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    Summary
    EudraCT Number:2015-005093-38
    Sponsor's Protocol Code Number:GDS02C/V503-004
    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:2016-05-18
    Trial results View 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 number2015-005093-38
    A.3Full title of the trial
    An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27- to 45-Year-Olds) Compared to Young Adult Women (16-to-26 Year-Olds)
    Sperimentazione clinica in aperto di Fase III per studiare l'immunogenicità e la tollerabilità di GARDASIL®9 (vaccino multivalente contenente particelle virus-simili [VLP] della proteina L1 del papillomavirus umano [HPV]) nelle donne adulte (di età compresa tra 27 e 45 anni) rispetto alle adolescenti (di età compresa tra 16 e 26 anni)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to study the antibody response and tolerability of GARDASIL®9 in women aged 27 to 45 years old compared to women aged 16 to 26 years old.
    Una sperimentazione clinica per studiare la risposta anticorpale e la tollerabilità di GARDASIL®9 in donne di età compresa da 27 a 45 anni rispetto alle donne di età compresa tra 16 e 26 anni.
    A.4.1Sponsor's protocol code numberGDS02C/V503-004
    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 SponsorSanofi Pasteur MSD S.N.C
    B.1.3.4CountryFrance
    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 supportSanofi Pasteur MSD S.N.C.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur MSD
    B.5.2Functional name of contact pointStudy Management Head
    B.5.3 Address:
    B.5.3.1Street Address162 avenue Jean Jaures
    B.5.3.2Town/ cityLyon Cedex 07
    B.5.3.3Post code69367
    B.5.3.4CountryFrance
    B.5.4Telephone number33437 28 40 00
    B.5.5Fax number33437 28 44 51
    B.5.6E-mailclinicaldevelopment@spmsd.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 GARDASIL®9
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD SNC
    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 nameHuman Papillomavirus 9-valent Vaccine, Recombinant
    D.3.2Product code V503
    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
    D.3.9.4EV Substance CodeSUB22591
    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
    D.3.9.4EV Substance CodeSUB22592
    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
    D.3.9.4EV Substance CodeSUB22593
    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
    D.3.9.4EV Substance CodeSUB22594
    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
    D.3.9.4EV Substance CodeSUB91674
    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
    D.3.9.4EV Substance CodeSUB91675
    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
    D.3.9.4EV Substance CodeSUB91676
    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
    D.3.9.4EV Substance CodeSUB91677
    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
    D.3.9.4EV Substance CodeSUB91678
    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 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
    Prevention of cervical,vulvar,vaginal, and anal cancers and related precancers, external genital lesions, Pap test abnormalities, and persistent infection caused by HPV Types 6,11,16,18,31,33,45,52,58
    Prevenzione dei tumori della cervice, della vulva, della vagina e dell'ano e delle lesioni precancerose correlate, delle lesioni genitali esterne, delle anomalie del Pap test e dell'infezione persistente provocate dai tipi di HPV 6, 11, 16, 18, 31, 33, 45, 52 e 58.
    E.1.1.1Medical condition in easily understood language
    Prevention of cervical,vulvar,vaginal, and anal cancers and related precancers, external genital lesions, Pap test abnormalities, and persistent infection caused by Human Papillomavirus
    Prevenzione dei tumori della cervice,vulva,vagina e dell'ano e delle lesioni precancerose correlate,lesioni genitali esterne,delle anomalie del Pap test e dell'infezione persistente provocate dal HPV
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10052182
    E.1.2Term Vaginal papilloma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10066416
    E.1.2Term Vulvovaginal human papilloma virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLT
    E.1.2Classification code 10033724
    E.1.2Term Papilloma viral infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that the administration of GARDASIL®9 in 27- to 45 year old women induces non inferior geometric mean titres (GMTs) for serum anti-HPV 16, 18, 31, 33, 45, 52, and 58 compared with 16- to 26-year-old women.
    Dimostrare che la somministrazione di GARDASIL®9 a donne di età compresa tra 27 e 45 anni induce una media geometrica dei titoli (GMT) anticorpali sierici anti-HPV 16, 18, 31, 33, 45, 52 e 58 non inferiore rispetto a quella indotta in donne di età compresa tra 16 e 26 anni.
    E.2.2Secondary objectives of the trial
    To evaluate the safety/tolerability of GARDASIL®9 in 27- to 45-year-old women compared with 16 to 26-year-old women
    To demonstrate that GARDASIL®9 is immunogenic with respect to HPV types 16, 18, 31, 33, 45, 52, and 58 in 27- to 45-year-old women
    Valutare la sicurezza/tollerabilità di GARDASIL®9 in donne di età compresa tra 27 e 45 anni rispetto a donne di età compresa tra 16 e 26 anni

    Dimostrare che GARDASIL®9 è immunogenico in relazione ai tipi di HPV 16, 18, 31, 33, 45, 52 e 58 in donne di età compresa tra 27 e 45 anni
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be included in the study and to receive the first study vaccination, subjects must meet all inclusion criteria. For items with an asterisk (*), if the subject does not meet these inclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria can be met.
    1. Independent Ethics Committee (IEC)-approved written informed consent form (ICF) and privacy language as per national regulations must be obtained from the subject and/or from the subject’s parent(s) or legal guardian(s) prior to any study-related procedures (including discontinuation of prohibited medication, if applicable); assent (for minor subjects) by the subject is given as required by local law.
    2. Subject is a woman between the ages 16 years and 0 days and 45 years and 364 days as of first vaccination.
    3. Subject is judged to be in good physical health on the basis of medical history, physical examination (if deemed necessary), and laboratory testing.
    4. Subject, or subject's parent or guardian, is able to understand and adhere to the study procedures (e.g., is not planning to relocate far from the investigational centre during the study period); is able to read, understand, and complete the vaccination report card (VRC); is able to understand the risks involved with the study; and voluntarily agrees to participate in the study by giving written informed consent.
    5. For sexually active women: Subject has used effective contraception for 2 weeks prior to enrolment and agrees to use effective contraception through Month 7 of the study. Effective contraception includes oral contraceptives, injection or implant contraception, hormonal patch, intra-uterine device, sterilization or abstinence. Emergency contraception is not considered effective contraception for enrolment into the study.
    6.* Subject has had no temperature ≥37.8°C or 100.0°F (oral) within 24 hours prior to the first injection.
    7. Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
    Per essere inclusi nello studio e ricevere la prima vaccinazione dello studio, i soggetti devono soddisfare tutti i criteri di inclusione. Per le voci contrassegnate con un asterisco (*), se il soggetto non soddisfa questi criteri di inclusione, la visita del Giorno 1 può essere riprogrammata in un momento in cui questi criteri possono essere soddisfatti.
    1. Il modulo di consenso informato (ICF) scritto approvato dal Comitato Etico Indipendente (CEI) e il testo sulla privacy in base alle normative locali devono essere ottenuti dal soggetto e/o dal/i genitore/i o tutore/i legale/i del soggetto prima di qualsiasi procedura correlata allo studio (inclusa sospensione di farmaci vietati se applicabile); l'assenso (per soggetti minorenni) da parte del soggetto è fornito in conformità alle leggi locali.
    2. Il soggetto è una donna di età compresa tra 16 anni e 0 giorni e 45 anni e 364 giorni dalla prima vaccinazione.
    3. Il soggetto si ritiene essere in buona salute fisica sulla base di anamnesi medica, esame obiettivo (se ritenuto necessario) e analisi di laboratorio.
    4. Il soggetto, o il genitore o tutore del soggetto, è in grado di comprendere e rispettare le procedure dello studio (per esempio non sta programmando di trasferirsi lontano dal centro sperimentale durante il periodo dello studio); è in grado di leggere, comprendere e compilare la scheda di vaccinazione (VRC); è in grado di comprendere i rischi implicati nello studio; e accetta volontariamente di partecipare allo studio fornendo un consenso informato scritto.
    5. Per donne sessualmente attive: Il soggetto ha usato un metodo di contraccezione efficace per 2 settimane prima dell'arruolamento e accetta di usare un metodo di contraccezione efficace fino al Mese 7 dello studio. I contraccettivi efficaci includono contraccettivi orali, contraccettivi per iniezione o impiantabili, cerotto ormonale, dispositivo intrauterino, sterilizzazione o astinenza. La contraccezione di emergenza non è considerata contraccezione efficace per l'arruolamento in questo studio.
    6. * Nelle 24 ore precedenti la prima iniezione, la temperatura del soggetto non era ≥37,8 °C o 100,0 °F (orale).
    7. Il soggetto accetta di fornire al personale dello studio un numero di telefono principale e un numero di telefono alternativo per scopi di follow-up.
    E.4Principal exclusion criteria
    To be included and receive the first study vaccination, subjects should not have any exclusion criteria. For items with an asterisk (*), if the subject meets these exclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria are not met.
    1. Subject has a history of an abnormal Pap test or abnormal cervical biopsy results (showing cervical intraepithelial neoplasia or worse) or cervical disease (i.e., surgical treatment for cervical lesions).
    2. Subject has history of genital warts, Vulvar Intraepithelial Neoplasia or Vaginal Intraepithelial Neoplasia.
    3. Subject has a history of a positive test for HPV.
    4. Subject has a history of known prior vaccination with an HPV vaccine, i.e., received a marketed HPV vaccine, or has participated in an HPV vaccine clinical study and has received either active agent or placebo.
    5. Subject is pregnant (as determined by urine pregnancy test).
    6. Subject is, at the time of signing ICF, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
    7. Subject has a history of severe allergic reaction, including known allergy to any vaccine component, including aluminum, yeast, or BENZONASE® (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]) (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that met the criteria for serious adverse experiences defined in this protocol.
    8. Subject has had a splenectomy, or is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune or immunosuppressive condition, or has a history of any disease, which, in the investigator’s opinion, may confound the results of the study or pose an additional risk to the subject.
    9. Subject is receiving or has received in the year prior to enrolment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (tumour necrosis factor-α antagonists, monoclonal antibody therapies (including rituximab [Rituxan]), intravenous gamma globulin, antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrolment) received such therapy, or has received 2 or more courses of high dose corticosteroids (≥20mg/day of prednisone [or equivalent] orally or parenterally) lasting at least 1 week in duration in the year prior to enrolment. Subjects using inhaled, nasal, or topical corticosteroids are considered eligible for the study.
    10. Subject has received any immune globulin or blood-derived product within the 3 months prior to the Day 1 vaccination, or plans to receive any such product during Day 1 through Month 7 of the study.
    11. * Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
    12. Subject has thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injections.
    13. Subject is concurrently enrolled in a clinical study of investigational agent.
    14. Subject has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
    Per essere inclusi e ricevere la prima vaccinazione dello studio, i soggetti non devono soddisfare alcun criterio di esclusione. Per le voci contrassegnate con un asterisco (*), se il soggetto soddisfa questi criteri di esclusione, la visita del Giorno 1 può essere riprogrammata in un momento in cui questi criteri non sono soddisfatti.
    1. Il soggetto ha un’anamnesi di risultati anomali del Pap test o della biopsia cervicale (che mostrano neoplasia intraepiteliale cervicale o un esito peggiore) o patologia a carico della cervice (ossia trattamento chirurgico per lesioni alla cervice).
    2. Il soggetto ha un’anamnesi di verruche genitali, neoplasia intraepiteliale vulvare o neoplasia intraepiteliale vaginale.
    3. Il soggetto ha un’anamnesi di un test positivo per HPV.
    4. Il soggetto ha un’anamnesi di nota vaccinazione precedente con vaccino per HPV, ossia ha ricevuto un vaccino per HPV disponibile in commercio, o ha partecipato a uno studio clinico su un vaccino per HPV e ha ricevuto agente attivo o placebo.
    5. Il soggetto è in gravidanza (stabilita da test di gravidanza sulle urine).
    6. Il soggetto, al momento della firma del Modulo di consenso informato, fa uso di droghe ricreative o illecite o ha avuto un’anamnesi recente (entro l'ultimo anno) di abuso o dipendenza da droga o alcol. Si definiscono persone che fanno abuso di alcol coloro che bevono nonostante problemi sociali, interpersonali e/o legali ricorrenti, conseguenti all'uso di alcol.
    7. Il soggetto ha un’anamnesi di grave reazione allergica, inclusa nota allergia a qualsiasi componente del vaccino, inclusi alluminio, lievito o BENZONASE® (nucleasi, Nycomed [usato per rimuovere acidi nucleici residui da questo e altri vaccini]) (per esempio gonfiore della bocca o della gola, difficoltà respiratorie, ipotensione o shock) che soddisfano i criteri per le esperienze avverse serie definiti in questo protocollo.
    8. Il soggetto ha subito una splenectomia, o è attualmente immuno-compromesso o ha ricevuto una diagnosi di immunodeficienza acquisita o congenita, infezione da HIV, linfoma, leucemia, lupus eritematoso sistemico, artrite reumatoide, artrite reumatoide giovanile, malattia infiammatoria intestinale o altre condizioni autoimmuni o immunosoppressive, o ha un’anamnesi di qualsiasi malattia, che, a giudizio dello sperimentatore, potrebbe alterare i risultati dello studio o costituire un rischio aggiuntivo per il soggetto.
    9. Il soggetto sta ricevendo o ha ricevuto nell'anno precedente all'arruolamento le seguenti terapie immunosoppressive: radioterapia, ciclofosfamide, azatioprina, metotrexato, chemioterapia, ciclosporina, leflunomide (antagonisti del fattore di necrosi tumorale α, terapie con anticorpi monoclonali (incluso rituximab [Rituxan]), gamma globulina endovenosa, siero antilinfocitario, o altra terapia che notoriamente interferisce con la risposta immunitaria. Per quanto riguarda i corticosteroidi sistemici, un soggetto sarà escluso se sta attualmente ricevendo terapia a base di steroidi, ha recentemente (entro 2 settimane dall'arruolamento) ricevuto tale terapia, o ha ricevuto 2 o più cicli di corticosteroidi a dosaggio elevato (≥20mg/die di prednisone [o equivalente] per via orale o parenterale) per almeno 1 settimana nell'anno precedente all'arruolamento. I soggetti che utilizzano corticosteroidi per inalazione, nasali o topici sono considerati eleggibili per lo studio.
    10. Il soggetto ha ricevuto immunoglobuline o prodotti derivati dal sangue entro i 3 mesi precedenti la vaccinazione del Giorno 1, o ha in programma di ricevere tali prodotti durante il periodo dal Giorno 1 fino al Mese 7 dello studio.
    11. * Il soggetto ha ricevuto vaccini non-replicativi (inattivati) entro 14 giorni prima della vaccinazione del Giorno 1 o ha ricevuto vaccini replicativi (vivi) entro 21 giorni prima della vaccinazione del Giorno 1.
    12. Il soggetto è affetto da trombocitopenia o altro disturbo della coagulazione per cui le iniezioni intramuscolari sono controindicate.
    13. Il soggetto è contemporaneamente arruolato in uno studio clinico su un agente sperimentale.
    14. Il soggetto ha un’anamnesi o presenta evidenza attuale di qualsiasi condizione, terapia, anomalia di laboratorio o altra circostanza che potrebbe alterare i risultati dello studio o interferire con la partecipazione del soggetto per l'intera durata dello studio, in modo tale che non sia nel migliore interesse del soggetto partecipare.
    E.5 End points
    E.5.1Primary end point(s)
    The primary immunogenicity endpoints are the cLIA GMTs to HPV 16, 18, 31, 33, 45, 52 and 58.
    Gli endpoint primari di immunogenicità sono le GMT di cLIA per HPV 16, 18, 31, 33, 45, 52 e 58.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 4 weeks after Dose 3.
    Alla settimana 4 dopo Dose 3
    E.5.2Secondary end point(s)
    The secondary immunogenicity endpoints are:

    the cLIA seroconversion percentages to HPV 16, 18, 31, 33, 45, 52 and 58 in 27- to 45-year-old women.

    the cLIA GMTs and the cLIA seroconversion percentages to each of HPV 6,11,16,18,31,33,45,52, and 58 in 16- to 26-year-old women and 27- to 45 year-old women.

    The Safety assessment will focus on injection site adverse reactions and elevated temperatures reported on the VRC. SAEs, pregnancy, and pregnancy-related events will be collected.

    Gli endpoint secondari di immunogenicità includono:
    le percentuali di sieroconversione cLIA in relazione ai tipi di HPV 16, 18, 31, 33, 45, 52 e 58 in donne di età compresa tra 27 e 45 anni.
    le GMT di cLIA e le percentuali di sieroconversione in relazione a ciascuno dei tipi di HPV 16, 18, 31, 33, 45, 52 e 58 in donne di età compresa tra 27 e 45 anni.
    La valutazione di sicurezza sarà incentrata sulle reazioni avverse al sito di iniezione e le temperature elevate segnalate su VRC. Saranno raccolti SAE, gravidanza, ed eventi correlati alla gravidanza.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity: by 4 weeks after Dose 3.
    Safety: for injection Day 1 to Day 5 post-vaccination and systemic AEs Day 1 to Day 15 post-vaccination. For SAEs, pregnancy, and pregnancy-related events , from the time the ICF is signed through 1 month following the last vaccination
    Immunogenicità: entro 4 settimane dopo la Dose 3.
    Sicurezza: per iniezione dal Giorno 1 al Giorno 5 post-vaccinazione ed Eventi avversi sistemici dal Giorno 1 al Giorno 15 post-vaccinazione. Per SAE, gravidanza ed eventi correlati alla gravidanza, dal momento della firma dell'ICF fino a 1 mese dopo l'ultima vaccinazione
    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
    This is an international, multicentre; open-label, immunogenicity and tolerability study of GARDASIL®9 in 16- to 45-year-old women.
    Si tratta di uno studio internazionale, multicentrico, in aperto, di immunogenicità e tollerabilità di GARDASIL®9 somministrato a donne di età compresa tra 16- e 45-anni.
    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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Differente Gruppo d’età
    different age group
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    The end of the study will be defined as the end of data collection including availability of serology results.
    La fine dello studio sarà definita come la fine della raccolta dei dati, inclusa la disponibilità dei risultati dei test sierologici.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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 Yes
    F.1.1Number of subjects for this age range: 150
    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: 150
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1050
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state320
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1200
    F.4.2.2In the whole clinical trial 1200
    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
    ulla
    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 Decision2016-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-09
    P. End of Trial
    P.End of Trial StatusOngoing
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