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    Summary
    EudraCT Number:2007-000744-28
    Sponsor's Protocol Code Number:X06-Z-305
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-10
    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 ConcernedFinland - Fimea
    A.2EudraCT number2007-000744-28
    A.3Full title of the trial
    An open-label, randomised, comparative, multi-centre study of the immunogenicity and safety of a 1-dose regimen and different 2-dose regimens of a Zoster vaccine (Live), ZOSTAVAX ®, in subjects ≥ 70 years of age
    A.4.1Sponsor's protocol code numberX06-Z-305
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameVaricella-zoster virus (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
    Herpes zoster [shingles] and post-herpetic neuralgia
    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 demonstrate that a second dose of Zostavax® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of Zostavax® whether given as a 0-1 month schedule or a 0-3 month schedule in subjects from 70 years of age as measured at 4 weeks post vaccination.
    E.2.2Secondary objectives of the trial
    To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4- weeks post-vaccination after each dose of each 2-doses regimen of Zostavax® administered to subjects ≥ 70 years of age.

    To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of Zostavax® administered to subjects ≥ 70 years of age.

    To summarise the VZV antibody titres annually at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of Zostavax® administered to subjects ≥ 70 years of age.

    To assess the safety profile of a 1-dose regimen and the safety profile of each 2-doses regimen of Zostavax® administered to subjects ≥ 70 years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects will be included in this study if they meet all of the following inclusion criteria:

    1. Age ≥ 70 years
    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
    E.4Principal exclusion criteria
    Subjects will not be included in the study if they meet any of the following non-inclusion criteria:

    1. Febrile (oral temperature ≥ 38.3°C) within the last 72 hours before the first vaccination
    2. History of hypersensitivity / 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 the first vaccination by continuous household contact, or non-household contact (generally strictly greater than 1 hour of exposure indoors), or hospital contact (in same 2- to 4-bed 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. Significant underlying illness preventing completion of the study vaccination schedules
    7. Known active tuberculosis
    8. Immune deficiency disorder, including active neoplastic disease (except local skin cancer) within the prior 5 years
    9. Immune function inpairment caused by medical condition (congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalised malignancy), or immunosuppressive therapy (examples: chemotherapy agents to treat cancer, treatments associated with organ or bone marrow transplantation, daily - or on alternate days - systemic corticosteroids at a dose ≥5 mg/day prednisone equivalent for at least 14 days in the 4 weeks prior to the first vaccination), or any other cause
    10. Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination
    11. Receipt of any other live vaccine within the 4 weeks prior to the first vaccination
    12. Receipt of immunoglobulins or blood-derived products within the first 5 months prior to the first vaccination
    13. Concomitant use of non-topical anti-viral therapy (examples: acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, cidofovir, brivudine)
    14. History of alcohol or recreational drug abuse which in the opinion of the investigator could interfere with study compliance
    15. Any other condition / 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), or any other cause

    There are also a list of temporary contra-indications to further vaccination and definite contra-indications to further vaccination. See Study Protocol Section IV.3 and IV.4.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity

    The primary criteria defined for immunogenicity are the 4 weeks post-dose 1 and 4 weeks post-dose 2 VZV antibody titres (i.e. GMT in gpELISA units/mL) in group 2 and in group 3.

    There are a number of secondary criteria defined for immunogenicity. See Study Protocol Section XI.1.2 for a listing of these [Evaluation criteria, Secondary criteria].
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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 Information not present in EudraCT
    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
    The maximal follow-up duration will be of 36 months post last-dose. This period may be decreased after analyses of results 12 months post last-dose.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) No
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 750
    F.4.2.2In the whole clinical trial 750
    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)
    The treatment is a prophylactic vaccination. There are no plans for continuation treatment after the end of the trial.
    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 Decision2007-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-15
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