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    Summary
    EudraCT Number:2013-000601-23
    Sponsor's Protocol Code Number:V78_11S
    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:2013-03-19
    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 number2013-000601-23
    A.3Full title of the trial
    A Phase III, Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of a Trivalent, Surface Antigen Inactivated Subunit Influenza Virus Vaccine (Fluvirin®) in Healthy Adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Seasonal Fluvirin trial 2013/14
    A.3.2Name or abbreviated title of the trial where available
    Fluvirin
    A.4.1Sponsor's protocol code numberV78_11S
    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.1.3.4CountryNetherlands
    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 supportNovartis Vaccines and Diagnostics S.r.l.
    B.4.2CountryItaly
    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 pointHead of Central and Northern Europe
    B.5.3 Address:
    B.5.3.1Street AddressIndustriestrasse 25
    B.5.3.2Town/ cityHolzkirchen
    B.5.3.3Post code83607
    B.5.3.4CountryGermany
    B.5.4Telephone number+49080246465401
    B.5.5Fax number+49080246465480
    B.5.6E-maildietrich.bosse@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 Fluvirin® Influenza Vaccine (Surface Antigen, Inactivated)
    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)
    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.3.8INN - Proposed INNA/ (H1N1)-LIKE VIRUS ANTIGEN
    D.3.9.3Other descriptive nameA/ (H1N1)-LIKE VIRUS ANTIGEN
    D.3.9.4EV Substance CodeSUB117552
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNA/ (H3N2)-LIKE VIRUS ANTIGEN
    D.3.9.3Other descriptive nameA/ (H3N2)-LIKE VIRUS ANTIGEN
    D.3.9.4EV Substance CodeSUB117553
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNB/ -LIKE VIRUS ANTIGEN
    D.3.9.3Other descriptive nameB/ -LIKE VIRUS ANTIGEN
    D.3.9.4EV Substance CodeSUB117554
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    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
    Prophylaxis of influenza
    E.1.1.1Medical condition in easily understood language
    healthy subjects
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Immunogenicity Objective
    To evaluate the antibody response to each influenza vaccine antigen after vaccination with the TIVf vaccine, as measured by single radial hemolysis (SRH) or hemagglutination inhibition (HI) assay in accordance with Guidance CPMP/BWP/214/96

    Safety Objective
    To evaluate the safety of TIVf in adult subjects in compliance with the requirements of the current European Union recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96)
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to participate in this study, a subject must meet ALL of the following inclusion criteria:
    - Is a male or female volunteer ages 18 years or older, mentally competent, willing and able to give written informed consent prior to study entry;
    - Is able to comply with all the study requirements; and
    - Is in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
    E.4Principal exclusion criteria
    In order to participate in this study, a subject must not meet any of the following exclusion criteria:
    ▫ Has 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;
    ▫ Has a 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 >2 years without treatment)
    - medically significant advanced congestive heart failure (ie, New York Heart Association [NYHA] class III and IV)
    - chronic obstructive pulmonary disease (ie, Global initiative for chronic Obstructive Lung Disease [GOLD] stage III and IV)
    - autoimmune disease (including rheumatoid arthritis and excepting 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 (eg, Down’s syndrome)
    - acute or progressive hepatic disease
    - acute or progressive renal disease
    - severe neurological (especially Guillain–Barré syndrome) or psychiatric disorder
    - severe asthma
    ▫ Has a history of any anaphylactic reaction and/or serious allergic reaction to any component of the study vaccine (see section 5.1);
    ▫ Has a 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 within the past 6 months,
    - receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within the past 3 months and for the full length of the study, or
    - suspected or known human immunodeficiency virus (HIV) infection or HIV related disease
    ▫ Has known or suspected drug or alcohol abuse within the past 2 years;
    ▫ Has bleeding diathesis or conditions associated with prolonged bleeding time that, in the investigator’s opinion, would interfere with the safety of the subject;
    ▫ Is not able to comprehend and to follow all required study procedures for the whole period of the study;
    ▫ Has a history or any illness that, in the opinion of the investigator, would pose additional risk to the subjects because of participation in the study;
    ▫ Has the following within the past 6 months:
    - had any laboratory confirmed seasonal or pandemic influenza disease
    - received any seasonal or pandemic influenza vaccine
    ▫ Has received any other vaccine within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine during the study;
    ▫ Has acute or chronic infections requiring antiviral therapy within the last 7 days;
    ▫ Has experienced fever (ie, body temperature [preferably oral] ≥38.0°C) within the last 3 days of intended study vaccination;
    ▫ Has been participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intends to participate in another clinical study at any time during the conduct of this study;
    ▫ Is part of study personnel or has close family members conducting this study;
    ▫ Has a body mass index (BMI) >35 kg/m2 (BMI is calculated by dividing the subject’s weight in kilograms by the subject’s height in meters multiplied by the subject’s height in meters);
    ▫ Is pregnant (confirmed by positive urine pregnancy test) or nursing (breastfeeding) or is a female of childbearing potential who refuses to use an acceptable method of birth control for the whole duration of the study.



    Female of childbearing potential is defined as a post onset menarche and premenopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) bilateral oophorectomy or hysterectomy.

    Reliable birth control method is defined as hormonal (eg, oral, injection, transdermal patch, implant, cervical ring), barrier (eg, condom with spermicide or diaphragm with spermicide), intrauterine device (eg, IUD), monogamous relationship with partner who has been vasectomized for 6 months or more prior to the subject’s study entry, or sexual abstinence for 2 months or more prior to the subject’s study entry and agreement at enrollment to continue abstinence through day 22 ( 1/+3) of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity Endpoints:
    Antibody responses will be evaluated by the SRH assay according to the following endpoints:
    ▫ The percentage of subjects with SRH area ≥25 mm2
    ▫ The percentage of subjects achieving seroconversion or significant increase by SRH area
    - Seroconversion is defined as day 1 SRH area with a negative result (SRH area ≤4 mm2) and day 22 ( 1/+3) SRH area ≥25 mm2
    - Significant increase is defined as a positive day 1 SRH area (SRH area >4 mm2) and at least a 50% increase in SRH area on day 22 ( 1/+3)
    ▫ Geometric mean ratio (GMR) day 22 ( 1/+3)/day 1
    Antibody responses will be evaluated by the HI assay according to the following endpoints:
    ▫ The percentage of subjects with HI titer ≥1:40
    ▫ The percentage of subjects achieving seroconversion or significant increase in HI titer
    - Seroconversion is defined as day 1 HI titer <1:10 and day 22 ( 1/+3) HI titer ≥1:40
    - Significant increase is defined as day 1 HI titer ≥1:10 and at least a 4-fold increase in HI titer on day 22 ( 1/+3)
    ▫ GMR day 22 ( 1/+3)/day 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of trial, day 22
    E.5.2Secondary end point(s)
    Safety Endpoints:
    Safety endpoints are based on solicited and unsolicited AEs.
    The measures for assessing safety are as follows:
    ▫ Percentages of subjects with solicited local and systemic AEs and other solicited events as measured for 4 days (day 1 through day 4, inclusive) following vaccination
    - Calculated for 2 time intervals after vaccination: 30 minutes, day 1 (after 6 hours) through day 4 (inclusive, ie, excluding the observations at 30 minutes)
    ▫ Percentages of subjects with any unsolicited AEs reported for 4 days (day 1 through day 4, inclusive) following vaccination
    ▫ Percentages of subjects reporting unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study, and concomitant medications/vaccinations associated with these events as collected from day 1 through day 22 ( 1/+3)
    Solicited local AEs will include injection-site induration, erythema, ecchymosis, and pain.
    Solicited systemic AEs will include fever (derived from measured body temperature [preferably oral] ≥38.0°C), shivering/chills, myalgia, arthralgia, headache, fatigue, and malaise.
    Other solicited AEs will include use of analgesic/antipyretic medication before and after vaccination in response to fever or pain.
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of trial, day 22
    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 No
    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 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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    Please refer to the protocol
    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 days22
    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: 63
    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 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 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)
    none
    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 Decision2013-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-25
    P. End of Trial
    P.End of Trial StatusCompleted
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