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    Clinical Trial Results:
    A Phase 4 Double-blind Study to Evaluate the Shedding and Immunogenicity of Trivalent and Quadrivalent Formulations of FluMist in Children 24 to < 48 Months of Age

    Summary
    EudraCT number
    2018-003701-26
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    29 Sep 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Dec 2018
    First version publication date
    01 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D2560C00013
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03143101
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States, 20878
    Public contact
    Raburn Mallory, MedImmune, LLC, +1 3013 985799, information.center@astrazeneca.com
    Scientific contact
    Raburn Mallory, MedImmune, LLC, +1 3013 985799, information.center@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
    29 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to describe the level of serum hemagglutination inhibition (HAI) antibody responses induced by trivalent and quadrivalent formulations of FluMist against antigenically matched influenza strains.
    Protection of trial subjects
    The conduct of this clinical study met all local and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization guideline: Good Clinical Practice, and applicable regulatory requirements. Subjects signed an informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 May 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 States: 200
    Worldwide total number of subjects
    200
    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)
    200
    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 study was conducted from 08 May 2017 through 29 Sep 2017 in the USA.

    Pre-assignment
    Screening details
    A total of 200 subjects were randomized and participated in the study.

    Period 1
    Period 1 title
    Overall Study (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
    FluMist trivalent (2015-2016)
    Arm description
    Subjects received intranasal spray of 0.2 milliliter (mL) (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 fluorescent focus units (FFU) of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).
    Arm type
    Experimental

    Investigational medicinal product name
    FluMist trivalent vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    Intranasal spray of 0.2 mL (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).

    Arm title
    FluMist Quadrivalent (2015-2016)
    Arm description
    Subjects received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
    Arm type
    Experimental

    Investigational medicinal product name
    FluMist quadrivalent vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    Intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).

    Arm title
    FluMist Quadrivalent (2017-2018)
    Arm description
    Subjects received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).
    Arm type
    Experimental

    Investigational medicinal product name
    FluMist quadrivalent vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    Intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).

    Number of subjects in period 1
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Started
    67
    66
    67
    Completed
    65
    63
    67
    Not completed
    2
    3
    0
         Consent withdrawn by subject
             -
             1
             -
         Lost to follow-up
             2
             2
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FluMist trivalent (2015-2016)
    Reporting group description
    Subjects received intranasal spray of 0.2 milliliter (mL) (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 fluorescent focus units (FFU) of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).

    Reporting group title
    FluMist Quadrivalent (2015-2016)
    Reporting group description
    Subjects received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).

    Reporting group title
    FluMist Quadrivalent (2017-2018)
    Reporting group description
    Subjects received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).

    Reporting group values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018) Total
    Number of subjects
    67 66 67 200
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    67 66 67 200
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    0 0 0 0
        From 65-84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    35.96 ± 6.41 34.96 ± 6.78 34.94 ± 6.80 -
    Sex: Female, Male
    Units: Subjects
        Female
    27 32 35 94
        Male
    40 34 32 106
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 1 0 1
        Asian
    1 0 0 1
        Native Hawaiian or Other Pacific Islander
    2 0 1 3
        Black or African American
    9 9 13 31
        White
    52 55 49 156
        More than one race
    3 1 3 7
        Unknown or Not Reported
    0 0 1 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    11 9 14 34
        Not Hispanic or Latino
    56 57 53 166
        Unknown or Not Reported
    0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    FluMist trivalent (2015-2016)
    Reporting group description
    Subjects received intranasal spray of 0.2 milliliter (mL) (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 fluorescent focus units (FFU) of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).

    Reporting group title
    FluMist Quadrivalent (2015-2016)
    Reporting group description
    Subjects received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).

    Reporting group title
    FluMist Quadrivalent (2017-2018)
    Reporting group description
    Subjects received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).

    Primary: Percentage of Subjects With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28

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    End point title
    Percentage of Subjects With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28
    End point description
    Seroconversion rate is defined as at least (>=) 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of subjects with >= 4-fold rise in A/H1N1 HAI antibody titer at Day 28 is reported. Immunogenicity population included all subjects in the as-treated population (ATP) who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, "N" signifies number of subjects analyzed for this end point. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.
    End point type
    Primary
    End point timeframe
    Day 28
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    60
    56
    64
    Units: Percentage of subjects
        number (confidence interval 95%)
    10.0 (3.8 to 20.5)
    5.4 (1.1 to 14.9)
    23.4 (13.8 to 35.7)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    FluMist Quadrivalent (2015-2016) v FluMist Quadrivalent (2017-2018)
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006 [1]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Mean difference (net)
    Point estimate
    18.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.8
         upper limit
    30.9
    Notes
    [1] - p-value is calculated from the Cochran–Mantel–Haenszel (CMH) test adjusting for the prior influenza vaccination status.

    Primary: Percentage of Subjects With A/H3N2 HAI Antibody Seroconversion Rate at Day 28

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    End point title
    Percentage of Subjects With A/H3N2 HAI Antibody Seroconversion Rate at Day 28 [2]
    End point description
    Seroconversion rate is defined as >= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of subjects with >= 4-fold rise in A/H3N2 HAI antibody titer at Day 28 is reported. Immunogenicity population included all subjects in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, "N" signifies number of subjects analyzed for this end point.
    End point type
    Primary
    End point timeframe
    Day 28
    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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    60
    56
    64
    Units: Percentage of subjects
        number (confidence interval 95%)
    51.7 (38.4 to 64.8)
    64.3 (50.4 to 76.6)
    31.3 (20.2 to 44.1)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With B/Yamagata HAI Antibody Seroconversion Rate at Day 28

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    End point title
    Percentage of Subjects With B/Yamagata HAI Antibody Seroconversion Rate at Day 28 [3]
    End point description
    Seroconversion rate is defined as >= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of subjects with >= 4-fold rise in B/Yamagata HAI antibody titer at Day 28 is reported. Immunogenicity population included all subject in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, "N" signifies number of subjects analyzed for this end point.
    End point type
    Primary
    End point timeframe
    Day 28
    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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    60
    56
    64
    Units: Percentage of subjects
        number (confidence interval 95%)
    50.0 (36.8 to 63.2)
    42.9 (29.7 to 56.8)
    57.8 (44.8 to 70.1)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With B/Victoria HAI Antibody Seroconversion Rate at Day 28

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    End point title
    Percentage of Subjects With B/Victoria HAI Antibody Seroconversion Rate at Day 28 [4]
    End point description
    Seroconversion rate is defined as >= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of subjects with >= 4-fold rise in B/Victoria HAI antibody titer at Day 28 is reported. Immunogenicity population included all subjects in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, "N" signifies number of subjects analyzed for this end point.
    End point type
    Primary
    End point timeframe
    Day 28
    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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    0 [5]
    56
    64
    Units: Percentage of subjects
        number (confidence interval 95%)
    ( to )
    14.3 (6.4 to 26.2)
    35.9 (24.3 to 48.9)
    Notes
    [5] - B/Victoria strain was not included in this arm.
    No statistical analyses for this end point

    Primary: Percentage of Subjecs With A/H1N1 HAI Antibody Seroconversion Rate at Day 56

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    End point title
    Percentage of Subjecs With A/H1N1 HAI Antibody Seroconversion Rate at Day 56
    End point description
    Seroconversion rate is defined as >= 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of subjects with >= 4-fold rise in A/H1N1 HAI antibody titer at Day 56 is reported. Immunogenicity population included all subjects in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, "N" signifies number of subjects analyzed for this end point. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.
    End point type
    Primary
    End point timeframe
    Day 56
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    59
    56
    62
    Units: Percentage of subjects
        number (confidence interval 95%)
    23.7 (13.6 to 36.6)
    12.5 (5.2 to 24.1)
    45.2 (32.5 to 58.3)
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    FluMist Quadrivalent (2015-2016) v FluMist Quadrivalent (2017-2018)
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [6]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Mean difference (net)
    Point estimate
    32.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    14.4
         upper limit
    47.8
    Notes
    [6] - p-value is calculated from the CMH test adjusting for the prior influenza vaccination status.

    Primary: Percentage of Subjects With A/H3N2 HAI Antibody Seroconversion Rate at Day 56

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    End point title
    Percentage of Subjects With A/H3N2 HAI Antibody Seroconversion Rate at Day 56 [7]
    End point description
    Seroconversion rate is defined as >= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of subjects with >= 4-fold rise in A/H3N2 HAI antibody titer at Day 56 is reported. Immunogenicity population included all subjects in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, "N" signifies number of subjects analyzed for this end point.
    End point type
    Primary
    End point timeframe
    Day 56
    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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    59
    56
    62
    Units: Percentage of subjects
        number (confidence interval 95%)
    54.2 (40.8 to 67.3)
    66.1 (52.2 to 78.2)
    40.3 (28.1 to 53.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With B/Yamagata HAI Antibody Seroconversion Rate at Day 56

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    End point title
    Percentage of Subjects With B/Yamagata HAI Antibody Seroconversion Rate at Day 56 [8]
    End point description
    Seroconversion rate is defined as >= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of subjects with >= 4-fold rise in B/Yamagata HAI antibody titer at Day 56 is reported. Immunogenicity population included all subjects in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, "N" signifies number of subjects analyzed for this end point.
    End point type
    Primary
    End point timeframe
    Day 56
    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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    60
    56
    62
    Units: Percentage of subjects
        number (confidence interval 95%)
    50.0 (36.8 to 63.2)
    53.6 (39.7 to 67.0)
    54.8 (41.7 to 67.5)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With B/Victoria HAI Antibody Seroconversion Rate at Day 56

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    End point title
    Percentage of Subjects With B/Victoria HAI Antibody Seroconversion Rate at Day 56 [9]
    End point description
    Seroconversion rate is defined as >= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of subjects with >= 4-fold rise in B/Victoria HAI antibody titer at Day 56 is reported. Immunogenicity population included all subjects in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, "N" signifies number of subjects analyzed for this end point.
    End point type
    Primary
    End point timeframe
    Day 56
    Notes
    [9] - 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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    0 [10]
    56
    62
    Units: Percentage of subjects
        number (confidence interval 95%)
    ( to )
    25.0 (14.4 to 38.4)
    40.3 (28.1 to 53.6)
    Notes
    [10] - B/Victoria strain was not included in this arm.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)

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    End point title
    Percentage of Subjects Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)
    End point description
    Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Percentage of subjects who shed virus are reported. Immunogenicity population included all subjects in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. Here, "n" signifies number of subjects analyzed for specified category. An arbitrary value '99999' signifies data not applicable, as no subjects were analyzed for specified arm group.
    End point type
    Secondary
    End point timeframe
    Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4, and 6 after Dose 2 (Day 28 dose)
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    67
    66
    67
    Units: Percentage of subjects
    number (not applicable)
        A/H1N1/HAI:negative/Dose 1 (n=30,43,39)
    86.7
    81.4
    94.9
        A/H1N1/HAI:negative/Dose 2 (n=29,43,39)
    17.2
    25.6
    46.2
        A/H1N1/HAI:positive/Dose 1 (n=36,22,28)
    86.1
    63.6
    71.4
        A/H1N1/HAI positive/Dose 2 (n=35,21,27)
    22.9
    23.8
    29.6
        A/H3N2/HAI:negative/Dose 1 (n=21,35,24)
    100.0
    100.0
    95.8
        A/H3N2/HAI:negative/Dose 2 (n=20,35,24)
    55.0
    60.0
    79.2
        A/H3N2/HAI:positive/Dose 1 (n=45,30,43)
    95.6
    83.3
    95.3
        A/H3N2/HAI:positive/Dose 2 (n=44,29,42)
    47.7
    44.8
    59.5
        B/Yamagata/HAI:negative/Dose 1 (n=51,54,51)
    100.0
    98.1
    100.0
        B/Yamagata/HAI:negative/Dose 2 (n=50,53,51)
    42.0
    39.6
    31.4
        B/Yamagata/HAI:positive/Dose 1 (n=15,11,16)
    73.3
    81.8
    93.8
        B/Yamagata/HAI:positive/Dose 2 (n=14,11,15)
    50.0
    54.5
    53.3
        B/Victoria/HAI:negative/Dose 1 (n=0,59,39)
    99999
    100.0
    100.0
        B/Victoria/HAI:negative/Dose 2 (n=0,58,39)
    99999
    44.8
    53.8
        B/Victoria/HAI:positive/Dose 1 (n=0,6,28)
    99999
    83.3
    100.0
        B/Victoria/HAI:positive/Dose 2 (n=0,6,27)
    99999
    50.0
    37.0
    No statistical analyses for this end point

    Secondary: Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR

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    End point title
    Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR
    End point description
    Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Number of days of virus shedding are reported. Subjects included in immunogenicity population and who shed vaccine virus were analyzed for this end point. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. Here, "n" signifies number of subjects analyzed for specified category. An arbitrary value '99999' signifies data not applicable, as no subjects were analyzed for specified arm group.
    End point type
    Secondary
    End point timeframe
    Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4 and 6 after Dose 2 (Day 28 dose)
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    66
    65
    67
    Units: Days
    arithmetic mean (standard deviation)
        A/H1N1/HAI:negative/Dose 1 (n=26,35,37)
    2.2 ± 1.2
    2.2 ± 1.0
    2.8 ± 1.3
        A/H1N1/HAI:negative/Dose 2 (n=5,11,18)
    1.2 ± 0.4
    1.4 ± 0.7
    1.3 ± 0.5
        A/H1N1/HAI:positive/Dose 1 (n=31,14,20)
    2.2 ± 1.0
    1.9 ± 0.7
    2.0 ± 1.3
        A/H1N1/HAI:positive/Dose 2 (n=8,5,8)
    1.1 ± 0.4
    1.0 ± 0.0
    1.1 ± 0.4
        A/H3N2/HAI:negative/Dose 1 (n=21,35,23)
    4.5 ± 1.0
    4.5 ± 0.9
    3.9 ± 1.2
        A/H3N2/HAI:negative/Dose 2 (n=11,21,19)
    1.3 ± 0.6
    1.1 ± 0.4
    1.7 ± 0.8
        A/H3N2/HAI: positive/Dose 1 (n=43,25,41)
    3.8 ± 1.5
    3.4 ± 1.6
    2.5 ± 1.4
        A/H3N2/HAI: positive/Dose 2 (n=21,13,25)
    1.3 ± 0.6
    1.5 ± 0.8
    1.4 ± 0.6
        B/Yamagata/HAI:negative/Dose 1 (n=51,53,51)
    3.6 ± 1.3
    3.6 ± 1.3
    4.0 ± 1.1
        B/Yamagata/HAI:negative/Dose 2 (n=21,21,16)
    1.3 ± 0.6
    1.3 ± 0.7
    1.1 ± 0.3
        B/Yamagata/HAI:positive/Dose 1 (n=11,9,15)
    2.5 ± 1.2
    3.3 ± 1.0
    3.1 ± 1.6
        B/Yamagata/HAI:positive/Dose 2 (n=7,6,8)
    1.1 ± 0.4
    1.0 ± 0.0
    1.3 ± 0.5
        B/Victoria/HAI:negative/Dose 1 (n=0,59,39)
    99999 ± 99999
    3.9 ± 1.2
    4.6 ± 0.8
        B/Victoria/HAI:negative/Dose 2 (n=0,26,21)
    99999 ± 99999
    1.4 ± 0.6
    1.4 ± 0.6
        B/Victoria/HAI:positive/Dose 1 (n=0,5,28)
    99999 ± 99999
    2.0 ± 1.0
    3.5 ± 1.5
        B/Victoria/HAI:positive/Dose 2 (n=0,3,10)
    99999 ± 99999
    1.0 ± 0.0
    1.1 ± 0.3
    No statistical analyses for this end point

    Secondary: Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR

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    End point title
    Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR
    End point description
    Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral titer from the nasopharyngeal swabs. Viral titers are reported. Subjects included in immunogenicity population and who shed vaccine virus were analyzed for this end point. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. Here, "n" signifies number of subjects analyzed for specified category. An arbitrary value '99999' signifies data not applicable, as no subjects were analyzed for specified arm group and an arbitrary value '999999' signifies standard deviation data not applicable as only one subject was evaluable for the specified arm group.
    End point type
    Secondary
    End point timeframe
    Day (D) 2, D3, D4, D5, and D7 after Dose 1 (D1 dose) and on D2, D4 and D6 after Dose 2 (D28 dose)
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    66
    65
    67
    Units: log10 viral particles/mL
    arithmetic mean (standard deviation)
        A/H1N1/HAI:negative/Dose 1 D2 (n=13,16,16)
    3.79 ± 0.56
    3.76 ± 0.71
    3.70 ± 0.49
        A/H1N1/HAI:negative/Dose 1 D3 (n=16,20,25)
    3.66 ± 0.55
    3.81 ± 0.83
    4.21 ± 0.97
        A/H1N1/HAI:negative/Dose 1 D4 (n=4,6,19)
    3.63 ± 0.34
    3.34 ± 0.56
    3.81 ± 0.94
        A/H1N1/HAI:negative/Dose 1 D5 (n=3,3,9)
    3.12 ± 0.16
    3.17 ± 0.10
    3.85 ± 0.48
        A/H1N1/HAI:negative/Dose 1 D7 (n=2,0,3)
    3.17 ± 0.40
    99999 ± 99999
    2.93 ± 0.23
        A/H1N1/HAI:negative/Dose 2 D2 (n=4,7,6)
    3.68 ± 0.88
    3.29 ± 0.30
    3.90 ± 1.04
        A/H1N1/HAI:negative/Dose 2 D4 (n=0,3,4)
    99999 ± 99999
    3.49 ± 0.37
    4.02 ± 1.24
        A/H1N1/HAI:negative/Dose 2 D6 (n=0,0,0)
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        A/H1N1/ HAI:positive/Dose 1 D2 (n=17,9,13)
    3.66 ± 0.46
    3.48 ± 0.62
    3.14 ± 0.45
        A/H1N1/ HAI:positive/Dose 1 D3 (n=17,7,7)
    3.39 ± 0.57
    4.03 ± 0.91
    3.99 ± 0.84
        A/H1N1/HAI:positive/Dose 1 D4 (n=5,2,6)
    3.09 ± 0.62
    3.39 ± 0.25
    3.97 ± 0.73
        A/H1N1/HAI:positive/Dose 1 D5 (n=3,0,3)
    3.35 ± 0.64
    99999 ± 99999
    3.73 ± 0.62
        A/H1N1/HAI:positive/Dose 1 D7 (n=1,0,0)
    3.10 ± 999999
    99999 ± 99999
    99999 ± 99999
        A/H1N1/HAI:positive/Dose 2 D2 (n=6,1,5)
    3.38 ± 0.78
    2.86 ± 999999
    3.36 ± 0.56
        A/H1N1/HAI:positive/Dose 2 D4 (n=0,0,1)
    99999 ± 99999
    99999 ± 99999
    3.65 ± 999999
        A/H1N1/HAI:positive/Dose 2 D6 (n=0,0,0)
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        A/H3N2/HAI:negative/Dose 1 D2 (n=19,29,15)
    4.20 ± 0.99
    4.15 ± 0.93
    3.52 ± 0.77
        A/H3N2/HAI:negative/Dose 1 D3 (n=19,30,18)
    5.20 ± 1.12
    5.39 ± 1.19
    4.34 ± 0.86
        A/H3N2/HAI:negative/Dose 1 D4 (n=20,33,18)
    4.86 ± 0.99
    4.51 ± 1.14
    4.51 ± 1.05
        A/H3N2/HAI :negative/Dose 1 D5 (n=18,31,17)
    4.04 ± 1.09
    4.16 ± 1.20
    3.67 ± 1.06
        A/H3N2/HAI:negative/Dose 1 D7 (n=14,24,9)
    4.10 ± 0.97
    4.12 ± 0.88
    3.58 ± 1.26
        A/H3N2/HAI:negative/Dose 2 D2 (n=7,12,12)
    3.67 ± 1.03
    3.33 ± 0.67
    3.01 ± 0.49
        A/H3N2/HAI:negative/Dose 2 D4 (n=0,2,8)
    99999 ± 99999
    3.41 ± 0.26
    3.68 ± 0.70
        A/H3N2/HAI:negative/Dose 2 D6 (n=0,1,3)
    99999 ± 99999
    2.72 ± 999999
    3.05 ± 0.61
        A/H3N2/HAI:positive/Dose 1 D2 (n=38,18,28)
    3.80 ± 1.07
    3.98 ± 1.02
    3.19 ± 0.67
        A/H3N2/HAI:positive/Dose 1 D3 (n=33,16,17)
    4.79 ± 1.29
    5.06 ± 1.20
    3.54 ± 0.98
        A/H3N2/HAI:positive/Dose 1 D4 (n=31,17,14)
    4.34 ± 1.03
    4.45 ± 1.14
    4.00 ± 1.24
        A/H3N2/HAI:positive/Dose 1 D5 (n=26,11,13)
    3.99 ± 1.05
    4.01 ± 0.98
    3.98 ± 0.72
        A/H3N2/HAI:positive/Dose 1 D7 (n=21,5,6)
    3.92 ± 1.06
    4.10 ± 1.36
    3.30 ± 0.55
        A/H3N2/HAI:positive/Dose 2 D2 (n=16,9,9)
    3.30 ± 0.89
    3.55 ± 0.93
    3.54 ± 0.78
        A/H3N2/HAI:positive/Dose 2 D4 (n=3,4,4)
    2.71 ± 0.62
    3.38 ± 0.90
    3.26 ± 0.60
        A/H3N2/HAI:positive/Dose 2 D6 (n=1,1,1)
    3.82 ± 999999
    2.32 ± 999999
    3.17 ± 999999
        B/Yamagata/HAI:negative/Dose1D2 (n=18,20,21)
    3.93 ± 0.40
    4.09 ± 0.53
    4.16 ± 0.58
        B/Yamagata/HAI:negative/Dose1D3 (n=26,29,29)
    4.10 ± 0.60
    4.60 ± 0.77
    4.72 ± 0.92
        B/Yamagata/HAI:negative/Dose1D4 (n=27,29,33)
    4.04 ± 0.61
    4.60 ± 0.83
    4.72 ± 0.88
        B/Yamagata/HAI:negative/Dose1D5 (n=19,22,29)
    4.56 ± 0.53
    4.42 ± 0.72
    4.59 ± 0.80
        B/Yamagata/HAI:negative/Dose1D7 (n=19,14,23)
    4.37 ± 0.86
    3.93 ± 0.50
    3.98 ± 0.62
        B/Yamagata/HAI:negative/Dose2D2 (n=4,5,5)
    3.92 ± 0.31
    4.10 ± 0.55
    3.80 ± 0.35
        B/Yamagata/HAI:negative/Dose2D4 (n=4,5,0)
    3.74 ± 0.60
    3.85 ± 0.52
    99999 ± 99999
        B/Yamagata/HAI:negative/Dose2D6 (n=2,0,0)
    3.83 ± 0.35
    99999 ± 99999
    99999 ± 99999
        B/Yamagata/HAI:positive/Dose1D2 (n=3,7,5)
    3.93 ± 0.20
    3.57 ± 0.19
    4.15 ± 0.78
        B/Yamagata/HAI:positive/Dose1D3 (n=5,6,5)
    3.93 ± 0.58
    3.92 ± 0.51
    4.67 ± 0.79
        B/Yamagata/HAI:positive/Dose1D4 (n=2,2,7)
    3.46 ± 0.04
    4.60 ± 1.44
    4.94 ± 1.28
        B/Yamagata/HAI:positive/Dose1D5 (n=1,1,7)
    3.84 ± 999999
    5.01 ± 999999
    4.82 ± 0.65
        B/Yamagata/HAI:positive/Dose1D7 (n=1,0,5)
    5.46 ± 999999
    99999 ± 99999
    3.91 ± 0.63
        B/Yamagata/HAI:positive/Dose2D2 (n=0,1,3)
    99999 ± 99999
    3.38 ± 999999
    3.70 ± 0.11
        B/Yamagata/HAI:positive/Dose2D4 (n=0,0,0)
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        B/Yamagata/HAI:positive/Dose2D6 (n=1,0,0)
    3.92 ± 999999
    99999 ± 99999
    99999 ± 99999
        B/Victoria/HAI:negative/Dose1D2 (n=0,33,25)
    99999 ± 99999
    3.41 ± 0.58
    3.49 ± 0.72
        B/Victoria/HAI:negative/Dose1D3 (n=0,44,31)
    99999 ± 99999
    4.12 ± 1.02
    4.39 ± 0.98
        B/Victoria/HAI:negative/Dose1D4 (n=0,41,35)
    99999 ± 99999
    4.02 ± 1.13
    4.58 ± 1.24
        B/Victoria/HAI:negative/Dose1D5 (n=0,29,34)
    99999 ± 99999
    3.98 ± 1.05
    4.09 ± 1.02
        B/Victoria/HAI:negative/Dose1D7 (n=0,30,26)
    99999 ± 99999
    3.57 ± 0.79
    4.14 ± 0.84
        B/Victoria/HAI:negative/Dose2D2 (n=0,10,6)
    99999 ± 99999
    3.43 ± 1.01
    2.94 ± 0.36
        B/Victoria/HAI:negative/Dose2D4 (n=0,5,3)
    99999 ± 99999
    3.48 ± 0.88
    2.67 ± 0.29
        B/Victoria/HAI:negative/Dose2D6 (n=0,0,0)
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        B/Victoria/HAi:positive/Dose1D2 (n=0,2,11)
    99999 ± 99999
    2.73 ± 0.01
    3.10 ± 0.53
        B/Victoria/HAI:positive/Dose1D3 (n=0,3,14)
    99999 ± 99999
    3.09 ± 0.42
    3.96 ± 1.08
        B/Victoria/HAI:positive/Dose1D4 (n=0,1,16)
    99999 ± 99999
    2.73 ± 999999
    4.40 ± 0.98
        B/Victoria/HAI:positive/Dose1D5 (n=0,0,15)
    99999 ± 99999
    99999 ± 99999
    4.26 ± 0.90
        B/Victoria/HAI:positive/Dose1D7 (n=0,0,12)
    99999 ± 99999
    99999 ± 99999
    4.00 ± 0.96
        B/Victoria/HAI:positive/Dose2D2 (n=0,0,4)
    99999 ± 99999
    99999 ± 99999
    3.41 ± 0.51
        B/Victoria/HAI:positive/Dose2D4 (n=0,0,0)
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        B/Victoria/HAI:positive/Dose2D6 (n=0,0,0)
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus

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    End point title
    Percentage of Subjects With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus
    End point description
    Seroconversion rate is defined as >= 4-fold rise from baseline in strain specific microneutralizing antibody titer. Baseline microneutralization values of less than or equal to (<=) 10 were considered as microneutralization status negative and values greater than (>) 10 were considered microneutralization positive. Percentage of subjects with >= 4-fold rise in strain specific neutralizing antibody titer at Days 28 and 56 are reported. Immunogenicity population included all subjects in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. Here, "n" signifies number of subjects analyzed for specified category. An arbitrary value '99999' signifies data not applicable, as no subjects were analyzed for specified arm group.
    End point type
    Secondary
    End point timeframe
    Days 28 and 56
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    66
    65
    67
    Units: Percentage of subjects
    number (confidence interval 95%)
        A/H1N1/Seronegative/Day 28 (n=8,20,0)
    0.0 (0.0 to 36.9)
    10.0 (1.2 to 31.7)
    99999 (99999 to 99999)
        A/H1N1/Seronegative/Day 56 (n=8,20,0)
    37.5 (8.5 to 75.5)
    25.0 (8.7 to 49.1)
    99999 (99999 to 99999)
        A/H1N1/Seropositive/Day 28 (n=52,36,63)
    3.8 (0.5 to 13.2)
    2.8 (0.1 to 14.5)
    15.9 (7.9 to 27.3)
        A/H1N1/Seropositive/Day 56 (n=51,36,60)
    11.8 (4.4 to 23.9)
    2.8 (0.1 to 14.5)
    31.7 (20.3 to 45.0)
        A/H3N2/Seronegative/Day 28 (n=14,27,15)
    100.0 (76.8 to 100.0)
    100.0 (87.2 to 100.0)
    46.7 (21.3 to 73.4)
        A/H3N2/Seronegative/Day 56 (n=16,26,13)
    93.8 (69.8 to 99.8)
    100.0 (86.8 to 100.0)
    84.6 (54.6 to 98.1)
        A/H3N2/Seropositive/Day 28 (n=46,29,48)
    47.8 (32.9 to 63.1)
    34.5 (17.9 to 54.3)
    25.0 (13.6 to 39.6)
        A/H3N2/Seropositive/Day 56 (n=43,30,47)
    44.2 (29.1 to 60.1)
    43.3 (25.5 to 62.6)
    14.9 (6.2 to 28.3)
        B/Yamagata/Seronegative/Day 28 (n=44,46,50)
    59.1 (43.2 to 73.7)
    45.7 (30.9 to 61.0)
    58.0 (43.2 to 71.8)
        B/Yamagata/Seronegative/Day 56 (n=44,47,49)
    77.3 (62.2 to 88.5)
    68.1 (52.9 to 80.9)
    75.5 (61.1 to 86.7)
        B/Yamagata/Seropositive/Day 28 (n=16,10,14)
    18.8 (4.0 to 45.6)
    0.0 (0.0 to 30.8)
    14.3 (1.8 to 42.8)
        B/Yamagata/Seropositive/Day 56 (n=16,9,13)
    18.8 (4.0 to 45.6)
    0.0 (0.0 to 33.6)
    7.7 (0.2 to 36.0)
        B/Victoria/Serosnegative/Day 28 (n-0,48,53)
    99999 (99999 to 99999)
    20.8 (10.5 to 35.0)
    18.9 (9.4 to 32.0)
        B/Victoria/Seronegative/Day 56 (n=0,49,51)
    99999 (99999 to 99999)
    16.3 (7.3 to 29.7)
    23.5 (12.8 to 37.5)
        B/Victoria/Seropositive/Day 28 (n=0,8,10)
    99999 (99999 to 99999)
    12.5 (0.3 to 52.7)
    10.0 (0.3 to 44.5)
        B/Victoria/Seropositive/Day 56 (n=0,7,9)
    99999 (99999 to 99999)
    14.3 (0.4 to 57.9)
    11.1 (0.3 to 48.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Strain-specific Nasal Immunoglobulin A (IgA) seroconversion Rate From Baseline Through Days 28 and 56

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    End point title
    Percentage of Subjects With Strain-specific Nasal Immunoglobulin A (IgA) seroconversion Rate From Baseline Through Days 28 and 56
    End point description
    Seroconversion rate is defined as >= 2-fold rise from baseline in strain speciific nasal IgA antibody titer. Percentage of subjects with >= 2-fold rise in strain speciific nasal IgA antibody titer at Days 28 and 56 are reported for this end point. Immunogenicity population included all subjects in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. Here, "n" signifies number of subjects analyzed for specified category. An arbitrary value '99999' signifies data not applicable, as no subjects were analyzed for specified arm group.
    End point type
    Secondary
    End point timeframe
    Days 28 and 56
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    66
    65
    67
    Units: Percentage of subjects
    number (confidence interval 95%)
        A/H1N1/Day 28 (n=62,63,67)
    33.9 (22.3 to 47.0)
    31.7 (20.6 to 44.7)
    40.3 (28.5 to 53.0)
        A/H1N1//Day 56 (n=64,60,65)
    40.6 (28.5 to 53.6)
    46.7 (33.7 to 60.0)
    67.7 (54.9 to 78.8)
        A/H3N2//Day 28 (n=63,62,67)
    79.4 (67.3 to 88.5)
    79.0 (66.8 to 88.3)
    44.8 (32.6 to 57.4)
        A/H3N2/Day 56 (n=64,61,65)
    89.1 (78.8 to 95.5)
    88.5 (77.8 to 95.3)
    55.4 (42.5 to 67.7)
        B/Yamagata//Day 28 (n=63,63,67)
    69.8 (57.0 to 80.8)
    79.4 (67.3 to 88.5)
    77.6 (65.8 to 86.9)
        B/Yamagata//Day 56 (n=64,61,66)
    81.3 (69.5 to 89.9)
    88.5 (77.8 to 95.3)
    86.4 (75.7 to 93.6)
        B/Victoria//Day 28 (0,63,67)
    99999 (99999 to 99999)
    73.0 (60.3 to 83.4)
    79.1 (67.4 to 88.1)
        B/Victoria//Day 56 (n=0,61,66)
    99999 (99999 to 99999)
    91.8 (81.9 to 97.3)
    84.8 (73.9 to 92.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Any Post Dose Strain-specific Antibody Response

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    End point title
    Percentage of Subjects With Any Post Dose Strain-specific Antibody Response
    End point description
    Strain specific antibody response defined as >= 4-fold increase in HAI antibodies or >= 4-fold increase in neutralizing antibodies (NA) or >= 2-fold increase in IgA antibodies titer. Immunogenicity population included all subjects in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. Here, "n" signifies number of subjects analyzed for specified category. An arbitrary value '99999' signifies data not applicable, as no subjects were analyzed for specified arm group.
    End point type
    Secondary
    End point timeframe
    Days 28 and 56
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    66
    65
    67
    Units: Percentage of subjects
    number (not applicable)
        A/H1N1/HAI response/Day 28 (n=60,56,64)
    10.0
    5.4
    23.4
        A/H1N1/NA response/Day 28 (n=60,56,63)
    3.3
    5.4
    15.9
        A/H1N1/Nasal IgA response/Day 28 (n=63,63,67)
    46.0
    52.4
    35.8
        A/H1N1/HAI response/Day 56 (n=59,56,62)
    23.7
    12.5
    45.2
        A/H1N1/NA response/Day 56 (n=59,56,60)
    15.3
    10.7
    31.7
        A/H1N1/Nasal IgA response/Day 56 (n=64,60,65)
    46.9
    53.3
    61.5
        A/H3N2/HAI response/Day 28 (n=60,56,64)
    51.7
    64.3
    31.3
        A/H3N2/NA response/Day 28 (n=60,56,63)
    60.0
    66.1
    30.2
        A/H3N2/Nasal IgA response/Day 28 (n=64,62,67)
    81.3
    85.5
    38.8
        A/H3N2/HAI response/Day 56 (n=59,56,62)
    54.2
    66.1
    40.3
        A/H3N2/NA response/Day 56 (n=59,56,60)
    57.6
    69.6
    30.0
        A/H3N2/Nasal IgA response/Day 56 (n=64,61,65)
    76.6
    82.0
    50.8
        B/Yamagata/HAI response/Day 28 (n=60,56,64)
    50.0
    42.9
    57.8
        B/Yamagata/NA response/Day 28 (n=60,56,64)
    48.3
    37.5
    48.4
        B/Yamagata/Nasal IgA response/Day 28 (n=64,63,67)
    65.6
    87.3
    61.2
        B/Yamagata/HAI response/Day 56 (n=60,56,62)
    50.0
    53.6
    54.8
        B/Yamagata/NA response/Day 56 (n=60,56,62)
    61.7
    57.1
    61.3
        B/Yamagata/Nasal IgA response/Day 56 (n=64,61,66)
    70.3
    83.6
    77.3
        B/Victoria/HAI response/Day 28 (n=0,56,64)
    99999
    14.3
    35.9
        B/Victoria/NA response/Day 28 (n=0,56,63)
    99999
    19.6
    17.5
        B/Victoria/Nasal IgA response/Day 28 (n=0,63,67)
    99999
    76.2
    55.2
        B/Victoria/HAI response/Day 56 (n=0,56,62)
    99999
    25.0
    40.3
        B/Victoria/NA response/Day 56 (n=0,56,60)
    99999
    16.1
    21.7
        B/Victoria/Nasal IgA response/Day 56 (n=0,61,66)
    99999
    83.6
    78.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Any Solicited Symptoms

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    End point title
    Percentage of Subjects With Any Solicited Symptoms
    End point description
    Solicited symptoms included fever by any route (temperature ≥ 100.4 degrees Fahrenheit), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, lethargy or tiredness/weakness, and decreased appetite. ATP included all subjects who received any amount of investigational drug.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 14 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose)
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    67
    66
    67
    Units: Percentage of subjects
    number (not applicable)
        Fever: Dose 1 (n=67,65,67)
    3.0
    1.5
    10.4
        Fever: Dose 2 (n=63,61,63)
    3.2
    8.2
    6.3
        Runny/Stuffy Nose: Dose 1 (n=67,65,67)
    34.3
    41.5
    43.3
        Runny/Stuffy Nose: Dose 2 (n=63,60,64)
    33.3
    36.7
    34.4
        Sore Throat: Dose 1 (n=67,65,67)
    6.0
    1.5
    4.5
        Sore Throat: Dose 2 (n=63,60,64)
    3.2
    3.3
    4.7
        Cough: Dose 1 (n=67,65,67)
    19.4
    15.4
    10.4
        Cough: Dose 2 (n=63,60,64)
    19.0
    21.7
    10.9
        Headache: Dose 1 (n=67,65,67)
    1.5
    4.6
    6.0
        Headache: Dose 2 (n=63,60,64)
    3.2
    5.0
    3.1
        Generalized Muscle Aches: Dose 1 (n=67,65,67)
    4.5
    4.6
    1.5
        Generalized Muscle Aches: Dose 2 (n=63,60,64)
    0.0
    3.3
    0.0
        Lethargy/Tiredness/Weakness: Dose 1 (n=67,65,67)
    13.4
    13.8
    16.4
        Lethargy/Tiredness/Weakness: Dose 2 (n=63,60,64)
    12.7
    11.7
    7.8
        Decreased Appetite: Dose 1 (n=67,65,67)
    13.4
    12.3
    11.9
        Decreased Appetite: Dose 2 (n=63,60,64)
    9.5
    8.3
    7.8
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

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    End point title
    Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
    End point description
    An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug. ATP included all subjects who received any amount of investigational drug.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 28 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose)
    End point values
    FluMist trivalent (2015-2016) FluMist Quadrivalent (2015-2016) FluMist Quadrivalent (2017-2018)
    Number of subjects analysed
    67
    66
    67
    Units: Subjects
        TEAEs|
    29
    31
    34
        TESAEs|
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 through Day 28 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose)
    Adverse event reporting additional description
    ATP included all subjects who received any investigational drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    FluMist Trivalent (2015-2016)
    Reporting group description
    Subjects received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist trivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the trivalent vaccine were: A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), and B/Phuket/3073/2013 (B/Yamagata-lineage).

    Reporting group title
    FluMist Quadrivalent (2017-2018)
    Reporting group description
    Subjects received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were the new A/H1N1 (A/Slovenia/2903/2015), A/H3N2 (A/New Caledonia/71/2014), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).

    Reporting group title
    FluMist Quadrivalent (2015-2016)
    Reporting group description
    Subjects received intranasal spray of 0.2 mL (total dose in both nostrils) FluMist quadrivalent vaccine on Days 1 and 28. Each 0.2 mL dose contained 10^7±0.5 FFU of each vaccine strain. Strains included in the vaccine were A/H1N1 (A/Bolivia/559/2013), A/H3N2 (A/Switzerland/9715293/2013), B/Phuket/3073/2013 (B/Yamagata-lineage), and B/Brisbane/60/2008 (B/Victoria-lineage).

    Serious adverse events
    FluMist Trivalent (2015-2016) FluMist Quadrivalent (2017-2018) FluMist Quadrivalent (2015-2016)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    FluMist Trivalent (2015-2016) FluMist Quadrivalent (2017-2018) FluMist Quadrivalent (2015-2016)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 67 (43.28%)
    34 / 67 (50.75%)
    31 / 66 (46.97%)
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    Seasonal allergy
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 67 (2.99%)
    0 / 66 (0.00%)
         occurrences all number
    0
    2
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    Developmental delay
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 67 (2.99%)
    7 / 66 (10.61%)
         occurrences all number
    1
    2
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Irritability
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 67 (1.49%)
    2 / 66 (3.03%)
         occurrences all number
    1
    1
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 67 (1.49%)
    2 / 66 (3.03%)
         occurrences all number
    2
    1
    2
    Laceration
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    Radial head dislocation
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    Thermal burn
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Cough
         subjects affected / exposed
    4 / 67 (5.97%)
    4 / 67 (5.97%)
    5 / 66 (7.58%)
         occurrences all number
    4
    4
    5
    Dysphonia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 67 (1.49%)
    3 / 66 (4.55%)
         occurrences all number
    3
    2
    3
    Nasal congestion
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 67 (1.49%)
    1 / 66 (1.52%)
         occurrences all number
    1
    1
    1
    Paranasal sinus discomfort
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngeal erythema
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    1
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    4 / 67 (5.97%)
    9 / 67 (13.43%)
    7 / 66 (10.61%)
         occurrences all number
    4
    9
    7
    Sneezing
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    1 / 66 (1.52%)
         occurrences all number
    0
    1
    1
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    1
    0
    1
    Lethargy
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Eye oedema
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    Strabismus
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    2
    0
    Constipation
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    1
    0
    1
    Dental caries
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    9 / 67 (13.43%)
    4 / 67 (5.97%)
    5 / 66 (7.58%)
         occurrences all number
    10
    5
    5
    Haematochezia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Oral discomfort
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    Oral pain
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    2 / 66 (3.03%)
         occurrences all number
    0
    0
    2
    Toothache
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    3 / 67 (4.48%)
    4 / 67 (5.97%)
    5 / 66 (7.58%)
         occurrences all number
    4
    5
    6
    Skin and subcutaneous tissue disorders
    Cold sweat
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis diaper
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    4
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 67 (2.99%)
    0 / 66 (0.00%)
         occurrences all number
    1
    2
    0
    Croup infectious
         subjects affected / exposed
    3 / 67 (4.48%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    3
    0
    0
    Ear infection
         subjects affected / exposed
    3 / 67 (4.48%)
    1 / 67 (1.49%)
    1 / 66 (1.52%)
         occurrences all number
    4
    1
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 67 (0.00%)
    1 / 66 (1.52%)
         occurrences all number
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    1
    1
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes simplex
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Localised infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis media acute
         subjects affected / exposed
    1 / 67 (1.49%)
    3 / 67 (4.48%)
    1 / 66 (1.52%)
         occurrences all number
    1
    4
    1
    Pharyngitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 67 (0.00%)
    0 / 66 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 67 (0.00%)
    3 / 67 (4.48%)
    0 / 66 (0.00%)
         occurrences all number
    0
    4
    0
    Pneumonia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 67 (5.97%)
    2 / 67 (2.99%)
    2 / 66 (3.03%)
         occurrences all number
    4
    2
    2
    Viral pharyngitis
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 67 (2.99%)
    0 / 66 (0.00%)
         occurrences all number
    1
    2
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 67 (1.49%)
    0 / 66 (0.00%)
         occurrences all number
    0
    1
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Jun 2017
    Inclusion Criterion 1 (subject age criterion) was amended from “Age 24 months to less than (<) 48 months of age at the time of randomization” to “Age 24 months to < 48 months of age at the time of screening”. The screening period was extended from 30 days to 75 days. The duration of subject participation was extended from “2 to 3 months” to “3 to 4 months”. Updated Table 4.2-1 (Schedule of Study Procedures), study days for screening study period amended from “-30 to 1” to “-75 to 1”.

    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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