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    Summary
    EudraCT Number:2013-005581-19
    Sponsor's Protocol Code Number:719_OPBG_2014
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2014-07-09
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-005581-19
    A.3Full title of the trial
    Immune memory to HPV induced by Gardasil in girls and boys
    Memoria immunologica indotta da Gardasil verso il Papilloma Virus nei maschi e nelle femmine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immune memory to HPV induced by Gardasil in girls and boys
    Memoria immunologica indotta da Gardasil verso il Papilloma Virus nei maschi e nelle femmine
    A.3.2Name or abbreviated title of the trial where available
    B-cell memory to Gardasil®
    Mempria delle cellule B indotta da Gardasil
    A.4.1Sponsor's protocol code number719_OPBG_2014
    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 SponsorBambino Gesù Children’s Hospital
    B.1.3.4CountryItaly
    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 supportSanofi Pasteur MSD
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBambino Gesù Children’s Hospital
    B.5.2Functional name of contact pointRita Carsetti
    B.5.3 Address:
    B.5.3.1Street AddressP.zza S. Onofrio 4
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00165
    B.5.3.4CountryItaly
    B.5.4Telephone number00390668592647
    B.5.5Fax number00390668592904
    B.5.6E-mailrita.carsetti@opbg.net
    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.2.1.1.1Trade name Gardasil
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD SNC
    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.3.1Product nameGardasil
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 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
    Healthy subjects undergoing voluntary vaccination
    Soggetti sani che stanno effettuando la vaccinazione volontariamente
    E.1.1.1Medical condition in easily understood language
    Healthy subjects undergoing voluntary vaccination
    Soggetti sani che stanno effettuando la vaccinazione volontariamente
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the frequency of B cells able to produce antibodies specific for HPV6/11/16/18 before and after vaccination with Gardasil® at any vaccination point from 2 dose vaccine schedule.
    Misurare la frequenza delle cellule B della memoria indotta dalla vaccinazione: verrà effettuato, pertanto, un prelievo al t0 prima della prima dose di vaccino e della seconda dose di vaccino e per verificarne poi la persistenza a 12, 24 e 36 mesi dal termine del ciclo vaccinale.
    E.2.2Secondary objectives of the trial
    To evaluate the influence of each vaccine dose on the frequency of memory B cells and the level of specific antibodies in the serum
    To correlate the level of serum antibodies to the frequency of specific memory B cells
    Valutare l'influenza di ciascuna dose di vaccino sulla frequenza di cellule B di memoria e il livello di anticorpi specifici nel siero
    Correlare il livello di anticorpi del siero e la frequenza di cellule B memoria specifiche
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Age 11 to 12 years old, at enrolment
    Male and female
    undergoing voluntary vaccination
    Expected compliance form the subject and his/her parents to the study protocol
    Signed Informed Consent Form (ICF) by parent(s) or legal representative(s) and by the subject
    soggetti di 11 e 12 anni di età, già compiuti all’arruolamento;
    entrambi i sessi;
    soggetti che sono volontariamente in procinto di effettuare la vaccinazione contro l’HPV
    soggetti e loro genitori/tutore legale in grado di essere complianti con il protocollo di studio
    ottenimento del consenso/assenso alla partecipazione da parte dei genitori/tutore legale e dei soggetti
    E.4Principal exclusion criteria
    Subjects suffering from hypersensitivity to human papillomavirus vaccine, yeast, or any component
    Subjects under immunosuppressive treatment, suffering from hematological and neoplastic diseases
    Soggetti ipersensibili al vaccino , al lievito o ad altri componenti trattamento immunosoppressivo, malattie ematologiche e neoplastiche
    E.5 End points
    E.5.1Primary end point(s)
    To determine the frequency of B cells able to produce antibodies specific for HPV6/11/16/18 before and after vaccination with Gardasil® at any vaccination point from 2 dose vaccine schedule.
    Misurare la frequenza delle cellule B della memoria indotta dalla vaccinazione: verrà effettuato, pertanto, un prelievo al t0 prima della prima dose di vaccino e della seconda dose di vaccino e per verificarne poi la persistenza a 12, 24 e 36 mesi dal termine del ciclo vaccinale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 months
    48 mesi
    E.5.2Secondary end point(s)
    To evaluate the influence of each vaccine dose on the frequency of memory B cells and the level of specific antibodies in the serum
    To correlate the level of serum antibodies to the frequency of specific memory B cells
    Valutare l'influenza di ciascuna dose di vaccino sulla frequenza di cellule B di memoria e il livello di anticorpi specifici nel siero
    Correlare il livello di anticorpi del siero e la frequenza di cellule B memoria specifiche
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 months
    48 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 No
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State 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 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
    LVLS
    Ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months48
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In 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.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients 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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children 11 and 12 years old
    Bambini di 11 e 12 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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 Decision2014-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-11
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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