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    Summary
    EudraCT Number:2012-000789-39
    Sponsor's Protocol Code Number:116663
    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:2012-04-27
    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 number2012-000789-39
    A.3Full title of the trial
    A Phase III, open, non-randomized, multi-centre, single dose study to assess immunogenicity and safety of Fluarix/Influsplit SSW 2012/2013 injected intramuscularly in adults (18 to 60 years) and in elderly (over 60 years).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study for evaluation of immunogenicity and reactogenicity of Fluarix/Influsplit SSW 2012/2013 in people aged 18 years and above.
    A.3.2Name or abbreviated title of the trial where available
    FLUARIX-071
    A.4.1Sponsor's protocol code number116663
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l’Institut, 89
    B.5.3.2Town/ cityRixensaert
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.5Fax number----
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    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 Fluarix/Influsplit SSW/alpha-rix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    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 nameA/California/7/2009 (H1N1)pdm09-like virus
    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.3.9.3Other descriptive nameA/Victoria/361/2011 (H3N2)-like virus-like strain
    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.3.9.3Other descriptive nameB/Wisconsin/1/2010-like virus
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 of healthy adults
    E.1.1.1Medical condition in easily understood language
    Flu
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10059430
    E.1.2Term Influenza immunization
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 humoral response (anti-haemagglutinin [HA] antibodies tested by Haemagglutination Inhibition [HI]) against each vaccine strain in adults 18-60 years and >60 years of age, 21 days after vaccination with Fluarix/Influsplit SSW 2012/2013.
    E.2.2Secondary objectives of the trial
    To evaluate the humoral response (anti-HA antibodies tested by HI) against each vaccine strain, 21 days after vaccination, in adults >60 years of age who have not and who have received an influenza vaccine in the 2011-2012 season.
    To describe the reactogenicity and safety of Fluarix/Influsplit SSW 2012/2013 in adults 18-60 years and >60 years of age, in terms of solicited adverse events (AEs), unsolicited AEs and serious adverse events (SAEs).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who the investigator believes can and will comply with the requirements of the protocol.
    A male or female aged 18 years or above at the time of vaccination.
    Written informed consent obtained from the subject.
    Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
    Female subjects of non-childbearing potential may be enrolled in the study.
    Female subjects of childbearing potential may be enrolled in the study, if the subject:
    has practiced adequate contraception for 30 days prior to vaccination, and
    has a negative pregnancy test on the day of vaccination, and
    has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.
    E.4Principal exclusion criteria
    Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
    Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
    Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
    Administration of an influenza vaccine within the six months preceding the study vaccination.
    Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period.
    Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
    Acute disease and/or fever at the time of enrolment.
    Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
    Chronic underlying disease, not stabilized or clinically serious.
    History of chronic alcohol consumption and/or drug abuse.
    Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    History of Guillain-Barré syndrome.
    History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    Anaphylaxis following the administration of vaccine(s).
    Pregnant or lactating female.
    Female planning to become pregnant or planning to discontinue contraceptive precautions.
    Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains.
    Geometric mean titres (GMTs) of anti-HA antibody titres.
    Seroprotection rates* (SPR).
    Seroconversion rates** (SCR).
    Mean geometric increase*** ([MGI] also known as the seroconversion factor [SCF]).
    Seroprotection power**** (SPP).
    *SPR: The percentage of vaccinees with serum HI titre ≥ 1:40; usually accepted as indicating protection.
    **SCR: The percentage of vaccinees with either a pre-vaccination titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least 4-fold increase in post-vaccination titre.
    ***MGI: The fold increase in serum HI geometric mean titres post-vaccination compared to Day 0.
    ****SPP: The percentage of subjects who have a pre-vaccination titre < 1:40 and a post-vaccination titre ≥ 1:40.
    E.5.1.1Timepoint(s) of evaluation of this end point
    GMTs and SPRs: at Days 0 and 21
    SCRs, MGI and SPP at Day 21
    E.5.2Secondary end point(s)
    Humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains, by influenza vaccination status in the 2011-2012 season, in subjects aged >60 years.
    GMTs of anti-HA antibody titres and SPRs, by influenza vaccination status in the 2011-2012 season.
    SCRs and MGI by influenza vaccination status in the 2011-2012 season.
    Occurrence of solicited local and general symptoms
    Percentage, intensity and duration of solicited local symptoms.
    Percentage, intensity, duration and relationship to vaccination of solicited general symptoms.
    Occurrence of unsolicited symptoms
    Percentage, intensity and relationship to vaccination of unsolicited symptoms.
    Occurrence of serious adverse events
    Percentage, intensity and relationship to vaccination of SAEs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Humoral immune response: At Days 0 and 21
    Solicited local and general symptoms: During the 4-day (Day 0-Day 3) follow-up period after vaccination
    Unsolicited symptoms: During the 21-day (Day 0-Day 20) follow-up period after vaccination
    Serious adverse events: During the 21-day (Day 0-Day 20) follow-up period after 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 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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) Yes
    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.8.2.4Number of treatment arms in the trial2
    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 concerned4
    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 No
    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
    Last subject last visit
    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 months0
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days21
    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.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 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 state120
    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)
    A plan for treatment or care after the subject has ended the participation in this trial is not provided for prophylactic vaccine studies as the subjects are healthy and do not need any treatment or care after end of the study.
    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 Decision2012-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
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