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    Summary
    EudraCT Number:2012-000085-38
    Sponsor's Protocol Code Number:V70_39S
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-000085-38
    A.3Full title of the trial
    A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD® Surface Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine, Formulation 2012-2013, when Administered to Elderly Subjects
    A.3.2Name or abbreviated title of the trial where available
    Ph2, safety, immuno, >65y, NH seasonal 2012
    A.4.1Sponsor's protocol code numberV70_39S
    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 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 organisationNovartis Vaccines and Diagnostics GmbH
    B.5.2Functional name of contact pointMarkus Weissbach
    B.5.3 Address:
    B.5.3.1Street AddressEmil-von-Behring-Strasse 76
    B.5.3.2Town/ cityMarburg
    B.5.3.3Post code35041
    B.5.3.4CountryGermany
    B.5.4Telephone number004980246465400
    B.5.5Fax number004980246465480
    B.5.6E-mailmarkus.weissbach@novartis.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 Fluad
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameFluad
    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.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    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) 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
    Influenza
    E.1.1.1Medical condition in easily understood language
    Flu
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    Safety Objectives:
    To evaluate the safety of a single intramuscular (IM) injection of Fluad in 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).

    Immunogenicity Objectives:
    Primary
    To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at approximately 21 days post-immunization in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

    Antibodies maybe additionally quantified using the hemagglutination inhibition (HI) test for confirmation purposes (Note for Guidance on Harmonization of Requirements for Influenza Vaccines CPMP/BWP/214/96: 12 March 1997).
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female volunteers of 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry;
    2. Individuals able to comply with all the study requirements;
    3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
    E.4Principal exclusion criteria
    1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
    2. Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:
    - Medically significant Cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years or localized prostate cancer that has been clinically stable for more than 2 years without treatment)
    - Medically significant advanced congestive heart failure (ie. NYHA class III and IV)
    - Chronic obstructive pulmonary disease (COPD; i.e., GOLD Stage III and IV)
    - Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's thyroiditis that has been clinically stable for ≥ 5 years)
    - Diabetes mellitus type I;
    - Poorly controlled diabetes mellitus type II;
    - Advanced arteriosclerotic disease;
    - History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down’s syndrome);
    - Acute or progressive hepatic disease;
    - Acute or progressive renal disease;
    - Severe neurological (es. Guillain–Barré syndrome) or psychiatric disorder;
    - Severe asthma.
    3. Individuals with 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 eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate).
    4. Individuals with 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:
    - 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;
    - receipt of immunostimulants;
    - receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
    - suspected or known HIV infection or HIV-related disease.
    5. Individuals with known or suspected history of drug or alcohol abuse.
    6. Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject.
    7. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.
    8. Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study.
    9. Individuals who within the past 6 months have:
    - had any laboratory confirmed seasonal or pandemic influenza disease;
    - received any seasonal or pandemic influenza vaccine.
    10. Individuals who received any other vaccine within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine during the study.
    11. Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
    12. Individuals that have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days of intended study vaccination.
    13. Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
    14. Individuals who are part of study personnel or close family members conducting this study.
    15. BMI > 35 kg/m2.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity Endpoints
    The following serological assessments will be considered for each strain in elderly subjects, aged 65 years and over, and at least one of the assessments should meet the indicated requirements:
    - Proportion of seroconversion or significant increase in HI titer or SRH area >30%
    - Mean geometric increase >2.0
    - The proportion of subjects achieving an HI titer ≥40 or SRH area ≥25 mm2 should be > 60%
    Circulating anti-HA antibodies will be measured by SRH and possibly HI assay just prior to vaccination (Day 1) and approximately 3 weeks after the vaccination (Day 22). For the purposes of calculation, any HI result <10 (i.e. undetectable) will be expressed as 5, and any negative SRH result will be expressed as 4 mm2.
    In HI tests, seroconversion or significant increase in antibody titer corresponds to:
    • negative pre-vaccination serum / post-vaccination serum titer ≥40 or
    • at least a four-fold increase in titer from positive pre-vaccination serum
    In SRH tests, seroconversion or significant increase in antibody titer corresponds to:
    • negative pre-vaccination serum / post-vaccination serum area ≥25 mm2
    • at least a 50% increase in area from positive pre-vaccination serum

    Safety Endpoints
    Safety will be assessed in accordance with available safety data on influenza vaccines:
    • Local and systemic reactions will be assessed for 3 days post the day of vaccination
    • AEs Days 1 to 4. From Day 5 to study end AEs necessitating a physician’s visit or consultation and/or leading to premature study discontinuation and SAEs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Immunogenicity 21 days after vaccination
    • Local and systemic reactions will be assessed for 3 days post the day of vaccination
    • AEs Days 1 to 4. From Day 5 to study end AEs necessitating a physician’s visit or consultation and/or leading to premature study discontinuation and SAEs.
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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
    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) 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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 years
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months1
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 63
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state63
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 63
    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 Decision2012-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-14
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