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    Clinical Trial Results:
    A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Subjects aged 6 months to 17 years

    Summary
    EudraCT number
    		 2007-002480-27
    Trial protocol
    		 FI  
    Global end of trial date
    18 May 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    04 Feb 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Required for the re-QC project because of the EudraCT system glitch and possible updates to results may be required. Moreover, a change in system user for this study is necessary.

    Trial information

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    Trial identification
    Sponsor protocol code
    V87P6
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00537524
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics GmbH & Co. KG
    Sponsor organisation address
    Emil-von-Behring-Strasse 76, Marburg, Germany, 35006
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics GmbH & Co. KG, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics GmbH & Co. KG, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000663-PIP01-09
    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
    05 Aug 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 May 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the magnitude of antibody responses to two doses of MF59-PanH5N1 influenza vaccine, each containing 7.5μg of H5N1 antigen administered 3 weeks apart in subjects of different ages.
    Protection of trial subjects
    This clinical study was designed, implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki. Standard immunization practices should be observed and care should be taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision should be readily available in case of anaphylactic reactions following administration of the study vaccine, in accordance with local practice/guidelines such as epinephrine 1:1000 and diphenhydramine. Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. An oral temperature ≥38.0°C (≥100.4°F) or serious active infection was a reason for delaying vaccination. Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine is not injected into a blood vessel.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Sep 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 472
    Worldwide total number of subjects
    472
    EEA total number of subjects
    472
    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)
    134
    Children (2-11 years)
    247
    Adolescents (12-17 years)
    91
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at one study center in Finland.

    Pre-assignment
    Screening details
    		 All subjects enrolled were included in the trial, except for one subject whose parent/guardian withdrew of consent on day 1.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MF59-PANH5N1 IV (6 to <36months)
    Arm description
    		 Toddlers received two doses 0.5 mL of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    MF59-PanH5N1 IV vaccine
    Investigational medicinal product code
    Other name
    Aflunov
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of two 0.5 mL doses of H5N1 influenza vaccine and one 0.5 mL dose of H5N1 vaccine administered IM in the left deltoid or anterolateral thigh

    Arm title
    		 MF59-PANH5N1 IV (3 to <9 years)
    Arm description
    		 Children received two doses 0.5 mL of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    MF59-PanH5N1 IV vaccine
    Investigational medicinal product code
    Other name
    Aflunov
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of two 0.5 mL doses of H5N1 influenza vaccine and one 0.5 mL dose of H5N1 vaccine administered IM in the left deltoid or anterolateral thigh

    Arm title
    		 MF59-PANH5N1 IV (9 to <18 years)
    Arm description
    		 Adolescents received two doses 0.5 mL of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    MF59-PanH5N1 IV vaccine
    Investigational medicinal product code
    Other name
    Aflunov
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of two 0.5 mL doses of H5N1 influenza vaccine and one 0.5 mL dose of H5N1 vaccine administered IM in the left deltoid or anterolateral thigh

    Arm title
    		 MF59-Seasonal IV (6 to <36months)
    Arm description
    		 Toddlers received two 0.25mL or 0.5mL doses of H5N1 influenza vaccine, administered 3 weeks apart
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MF59-Seasonal IV vaccine
    Investigational medicinal product code
    Other name
    Fluad
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of two 0.25mL or 0.5mL doses of H5N1 influenza vaccine administered IM in the left deltoid or anterolateral thigh

    Arm title
    		 MF59-Seasonal IV (3 to <9 years)
    Arm description
    		 Children received two 0.25mL or 0.5mL doses of H5N1 influenza vaccine, administered 3 weeks apart
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MF59-Seasonal IV vaccine
    Investigational medicinal product code
    Other name
    Fluad
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of two 0.25mL or 0.5mL doses of H5N1 influenza vaccine administered IM in the left deltoid or anterolateral thigh

    Arm title
    		 MF59-Seasonal IV (9 to <18 years)
    Arm description
    		 Adolescents received two 0.25mL or 0.5mL doses of H5N1 influenza vaccine, administered 3 weeks apart
    Arm type
    		 Active comparator

    Investigational medicinal product name
    MF59-Seasonal IV vaccine
    Investigational medicinal product code
    Other name
    Fluad
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of two 0.25mL or 0.5mL doses of H5N1 influenza vaccine administered IM in the left deltoid or anterolateral thigh

    Number of subjects in period 1
    		MF59-PANH5N1 IV (6 to <36months) MF59-PANH5N1 IV (3 to <9 years) MF59-PANH5N1 IV (9 to <18 years) MF59-Seasonal IV (6 to <36months) MF59-Seasonal IV (3 to <9 years) MF59-Seasonal IV (9 to <18 years)
    Started
    145
    96
    94
    56
    40
    41
    Completed
    122
    84
    83
    56
    38
    40
    Not completed
    23
    12
    11
    0
    2
    1
         Adverse event, serious fatal
    1
    2
    -
    -
    1
    -
         Consent withdrawn by subject
    16
    8
    6
    -
    -
    1
         Unable to classify
    1
    -
    1
    -
    -
    -
         Lost to follow-up
    5
    2
    3
    -
    1
    -
         Protocol deviation
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MF59-PANH5N1 IV (6 to <36months)
    Reporting group description
    		 Toddlers received two doses 0.5 mL of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Reporting group title
    MF59-PANH5N1 IV (3 to <9 years)
    Reporting group description
    		 Children received two doses 0.5 mL of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Reporting group title
    MF59-PANH5N1 IV (9 to <18 years)
    Reporting group description
    		 Adolescents received two doses 0.5 mL of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Reporting group title
    MF59-Seasonal IV (6 to <36months)
    Reporting group description
    		 Toddlers received two 0.25mL or 0.5mL doses of H5N1 influenza vaccine, administered 3 weeks apart

    Reporting group title
    MF59-Seasonal IV (3 to <9 years)
    Reporting group description
    		 Children received two 0.25mL or 0.5mL doses of H5N1 influenza vaccine, administered 3 weeks apart

    Reporting group title
    MF59-Seasonal IV (9 to <18 years)
    Reporting group description
    		 Adolescents received two 0.25mL or 0.5mL doses of H5N1 influenza vaccine, administered 3 weeks apart

    Reporting group values
    		 MF59-PANH5N1 IV (6 to <36months) MF59-PANH5N1 IV (3 to <9 years) MF59-PANH5N1 IV (9 to <18 years) MF59-Seasonal IV (6 to <36months) MF59-Seasonal IV (3 to <9 years) MF59-Seasonal IV (9 to <18 years) Total
    Number of subjects
    		 145 96 94 56 40 41 472
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 96 0 0 38 0 0 134
        Children (2-11 years)
    		 49 96 31 18 40 13 247
        Adolescents (12-17 years)
    		 0 0 63 0 0 28 91
        Adults (18-64 years)
    		 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 19.1 ± 8.7 5.5 ± 1.7 13 ± 2.7 18.7 ± 9.1 5.5 ± 1.6 13 ± 2.7 -
    Gender categorical
    Units: Subjects
        Female
    		 78 44 57 29 13 20 241
        Male
    		 67 52 37 27 27 21 231

    End points

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    End points reporting groups
    Reporting group title
    MF59-PANH5N1 IV (6 to <36months)
    Reporting group description
    		 Toddlers received two doses 0.5 mL of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Reporting group title
    MF59-PANH5N1 IV (3 to <9 years)
    Reporting group description
    		 Children received two doses 0.5 mL of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Reporting group title
    MF59-PANH5N1 IV (9 to <18 years)
    Reporting group description
    		 Adolescents received two doses 0.5 mL of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Reporting group title
    MF59-Seasonal IV (6 to <36months)
    Reporting group description
    		 Toddlers received two 0.25mL or 0.5mL doses of H5N1 influenza vaccine, administered 3 weeks apart

    Reporting group title
    MF59-Seasonal IV (3 to <9 years)
    Reporting group description
    		 Children received two 0.25mL or 0.5mL doses of H5N1 influenza vaccine, administered 3 weeks apart

    Reporting group title
    MF59-Seasonal IV (9 to <18 years)
    Reporting group description
    		 Adolescents received two 0.25mL or 0.5mL doses of H5N1 influenza vaccine, administered 3 weeks apart

    Subject analysis set title
    Full Analysis Population (HI)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who actually received a study vaccination, and provided at least one evaluable serum sample at post baseline.

    Subject analysis set title
    Full Analysis Population (SRH, MN)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who actually received a study vaccination, and provided at least one evaluable serum sample at post baseline.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed population who provided post vaccination and post-baseline safety data.

    Primary: Percentages of subjects with HI titers ≥ 40 after primary vaccination in toddlers-FAS

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    End point title
    		 Percentages of subjects with HI titers ≥ 40 after primary vaccination in toddlers-FAS [1] [2]
    End point description
    The immune response was measured as the percentage of subjects with HI titers ≥40 after primary vaccination, as defined by CHMP (MF59-PanH5N1 IV) against HI Strain H5N1 A/Vietnam administered 3 weeks apart in toddlers.
    End point type
    Primary
    End point timeframe
    Day 1 and Day 43
    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: There were no statistical analysis done.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (6 to <36months) MF59-Seasonal IV (6 to <36months)
    Number of subjects analysed
    134
    55
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 1 (N=134,55)
    1 (0.019 to 4)
    0 (0 to 6)
        Day 43 (N=131,54)
    97 (92 to 99)
    0 (0 to 7)
    No statistical analyses for this end point

    Primary: Percentages of subjects with HI titers ≥ 40 after primary vaccination in children-FAS

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    End point title
    		 Percentages of subjects with HI titers ≥ 40 after primary vaccination in children-FAS [3] [4]
    End point description
    The immune response was measured as the percentage of subjects with HI titers ≥40 after primary vaccination, as defined by CHMP (MF59-PanH5N1 IV) against HI Strain H5N1 A/Vietnam administered 3 weeks apart in children
    End point type
    Primary
    End point timeframe
    Day 1 and Day 43
    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: There were no statistical analysis done.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (3 to <9 years) MF59-Seasonal IV (3 to <9 years)
    Number of subjects analysed
    91
    40
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 1 (N=91,40)
    0 (0 to 4)
    0 (0 to 9)
        Day 43 (N=91,39)
    97 (91 to 99)
    0 (0 to 9)
    No statistical analyses for this end point

    Primary: Percentages of subjects with HI titers ≥ 40 after primary vaccination in adolescents-FAS

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    End point title
    		 Percentages of subjects with HI titers ≥ 40 after primary vaccination in adolescents-FAS [5] [6]
    End point description
    The immune response was measured as the percentage of subjects with HI titers ≥40 after primary vaccination, as defined by CHMP (MF59-PanH5N1 IV) against HI Strain H5N1 A/Vietnam administered 3 weeks apart in adolescents.
    End point type
    Primary
    End point timeframe
    Day 1 and Day 43
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (9 to <18 years) MF59-Seasonal IV (9 to <18 years)
    Number of subjects analysed
    89
    40
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 1 (N=89,40)
    1 (0.028 to 6)
    0 (0 to 9)
        Day 43 (N=89,40)
    89 (80 to 94)
    0 (0 to 9)
    No statistical analyses for this end point

    Primary: The geometric mean titers (GMTs) determined by HI assay after primary vaccination in toddlers-FAS

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    End point title
    		 The geometric mean titers (GMTs) determined by HI assay after primary vaccination in toddlers-FAS [7] [8]
    End point description
    The immune response was measured as the geometric mean bactericidal titers directed against HI Strain H5N1 A/Vietnam administered 3 weeks apart in toddlers.
    End point type
    Primary
    End point timeframe
    Day 1 and Day 43
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (6 to <36months) MF59-Seasonal IV (6 to <36months)
    Number of subjects analysed
    134
    55
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 1 (N=134,55)
    5.12 (4.92 to 5.32)
    5.01 (4.71 to 5.32)
        Day 43 (N=131,54)
    658 (560 to 773)
    5.03 (3.91 to 6.47)
    No statistical analyses for this end point

    Primary: The geometric mean titers (GMTs) determined by HI assay after primary vaccination in children-FAS

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    End point title
    		 The geometric mean titers (GMTs) determined by HI assay after primary vaccination in children-FAS [9] [10]
    End point description
    The immune response was measured as the geometric mean bactericidal titers directed against HI Strain H5N1 A/Vietnam administered 3 weeks apart in children
    End point type
    Primary
    End point timeframe
    Day 1 and Day 43
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There were no statistical analysis done.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (3 to <9 years) MF59-Seasonal IV (3 to <9 years)
    Number of subjects analysed
    91
    40
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 1 (N=91,40)
    5 (5 to 5)
    5 (5 to 5)
        Day 43 (N=91,39)
    585 (484 to 708)
    4.93 (3.68 to 6.6)
    No statistical analyses for this end point

    Primary: The geometric mean titers (GMTs) determined by HI assay after primary vaccination in adolescents-FAS

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    End point title
    		 The geometric mean titers (GMTs) determined by HI assay after primary vaccination in adolescents-FAS [11] [12]
    End point description
    The immune response was measured as the geometric mean bactericidal titers directed against HI Strain H5N1 A/Vietnam administered 3 weeks apart in adolescents
    End point type
    Primary
    End point timeframe
    Day 1 and Day 43
    Notes
    [11] - 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: There were no statistical analysis done.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (9 to <18 years) MF59-Seasonal IV (9 to <18 years)
    Number of subjects analysed
    89
    40
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 1 (N=89,40)
    5.15 (4.95 to 5.43)
    5.01 (4.64 to 5.4)
        Day 43 (N=89,40)
    344 (261 to 453)
    5.07 (3.36 to 7.65)
    No statistical analyses for this end point

    Primary: Percentages of subjects with Seroconversion or Significant increase from day 1 in HI titers after primary vaccination in toddlers-FAS

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    End point title
    		 Percentages of subjects with Seroconversion or Significant increase from day 1 in HI titers after primary vaccination in toddlers-FAS [13] [14]
    End point description
    The immune response was measured as the percentage of subjects with Seroconversion or Significant increase from day 1 in HI titers after primary vaccination, as defined by CHMP (MF59-PanH5N1 IV) against HI Strain H5N1 A/Vietnam administered 3 weeks apart in toddlers.
    End point type
    Primary
    End point timeframe
    Day 43
    Notes
    [13] - 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: There were no statistical analysis done.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (6 to <36months) MF59-Seasonal IV (6 to <36months)
    Number of subjects analysed
    134
    55
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 43 (N-131, 54)
    97 (92 to 99)
    0 (0 to 7)
    No statistical analyses for this end point

    Primary: Percentages of subjects with Seroconversion or Significant increase from day 1 in HI titers after primary vaccination in children-FAS

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    End point title
    		 Percentages of subjects with Seroconversion or Significant increase from day 1 in HI titers after primary vaccination in children-FAS [15] [16]
    End point description
    The immune response was measured as the percentage of subjects with Seroconversion or Significant increase from day 1 in HI titers after primary vaccination, as defined by CHMP (MF59-PanH5N1 IV) against HI Strain H5N1 A/Vietnam administered 3 weeks apart in children
    End point type
    Primary
    End point timeframe
    Day 43
    Notes
    [15] - 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: There were no statistical analysis done.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (3 to <9 years) MF59-Seasonal IV (3 to <9 years)
    Number of subjects analysed
    91
    40
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 43 (N=91,39)
    97 (91 to 99)
    0 (0 to 9)
    No statistical analyses for this end point

    Primary: Percentages of subjects with Seroconversion or Significant increase from day 1 in HI titers after primary vaccination in adolescents-FAS

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    End point title
    		 Percentages of subjects with Seroconversion or Significant increase from day 1 in HI titers after primary vaccination in adolescents-FAS [17] [18]
    End point description
    The immune response was measured as the percentage of subjects with Seroconversion or Significant increase from day 1 in HI titers after primary vaccination, as defined by CHMP (MF59-PanH5N1 IV) against HI Strain H5N1 A/Vietnam administered 3 weeks apart in adolescents
    End point type
    Primary
    End point timeframe
    Day 43
    Notes
    [17] - 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: There were no statistical analysis done.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (9 to <18 years) MF59-Seasonal IV (9 to <18 years)
    Number of subjects analysed
    89
    40
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 43 (N=89,40)
    89 (80 to 94)
    0 (0 to 9)
    No statistical analyses for this end point

    Primary: Number of subjects reporting solicited local and systemic adverse events after receiving 2 doses of MF59-PanH5N1 IV vaccine

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    End point title
    		 Number of subjects reporting solicited local and systemic adverse events after receiving 2 doses of MF59-PanH5N1 IV vaccine [19]
    End point description
    The safety and tolerability of the 2 doses of MF59-PanH5N1 IV vaccine administered 3 weeks apart in subjects (all age groups) according to different schedules is reported as number of subjects with solicited local* and systemic adverse events.
    End point type
    Primary
    End point timeframe
    From day 1 to day 7 after vaccination
    Notes
    [19] - 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: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (6 to <36months) MF59-PANH5N1 IV (3 to <9 years) MF59-PANH5N1 IV (9 to <18 years) MF59-Seasonal IV (6 to <36months) MF59-Seasonal IV (3 to <9 years) MF59-Seasonal IV (9 to <18 years)
    Number of subjects analysed
    138
    93
    91
    56
    39
    40
    Units: Percentage of subjects
        Any (vaccination 2)
    68
    68
    82
    63
    56
    78
        Any local (vaccination 2)
    46
    58
    70
    41
    49
    65
        Any systemic (vaccination 2)
    51
    33
    52
    46
    36
    50
        Any Other (vaccination 2)
    16
    12
    15
    20
    15
    8
    No statistical analyses for this end point

    Secondary: The geometric mean titers (GMTs) determined by HI assay after booster vaccinations in MF59-PanH5N1 IV in toddlers-FAS

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    End point title
    		 The geometric mean titers (GMTs) determined by HI assay after booster vaccinations in MF59-PanH5N1 IV in toddlers-FAS [20]
    End point description
    The immune response was measured as the geometric mean bactericidal titers directed against HI Strain H5N1 A/Vietnam following 12 month booster dose in toddlers
    End point type
    Secondary
    End point timeframe
    Day 382 and Day 403
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (6 to <36months)
    Number of subjects analysed
    113
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 382 (N=113)
    25 (18 to 34)
        Day 403 (N=113)
    1365 (1166 to 1598)
    No statistical analyses for this end point

    Secondary: The geometric mean titers (GMTs) determined by HI assay after booster vaccinations in MF59-PanH5N1 IV in children-FAS

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    End point title
    		 The geometric mean titers (GMTs) determined by HI assay after booster vaccinations in MF59-PanH5N1 IV in children-FAS [21]
    End point description
    The immune response was measured as the geometric mean bactericidal titers directed against HI Strain H5N1 A/Vietnam following 12 month booster dose in children
    End point type
    Secondary
    End point timeframe
    Day 382 and Day 403
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (3 to <9 years)
    Number of subjects analysed
    83
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 382 (N=83)
    10 (7.93 to 14)
        Day 403 (N=83)
    766 (613 to 958)
    No statistical analyses for this end point

    Secondary: The geometric mean titers (GMTs) determined by HI assay after booster vaccinations in MF59-PanH5N1 IV in adolescents-FAS

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    End point title
    		 The geometric mean titers (GMTs) determined by HI assay after booster vaccinations in MF59-PanH5N1 IV in adolescents-FAS [22]
    End point description
    The immune response was measured as the geometric mean bactericidal titers directed against HI Strain H5N1 A/Vietnam following 12 month booster dose in adolescents
    End point type
    Secondary
    End point timeframe
    Day 382 and Day 403
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (9 to <18 years)
    Number of subjects analysed
    81
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 383 (N=81)
    12 (8.92 to 16)
        Day 403 (N=81)
    472 (335 to 667)
    No statistical analyses for this end point

    Secondary: Percentage of subjects Showing Seroprotection (CHMP) by SRH Assay (MF59-PanH5N1 IV) in toddlers-FAS

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    End point title
    		 Percentage of subjects Showing Seroprotection (CHMP) by SRH Assay (MF59-PanH5N1 IV) in toddlers-FAS [23]
    End point description
    Evaluate cross-protection of MF59-PanH5N1 IV in toddlers-FAS persistence population
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 382
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (6 to <36months)
    Number of subjects analysed
    122
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 1 (N=122)
    3 (1 to 8)
        Day 382 (N=122)
    88 (81 to 93)
    No statistical analyses for this end point

    Secondary: Percentage of subjects Showing Seroprotection (CHMP) by SRH Assay (MF59-PanH5N1 IV) in children-FAS

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    End point title
    		 Percentage of subjects Showing Seroprotection (CHMP) by SRH Assay (MF59-PanH5N1 IV) in children-FAS [24]
    End point description
    Evaluate cross-protection of MF59-PanH5N1 IV in children-FAS persistence population
    End point type
    Secondary
    End point timeframe
    Day 1 and 382
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (3 to <9 years)
    Number of subjects analysed
    85
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 1 (N=85)
    0 (0 to 4)
        Day 382 (N=85)
    71 (60 to 80)
    No statistical analyses for this end point

    Secondary: Percentage of subjects Showing Seroprotection (CHMP) by SRH Assay (MF59-PanH5N1 IV) in adolescents-FAS

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    End point title
    		 Percentage of subjects Showing Seroprotection (CHMP) by SRH Assay (MF59-PanH5N1 IV) in adolescents-FAS [25]
    End point description
    Evaluate cross-protection of MF59-PanH5N1 IV in adolescents-FAS persistence population
    End point type
    Secondary
    End point timeframe
    Day 1 and 382
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: There were no statistical analysis done.
    End point values
    		 MF59-PANH5N1 IV (9 to <18 years)
    Number of subjects analysed
    82
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 1 (N=82)
    5 (1 to 12)
        Day 382 (N=82)
    61 (50 to 72)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local and systemic adverse events after receiving one dose of MF59-PanH5N1 IV vaccine after 12 months of 2nd dose

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    End point title
    		 Number of subjects reporting solicited local and systemic adverse events after receiving one dose of MF59-PanH5N1 IV vaccine after 12 months of 2nd dose
    End point description
    The safety and tolerability of the 1 dose of MF59-PanH5N1 IV vaccine administered 12 months after 2nd dose in subjects (all age groups) according to different schedules is reported as number of subjects with solicited local* and systemic adverse events.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 7 after vaccination
    End point values
    		 MF59-PANH5N1 IV (6 to <36months) MF59-PANH5N1 IV (3 to <9 years) MF59-PANH5N1 IV (9 to <18 years) MF59-Seasonal IV (6 to <36months) MF59-Seasonal IV (3 to <9 years) MF59-Seasonal IV (9 to <18 years)
    Number of subjects analysed
    124
    85
    83
    0 [26]
    0 [27]
    0 [28]
    Units: Percentage of subjects
        Any (vaccination 3)
    80
    79
    89
        Any local (vaccination 3)
    60
    74
    81
        Any Systemic (vaccination 3)
    54
    45
    69
        Any other (vaccination 3)
    19
    14
    16
    Notes
    [26] - Booster dose not given for the active comparator cohort
    [27] - Booster dose not given for the active comparator cohort
    [28] - Booster dose not given for the active comparator cohort
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited local and systemic adverse events after receiving one dose of MF59-PanH5N1 IV vaccine after 12 months of 2nd dose

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    End point title
    		 Number of subjects reporting unsolicited local and systemic adverse events after receiving one dose of MF59-PanH5N1 IV vaccine after 12 months of 2nd dose
    End point description
    End point type
    Secondary
    End point timeframe
    From day 1 to day 21 after vaccination
    End point values
    		 MF59-PANH5N1 IV (6 to <36months) MF59-PANH5N1 IV (3 to <9 years) MF59-PANH5N1 IV (9 to <18 years) MF59-Seasonal IV (6 to <36months) MF59-Seasonal IV (3 to <9 years) MF59-Seasonal IV (9 to <18 years)
    Number of subjects analysed
    124
    85
    83
    0 [29]
    0 [30]
    0 [31]
    Units: Percentage of subjects
        Any AEs
    23
    12
    8
        At least possibly related AEs
    0
    0
    0
        Serious AEs
    2
    0
    0
        AEs leading to discontinuation
    0
    0
    0
    Notes
    [29] - Booster dose not given to the active comparator cohort
    [30] - Booster dose not given to the active comparator cohort
    [31] - Booster dose not given to the active comparator cohort
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study period (day 1 to after primary vaccination after a 12 month booster vaccination)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    MF59-PANH5N1 IV (3 to <9 years)
    Reporting group description
    		 Children received two doses 0.5 ml of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Reporting group title
    MF59-PANH5N1 IV (9 to <18 years)
    Reporting group description
    		 Adolescents received two doses 0.5 ml of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Reporting group title
    MF59-Seasonal IV (6 to <36months)
    Reporting group description
    		 Toddlers received two doses 0.5 ml of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Reporting group title
    MF59-Seasonal IV (3 to <9 years)
    Reporting group description
    		 Children received two doses 0.5 ml of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Reporting group title
    MF59-Seasonal IV (9 to <18 years)
    Reporting group description
    		 Adolescents received two doses 0.5 ml of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Reporting group title
    MF59-PANH5N1 IV (6 to <36months)
    Reporting group description
    		 Toddlers received two doses 0.5 ml of H5N1 influenza vaccine, administered 3 weeks apart, and one dose of H5N1 vaccine 12 months after the second dose

    Serious adverse events
    		 MF59-PANH5N1 IV (3 to <9 years) MF59-PANH5N1 IV (9 to <18 years) MF59-Seasonal IV (6 to <36months) MF59-Seasonal IV (3 to <9 years) MF59-Seasonal IV (9 to <18 years) MF59-PANH5N1 IV (6 to <36months)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 96 (3.13%)
    3 / 93 (3.23%)
    2 / 56 (3.57%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    16 / 145 (11.03%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic renal injury
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    5 / 145 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 56 (1.79%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 56 (1.79%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 145 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    3 / 145 (2.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MF59-PANH5N1 IV (3 to <9 years) MF59-PANH5N1 IV (9 to <18 years) MF59-Seasonal IV (6 to <36months) MF59-Seasonal IV (3 to <9 years) MF59-Seasonal IV (9 to <18 years) MF59-PANH5N1 IV (6 to <36months)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    92 / 96 (95.83%)
    92 / 93 (98.92%)
    52 / 56 (92.86%)
    34 / 40 (85.00%)
    39 / 41 (95.12%)
    141 / 145 (97.24%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    34 / 96 (35.42%)
    58 / 93 (62.37%)
    1 / 56 (1.79%)
    12 / 40 (30.00%)
    28 / 41 (68.29%)
    2 / 145 (1.38%)
         occurrences all number
    49
    114
    1
    20
    45
    3
    Somnolence
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    14 / 56 (25.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    65 / 145 (44.83%)
         occurrences all number
    0
    0
    21
    0
    0
    99
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    17 / 96 (17.71%)
    18 / 93 (19.35%)
    5 / 56 (8.93%)
    9 / 40 (22.50%)
    15 / 41 (36.59%)
    10 / 145 (6.90%)
         occurrences all number
    19
    33
    7
    10
    17
    12
    Crying
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    23 / 56 (41.07%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    70 / 145 (48.28%)
         occurrences all number
    0
    0
    33
    0
    0
    142
    Fatigue
         subjects affected / exposed
    38 / 96 (39.58%)
    38 / 93 (40.86%)
    0 / 56 (0.00%)
    15 / 40 (37.50%)
    22 / 41 (53.66%)
    0 / 145 (0.00%)
         occurrences all number
    61
    69
    0
    24
    37
    0
    Injection site erythema
         subjects affected / exposed
    58 / 96 (60.42%)
    40 / 93 (43.01%)
    19 / 56 (33.93%)
    21 / 40 (52.50%)
    12 / 41 (29.27%)
    90 / 145 (62.07%)
         occurrences all number
    91
    62
    27
    26
    17
    151
    Injection site haemorrhage
         subjects affected / exposed
    14 / 96 (14.58%)
    15 / 93 (16.13%)
    8 / 56 (14.29%)
    4 / 40 (10.00%)
    4 / 41 (9.76%)
    28 / 145 (19.31%)
         occurrences all number
    18
    17
    8
    6
    4
    38
    Injection site induration
         subjects affected / exposed
    26 / 96 (27.08%)
    32 / 93 (34.41%)
    4 / 56 (7.14%)
    6 / 40 (15.00%)
    3 / 41 (7.32%)
    55 / 145 (37.93%)
         occurrences all number
    32
    48
    4
    9
    4
    71
    Injection site pain
         subjects affected / exposed
    82 / 96 (85.42%)
    88 / 93 (94.62%)
    22 / 56 (39.29%)
    22 / 40 (55.00%)
    35 / 41 (85.37%)
    80 / 145 (55.17%)
         occurrences all number
    163
    205
    28
    36
    56
    131
    Injection site swelling
         subjects affected / exposed
    28 / 96 (29.17%)
    32 / 93 (34.41%)
    4 / 56 (7.14%)
    9 / 40 (22.50%)
    11 / 41 (26.83%)
    54 / 145 (37.24%)
         occurrences all number
    33
    43
    4
    9
    14
    59
    Malaise
         subjects affected / exposed
    22 / 96 (22.92%)
    31 / 93 (33.33%)
    0 / 56 (0.00%)
    7 / 40 (17.50%)
    17 / 41 (41.46%)
    0 / 145 (0.00%)
         occurrences all number
    31
    54
    0
    10
    22
    0
    Pyrexia
         subjects affected / exposed
    17 / 96 (17.71%)
    7 / 93 (7.53%)
    16 / 56 (28.57%)
    5 / 40 (12.50%)
    2 / 41 (4.88%)
    60 / 145 (41.38%)
         occurrences all number
    20
    9
    20
    5
    2
    85
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    18 / 96 (18.75%)
    16 / 93 (17.20%)
    17 / 56 (30.36%)
    4 / 40 (10.00%)
    5 / 41 (12.20%)
    55 / 145 (37.93%)
         occurrences all number
    30
    21
    23
    4
    6
    84
    Nausea
         subjects affected / exposed
    16 / 96 (16.67%)
    23 / 93 (24.73%)
    0 / 56 (0.00%)
    4 / 40 (10.00%)
    14 / 41 (34.15%)
    0 / 145 (0.00%)
         occurrences all number
    23
    31
    0
    5
    23
    0
    Teething
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    4 / 56 (7.14%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    2 / 145 (1.38%)
         occurrences all number
    0
    0
    6
    0
    0
    2
    Vomiting
         subjects affected / exposed
    9 / 96 (9.38%)
    3 / 93 (3.23%)
    6 / 56 (10.71%)
    5 / 40 (12.50%)
    2 / 41 (4.88%)
    20 / 145 (13.79%)
         occurrences all number
    10
    3
    6
    6
    2
    27
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 96 (0.00%)
    7 / 93 (7.53%)
    0 / 56 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    0 / 145 (0.00%)
         occurrences all number
    0
    8
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 96 (11.46%)
    3 / 93 (3.23%)
    7 / 56 (12.50%)
    6 / 40 (15.00%)
    0 / 41 (0.00%)
    33 / 145 (22.76%)
         occurrences all number
    12
    5
    9
    7
    0
    54
    Oropharyngeal spasm
         subjects affected / exposed
    3 / 96 (3.13%)
    7 / 93 (7.53%)
    0 / 56 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    4 / 145 (2.76%)
         occurrences all number
    4
    7
    0
    1
    0
    4
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    10 / 96 (10.42%)
    17 / 93 (18.28%)
    1 / 56 (1.79%)
    5 / 40 (12.50%)
    7 / 41 (17.07%)
    15 / 145 (10.34%)
         occurrences all number
    13
    23
    1
    8
    10
    18
    Psychiatric disorders
    Eating disorder
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    16 / 56 (28.57%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    52 / 145 (35.86%)
         occurrences all number
    0
    0
    20
    1
    0
    83
    Irritability
         subjects affected / exposed
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    20 / 56 (35.71%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    82 / 145 (56.55%)
         occurrences all number
    0
    0
    30
    0
    0
    154
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 96 (6.25%)
    9 / 93 (9.68%)
    0 / 56 (0.00%)
    2 / 40 (5.00%)
    5 / 41 (12.20%)
    0 / 145 (0.00%)
         occurrences all number
    9
    12
    0
    2
    6
    0
    Myalgia
         subjects affected / exposed
    27 / 96 (28.13%)
    57 / 93 (61.29%)
    0 / 56 (0.00%)
    11 / 40 (27.50%)
    18 / 41 (43.90%)
    0 / 145 (0.00%)
         occurrences all number
    36
    105
    0
    13
    23
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    5 / 56 (8.93%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    11 / 145 (7.59%)
         occurrences all number
    1
    0
    5
    1
    0
    13
    Conjunctivitis
         subjects affected / exposed
    6 / 96 (6.25%)
    1 / 93 (1.08%)
    2 / 56 (3.57%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    12 / 145 (8.28%)
         occurrences all number
    6
    1
    3
    1
    0
    13
    Ear infection
         subjects affected / exposed
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    2 / 56 (3.57%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    20 / 145 (13.79%)
         occurrences all number
    1
    0
    2
    0
    0
    29
    Nasopharyngitis
         subjects affected / exposed
    3 / 96 (3.13%)
    5 / 93 (5.38%)
    4 / 56 (7.14%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
    15 / 145 (10.34%)
         occurrences all number
    3
    6
    4
    0
    2
    16
    Otitis media
         subjects affected / exposed
    14 / 96 (14.58%)
    1 / 93 (1.08%)
    14 / 56 (25.00%)
    5 / 40 (12.50%)
    0 / 41 (0.00%)
    42 / 145 (28.97%)
         occurrences all number
    22
    2
    18
    6
    0
    61
    Respiratory tract infection
         subjects affected / exposed
    3 / 96 (3.13%)
    4 / 93 (4.30%)
    4 / 56 (7.14%)
    2 / 40 (5.00%)
    0 / 41 (0.00%)
    11 / 145 (7.59%)
         occurrences all number
    4
    4
    5
    3
    0
    15
    Rhinitis
         subjects affected / exposed
    10 / 96 (10.42%)
    6 / 93 (6.45%)
    17 / 56 (30.36%)
    6 / 40 (15.00%)
    1 / 41 (2.44%)
    41 / 145 (28.28%)
         occurrences all number
    15
    6
    22
    6
    1
    51
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 96 (8.33%)
    7 / 93 (7.53%)
    11 / 56 (19.64%)
    2 / 40 (5.00%)
    2 / 41 (4.88%)
    26 / 145 (17.93%)
         occurrences all number
    10
    7
    13
    2
    2
    31

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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