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    Clinical Trial Results:
    Assessment of viral shedding in children previously in receipt of multiple doses of live attenuated influenza vaccine (LAIV) compared to influenza vaccine-naïve controls

    Summary
    EudraCT number
    		 2017-000952-24
    Trial protocol
    		 GB  
    Global end of trial date
    28 Feb 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Feb 2019
    First version publication date
    07 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Flu-shed
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03104790
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Public Health England
    Sponsor organisation address
    Wellington House , London , United Kingdom, SE1 8UG
    Public contact
    Elizabeth Coates elizabeth.coates@phe.gov.uk, Public Health England Wellington House, London SE1 8UG, +44 01980612922, elizabeth.coates@phe.gov.uk
    Scientific contact
    Elizabeth Coates elizabeth.coates@phe.gov.uk, Public Health England Wellington House, London SE1 8UG, +44 01980612922, elizabeth.coates@phe.gov.uk
    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
    28 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To measure type-specific vaccine virus shedding and immunogenicity in 2017/18 and determine if there has been any change compared to previous studies in 2016/17 (conducted by this group, Eudract 2013-003592-35 and 2016-002352‐24) following change in the A/H1N1pdm09 vaccine virus strain amongst children with the same prior vaccine history
    Protection of trial subjects
    Oral Fluids used and no blood taken or vaccines given intramuscularly so no pain
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Sep 2017
    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
    United Kingdom: 362
    Worldwide total number of subjects
    362
    EEA total number of subjects
    362
    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)
    247
    Adolescents (12-17 years)
    115
    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
    		 362 subjects received LAIV and were asked to take three nasal swabs in the ten days after vaccination to assess vaccine virus shedding

    Pre-assignment
    Screening details
    		 Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue). Previous systemic allergic reaction to LAIV. Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the CI to confirm patient suitability. Children/adolescents who are clinically immunode

    Period 1
    Period 1 title
    PERIOD 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ARM1
    Arm description
    		 All children
    Arm type
    		 Experimental

    Investigational medicinal product name
    LAIV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    0.2ml

    Number of subjects in period 1
    		ARM1
    Started
    362
    Completed
    362

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PERIOD 1
    Reporting group description
    		 -

    Reporting group values
    		 PERIOD 1 Total
    Number of subjects
    		 362 362
    Age categorical
    Age of children
    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)
    		 247 247
        Adolescents (12-17 years)
    		 115 115
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Sex of participants
    Units: Subjects
        Female
    		 194 194
        Male
    		 168 168

    End points

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    End points reporting groups
    Reporting group title
    ARM1
    Reporting group description
    		 All children

    Primary: Proportion shedding vaccine virus for H1N1

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    End point title
    		 Proportion shedding vaccine virus for H1N1 [1]
    End point description
    End point type
    Primary
    End point timeframe
    within 10 days of 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: Descriptive analysis only
    End point values
    		 ARM1
    Number of subjects analysed
    362
    Units: Percentage
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Within three weeks of vaccination
    Adverse event reporting additional description
    NONE
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 -

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 362 (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
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 362 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Virus Shedding study only and no adverse events were solicited

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Aug 2017
    Addition of substudy in which additional samples (nasal, blood) will be collected allowing more detailed assessment of the immune response to LAIV and how this compares with previous years

    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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