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    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-002480-27
    Sponsor's Protocol Code Number:V87P6
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-20
    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 ConcernedFinland - Fimea
    A.2EudraCT number2007-002480-27
    A.3Full title of the trial
    A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Subjects aged 6 months to 17 years
    A.4.1Sponsor's protocol code numberV87P6
    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 SponsorNovartis Vaccines and Diagnostics 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 No
    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-H5N1
    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
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInfluenza virus surface antigen (HA and NA), H5N1 (A/Vietnam/1194/2004 NIBRG-14)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number7.5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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. (formerly Chiron S.r.l.) - Via Fiorentina 1; Siena, Italy
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameInfluenza A/Solomon Islands/3/2006 - like (H1N1) virus/15µg/0.5ml dose
    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.3.9.3Other descriptive nameInfluenza A/Wisconsin/67/2005 - like (H3N2) virus/15µg HA/0.5mL dose
    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.3.9.3Other descriptive nameInfluenza B/Malaysia/2506/2004 - like virus/15µg/0.5mL dose
    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) 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
    avian 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 10064097
    E.1.2Term Avian 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 safety and tolerability of and the magnitude of antibody responses to two 0.5mL intramuscular (IM) injections of FLUAD-H5N1 influenza vaccine each containing 7.5µg of A/H5N1 influenza antigen, administered 3 weeks apart.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of one 0.5mL IM injection of FLUAD-H5N1 influenza vaccine containing 7.5µg of A/H5N1 influenza antigen, administered 12 months after the second dose.
    To evaluate the magnitude of antibody response to a 12 months booster dose of FLUAD-H5N1 influenza vaccine, containing 7.5µg of H5N1 antigen in subjects of different ages.
    To evaluate the persistence of specific antibodies 12 months after primary immunization in subjects of different ages.
    To evaluate the cross-protection of a FLUAD-H5N1 influenza vaccine, containing 7.5µg of H5N1 antigen in subjects of different ages.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female or male subjects aged 6 months to <18 years whose parents/legal guardians have signed an informed consent form after having received a detailed explanation of the study protocol. Subjects from 9 to <18 years of age additionally have to sign an assent form having received a detailed explanation of the study protocol.
    2. Good health as determined by:
    a. Medical history,
    b. Physical examination,
    c. Clinical judgment of the Investigator;
    3. Able to comply with all study procedures, can be contacted, and will be available for all study visits
    E.4Principal exclusion criteria
    1. Participation in another clinical study at the same time or within the last 3 months and unwilling to refuse participation in another clinical study through the end of this study;
    2. Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant;
    3. Receipt of influenza vaccination for the current season 2007/2008;
    4. Receipt of another vaccine within 3 weeks before and after each study vaccination;
    5. Any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days;
    6. Fever (defined as axillary temperature ≥38.0°C) within 3 days prior to Visit 1,
    7. Pregnant or breastfeeding;
    8. Females of childbearing potential (i.e., after first menstrual bleeding until 2 years after last menstrual bleeding, except females with hysterectomy or abstinent females) who refuse to use an acceptable method of birth control for the duration of the study and who refuse to perform a urine pregnancy test prior to vaccination. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), or monogamous relationship with a vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry;
    9. Any serious disease, such as:
    a. Cancer,
    b. Autoimmune disease (including rheumatoid arthritis),
    c. Diabetes mellitus,
    d. Asthma, chronic pulmonary disease (steroids administered by inhalation only or clinical symptoms less frequent than once a day are acceptable),
    e. Acute or progressive hepatic disease,
    f. Acute or progressive renal disease;
    10. Known or suspected impairment/alteration of immune function, for example, resulting from:
    a. Receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy, immunoglobulins), asthma under inhalation therapy only acceptable,
    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. High risk for developing an immunocompromising disease;
    11. Surgery planned during the study period;
    12. Bleeding diathesis;
    13. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
    14. History of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
    15. History of neurological disorder or seizures (febrile seizures allowed);
    16. Children who are in the local recommendation for influenza vaccination;
    17. History of (or current) drug or alcohol abuse that in the investigator’s opinion would interfere with safety of the subject or the evaluation of study objectives;
    18. 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)
    The measures of immunogenicity, collected for all evaluable subjects of the FLUAD-H5N1 group include:
    - Geometric mean titers/area (GMTs/GMAs) and geometric mean ratios (GMRs) on days 1, 22, and 43, 382 and day 403 as determined by HI, SRH, and MN.
    - Percentage of subjects achieving seroconversion or significant increase in antibody titer on days 22, 43, 382, and 403 as measured by HI and SRH.
    - Percentage of subjects with MN titers ≥1:20, ≥1:40, ≥1:80 on day 1, day 22, and day 43.
    - Percentage of subjects achieving at least a four-fold rise in antibody titer on days 22, 43, 382, and 403 as measured by MN.
    - Percentage of subjects achieving a titer ≥40/ area ≥25mm2 on days 22, 43, 382 and 403 as determined by HI and SRH.

    Number and percentage of subjects with at least one local reaction between day 1 and day 7 after each vaccine injection.
    Number and percentage of subjects with at least one systemic reaction between day 1 and day 7 days after each vaccine injection.
    Number and percentage of subjects with at least one adverse event between day 1 and day 43 or between day 382 and day 403 (FLUAD-H5N1 group only).
    Number and percentage of subjects with serious adverse events or adverse events necessitating a physician’s visit or consultation and/or leading to withdrawal from the study between day 1 and the study termination visit.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    observer blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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 Yes
    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, here by phone call
    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 months20
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months20
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    subjects younger than 18 years; subjects from 9 to <18 years of age additionally have to sign an assent form after having received a detailed explanation of the study protocol
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state469
    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 Decision2007-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-18
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