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    Summary
    EudraCT Number:2014-003400-70
    Sponsor's Protocol Code Number:D2560C00006
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-03-24
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-003400-70
    A.3Full title of the trial
    A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MEDI3250 Compared to Placebo in Healthy Japanese Children age 7 years through 18 years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children age 7 years through 18 years
    A.4.1Sponsor's protocol code numberD2560C00006
    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 SponsorAstraZeneca K.K.
    B.1.3.4CountryJapan
    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 supportAstraZeneca K.K.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca K.K.
    B.5.2Functional name of contact pointResearch & Development
    B.5.3 Address:
    B.5.3.1Street Address3-1, Ofuka-sho, Kitaku,
    B.5.3.2Town/ cityOsaka
    B.5.3.3Post code5300011
    B.5.3.4CountryJapan
    B.5.4Telephone number8167711 4699
    B.5.5Fax number8164802 3563
    B.5.6E-mailTakenobu.Masaoka@astrazeneca.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 Fluenz Tetra
    D.2.1.1.2Name of the Marketing Authorisation holderMedImmune LLC
    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.3.1Product nameQuadrivalent Live Attenuated Influenza Vaccine
    D.3.2Product code MEDI3250
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal spray
    D.8.4Route of administration of the placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy Children
    E.1.1.1Medical condition in easily understood language
    Healthy Children
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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
    To assess the efficacy (the incidence of laboratory-confirmed influenza infection caused by any community-acquired wild-type strains matched to the vaccine) of MEDI3250 compared to placebo.

    To assess the safety and tolerability of MEDI3250 compared to placebo.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of MEDI3250 compared to placebo.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 7 through 18 years of age at the time of randomization. 2. A written informed consent should be obtained from the subject’s legally acceptable representative, and a written informed assent should be obtained from the subject if possible. 3. Available for illness visits at clinic during the influenza surveillance period. 4. Ability of the legal representative to understand and comply with the requirements of the protocol. 5. Parent/guardian available by telephone, email or etc. 6. Females of childbearing potential, unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), has sterile male partner, is premenarchal, or practices abstinence, must have used an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap with spermicide, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of investigational product, and must agree to continue using such precautions for 60 days after the final dose of investigational product. 7. A subject who is considered by the investigator to be at risk of pregnancy must also have a negative urine pregnancy test at screening and, if screening and Day 0 do not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment is required to assess each subject's need for pregnancy testing. 8. Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization has not been required in the previous year
    E.4Principal exclusion criteria
    1. Subjects who were previously administered influenza vaccine in 2014-2015 influenza season 2. Previous randomisation in the present study 3. Participation in another clinical study with an investigational product during the last 3 month 4. Acute illness or evidence of significant active infection at randomization; 5. Fever ≥99.5°F (37.5°C) at randomization; 6. Any drug therapy from 15 days prior to randomization or expected drug therapy through 28 days post last dose with the exception of the following classes/types of medications, which are allowed: Contraceptives (change in contraceptive type or method is acceptable as long as guidelines are followed for prevention of pregnancy during change); Topical corticosteroids, calcineurin inhibitors, or antifungals for uncomplicated dermatitis; Chronic medications (including those taken on an as-needed basis) that have been well tolerated and were not initiated and/or did not have a dosage change within 90 days prior to randomization. 7. Current or expected receipt of immunosuppressive medications within a 28-day window around any dose, including an immunosuppressive dose of corticosteroids, which is defined as ≥20 mg/day of prednisone or its equivalent, given daily or on alternate days for ≥15 days (intranasal, intra-articular, and topical corticosteroids are permitted); Note: topical corticosteroids for uncomplicated dermatitis may be used throughout the study according to the judgment of the investigator; topical calcineurin inhibitors may be used in accordance with their package insert at entry and during study participation. 8. Any known immunosuppressive condition or immune deficiency disease including known or suspected infection with human immunodeficiency virus (HIV); 9. History of allergic disease or reactions likely to be exacerbated by any component of the investigational product including allergy to eggs, egg proteins, gentamicin, or gelatin or serious, life threatening, or severe reactions to previous influenza vaccinations; 10. Use of aspirin or salicylate-containing medications within 28 days prior to randomization or expected receipt through the entire study; 11. History of Guillain-Barré syndrome; 12. Use of antiviral agents with activity against influenza virus (including amantadine, rimantadine, oseltamivir, and zanamivir) within 28 days prior to first dose of investigational product or anticipated use of such agents in the study period; 13. Administration of any live virus vaccine within 30 days prior to enrolment, or if receipt of another live virus vaccine is expected within 30 days of any study vaccination; 14. Administration of any inactivated vaccine within 14 days prior to enrolment or if receipt of another inactivated vaccine is expected within 14 days of any study vaccination; 15. Receipt of any blood product within 90 days prior to vaccination or expected receipt during this study; 16. Pregnant or lactating female 17. Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site as a legal representative) 18. Any condition that, in the opinion of the investigator, might interfere with the interpretation or evaluation of the vaccines.
    E.5 End points
    E.5.1Primary end point(s)
    The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed symptomatic influenza infection caused by any community-acquired wild-type strains matched to the vaccine, occurring during the influenza surveillance period and at least 14 days after the last required vaccination. For the primary endpoint, laboratory-confirmed symptomatic influenza infection is defined as the presence of modified Centers for Disease Control (CDC)-ILI associated with laboratory-confirmed influenza. Modified CDC-ILI is defined as increased temperature ≥100°F (37.8°C) oral or equivalent plus the presence of cough, sore throat, or runny nose/nasal congestion occurring on the same or consecutive days.

    • Solicited symptoms experienced from administration of investigational product through 14 days post vaccination by dose number (as appropriate), • Adverse events experienced from administration of investigational product through 28 days post vaccination by dose number (as appropriate), • Treatment-emergent SAEs experienced from administration of investigational product through 28 days post vaccination by dose number (as appropriate). • Treatment-emergent SAEs experienced from informed consent through the end of the enrolled influenza season.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The vsaccine efficacy: Through the end of the enrolled influenza season(April 2015) in serious adverse event

    Safety:
    14 days post vaccination by dose number in solicited symptoms
    28 days post vaccination by dose number in adverse events
    28 days post vaccination by dose number in serious adverse event
    Through the end of the enrolled influenza season(April 2015) in serious adverse event
    E.5.2Secondary end point(s)
    The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed symptomatic influenza infection caused by any community-acquired wild-type strains regardless of match to the vaccine, occurring during the influenza surveillance period and at least 14 days after the last required vaccination. For the secondary endpoint, laboratory-confirmed symptomatic influenza infection is defined as the presence of modified CDC-ILI associated with laboratory-confirmed influenza. Modified CDC-ILI is defined as increased temperature ≥ 100°F (37.8°C) oral or equivalent plus the presence of cough, sore throat, or runny nose/nasal congestion occurring on the same or consecutive days.


    E.5.2.1Timepoint(s) of evaluation of this end point
    Through the end of the enrolled influenza season(April 2015) in serious adverse event
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    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
    Efficacy data including the presence or absence of criteria defining CDC-ILI, will be collected from Day 1 through the end of the influenza surveillance period. The influenza surveillance periods are provisionally defined as September, 2014 through April 30, 2015. The date of April 30 date, 2015 may be modified if, based on national, regional, and/or locally available influenza surveillance data, the season ends sooner or extends beyond this date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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.1.1Number of subjects for this age range: 1008
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 1008
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1008
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1008
    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
    Subject's parent/guardian provides signed and dated informed consent before conducting any procedure specifically for the study. And written informed assent from subjects if available.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1008
    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)
    Any AEs that are unresolved at the subject’s last AE assessment in the study are followed up by the Investigator for as long as medically indicated. AstraZeneca retains the right to request additional information for any subject with ongoing AE(s)/SAE(s) at the end of the study, if judged necessary.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.3.4Network Country Japan
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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