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    Summary
    EudraCT Number:2020-003734-20
    Sponsor's Protocol Code Number:COV-1/2-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003734-20
    A.3Full title of the trial
    A Phase I/II study to assess the safety and immunogenicity of COVID-eVax, a candidate plasmid DNA vaccine for COVID-19, in healthy adult volunteers.
    Studio di Fase I/II per determinare la sicurezza e l’immunogenicità di COVID-eVax, un vaccino a DNA plasmidico per COVID-19, in volontari sani adulti.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to determine the safety and immunogenicity of COVID-eVax, a vaccine for COVID-19 in healthy adult volunteers.
    Studio per determinare la sicurezza e l’immunogenicità di COVID-eVax, un vaccino per COVID-19 in volontari sani adulti.
    A.3.2Name or abbreviated title of the trial where available
    COVID-eVax
    COVID-eVax
    A.4.1Sponsor's protocol code numberCOV-1/2-01
    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 SponsorTakis S.r.l.
    B.1.3.4CountryItaly
    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 supportTakis S.r.l.
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportRottapharm Biotech S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPIS s.r.l.
    B.5.2Functional name of contact pointDipartimento Medico
    B.5.3 Address:
    B.5.3.1Street AddressPalazzo Aliprandi - Via Matteotti, 10
    B.5.3.2Town/ cityDesio (MB)
    B.5.3.3Post code20832
    B.5.3.4CountryItaly
    B.5.4Telephone number03626331
    B.5.5Fax number0362633633
    B.5.6E-mailinfo.studiclinici@opis.it
    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 No
    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 nameCOVID-eVax Solution for Injection
    D.3.2Product code [COVID-eVax]
    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 INNCOVID-eVax
    D.3.9.2Current sponsor codeCOVID-eVax
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    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
    COVID-19 prevention.
    Prevenzione della malattia COVID-19.
    E.1.1.1Medical condition in easily understood language
    COVID-19 prevention.
    Prevenzione della malattia COVID-19.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I (Dose Escalation):
    - To assess the safety and reactogenicity of the candidate vaccine COVID-eVax in healthy adult volunteers
    - To identify the dose(s)/schedule(s) to be used in the Phase II (Dose Expansion)

    Phase II (Dose Expansion):
    - To assess the immunogenicity of the selected dose(s)/schedule(s) of the candidate vaccine COVID-eVax in healthy adult volunteers
    Fase I (Incremento Progressivo della Dose):
    - Valutare la sicurezza e la reattogenicità del vaccino candidato COVID-eVax in volontari sani adulti
    - Identificare la dose(le dosi)/lo schema(gli schemi) di trattamento da utilizzare nella Fase II (Espansione della Dose)

    Fase II (Espansione della Dose):
    - Valutare l’immunogenicità della dose(delle dosi)/dello schema(degli schemi) di trattamento del vaccino candidato COVID-eVax in volontari sani adulti
    E.2.2Secondary objectives of the trial
    Phase I (Dose Escalation):
    - To preliminarily assess the immunogenicity of the candidate vaccine COVIDeVax in healthy adult volunteers

    Phase II (Dose Expansion):
    - To assess the duration of the immune response of the selected dose(s)/schedule(s) of the candidate vaccine COVID-eVax in healthy adult volunteers
    - To assess the (long-term post-administration) safety of the candidate vaccine COVID-eVax in healthy adult volunteers
    Fase I (Incremento Progressivo della Dose):
    - Valutare in modo preliminare l’immunogenicità del vaccino candidato COVID-eVax in volontari sani adulti

    Fase II (Espansione della Dose):
    - Valutare la durata della risposta immunitaria della dose(delle dosi)/dello schema(degli schemi) di trattamento del vaccino candidato COVID-eVax in volontari sani adulti
    - Valutare la sicurezza (a lungo termine post-somministrazione) del vaccino candidato COVID-eVax in volontari sani adulti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent obtained before undergoing any study-specific procedure
    2. Healthy male or female aged =18 and = 65 years
    3. Body Mass Index >18.5 and =30 kg/m2
    4. Vital signs within the following values or ranges:
    a. Body temperature = 37,5 °C
    b. Pulse frequency =51 and =100 beats per minute
    c. Diastolic BP =60 mmHg, = 90 mmHg
    d. Systolic BP = 90 mmHg, = 140 mmHg
    e. Respiratory rate = 12 breaths per minute, = 16 breaths per minute
    5. ECG at screening normal or with no clinically significant findings (pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome are absolute exclusion criteria)
    6. Laboratory examinations within normal reference range or with no clinically significant abnormalities
    7. Absence of any respiratory and flu-like symptoms
    8. Non-pregnant women of childbearing potential, willing to practice a highly effective method of contraception from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal
    9. For sexually active men with a female partner of childbearing potential, willingness to use a condom and to refrain from donating sperm from enrolment up to study completion or at least 90 days after the last vaccination in case of withdrawal
    10. Agreement to refrain from blood donation during the course of the study
    11. Able and willing to comply with all study procedures.
    1. Consenso informato firmato e datato ottenuto prima di sottoporsi a qualsiasi procedura specifica dello studio
    2. Maschio o femmina sano di età = 18 e = 65 anni
    3. Indice di massa corporea >18,5 e =30 kg/m2
    4. Segni vitali entro i seguenti valori o intervalli:
    a. temperatura corporea = 37,5 °C
    b. Frequenza cardiaca =51 e =100 battiti al minuto
    c. BP diastolica =60 mmHg, = 90 mmHg
    d. BP sistolica = 90 mmHg, = 140 mmHg
    e. Frequenza respiratoria = 12 respiri al minuto, = 16 respiri al minuto
    5. ECG allo screening normale o senza risultati clinici significativi (le sindromi pre-eccitazione, ad esempio la sindrome di Wolff-Parkinson-White sono criteri di esclusione assoluta)
    6. Esami di laboratorio entro il normale intervallo di riferimento o senza anomalie clinicamente significative
    7. Assenza di sintomi respiratori e simil-influenzali
    8. Donne potenzialmente fertili non in stato di gravidanza, disposte a praticare un metodo contraccettivo altamente efficace dall'iscrizione fino al completamento dello studio o almeno 90 giorni dopo l'ultima vaccinazione in caso di astinenza
    9. Per gli uomini sessualmente attivi con un partner femminile in età fertile, disponibilità ad usare il preservativo e ad astenersi dal donare sperma dall'iscrizione fino al completamento dello studio o almeno 90 giorni dopo l'ultima vaccinazione in caso di astinenza
    10. Accordo di astenersi dalla donazione di sangue durante lo studio
    11. Capacità e disposizione del soggetto partecipante a rispettare tutte le procedure di studio.
    E.4Principal exclusion criteria
    1. History of confirmed infection with SARS-CoV-2, by positive nasopharingeal swab or by positive serological test for SARS-CoV-2 antibodies
    2. Positive serological test for SARS-CoV-2 antibodies at screening
    3. Subjects at high risk of SARS-CoV-2 infection prior or during the trial, including:
    a. subjects with any known exposure in the 4 weeks before enrolment
    b. close contacts of suspected or confirmed COVID-19 or SARS-CoV-2 infection cases
    c. subjects quarantined for any reason
    d. frontline healthcare professionals working in Emergency departments, ICU and other higher risk healthcare areas
    4. Positive serological tests for:
    a. Hepatitis B surface antigen (HBsAg)
    b. Hepatitis C antibodies
    c. Human Immunodeficiency Virus (HIV) antibodies
    5. Subjects with any of the following specific contraindications, even in medical history:
    a. Type 2 diabetes or glucose intolerance, even if controlled
    b. Hypertension, even if controlled
    c. COPD
    d. Any cardiac disease, even if not evident at ECG
    e. Pacemaker
    6. Use of any investigational drugs/treatments, or enrolment in a clinical trial during the 6 months preceding screening
    7. Prior administration of any vaccine in the 2 weeks preceding screening
    8. Administration of any monoclonal or polyclonal antibody product within 4 weeks preceding screening
    9. Administration of any blood product within 3 months of screening
    10. Current or prior administration, within the 6 months preceding screening, of immunosuppressants (inhaled, topical skin and/or eye drop-containing corticosteroids; a short course of corticosteroids, defined as =20 mg/day prednisone or equivalent for 10 days, and low-dose methotrexate are allowed until 4 weeks prior to screening)
    11. Any prior major surgery or any chemio- or radiation therapy within 5 years of screening
    12. Current or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, recurrent severe infections
    13. Active, known, or suspected autoimmune disease (except mild psoriasis, wellcontrolled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy)
    14. Bleeding disorders (e.g. coagulopathy or platelet disorder or coagulation factor deficiency) or prior history of significant bleeding or bruising following IM injections or venipuncture
    15. History of seizures or mental illness
    16. History of allergy to vaccines or of severe allergic reaction of any kind
    17. Metal implants within 20 cm of the planned site(s) of injection
    18. Presence of keloid scar formation or hypertrophic scar, or other clinically significant medical condition at the planned site(s) of injection
    19. Any abnormality or permanent body art (e.g. tattoos) that would interfere with the ability to observe local reactions at the injection site in the deltoid area
    20. History of alcohol or drug abuse during the 12 months preceding the screening
    21. Pregnancy (i.e. positive pregnancy test) or willingness/intention to become pregnant during the study
    22. Breastfeeding
    23. Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject’s safety during trial participation.
    1. Storia di infezione confermata da SARS-CoV-2, da tampone nasofaringeo positivo o da test sierologico positivo per gli anticorpi SARS-CoV-2
    2. Test sierologico positivo per la ricerca di anticorpi anti SARS-CoV-2 allo screening
    3. Soggetti ad alto rischio di infezione da SARS-CoV-2 prima o durante lo studio:
    a. soggetti con qualsiasi esposizione nota nelle 4 settimane precedenti l'arruolamento
    b. contatti ravvicinati con casi di infezione sospetta o confermata da COVID-19 o SARS-CoV-2
    c. soggetti in quarantena per qualsiasi motivo
    d. operatori sanitari in prima linea che lavorano nei reparti di pronto soccorso, in terapia intensiva e in altre aree sanitarie a rischio più elevato
    4. Test sierologici positivi per:
    a. Antigene di superficie dell'epatite B (HBsAg)
    b. Anticorpi dell'epatite C
    c. Anticorpi del virus dell'immunodeficienza umana (HIV)
    5. Soggetti con una delle seguenti controindicazioni specifiche, anche nell'anamnesi:
    a. Diabete di tipo 2 o intolleranza al glucosio, anche se controllato
    b. Ipertensione, anche se controllata
    c. COPD
    d. Qualsiasi malattia cardiaca, anche se non evidente all'ECG
    e. Pacemaker
    6. Uso di qualsiasi farmaco/trattamento sperimentale o iscrizione ad uno studio clinico nei 6 mesi precedenti lo screening
    7. Somministrazione preventiva di qualsiasi vaccino nelle 2 settimane precedenti lo screening
    8. Somministrazione di qualsiasi prodotto anticorpale monoclonale o policlonale entro 4 settimane prima dello screening
    9. Somministrazione di qualsiasi prodotto sanguigno entro 3 mesi dallo screening
    10. La somministrazione attuale o precedente, entro i 6 mesi precedenti lo screening, di immunosoppressori (corticosteroidi per via inalatoria, per via topica e/o oculare contenenti gocce di corticosteroidi; un breve ciclo di corticosteroidi, definito come =20 mg/giorno di prednisone o equivalente per 10 giorni, e metotrexate a basso dosaggio sono consentiti fino a 4 settimane prima dello screening)
    11. Qualsiasi precedente intervento chirurgico importante o qualsiasi intervento di chemioterapia o radioterapia entro 5 anni dallo screening
    12. Stato attuale o sospetto di immunosoppressione o immunodeficienza, compresa l'infezione da HIV, asplenia, infezioni gravi ricorrenti
    13. Malattia autoimmune attiva, nota o sospetta (ad eccezione della psoriasi lieve, della malattia autoimmune tiroidea ben controllata, della vitiligine o della celiachia stabile che non richiede una terapia immunosoppressiva o immunomodulatoria)
    14. Disturbi emorragici (ad esempio coagulopatia o disordine piastrinico o carenza di fattore di coagulazione) o precedenti di emorragie o ematomi significativi in seguito a iniezioni di IM o venipuntura
    15. Storia di crisi epilettiche o malattie mentali
    16. Cronologia di allergie ai vaccini o di reazioni allergiche gravi di qualsiasi tipo
    17. Impianti metallici entro 20 cm dal/i sito/i di iniezione previsto/i
    18. Presenza di formazione di cicatrici cheloidi o cicatrici ipertrofiche o altre condizioni mediche clinicamente significative nel sito o nei siti di iniezione previsti
    19. Qualsiasi anomalia o arte corporea permanente (ad es. tatuaggi) che possa interferire con la capacità di osservare le reazioni locali nel sito di iniezione nell'area del deltoide
    20. Precedenti di abuso di alcol o droghe nei 12 mesi precedenti lo screening
    21. Gravidanza (cioè test di gravidanza positivo) o volontà/intenzione di rimanere incinta durante lo studio
    22. Allattamento al seno
    23. Qualsiasi altra malattia e condizione clinicamente rilevante che, secondo il parere dello Sperimentatore, può mettere a repentaglio l'efficacia o la valutazione della sicurezza o può compromettere la sicurezza del soggetto durante la partecipazione allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I (Dose Escalation):
    - Incidence of solicited local AEs at the injection site and solicited systemic AEs.
    - Incidence of unsolicited AEs and changes in safety laboratory parameters.

    Phase II (Dose Expansion):
    - See secondary immunogenicity endpoints evaluated through 4 weeks post-last vaccination described for Phase I.

    In both study Phases, all primary and secondary endpoints will also be assessed in the time frame through study completion (6 months).
    Fase I (Incremento Progressivo della Dose):
    - Incidenza di eventi avversi locali al sito di iniezione, e di eventi avversi sistemici, esplicitamente richiesti al soggetto.
    - Incidenza di eventi avversi, non esplicitamente richiesti al soggetto, e variazioni nei parametri di laboratorio di sicurezza.

    Fase II (Espansione della Dose):
    - Fare riferimento agli endpoint secondari di immunogenicità descritti per la Fase I.

    In entrambe le Fasi dello studio, tutti gli endpoint primari e secondari saranno valutati anche nella finestra temporale fino al completamento dello studio (6 mesi).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I (Dose Escalation):
    - Through 7 days post-each vaccination
    - Through 4 weeks post-each vaccination

    Phase II (Dose Expansion):
    - Through 4 weeks post-each vaccination
    Fase I (Incremento Progressivo della Dose):
    - Nei 7 giorni successivi a ciascuna vaccinazione.
    - Nelle 4 settimane successive all’ultima vaccinazione.

    Fase II (Espansione della Dose):
    - Nelle 4 settimane successive all’ultima vaccinazione.
    E.5.2Secondary end point(s)
    Phase I (Dose Escalation):
    1. Quantitative antibody titers, binding to the specific SARS-CoV-2 antigen and SARS-CoV-2 neutralizing antibody titer (Geometric Mean Titer (GMT) and Geometric Mean Fold Rise (GMFR).
    2. Change in antigen-specific cellular immune responses to SARSCoV-2.
    3. Percentage of subjects who seroconverted.
    4. Duration of the immune response on all criteria and parameters.
    5. Incidence of unsolicited AEs.

    Phase II (Dose Expansion):
    See primary endpoints described for Phase I.
    1. Duration of the immune response on all criteria and parameters.
    2. Incidence of unsolicited AEs.
    Fase I (Incremento Progressivo della Dose):
    1. Dosaggio quantitativo di anticorpi che si legano agli antigeni specifici per SARS-CoV-2 e titolazione degli anticorpi neutralizzanti contro SARS-CoV-2
    2. Variazione rispetto al basale nelle risposte immunitarie cellulari specifiche contro SARS-CoV-2
    3. Percentuale di soggetti che presentano sieroconversione
    4. Durata della risposta immunitaria su tutti i criteri e parametri
    5. Incidenza di eventi avversi non esplicitamente richiesti al soggetto

    Fase II (Espansione della Dose):
    Fare riferimento agli endpoint primari descritti per la Fase I.
    1. Durata della risposta immunitaria su tutti i criteri e parametri
    2. Incidenza degli eventi avversi non esplicitamente richiesti al soggetto
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I (Dose Escalation):
    1. Through 4 weeks post-each vaccination
    2. Through 4 weeks post-each vaccination
    3. Through 4 weeks post-each vaccination
    4. Through study completion (6 months)
    5. Through study completion (6 months)

    Phase II (Dose Expansion):
    1. Through study completion (6 months)
    2. Through study completion (6 months)
    Fase I (Incremento Progressivo della Dose):
    1. Nelle 4 settimane successive all’ultima vaccinazione
    2. Nelle 4 settimane successive all’ultima vaccinazione
    3. Nelle 4 settimane successive all’ultima vaccinazione
    4. Fino al completamento dello studio (6 mesi)
    5. Fino al completamento dello studio (6 mesi)

    Fase II (Espansione della Dose):
    1. Fino al completamento dello studio (6 mesi).
    2. Fino alla conclusione dello studio (6 mesi).
    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 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
    Reactogenicity and Immunogenicity
    Reattogenicità e Immunogenicità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Disegno in aperto con dose escalation
    Open-label design with dose escalation
    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 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 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 Information not present in EudraCT
    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
    Study completion will occur when all subjects have completed the 6-month observation period (estimated November 2021).
    Il completamento dello studio avverrà quando tutti i soggetti avranno completato il periodo di osservazione di 6 mesi (stimato novembre 2021).
    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 months0
    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: 152
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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.
    Nessuno.
    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 Decision2021-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-03
    P. End of Trial
    P.End of Trial StatusOngoing
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