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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-000430-20
    Sponsor's Protocol Code Number:V44P9S
    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:2005-05-02
    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 number2005-000430-20
    A.3Full title of the trial
    A phase III, multicenter, uncontrolled, open label study to demonstrate safety, tolerability and immunogenicity of the Chiron Behring preservative free inactivated split influenza vaccine using the strain composition 2005/2006
    A.3.2Name or abbreviated title of the trial where available
    n/a
    A.4.1Sponsor's protocol code numberV44P9S
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbern/a
    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 SponsorChiron Behring GmbH & Co KG
    B.1.3.4CountryGermany
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Begrivac
    D.2.1.1.2Name of the Marketing Authorisation holderChiron Behring GmbH & Co KG
    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.3.1Product nameInfluenza vaccine (split virion, inactivated)
    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
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInfluenza A/New Caledonia/20/99 - like (H1N1) virus/15 microgam/0,5 millilitres Heamagglutinin
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInfluenza A/California/7/2004 - like (H3N2) virus / 15 microgram/0,5 millilitres Haemagglutinin
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInfluenza B/Shanghai/361/2002 - like virus / 15 microgram/0,5 millilitres Haemagglutinin
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    no medical condition; healthy volunteers will be recruited into clinical trial for annual approval of Influenza vaccine with new strain composition according to WHO and EMEA recommendation and CPMP criteria (Note for Guidance on Harmonisation of Requirements for Influenza Vaccines, 12 March 1997, CPMP/BWP/214/96),
    Influenza vaccine for prevention of influenza
    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
    Immunogenicity Objectives
    Immunogenicity with respect to specific antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21, i.e., 21 days after vaccination, in compliance with the requirements of the current EU recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).
    E.2.2Secondary objectives of the trial
    Safety Objectives
    To demonstrate the safety and tolerability of a single IM dose of the split influenza vaccine (using solicited local and systemic reactions and adverse event reporting).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects eligible for enrollment into this study are male and female adults who are
    1. ≥ 18 years of age, mentally competent, willing and able to give informed consent
    2. have given the written informed consent prior to the study entry and after the nature of the study has been explained
    3. available for all the visits scheduled in the study
    4. in good health as determined by:
    - medical history
    - physical examination
    - clinical judgment of the investigator
    Informed consent must be obtained from all the subjects before enrollment in the study.
    E.4Principal exclusion criteria
    Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
    1. They have any serious chronic disease such as:
    a. history of cancer (leukemia, lymphomas, neoplasm)
    b. congestive heart failure
    c. advanced arteriosclerotic disease
    d. COPD requiring oxygen therapy
    e. autoimmune disease
    f. insulin dependent diabetes mellitus
    g. acute or progressive hepatic disease
    h. acute or progressive renal failure
    2. They have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component.
    3. They have a known or suspected impairment/alteration of immune function resulting for example from:
    a. receipt of immunosuppressive therapy (any systemic cortical steroid or cancer chemotherapy) within the last 2 months and for the full length of the study,
    b. receipt of immunostimulants,
    c. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
    d. suspected or known HIV infection or HIV-related disease.
    4. They have a known or suspected history of drug or alcohol abuse.
    5. They have a bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
    6. Women who are pregnant or who could become pregnant during the study but are not willing to practice acceptable contraception for the duration of the study (21 days).
    7. Within the last 6 months they have
    a) had laboratory confirmed influenza disease
    b) have been vaccinated against influenza
    8. Within the last 4 weeks they have received
    a) another vaccine
    b) any investigational agent
    9. They have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 14 days.
    10. They have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the last 14 days.
    11. They have experienced fever (i.e. body temperature ³ 38.0°C) within the past 3 days.
    12. They are taking part in another clinical study.
    13. They have any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity with respect to specific antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21, i.e., 21 days after vaccination.

    Safety measurements:
    Subjects will be observed in the clinic for 30 minutes after vaccination for possible immediate hypersensitivity reactions. Local and systemic reactions occurring within 3 days (Days 0-3) after vaccination will be collected in a subject’s diary (Local reactions: pain at the injection site, erythema, ecchymosis, swelling and induration. Systemic reactions: fever, chills/shivering, malaise, headache, myalgia, arthralgia, sweating and fatigue). Serious adverse events and/or adverse events necessitating a physician’s visit and/or resulting in subject withdrawal from study will be collected throughout the study. All other adverse events will be collected up to 3 days after vaccination.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Yes
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 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) 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 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Trial ends with last subject last visit and is finalized with sign off of the report, for the subject with the 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
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-05-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.3.3.6.1Details of subjects incapable of giving consent
    Woman of childbearing potential can be recruited if not pregnant and the subject agrees to use an appropriate method of birth control while on trial. Volunteers who might be pregnant and do not agree to a pregnancy test cannot participate
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 120
    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)
    since healthy volunteers only will be recruited, no treatment or special care is applicable
    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 Decision2005-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-06-02
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