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    Summary
    EudraCT Number:2010-023156-89
    Sponsor's Protocol Code Number:V212-011
    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:2012-03-20
    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 number2010-023156-89
    A.3Full title of the trial
    A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy.
    Sperimentazione clinica di Fase III, randomizzata, controllata verso placebo, per studiare la sicurezza e l'efficacia di V212 in pazienti adulti affetti da neoplasia solida o neoplasia ematologica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy.
    Sperimentazione clinica di Fase III, randomizzata, controllata verso placebo, per studiare la sicurezza e l'efficacia di V212 in pazienti adulti affetti da neoplasia solida o neoplasia ematologica.
    A.3.2Name or abbreviated title of the trial where available
    V212-011-00
    V212-011-00
    A.4.1Sponsor's protocol code numberV212-011
    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 SponsorMERCK SHARP & DOHME CORP.
    B.1.3.4CountryUnited States
    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 supportMSD Italia S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Italia S.r.l.
    B.5.2Functional name of contact pointPaola Chiaretta Fattore
    B.5.3 Address:
    B.5.3.1Street AddressVia Vitorchiano, 151
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number06.36191
    B.5.5Fax number06.36191
    B.5.6E-mailpaola.fattore@merck.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 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 nameInactivated Varicella Zoster Virus Vaccine
    D.3.2Product code V212
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeV212
    D.3.9.3Other descriptive nameVaricella Zoster Virus Inactivated
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number8.7
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adult patients with solid tumor or hematologic malignancy.
    Pazienti adulti affetti da neoplasia solida o neoplasia ematologica.
    E.1.1.1Medical condition in easily understood language
    Adult patients with solid tumor or hematologic malignancy.
    Pazienti adulti affetti da neoplasia solida o neoplasia ematologica.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019974
    E.1.2Term Herpes zoster
    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 assess the safety and tolerability of V212 (inactivated VZV vaccine) in adults with solid tumor or hematologic malignancy and to assess the impact of inactivated VZV vaccine on the development of HZ in adults with solid tumor or hematologic malignancy
    Valutare la sicurezza e la tollerabilita' del V212 (vaccino inattivato VZV) negli adulti con tumori solidi o neoplasie ematologiche e di valutare l`impatto del vaccino inattivato VZV sullo sviluppo della HZ negli adulti con tumori solidi o neoplasie ematologiche
    E.2.2Secondary objectives of the trial
    To assess the impact of inactivated VZV vaccine on: 1) the development of V212 in adults with STM; 2) the development of V212 in adults with HM; 3)the development of moderate to severe HZ-associated pain at any time from HZ onset through the end of the 6 month HZ follow-up period; 4) the development of HZ complications, and 5) the development of PHN.
    Per valutare l'impatto del vaccino inattivato VZV su: 1) lo sviluppo del V212 in adulti con STM,2) lo sviluppo del V212 in adulti con HM,3) lo sviluppo di moderata a grave dolore HZ-associato in qualsiasi momento dalla comparsa HZ fino alla fine del mese 6 Hz periodo di follow up,4) lo sviluppo di complicanze HZ,e 5) lo sviluppo di PHN.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OTHER SUBSTUDIES:
    ELISPOT substudy will enroll a subset of patients (~1000 patients of the total ~5136) to measure immune response by interferon-gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay.
    ALTRI SOTTOSTUDI:
    I pazienti che non hanno ricevuto prodotti ematici nei 3 mesi prima dell'arruolamento saranno idonei per l’arruolamento nel sottostudio ELISPOT (solo per i centri che partecipano al sottostudio).
    E.3Principal inclusion criteria
    Patient is ≥18 years of age with a solid tumor or hematologic malignancy receiving immunosuppressive or cytotoxic chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years (if patient is <30 years old, attended primary or secondary school in a country with endemic VZV infection), is not likely to undergo hematopoietic cell transplant, and has not/will not be treated with rituximab in the time period from 3 months prior to enrollment through 28 days following the last dose of study vaccine, is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus. Patient is ≥50 years of age with a hematologic malignancy not in remission, may or may not be receiving chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years, is not likely to undergo hematopoietic cell transplant, and has not/will not be treated with rituximab from 3 months prior to enrolment through 28 days following the last dose of study vaccine is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus.
    Il paziente e' ≥ 18 anni di eta' con un tumore solido o neoplasie ematologiche sottoposti a chemioterapia citotossica o immunosoppressiva, ha una precedente storia di varicella, gli anticorpi anti VZV o la residenza in un paese con infezione endemica da VZV per&gt; 30 anni (se il paziente e' &lt;30 anni, ha frequentato la scuola primaria o secondaria in un paese con infezione endemica da VZV), non e' in grado di sottoporsi a trapianto di cellule emopoietiche, e non ha / non saranno trattati con rituximab nel periodo di tempo dai 3 mesi precedenti l`arruolamento attraverso 28 giorni dopo l`ultima dose di vaccino studio, non e' probabile che hanno ricevuto la profilassi a lungo termine antivirale di durata maggiore di 4 settimane, con attivita' contro VZV, il citomegalovirus o herpes simplex virus. Il paziente e' ≥ 50 anni di eta' con una neoplasia ematologica non in remissione, puo' essere o non essere sottoposti a chemioterapia, ha una precedente storia di varicella, gli anticorpi anti VZV o la residenza in un paese con infezione endemica da VZV per&gt; 30 anni, non e' probabilita' di essere sottoposti a trapianto di cellule emopoietiche, e non ha / non saranno trattati con rituximab da 3 mesi precedenti l`arruolamento attraverso 28 giorni dopo l`ultima dose di vaccino studio e' probabile che non hanno ricevuto la profilassi a lungo termine antivirale di durata maggiore di 4 settimane, con attivita' contro VZV, il citomegalovirus o herpes simplex virus.
    E.4Principal exclusion criteria
    Patient has a prior history of HZ within 1-year of enrolment, a prior history of receipt of any varicella or zoster vaccine, is likely to undergo hematopoietic cell transplant, and has been treated with rituximab or is expected to be treated with rituximab in the period from 3 months prior to enrolment through 28 days following the last dose of study vaccine and is likely to receive long term antiviral prophylaxis (greater than 4 weeks duration) with activity against varicella-zoster virus zoster, cytomegalovirus, or herpes simplex virus.
    Il paziente ha una storia di HZ entro 1 anno di iscrizione, una storia di ricevimento di ogni vaccino contro la varicella o zoster, e' suscettibile di subire il trapianto di cellule ematopoietiche, ed e' stato trattato con rituximab o dovrebbe essere trattato con rituximab in periodo da 3 mesi precedenti l`arruolamento attraverso 28 giorni dopo l`ultima dose di vaccino studio ed e' probabile che per ricevere la profilassi a lungo termine antivirale (maggiore durata di 4 settimane), con attivita' contro il virus della varicella-zoster zoster, il citomegalovirus, o virus herpes simplex.
    E.5 End points
    E.5.1Primary end point(s)
    The primary clinical efficacy endpoint is the incidence of herpes zoster.
    L`endpoint primario di efficacia clinica e' l`incidenza di herpes zoster.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary safety endpoint of the study will be based on the incidence of serious adverse experiences observed during the period up to 28 days Postdose 4 in each vaccination group.
    L’endpoint primario di sicurezza dello studio sara' basato sull’incidenza di esperienze avverse gravi osservate durante il periodo fino a 28 giorni post-dose 4 in ciascun gruppo di vaccinazione.
    E.5.2Secondary end point(s)
    Three secondary efficacy endpoints are defined for this protocol. The first is the incidence of moderate to severe HZ-associated pain. The second is a composite efficacy endpoint of the incidence of HZ complications. The third endpoint is the incidence of PHN
    Sono previsti 3 endponts secondari. Il primo e' l`incidenza del dolore HZ-associato da moderato a grave. Il secondo e' un endpoint composito di efficacia sulla incidenza di complicanze HZ. Il terzo endpoint e' l`incidenza di PHN.
    E.5.2.1Timepoint(s) of evaluation of this end point
    First endoint: at any time from HZ onset through the end of the 6 month HZ-follow-up period. Second endpoint:during all the study Third endpoint: 90 days after the onset of the HZ rash
    Primo endpoint:in qualsiasi momento dall'inizio dell'HZ fino al termine dei 6 mesi di follow-up. Secondo endpoint: durante tutto lo studio. Terzo endpoint: 90 giorni dopo l'inizio dell'eruzione cutanea HZ.
    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 Yes
    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
    immunogenic response to vaccine
    risposta immunogenica al vaccino
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Colombia
    Ecuador
    Guatemala
    Honduras
    Hong Kong
    India
    Jordan
    Korea, Democratic People's Republic of
    Korea, Republic of
    Lebanon
    Mexico
    New Zealand
    Panama
    Peru
    Philippines
    Russian Federation
    Singapore
    South Africa
    Taiwan
    Thailand
    Turkey
    United Arab Emirates
    United States
    Venezuela, Bolivarian Republic of
    E.8.7Trial has a data monitoring committee Yes
    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 15/04/16
    LVLS 15/04/16
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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.1.1Number of subjects for this age range: 0
    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: 3624
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1812
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    immunocompromised individuals with solid tuomr or hematologic malignancy.
    pazienti immunocompromessi affetti da neoplasia solida o neoplasia ematologica.
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1339
    F.4.2.2In the whole clinical trial 5436
    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)
    n.a.
    n.a.
    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 Decision2011-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
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