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    Clinical Trial Results:
    A Phase 2, Open-Label, Single-Arm Trial to Evaluate the Shedding and Safety of CAIV-T Administered to Children 6 to <60 Months of Age

    Summary
    EudraCT number
    		 2017-000848-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    27 Dec 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2018
    First version publication date
    03 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MI-CP129
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00344305
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States, MD 20878
    Public contact
    Raburn Mallory MD/ Sr Dir Clinical Development, MedImmune, LLC, +1 3013980000, clinicaltrialenquiries@medimmune.com
    Scientific contact
    Raburn Mallory MD/ Sr Dir Clinical Development, MedImmune, LLC, +1 3013980000, clinicaltrialenquiries@medimmune.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
    27 Dec 2006
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to describe the percentage of participants who shed vaccine strain viruses.
    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. Participants signed 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
    15 May 2006
    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)
    92
    Children (2-11 years)
    108
    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
    		 A total of 200 participants were enrolled in the study from 15-May-2006 through 22-Jun-2006 at 16 sites in the United States of America.

    Pre-assignment
    Screening details
    		 A total of 200 participants were stratified on the basis of their age into two cohorts: Cohort 1 (participants aged between 6 to less than [<] 24 months) and Cohort 2 (participants aged between 24 to < 60 months).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Participants Between 6 to < 24 Months Age
    Arm description
    		 Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
    Arm type
    		 Experimental

    Investigational medicinal product name
    FluMist
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution in single-dose container
    Routes of administration
    Intranasal use
    Dosage and administration details
    Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

    Arm title
    		 Cohort 2: Participants Between 24 to < 60 Months Age
    Arm description
    		 Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
    Arm type
    		 Experimental

    Investigational medicinal product name
    FluMist
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution in single-dose container
    Routes of administration
    Intranasal use
    Dosage and administration details
    Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

    Number of subjects in period 1
    		Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Started
    100
    100
    Completed
    98
    99
    Not completed
    2
    1
         Participant was not contacted in window
    -
    1
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Participants Between 6 to < 24 Months Age
    Reporting group description
    		 Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

    Reporting group title
    Cohort 2: Participants Between 24 to < 60 Months Age
    Reporting group description
    		 Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

    Reporting group values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age Total
    Number of subjects
    		 100 100 200
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 92 0 92
        Children (2-11 years)
    		 8 100 108
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 14.87 ( 5.50 ) 41.31 ( 9.98 ) -
    Gender categorical
    Units: Subjects
        Female
    		 51 53 104
        Male
    		 49 47 96
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 7 15 22
        Not Hispanic or Latino
    		 93 85 178
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 0 2 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 14 7 21
        White
    		 86 89 175
        More than one race
    		 0 1 1
        Unknown or Not Reported
    		 0 0 0
    History of laboratory-confirmed influenza illness
    Units: Subjects
        Positive
    		 1 2 3
        Negative
    		 99 98 197
    History of receiving an influenza vaccine
    Units: Subjects
        Positive
    		 43 73 116
        Negative
    		 57 27 84
    Subject analysis sets

    Subject analysis set title
    All Participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants between 6 to < 60 months age received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

    Subject analysis sets values
    		 All Participants
    Number of subjects
    200
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    92
        Children (2-11 years)
    108
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    28.09 ( 15.50 )
    Gender categorical
    Units: Subjects
        Female
    104
        Male
    96
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    22
        Not Hispanic or Latino
    178
        Unknown or Not Reported
    0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    1
        Asian
    2
        Native Hawaiian or Other Pacific Islander
    0
        Black or African American
    21
        White
    175
        More than one race
    1
        Unknown or Not Reported
    0
    History of laboratory-confirmed influenza illness
    Units: Subjects
        Positive
    3
        Negative
    197
    History of receiving an influenza vaccine
    Units: Subjects
        Positive
    116
        Negative
    84

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Participants Between 6 to < 24 Months Age
    Reporting group description
    		 Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

    Reporting group title
    Cohort 2: Participants Between 24 to < 60 Months Age
    Reporting group description
    		 Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

    Subject analysis set title
    All Participants
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants between 6 to < 60 months age received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

    Primary: Percentage of Participants Who Shed Any Vaccine Virus

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    End point title
    		 Percentage of Participants Who Shed Any Vaccine Virus [1]
    End point description
    Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 [B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus. Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Days 1-28 after study vaccination (up to Day 28)
    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: Statistical analysis was not applicable since there were no inferential statistics planned for primary outcome measures, only descriptive statistics were reported.
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    99
    100
    Units: percentage of participants
        number (confidence interval 95%)
    88.9 (81.0 to 94.3)
    69.0 (59.0 to 77.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Shed A/H1N1 Vaccine Virus

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    End point title
    		 Percentage of Participants Who Shed A/H1N1 Vaccine Virus [2]
    End point description
    Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus. Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Days 1-28 after study vaccination (up to 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 planned for primary outcome measures, only descriptive statistics were reported.
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    99
    100
    Units: percentage of participants
        number (confidence interval 95%)
    76.8 (67.2 to 84.7)
    52.0 (41.8 to 62.1)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Shed A/H3N2 Vaccine Virus

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    End point title
    		 Percentage of Participants Who Shed A/H3N2 Vaccine Virus [3]
    End point description
    Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 [B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus. Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Days 1-28 after study vaccination (up to 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 planned for primary outcome measures, only descriptive statistics were reported.
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    99
    100
    Units: percentage of participants
        number (confidence interval 95%)
    57.6 (47.2 to 67.5)
    15.0 (8.6 to 23.5)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Shed B Vaccine Virus

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    End point title
    		 Percentage of Participants Who Shed B Vaccine Virus [4]
    End point description
    Viral shedding is defined as the detection of virus by viral culture and vaccine-type virus was confirmed by polymerase chain reaction (PCR) based assays. Viral shedding (A/New Caledonia/20/99 [H1N1]; A/Wyoming/03/2003 [H3N2] (A/Fujian/411/2002-like); B/Jilin/20/2003 [B/Shanghai/361/2002-like]) was measured from samples obtained from nasal swabs daily from Days 1 to 7 post vaccination and approximately every other day thereafter from Days 9 to 28. Participants whose Day 25 or 28 shedding sample was positive for vaccine virus had additional shedding samples collected approximately every 7 days, or as soon as possible upon awareness of culture positivity, until 2 consecutive samples were negative for vaccine virus. Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Days 1-28 after study vaccination (up to 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 planned for primary outcome measures, only descriptive statistics were reported.
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    99
    100
    Units: percentage of participants
        number (confidence interval 95%)
    37.4 (27.9 to 47.7)
    37.0 (27.6 to 47.2)
    No statistical analyses for this end point

    Secondary: Duration of Any Vaccine Virus Shedding

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    End point title
    		 Duration of Any Vaccine Virus Shedding
    End point description
    The number of days of shedding was summarized for all participants who shed any vaccine virus. Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
    End point type
    Secondary
    End point timeframe
    Days 1-28 after study vaccination (up to Day 28)
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    88
    69
    Units: days
        arithmetic mean (standard deviation)
    3.0 ( 1.5 )
    2.7 ( 1.6 )
    No statistical analyses for this end point

    Secondary: Duration of Confirmed A/H1N1 Vaccine Virus Shedding

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    End point title
    		 Duration of Confirmed A/H1N1 Vaccine Virus Shedding
    End point description
    The number of days of shedding was summarized for all participants who shed confirmed A/H1N1 strain virus. Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
    End point type
    Secondary
    End point timeframe
    Days 1-28 after study vaccination (up to Day 28)
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    76
    52
    Units: days
        arithmetic mean (standard deviation)
    2.1 ( 1.0 )
    2.2 ( 1.3 )
    No statistical analyses for this end point

    Secondary: Duration of Confirmed A/H3N2 Vaccine Virus Shedding

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    End point title
    		 Duration of Confirmed A/H3N2 Vaccine Virus Shedding
    End point description
    The number of days of shedding was summarized for all participants who shed confirmed A/H3N2 strain virus. Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
    End point type
    Secondary
    End point timeframe
    Days 1-28 after study vaccination (up to Day 28)
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    57
    15
    Units: days
        arithmetic mean (standard deviation)
    1.8 ( 0.9 )
    1.7 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Duration of Confirmed B Vaccine Virus Shedding

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    End point title
    		 Duration of Confirmed B Vaccine Virus Shedding
    End point description
    The number of days of shedding was summarized for all participants who shed confirmed B strain virus. Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
    End point type
    Secondary
    End point timeframe
    Days 1-28 after study vaccination (up to Day 28)
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    37
    37
    Units: days
        arithmetic mean (standard deviation)
    2.1 ( 1.5 )
    1.8 ( 1.2 )
    No statistical analyses for this end point

    Secondary: Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day

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    End point title
    		 Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day
    End point description
    Quantitation of confirmed A/H1N1 shed vaccine virus was evaluated using the log transformed median tissue culture infectious dose (TCID50) per (/) millilitre (mL) for A/H1N1 vaccine strain and summarized for all participants who shed vaccine virus. Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
    End point type
    Secondary
    End point timeframe
    Days 1-28 after study vaccination (up to Day 28)
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    52
    45
    Units: log (TCID50)/mL
        arithmetic mean (standard deviation)
    2.14 ( 0.98 )
    2.62 ( 0.97 )
    No statistical analyses for this end point

    Secondary: Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day

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    End point title
    		 Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day
    End point description
    Quantitation of confirmed A/H3N2 shed vaccine virus was evaluated using the log (TCID50)/mL for A/H3N2 vaccine strain and summarized for all participants who shed vaccine virus. Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
    End point type
    Secondary
    End point timeframe
    Days 1-28 after study vaccination (up to Day 28)
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    24
    5
    Units: log (TCID50)/mL
        arithmetic mean (standard deviation)
    1.59 ( 0.95 )
    1.10 ( 0.53 )
    No statistical analyses for this end point

    Secondary: Quantitation of Confirmed B Shed Vaccine Virus on Any Day

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    End point title
    		 Quantitation of Confirmed B Shed Vaccine Virus on Any Day
    End point description
    Quantitation of confirmed B shed vaccine virus was evaluated using the log (TCID50)/mL for B vaccine strain and summarized for all participants who shed vaccine virus. Shedding population included all participants who received a full dose of study drug and had assay results from nasal specimens obtained at any post-dosing time point. Here, number of participants analyzed signified those participants who shed any confirmed strain virus.
    End point type
    Secondary
    End point timeframe
    Days 1-28 after study vaccination (up to Day 28)
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    28
    29
    Units: log (TCID50)/mL
        arithmetic mean (standard deviation)
    1.70 ( 1.09 )
    1.24 ( 0.68 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus

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    End point title
    		 Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus
    End point description
    The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the cold-adapted (ca) and temperature-sensitive (ts) phenotypes. Viruses were considered ts if their titer at 39 degrees Celsius (°C) was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes. Here, number of participants analyzed signified those participants who were evaluable for this endpoint and “n” signified those participants who were evaluable for a specified category. The number 99999 signified data not available because no participant was evaluable for the specified category.
    End point type
    Secondary
    End point timeframe
    Days 1-28 after study vaccination (up to Day 28)
    End point values
    		 All Participants
    Number of subjects analysed
    93
    Units: participants
        Genotypic Stability (n=0)
    99999
        Phenotypic Stability (n=93)
    90
    No statistical analyses for this end point

    Secondary: Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus

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    End point title
    		 Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus
    End point description
    The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 39°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes. Here, number of participants analyzed signified those participants who were evaluable for this endpoint and “n” signified those participants who were evaluable for a specified category. The number 99999 signified data not available because no participant was evaluable for the specified category.
    End point type
    Secondary
    End point timeframe
    Days 1-28 after study vaccination (up to Day 28)
    End point values
    		 All Participants
    Number of subjects analysed
    39
    Units: participants
        Genotypic Stability (n=0)
    99999
        Phenotypic Stability (n=39)
    37
    No statistical analyses for this end point

    Secondary: Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus

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    End point title
    		 Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus
    End point description
    The genetic and phenotypic stability of shed vaccine virus was evaluated by determination of genomic sequence and assessment of the ca and ts phenotypes. Viruses were considered ts if their titer at 37°C was at least two logs (100-fold) lower than their titer at 33°C. Viruses were considered ca if they replicated at 25°C to a titer that was no more than two logs (100-fold) lower than the titer at 33°C. After additional phenotypic and genotypic analyses, all evaluable samples retained the ca and ts phenotypes. Here, number of participants analyzed signified those participants who were evaluable for this endpoint and “n” signified those participants who were evaluable for a specified category.
    End point type
    Secondary
    End point timeframe
    Days 1-28 after study vaccination (up to Day 28)
    End point values
    		 All Participants
    Number of subjects analysed
    61
    Units: participants
        Genotypic Stability (n=33)
    33
        Phenotypic Stability (n=61)
    29
    No statistical analyses for this end point

    Secondary: Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination

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    End point title
    		 Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination
    End point description
    REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Safety population included all participants who received any study drug and had experienced any follow-up for safety.
    End point type
    Secondary
    End point timeframe
    Days 0-28 after vaccination (up to Day 28)
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    100
    100
    Units: participants
        Any REs
    84
    77
        AEs
    48
    31
    No statistical analyses for this end point

    Secondary: Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination

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    End point title
    		 Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination
    End point description
    An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An SNMC is defined as a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. SNMCs included, but were not limited to, diabetes, asthma, autoimmune disease (lupus, rheumatoid arthritis), and neurological disease (epilepsy, autism). Safety population included all participants who received any study drug and had experienced any follow-up for safety.
    End point type
    Secondary
    End point timeframe
    Days 0-180 after vaccination (up to 6.5 months)
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    100
    100
    Units: participants
        SAEs
    1
    0
        SNMC
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With REs in Relation to Any Vaccine Virus Shedding

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    End point title
    		 Number of Participants With REs in Relation to Any Vaccine Virus Shedding
    End point description
    REs were predefined solicited events that could potentially occur after vaccination. The REs for this study were fever, runny/stuffy nose, sore throat, cough, vomiting, headache, abdominal pain (stomach ache), muscle ache, chills, decreased activity level (lethargy), decreased appetite, and irritability. Safety population included all participants who received any study drug and had experienced any follow-up for safety. Here, number of participants analyzed signified those participants who had REs.
    End point type
    Secondary
    End point timeframe
    Days 0-28 after study vaccination (up to Day 28)
    End point values
    		 Cohort 1: Participants Between 6 to < 24 Months Age Cohort 2: Participants Between 24 to < 60 Months Age
    Number of subjects analysed
    83
    77
    Units: participants
    75
    55
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs - Days 0-28 post dosing (up to Day 28); SAEs - Days 0-180 post dosing (up to 6.5 months).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Cohort 2: Participants Between 24 to < 60 Months Age
    Reporting group description
    		 Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

    Reporting group title
    Cohort1: Participants Between 6 to < 24 Months Age
    Reporting group description
    		 Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

    Serious adverse events
    		 Cohort 2: Participants Between 24 to < 60 Months Age Cohort1: Participants Between 6 to < 24 Months Age
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Cohort 2: Participants Between 24 to < 60 Months Age Cohort1: Participants Between 6 to < 24 Months Age
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 100 (25.00%)
    48 / 100 (48.00%)
    Investigations
    BODY TEMPERATURE INCREASED
         subjects affected / exposed
    2 / 100 (2.00%)
    3 / 100 (3.00%)
         occurrences all number
    2
    4
    Injury, poisoning and procedural complications
    ARTHROPOD BITE
         subjects affected / exposed
    3 / 100 (3.00%)
    4 / 100 (4.00%)
         occurrences all number
    3
    4
    ARTHROPOD STING
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    OTORRHOEA
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    2
    Eye disorders
    CONJUNCTIVITIS
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    9 / 100 (9.00%)
    5 / 100 (5.00%)
         occurrences all number
    11
    6
    FLATULENCE
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    4
    TEETHING
         subjects affected / exposed
    0 / 100 (0.00%)
    21 / 100 (21.00%)
         occurrences all number
    0
    30
    Respiratory, thoracic and mediastinal disorders
    EPISTAXIS
         subjects affected / exposed
    2 / 100 (2.00%)
    3 / 100 (3.00%)
         occurrences all number
    2
    3
    Skin and subcutaneous tissue disorders
    ECZEMA
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    2
    HEAT RASH
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    HERPANGINA
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    2
    OTITIS MEDIA
         subjects affected / exposed
    0 / 100 (0.00%)
    4 / 100 (4.00%)
         occurrences all number
    0
    4
    PHARYNGITIS STREPTOCOCCAL
         subjects affected / exposed
    3 / 100 (3.00%)
    1 / 100 (1.00%)
         occurrences all number
    3
    1
    VIRAL INFECTION
         subjects affected / exposed
    2 / 100 (2.00%)
    3 / 100 (3.00%)
         occurrences all number
    2
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Mar 2006
    The protocol was amended to add definition of Reactogenicity Events (REs).

    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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