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    Summary
    EudraCT Number:2009-011450-18
    Sponsor's Protocol Code Number:CSLCT-NHF-09-57
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-011450-18
    A.3Full title of the trial
    A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2009/2010 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: ‘Adults’ (aged ≥ 18 to < 60 years) and ‘Older Adults’ (aged ≥ 60 years)
    A.4.1Sponsor's protocol code numberCSLCT-NHF-09-57
    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 SponsorCSL Limited
    B.1.3.4CountryAustralia
    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 Yes
    D.2.1.1.1Trade name Enzira
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Biotherapies GmbH
    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 nameEnzira
    D.3.2Product code Influenza Vaccine CSL Limited
    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.3.8INN - Proposed INNA/Brisbane/59/2007 (H1N1)-like virus, A/Brisbane/10/2007 (H3N2)-like virus, B/Brisbane/60/2008-like virus
    D.3.9.3Other descriptive nameinfluenza haemagglutinin antigens
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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 No
    D.3.11.8Extractive medicinal product No
    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
    Prophylaxis of influenza
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    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 immunogenicity of the 2009/2010 formulation of the Enzira® vaccine in healthy ‘Adults’ (aged ≥ 18 to < 60 years) and in healthy ‘Older Adults’ (aged ≥ 60 years) according to the criteria outlined in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of the 2009/2010 formulation of Enzira® vaccine in healthy ‘Adults’ (aged ≥ 18 to < 60 years) and in healthy ‘Older Adults’ (aged ≥ 60 years).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females aged ≥ 18 years at the time of providing informed consent.
    2. Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent.
    3. Willing and able to adhere to all protocol requirements
    4. Able to provide a sample of up to 17 ml of venous blood on two separate occasions without undue distress/discomfort.
    5. Females of child bearing potential (i.e. ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Accepted contraceptive precautions are determined as: oral contraception, intrauterine contraceptive device or equivalent hormonal contraception (e.g. progestogen-only implant, vaginal contraceptive ring, cutaneous hormonal patch or injectable contraceptives), abstinence, partner vasectomy, condoms used in conjunction with spermicide. Females of child bearing potential must return a negative urine pregnancy test result at enrolment, prior to vaccination with Enzira® vaccine.
    E.4Principal exclusion criteria
    1. Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine.
    2. Clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°C) at study entry.
    3. A clinically significant medical or psychiatric condition, as follows:
    • For acute conditions (active or recent); the condition required hospitalisation within the last month; or
    • For chronic conditions: the Investigator feels that the chronic condition is unstable, such as illness exacerbations within the previous month:
    i. requiring hospitalisation;
    ii. with significant organ function deterioration;
    iii. with major changes to treatment dosages;
    iv. requiring major new treatments; or
    • The Investigator feels the participant has a clinical condition that may be adversely affected through study participation.
    4. A confirmed or suspected immunosuppressive condition (congenital or acquired; including cancer and human immunodeficiency virus infection).
    5. History of seizures, with the exception of a past history of a single seizure event at any age that occured more than 2 years previously;
    6. History of Guillain-Barré Syndrome.
    7. Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine (e.g. a candidate pandemic influenza virus vaccine or a novel influenza virus vaccine) in the 6 months preceding study entry.
    8. Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of the Enzira® vaccine.
    9. Currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry:
    • Chronic or long term corticosteroids: ≥ 15 mg/day of oral prednisolone or equivalent daily;
    • Sporadic corticosteroids: ≥ 40 mg/day of oral prednisolone or equivalent for 2 or more short courses of > 3 days in the 3 months preceding vaccination;
    10. Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the Enzira® vaccine.
    11. Currently participating in another investigational study or recent study participation ending 3 months preceding administration of the Enzira® vaccine.
    12. Currently receiving treatment with warfarin or other anticoagulants.
    13. Evidence or history of substance or alcohol abuse within the 12 months before study entry.
    14. Females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period.
    15. Females who are pregnant or lactating.
    16. Any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity of Enzira® vaccine will be assessed in the two groups of healthy volunteers (‘Adults’ and ‘Older Adults’) according to the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. Enzira® vaccine will be considered immunogenic for a given strain if at least one of the three immunogenicity criteria is met.
    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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 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.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    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 months
    E.8.9.1In the Member State concerned days25
    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 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
    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 Decision2009-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-28
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