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    Summary
    EudraCT Number:2006-002897-23
    Sponsor's Protocol Code Number:107564
    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:2006-07-26
    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 number2006-002897-23
    A.3Full title of the trial
    An observational study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly
    A.3.2Name or abbreviated title of the trial where available
    EPI-FLUAS25-002
    A.4.1Sponsor's protocol code number107564
    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 SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    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.2.5The 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 nameFluarix
    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.3.8INN - Proposed INNHaemagglutinin from A/New Caledonia/20/99 (IVR-116)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHaemagglutinin from A/Wisconsin/67/2005 (NYMCX-161)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHaemagglutinin from B/Malaysia/2506/2004
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Immunization against influenza in male and female subjects aged 50 years and over
    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
    During the influenza season and during the surveillance period, in subjects >= 50 years, after vaccination with Fluarix™:
    To evaluate the incidence of laboratory confirmed influenza; laboratory confirmation will be by detection of influenza A and /or B by virus culture and/or RT-PCR in nasal and throat swab specimens
    To evaluate the incidence of hospitalizations, emergency room visits, or unscheduled medical office visits due to ILI
    To evaluate the incidence of hospitalizations, emergency room visits or unscheduled medical office visits due to laboratory confirmed influenza
    To evaluate the frequency of hospitalization or emergency room visit for any cause
    To evaluate the incidence of pneumonia, ischemic heart disease (unstable angina or myocardial infarction), congestive heart failure, acute cerebrovascular disease and COPD exacerbation
    To evaluate the mortality due to laboratory confirmed influenza infection
    To evaluate all-cause mortality in the study cohort
    E.2.2Secondary objectives of the trial
    During the influenza season and during the surveillance period, in subjects >= 50 years, after vaccination with Fluarix™:
    To evaluate the incidence of hospitalizations, emergency room visits, or unscheduled medical office visits due to pneumonia, ischemic heart disease (unstable angina or myocardial infarction), congestive heart failure, acute cerebrovascular disease and COPD exacerbation
    To evaluate the incidence of laboratory confirmed RSV infection; laboratory confirmation will be by detection of RSV by RT-PCR in nasal and throat swab specimens
    To assess the baseline functional status and health related quality of life (EQ-5D health questionnaire). To compare it with the one observed at the onset of ILI episode and at Day 30 post ILI episode onset
    To provide related health economics measures
    To evaluate the safety of one dose of Fluarix in terms of occurrence of serious adverse events
    To evaluate the immune response in terms of HI antibody in a subset of subjects >= 50 years
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A male or female age 50 years and over at the time of the first vaccination.
    Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits, disease reporting by phone, and completion of PRO instrument (questionnaire) should be enrolled in the study.
    Written informed consent obtained from the subject.
    Availability to follow up by phone during the study period.
    Subjects with residence status allowing free mixing with general community.
    If the subject is female, she must be of non-childbearing potential
    E.4Principal exclusion criteria
    History of hypersensitivity to a previous dose of influenza vaccine.
    History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate.
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    Acute disease at the time of enrolment/ vaccination. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Tympanic temperature on oral setting <37.5°C (99.5°F) / Tympanic temperature on rectal setting <38°C (100.4°F).
    Any contra-indication to intramuscular administration of Fluarix™.
    Pregnancy
    For subjects enrolled in the immunogenicity subset only: Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 7 days prior to the vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed.).
    E.5 End points
    E.5.1Primary end point(s)
    During the influenza season and during the surveillance period, in subjects 50 years, after vaccination with Fluarix™:
    Incidence of influenza-like-illness.
    Incidence of laboratory-confirmed influenza A and/or B infection (viral culture and/or RT-PCR).
    Incidence of hospitalizations, emergency room visits, or unscheduled medical office visits due to ILI.
    Incidence of hospitalizations, emergency room visits or unscheduled medical office visits, due to laboratory confirmed influenza.
    Incidence of hospitalization or emergency room visit for any cause.
    Incidence of pneumonia, ischemic heart disease (unstable angina or myocardial infarction), congestive heart failure, acute cerebrovascular disease and COPD exacerbation.
    Incidence of hospitalizations, emergency room visits, or unscheduled medical office visits due to pneumonia, ischemic heart disease (unstable angina or myocardial infarction), congestive heart failure, acute cerebrovascular disease and COPD exacerbation.
    Number of deaths due to laboratory confirmed influenza infection.
    Number of deaths.
    Incidence of laboratory-confirmed Respiratory Syncytial Virus (RSV) infection (RT-PCR).
    Patient Reported Outcomes– health economics
    Patient Reported Outcome measures related to quality of life and health economics.
    Safety
    Occurrence of serious adverse events in all subjects during the entire study.
    Immunogenicity in a subset of subjects
    For each vaccine strain, seroconversion rate with 95% CI at day 21 defined as the proportion of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination titer > 1:40, or a pre-vaccination titer > 1:10 and a minimum four-fold increase in post-vaccination titer.
    For each vaccine strain, seroconversion factor at day 21 defined as the fold increase in serum HI antibody GMT on day 21 compared to day 0.
    For each vaccine strain, seroprotection rate with 95% CI at day 0 and day 21 defined as the proportion of vaccinees with a serum HI titer > 1:40.
    For each vaccine strain, geometric mean titer (GMT) of serum HI antibodies with 95% CI pre- and post-vaccination.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    epidemiology
    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) 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 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) 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state850
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2500
    F.4.2.2In the whole clinical trial 3000
    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 Decision2006-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-18
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