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    Clinical Trial Results:
    A Phase I Randomized, Double-Blind Trial of the Safety and Immunogenicity of FluMist® A Live, Intranasal Influenza Virus Vaccine vs. Placebo in Immunocompromised Children Ages 5 Through 17 Years of Age

    Summary
    EudraCT number
    		 2017-000849-50
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    31 Mar 2008

    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-CP114
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00112112
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, MD, United States, 20837
    Public contact
    Raburn Mallory, MedImmune, LLC, +1 3013980000, malloryr@medimmune.com
    Scientific contact
    Raburn Mallory, MedImmune, LLC, +1 3013980000, malloryr@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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Mar 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2008
    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 safety of FluMist compared with placebo in mild to moderately immunocompromised children with cancer.
    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
    08 Aug 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 20
    Worldwide total number of subjects
    20
    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)
    8
    Adolescents (12-17 years)
    12
    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 20 participants, 10 in the FluMist group and 10 in the placebo group, were enrolled in the study across 4 sites in the United States of America.

    Pre-assignment
    Screening details
    		 A total of 20 participants were randomized in a 1:1 ratio to either the FluMist or placebo group. Four participants were enrolled and treated in 2005, 8 in 2006, and 8 in 2007; each subset was assessed for vaccine-related serious adverse events prior to enrollment of the next subset.

    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
    		 Placebo
    Arm description
    		 Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 milliliter (mL) was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    The total volume of 0.5 mL of placebo was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

    Arm title
    		 FluMist
    Arm description
    		 The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 median tissue culture infectious dose (TCID50) of each of three influenza virus strains.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FluMist
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    The total volume of 0.5 mL of FluMist was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

    Number of subjects in period 1
    		Placebo FluMist
    Started
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 milliliter (mL) was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

    Reporting group title
    FluMist
    Reporting group description
    		 The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 median tissue culture infectious dose (TCID50) of each of three influenza virus strains.

    Reporting group values
    		 Placebo FluMist Total
    Number of subjects
    		 10 10 20
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 4 4 8
        Adolescents (12-17 years)
    		 6 6 12
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 12.2 ( 3.8 ) 12.2 ( 3.9 ) -
    Gender, Male/Female
    Units: Subjects
        Male
    		 6 3 9
        Female
    		 4 7 11

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 milliliter (mL) was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

    Reporting group title
    FluMist
    Reporting group description
    		 The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 median tissue culture infectious dose (TCID50) of each of three influenza virus strains.

    Primary: Number of Participants who had Reactogenicity Events (REs)

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    End point title
    		 Number of Participants who had Reactogenicity Events (REs) [1]
    End point description
    Reactogenicity events (REs) are predefined solicited adverse events (AEs) that can potentially occur after vaccine administration. The REs For this study included fever, runny nose/nasal congestion, sore throat, cough, vomiting, headache, muscle aches, chills, tiredness, and irritability. Participants who received any study vaccine and had any follow-up for REs and/or AEs were analysed for this end point. One participant in FluMist group did not have any RE data and was excluded from the RE analysis.
    End point type
    Primary
    End point timeframe
    0-42 days after study vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there were no inferential statistics planned for primary outcome measures, only descriptive statistics were reported.
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Participants
    9
    8
    No statistical analyses for this end point

    Primary: Number of Participants who had Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants who had Serious Adverse Events (SAEs) [2]
    End point description
    An SAE is any AE that results in any of the following outcomes: •Death • Life-threatening • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly/birth defect (in the offspring of a study participant) • An important medical event that may may jeopardize the study participant and may require medical or surgical intervention to prevent one of the outcomes listed above. Participants who received any study vaccine and had any follow-up for REs and/or AEs were analysed for this end point.
    End point type
    Primary
    End point timeframe
    0-180 days after study vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there were no inferential statistics planned for primary outcome measures, only descriptive statistics were reported.
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    10
    Units: Participants
    3
    1
    No statistical analyses for this end point

    Primary: Number of Participants who had Adverse Events (AEs)

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    End point title
    		 Number of Participants who had Adverse Events (AEs) [3]
    End point description
    An AE is any untoward medical occurrence in a patient or clinical investigations study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants who received any study vaccine and had any follow-up for REs and/or AEs were analysed for this end point.
    End point type
    Primary
    End point timeframe
    0-42 days after study vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there were no inferential statistics planned for primary outcome measures, only descriptive statistics were reported.
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    10
    Units: Participants
    10
    6
    No statistical analyses for this end point

    Primary: Number of Significant new Medical Conditions (SNMCs)

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    End point title
    		 Number of Significant new Medical Conditions (SNMCs) [4]
    End point description
    A significant new medical condition is defined as a new diagnosis of a chronic medical condition that does not meet the criteria of a SAE. Participants who received any study vaccine and had any follow-up for REs and/or AEs were analysed for this end point.
    End point type
    Primary
    End point timeframe
    43-180 days after study vaccination
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there were no inferential statistics planned for primary outcome measures, only descriptive statistics were reported.
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    10
    Units: Events
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants Shedding Vaccine-like Virus

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    End point title
    		 Number of Participants Shedding Vaccine-like Virus
    End point description
    Number of participants with nasal swab samples that contained vaccine-like virus are reported. Participants who received any study vaccine and had any follow-up for REs and/or AEs were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    3-5 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    10
    Units: Participants
    0
    3
    No statistical analyses for this end point

    Secondary: Number of Participants Shedding Vaccine-like Virus

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    End point title
    		 Number of Participants Shedding Vaccine-like Virus
    End point description
    Number of participants with nasal swab samples that contained vaccine-like virus are reported. Participants who received any study vaccine and had any follow-up for REs and/or AEs were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    10
    Units: Participants
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Participants Shedding Vaccine-like Virus

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    End point title
    		 Number of Participants Shedding Vaccine-like Virus
    End point description
    Number of participants with nasal swab samples that contained vaccine-like virus are reported. Participants who received any study vaccine and had any follow-up for REs and/or AEs were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    14-28 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    10
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants Shedding Vaccine-like Virus

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    End point title
    		 Number of Participants Shedding Vaccine-like Virus
    End point description
    Number of participants with nasal swab samples that contained vaccine-like virus are reported. Sample was collected at this time point only if health assessment indicated presence of a respiratory illness, including otitis media. Participants who received any study vaccine and had any follow-up for REs and/or AEs were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    10
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants Shedding Vaccine-like Virus

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    End point title
    		 Number of Participants Shedding Vaccine-like Virus
    End point description
    Number of participants with nasal swab samples that contained vaccine-like virus are reported. Participants who received any study vaccine and had any follow-up for REs and/or AEs were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Unscheduled visits occurring during 0-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    10
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - Cluster of Differentiation (CD) 19
    End point description
    Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    4.8 ( 8.3 )
    8.6 ( 7.4 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - CD3

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - CD3
    End point description
    Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    89.1 ( 10.3 )
    83.6 ( 8.9 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - CD4

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - CD4
    End point description
    Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    46.7 ( 7.5 )
    47.3 ( 9.8 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - CD8

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - CD8
    End point description
    Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    38.8 ( 7.8 )
    31.4 ( 8.1 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - CD19

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - CD19
    End point description
    Mean and standard deviation results of CD19 lymphocyte subsets as a percentage of total lymphocytes. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    8
    9
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    5.1 ( 8.6 )
    10.2 ( 10.8 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - CD3

    		 Close Top of page
    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - CD3
    End point description
    Mean and standard deviation results of CD3 lymphocyte subsets as a percentage of total lymphocytes. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    8
    9
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    89.9 ( 11.6 )
    82.0 ( 9.9 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - CD4

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - CD4
    End point description
    Mean and standard deviation results of CD4 lymphocyte subsets as a percentage of total lymphocytes. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    8
    9
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    46.5 ( 11.4 )
    48.2 ( 11.8 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - CD8

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - CD8
    End point description
    Mean and standard deviation results of CD8 lymphocyte subsets as a percentage of total lymphocytes. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    8
    9
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    39.6 ( 10.1 )
    27.9 ( 8.0 )
    No statistical analyses for this end point

    Secondary: Interferon (INF)-Gamma

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    End point title
    		 Interferon (INF)-Gamma
    End point description
    Mean and standard deviation for INF-Gamma (spots-forming cells per 10^5 T cells) is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    7
    Units: Cells per 10^5 T cells
        arithmetic mean (standard deviation)
    16.5 ( 25.9 )
    17.0 ( 27.2 )
    No statistical analyses for this end point

    Secondary: INF-Gamma

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    End point title
    		 INF-Gamma
    End point description
    Mean and standard deviation for INF-Gamma (spots-forming cells per 10^5 T cells) is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    7
    Units: Cells per 10^5 T cells
        arithmetic mean (standard deviation)
    7.5 ( 7.6 )
    28.6 ( 43.7 )
    No statistical analyses for this end point

    Secondary: INF-Gamma

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    End point title
    		 INF-Gamma
    End point description
    Mean and standard deviation for INF-Gamma (spots-forming cells per 10^5 T cells) is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    7
    Units: Cells per 10^5 T cells
        arithmetic mean (standard deviation)
    16.6 ( 27.0 )
    28.0 ( 38.7 )
    No statistical analyses for this end point

    Secondary: Interleukin (IL)-4

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    End point title
    		 Interleukin (IL)-4
    End point description
    Mean and standard deviation for IL-4 (spots-forming cells per 10^5 T cells) is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    8
    Units: Cells per 10^5 T cells
        arithmetic mean (standard deviation)
    5.5 ( 8.4 )
    2.6 ( 4.3 )
    No statistical analyses for this end point

    Secondary: IL-4

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    End point title
    		 IL-4
    End point description
    Mean and standard deviation for IL-4 (spots-forming cells per 10^5 T cells) is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    8
    Units: Cells per 10^5 T cells
        arithmetic mean (standard deviation)
    2.6 ( 3.5 )
    1.9 ( 2.7 )
    No statistical analyses for this end point

    Secondary: IL-4

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    End point title
    		 IL-4
    End point description
    Mean and standard deviation for IL-4 (spots-forming cells per 10^5 T cells) is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    8
    Units: Cells per 10^5 T cells
        arithmetic mean (standard deviation)
    4.7 ( 6.1 )
    2.9 ( 3.9 )
    No statistical analyses for this end point

    Secondary: Human Leukocyte Antigen (HLA) Matched Tetramers CD8+

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    End point title
    		 Human Leukocyte Antigen (HLA) Matched Tetramers CD8+
    End point description
    The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    5
    6
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    12.778 ( 6.579 )
    11.045 ( 6.452 )
    No statistical analyses for this end point

    Secondary: HLA Matched Tetramers CD8+

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    End point title
    		 HLA Matched Tetramers CD8+
    End point description
    The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    5
    6
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    8.632 ( 4.126 )
    8.048 ( 6.701 )
    No statistical analyses for this end point

    Secondary: HLA Matched Tetramers CD8+

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    End point title
    		 HLA Matched Tetramers CD8+
    End point description
    The antigen-specific response of the T cell populations was measured using HLA-matched tetramers specific for human CD8 cell populations. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    5
    6
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    12.922 ( 8.607 )
    7.997 ( 3.143 )
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42

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    End point title
    		 Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Hemagglutination Inhibition (HAI) Titers From Baseline to Day 35-42
    End point description
    Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had samples available for the specified days were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Participants
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42

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    End point title
    		 Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 HAI Titers From Baseline to Day 35-42
    End point description
    Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had samples available for the specified days were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Participants
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42

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    End point title
    		 Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza B HAI Titers From Baseline to Day 35-42
    End point description
    Participants with a geometric mean fold-rise in influenza-specific nasal HAI titers >= 4 from baseline are reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had samples available for the specified days were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Participants
    0
    1
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42

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    End point title
    		 Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H1N1 Microneutralization Titers From Baseline to Day 35-42
    End point description
    Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had samples available for the specified days were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Participants
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42

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    End point title
    		 Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza A/H3N2 Microneutralization Titers From Baseline to Day 35-42
    End point description
    Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had samples available for the specified days were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Participants
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza B Microneutralization Titers From Baseline to Day 35-42

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    End point title
    		 Number of Participants who Experienced a >= 4-fold Rise in Serum Influenza B Microneutralization Titers From Baseline to Day 35-42
    End point description
    Participants with a geometric mean fold-rise in influenza-specific nasal microneutralization titers >= 4 from baseline are reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had samples available for the specified days were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline (Pre-dosing on Day 0) and Day 35-42 after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Participants
    0
    1
    No statistical analyses for this end point

    Secondary: Influenza A/H1N1 Immunoglobulin A (IgA)

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    End point title
    		 Influenza A/H1N1 Immunoglobulin A (IgA)
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.5 ( 0.0 )
    0.8 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Influenza A/H1N1 IgA

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    End point title
    		 Influenza A/H1N1 IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    3-5 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.5 ( 0.0 )
    0.8 ( 0.7 )
    No statistical analyses for this end point

    Secondary: Influenza A/H1N1 IgA

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    End point title
    		 Influenza A/H1N1 IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.5 ( 0.0 )
    1.1 ( 1.1 )
    No statistical analyses for this end point

    Secondary: Influenza A/H1N1 IgA

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    End point title
    		 Influenza A/H1N1 IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    14-28 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    1.1 ( 1.3 )
    0.9 ( 0.9 )
    No statistical analyses for this end point

    Secondary: Influenza A/H1N1 IgA

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    End point title
    		 Influenza A/H1N1 IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.5 ( 0.0 )
    1.3 ( 1.3 )
    No statistical analyses for this end point

    Secondary: Influenza A/H3N2 IgA

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    End point title
    		 Influenza A/H3N2 IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.7 ( 0.5 )
    1.0 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Influenza A/H3N2 IgA

    		 Close Top of page
    End point title
    		 Influenza A/H3N2 IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    3-5 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.5 ( 0.0 )
    0.7 ( 0.5 )
    No statistical analyses for this end point

    Secondary: Influenza A/H3N2 IgA

    		 Close Top of page
    End point title
    		 Influenza A/H3N2 IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.7 ( 0.5 )
    1.2 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Influenza A/H3N2 IgA

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    End point title
    		 Influenza A/H3N2 IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    14-28 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    1.1 ( 0.9 )
    0.7 ( 0.5 )
    No statistical analyses for this end point

    Secondary: Influenza A/H3N2 IgA

    		 Close Top of page
    End point title
    		 Influenza A/H3N2 IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.5 ( 0.0 )
    1.7 ( 1.0 )
    No statistical analyses for this end point

    Secondary: Influenza B IgA

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    End point title
    		 Influenza B IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.5 ( 0.0 )
    0.5 ( 0.0 )
    No statistical analyses for this end point

    Secondary: Influenza B IgA

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    End point title
    		 Influenza B IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    3-5 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.5 ( 0.0 )
    0.5 ( 0.0 )
    No statistical analyses for this end point

    Secondary: Influenza B IgA

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    End point title
    		 Influenza B IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.5 ( 0.0 )
    0.5 ( 0.0 )
    No statistical analyses for this end point

    Secondary: Influenza B IgA

    		 Close Top of page
    End point title
    		 Influenza B IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    14-28 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.5 ( 0.0 )
    0.5 ( 0.0 )
    No statistical analyses for this end point

    Secondary: Influenza B IgA

    		 Close Top of page
    End point title
    		 Influenza B IgA
    End point description
    Mean of influenza-specific IgA from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    0.5 ( 0.0 )
    0.7 ( 0.5 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - CD56

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - CD56
    End point description
    Mean and standard deviation results of CD56 lymphocyte subsets is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    5.2 ( 3.2 )
    7.6 ( 5.5 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - CD56

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - CD56
    End point description
    Mean and standard deviation results of CD56 lymphocyte subsets is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    8
    9
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    4.6 ( 3.4 )
    6.6 ( 5.6 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells
    End point description
    Mean and standard deviation results of white blood cells subsets is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Cells per 10^3/UL
        arithmetic mean (standard deviation)
    4.19 ( 1.49 )
    3.91 ( 1.56 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - White Blood Cells
    End point description
    Mean and standard deviation results of white blood cells subsets is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    9
    8
    Units: Cells per 10^3/UL
        arithmetic mean (standard deviation)
    3.24 ( 1.10 )
    4.05 ( 1.33 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes
    End point description
    Mean and standard deviation results of lymphocytes subsets is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    17.62 ( 7.56 )
    27.56 ( 9.25 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - Lymphocytes
    End point description
    Mean and standard deviation results of lymphocytes subsets is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    9
    8
    Units: Percentage of lymphocytes
        arithmetic mean (standard deviation)
    22.58 ( 11.89 )
    23.13 ( 8.23 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes
    End point description
    Mean and standard deviation results of absolute lymphocytes subsets is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Cells per 10^3/UL
        arithmetic mean (standard deviation)
    0.77 ( 0.51 )
    1.03 ( 0.50 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Lymphocytes
    End point description
    Mean and standard deviation results of absolute lymphocytes subsets is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    7-10 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    9
    8
    Units: Cells per 10^3/UL
        arithmetic mean (standard deviation)
    0.77 ( 0.58 )
    0.98 ( 0.57 )
    No statistical analyses for this end point

    Secondary: T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils

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    End point title
    		 T- and B-lymphocyte Subsets by Flow Cytometry - Absolute Neutrophils
    End point description
    Mean and standard deviation results of absolute neutrophils subsets is reported. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    5
    7
    Units: Cells per 10^3/UL
        arithmetic mean (standard deviation)
    3300.0 ( 1534.6 )
    2728.6 ( 1162.9 )
    No statistical analyses for this end point

    Secondary: Influenza A/H1N1 Immunoglobulin G (IgG)

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    End point title
    		 Influenza A/H1N1 Immunoglobulin G (IgG)
    End point description
    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    954.7 ( 1245.3 )
    672.4 ( 492.8 )
    No statistical analyses for this end point

    Secondary: Influenza A/H1N1 IgG

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    End point title
    		 Influenza A/H1N1 IgG
    End point description
    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    924.3 ( 1207.2 )
    844.0 ( 645.7 )
    No statistical analyses for this end point

    Secondary: Influenza A/H3N2 IgG

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    End point title
    		 Influenza A/H3N2 IgG
    End point description
    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    799.1 ( 426.2 )
    1842.4 ( 1989.1 )
    No statistical analyses for this end point

    Secondary: Influenza A/H3N2 IgG

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    End point title
    		 Influenza A/H3N2 IgG
    End point description
    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    742.9 ( 432.2 )
    1671.9 ( 1646.6 )
    No statistical analyses for this end point

    Secondary: Influenza B IgG

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    End point title
    		 Influenza B IgG
    End point description
    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    599.1 ( 344.2 )
    638.6 ( 334.5 )
    No statistical analyses for this end point

    Secondary: Influenza B IgG

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    End point title
    		 Influenza B IgG
    End point description
    Mean of influenza-specific IgG from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    620.2 ( 472.8 )
    1020.3 ( 715.6 )
    No statistical analyses for this end point

    Secondary: Influenza A/H1N1 Immunoglobulin M (IgM)

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    End point title
    		 Influenza A/H1N1 Immunoglobulin M (IgM)
    End point description
    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    150.1 ( 107.0 )
    160.4 ( 105.4 )
    No statistical analyses for this end point

    Secondary: Influenza A/H1N1 IgM

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    End point title
    		 Influenza A/H1N1 IgM
    End point description
    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    171.3 ( 106.7 )
    134.8 ( 100.7 )
    No statistical analyses for this end point

    Secondary: Influenza A/H3N2 IgM

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    End point title
    		 Influenza A/H3N2 IgM
    End point description
    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    153.1 ( 109.4 )
    134.7 ( 100.4 )
    No statistical analyses for this end point

    Secondary: Influenza A/H3N2 IgM

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    End point title
    		 Influenza A/H3N2 IgM
    End point description
    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    189.9 ( 98.5 )
    136.9 ( 103.1 )
    No statistical analyses for this end point

    Secondary: Influenza B IgM

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    End point title
    		 Influenza B IgM
    End point description
    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    pre-dosing (Day 0)
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    69.3 ( 61.0 )
    72.2 ( 66.7 )
    No statistical analyses for this end point

    Secondary: Influenza B IgM

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    End point title
    		 Influenza B IgM
    End point description
    Mean of influenza-specific IgM from nasal swab is reported. Titers of < 1 were assigned the value of 0.5. All randomized participants who received a full dose of study vaccine, had any valid results in the evaluation of immune response, had no protocol deviations, and had sample available for the specified day were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    35-42 days after study vaccination
    End point values
    		 Placebo FluMist
    Number of subjects analysed
    10
    9
    Units: Titer
        arithmetic mean (standard deviation)
    82.0 ( 69.7 )
    68.4 ( 55.3 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected from the time of investigational product administration through Day 42. Serious adverse events (SAEs) were collected from the time of study drug administration through Day 180.
    Adverse event reporting additional description
    Participants who received any study vaccine and had any follow-up for REs and/or AEs were analysed for AEs and SAEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).

    Reporting group title
    FluMist
    Reporting group description
    		 The total volume of 0.5 mL of FluMist was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10^7 TCID50 (median tissue culture infectious dose) of each of three influenza virus strains.

    Serious adverse events
    		 Placebo FluMist
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo FluMist
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 10 (90.00%)
    5 / 10 (50.00%)
    Injury, poisoning and procedural complications
    Animal scratch
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Ankle fracture
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Oral pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Sneezing
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Dry skin
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia facial
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Skin chapped
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Insomnia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Fungal skin infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Oral intake reduced
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Mar 2005
    • The number of study sites was increased. The isolation procedures specific to St. Jude’s were modified to reflect those recommended by the Advisory Committee on Immunization Practices, to accommodate procedures across multiple study sites. The reporting period of significant new medical conditions was clarified. • The exclusion criteria were clarified and/or modified to accommodate participants/regimens across multiple study sites. Specifically, the exclusion criterion for cluster of differentiation 4 (CD4) + T-cell count < 500 cells/mm^3 was revised to CD4 + T-cell percentage < 15%; the exclusion criterion for B-cell count < 5% was deleted; and the absolute neutrophil count ANC count <= 500 cells/mm3 at screening was revised at study entry. • The screening period was extended to within 16 days before study dosing. Central randomization was implemented with the change to a multiple site study, and the randomization procedures were described. The conditions under which additional participants could be enrolled were added. • The identity and concentration of the influenza virus strains for FluMist study vaccine were revised based on the strains used in the commercially available vaccine during the 2004-2005 influenza season. • The allocation of participants to each treatment group was revised to “approximately” 10 due to the change to a multiple center study. • Collection of radiation therapy with concomitant medication use was added. • The schedule of participant evaluations was revised to accommodate chemotherapy regimens for potential study participants. The reporting period for safety events and the collection procedures for blood samples and nasal specimens were revised or clarified. • Study visits at Days 3 through 5 and Days 17 through 28 were revised to be clinic or at-home visits. • Significant new medical conditions were added as a safety event that would be assessed for severity and for relationship to study vaccine.
    08 Mar 2006
    • Safety information from an immunosuppressed animal model were added. • Safety information for the first four participants vaccinated in the 2005 enrollment period was added. • The Day 17 to 28 visit was revised to occur from Day 14 to 21, with an additional contact on Day 22 to 28, for safety monitoring purposes. Biomarkers for immune response were revised based on actual testing parameters. • Criterion #6 was modified to clarify current status for participants with hematologic malignancy. • Criterion #15 was revised to clarify pregnancy testing. Criterion #19 was modified to have the ANC evaluation be within 24 hours of study entry to possibly avoid multiple blood draws on the same day. Criteria #20 and #21 were combined and modified to exclude only participants who were receiving highdose steroids for >= 14 days, which is consistent with the AAP Red Book guidelines for administration of live viral vaccines. • The staggered enrollment schedule was revised to reflect enrollment of the first 4 participants in the 2005 summer enrollment period • The vaccine strains that were to be administered to participants entered during the 2006 enrollment period were updated. The relevant years and influenza seasons were revised to reflect enrollment in a second season. FluMist storage conditions were updated to be consistent with the current labelling.
    16 Jan 2007
    • Information was updated to reflect clinical research use of the refrigerated formulation that had been recently approved. Data from a pivotal pediatric efficacy trial were added. • Safety and shedding data were added for a second pediatric trial in human immunodeficiency virus-infected children. Safety, shedding, and immunogenicity data were added for a post-marketing trial in children and adults. • Updated safety information was provided for the 12 participants who had been enrolled in the first two years of the study. Text was added to reflect target enrollment in 2007 at the end of the 2006-2007 influenza season. • Influenza vaccine strain information was updated for 2007 enrollment. • Pregnancy was added as an immediately reportable event due to the age of the participants eligible for this study.

    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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