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    Summary
    EudraCT Number:2021-000644-22
    Sponsor's Protocol Code Number:2020PI198
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-07-09
    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 number2021-000644-22
    A.3Full title of the trial
    Effectiveness and Safety of Intra-Dermal Hepatitis B Vaccination after topical application of IMIQUIMOD, in cirrhotic patients, who did not respond to the conventional vaccine regimen: a pilot study
    Efficacité et Sécurité de la Vaccination contre l’hépatite B en intra-dermique après une application topique d’IMIQUIMOD, chez les patients cirrhotiques, non répondeurs au schéma vaccinal classique : une étude pilote
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness and Safety of Intra-Dermal Hepatitis B Vaccination after a local application of cream, called IMIQUIMOD, in cirrhotic patients who did not respond to the conventional (intra-muscular) vaccine regimen.
    Efficacité et Sécurité de la Vaccination contre l’hépatite B en intra-dermique après une application locale de crème, appelée IMIQUIMOD, chez les patients cirrhotiques, n'ayant pas répondus au schéma vaccinal classique ( intra -musculaire )
    A.3.2Name or abbreviated title of the trial where available
    ID MOD VHB
    ID MOD VHB
    A.4.1Sponsor's protocol code number2020PI198
    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 SponsorCHRU de Nancy
    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 supportCHRU de Nancy
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Nancy
    B.5.2Functional name of contact pointBernard
    B.5.3 Address:
    B.5.3.1Street Address29 avenue du Maréchal de Lattre de Tassigny
    B.5.3.2Town/ cityNANCY
    B.5.3.3Post code54000
    B.5.3.4CountryFrance
    B.5.4Telephone numberFranc383155285
    B.5.6E-maildripromoteur@chru-nancy.fr
    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 ALDARA
    D.2.1.1.2Name of the Marketing Authorisation holderMEDA AB
    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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMIQUIMOD
    D.3.9.1CAS number 99011-02-6
    D.3.9.4EV Substance CodeSUB12453MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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) No
    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 ENGERIX B 20 microgrammes/1 ml
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxosmithkline
    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 nameENGERIX B 20 microgrammes/1 ml
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHEPATITIS B SURFACE ANTIGEN
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN (RDNA) ADSORBED ON ALUMINIUM HYDROXIDE [PRODUCED IN S. CEREVISIAE (STRAIN 2150-2-3) BY RDNA]
    D.3.9.4EV Substance CodeSUB25332
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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.IMP: 3
    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 ENGERIX B 20 microgrammes/1 ml
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxosmithkline
    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 nameENGERIX B 20 microgrammes/1 ml
    D.3.4Pharmaceutical form Solution 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 INNHEPATITIS B SURFACE ANTIGEN
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN (RDNA) ADSORBED ON ALUMINIUM HYDROXIDE [PRODUCED IN S. CEREVISIAE (STRAIN 2150-2-3) BY RDNA]
    D.3.9.4EV Substance CodeSUB25332
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cirrhotic patients who have already received a HBV vaccination with a conventional regimen and who have not responded (characterized by a level of antibody Hbs < 10UI/ml at the end of the vaccine regimen).
    Patients cirrhotiques ayant déjà bénéficié d’une vaccination contre le VHB avec un schéma classique et n’ayant pas répondu (caractérisé par un taux d’anticorps anti Hbs < 10UI/ml la fin du schéma vaccinal)
    E.1.1.1Medical condition in easily understood language
    Cirrhotic patients who have already received a HBV vaccination with a conventional regimen and who have not responded
    Patients cirrhotiques ayant déjà bénéficié d’une vaccination contre le VHB avec un schéma classique et n’ayant pas répondu
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10019641
    E.1.2Term Hepatic cirrhosis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10054130
    E.1.2Term Hepatitis B immunisation
    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
    Describe the proportion of patients with HBs antibody levels greater than 10mUI/mL at 1 month of the last injection of vaccine ; with a M0-M1-M6 vaccine regimen using 3 vaccines strategies:
    _ After simple intramuscular vaccine (IM) ( Control group )
    _ After simple intradermal vaccine
    _ after IMIQUIMOD's application followed by intradermal vaccine administration
    Décrire la proportion de patients avec un taux d’anticorps anti-HBs supérieur à 10mUI/mL à 1 mois de la dernière injection avec un schéma vaccinal M0-M1-M6 selon 3 stratégies vaccinales :
    _après administration du vaccin en intramusculaire (IM)
    _après administration du vaccin en intradermique
    _après administration du vaccin en intradermique après application d’IMIQUIMOD
    E.2.2Secondary objectives of the trial
    1) Describe the proportion of patients with an anti-HB antibody level greater than 10mUI/mL at 1 month of the first injection (M1) with a vaccine regimen according to the vaccine strategy
    2) Describe the proportion of patients with an anti-HB antibody level greater than 10mUI/mL at 6 months of the first injection (M6) with a vaccine regimen according to the vaccine strategy
    3) Describe the evolution of the level of anti-HBs antibodies between 2 successive visits according to the vaccine strategy;
    4) Describe the rate of adverse events (by severity level) following the injection of a dose of intradermal vaccine
    5) Describe the rate of adverse events (by severity level) following the injection of an intradermal vaccine dose after prior application of Imiquimod
    1) Décrire la proportion de patients avec un taux d’anticorps anti-HBs supérieur à 10mUI/mL à 1 mois de la première injection (M1) avec un schéma vaccinal selon la stratégie vaccinale
    2) Décrire la proportion de patients avec un taux d’anticorps anti-HBs supérieur à 10mUI/mL à 6 mois de la première injection (M6) avec un schéma vaccinal selon la stratégie vaccinale
    3) Décrire l’évolution du taux d’anticorps anti-HBs entre 2 visites successives selon la stratégie vaccinale ;
    4) Décrire le taux de survenue d’évènement indésirables (par niveau de gravité) consécutif à l’injection d’une dose de vaccin en intradermique
    5) Décrire le taux de survenue d’évènement indésirables (par niveau de gravité) consécutif à l’injection d’une dose de vaccin en intradermique après application préalable d’Imiquimod
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adults (> 18 years old)
    _ Cirrhotic patient, all etiologies except related to chronic HBV infection.
    _Cirrhotic patient who did not respond to a 1st conventional hepatitis B vaccination regimen administered intramuscularly (ac Anti HBs < 10 mUI/ml)
    _Person affiliated to a social security plan
    _Person who received complete information about the organization of the research and who signed informed consent
    Personne majeure ( > 18 ans )
    • Patient cirrhotique, toutes étiologies confondues hormis lié à une infection chronique VHB.
    • Patient cirrhotique ET n’ayant pas répondu à un 1er schéma de vaccination classique contre l’hépatite B administré en intramusculaire (ac Anti HBs < 10 mUI/ml)
    • Personne affilié à un régime de sécurité sociale ou bénéficiaire d’un tel régime
    • Personne ayant reçu l’information complète sur l’organisation de la recherche et ayant signé son consentement éclairé
    E.4Principal exclusion criteria
    Patients with contraindication to the use of an intramuscular vaccine : Patients on Anticoagulants; Hemophiliac Patients, Patients with Severe Hemostasis Disorder (objectified by TP < 30%; and/or a Thombopenia with platelets < 30G/L)
    _Patients with end-stage chronic kidney failure defined by DFG < 15ml/min/1.73m2
    _ hemodialysised Patients
    _Patients with a skin condition that does not allow vaccination (intra-dermal or intra-muscle): Skin sores on both arms: ulcers/abrasions/bubbles ; without healthy skin intervals.
    _Femme of childbearing age who does not have an effective method of contraception
    _Personne referred to sections L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.
    Pregnant, parturient or breastfeeding mother
    Minor (unassecipated)
    An adult subject to a legal protection measure (tutelage, curate, safeguarding of justice)
    Adult person undying to express consent
    _Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under sections L. 3212-1 and L. 3213-1.
    • Personne présentant une allergie connue à l’un des composant du produit évalué
    • Personne présentant une contre-indication aux produits évalués (IMIQUIMOD, ENGERIX) :
     Patients atteints d’une pathologie dysimmunitaire
     Patients présentant une contre-indication à l’utilisation d’un vaccin intra-musculaire (Patients sous Anticoagulants, Patients Hémophiles, ) -– Patients avec un Trouble de l’hémostase sévère objectivé par un ( TP < 30% ; et/ou une Thombopénie avec plaquettes < 30G/L )
     Patients atteints d’une insuffisance rénale chronique terminale définie par un DFG < 15ml/min/1.73m2
     Patients hémodialysés
     Patients avec un état cutanée ne permettant pas une vaccination (intra dermique ou intra musculaire) : Plaies cutanées sur les deux bras : ulcérations/ ulcères/ abrasions / bulles / érythèmes ; sans intervalle de peau saine.
    • Patients cirrhotiques post-VHB
    • Femme en âge de procréer ne disposant pas de moyen de contraception efficace
    • Personne visée aux articles L. 1121-5, L. 1121-7 et L1121-8 du code de la santé publique.
    ­ Femme enceinte, parturiente ou mère qui allaite
    ­ Personne mineure (non émancipé)
    ­ Personne majeure faisant l'objet d'une mesure de protection légale (tutelle, curatelle, sauvegarde de justice)
    ­ Personne majeure hors d'état d'exprimer son consentement
    • Les personnes privées de liberté par une décision judiciaire ou administrative, les personnes faisant l'objet de soins psychiatriques en vertu des articles L. 3212-1 et L. 3213-1.
    E.5 End points
    E.5.1Primary end point(s)
    For each vaccine strategy: proportion of patients with an anti-HBs antibody level greater than 10mUI/mL at M7 from the initial injection.
    Pour chaque stratégie vaccinale : proportion de patients pour lesquels un taux d’anticorps anti-HBs supérieur à 10mUI/mL est retrouvé à M7 de l’injection initiale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7th month of initial injection
    7 ème mois de l'injection initiale
    E.5.2Secondary end point(s)
    1) For each vaccine strategy: proportion of patients for whom an anti-HBs antibody level greater than 10mUI/mL is found at M1 from the initial injection.
    2) For each vaccine strategy: proportion of patients for whom an anti-HBs antibody level greater than 10mUI/mL is found at M6 from the initial injection.
    3) For each vaccine strategy, the evolution of the HB antibody title (in mUI/mL) will be considered:
    - Between dosages made at M0 and M1 (before versus 1 month of the first injection)
    - Between dosages at M1 and M6 (before versus 5 months of the 2nd injection)
    - Between dosages at M6 and M7 (before versus 1 month of the 3rd injection)
    4) In patients who received the intradermal vaccine without prior application of Imiquimod: number of side effects and sevre side effects immediately or delayed at the injection site in relation to the number of intradermal injections performed in these patients;
    5) In patients who received the intradermal vaccine after prior application of Imiquimod: the number of side effects and severe side effects immediately or delayed at the Imiquimod application area and injection site in relation to the number of intradermal injections after prior application of Imiquimod in these patients.
    1) Pour chaque stratégie vaccinale : proportion de patients pour lesquels un taux d’anticorps anti-HBs supérieur à 10mUI/mL est retrouvé à M1 de l’injection initiale.
    2) Pour chaque stratégie vaccinale : proportion de patients pour lesquels un taux d’anticorps anti-HBs supérieur à 10mUI/mL est retrouvé à M6 de l’injection initiale.
    3) Pour chaque stratégie vaccinale, l’évolution du titre d’anticorps anti-HBs (en mUI/mL) sera considérée :
    - Entre les dosages réalisés à M0 et M1 (avant versus à 1 mois de la 1ère injection)
    - Entre les dosages réalisés à M1 et M6 (avant versus à 5 mois de la 2nde injection)
    - Entre les dosages réalisés à M6 et M7 (avant versus à 1 mois de la 3ème injection)
    4) Chez les patients ayant reçu le vaccin en intradermique sans application préalable d’Imiquimod : nombre d’EI et d’EIG immédiats ou retardés au point d’injection rapporté au nombre d’injections intradermiques réalisés chez ces patients ;
    5) Chez les patients ayant reçu le vaccin en intradermique après application préalable d’Imiquimod : nombre d’EI et d’EIG immédiats ou retardés au niveau de la zone d’application de l’Imiquimod et du point d’injection rapporté au nombre d’injections intradermiques après application préalable d’Imiquimod réalisés chez ces patients.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 1st month (M1) of initial injection
    2) 6th month (M6) of initial injection
    3) - Between dosages at M0 and M1 (before versus 1 month of first injection)
    - Between dosages at M1 and M6 (before versus 5 months of the 2nd injection)
    - Between dosages at M6 and M7 (before versus 1 month of the 3rd injection)
    4) M0, M1, M6 and M7
    5) M0, M1, M6 and M7
    1) 1er mois (M1) de l'injection initiale
    2) 6ème mois (M6) de l'injection initiale
    3) - Entre les dosages réalisés à M0 et M1 (avant versus à 1 mois de la 1ère injection)
    - Entre les dosages réalisés à M1 et M6 (avant versus à 5 mois de la 2nde injection)
    - Entre les dosages réalisés à M6 et M7 (avant versus à 1 mois de la 3ème injection)
    4) M0, M1, M6 et M7
    5) M0, M1, M6 et M7
    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 Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Last visit of last subject
    Date de la dernière visite de la dernière personne participant l’essai.
    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 months37
    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 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    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
    Aucun
    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 Decision2021-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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