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    The EU Clinical Trials Register currently displays   37733   clinical trials with a EudraCT protocol, of which   6184   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-000855-42
    Sponsor's Protocol Code Number:200160
    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:2013-04-26
    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 number2013-000855-42
    A.3Full title of the trial
    A Phase III, open-label, non-randomised, multi-centre, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2013/2014 injected intramuscularly in adults (18 to 60 years of age) and in the elderly (over 60 years of age)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine, Fluarix / Influsplit SSW (2013/2014 season), in adults 18 years of age and older.
    A.3.2Name or abbreviated title of the trial where available
    FLUARIX-072
    A.4.1Sponsor's protocol code number200160
    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/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    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 s.a.
    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 in pre-filled syringe
    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.3.8INN - Proposed INNANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09
    D.3.9.3Other descriptive nameANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VIRUS PDM09
    D.3.9.4EV Substance CodeSUB75743
    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 INNANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS
    D.3.9.3Other descriptive nameANTIGENS OF THE INFLUENZA VIRUS A/VICTORIA/361/2011 (H3N2)-LIKE VIRUS
    D.3.9.4EV Substance CodeSUB88544
    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 INNANTIGENS OF THE INFLUENZA VIRUS B/MASSACHUSETTS/02/2012-LIKE VIRUS
    D.3.9.3Other descriptive nameANTIGENS OF THE INFLUENZA VIRUS B/MASSACHUSETTS/02/2012-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 of healthy adults against influenza
    E.1.1.1Medical condition in easily understood language
    Seasonal 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 100000004865
    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 2013/2014.
    E.2.2Secondary objectives of the trial
    1) To describe the reactogenicity and safety of Fluarix/Influsplit SSW 2013/2014 in adults 18-60 years and >60 years of age, in terms of solicited adverse events (AEs), unsolicited AEs and serious adverse events (SAEs).
    2) To evaluate the humoral response (anti-HA antibodies tested by HI) against each vaccine strain, 21 days after vaccination, in adults 18-60 years and >60 years of age who have and who have not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013
    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
    - Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause
    • 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
    • Participation in previous year’s Fluarix registration study (116663)
    • Use of any investigational or non-registered product (drug or vaccine) 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.
    • Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period.
    • 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 twelve months preceding the study vaccination.
    • Receipt of a vaccine other than the study vaccine within 30 days before study vaccination and/or plan to receive any vaccine other than the study vaccine 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.
    - Fever is defined as temperature ≥ 37.5°C/99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary.
    - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
    • Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
    • Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), 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 (no laboratory testing required).
    • History of Guillain-Barré syndrome.
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including latex.
    • 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 or would make intramuscular injection unsafe.
    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.

    The following parameters will be calculated with 95% confidence intervals (CIs):
    - Geometric mean titres (GMT) of anti-HA antibody titres
    - Seroprotection rates (SPR)*
    *SPR is defined as the percentage of vaccinees with serum HI titre ≥ 1:40; usually accepted as indicating protection in at least 50% of the vaccinees.

    The following parameters will be calculated with 95% confidence intervals (CIs):
    - Seroconversion rates (SCR)*.
    - Mean geometric increase ([MGI] also known as the Seroconversion factor [SCF])**.
    - Seroprotection power (SPP)***.
    *SCR is defined as 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 or SCF is defined as the fold increase in serum HI geometric mean titres post-vaccination compared to Day 0.
    ***SPP is defined as 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
    At Day 0 and Day 21 post-vaccination for Geometric Mean Titres and Seroprotection Rates

    At Day 21 post-vaccination for Seroconversion Rates, Mean Geometric Increases (Seroconversion Factors), and Seroprotection Powers.
    E.5.2Secondary end point(s)
    1) Reactogenicity:
    • 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 (SAEs)
    - Percentage, intensity and relationship to vaccination of SAEs

    2) Humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains, in subjects aged 18-60 years and >60 years who have and who have not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
    • The following parameters will be calculated with 95% CIs:
    - GMTs of anti-HA antibody titres and SPRs, in subjects who have and who have not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Solicited local and general symptoms: During a 4-day follow-up period after vaccination (Days 0-3) (i.e. day of vaccination and 3 subsequent days).
    • Unsolicited symptoms: During a 21-day follow-up period after vaccination (Days 0-20) (i.e. day of vaccination and 20 subsequent days).
    • Serious adverse events: During the entire study period (Day 0-Day 21)

    • Humoral immune response in subjects who have and who have not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013: At Day 0 and Day 21 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 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 No
    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 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
    LVLS
    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
    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 Decision2013-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
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