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    Summary
    EudraCT Number:2009-013105-34
    Sponsor's Protocol Code Number:810706
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-013105-34
    A.3Full title of the trial
    ESTUDIO DE FASE I/II PARA EVALUAR EN LACTANTES, NIÑOS Y ADOLESCENTES
    SANOS DE 6 MESES A 17 AÑOS DE EDAD LA SEGURIDAD Y LA INMUNOGENICIDAD
    DE UNA VACUNA CONTRA LA GRIPE DE VIRUS H5N1 ENTEROS, PRODUCIDA EN
    CÉLULAS VERO.
    A PHASE I/II STUDY TO ASSESS THE SAFETY AND IMMUNOGENICITY OF A VERO CELL-DERIVED WHOLE VIRUS H5N1 INFLUENZA VACCINE IN HEALTHY INFANTS, CHILDREN AND ADOLESCENTS AGED 6 MONTHS TO 17 YEARS
    A.3.2Name or abbreviated title of the trial where available
    Phase I/II Study of a H5N1 Vaccine in the Pediatric Population
    A.4.1Sponsor's protocol code number810706
    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 SponsorBaxter Innovations GmbH
    B.1.3.4CountryAustria
    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 nameVirión entero producido en células Vero.Vero Cell-Derived Whole Virus
    D.3.4Pharmaceutical form Solution 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.3.8INN - Proposed INNvirión entero,producido en células vero,inactivadas
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.75
    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
    Estudio para evaluar en lactantes, niños y adolescentes sanos de 6 meses a 17 años de edad la
    seguridad y la inmunogenicidad de la vacuna contra la gripe H5N1. Study to assess the Safety and Immunogenicity os Baxter´s H5N1 Influenza Vaccine in Healthy Infants,Children and Adolescents aged 6 months to 17 years.
    Study to assess the Safety and Immunogenicity of Baxter's H5N1 Influenza Vaccine in Healthy Infants, Children and Adolescents aged 6 months to 17 years.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10059430
    E.1.2Term Influenza immunization
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess safety: Frequency and severity of systemic reactions until 21 days after the first and second vaccination.
    To assess immunogenicity: Rate of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test >= 1:20.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of a non-adjuvanted H5N1 influenza vaccine in healthy infants, children and
    adolescents aged 6 months to 17 years;
    Rate of subjects with antibody 21 days after the first and second vaccination ; Fold increase of antibody response
    21 days after the first and second vaccination as compared to baseline; Rate of subjects with seroconversion
    21 days after the first, second and booster vaccination; Rate of subjects with antibody response associated with
    protection 360 days after the first vaccination and 21 days after the booster vaccination; Antibody response 360
    days after the first vaccination and 21 days after the booster vaccination; Fold increase of antibody response 21
    days after the booster vaccination as compared to before the booster;
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female subjects will be eligible for participation in this study if:
    • They are 9 to 17ii years of age on the day of screening (for Stratum A only);
    • They are 3 to 8iii years of age on the day of screening (for Stratum B onl
    • They are 6 to 35iv months of age on the day of screening (for Stratum C only);
    • They were born at full term of pregnancy (&#8805; 37 weeks) with a birth weight &#8805; 2 kg (for Stratum C only);
    • They and/or their parents/legal guardians understand the nature and procedures of the study and agree to its
    provisions;
    • Their parents/legal guardians provide written consent for participation according to national law. In case the
    parents/legal guardians are illiterate, the informed consent is also to be signed by an independent witness;
    • They provide written assent according to their age and capacity of understanding;
    • They are generally healthy, as determined by the investigator’s clinical judgment through collection of medical
    history and performance of a physical examination;
    • They are physically and mentally capable of participating in the study and follow its procedures;
    • They and/or their parents/legal guardians agree to keep a daily record of symptoms for the duration of the study;
    • If female of childbearing potential – have a negative urine pregnancy test result within 24 hours prior to the
    scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.
    ii From the 9th birthday to the last day before the 18th birthday
    iii From the 3rd birthday to the last day before the 9th birthday
    iv From 6 months of age to the last day before the 3rd birthday
    E.4Principal exclusion criteria
    Subjects will be excluded from participation in this study if:
    • They have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine;
    • They are at high risk of contracting H5N1 influenza infection (e.g. contact with poultry);
    • They currently have or have a history of a significant neurological, cardiovascular, pulmonary (including
    asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorderv;
    • They have any inherited or acquired immunodeficiency;
    • They have a disease or are currently undergoing a form of treatment or were undergoing a form of treatment
    within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes,
    but is not limited to, systemic or high dose inhaled (>800&#956;g/day of beclomethasone dipropionate or equivalent)
    corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs;
    • They have a history of severe allergic reactions or anaphylaxis;
    • They have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating;
    • They have received a blood transfusion or immunoglobulins within 90 days prior to study entry;
    • They have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination
    in this study;
    • They have a functional or surgical asplenia;
    • They have a known or suspected problem with alcohol or drug abuse;
    • They were administered an investigational drug within 6 weeks prior to study entry or are concurrently
    participating in a clinical study that includes the administration of an investigational product;
    • They are in a dependent relationship with the study site personnel. Dependent relationships include close
    relatives (i.e., children, siblings);
    • If female: are pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    • Frequency and severity of systemic reactions until 21 days after the first and second vaccination.
    Immunogenicity:
    • Rate of subjects with antibody response to the vaccine strain associated with protection 21 days after the second
    vaccination defined as titer measured by Microneutralization (MN) test &#8805; 1:20.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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
    Estudio de fase I/II de la vacuna H5N1
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    This study is terminated when the last subject completes day 381 (Visit 8).The study may be prematurely
    terminated if SAEs or other significant vaccine related side effects occur. In addition the Sponsor may stop the
    entire study for any medical reason at any time.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days16
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Los sujetos no tienen la edad legal.
    Subject are not of legal age.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 900
    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 Decision2009-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
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