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    Summary
    EudraCT Number:2011-000757-22
    Sponsor's Protocol Code Number:114700
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-16
    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 number2011-000757-22
    A.3Full title of the trial
    A Phase IIIb open-label, randomised, multi-centre primary immunization study to evaluate the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to alternative 2-dose schedules in 9 - 14 year old healthy females compared to the standard 3-dose schedule for GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine in 15 - 25 year old healthy females
    Studio clinico d’immunizzazione primaria, multicentrico, di Fase IIIb, in aperto, randomizzato, volto a valutare l’immunogenicita' e la sicurezza del vaccino HPV-16/18 L1 VLP AS04 di GlaxoSmithKline (GSK) Biologicals somministrato a ragazze sane di 9-14 anni d’eta', per via intramuscolare, secondo schedule alternative a 2 dosi in confronto alla somministrazione dello stesso vaccino secondo la schedula standard a 3 dosi, in giovani donne sane di 15-25 anni d’eta'.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of immunogenicity and safety of two 2-dose Human Papillomavirusthe (HPV) vaccine schedules in 9-14 years old girls.
    Valutazione della sicurezza e dell'immunogenicita' del vaccino HPV (Papillomavirus umano)somministrato in due dosi a ragazze sane di 9-14 anni d’eta'.
    A.3.2Name or abbreviated title of the trial where available
    HPV-070 PRI
    HPV-070 PRI
    A.4.1Sponsor's protocol code number114700
    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 SponsorGLAXO SMITHKLINE
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l'Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number44 20 8990 1234
    B.5.5Fax number//
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 CERVARIX*IM 1SIR 0,5ML
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 VACCINE [TYPES 16, 18] (RECOMBINANT, ADJUVANTED, ADSORBED)
    D.3.9.4EV Substance CodeSUB27633
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Cervarix is indicated in females from 10 years of age onwards for the prevention of persistent infection, premalignant cervical lesions and cervical cancer (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic human papillomaviruses (HPV) types 16 and 18. In addition, Cervarix has shown efficacy against persistent infection caused by oncogenic HPV types other than HPV-16 and HPV-18.
    Cervarix è indicato nelle donne dai 10 anni in poi per la prevenzione di infezione persistente, lesioni cervicali precancerose e cancro del collo dell'utero (carcinoma a cellule squamose e adenocarcinoma) causati da papillomavirus umani (HPV) oncogenici di tipo 16 e 18.Inoltre, Cervarix ha dimostrato l'efficacia contro l'infezione persistente causato da tipi di HPV oncogenici diversi da HPV-16 e HPV-18.
    E.1.1.1Medical condition in easily understood language
    Cervarix is a vaccine that protects women against infection caused by Human Papillomavirus (HPV) type 16 and 18.These viruses can infect the skin or the genitals, which can lead to cancer
    Cervarix è un vaccino che protegge le donne dall’infezione causata daiPapillomavirus Umani diTipo16e18,che possono infettare la pelle o gli organi genitali,potendo anche provocare il cancro
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10063001
    E.1.2Term Human papilloma virus infection
    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 immunogenicity (as determined by ELISA) of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females is non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females,1 month after the last dose of study vaccine.
    Dimostrare (mediante ELISA) che l’immunogenicità del vaccino HPV-16/18 L1 VLP AS04 somministrato secondo una schedula a 2 dosi a 0,6 mesi in ragazze di 9-14 anni è non-inferiore all’immunogenicità del vaccino somministrato in giovani donne di 15-25 anni secondo la schedula standard a 3 dosi a 0,1,6 mesi, un mese dopo l’ultima dose del vaccino in studio.
    E.2.2Secondary objectives of the trial
    1.If the primary objective is reached, the following objective will be tested:to demonstrate that the immunogenicity(by ELISA)of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females is non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 6 months,12 months,18 months and 30 months after the last dose of study vaccine;2.To demonstrate that the immunogenicity(by ELISA) of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered according to a 2-dose schedule of 0,12 months in 9-14 year old females is noninferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females,1 month,6 months and 12 months after the last dose of study vaccine.For major details please refer to the protocol.
    1.Dimostrare (mediante ELISA) che l’immunogenicità del vaccino HPV-16/18 L1 VLP AS04 somministrato secondo una schedula a 2 dosi a 0,6 mesi in ragazze di 9-14 anni è non-inferiore all’immunogenicità del vaccino somministrato in giovani donne di 15-25 anni secondo la schedula standard a 3 dosi a 0,1,6 mesi, 6 mesi, 12 mesi, 18 mesi e 30 mesi dopo l’ultima dose del vaccino in studio;2.Dimostrare (mediante ELISA) che l’immunogenicità del vaccino HPV-16/18 L1 VLP AS04 somministrato secondo una schedula a 2 dosi a 0,12 mesi in ragazze di 9-14 anni è non-inferiore all’immunogenicità del vaccino somministrato in giovani donne di 15-25 anni secondo la schedula standard a 3 dosi a 0,1,6 mesi, 1 mese, 6 mesi e 12 mesi dopo l’ultima dose del vaccino in studio. Per maggiori dettagli fare riferimento al protocollo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A female between, and including, 9 and 25 years of age at the time of the first vaccination;2.Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form;3.Healthy subjects as established by medical history and clinical examination before entering into the study; 4.Female subjects of non-childbearing potential may be enrolled in the study;5.Nonchildbearing potential is defined as pre-menarche, current tubal ligation,hysterectomy, ovariectomy or post-menopause; 6.Female subjects of childbearing potential may be enrolled in the study, if the subject:a. has practiced adequate contraception for 30 days prior to vaccination,b. has a negative pregnancy test on the day of vaccination, c.has agreed to continue adequate contraception during the entire vaccination period and up to two months after the last study vaccine dose.
    1.Soggetti che, e/o soggetti i cui genitori/tutore legale, siano ritenuti dallo Sperimentatore capaci e desiderosi di osservare quanto richiesto dal protocollo di studio;2.Soggetti femminili che al momento della prima vaccinazione abbiano un’età compresa tra 9 e 25 anni (che non abbiano ancora raggiunto il 26° compleanno);3.Consenso informato scritto ottenuto, prima dell’arruolamento nello studio, dal soggetto maggiorenne e dai genitori/tutore legale del soggetto minorenne; i soggetti minori, inoltre, possono firmare e datare un modulo di assenso informato scritto;4.Soggetti sani, come accertato attraverso l’anamnesi e la visita medica prima dell’arruolamento nello studio;5.Soggetti non a rischio di concepimento, cioè in fase pre-menarca o con legatura delle tube, isterectomia, ovariectomia o in post-menopausa;6.Soggetti potenzialmente fertili possono essere arruolate nello studio se:a.hanno praticato un’adeguata contraccezione almeno da 30 giorni prima della vaccinazione, b.risultano negative al test di gravidanza urinario eseguito il giorno stesso della vaccinazione, c.sono d’accordo di continuare l’adeguata contraccezione per l’intero periodo delle vaccinazioni e fino a due mesi dopo l’ultima dose di vaccino in studio.
    E.4Principal exclusion criteria
    1.Pregnant or breastfeeding;2.A female planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose;3.Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol;4.Child in care;5.Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 36);6.Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine/product dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day (for adult subjects) or ≥ 0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed;7.History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines;8.Cancer or autoimmune disease under treatment;9.Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window;10.Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device);11.Previous administration of MPL or AS04 adjuvant;12.Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. 13.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required);14.Family history of congenital or hereditary immunodeficiency. 15.Major congenital defects or serious chronic illness;16.Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine;17.Acute disease and/or fever at the time of enrolment.Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting, or ≥ 38.0°C (100.4°F) on rectal setting;18. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.Enrolment will be deferred until condition is resolved.
    1.Soggetto in gravidanza o in allattamento;2.Soggetto che durante l’intero periodo delle vaccinazioni e fino a due mesi dopo l’ultima dose di vaccino in studio, pianifichi una gravidanza o abbia probabilità di restare incinta, a giudizio dello Sperimentatore, o programmi d’interrompere le precauzioni contraccettive;3.Precedente vaccinazione anti-HPV o vaccinazione programmata, durante lo studio, con un altro vaccino anti-HPV diverso da quello previsto dal presente protocollo. 4.Minore legalmente affidato ad istituto/servizio/comunità socio-assistenziali;5.Utilizzo di qualsiasi farmaco o vaccino sperimentale o non registrato, escluso il presente vaccino in studio, nei 30 giorni antecedenti la prima dose del vaccino in studio; o programmazione del loro uso durante lo studio clinico (fino al Mese 36);6.Somministrazione cronica (definita come più di 14 giorni consecutivi in totale) di immunosoppressori o di altri farmaci immuno-modulatori nei sei mesi antecedenti la prima vaccinazione. Per i corticosteroidi si intenda prednisone, o un equivalente, in dose ≥ 20 mg/die per i soggetti adulti o ≥ 0.5 mg/kg/die per i soggetti pediatrici. Sono consentiti steroidi topici e per inalazione;7.Storia di malattia allergica, di sospetta allergia o di reazioni allergiche che potrebbero essere aggravate da un qualsiasi componente del vaccino in studio;8.Cancro o patologia autoimmune in corso di trattamento;9.Somministrazione/programmazione della somministrazione di un vaccino non previsto dal protocollo di studio nei 30 giorni antecedenti ciascuna dose di vaccino. E’ permessa la somministrazione di vaccini di routine, come l’anti-meningococco, l’anti-epatite A e B, i vaccini inattivati per l’influenza e i vaccini contenenti gli antigeni di difterite/tetano fino a 8 giorni prima di ciascuna dose del vaccino in studio. L’arruolamento potrà essere posticipato fino a che il soggetto sarà fuori dalla finestra temporale richiesta;10.Contemporanea partecipazione, in qualsiasi momento del presente studio, ad un altro studio clinico, in cui il soggetto è stato o sarà esposto ad un prodotto ( farmaco o dispositivo) sperimentale o non sperimentale;11.Precedente somministrazione dell’adiuvante MPL (3-O-desacil-4’monofosforil lipide A) o AS04;12.Somministrazione d’immunoglobuline e/o di qualsiasi emo-derivato nei tre mesi antecedenti la prima dose del vaccino in studio o programmazione della loro somministrazione durante lo studio;13.Conferma o sospetto, in base alla storia medica e all’esame fisico del soggetto, di qualsiasi condizione d’immunosoppressione o d’immunodeficienza ( non sono richiesti test di laboratorio);14.Storia familiare d’immunodeficienza congenita o ereditaria;15.Difetti congeniti maggiori o gravi malattie croniche;16.Disfunzioni polmonari, cardiovascolari, epatiche o renali acute o croniche, clinicamente significative, dimostrate mediante visita medica o test di laboratorio e che, a giudizio del Medico Sperimentatore, precludano la somministrazione del vaccino in studio;17.Malattia acuta e/o febbre al momento dell’arruolamento.Si definisce febbre una temperatura ≥ 37,5°C alla misurazione orale, ascellare o timpanica oppure ≥ 38,0°C alla misurazione rettale; 18.Soggetti con malattie minori (come diarrea moderata, infezioni lievi del tratto respiratorio superiore) senza febbre, possono essere arruolate a discrezione del Medico Sperimentatore. L’arruolamento sarà posticipato fino alla risoluzione della malattia.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity: Anti-HPV-16/18 seroconversion rates and antibody titres (by ELISA) 1 month after the last dose of study vaccine, in the group (0,6) and the group (0,1,6).
    Immunogenicità: Percentuali di sieroconversione e titoli anticorpali anti-HPV-16/18 misurati, mediante ELISA, un mese dopo l’ultima dose di vaccino in studio, nel Gruppo (0,6) e nel Gruppo (0,1,6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month after the last dose of vaccine.
    1 mese dopo l'ultima dose di vaccino.
    E.5.2Secondary end point(s)
    A.Immunogenicity: 1.Anti-HPV-16/18 seroconversion rates and antibody titres (by ELISA) at Day 0 and Months 7, 12, 18, 24 and 36 (for subjects having received their last vaccine dose at Month 6) or at Day 0 and Months 13, 18, 24 and 36 (for subjects having received their last vaccine dose at Month 12) in all subjects; 2.Anti-HPV-16/18 antibody titres (by PBNA) at Day 0 and Months 7, 12, 18, 24 and 36 (for subjects having received their last vaccine dose at Month 6) or at Day 0 and Months 13, 18, 24 and 36 (for subjects having received their last vaccine dose at Month 12) in a subset of subjects; 3.Anti HPV-16/18 specific T and B cell-mediated immune responses (frequency of cytokine-positive CD4 or CD8 T-lymphocytes and frequency of memory B-cells) at Day 0, Months 7, 12, 24 and 36 (for subjects having received their last vaccine dose at Month 6) or at Day 0, Months 13, 18 and 36 (for subjects having received their last vaccine dose at Month 12) in a sub-cohort of subjects. B Safety: 1.The occurrence and intensity of solicited local symptoms during the 7-day period (day 0-6) following each vaccination in all groups;2.The occurrence, intensity and relationship to vaccination of solicited general symptoms during the 7-day period (day 0-6) following each vaccination in all groups;3.The occurrence, intensity and relationship to vaccination of unsolicited symptoms during the 30-day period (day 0-29) following each vaccination in all groups;4.The occurrence of pIMDs from first vaccination to 6 months after the last vaccine dose in all groups;5.The occurrence of MSCs throughout the study period (from Day 0 up to Month 36)in all groups; 6.The occurrence of SAEs throughout the study period (from Day 0 up to Month 36) in all groups; 7.The occurrence of SAEs related to the investigational product, to study participation, to GSK concomitant products or any fatal SAE throughout the study period (from Day 0 up to Month 36) in all groups;8.The occurrence of pregnancy and pregnancy outcomes throughout the study period (from Day 0 up to Month 36) in all groups; 9.The percentage of subjects completing the vaccination schedule in all groups.
    A. Immunogenicità: 1.Percentuali di sieroconversione e titoli anticorpali anti-HPV-16/18 misurati in tutti i soggetti, mediante ELISA, al Giorno 0 e ai Mesi 7, 12, 18, 24 e 36 (per i soggetti che hanno ricevuto l’ultima dose di vaccino al Mese 6) o al Giorno 0 e ai Mesi 13, 18, 24 e 36 (per i soggetti che hanno ricevuto l’ultima dose di vaccino al Mese 12); 2.Titoli anticorpali anti-HPV-16/18 misurati in un sotto-gruppo di soggetti, mediante PBNA, al Giorno 0 e ai Mesi 7, 12, 18, 24 e 36 (per i soggetti che hanno ricevuto l’ultima dose di vaccino al Mese 6) o al Giorno 0 e ai Mesi 13, 18, 24 e 36 (per i soggetti che hanno ricevuto l’ultima dose di vaccino al Mese 12); 3.Risposte immuni anti-HPV-16/18 mediate da cellule T e B specifiche, misurate in una sotto-coorte di soggetti in termini di frequenza di linfociti-T CD4 o CD8 positivi alle citochine e di frequenza di cellule B della memoria, al Giorno 0 e ai Mesi 7, 12, 24 e 36 (per i soggetti che hanno ricevuto l’ultima dose di vaccino al Mese 6) o al Giorno 0 e ai Mesi 13, 18 e 36 (per i soggetti che hanno ricevuto l’ultima dose di vaccino al Mese 12). B. Sicurezza: 1.Comparsa e intensità di sintomi locali evocati, nei 7 giorni (giorni 0-6) successivi ad ogni vaccinazione, in tutti i Gruppi di soggetti;2.Comparsa, intensità e correlazione con la vaccinazione di sintomi generali evocati*, nei 7 giorni (giorni 0-6) successivi ad ogni vaccinazione, in tutti i Gruppi di soggetti; 3.Comparsa, intensità e correlazione con la vaccinazione di sintomi non evocati*, nei 30 giorni (giorni 0-29) successivi ad ogni vaccinazione, in tutti i Gruppi di soggetti; 4.Comparsa di pIMDs (potential Immune-Mediated Diseases = potenziali malattie immuno-mediate) a partire dalla prima vaccinazione fino a 6 mesi dopo l’ultima dose di vaccino in tutti i Gruppi di soggetti; 5.Comparsa di MSCs (Medically Significant Conditions = condizioni medicalmente significative) durante tutta la durata dello studio, cioè dal Giorno 0 fino al Mese 36, in tutti i Gruppi di soggetti; 6.Comparsa di SAEs durante tutta la durata dello studio, cioè dal Giorno 0 fino al Mese 36, in tutti i Gruppi di soggetti; 7.Comparsa di SAEs correlati al prodotto in studio, alla partecipazione allo studio, a concomitanti farmaci di GSK o comparsa di qualsiasi SAE fatale durante tutta la durata dello studio, cioè dal Giorno 0 fino al Mese 36, in tutti i Gruppi di soggetti; 8.Verificarsi di gravidanze e loro esito, durante tutta la durata dello studio, cioè dal Giorno 0 fino al Mese 36, in tutti i Gruppi di soggetti; 9.Percentuale di soggetti che completano il ciclo vaccinale in tutti i Gruppi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    7-12-18-24-36 months.
    7-12-18-24-36 mesi.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunogenicità
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Taiwan
    Thailand
    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
    LVLS
    LVLS
    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 months41
    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 months41
    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: 1095
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 476
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 619
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 333
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 612
    F.4.2.2In the whole clinical trial 1428
    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)
    If non-inferiority of any of the 2-dose schedule (0,6 month or 0,12 month) versus the standard 3-dose schedule (0,1,6) cannot be demonstrated 1 month after the last dose of study vaccine, or at any further time-point, a third vaccine dose will be offered to the subjects of the group with the 2-dose schedule at the end of the study (according to local prescribing information).
    Se la non-inferiorità di una qualsiasi delle schedule a 2 dosi ( Mese 0,6 o Mese 0,12) rispetto alla schedula standard a 3 dosi non potesse essere dimostrata un mese dopo l’ultima dose del vaccino in studio, o in un qualsiasi time-point successivo, alla fine dello studio sarà offerta una terza dose del vaccino ai soggetti appartenenti al Gruppo con la schedula a 2 dosi (da somministrarsi secondo le indicazioni prescrittive locali).
    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 Decision2011-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-13
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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