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    Clinical Trial Results:
    Protection induced by Live Attenuated Influenza Vaccine (LAIV or Fluenz Tetra) - applied epidemiological study

    Summary
    EudraCT number
    		 2015-003250-41
    Trial protocol
    		 GB  
    Global end of trial date
    13 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2019
    First version publication date
    27 Nov 2019
    Other versions
    Summary report(s)
    		 Baseline Characteristics of Participants by Study Year
    LAIV Protect Final Analysis
    PCR Test Results of Samples Tested

    Trial information

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    Trial identification
    Sponsor protocol code
    1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Public Health England
    Sponsor organisation address
    61 Colindale Avenue, London, United Kingdom, NW9 5EQ
    Public contact
    Epidemiologist, Public Health England, 004 2083277147, chinelo.obi@phe.gov.uk
    Scientific contact
    Epidemiologist, Public Health England, 0044 2083277147, chinelo.obi@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
    07 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine efficacy of LAIV in a school age UK population
    Protection of trial subjects
    Vaccine administered nasally and nasal swabs collected. No blood taken or vaccines given intramuscularly so no pain
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 24 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 276
    Worldwide total number of subjects
    276
    EEA total number of subjects
    276
    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)
    4
    Adolescents (12-17 years)
    268
    Adults (18-64 years)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 276 children aged 10 -16 years were offered a single dose of LAIV vaccination and were given a nasal swab and asked to self-swab if they experienced flu like illness.

    Pre-assignment
    Screening details
    		 Hypersensitivity to the active ingredients, previous systemic allergic reaction to LAIV. Previous systemic 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 who are clinically immunodeficient.

    Period 1
    Period 1 title
    Start of Season
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 ARM 1
    Arm description
    		 -
    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. 0.1ml to each nostril

    Arm title
    		 ARM 2
    Arm description
    		 The second survey where participants where followed up and self-reported any respiratory symptoms. Non of the participants were vaccinated.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		ARM 1 ARM 2
    Started
    276
    243
    Completed
    251
    243
    Not completed
    25
    0
         Lost to follow-up
    25
    -
    Period 2
    Period 2 title
    End of Season
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 ARM 1
    Arm description
    		 -
    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. 0.1ml to each nostril

    Arm title
    		 ARM 2
    Arm description
    		 The second survey where participants where followed up and self-reported any respiratory symptoms. Non of the participants were vaccinated.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		ARM 1 ARM 2
    Started
    276
    243
    Completed
    251
    243
    Not completed
    25
    0
         Lost to follow-up
    25
    -

    Baseline characteristics

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

    Reporting group title
    ARM 2
    Reporting group description
    		 The second survey where participants where followed up and self-reported any respiratory symptoms. Non of the participants were vaccinated.

    Reporting group values
    		 ARM 1 ARM 2 Total
    Number of subjects
    		 276 243 276
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 272 239 272
        Adults (18-64 years)
    		 4 4 4
    Gender categorical
    Units: Subjects
        Female
    		 78 50 78
        Male
    		 198 193 198

    End points

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    End points reporting groups
    Reporting group title
    ARM 1
    Reporting group description
    		 -

    Reporting group title
    ARM 2
    Reporting group description
    		 The second survey where participants where followed up and self-reported any respiratory symptoms. Non of the participants were vaccinated.
    Reporting group title
    ARM 1
    Reporting group description
    		 -

    Reporting group title
    ARM 2
    Reporting group description
    		 The second survey where participants where followed up and self-reported any respiratory symptoms. Non of the participants were vaccinated.

    Primary: PCR positive to Influenza

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    End point title
    		 PCR positive to Influenza
    End point description
    Participants sent swab each time they experienced symptoms similar to respiratory infections. The swabs were tested for influenza
    End point type
    Primary
    End point timeframe
    Flu Week 20 to 40
    End point values
    		 ARM 1 ARM 2
    Number of subjects analysed
    47
    37
    Units: PCR Positive
    1
    3
    Statistical analysis title
    		 Characteristics of participants with ILI
    Statistical analysis description
    Participants reporting respiratory symptoms (ILI) during the first survey were compared to those reporting in the second year of the survey to establish if there was any evidence of longevity of the flu vaccine
    Comparison groups
    ARM 1 v ARM 2
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≥ 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 1.8
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    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
    68 / 251 (27.09%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Influenza like illness
    Additional description: Participants reported presence of flu like symptoms during the study period
         subjects affected / exposed
    68 / 251 (27.09%)
         occurrences causally related to treatment / all
    0 / 154
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    130 / 251 (51.79%)
    Respiratory, thoracic and mediastinal disorders
    Sore throat
         subjects affected / exposed
    130 / 251 (51.79%)
         occurrences all number
    130

    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
    For support, Contact us.
    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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