Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37700   clinical trials with a EudraCT protocol, of which   6177   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-005200-18
    Sponsor's Protocol Code Number:113808
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-05-13
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2012-005200-18
    A.3Full title of the trial
    A phase III, double-blind, randomised, placebo-controlled, multi-centre study to assess the efficacy, immunogenicity and safety of two doses of GSK Biologicals’ oral live attenuated liquid human rotavirus (HRV) vaccine in healthy Chinese infants.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy, immunogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated liquid human rotavirus (HRV) vaccine (444563), in healthy infants.
    A.3.2Name or abbreviated title of the trial where available
    Rota-075
    A.4.1Sponsor's protocol code number113808
    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 l'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 Rotarix Oral Suspension
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals S.A.
    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.3.2Product code HRV
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameHUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED)
    D.3.9.4EV Substance CodeSUB22357
    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 number6.0
    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 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 Infanrix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals S.A.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.2Product code DTPa
    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 INN-
    D.3.9.2Current sponsor codeD
    D.3.9.3Other descriptive nameDIPHTHERIA TOXOID
    D.3.9.4EV Substance CodeSUB12489MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codeT
    D.3.9.3Other descriptive nameTETANUS TOXOID
    D.3.9.4EV Substance CodeSUB12608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive namePERTUSSIS TOXOID
    D.3.9.4EV Substance CodeSUB14817MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codeFHA
    D.3.9.3Other descriptive nameFILAMENTOUS HAEMAGGLUTININ
    D.3.9.4EV Substance CodeSUB38509
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codePRN
    D.3.9.3Other descriptive namePERTUSSIS PERTACTIN
    D.3.9.4EV Substance CodeSUB20527
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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: 3
    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 Oral Poliovirus Vaccine
    D.2.1.1.2Name of the Marketing Authorisation holderInstitute of Medical Biology Chinese Academy of Medical Sciences
    D.2.1.2Country which granted the Marketing AuthorisationChina
    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 Oral liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive namePolio-virus type 1
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50 log10 cell culture infective dose 50
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number6.00
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive namePolio-virus type 2
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50 log10 cell culture infective dose 50
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive namePolio-virus type 3
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50 log10 cell culture infective dose 50
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5.5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers (Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV))
    E.1.1.1Medical condition in easily understood language
    Rotavirus gastroenteritis
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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 assess the efficacy of two doses of GSK Biologicals’ liquid HRV vaccine against severe RV GE caused by the circulating wild-type RV strains during the efficacy follow-up period.
    Criteria: The primary objective will be reached if the lower limit of the 95% Confidence Interval (CI) on vaccine efficacy is at least 10%.
    E.2.2Secondary objectives of the trial
    •To assess the efficacy of 2 doses of HRV vaccine during the efficacy follow-up period against
    -any RV GE caused by circulating wild-type RV strain & hospitalisation due to it, any & severe RV GE caused by G1 & by non-G1 type RV strains
    -any & severe all cause GE
    At Visit 3 & 6, to assess:
    •in immunogenicity sub-cohort (SC) 1, the serum anti-rotavirus Ab SCR of HRV group compared to the placebo group & seropositivity rate & when co-ad with the routine childhood vaccines in immunogenicity SC2
    •in SC1 immunogenicity of HRV vaccine in terms of serum anti-rotavirus Ab conc & when co-ad with the routine childhood vaccines in SC2.
    •Immunogenicity SC2: effect of HRV vaccine on the immune response to all Ags contained in each of the co-ad childhood vaccines
    •In terms of occurrence of solicited AEs, reactogenicity of the co-ad vaccines when co-ad with HRV vaccine/placebo in immunogenicity SC2 & of the HRV vaccine/placebo in the rest
    •HRV vaccine safety in terms of unsolicited AEs & SAEs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects who the investigator believes that their parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
    •A male or female infant of Chinese origin between, and including, 6 and 16 weeks (42-112 days) of age at the time of the first vaccination.
    •Written informed consent obtained from the parents/LARs of the subject.
    •Healthy subjects as established by medical history and clinical examination before entering into the study.
    •Born after a gestation period of 36 to 42 weeks inclusive.
    E.4Principal exclusion criteria
    •Child in care.
    •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, prednisone 0.5 mg/kg/day, or equivalent, inhaled and topical steroids are allowed.
    •Planned administration/administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccines and ending 14 days after f the first dose of the HRV vaccine or placebo except for the routine childhood vaccinations.
    •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 (pharmaceutical product or device).
    •Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
    •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    •Family history of congenital or hereditary immunodeficiency.
    •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
    •Major congenital defects or serious chronic illness.
    •History of confirmed RV GE.
    •Acute disease and/or fever at the time of enrolment.
    -Fever is defined as temperature (37.1°C on axillary setting as defined by the Chinese authorities.
    -Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator (warrants deferral of the vaccination).
    •GE within 7 days preceding the study vaccine or placebo administration (warrants deferral of the vaccination).
    •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
    In addition to the criteria mentioned above, the following criteria will be applicable to all subjects in the immunogenicity sub-cohort 2:
    •History of diphtheria, tetanus and pertussis disease.
    •History of seizures or progressive neurological disease.
    •Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of severe RV GE caused by the circulating wild-type RV strains in subjects vaccinated with liquid HRV vaccine/placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the efficacy follow-up period (two weeks post-Dose 2 till Visit 7)
    E.5.2Secondary end point(s)
    Occurrence of any and severe RV GE caused by the circulating wild-type RV strains, G1 and non-G1 type strains, and hos-pitalisation due to RV GE by circulating wild-type RV strains during the efficacy follow-up period in subjects vaccinated with liquid HRV vaccine/placebo.
    Anti-rotavirus IgA antibody concentrations in terms of serocon-version rate at Visit 3 and (SCR), seropositivity rate at Visit 6.,
    Serum anti-rotavirus IgA antibody concentrations expressed as and geometric mean concentration (GMC)
    Anti-tetanus, anti-diphtheria, anti-pertussis toxoid (PT), anti-filamentous haemagglutinin (FHA), anti-pertactin (PRN), anti-poliovirus type 1, anti-poliovirus type 2 and anti-poliovirus type 3 antibody concentrations/titres and seroprotection/seropositivity rates at Visit 5.
    Occurrence of each general solicited symptom (fever, fussi-ness/irritability, loss of appetite, cough/runny nose, diarrhoea and vomiting)
    Occurrence of local (pain, swelling, redness) and general solic-ited symptoms (fever, irritability/fussiness, drowsiness, loss of appetite and gastrointestinal symptoms)
    Occurrence of unsolicited symptoms after any dose of liquid HRV vaccine or placebo, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.
    Occurrence of SAEs, according to the MedDRA classification.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Occurrence of RV GE: During the efficacy follow-up period (two weeks post-Dose 2 till Visit 7
    Antirotavirus seroconversion and seropositivity: At Visit 3 (SCR) and at Visit 6 (Seropositivity rate) At Visits 3 and 6 (GMC)
    Other seroprotection and seropositivity: At Visit 5
    General and local symptoms: Within the 8-day (Days 0 to Day -7) follow-up period after each dose of liquid HRV vaccine dose/ placebo.
    Unsolicited symptoms: Day 0 to Day 30 after each vaccine dose
    SAEs: Throughout study period
    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) 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 Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    China
    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.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 3333
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 3333
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 3333
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA