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    Summary
    EudraCT Number:2007-000344-26
    Sponsor's Protocol Code Number:V211
    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:2007-05-22
    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 number2007-000344-26
    A.3Full title of the trial
    A phase III doule blind randomized multicenter study to evaluate the safety, tolerability and immunogenicity of ZOSTAVAX TM administered concomitantly versus non concomitantly with PNEUMOVAX TM 23 in subjects 60 years of age nad older.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberV211
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMERCK SHARP DOHME
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 ZOSTAVAX
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK & Co., Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.65
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.IMP: 2
    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 PNEUMO 23
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR MSD 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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPneumococcus, purified polysaccharides antigen
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.65
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    D.8 Placebo: 2
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level HLGT
    E.1.2Classification code 10027665
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objectives

    1. To determine whether ZOSTAVAXﾙ administered concomitantly with PNEUMOVAXﾙ 23 elicits a VZV antibody response that is noninferior to that of ZOSTAVAXﾙ administered nonconcomitantly.

    2. To demonstrate whether ZOSTAVAXﾙ elicits an acceptable VZV antibody response when administered concomitantly with PNEUMOVAXﾙ 23.

    3. To assess whether PNEUMOVAXﾙ 23 administered concomitantly with ZOSTAVAXﾙ elicits serotype-specific pneumococcal antibody responses for serotypes 3, 14, 19A, and 22F that are noninferior to those of PNEUMOVAXﾙ 23 administered nonconcomitantly.
    E.2.2Secondary objectives of the trial
    Secondary Objective

    To assess the safety and tolerability of ZOSTAVAXﾙ and PNEUMOVAXﾙ 23 when administered concomitantly.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    SUBJECT/PATIENT INCLUSION CRITERIA

    A subject will be eligible to participate in this study if all of the following criteria apply:

    a. Age 60 years or older

    b. Signed an informed consent prior to any study procedures

    c. Afebrile (<101.0ﾰF [<38.3ﾰC] oral or equivalent) on day of vaccination.

    d. Females must be postmenopausal (self-reported) or have a negative urine pregnancy test.

    e. Any underlying chronic illness must be in stable condition.
    E.4Principal exclusion criteria
    SUBJECT/PATIENT EXCLUSION CRITERIA

    A subject will not be eligible to participate in this study if any of the following criteria apply:

    a. A history of allergic reaction to any vaccine component (including gelatin), or an anaphylactic/anaphylactoid reaction to neomycin or phenol (note that subjects with a history of contact dermatitis from neomycin may receive the vaccine).

    b. Prior history of HZ.

    c. History of invasive pneumococcal disease (positive culture from blood, cerebrospinal fluid, or other normally sterile site).

    d. Known history of other culture-positive pneumococcal disease.

    e. Prior receipt of any pneumococcal, varicella or zoster vaccine.

    f. Any live virus vaccine administered or scheduled in the period from 4 weeks prior to Visit 1 through Visit 3.

    g. Immunoglobulin or any blood products administered or scheduled in the period from 5 months prior to Visit 1 through Visit 3.

    h. Any inactivated vaccine administered or scheduled in the period from 7 days prior to Visit 1 through Visit 3.

    Exception: Inactivated influenza vaccine can be administered during the study, but must be given at least 7 days prior to receipt of the study vaccines or at least 15 days after receipt of the study vaccines.

    i. Participation in an investigational drug or vaccine study within the last 30 days prevaccination.

    j. Any acute intercurrent illness or significant underlying illness that may interfere with the interpretation of the study.

    k. Subject is pregnant or breastfeeding or expecting to conceive within the projected duration of the study.

    l. Use of immunosuppressive therapy. Subjects on corticosteroids should be excluded if they are receiving or are expected to receive, in the period from 4 weeks prior to Visit 1 through Visit 3, systemic doses greater than required for physiological replacement, i.e., >5 mg of prednisone (or equivalent) daily and for >2 weeks. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease.

    m. Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkinﾒs disease, multiple myeloma, generalized malignancy, or autoimmune disease. Subjects with a history of cancer who are not on active treatment and are not thought to be immunosuppressed at enrollment will be eligible for enrollment.

    Note: Subjects with prostate or breast cancer who are not on chemotherapeutic drugs (other than hormone-blocking drugs), subjects with skin cancer who are not receiving radiation therapy or chemotherapy, and subjects with a history of other malignancies who have been disease-free for at least 6 months, will be eligible for enrollment.

    n. Any concomitant use of nontopical antiviral therapy with activity against herpesviruses, including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir.

    o. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
    E.5 End points
    E.5.1Primary end point(s)
    Hypothesis

    1. The geometric mean titer (GMT) of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAXﾙ concomitantly with PNEUMOVAXﾙ 23 will be noninferior to that in subjects who receive ZOSTAVAXﾙ and PNEUMOVAXﾙ 23 nonconcomitantly. (The statistical criterion corresponds to the lower bound of the two-sided 95% confidence interval (CI) on the VZV antibody GMT ratio [concomitant/nonconcomitant] being >0.67.)

    2. ZOSTAVAXﾙ when administered concomitantly with PNEUMOVAXﾙ 23 will elicit an acceptable geometric mean fold rise (GMFR) in VZV antibody titers from prevaccination to 4 weeks postvaccination. (The statistical criterion corresponds to the lower bound of the two-sided 95% CI on GMFR of VZV antibody titers in the concomitant vaccination group being >1.4).



    3. The GMTs of the serotype-specific PnPs antibody responses to serotypes 3, 14, 19A, and 22F at 4 weeks postvaccination in subjects who receive ZOSTAVAXﾙ concomitantly with PNEUMOVAXﾙ 23 will be noninferior to those in subjects who receive ZOSTAVAXﾙ and PNEUMOVAXﾙ 23 nonconcomitantly. (The statistical criterion corresponds to the lower bound of the two-sided 95% CI on the GMT ratio [concomitant/ nonconcomitant] being >0.5.)

    Overall study success requires that all primary hypotheses be met.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 No
    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) Yes
    E.8.2.2Placebo Yes
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 344
    F.4.2.2In the whole clinical trial 472
    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 Decision2007-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-11
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