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    Summary
    EudraCT Number:2009-012458-19
    Sponsor's Protocol Code Number:ZTV03C
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-15
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-012458-19
    A.3Full title of the trial
    An open-label, randomised, comparative, multicentre study of the
    immunogenicity and safety of ZOSTAVAX® when administered by
    intramuscular route or subcutaneous route to subjects ≥50 years of age
    A.4.1Sponsor's protocol code numberZTV03C
    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 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 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 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 nameZostavax
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPreparation of shingles (herpes zoster) vaccine (live)
    D.3.9.1CAS number NA
    D.3.9.3Other descriptive nameVARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
    D.3.10 Strength
    D.3.10.1Concentration unit PFU plaque forming unit
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number19400
    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 No
    D.3.11.8Extractive medicinal product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Not applicable as Prevention of herpes zoster ("zoster" or shingles) and herpes zoster-related post-herpetic neuralgia (PHN).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10019974
    E.1.2Term Herpes zoster
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Two co-primary objectives are:
    To demonstrate that ZOSTAVAX® administered by intramuscular (IM) route is non-inferior to ZOSTAVAX® administered by subcutaneous (SC) route in terms of 4-week post-vaccination antibody titres as measured by glycoprotein enzyme-linked
    immunosorbent assay (gpELISA) to varicella-zoster virus (VZV) in subjects ≥50 years
    of age.
    To demonstrate that ZOSTAVAX® administered by IM route induces an acceptable
    fold-rise of VZV antibody titres (gpELISA) from pre to 4-week post-vaccination in
    subjects ≥50 years of age.
    E.2.2Secondary objectives of the trial
    The secondary immunogenicity objectives are:
    To evaluate the immunogenicity as measured by VZV antibody titres (gpELISA) at
    4 weeks following ZOSTAVAX® administered by IM or SC route.
    To evaluate the immune response as measured by a second assay, the VZV IFN-γ-ELISPOT at 4 weeks following ZOSTAVAX® administered by IM or SC route.

    Safety objective
    To describe the safety profile of ZOSTAVAX® administered by IM or SC route.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject of either gender aged ≥50 years on day of vaccination
    2. Varicella history-positive or residence for >30 years in a country with endemic
    VZV infection
    3. Signed informed consent form prior to any study procedure
    4. Female subjects who are of reproductive potential must have a negative serum
    or urine pregnancy test and agree to remain abstinent, or use (or have their
    partner use) 2 acceptable methods of birth control for 3 months postvaccination.
    (In areas where abstinence is not a locally acceptable method of contraception, 2 acceptable methods of birth control must be used for 3 months postvaccination)
    An acceptable method of birth control is defined as: intrauterine device,
    oral contraception, diaphragm with spermicide, contraceptive sponge, condom,
    vasectomy.
    5. Subject able to attend all scheduled visits and to comply with all study
    procedures.
    E.4Principal exclusion criteria
    1. Febrile (oral temperature ≥38.3°C) within the last 72 hours before vaccination
    2. History of hypersensitivity or anaphylactoid reaction to ZOSTAVAX® components
    including gelatin or neomycin
    3. Prior herpes zoster episode clinically diagnosed by a physician
    4. Prior receipt of varicella or zoster vaccine
    5. Exposure to varicella or herpes zoster within the 4 weeks prior to vaccination by:
    - continuous household contact, or
    - non-household contact (generally >1 hour of exposure indoors), or
    - hospital contact (in same 2- to 4-beds room or adjacent beds in a large
    ward or face-to-face contact with an infectious staff member or
    subject), or
    - contact with a newborn whose mother had onset of varicella 5 days or
    less before delivery or within 48 hours after delivery
    6. Active untreated tuberculosis
    7. Any severe thrombocytopenia or any other coagulation disorder that would
    contraindicate intramuscular injection
    8. Receipt of immunosuppressive therapy or expected to receive
    immunosuppressive therapy during the study as examples:
    - Chemotherapy agents to treat cancer, treatments associated with
    organ or bone marrow transplantation,
    - Daily -or on alternate days- systemic corticosteroids at a dose
    >5mg/day of prednisone (or equivalent) for > 14 days in the 4 weeks
    prior to the vaccination
    9. Known or suspected immune dysfunction that is caused by a medical condition,
    or any other cause.
    - Examples: immune dysfunction including congenital immunodeficiency,
    human immunodeficiency virus (HIV) infection, organ or bone marrow
    transplantation, leukaemia, lymphoma, Hodgkin’s disease, multiple
    myeloma, or generalized malignancy
    - Exceptions: subjects with prostate or breast cancer with no
    chemotherapeutic drugs or receiving only 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 can be included
    10. Receipt of any other live virus vaccine within ≤ 28 days prior to vaccination, or
    planned vaccination with any other live virus vaccine during the study
    11. Receipt of any inactivated vaccine within ≤ 14 days prior to vaccination, or ,planned vaccination with any inactivated vaccine during the study
    12. Receipt of immunoglobulins or any blood products, other than autologous blood
    transfusion, given during the 5 months prior to vaccination or expected
    treatment with immunoglobulins or blood products during the study
    13. Concomitant use of non-topical antiviral therapy (examples: acyclovir,
    famciclovir, valacyclovir, ganciclovir, foscarnet, cidofovir, brivudine) or expected
    to receive non-topical antiviral therapy during the study
    14. The subject is at the time of signing informed consent, a user of recreational or
    illicit drugs or a user who has had a recent history (within the last year) of drug
    or alcohol abuse or dependence
    15. Any other condition or situation that in the opinion of the investigator could
    interfere with the interpretation of the study, including possible interference
    caused by acute intercurrent illness (examples: upper respiratory infection,
    influenza)
    16. Participation in any other clinical study within 4 weeks prior to study vaccination
    or planned during the duration of the study
    E.5 End points
    E.5.1Primary end point(s)
    PRIMARY EVALUATION ENDPOINTS:
    Immunogenicity: Two primary endpoints are defined:
    The 4 week post-vaccination VZV antibody GMT in both groups,
    The VZV antibody GMFR from pre to 4-week post-vaccination in the IM Group.
    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 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 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) 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
    administration of vaccine by SC route as per SmPC
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 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
    End of study is defined as the end of data collection including availability of immune results.
    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 months8
    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 months8
    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.1.1.1In 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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 354
    F.4.2.2In the whole clinical trial 354
    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)
    Not applicable.
    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 Decision2009-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-24
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