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    Summary
    EudraCT Number:2021-004526-29
    Sponsor's Protocol Code Number:uni-koeln-4602
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-02-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-004526-29
    A.3Full title of the trial
    A MULTINATIONAL, PHASE 2, RANDOMISED, ADAPTIVE PROTOCOL TO EVALUATE IMMUNOGENICITY AND REACTOGENICITY OF DIFFERENT COVID-19 VACCINES ADMINISTRATION IN OLDER ADULTS (≥75) ALREADY VACCINATED AGAINST SARS-COV-2 (EU-COVAT-1 AGED)
    Estudio multinacional, de fase 2, aleatorizado y adaptativo para evaluar la
    inmunogenicidad y reactogenicidad tras la administración de diferentes
    vacunas COVID-19 en adultos mayores (≥75) ya vacunados contra el SARSCoV-2 (EU-COVAT-1 Aged)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multinational, phase 2, randomised, adaptive protocol to assess immune response and side effects of different COVID-19 vaccines given in older adults (75 years and older) already vaccinated against SARS-CoV-2
    Protocolo adaptativo multinacional, de fase 2, aleatorizado, para evaluar la respuesta inmune y los efectos secundarios de diferentes vacunas COVID-19 administradas en adultos mayores (75 años y más) ya vacunados contra el SARS-CoV-2
    A.3.2Name or abbreviated title of the trial where available
    EU-COVAT-1 AGED
    EU-COVAT-1 AGED
    A.4.1Sponsor's protocol code numberuni-koeln-4602
    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 of Cologne
    B.1.3.4CountryGermany
    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 supportEuropean Commission
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación de Invetsigación Biomédica del Hospital Universitario La Paz
    B.5.2Functional name of contact pointGestor de proyecto
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34914975485
    B.5.6E-mailpaulaprieto.ucicec@gmail.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 Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech Manfacturing 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 Spikevax
    D.2.1.1.2Name of the Marketing Authorisation holderMODERNA BIOTECH SPAIN, S.L.
    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 nameSpikevax
    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.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
    Prevention of COVID-19 infection
    Prevención de la infección por COVID-19
    E.1.1.1Medical condition in easily understood language
    Prevention of COVID-19 infection
    Prevención de la infección por COVID-19
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084464
    E.1.2Term COVID-19 immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084465
    E.1.2Term COVID-19 vaccination
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10085559
    E.1.2Term Revaccination with different COVID-19 vaccine
    E.1.2System Organ Class 100000004865
    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 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084463
    E.1.2Term SARS-CoV-2 immunisation
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084466
    E.1.2Term SARS-CoV-2 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
    To compare the reactogenicity between treatment arms after a 4th vaccination dose against SARS-CoV-2.
    Comparar la reactogenicidad entre los brazos de tratamiento después de administrar la 4ª dosis de la vacuna contra el SARS-CoV-2.
    E.2.2Secondary objectives of the trial
    • To compare the immunogenicity against wild-type SARS-CoV-2 between treatment arms after a 4th vaccination dose against SARS-CoV-2.
    • To evaluate descriptively the immunogenicity against SARS-CoV-2 variants of concern between treatment arms after a 4th vaccination dose against SARS-CoV-2.
    • To evaluate descriptively the long-term humoral immune response (reactogenicity and immunogenicity) of 4th vaccination dose against SARS-CoV-2.
    Comparar la inmunogenicidad contra el SARS-CoV-2 de tipo salvaje
    entre los brazos de tratamiento tras la administración de una 4ª dosis de la vacuna frente al SARS-CoV-2.

    Evaluar descriptivamente la inmunogenicidad frente a las variantes
    de SARS-CoV-2 entre los brazos de tratamiento después de una cuarta dosis de vacunación contra el SARS-CoV-2.

    Evaluar descriptivamente la respuesta inmune humoral a largo plazo (reactogenicidad e inmunogenicidad) de la 4ª dosis de vacunación frente al SARS CoV-2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject is ≥75 years old.
    • For study entry in Part B the subject was vaccinated with one of the following vaccination regimens (1st + 2nd + 3rd dose):
    o BNT162b2 + BNT162b2 + BNT162b2
    o BNT162b2 + BNT162b2 + mRNA-1273
    o mRNA-1273 + mRNA-1273 + mRNA-1273
    o mRNA-1273 + mRNA-1273 + BNT162b2
    o ChAdOx-1-S + ChAdOx-1-S + BNT162b2
    o ChAdOx-1-S + ChAdOx-1-S + mRNA-1273

    • The last dose of the above vaccinations must have been administered at least 1 month prior to study entry. Vaccination status should be documented in the source data and will be captured in the eCRF.
    • No contra-indication against any of the vaccine products in the trial.
    • Written informed consent from subject has been obtained.
    Población de edad avanzada (≥75 años).

    Para entrar en la parte B del estudio, el sujeto vacunado mediante una de las siguientes pautas de vacunación antes de entrar al estudio:
    o BNT162b2 + BNT162b2 + BNT162b2
    o BNT162b2 + BNT162b2 + mRNA-1273
    o mRNA-1273 + mRNA-1273 + mRNA-1273
    o mRNA-1273 + mRNA-1273 + BNT162b2
    o ChAdOx-1-S + ChAdOx-1-S + BNT162b2
    o ChAdOx-1-S + ChAdOx-1-S + mRNA-1273

    La última dosis debe haber sido recibida al menos 1 mes antes de entrar en el estudio. El estado de vacunación debe documentarse en el documento fuente y en el eCRD

    El sujeto no puede presentar contraindicaciones a ninguna de las vaucnas que se van a administrar en el estudio

    Firma voluntaria del consentimiento informado
    E.4Principal exclusion criteria
    • Prior to study entry the subject got vaccinated with a regimen not included in the above list.
    • Last anti-SARS-CoV-2 vaccine dose administered less than one month prior to study entry.
    • Vaccination against a disease other than COVID-19 within 2 weeks prior to study entry. Only exception: Influenza vaccination which is allowed at any time.
    • Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to >10 mg/day prednisolone.
    • Subject participates or participated in Part A of this trial.
    Paciente vacunado con un esquema de vacunación no contemplado en los criterios de inclusión

    Última dosis de la vacuna recibida hace menos de un mes de la entrada en el estudio

    Paciente vacunado frente a otra enfermedad en las 2 últimas semanas previas a la entrada en el estudio. La única vacuna que se permite haber recibido es la vacuna contra la gripe

    Paciente recibiendo terapia inmunosupresora, por ejemplo paciente que está en continuo tratamiento con glucocorticosteroides recibiendo una dosis equivalente a >10 mg/día de prednisolona

    Sujeto que está participando o ha participado en la parte A de este ensayo clínico
    E.5 End points
    E.5.1Primary end point(s)
    • Rate of 2-fold antibody titre increase 14 days after the 4th vaccination dose measured by quantitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wild-type virus.
    Tasa de aumento de los títulos de anticuerpos en el doble de la cantidad inicial tras la 4ª dosis de la vacuna, medido mediante un ensayo inmunoabsorbente ligado a enzima cuantitativo (Anti-RBD-ELISA) contra la cepa inicial del virus, 14 días después de la 4ª dosis
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days after IMP administration
    14 días tras la administración del IMP
    E.5.2Secondary end point(s)
    Safety endpoint:
    • Unsolicited AEs until the end of trial.
    • Solicited AEs for 7 days after a 4th vaccination dose.
    • Rate of severe adverse events (AEs) Grade ≥3 according to the National Cancer Institute Common Toxicity Criteria up to three months after a 4th vaccination dose

    Secondary endpoints:
    • Change in neutralizing antibody titre (Virus Neutralisation Assay) against wild-type 14 days after a 4th vaccination dose, to be performed in a subgroup only.
    • Change in neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern 14 days after a 4th vaccination dose, to be performed in a subgroup only.
    • Antibody titre level 12 months after a 4th vaccination dose measured by a quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA assay).
    • Neutralizing antibody titre (Virus Neutralisation Assay) against wild-type SARS-CoV-2 at 12 months after a 4th vaccination dose.
    • Neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern at 12 months after a 4th vaccination dose.

    Exploratory endpoints:
    • Change in cellular immune response measured by qPCR 14 days after 4th booster dose in a subgroup analysis.
    • Neutralising capacity measured by neutralising activity against newly emerging variants in bio-banked samples in a subgroup analysis after a 4th vaccination dose.
    • Correlates of humoral immune response, cellular immune responses and viral neutralising capacity against SARS-CoV-2 variants of concern (VOCs).
    Variables de seguridad:
    Acontecimientos adversos no solicitados hasta el final del estudio

    Acontecimientos adversos solicitados durante los 7 primeros días tras haber recibido la 4ª dosis

    Tasa de acontecimientos adversos graves (AAG) de grado ≥3 según los Criterios Comunes de Toxicidad del Instituto Nacional de Cáncer
    ocurridos hasta tres meses después de la administración de la 4ª dosis de la vacuna

    Variables secundarias:
    Cambio en el título de anticuerpos neutralizantes (ensayo de
    neutralización del virus) contra la cepa inicial del virus 14 días después de haber recibido una 4ª dosis de la vacuna en un subgrupo de sujetos.

    Cambio en el título de anticuerpos neutralizantes (ensayo de
    neutralización del virus) frente a variantes de interés en un subgrupo de pacientes, 14 días después de haber recibido la 4ª dosis de la vacuna.

    Nivel del título de anticuerpos a los 12 meses después de haber recibido una 4º dosis de la vacuna medido medicante un ensayo cuantitativo inmunoabsorbente ligado a enzimas (ensayo anti-RBD-ELISA).

    Título de anticuerpos neutralizantes (ensayo de neutralización del virus) frente al tipo salvaje SARS-CoV-2 a los 12 meses de haber recibido una 4ª dosis de la vacuna.

    Título de anticuerpos neutralizantes (ensayo de neutralización del virus) frente a las distintas variantes de interés del SARS-CoV-2 12 meses después de haber recibido una 4ª dosis de vacunación.

    Variables exploratorias:
    Cambio en la respuesta inmune celular (respuesta celular CD4+ y CD8+ T) medida por qPCR 14 días despuésde la 4ª dosis en un análisis de subgrupos.

    Título de anticuerpos neutralizantes (ensayo de neutralización del virus) frente a variantes emergentes de SARS-CoV-2 encontradas en muestras de biobanco después de haber recibido la 4ª dosis en un análisis de subgrupos.

    Correlación entre la respuesta inmune humoral, la respuesta inmune
    celular y la capacidad de neutralización viral contra las variantes de
    interés (COV) del SARS-CoV-2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 7 days, 14 days and/or 12 months after IMP administration
    a los 7 días, 14 días y/o 12 meses después de la administración de IMP
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenicidad
    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 No
    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 No
    E.8.2.4Number of treatment arms in the trial18
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Germany
    Ireland
    Lithuania
    Norway
    Spain
    Sweden
    Switzerland
    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
    day of database lock
    El día del cierre de la base de datos
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months21
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 600
    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
    ninguno
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
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