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    Clinical Trial Results:
    Assessment of viral shedding week following administration of live attenuated influenza vaccine in children: FluSHED-2 study

    Summary
    EudraCT number
    		 2018-002470-42
    Trial protocol
    		 GB  
    Global end of trial date
    01 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2022
    First version publication date
    16 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FluSHED-2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03735147
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 HRA IRAS: 250312
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    Norfolk Place, London, United Kingdom,
    Public contact
    Turner, IMPERIAL COLLEGE LONDON, 44 02033127754, p.turner@imperial.ac.uk
    Scientific contact
    Turner, IMPERIAL COLLEGE LONDON, 44 02033127754, p.turner@imperial.ac.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
    30 Sep 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Technical version: To measure type-specific vaccine virus shedding in 2018/19 following LAIV administration. Lay version: To measure the amount and strains of flu virus in the nose of children who have had the nasal flu vaccine in the week following their vaccination.
    Protection of trial subjects
    The trial involved non-invasive nasal swabbing following a routine immunisation (LAIV) to assess for timing kinetics of viral shedding. Participants were protected under GCP protocols.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2018
    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: 12
    Worldwide total number of subjects
    12
    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)
    6
    Adolescents (12-17 years)
    6
    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
    		 Subjects were recruited from existing paediatric services at St Mary’s Hospital, London. Recruitment was via publicity (posters, flyers), email and postal mailing.

    Pre-assignment
    Screening details
    		 Potential participants were evaluated according to eligibility criteria as outlined in the study protocol.

    Period 1
    Period 1 title
    Intervention LAIV (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    n/a

    Arms
    Arm title
    		 Intervention
    Arm description
    		 Dose of LAIV given as per UK vaccine programme/national guidance
    Arm type
    		 Experimental

    Investigational medicinal product name
    live attenuated influenza vaccine
    Investigational medicinal product code
    Other name
    Fluenz Tetra
    Pharmaceutical forms
    Nasal/oromucosal spray, solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    Live Attenuated Intranasal Vaccine (LAIV) Quadrivalent vaccine (Fluenz-Tetra, Astra Zeneca), as provided for use by the Department of Health as part of the UK National Immunisation Schedule DOSAGE AND ROUTE OF ADMINISTRATION 0.2 ml (administered as 0.1 ml per nostril). Immunisation will be carried out by nasal administration, as per the SmPC provided.

    Number of subjects in period 1
    		Intervention
    Started
    12
    Completed
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention LAIV
    Reporting group description
    		 -

    Reporting group values
    		 Intervention LAIV Total
    Number of subjects
    		 12 12
    Age categorical
    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)
    		 6 6
        Adolescents (12-17 years)
    		 6 6
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 7 7
    Subject analysis sets

    Subject analysis set title
    Overall cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Overall cohort

    Subject analysis sets values
    		 Overall cohort
    Number of subjects
    12
    Age categorical
    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)
    6
        Adolescents (12-17 years)
    6
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Dose of LAIV given as per UK vaccine programme/national guidance

    Subject analysis set title
    Overall cohort
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Overall cohort

    Primary: Viral shedding - Day 1

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    End point title
    		 Viral shedding - Day 1 [1]
    End point description
    type-specific vaccine virus shedding in 2018/19 and how this varies in the 8 days following vaccination
    End point type
    Primary
    End point timeframe
    Day 1 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: Minimal evidence of low level viral shedding in the minority of participants, thus no statistical analyses were feasible.
    End point values
    		 Intervention Overall cohort
    Number of subjects analysed
    12
    12
    Units: No. with detected viral shedding
    3
    3
    Attachments
    		 Viral shedding data days 1-8
    No statistical analyses for this end point

    Primary: Viral shedding - day 2

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    End point title
    		 Viral shedding - day 2 [2]
    End point description
    End point type
    Primary
    End point timeframe
    Day 2 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: Minimal evidence of low level viral shedding in the minority of participants, thus no statistical analyses were feasible.
    End point values
    		 Intervention Overall cohort
    Number of subjects analysed
    12
    12
    Units: % with detected viral shedding
    3
    3
    No statistical analyses for this end point

    Primary: Viral shedding - Day 3

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    End point title
    		 Viral shedding - Day 3 [3]
    End point description
    End point type
    Primary
    End point timeframe
    Day 3 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: Minimal evidence of low level viral shedding in the minority of participants, thus no statistical analyses were feasible.
    End point values
    		 Intervention Overall cohort
    Number of subjects analysed
    12
    12
    Units: % with detected viral shedding
    1
    1
    No statistical analyses for this end point

    Primary: Viral shedding - Day 4

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    End point title
    		 Viral shedding - Day 4 [4]
    End point description
    End point type
    Primary
    End point timeframe
    Day 4 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: Minimal evidence of low level viral shedding in the minority of participants, thus no statistical analyses were feasible.
    End point values
    		 Intervention Overall cohort
    Number of subjects analysed
    12
    12
    Units: % with detected viral shedding
    3
    3
    No statistical analyses for this end point

    Primary: Viral shedding - Day 5

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    End point title
    		 Viral shedding - Day 5 [5]
    End point description
    End point type
    Primary
    End point timeframe
    Day 5 post vaccination
    Notes
    [5] - 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: Minimal evidence of low level viral shedding in the minority of participants, thus no statistical analyses were feasible.
    End point values
    		 Intervention Overall cohort
    Number of subjects analysed
    12
    12
    Units: % with detected viral shedding
    3
    3
    No statistical analyses for this end point

    Primary: Viral shedding - Day 6

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    End point title
    		 Viral shedding - Day 6 [6]
    End point description
    End point type
    Primary
    End point timeframe
    Day 6 post vaccination
    Notes
    [6] - 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: Minimal evidence of low level viral shedding in the minority of participants, thus no statistical analyses were feasible.
    End point values
    		 Intervention Overall cohort
    Number of subjects analysed
    12
    12
    Units: % with detected viral shedding
    3
    3
    No statistical analyses for this end point

    Primary: Viral shedding - Day 7

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    End point title
    		 Viral shedding - Day 7 [7]
    End point description
    End point type
    Primary
    End point timeframe
    Day 7 post vaccination
    Notes
    [7] - 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: Minimal evidence of low level viral shedding in the minority of participants, thus no statistical analyses were feasible.
    End point values
    		 Intervention Overall cohort
    Number of subjects analysed
    12
    2
    Units: % with detected viral shedding
    2
    12
    No statistical analyses for this end point

    Primary: Viral shedding - Day 8

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    End point title
    		 Viral shedding - Day 8 [8]
    End point description
    End point type
    Primary
    End point timeframe
    Day 8 post vaccination
    Notes
    [8] - 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: Minimal evidence of low level viral shedding in the minority of participants, thus no statistical analyses were feasible.
    End point values
    		 Intervention Overall cohort
    Number of subjects analysed
    12
    12
    Units: % with detected viral shedding
    2
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events up to Day 8 after LAIV. SAEs up to Day 28.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Dose of LAIV given as per UK vaccine programme/national guidance

    Serious adverse events
    		 Intervention
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (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
    		 Intervention
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (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: No Adverse Events were reported in the 8 days following vaccination for any of the participants.

    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.
    Minimal evidence of low level viral shedding in the minority of participants, thus no statistical analyses were feasible.
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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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