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    Summary
    EudraCT Number:2007-000165-38
    Sponsor's Protocol Code Number:V87P1E1
    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:2007-07-03
    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 number2007-000165-38
    A.3Full title of the trial
    A Phase II, Open-label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Booster Dose of FLUAD-H5N1 (Surface Antigen Adjuvanted with MF59C.1)

    Influenza Vaccine in Non-elderly Adult and Elderly Subjects
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberV87P1E1
    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 SponsorNOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
    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 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 namePandemic influenza vaccine adjuvanted with MF59C.1 (Fluad like- H5N1)
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namePandemic influenza vaccine adjuvanted with MF59C.1 (Fluad like- H5N1)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active immunoprofilaxis against potential pandemic influenza strain.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059429
    E.1.2Term Influenza immunisation
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess persistence of antibody titers 17-18 months after primary immunization with

    two 0.5mL intramuscular (IM) doses of FLUAD-H5N1 influenza vaccine containing

    either 7.5ﾵg or 15ﾵg of H5N1 influenza antigen, as measured by Hemagglutination

    Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test.



    2. To evaluate the safety of the administration of one 0.5mL IM booster dose of FLUADH5N1

    influenza vaccine containing 7.5ﾵg of H5N1 influenza antigen 17-18 months after

    primary immunization.
    E.2.2Secondary objectives of the trial
    1. To assess immunogenicity of one 0.5mL IM booster dose of FLUAD-H5N1 influenza

    vaccine containing 7.5ﾵg of H5N1 influenza antigen (A/Turkey/Turkey), as measured by

    HI and SRH test in compliance with the requirements of the current European Union

    recommendations (CPMP/BWP/214/96).



    2. To assess immunogenicity of one 0.5mL IM booster dose of FLUAD-H5N1 influenza

    vaccine containing 7.5 ﾵg of H5N1 influenza antigen, as measured by MN test.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female volunteers 18 years of age or older, mentally competent, willing and

    able to give written informed consent prior to study entry

    2. Previously participating in study V87P1, but did not receive the booster dose on

    day 202

    3. Able to comply with all the study requirements

    4. In general good health as determined by:

    a. Medical history

    b. Physical examination

    c. Clinical judgment of the investigator
    E.4Principal exclusion criteria
    1. Any serious disease such as:

    a. Cancer (except for benign or localized skin cancer and non metastatic prostate

    cancer not presently treated with chemotherapy)

    b. Autoimmune disease (including rheumatoid arthritis)

    c. Advanced atherosclerotic disease or complicated diabetes mellitus

    d. Chronic obstructive pulmonary disease (COPD) that requires oxygen therapy

    e. Acute or progressive hepatic disease

    f. Acute or progressive renal disease

    g. Congestive heart failure

    2. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein,

    neomycin or polymyxin or any other component of the vaccine

    3. History of neurological symptoms or signs, or anaphylactic shock following

    administration of any vaccine

    4. Known or suspected (or have a high risk of developing) impairment/ alteration of

    immune function (excluding that normally associated with advanced age) resulting,

    for example, from:

    a. Receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or

    cancer chemotherapy/radiotherapy) within the past 60 days and for the full length

    of the study

    b. Receipt of immunostimulants

    c. Receipt of parenteral immunoglobulin preparation, blood products and/or plasma

    derivates within the past 3 months

    d. Suspected or known HIV infection or HIV-related disease

    5. All females of childbearing potential who refuse to use an acceptable method of birth

    control for 21 days after the booster vaccination and/or who refuse to perform a urine

    pregnancy test prior to vaccination. Adequate contraception is defined as hormonal

    (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom

    with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), or

    monogamous relationship with vasectomized partner who has been vasectomized for

    6 months or more prior to the subject's study entry

    6. Pregnant or breastfeeding

    7. Receipt of another vaccine or any investigational agent within the past 4 weeks

    8. Experience of any acute disease or infections requiring systemic antibiotic or antiviral

    therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within

    the past 7 days

    9. Experience of fever (i.e., axillary temperature 38ﾰC) within the past 3 days

    10. Participation in another clinical study

    11. Surgery planned during the study period

    12. Any condition which, in the opinion of the investigator, might interfere with the

    evaluation of the study objective
    E.5 End points
    E.5.1Primary end point(s)
    The measures of immunogenicity, collected for all evaluable subjects include:

    - Geometric mean titers/areas (GMTs/GMAs) on days 382, 389, and 403 and GMRs for days 389 and 403 versus Day 382 as determined by HI, SRH, and MN.

    - Percentage of subjects achieving seroconversion1 or significant increase in antibody titer/area2 on days 389, and 403 as measured by HI and SRH.

    - Percentage of subjects with titers 20, titers 40, titers 80, on days 382, 389 and 403 and percentage of subjects with at least a four-fold rise in titer on days 389 and403 as determined by MN.

    - Percentage of subjects achieving a titer 40/ area 25 mm2 on days 382, 389, and 403 as determined by HI and SRH.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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 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 months8
    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 months8
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-07-03. Yes
    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 state60
    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 Decision2007-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
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