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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2021-004889-35
    Sponsor's Protocol Code Number:UCDCRC/21/10
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-03
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-004889-35
    A.3Full title of the trial
    An International Multicentre, Phase 2, Randomised, Adaptive Protocol to determine the need for, optimal timing of and immunogenicity of administering a booster mRNA vaccination dose against SARS-CoV-2 in the general population (18+ years) already vaccinated against SARS-CoV-2 (EU-COVAT-2 BOOSTAVAC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a multicentre Phase II trial evaluating different booster strategies in individuals already vaccinated against SARS-CoV-2. This trial allows testing of different booster strategies for comparative assessment of their immune responses and safety against SARS-CoV-2 and its variants. This study tests whether a booster vaccination dose is needed and determines the optimal booster vaccination schedule for further evaluation in a phase III trial.
    A.3.2Name or abbreviated title of the trial where available
    EU-COVAT-2 BOOSTAVAC
    A.4.1Sponsor's protocol code numberUCDCRC/21/10
    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 SponsorUniversity College Dublin
    B.1.3.4CountryIreland
    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 supportEU Horizon 2020 research and innovation funding framework
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College Dublin
    B.5.2Functional name of contact pointDepartment of Infectious Diseases
    B.5.3 Address:
    B.5.3.1Street AddressBelfield
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeDublin 4
    B.5.3.4CountryIreland
    B.5.4Telephone number35312215333
    B.5.5Fax number35312214136
    B.5.6E-mailcrc@ucd.ie
    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 Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    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.3.4Pharmaceutical form Concentrate for dispersion 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.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 Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    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.3.4Pharmaceutical form Dispersion 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.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 Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    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.3.4Pharmaceutical form Dispersion 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.IMP: 4
    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 Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manufacturing GmbH
    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.3.4Pharmaceutical form Concentrate for dispersion 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
    Severe Acute Respiratory Syndrome Coronavirus 19 (COVID-19/SARS-CoV-2)
    E.1.1.1Medical condition in easily understood language
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084457
    E.1.2Term COVID-19 immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084462
    E.1.2Term SARS-CoV-2 vaccination
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the need for, optimal timing of, and immune response after administering a mRNA booster vaccination dose against SARS-CoV-2 in the general population (18+ years) already vaccinated with the mRNA vaccines.
    E.2.2Secondary objectives of the trial
    - To determine the change in cellular immune response measured by a direct from blood qPCR based T-cell activation (dq-TACT) assay at 14 days after booster dose vaccine in comparison to prior to booster dose vaccination.
    - To correlate humoral immune response, cellular immune responses and viral neutralising capacity against wild type SARS-CoV-2
    - To determine the durability of humoral and cellular immune responses after 3rd dose of initial vaccination and shorter term responses to booster dose vaccination
    - To determine rates of, and maximum disease severity associated with confirmed SARS-CoV-2 infections occurring after enrolment in study participants before and after booster dose vaccine
    - To explore primary and secondary endpoints stratified by incident infection pre-booster dose vaccine or by any modification of vaccine epitope.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults aged 18 years or above at baseline
    - Be at least three but no more than 7 months from the date prior dose of mRNA vaccine at the time of consent
    - Have received at least three doses of mRNA vaccines (either Pfizer COMIRNATY® (BNT162b2) vaccine or Moderna Spikevax® vaccine) as primary vaccination against SARSCoV-2 (vaccination status should be documented).
    - Written informed consent from the subject has been obtained.
    E.4Principal exclusion criteria
    - Unable to provide written, informed consent
    - Participation in any other interventional trials
    - Any significant or uncontrolled disease posing a risk with vaccination as judged by the investigator (including recent, confirmed positive SARS-CoV-2 test within the previous three weeks)
    - Any significant medical condition that in the opinion of the investigator would necessitate booster vaccination against SARS-CoV-2 within the trial timelines
    - Any kind of dependency on the sponsor or principal investigator or be directly employed by the principal investigator
    - Where a subject's primary vaccination and any booster vaccination was not with an mRNA vaccine
    - Any contraindication to the vaccines in the trial as per the Summary of Medicinal Product Characteristics (SmPC) or the Investigator's Brochure, if appropriate, including known or suspected allergic reaction or hypersensitivity to any component of the vaccine. A list of contraindications (including prior anaphylaxis to BNT162b2) are listed in the SmPC
    - Subjects with known bleeding disorders that would, in the opinion of the investigator, be a contraindication to intramuscular injection
    - Subjects who have received any blood/plasma products or immunoglobulins within 60 days prior to enrolment or who plan to receive during the study period
    - Use of drugs with significant interaction with the investigational product as per the SmPC
    - Subjects who are pregnant and who are planning to become pregnant
    - Nursing mothers
    - Women of child-bearing potential (i.e. who are not post-menopausal (see below)) who are unwilling to use highly effective contraceptive methods. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly-effective:
    o Oral hormonal contraception prescribed for inhibition of ovulation
    o Dermal hormonal contraception associated with inhibition of ovulation
    o Vaginal hormonal contraception (NuvaRing®) associated with inhibition of ovulation
    o Contraceptive plaster associated with inhibition of ovulation
    o Long-acting injectable contraceptives associated with inhibition of ovulation
    o Implants that release progesterone (Implanon®) associated with inhibition of ovulation
    o Tubal ligation (female sterilisation)
    o Intrauterine devices that release hormones (hormone spiral)

    This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).

    Definition of post-menopausal status:
    For the purposes of this trial, postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A prior documented high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women with no menses for 12 months who are not using hormonal contraception or hormonal replacement therapy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint comprises a composite endpoint of either an increase in anti-RBD antibody titre to ≥500 IU/mL at day 14 post booster dose vaccine in those with anti-RBD antibody titre of ≤500 IU/mL immediately before booster dose vaccination or a 2-fold increase in anti-RBD antibody titre at day 14 following booster dose vaccination in those with anti-RBD titre of ≥500 IU/mL immediately before booster dose vaccination, as measured by quantitative immunoassay targeting the anti-RBD antibody.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days after booster dose vaccine
    E.5.2Secondary end point(s)
    - The proportion of subjects reporting positive tests (PCR and/or antigen tests) for SARS-CoV-2 at each reporting time point after enrolment
    - The proportion of subjects who receive booster dose vaccination at each specific timepoint that achieve a 2-fold increase in RBD antibody titre 14 days after the booster dose vaccine
    - The proportion of subjects who receive booster dose vaccination at each specific timepoint that achieve an anti-RBD antibody titre ≥500 IU/mL 14 days after the booster dose vaccine
    - Rate of 2-fold RBD antibody titre increase following booster dose vaccination measured by quantitative immunoassay targeting the spike 1 (S1) and nucleocapsid (NC) antibodies at 14 days after booster dose vaccine as compared to immediately before vaccination
    - Analysis stratified by incident pre-booster dose SARS-CoV-2 infections and any modification of vaccine epitope
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 days after booster dose vaccine
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.2.3.1Comparator description
    Arm 1 (control group) will not receive a booster dose of vaccination
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    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 months0
    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 months6
    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 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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation VACCELERATE
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-09
    P. End of Trial
    P.End of Trial StatusOngoing
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