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    Summary
    EudraCT Number:2021-000333-13
    Sponsor's Protocol Code Number:APHP200046
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-08-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-000333-13
    A.3Full title of the trial
    Efficacy of the nonavalent HPV vaccine in the treatment of difficult-to-treat palmo-plantar warts
    Efficacité du vaccin HPV nonavalent dans le traitement des verrues palmo-plantaires difficiles à traiter
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of the nonavalent HPV vaccine in the treatment of difficult-to-treat palmo-plantar warts
    Efficacité du vaccin HPV nonavalent dans le traitement des verrues palmo-plantaires difficiles à traiter
    A.3.2Name or abbreviated title of the trial where available
    VAC-WARTS
    VAC-WARTS
    A.4.1Sponsor's protocol code numberAPHP200046
    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 SponsorAPHP DRCI
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Gardasil 9 suspension for injection.
    D.2.1.1.2Name of the Marketing Authorisation holderMSD VACCINS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameGardasil 9®
    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 INNHUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA
    D.3.9.4EV Substance CodeSUB26773
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA
    D.3.9.4EV Substance CodeSUB26763
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA
    D.3.9.4EV Substance CodeSUB26769
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA
    D.3.9.4EV Substance CodeSUB26771
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA
    D.3.9.4EV Substance CodeSUB177597
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA
    D.3.9.4EV Substance CodeSUB177598
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA
    D.3.9.4EV Substance CodeSUB177599
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA
    D.3.9.4EV Substance CodeSUB177600
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN - ADSORBED - IN THE FORM OF VIRUS-LIKE PARTICLES PRODUCED IN YEAST CELLS (SACCHAROMYCES CEREVISIAE CANADE 3C-5 (STRAIN 1895)) BY RDNA
    D.3.9.4EV Substance CodeSUB177601
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts in patients of more than 15 years and 3 months of age
    La vaccination par un vaccin nonavalent contre le HPV peut conduire à une résolution complète des verrues palmo-plantaires difficiles à traiter chez les patients âgés de plus de 15 ans et 3 mois.
    E.1.1.1Medical condition in easily understood language
    Vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts in patients of more than 15 years and 3 months of age
    La vaccination par un vaccin nonavalent contre le HPV peut conduire à une résolution complète des verrues palmo-plantaires difficiles à traiter chez les patients âgés de plus de 15 ans et 3 mois
    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
    The main objective is to evaluate if the nonavalent HPV vaccine, as compared to placebo, clears difficult-to-treat palmar or plantar warts (failure of two treatments before inclusion) one month after the third injection in immunocompetent patients
    L'objectif principal est d'évaluer si le vaccin nonavalent contre le HPV, par rapport au placebo, élimine les verrues palmaires ou plantaires difficiles à traiter (échec de deux traitements avant l'inclusion) un mois après la troisième injection chez les patients immunocompétents.
    E.2.2Secondary objectives of the trial
    To assess the improvement of quality-of-life
    To assess the improvement of pain
    To assess the improvement for walking and hand impairment
    Évaluer l'amélioration de la qualité de vie
    Évaluer l'amélioration de la douleur
    Évaluer l'amélioration de la marche et de la mobilité des mains
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients of age ≥ 15 years and 3 months with palmar or plantar warts since more than one year with:
    - ≥ 5 warts (X palmar and X plantar) or
    - ≥ 4 cm2 of Total surface involved by the warts
    (Y cm x Z cm).
    - Patients should have received two lines of treatment during the past year before inclusion, the last treatment must be at 3 weeks maximum before inclusion:
    -At least one months of application of topical salicylic acid
    -At least two sprays of liquid nitrogen
    - Painful warts (VAS ≥ 4) or functional discomfort (Revised foot function index (RFFI) or Cochin Hand Function Scale (CHSF) or social discomfort (DLQI)).
    - No topical or systemic immunosuppresive/ immunomodulating drugs
    - Women of childbearing potential must have a negative pregnancy test and an effective contraception (V1) and up the end of the vaccination period of 6 months;
    - Individuals affiliated to a social security regimen;
    - Individuals able to participate and to follow up during the study period.
    - Patients d'âge ≥ 15 ans et 3 mois présentant des verrues palmaires ou plantaires depuis plus d'un an avec :
    - ≥ 5 verrues (X palmaires et X plantaires) ou
    - ≥ 4 cm2 de surface totale concernée par les verrues.
    (Y cm x Z cm).
    - Les patients doivent avoir reçu deux lignes de traitement au cours de la dernière année avant l'inclusion, le dernier traitement doit être à 3 semaines maximum avant l'inclusion :
    -Au moins un mois d'application d'acide salicylique topique.
    -Au moins deux pulvérisations d'azote liquide
    - Verrues douloureuses (EVA ≥ 4) ou gêne fonctionnelle (indice révisé de la fonction du pied (RFFI) ou échelle de la fonction de la main de Cochin (CHSF) ou gêne sociale (DLQI)).
    - Pas de médicaments immunosuppresseurs/immunomodulateurs topiques ou systémiques.
    - Les femmes en âge de procréer doivent avoir un test de grossesse négatif et une contraception efficace (V1) et jusqu'à la fin de la période de vaccination de 6 mois ;
    - Les personnes affiliées à un régime de sécurité sociale ;
    - Les personnes capables de participer et d'être suivies pendant la période de l'étude.
    E.4Principal exclusion criteria
    - Recent (under 72 hours) Positive Covid test (PCR)
    - Any causes of immunosupression: organ transplant recipients, bone-marrow transplantation, immunosupressive regimens for any diseases, HIV positivity.
    - Women or men who received HPV Vaccine previously of the study;
    - Any serious chronic or progressive disease according to the judgement of the investigator;
    - Individuals with history of known allergies/hypersensitivity to any component of study vaccine;
    - Individuals who have any malignancy or lymphoproliferative disorder;
    - Individuals with thrombocytopenia or coagulation disorder contre-indicating intramusculary injections;
    - Patient with anticoagulant therapy
    - Individuals with body temperature > 38.0 degrees Celsius or/and acute disease within 3 days of intended study vaccination;
    - Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, during the first 6 months ½ of the study;
    - Individuals under a measure of legal protection or unable to consent;
    - Individuals participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of the study.
    - Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable
    - Patient on AME (state medical aid) (unless exemption from affiliation).
    - Patient wishing to be vaccinated with Gardasil 9® within 6 months or refusing the principle of postponing vaccination.
    - Test Covid (PCR) positif récent (moins de 72 heures)
    - Toute cause d'immunosupression : transplantation d'organes, greffe de moelle osseuse, régimes immunosupresseurs pour toute maladie, séropositivité.
    - Femmes ou hommes ayant reçu un vaccin contre le VPH avant l'étude ;
    - Toute maladie chronique ou progressive grave selon le jugement de l'investigateur ;
    - Les personnes ayant des antécédents d'allergies/hypersensibilité connus à l'un des composants du vaccin de l'étude ;
    - Les personnes atteintes d'une quelconque tumeur maligne ou d'un trouble lymphoprolifératif ;
    - Les individus présentant une thrombocytopénie ou un trouble de la coagulation contre-indiquant les injections intramusculaires ;
    - Patient sous traitement anticoagulant
    - Personnes ayant une température corporelle > 38,0 degrés Celsius ou/et une maladie aiguë dans les 3 jours précédant la vaccination prévue pour l'étude ;
    - Femmes enceintes ou allaitantes, ou en âge de procréer qui n'ont pas utilisé ou ne prévoient pas d'utiliser des mesures de contrôle des naissances acceptables, pendant les 6 premiers mois ½ de l'étude ;
    - Les individus sous mesure de protection juridique ou incapables de consentir ;
    - Individus participant à tout essai clinique avec un autre produit expérimental 28 jours avant la première visite de l'étude ou intention de participer à une autre étude clinique à tout moment pendant la réalisation de l'étude.
    - Participation à une autre étude interventionnelle impliquant des participants humains ou être dans la période d'exclusion à la fin d'une étude précédente impliquant des participants humains, le cas échéant.
    - Patient bénéficiant de l'AME (aide médicale d'État) (sauf dispense d'affiliation).
    - Patiente souhaitant être vaccinée par Gardasil 9® dans les 6 mois ou refusant le principe du report de la vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    Complete remission of cutaneous warts 7 months after the first injection of the vaccine
    Rémission complète des verrues cutanées 7 mois après la première injection du vaccin.
    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 Yes
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned14
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee 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
    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 months48
    E.8.9.1In the Member State concerned days
    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: 146
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 146
    F.1.2Adults (18-64 years) Yes
    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 No
    F.3.2Patients Yes
    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 state
    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 Decision2021-10-12
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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