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    Clinical Trial Results:
    A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children age 2 years through 6 years

    Summary
    EudraCT number
    		 2014-003401-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    16 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D2560C00007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca K.K.
    Sponsor organisation address
    3-1, Ofuka-cho, Kita-ku, Osaka, Japan, 5310076
    Public contact
    Research & Development, AstraZeneca K.K., 81 6 7711 4699, Takenobu.Masaoka@astrazeneca.com
    Scientific contact
    Research & Development, AstraZeneca K.K., 81 6 7711 4699, Takenobu.Masaoka@astrazeneca.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
    08 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of MEDI3250.
    Protection of trial subjects
    • Study data will be stored in a computer database, maintaining confidentiality in accordance with national data legislation • Patient 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)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 100
    Worldwide total number of subjects
    100
    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)
    100
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The targeted enrolled number of subject was 100 and 100 subjects were enrolled. First subject enrolled date was 01 Nov 2014 and Last subject last visit date was 03 Feb 2015.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 100
    Number of subjects completed
    		 100

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 MEDI3250
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI3250
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal/oromucosal spray, solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    For children age 2 years through 6 years, the recommended dosage schedule for intranasal administration is 0.2 mL (0.1 mL per nostril). For children not previously vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.

    Number of subjects in period 1
    		MEDI3250
    Started
    100
    Completed
    100

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MEDI3250
    Reporting group description
    		 -

    Reporting group values
    		 MEDI3250 Total
    Number of subjects
    		 100 100
    Age categorical
    Age 2 through 6 years of age was targeted.
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 100 100
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 4.2 ( 1.4 ) -
    Gender categorical
    Gender was not limited, ie, both male and female were targeted.
    Units: Subjects
        Female
    		 55 55
        Male
    		 45 45
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 100 100
    Race
    Units: Subjects
        Asian
    		 100 100
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Population includes all subjects who receive any amount of investigational product.

    Subject analysis sets values
    		 Safety population
    Number of subjects
    100
    Age categorical
    Age 2 through 6 years of age was targeted.
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    100
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    4.2 ( 1.4 )
    Gender categorical
    Gender was not limited, ie, both male and female were targeted.
    Units: Subjects
        Female
    55
        Male
    45
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    100
    Race
    Units: Subjects
        Asian
    100

    End points

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    End points reporting groups
    Reporting group title
    MEDI3250
    Reporting group description
    		 -

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Population includes all subjects who receive any amount of investigational product.

    Primary: The number of subjects with solicited symptom

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    End point title
    		 The number of subjects with solicited symptom [1]
    End point description
    Solicited symptoms experienced from administration of investigational product through 14 days post vaccination by dose number (as appropriate)
    End point type
    Primary
    End point timeframe
    for 14 days post vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is open-label, safety study to assess the safety and tolerability of MEDI3250, ie, no comparators/placebo, so there is no statistical analysis
    End point values
    		 MEDI3250 Safety population
    Number of subjects analysed
    100
    100
    Units: subject
    57
    57
    No statistical analyses for this end point

    Primary: To assess the safety and tolerability of MEDI3250

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    End point title
    		 To assess the safety and tolerability of MEDI3250 [2]
    End point description
    Adverse events experienced from administration of investigational product through 28 days post vaccination by dose number (as appropriate)
    End point type
    Primary
    End point timeframe
    for 28 days post vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is open-label, safety study to assess the safety and tolerability of MEDI3250, ie, no comparators/placebo, so there is no statistical analysis
    End point values
    		 MEDI3250 Safety population
    Number of subjects analysed
    100
    100
    Units: subject
    42
    42
    No statistical analyses for this end point

    Primary: To assess the safety and tolerability of MEDI3250

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    End point title
    		 To assess the safety and tolerability of MEDI3250 [3]
    End point description
    Treatment-emergent SAEs experienced from administration of investigational product through 28 days post vaccination by dose number (as appropriate)
    End point type
    Primary
    End point timeframe
    For 28 days post vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is open-label, safety study to assess the safety and tolerability of MEDI3250, ie, no comparators/placebo, so there is no statistical analysis
    End point values
    		 MEDI3250 Safety population
    Number of subjects analysed
    100
    100
    Units: subject
    0
    0
    No statistical analyses for this end point

    Primary: To assess the safety and tolerability of MEDI3250

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    End point title
    		 To assess the safety and tolerability of MEDI3250 [4]
    End point description
    Treatment-emergent SAEs experienced from informed consent to 28 days post last vaccination
    End point type
    Primary
    End point timeframe
    28 days post vaccination
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is open-label, safety study to assess the safety and tolerability of MEDI3250, ie, no comparators/placebo, so there is no statistical analysis
    End point values
    		 MEDI3250 Safety population
    Number of subjects analysed
    100
    100
    Units: subject
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For subjects with one dose, until Day 29 post-vaccination. For subjects with two doses, until Day 57 post-vaccination.
    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
    		 MEDI3250

    Serious adverse events
    		 MEDI3250
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MEDI3250
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 100 (13.00%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 100 (13.00%)
         occurrences all number
    13

    More information

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    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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