Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35486   clinical trials with a EudraCT protocol, of which   5827   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    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

    Summary
    EudraCT number
    2014-003400-70
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    20 Oct 2015

    Results information
    Results version number
    v2(current)
    This version publication date
    17 Mar 2017
    First version publication date
    20 Mar 2016
    Other versions
    v1
    Version creation reason

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    D2560C00006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca Clinical Study Information Center
    Sponsor organisation address
    Room Tatnall Bldg 1800 Concord Pike PO Box 15437, Wilmington, DE, United States, 19850-5437
    Public contact
    INformation Center, AstraZeneca Clinical Study Information Center, 1+ 877-240-9479, informationcenter@astrazeneca.com
    Scientific contact
    Raburn Mallony, MedImmune, 1+ 301-398-0000, ClinicalTrialEnquiries@Medimmune.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main 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.
    Protection of trial subjects
    The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/Good Clinical Practice, applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological Samples. The applicable regulatory requirements in Japan are ‘Good Clinical Practice for Trials on Drugs (MHLW Ordinance No. 28, 27 March 1997, partially revised by MHLW Ordinance and their related notifications. The Master Informed Consent Form will explain that: • Study data will be stored in a computer database, maintaining confidentiality in accordance with national data legislation • Subject data will be maintaining confidentiality in accordance with national data legislation • For data verification purposes, authorised representatives of AstraZeneca, a regulatory authority, an IRB may require direct access to parts of the hospital or practice source records relevant to the study, including subjects’ medical history • All data computer processed by AstraZeneca will be identified by study code and enrolment code (E-code) The combined data from the trivalent live, attenuated influenza vaccine development program and postmarketing experience provide substantial evidence to confirm the acceptable safety, tolerability, and efficacy of T/LAIV in individuals 24 months of age and older.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Oct 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 1369
    Worldwide total number of subjects
    1369
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    849
    Adolescents (12-17 years)
    486
    Adults (18-64 years)
    34
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    To enrol Japanese children age 7 years to through 18 years.

    Pre-assignment
    Screening details
    To meet all of the inclusion criteria and none of the exclusion criteria for this study.

    Pre-assignment period milestones
    Number of subjects started
    1369
    Number of subjects completed
    1301

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    last patients randomization: 68
    Period 1
    Period 1 title
    Up to end April 2015 (6 months) (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    MEDI3250
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    N/A
    Investigational medicinal product code
    MEDI3250
    Other name
    Pharmaceutical forms
    Suspension and solution for spray
    Routes of administration
    Nasal use
    Dosage and administration details
    intranasal administration of 0.2 mL (0.1 mL per nostril)

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Suspension and solution for spray
    Routes of administration
    Nasal use
    Dosage and administration details
    intranasal administration of 0.2 mL (0.1 mL per nostril)

    Number of subjects in period 1 [1]
    MEDI3250 Placebo
    Started
    868
    433
    Completed
    865
    432
    Not completed
    3
    1
         exclusion criteria 17
             3
             -
         Consent withdrawn by subject
             -
             1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 1,369 Japanese subjects whom written informed consent was provided were enrolled. Of these, 1,301 subjects were randomized to either MEDI3250 or placebo and received the investigational product.

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    MEDI3250
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group values
    MEDI3250 Placebo Total
    Number of subjects
    868 433 1301
    Age Categorical
    Units: Subjects
        Children (2-11 years)
    534 277 811
        Adolescents (12-17 years)
    314 145 459
        Adults (18-64 years)
    20 11 31
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    11 ± 3 10.8 ± 2.8 -
    Gender Categorical
    Units: Subjects
        Female
    408 226 634
        Male
    460 207 667
    Number of Doses of Study Vaccine Received
    Units: Subjects
        One
    841 421 1262
        Two
    27 12 39
    Prior Influenza Vaccination
    Units: Subjects
        Yes
    788 386 1174
        No
    80 47 127
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    ITT

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety analysis set

    Subject analysis set title
    PPS
    Subject analysis set type
    Per protocol
    Subject analysis set description
    PPS

    Subject analysis sets values
    ITT Safety analysis set PPS
    Number of subjects
    1301
    1301
    1279
    Age Categorical
    Units: Subjects
        Children (2-11 years)
    811
    811
    801
        Adolescents (12-17 years)
    459
    459
    449
        Adults (18-64 years)
    31
    31
    29
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    10.9 ± 2.9
    10.9 ± 2.9
    10.9 ± 2.9
    Gender Categorical
    Units: Subjects
        Female
    634
    634
    622
        Male
    667
    667
    657
    Number of Doses of Study Vaccine Received
    Units: Subjects
        One
    1262
    1262
    1240
        Two
    39
    39
    39
    Prior Influenza Vaccination
    Units: Subjects
        Yes
    1174
    1174
    1153
        No
    127
    127
    126

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    MEDI3250
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Subject analysis set title
    ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    ITT

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety analysis set

    Subject analysis set title
    PPS
    Subject analysis set type
    Per protocol
    Subject analysis set description
    PPS

    Primary: Influenza Attacked (Matched Strain)

    Close Top of page
    End point title
    Influenza Attacked (Matched Strain)
    End point description
    End point type
    Primary
    End point timeframe
    Until end of influenza surveillance period
    End point values
    MEDI3250 Placebo
    Number of subjects analysed
    849
    430
    Units: number
    0
    1
    Statistical analysis title
    Vaccine efficacy for matched strain
    Comparison groups
    MEDI3250 v Placebo
    Number of subjects included in analysis
    1279
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Vaccine Efficacy
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1875.3
         upper limit
    100

    Secondary: Influenza Attacked (Any Strain)

    Close Top of page
    End point title
    Influenza Attacked (Any Strain)
    End point description
    End point type
    Secondary
    End point timeframe
    Until end of influenza surveillance period
    End point values
    MEDI3250 Placebo
    Number of subjects analysed
    849
    430
    Units: number
    169
    118
    Statistical analysis title
    Vaccine efficacy for any strain
    Comparison groups
    MEDI3250 v Placebo
    Number of subjects included in analysis
    1279
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Vaccine Efficacy
    Point estimate
    27.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    7.4
         upper limit
    43

    Secondary: Influenza Attacked (Matched Strain, by Strain)

    Close Top of page
    End point title
    Influenza Attacked (Matched Strain, by Strain)
    End point description
    End point type
    Secondary
    End point timeframe
    Until end of influenza surveillance period
    End point values
    MEDI3250 Placebo
    Number of subjects analysed
    849
    430
    Units: number
        Strain A/H1N1
    0
    0
        Strain A/H3N2
    0
    0
        Strain B/Yamagata
    0
    1
        Strain B/Victoria
    0
    0
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected from Day 1 until the end of the influenza surveillance period. Serious adverse events were collected from informed consent until the end of the influenza surveillance period.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    MEDI3250
    Reporting group description
    Nasal spray administration of MEDI3250 0.2 mL (0.1 mL per nostril)

    Reporting group title
    Placebo
    Reporting group description
    Nasal spray administration of Placebo 0.2 mL (0.1 mL per nostril)

    Reporting group title
    Total
    Reporting group description
    Nasal spray administration of study drug 0.2 mL (0.1 mL per nostril)

    Serious adverse events
    MEDI3250 Placebo Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 868 (0.35%)
    3 / 433 (0.69%)
    6 / 1301 (0.46%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 868 (0.12%)
    0 / 433 (0.00%)
    1 / 1301 (0.08%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 868 (0.00%)
    1 / 433 (0.23%)
    1 / 1301 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteochondrosis
         subjects affected / exposed
    0 / 868 (0.00%)
    1 / 433 (0.23%)
    1 / 1301 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 868 (0.12%)
    0 / 433 (0.00%)
    1 / 1301 (0.08%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 868 (0.12%)
    0 / 433 (0.00%)
    1 / 1301 (0.08%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 868 (0.00%)
    1 / 433 (0.23%)
    1 / 1301 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    MEDI3250 Placebo Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    133 / 868 (15.32%)
    72 / 433 (16.63%)
    205 / 1301 (15.76%)
    Respiratory, thoracic and mediastinal disorders
    rhinorrhoea
         subjects affected / exposed
    14 / 868 (1.61%)
    9 / 433 (2.08%)
    23 / 1301 (1.77%)
         occurrences all number
    14
    9
    23
    Upper respiratory tract inflammation
         subjects affected / exposed
    18 / 868 (2.07%)
    8 / 433 (1.85%)
    26 / 1301 (2.00%)
         occurrences all number
    18
    8
    26
    cough
         subjects affected / exposed
    7 / 868 (0.81%)
    5 / 433 (1.15%)
    12 / 1301 (0.92%)
         occurrences all number
    7
    5
    12
    Rhinitis allergic
         subjects affected / exposed
    9 / 868 (1.04%)
    2 / 433 (0.46%)
    11 / 1301 (0.85%)
         occurrences all number
    9
    2
    11
    Gastrointestinal disorders
    diarrhoea
         subjects affected / exposed
    10 / 868 (1.15%)
    5 / 433 (1.15%)
    15 / 1301 (1.15%)
         occurrences all number
    10
    5
    15
    Infections and infestations
    nasopharyngitis
         subjects affected / exposed
    70 / 868 (8.06%)
    36 / 433 (8.31%)
    106 / 1301 (8.15%)
         occurrences all number
    70
    36
    106
    bronchitis
         subjects affected / exposed
    5 / 868 (0.58%)
    7 / 433 (1.62%)
    12 / 1301 (0.92%)
         occurrences all number
    5
    7
    12

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA