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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-000939-17
    Sponsor's Protocol Code Number:V78P6S
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-000939-17
    A.3Full title of the trial
    A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of FLUVIRIN® [Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur], Formulation 2008-2009, when Administered to Non-Elderly Adult and Elderly Subjects
    A.3.2Name or abbreviated title of the trial where available
    FLUVIRIN® 2008-2009 seasonal trial
    A.4.1Sponsor's protocol code numberV78P6S
    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 Limited
    B.1.3.4CountryUnited Kingdom
    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 FLUVIRIN® Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFLUVIRIN® Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur.
    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
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameA/Brisbane/59/2007 (H1N1)-like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameA/Brisbane/10/2007 (H3N2)-like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameB/Florida/4/2006-like virus
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Prophylaxis of influenza
    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 evaluate the antibody response to each influenza vaccine antigen, as measured by Haemagglutination Inhibition (HI) test at 21 days post-immunization in non-elderly adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96).
    E.2.2Secondary objectives of the trial
    To evaluate safety of a single IM (intramuscular) dose of the subunit influenza vaccine Fluvirin® in non-elderly adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccine (CPMP/BWP/214/96).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrollment into this study are male and female adult volunteers who are:

    1. >18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry;
    2. available for all the visits scheduled in the study and able to comply with all study requirements
    3. in general good health as determined by:
    a) medical history
    b) physical examination
    c) clinical judgment of the investigator

    Written informed consent must be obtained from all the subjects before enrollment in the study after the nature of the study has been explained.
    E.4Principal exclusion criteria
    Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:

    1. Any serious (in the judgment of the investigator) disease including, but not limited to:
    a. Cancer, except for localized skin cancer
    b. Advanced congestive heart failure
    c. Chronic Obstructive Pulmonary Disease (COPD)
    d. Autoimmune disease (including rheumatoid arthritis)
    e. Acute or progressive hepatic disease
    f. Acute or progressive renal disease
    g. Severe neurological or psychiatric disorder
    h. Severe asthma
    2. History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin, polymixin)
    3. 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 derivatives within the past 3 months and for the full length of the study,
    d. Suspected or known HIV infection or HIV-related disease.
    4. Known or suspected history of drug or alcohol abuse.
    5. The subject has a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject.
    6. Women who are pregnant or woman of child-bearing potential unwilling to practice acceptable contraception for the duration of the study (21 days).
    7. Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months
    8. Within the past 4 weeks, the subject has received:
    - another vaccine
    - any investigational agent
    9.Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
    10. The subject has experienced an acute exacerbation of a COPD within the past 14 days
    11. The subject has experienced fever (i.e. axillary temperature ≥38.0°C) within the last 3 days
    12. Severely obese with Body Mass Index (BMI) > 35 kg/m2
    13. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives

    Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.
    E.5 End points
    E.5.1Primary end point(s)
    The following serological assessments should be considered for each strain in non-elderly adult subjects, aged between 18 and 60 years, and at least one of the assessments should meet the indicated requirements:

    · The proportion of subjects achieving seroconversion or significant increase in anti-HA antibody titre should be > 40%
    · Mean geometric increase should be > 2.5
    · The proportion of subjects achieving an HI titre ≥ 40 or SRH titre ≥ 25 mm2 should be > 70%

    The following serological assessments should be considered for each strain in elderly subjects, aged over 60 years, and at least one of the assessments should meet the indicated requirements:

    · The proportion of subjects achieving seroconversion or significant increase in anti-HA antibody titre should be > 30%
    · Mean geometric increase should be > 2.0
    · The proportion of subjects achieving an HI titre ≥ 40 or SRH titer ≥ 25 mm2 should be > 60%

    Circulating anti-HA antibodies will be measured by HI assay just prior to vaccination (Day 0) and approximately 3 weeks after the vaccination (Day 21). For the purposes of calculation, any HI result < 10 (i.e. undetectable) will be expressed as 5. If an SRH assay is used, any negative SRH result will be expressed as 4 mm2.

    In HI tests, seroconversion or significant increase in antibody titre corresponds to:
    · negative prevaccination serum / postvaccination serum area ≥ 40
    · at least a four-fold increase in titre from positive prevaccination serum

    In SRH tests, seroconversion or significant increase in antibody titre corresponds to:
    · negative prevaccination serum / postvaccination serum ≥ 25 mm2
    · at least a 50% increase in area from positive prevaccination serum

    The statistical parameters to be determined are:
    · Geometric mean of prevaccination serum anti-HA titres
    · Increase in the geometric mean of antibody titre
    · Proportion of subjects with seroconversion or significant increase
    · Proportion of subjects above a particular antibody titer (for SRH area ≥ 25 mm2, for HI: titer ≥ 40) before vaccination
    · Proportion of subjects above a particular antibody titer (for SRH area ≥ 25 mm2, for HI: titer ≥ 40) after vaccination
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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) 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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    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 Information not present in EudraCT
    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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    End of Trial: corresponds to the last visit of the last subject undergoing the trial (LSLV).
    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 months2
    E.8.9.1In the Member State concerned days
    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 Yes
    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 2008-04-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    All women of childbearing potential are requested to undergo a pregnancy test and are asked to practice acceptable contraception for the duration of the trial (21 days).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state126
    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)
    N/A
    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 Decision2008-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-07
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