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10069547
    E.1.2Term Mumps immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10039276
    E.1.2Term Rubella with unspecified complications
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10069545
    E.1.2Term Measles immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10039274
    E.1.2Term Rubella with other specified complication
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10069564
    E.1.2Term Rubella immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10028274
    E.1.2Term Mumps with other specified complication
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10027021
    E.1.2Term Measles without mention of complication
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10027020
    E.1.2Term Measles with unspecified complication
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10027022
    E.1.2Term Measles-like rash
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To demonstrate the non-inferiority of INV_MMR vaccine to COM_MMR vaccine in terms of geometric mean concentrations (GMCs) for anti-measles, anti-mumps and anti-rubella antibodies at Day42.
    E.2.2Secondary objectives of the trial
    • To demonstrate the non-inferiority of INV_MMR vaccine to COM_MMR vaccine, in terms of seroresponse rates to measles, mumps and rubella viruses at Day 42.
    • To assess the percentage of subjects who achieve a minimum 4-fold rise in anti measles, anti mumps or anti rubella virus antibody concentrations at Day 42.
    • To assess safety and reactogenicity of INV_MMR vaccine and COM_MMR vaccine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects who the investigator believes that they and/or their parent(s) or Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
    • Male or female subjects 7 years of age or older and born after December 31, 1956*. *The only exception to this is health care workers born before 1957 without other evidence of immunity to mumps for which one dose of a live mumps virus vaccine is recommended; therefore this population is eligible for enrollment in this study.
    • For all children 7-17 years of age:
    -Written documentation of prior receipt of 1 dose of MMR vaccine administered on or after the first birthday.
    • For all adults 18 years of age and older:
    -Prior receipt (written or verbal history) of at least one dose of MMR vaccine.
    -Birth in the US.
    • Written informed consent obtained from the subject or from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects who are still legally minors in line with local rules and regulations).
    • Subjects in stable health as determined by investigator’s physical examination and assessment of subjects’ medical history.
    • Female subjects of non-childbearing potential may be enrolled in the study.
    -Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, or ovariectomy or post-menopause.
    • Female subjects of childbearing potential may be enrolled in the study, if the subject
    -Has agreed to be abstinent or practiced adequate contraception during the entire period starting 30 days prior to vaccination(s) until 3 months after receipt of the study vaccination and
    -Has a negative pregnancy test on the day of vaccination.
    E.4Principal exclusion criteria
    • Child in care.
    • For all children 7-17 years of age:
    -Previous receipt of more than 1 dose of a measles-containing vaccine.
    • Use of any investigational or non-registered product other than the study vaccine(s), during the period starting 30 days preceding the day of study vaccination, (i.e. 30 days prior to Day 0) or planned use during the entire study period.
    • Receipt of any measles, mumps or rubella-containing vaccine during the period starting 42 days before the day of study vaccination (i.e. 42 days prior to Day 0).
    • Chronic administration (defined as 14 or more consecutive days) of immunosuppressants or other immune-modifying drugs during the period starting 180 days before study vaccination or any planned administration of immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.
    • Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination through the immunogenicity evaluation at Visit 2 or Visit 3 (for one-dose or two-dose cohort, respectively).
    • Planned administration/ administration of any live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination and ending at Visit 2. Any inactivated vaccine required in the age group and inactivated influenza vaccine may be given at any time, including the day of study vaccination. (Inactivated vaccines must be administered at a different location than the study vaccine). Live intranasal influenza vaccine should not be given during the period starting 30 days prior to study vaccination and ending at Visit 2, except for the day of study vaccination.
    • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
    • History of measles, mumps, or rubella disease.
    • Known exposure to measles, mumps, or rubella, during the period starting 30 days before study start (i.e. 30 days prior to Day 0).
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including hypersensitivity to neomycin, latex or gelatin.
    • Blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms.
    • Acute disease at the time of enrollment.
    • Alcohol or drug abuse or history of any substance abuse.
    • Pregnant or lactating female.
    • Female planning to become pregnant or planning to discontinue contraceptive precautions during the entire study period.
    • Active untreated tuberculosis according to the subject’s medical history
    • Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of immunogenicity of the study vaccines in terms of antibody concentration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Day 42
    E.5.2Secondary end point(s)
    1. Evaluation of immunogenicity of the study vaccines in terms of seroresponse
    2. A minimum 4-fold rise in anti-measles, anti-mumps and anti-rubella virus antibody concentration.
    3. Occurrence of solicited local symptoms
    4. Occurrence of solicited general symptoms
    5. Occurrence of unsolicited adverse events (AEs)
    6. Occurrence of pre-specified AEs
    7. Occurrence of Serious Adverse Events (SAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Day 42
    2. At Day 42
    3. From Day 0 to Day 3 after vaccination
    4. From Day 0 to Day 42 after vaccination
    5. From Day 0 to Day 42 after vaccination
    6. From Day 0 through study end (Day 180)
    7. From Day 0 through study end (Day 180)
    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 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
    Immunogenicity
    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 No
    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
    Observer-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Estonia
    Slovakia
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 334
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 334
    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: 666
    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 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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 306
    F.4.2.2In the whole clinical trial 1000
    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 Decision2015-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-17
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