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    Summary
    EudraCT Number:2007-006532-66
    Sponsor's Protocol Code Number:ZTV02C
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-24
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-006532-66
    A.3Full title of the trial
    An open-label, single-arm, phase IV study assessing the immunogenicity and safety of ZOSTAVAX at minimum release specification approaching expiry potency in subjects ≥50 years old
    A.4.1Sponsor's protocol code numberZTV02C
    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 SNC
    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.3.2Product code J07BK02
    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
    Not applicable_Healthy volunteers_Up to 50 years of age
    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 whether or not ZOSTAVAX® at minimum release specification and approaching expiry potency elicits an acceptable VZV antibody fold rise (gpELISA) from pre-vaccination to 4 weeks post-vaccination
    E.2.2Secondary objectives of the trial
    To describe the safety profile of ZOSTAVAX® at minimum release specification and approaching expiry potency
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject of either gender aged ≥50 years on day of signing informed consent
    2. Positive history of varicella or residence for >30 years in a country with endemic VZV infection
    3. Subject affiliated to a health social security system
    4. Subject having signed the informed consent form prior to any study procedure
    5. Subject able to attend all scheduled visits and to comply with all study procedures
    E.4Principal exclusion criteria
    1. Subject febrile (oral temperature ≥38.3°C) within 72 hours prior to vaccination
    2. Subject with a prior history of Herpes Zoster clinically diagnosed by a physician
    3. Subject has previously received a varicella or zoster vaccine
    4. Exposure to varicella or herpes-zoster within 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-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
    5. Subject received any other live virus vaccine within 4 weeks prior to vaccination, or is expected to receive any other live virus vaccine during the study
    6. Subject received any inactivated vaccine within 14 days prior to vaccination, or is expected to receive any inactivated vaccine during the study
    7. Subject is treated with immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or expected during the study
    8. Subject is taking any nontopical antiviral therapy with activity against herpesviruses, (including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, cidofovir, brivudine)
    9. Subject is on 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 vaccination until the end of the study, systemic doses greater than required for physiological replacement, i.e., >5 mg of prednisone (or equivalent) for >2 weeks.
    • Excluded immunosuppressive therapies also involve chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation.
    10. Subject has 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’s disease, multiple myeloma, or generalized malignancy
    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 5 years will be eligible for enrollment.
    11. Subject has a history of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin
    12. Subject with known active tuberculosis
    13. Subject with significant underlying illness preventing completion of the study
    14. Subject is currently participating or has participated in a study with an investigational compound or device within 4 weeks of signing informed consent.
    15. Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
    16. Any other reason that in the opinion of the investigator might interfere with the study
    17. Volunteer having been paid more than 4500€ to take part in biomedical researches over the previous 12 months
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity:
    The geometric mean fold rise of VZV antibody titres from pre to post-vaccination (i.e. GMFR)
    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 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) 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 concerned6
    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 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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months3
    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) 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 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 state95
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 95
    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 Decision2008-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-25
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