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    Clinical Trial Results:
    A Phase IIIB, observer-blind, randomized, parallel groups, extension study to evaluate the immunogenicity and safety following a single intramuscular dose of FLUAD or Agrippal S1 influenza vaccines in healthy children previously vaccinated in the V70P5 study.

    Summary
    EudraCT number
    		 2010-021644-18
    Trial protocol
    		 FI  
    Global end of trial date
    22 Dec 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Jul 2016
    First version publication date
    15 May 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
    V70P5E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01210898
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics SRL
    Sponsor organisation address
    Via Florentina 1, Siena, Italy, 53100
    Public contact
    Anh Phung, Novartis Vaccines and Diagnostics SRL, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Anh Phung, Novartis Vaccines and Diagnostics SRL, RegistryContactVaccinesUS@novartis.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
    21 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To evaluate the immunogenicity of children previously primed with FLUAD® who receive a single IM injection of full dose FLUAD during the extension study. 2. To evaluate the immunogenicity of children previously primed with FLUAD® who receive a single IM injection of half dose FLUAD during the extension study. 3. To evaluate the immunogenicity of children previously primed with FLUAD® who receive a single IM injection of an unadjuvanted influenza vaccine during the extension study.
    Protection of trial subjects
    1. 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. 2. 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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Sep 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 197
    Worldwide total number of subjects
    197
    EEA total number of subjects
    197
    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)
    1
    Children (2-11 years)
    196
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The number of children to be enrolled during this extension study was up to 1970 children who received two doses of at least one of the vaccines in the V70P5 study, but only 197 subjects were enrolled.

    Pre-assignment
    Screening details
    		 All subjects enrolled were included in the trial.

    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
    		 Investigator, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MF59-eTIV_Full
    Arm description
    		 Subjects who received full dose of MF59-eTIV
    Arm type
    		 Experimental

    Investigational medicinal product name
    MF59-eTIV
    Investigational medicinal product code
    Other name
    FLUAD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose of 0.5 mL

    Arm title
    		 MF59-eTIV_Half
    Arm description
    		 Subjects who received half dose of MF59-eTIV
    Arm type
    		 Experimental

    Investigational medicinal product name
    MF59-eTIV
    Investigational medicinal product code
    Other name
    FLUAD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose of 0.25 mL

    Arm title
    		 eTIV_a Full
    Arm description
    		 Subjects who received full dose of eTIV_a
    Arm type
    		 Experimental

    Investigational medicinal product name
    eTIV_a
    Investigational medicinal product code
    Other name
    Agrippal S1
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose of 0.5 mL

    Arm title
    		 eTIV_a _Half
    Arm description
    		 Subjects who received half dose of eTIV_a
    Arm type
    		 Experimental

    Investigational medicinal product name
    eTIV_a
    Investigational medicinal product code
    Other name
    eTIV_a
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intrasternal use
    Dosage and administration details
    Each dose of 0.25 mL

    Number of subjects in period 1
    		MF59-eTIV_Full MF59-eTIV_Half eTIV_a Full eTIV_a _Half
    Started
    60
    75
    51
    11
    Completed
    59
    71
    47
    11
    Not completed
    1
    4
    4
    0
         Consent withdrawn by subject
    -
    2
    2
    -
         Lost to follow-up
    1
    2
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MF59-eTIV_Full
    Reporting group description
    		 Subjects who received full dose of MF59-eTIV

    Reporting group title
    MF59-eTIV_Half
    Reporting group description
    		 Subjects who received half dose of MF59-eTIV

    Reporting group title
    eTIV_a Full
    Reporting group description
    		 Subjects who received full dose of eTIV_a

    Reporting group title
    eTIV_a _Half
    Reporting group description
    		 Subjects who received half dose of eTIV_a

    Reporting group values
    		 MF59-eTIV_Full MF59-eTIV_Half eTIV_a Full eTIV_a _Half Total
    Number of subjects
    		 60 75 51 11 197
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 1 0 0 1
        Children (2-11 years)
    		 60 74 51 11 196
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 68.7 ( 18 ) 60.4 ( 23.2 ) 68 ( 17.1 ) 32.4 ( 1.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 30 40 35 5 110
        Male
    		 30 35 16 6 87

    End points

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    End points reporting groups
    Reporting group title
    MF59-eTIV_Full
    Reporting group description
    		 Subjects who received full dose of MF59-eTIV

    Reporting group title
    MF59-eTIV_Half
    Reporting group description
    		 Subjects who received half dose of MF59-eTIV

    Reporting group title
    eTIV_a Full
    Reporting group description
    		 Subjects who received full dose of eTIV_a

    Reporting group title
    eTIV_a _Half
    Reporting group description
    		 Subjects who received half dose of eTIV_a

    Subject analysis set title
    All Enrolled set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who have signed an informed consent, undergone screening procedure(s) and were randomized.

    Subject analysis set title
    MF59-eTIV_Half _F_(6-<36 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 6-<36 months who received half dose of MF59-eTIV, previously primed with MF59-eTIV in the parent study.

    Subject analysis set title
    eTIV_a _Half _F_(6-<36 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 6-<36 months who received half dose of eTIV_a, previously primed with MF59-eTIV in the parent study.

    Subject analysis set title
    MF59-eTIV_Half _I_(6-<36 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 6 – <36 months who received half dose of MF59-eTIV, previously primed with Influsplit SSW in the parent study.

    Subject analysis set title
    eTIV_a_Half_I_(6-<36 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 6 – <36 months who received half dose of eTIV_a, previously primed with Influsplit SSW in the parent study.

    Subject analysis set title
    MF59-eTIV_Half_M/E_(6-<36 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 6 – <36 months who received half dose of MF59-eTIV, previously primed with Menjugate/Encepur in the parent study.

    Subject analysis set title
    MF59-eTIV_Full_F_(36 -< 96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 36 – <96 months who received full dose of MF59-eTIV, previously primed with MF59-eTIV in the parent study.

    Subject analysis set title
    MF59-eTIV_Half _F_(36 -< 96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 36 – <96 months who received half dose of MF59-eTIV, previously primed with MF59-eTIV in the parent study.

    Subject analysis set title
    eTIV_a_Full _F_(36 -< 96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 36 – <96 months who received full dose of eTIV_a, previously primed with MF59-eTIV in the parent study.

    Subject analysis set title
    MF59-eTIV_Full_I_(36 -< 96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 36 – <96 months who received full dose of MF59-eTIV, previously primed with Influsplit SSW in the parent study.

    Subject analysis set title
    MF59-eTIV_Half_I_(36 -< 96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 36 – <96 months who received half dose of MF59-eTIV, previously primed with Influsplit SSW in the parent study.

    Subject analysis set title
    eTIV_a _Full_I_(36 -< 96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 36 – <96 months who received full dose of eTIV_a, previously primed with Influsplit SSW in the parent study.

    Subject analysis set title
    MF59-eTIV_Full_M/E_(36 -< 96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 36 – <96 months who received full dose of MF59-eTIV, previously primed with Menjugate/Encepur in the parent study.

    Subject analysis set title
    MF59-eTIV_Half_M/E_(36 -< 96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 36 – <96 months who received half dose of MF59-eTIV, previously primed with Menjugate/Encepur in the parent study.

    Subject analysis set title
    Safety Set
    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.

    Subject analysis set title
    MF59-eTIV_F (6 – <96 months )
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 6 – <96 months who received single dose of MF59-eTIV, previously primed with MF59-eTIV.

    Subject analysis set title
    eTIV_a _ F (6 – <96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 6 – <96 months who received single dose of eTIV_a, previously primed with MF59-eTIV.

    Subject analysis set title
    MF59-eTIV_ I (6 – <96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 6 – <96 months who received single dose of MF59-eTIV, previously primed with Influsplit SSW

    Subject analysis set title
    eTIV_a _ I (6 – <96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 6 – <96 months who received single dose of eTIV_a, previously primed with Influsplit SSW

    Subject analysis set title
    MF59-eTIV_ M/E (6 – <96 months)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects aged 6 – <96 months who received single dose of MF59-eTIV, previously primed with Menjugate/Encepur

    Subject analysis set title
    MF59-eTIV_Full_F (6-<36 months)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects aged 6 – <36 months who received full dose of MF59-eTIV, previously primed with MF59-eTIV in the parent study.

    Primary: The geometric mean ratio (GMRs) determined by HI assay at day 22 using CHMP criteria against homologous strains in subjects who received full dose of MF59-eTIV, previously primed with MF59-eTIV.

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    End point title
    		 The geometric mean ratio (GMRs) determined by HI assay at day 22 using CHMP criteria against homologous strains in subjects who received full dose of MF59-eTIV, previously primed with MF59-eTIV. [1]
    End point description
    The immune response was measured as the geometric mean ratio (GMRs) directed against HI homologous strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 in subjects who received full dose of MF59-eTIV, previously primed with MF59-eTIV.
    End point type
    Primary
    End point timeframe
    Day 22
    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: No inferential statistical analysis was done.
    End point values
    		 MF59-eTIV_Full_F_(36 -< 96 months)
    Number of subjects analysed
    22
    Units: Titers
    geometric mean (confidence interval 95%)
        A/H1N1
    25 (16 to 38)
        A/H3N2
    12 (6.39 to 24)
        Strain B
    18 (10 to 30)
    No statistical analyses for this end point

    Primary: The seroconversion (SC) or significant increase (SI) and seroprotection (SP) determined by HI assay at day 22 using CHMP criteria in subjects against homologous strains who received full dose of MF59-eTIV, previously primed with MF59-eTIV.

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    End point title
    		 The seroconversion (SC) or significant increase (SI) and seroprotection (SP) determined by HI assay at day 22 using CHMP criteria in subjects against homologous strains who received full dose of MF59-eTIV, previously primed with MF59-eTIV. [2]
    End point description
    The immune response was measured as the SC or SI (Seroconversion rates defined as: HI ≥ 40 for subjects negative at baseline [< 10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥ 10]) and SP (Seroprotection defined as the percentage of subjects with HI titer ≥ 40) directed against HI homologous strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 in subjects who received full dose of MF59-eTIV, previously primed with MF59-eTIV.
    End point type
    Primary
    End point timeframe
    Day 22
    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: No inferential statistical analysis was done.
    End point values
    		 MF59-eTIV_Full_F_(36 -< 96 months)
    Number of subjects analysed
    22
    Units: Percentages of subjects
    number (confidence interval 95%)
        A/H1N1 (SC or SI)
    100 (85 to 100)
        A/H3N2 (SC or SI)
    77 (55 to 92)
        Strain B (SC or SI)
    86 (65 to 97)
        A/H1N1 (HI titer ≥ 40)
    100 (85 to 100)
        A/H3N2 (HI titer ≥ 40)
    100 (85 to 100)
        Strain B (HI titer ≥ 40)
    100 (85 to 100)
    No statistical analyses for this end point

    Primary: The GMRs determined by HI assay at day 22 using CHMP criteria in subjects against homologous strains who received half dose of MF59-eTIV, previously primed with MF59-eTIV.

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    End point title
    		 The GMRs determined by HI assay at day 22 using CHMP criteria in subjects against homologous strains who received half dose of MF59-eTIV, previously primed with MF59-eTIV. [3]
    End point description
    The immune response was measured as the geometric mean ratio (GMRs) directed against HI homologous strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 in subjects who received half dose of MF59-eTIV, previously primed with MF59-eTIV.
    End point type
    Primary
    End point timeframe
    Day 22
    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: No inferential statistical analysis was done.
    End point values
    		 MF59-eTIV_Half _F_(6-<36 months) MF59-eTIV_Half _F_(36 -< 96 months)
    Number of subjects analysed
    8
    18
    Units: Titers
    geometric mean (confidence interval 95%)
        A/H1N1
    9.93 (3.53 to 28)
    18 (12 to 29)
        A/H3N2
    25 (12 to 49)
    13 (6.32 to 28)
        Strain B
    11 (6.1 to 21)
    14 (7.54 to 25)
    No statistical analyses for this end point

    Primary: The SC or SI and SP determined by HI assay at day 22 using CHMP criteria in subjects against homologous strains who received half dose of MF59-eTIV, previously primed with MF59-eTIV.

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    End point title
    		 The SC or SI and SP determined by HI assay at day 22 using CHMP criteria in subjects against homologous strains who received half dose of MF59-eTIV, previously primed with MF59-eTIV. [4]
    End point description
    The immune response was measured as the Seroconversion or Significant Increase (Seroconversion rates defined as: HI ≥ 40 for subjects negative at baseline [< 10]) and Seroprotection (Seroprotection defined as the percentage of subjects with HI titer ≥ 40) directed against HI homologous strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 in subjects who received half dose of MF59-eTIV, previously primed with MF59-eTIV.
    End point type
    Primary
    End point timeframe
    Day 22
    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: No inferential statistical analysis was done.
    End point values
    		 MF59-eTIV_Half _F_(6-<36 months) MF59-eTIV_Half _F_(36 -< 96 months)
    Number of subjects analysed
    8
    18
    Units: Percentages of subjects
    number (confidence interval 95%)
        A/H1N1 (SC or SI)
    75 (35 to 97)
    94 (73 to 100)
        A/H3N2 (SC or SI)
    100 (63 to 100)
    72 (47 to 90)
        Strain B (SC or SI)
    88 (47 to 100)
    78 (52 to 94)
        A/H1N1 (HI titer ≥ 40)
    75 (37 to 97)
    100 (81 to 100)
        A/H3N2 (HI titer ≥ 40)
    100 (63 to 100)
    100 (81 to 100)
        Strain B (HI titer ≥ 40)
    88 (47 to 100)
    83 (59 to 96)
    No statistical analyses for this end point

    Primary: The GMRs determined by HI assay at day 22 using CHMP criteria in subjects against homologous strains who received single dose of eTIV_a, previously primed with MF59-eTIV.

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    End point title
    		 The GMRs determined by HI assay at day 22 using CHMP criteria in subjects against homologous strains who received single dose of eTIV_a, previously primed with MF59-eTIV. [5]
    End point description
    The immune response was measured as the geometric mean ratio (GMRs) directed against HI homologous strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 in subjects who received single dose of eTIV_a, previously primed with MF59-eTIV.
    End point type
    Primary
    End point timeframe
    Day 22
    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: No inferential statistical analysis was done.
    End point values
    		 eTIV_a _Half _F_(6-<36 months) eTIV_a_Full _F_(36 -< 96 months)
    Number of subjects analysed
    7
    23
    Units: Titers
    geometric mean (confidence interval 95%)
        A/H1N1
    24 (7.87 to 72)
    8.89 (5.92 to 13)
        A/H3N2
    22 (10 to 45)
    5.41 (2.82 to 10)
        Strain B
    5.94 (3.07 to 12)
    12 (7.18 to 21)
    No statistical analyses for this end point

    Primary: The SC or SI and SP determined by HI assay at day 22 using CHMP criteria in subjects against homologous strains who received single dose of eTIV_a, previously primed with MF59-eTIV.

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    End point title
    		 The SC or SI and SP determined by HI assay at day 22 using CHMP criteria in subjects against homologous strains who received single dose of eTIV_a, previously primed with MF59-eTIV. [6]
    End point description
    The immune response was measured as the Seroconversion or Significant Increase (Seroconversion rates defined as: HI ≥ 40 for subjects negative at baseline [< 10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥ 10]) and Seroprotection (Seroprotection defined as the percentage of subjects with HI titer ≥ 40) directed against HI homologous strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 in subjects who received a single dose of eTIV_a, previously primed with MF59-eTIV.
    End point type
    Primary
    End point timeframe
    Day 22
    Notes
    [6] - 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: No inferential statistical analysis was done.
    End point values
    		 eTIV_a _Half _F_(6-<36 months) eTIV_a_Full _F_(36 -< 96 months)
    Number of subjects analysed
    7
    23
    Units: Percentages of subjects
    number (confidence interval 95%)
        A/H1N1 (SC or SI)
    86 (42 to 100)
    87 (66 to 97)
        A/H3N2 (SC or SI)
    100 (59 to 100)
    52 (31 to 73)
        Strain B (SC or SI)
    88 (59 to 100)
    74 (52 to 90)
        A/H1N1 (HI titer ≥ 40)
    100 (59 to 100)
    96 (78 to 100)
        A/H3N2 (HI titer ≥ 40)
    100 (59 to 100)
    100 (85 to 100)
        Strain B (HI titer ≥ 40)
    100 (59 to 100)
    83 (61 to 95)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with SC/SI and SP using CBER criteria after receiving full dose of MF59-eTIV, against homologous strains in subjects previously primed with MF59-eTIV.

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    End point title
    		 Percentages of subjects with SC/SI and SP using CBER criteria after receiving full dose of MF59-eTIV, against homologous strains in subjects previously primed with MF59-eTIV.
    End point description
    The immune response was measured as percentage of subjects with Seroconversion/significant increase and Seroprotection using CBER criteria (CBER criterion for seroconversion = the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody ≥40%, CBER criterion = the lower limit of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥40 is ≥70%) at day 22 directed against HI homologous strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 in subjects received full dose of MF59-eTIV, previously primed with MF59-eTIV.
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 MF59-eTIV_Full_F_(36 -< 96 months)
    Number of subjects analysed
    22
    Units: Percentages of subjects
    number (confidence interval 95%)
        A/H1N1 (SC or SI)
    100 (85 to 100)
        A/H3N2 (SC or SI)
    77 (55 to 92)
        Strain B (SC or SI)
    86 (65 to 97)
        A/H1N1 (HI titer ≥ 40)
    100 (85 to 100)
        A/H3N2 (HI titer ≥ 40)
    100 (85 to 100)
        Strain B (HI titer ≥ 40)
    100 (85 to 100)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with SC/SI and SP using CBER criteria after receiving half dose of MF59-eTIV, against homologous strains in subjects previously primed with MF59-eTIV.

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    End point title
    		 Percentages of subjects with SC/SI and SP using CBER criteria after receiving half dose of MF59-eTIV, against homologous strains in subjects previously primed with MF59-eTIV.
    End point description
    The immune response was measured as percentage of subjects with Seroconversion or Significant Increase (Seroconversion rates defined as: HI ≥ 40 for subjects negative at baseline [< 10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥ 10]) and Seroprotection (Seroprotection defined as the percentage of subjects with HI titer ≥ 40) using CBER criteria at day 22 directed against HI homologous strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 in subjects received half dose of MF59-eTIV, previously primed with MF59-eTIV.
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 MF59-eTIV_Half _F_(6-<36 months) MF59-eTIV_Half _F_(36 -< 96 months)
    Number of subjects analysed
    8
    18
    Units: Percentages of subjects
    number (confidence interval 95%)
        A/H1N1 (SC or SI)
    75 (35 to 97)
    94 (73 to 100)
        A/H3N2 (SC or SI)
    100 (63 to 100)
    72 (47 to 90)
        Strain B (SC or SI)
    88 (47 to 100)
    78 (52 to 94)
        A/H1N1 (HI titer ≥ 40)
    75 (35 to 97)
    100 (81 to 100)
        A/H3N2 (HI titer ≥ 40)
    100 (63 to 100)
    100 (81 to 100)
        Strain B (HI titer ≥ 40)
    88 (47 to 100)
    83 (59 to 96)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with SC/SI and SP using CBER criteria after receiving single dose of eTIV_a, against homologous strains in subjects previously primed with MF59-eTIV.

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    End point title
    		 Percentages of subjects with SC/SI and SP using CBER criteria after receiving single dose of eTIV_a, against homologous strains in subjects previously primed with MF59-eTIV.
    End point description
    The immune response was measured as percentage of subjects with Seroconversion or Significant Increase (Seroconversion rates defined as: HI ≥ 40 for subjects negative at baseline [< 10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥ 10]) and Seroprotection (Seroprotection defined as the percentage of subjects with HI titer ≥ 40) using CBER criteria at day 22 directed against HI homologous Strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 in subjects’ received single dose of eTIV_a, previously primed with MF59-eTIV.
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 eTIV_a _Half _F_(6-<36 months) eTIV_a_Full _F_(36 -< 96 months)
    Number of subjects analysed
    7
    23
    Units: Percentages of subjects
    number (confidence interval 95%)
        A/H1N1 (SC or SI)
    86 (42 to 100)
    87 (66 to 97)
        A/H3N2 (SC or SI)
    100 (59 to 100)
    52 (31 to 73)
        Strain B (SC or SI)
    100 (59 to 100)
    74 (52 to 90)
        A/H1N1 (HI titer ≥ 40)
    100 (59 to 100)
    96 (78 to 100)
        A/H3N2 (HI titer ≥ 40)
    100 (59 to 100)
    100 (85 to 100)
        Strain B (HI titer ≥ 40)
    100 (59 to 100)
    83 (61 to 95)
    No statistical analyses for this end point

    Secondary: The GMTs determined by HI assay and compared at day 22 in subjects who received single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur

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    End point title
    		 The GMTs determined by HI assay and compared at day 22 in subjects who received single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point description
    The immune response was measured as the geometric mean titers (GMTs) directed against HI homologous Strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 and compared in subjects who received single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 MF59-eTIV_Half _F_(6-<36 months) eTIV_a _Half _F_(6-<36 months) MF59-eTIV_Half _I_(6-<36 months) eTIV_a_Half_I_(6-<36 months) MF59-eTIV_Half_M/E_(6-<36 months) MF59-eTIV_Full_F_(36 -< 96 months) MF59-eTIV_Half _F_(36 -< 96 months) eTIV_a_Full _F_(36 -< 96 months) MF59-eTIV_Full_I_(36 -< 96 months) MF59-eTIV_Half_I_(36 -< 96 months) eTIV_a _Full_I_(36 -< 96 months) MF59-eTIV_Full_M/E_(36 -< 96 months) MF59-eTIV_Half_M/E_(36 -< 96 months)
    Number of subjects analysed
    8
    7
    7
    3
    2
    22
    18
    23
    22
    28
    28
    14
    11
    Units: Titers
    number (confidence interval 95%)
        A/H1N1
    515 (134 to 1986)
    552 (130 to 2334)
    1723 (984 to 3017)
    1016 (432 to 2391)
    1522 (2.06 to 1125772)
    1093 (672 to 1779)
    1776 (1037 to 3042)
    488 (303 to 785)
    1498 (962 to 2333)
    1249 (843 to 1849)
    707 (477 to 1046)
    2377 (1411 to 4005)
    1164 (646 to 2098)
        A/H3N2
    1174 (574 to 2400)
    1159 (540 to 2491)
    305 (118 to 789)
    63 (15 to 272)
    320 (-9999 to 9999)
    2021 (1469 to 2781)
    1993 (1401 to 2836)
    680 (498 to 929)
    934 (572 to 1525)
    780 (505 to 1205)
    308 (200 to 476)
    2152 (1252 to 3702)
    1452 (788 to 2676)
        Strain B
    113 (51 to 253)
    160 (68 to 378)
    10 (5.09 to 20)
    20 (7.13 to 56)
    20 (20 to 20)
    150 (96 to 235)
    109 (66 to 178)
    99 (64 to 153)
    72 (41 to 124)
    45 (28 to 74)
    26 (16 to 43)
    54 (21 to 138)
    43 (15 to 123)
    No statistical analyses for this end point

    Secondary: The GMRs determined by HI assay and compared at day 22 in subjects who received single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur

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    End point title
    		 The GMRs determined by HI assay and compared at day 22 in subjects who received single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point description
    The immune response was measured as the geometric mean ratios (GMRs) directed against HI homologous Strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 and compared in subjects who received single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 MF59-eTIV_Half _F_(6-<36 months) eTIV_a _Half _F_(6-<36 months) MF59-eTIV_Half _I_(6-<36 months) eTIV_a_Half_I_(6-<36 months) MF59-eTIV_Half_M/E_(6-<36 months) MF59-eTIV_Full_F_(36 -< 96 months) MF59-eTIV_Half _F_(36 -< 96 months) eTIV_a_Full _F_(36 -< 96 months) MF59-eTIV_Full_I_(36 -< 96 months) MF59-eTIV_Half_I_(36 -< 96 months) eTIV_a _Full_I_(36 -< 96 months) MF59-eTIV_Full_M/E_(36 -< 96 months) MF59-eTIV_Half_M/E_(36 -< 96 months)
    Number of subjects analysed
    8
    7
    7
    3
    2
    22
    18
    23
    22
    28
    28
    14
    11
    Units: Titers
    geometric mean (confidence interval 95%)
        A/H1N1
    9.93 (3.53 to 28)
    24 (7.87 to 72)
    32 (14 to 74)
    32 (8.86 to 116)
    19 (2.11 to 172)
    25 (16 to 38)
    18 (12 to 29)
    8.89 (5.92 to 13)
    32 (17 to 58)
    21 (12 to 36)
    13 (7.32 to 22)
    24 (13 to 45)
    35 (17 to 72)
        A/H3N2
    25 (12 to 49)
    22 (10 to 45)
    20 (8.72 to 48)
    10 (2.73 to 37)
    2.83 (-9999 to 9999)
    12 (6.39 to 24)
    13 (6.32 to 28)
    5.41 (2.82 to 10)
    17 (9.51 to 31)
    15 (9.08 to 26)
    10 (6.11 to 17)
    17 (9.83 to 29)
    12 (6.79 to 23)
        Strain B
    11 (6.1 to 21)
    5.94 (3.07 to 12)
    2 (1.02 to 3.93)
    4 (1.43 to 11)
    4 (4 to 4)
    18 (10 to 30)
    14 (7.54 to 25)
    12 (7.18 to 21)
    9.51 (6.19 to 15)
    6.9 (4.71 to 10)
    4.2 (2.87 to 6.16)
    9.28 (4.44 to 19)
    5.15 (2.24 to 12)
    No statistical analyses for this end point

    Secondary: The SC or SI and SP determined by HI assay at day 22 and compared in subjects who received single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur

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    End point title
    		 The SC or SI and SP determined by HI assay at day 22 and compared in subjects who received single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point description
    The immune response was measured as the Seroconversion or Significant Increase (Seroconversion rates defined as: HI ≥ 40 for subjects negative at baseline [< 10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥ 10]) and Seroprotection (Seroprotection defined as the percentage of subjects with HI titer ≥ 40) directed against HI homologous Strains A/California/2009 (A/H1N1), A/Perth/2009 (A/H3N2) and B/Brisbane/2008 in subjects who received a single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 MF59-eTIV_Half _F_(6-<36 months) eTIV_a _Half _F_(6-<36 months) MF59-eTIV_Half _I_(6-<36 months) eTIV_a_Half_I_(6-<36 months) MF59-eTIV_Half_M/E_(6-<36 months) MF59-eTIV_Full_F_(36 -< 96 months) MF59-eTIV_Half _F_(36 -< 96 months) eTIV_a_Full _F_(36 -< 96 months) MF59-eTIV_Full_I_(36 -< 96 months) MF59-eTIV_Half_I_(36 -< 96 months) eTIV_a _Full_I_(36 -< 96 months) MF59-eTIV_Full_M/E_(36 -< 96 months) MF59-eTIV_Half_M/E_(36 -< 96 months)
    Number of subjects analysed
    8
    7
    7
    3
    2
    22
    18
    23
    22
    28
    28
    14
    11
    Units: Percentage of subjects
    number (confidence interval 95%)
        A/H1N1 (SC or SI)
    75 (35 to 97)
    86 (42 to 100)
    100 (59 to 100)
    100 (29 to 100)
    100 (16 to 100)
    100 (85 to 100)
    94 (73 to 100)
    87 (66 to 97)
    100 (85 to 100)
    96 (82 to 100)
    86 (67 to 96)
    100 (77 to 100)
    100 (72 to 100)
        A/H3N2 (SC or SI)
    100 (63 to 100)
    100 (59 to 100)
    100 (59 to 100)
    100 (29 to 100)
    50 (1 to 99)
    77 (55 to 92)
    72 (47 to 90)
    52 (31 to 73)
    86 (65 to 97)
    82 (63 to 94)
    82 (63 to 94)
    100 (77 to 100)
    100 (72 to 100)
        Strain B (SC or SI)
    88 (47 to 100)
    100 (59 to 100)
    14 (0 to 58)
    33 (1 to 91)
    0 (0 to 84)
    86 (65 to 97)
    78 (52 to 94)
    74 (52 to 90)
    59 (36 to 79)
    57 (37 to 76)
    39 (22 to 59)
    64 (35 to 87)
    27 (6 to 61)
        A/H1N1(HI titer≥40)
    75 (35 to 97)
    100 (59 to 100)
    100 (59 to 100)
    100 (29 to 100)
    100 (16 to 100)
    100 (85 to 100)
    100 (81 to 100)
    96 (78 to 100)
    100 (85 to 100)
    100 (88 to 100)
    100 (88 to 100)
    100 (77 to 100)
    100 (72 to 100)
        A/H3N2 (HI titer≥40)
    100 (63 to 100)
    100 (59 to 100)
    100 (59 to 100)
    100 (29 to 100)
    100 (16 to 100)
    100 (85 to 100)
    100 (81 to 100)
    100 (85 to 100)
    100 (85 to 100)
    100 (88 to 100)
    100 (88 to 100)
    100 (77 to 100)
    100 (72 to 100)
        Strain B (HI titer ≥40)
    88 (47 to 100)
    100 (59 to 100)
    14 (0 to 58)
    33 (1 to 91)
    0 (0 to 84)
    100 (85 to 100)
    83 (59 to 96)
    83 (61 to 95)
    64 (41 to 83)
    57 (37 to 76)
    43 (24 to 63)
    64 (35 to 87)
    36 (11 to 69)
    No statistical analyses for this end point

    Secondary: The GMTs determined by HI assay and compared at day 22 in subjects who received single dose of MF59-eTIV/eTIV_a against heterologous strains previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur

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    End point title
    		 The GMTs determined by HI assay and compared at day 22 in subjects who received single dose of MF59-eTIV/eTIV_a against heterologous strains previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point description
    The immune response was measured as the geometric mean titers (GMTs) directed against HI heterologous Strains A/Brisbane/59/2007 (A/H1N1)/ A/Brisbane/10/2007 (A/H3N2)/ B/Malaysia/2506/2004/ B/Florida/2006 and compared in subjects who received single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 MF59-eTIV_F (6 – <96 months ) eTIV_a _ F (6 – <96 months) MF59-eTIV_ I (6 – <96 months) eTIV_a _ I (6 – <96 months) MF59-eTIV_ M/E (6 – <96 months)
    Number of subjects analysed
    48
    30
    57
    31
    27
    Units: Titers
    geometric mean (confidence interval 95%)
        A/Brisbane/59/2007(A/H1N1)/
    199 (152 to 259)
    214 (152 to 299)
    58 (37 to 90)
    59 (32 to 108)
    40 (22 to 72)
        A/Brisbane/10/2007(A/H3N2)/
    2017 (1607 to 2532)
    895 (671 to 1193)
    701 (506 to 971)
    239 (154 to 372)
    1170 (609 to 2247)
        B/Malaysia/2506/2004
    52 (40 to 67)
    40 (29 to 56)
    21 (16 to 28)
    13 (8.8 to 19)
    17 (9.78 to 29)
        B/Florida/2006
    271 (205 to 359)
    178 (125 to 253)
    64 (49 to 84)
    54 (38 to 78)
    25 (16 to 38)
    No statistical analyses for this end point

    Secondary: The GMRs determined by HI assay and compared at day 22 in subjects who received single dose of MF59-eTIV/eTIV_a, against heterologous strains previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur

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    End point title
    		 The GMRs determined by HI assay and compared at day 22 in subjects who received single dose of MF59-eTIV/eTIV_a, against heterologous strains previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point description
    The immune response was measured as the geometric mean ratios (GMRs) directed against HI heterologous Strains A/Brisbane/59/2007 (A/H1N1)/ A/Brisbane/10/2007 (A/H3N2)/ B/Malaysia/2506/2004/ B/Florida/2006 and compared in subjects who received single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 MF59-eTIV_F (6 – <96 months ) eTIV_a _ F (6 – <96 months) MF59-eTIV_ I (6 – <96 months) eTIV_a _ I (6 – <96 months) MF59-eTIV_ M/E (6 – <96 months)
    Number of subjects analysed
    48
    30
    57
    31
    27
    Units: Titers
    geometric mean (confidence interval 95%)
        A/Brisbane/59/2007(A/H1N1)/
    1.94 (1.63 to 2.31)
    1.29 (1.03 to 1.61)
    1.91 (1.63 to 2.23)
    1.48 (1.2 to 1.83)
    2.05 (1.57 to 2.68)
        A/Brisbane/10/2007(A/H3N2)/
    8.98 (6.17 to 13)
    5.16 (3.21 to 8.28)
    11 (7.66 to 14)
    7.32 (4.76 to 11)
    8.98 (6.24 to 13)
        B/Malaysia/2506/2004
    7.07 (5.57 to 8.98)
    6.13 (4.54 to 8.3)
    3.44 (2.64 to 4.48)
    2.53 (1.77 to 3.62)
    3.02 (1.83 to 4.97)
        B/Florida/2006
    9.04 (6.01 to 14)
    4.87 (2.9 to 8.17)
    3.9 (3 to 5.08)
    2.7 (1.89 to 3.87)
    3.06 (2.09 to 4.47)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with SC/SI and SP after receiving single dose of MF59-eTIV/eTIV_a, against heterologous strains previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur.

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    End point title
    		 Percentages of subjects with SC/SI and SP after receiving single dose of MF59-eTIV/eTIV_a, against heterologous strains previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur.
    End point description
    The immune response was measured as percentage of subjects with seroconversion/significant increase (Seroconversion rates defined as: HI ≥ 40 for subjects negative at baseline [< 10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥ 10]) and Seroprotection (Seroprotection defined as the percentage of subjects with HI titer ≥ 40) at day 22 directed against HI heterologous Strains A/Brisbane/59/2007 (A/H1N1)/ A/Brisbane/10/2007 (A/H3N2)/ B/Malaysia/2506/2004/ B/Florida/2006 in subjects’ received single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point type
    Secondary
    End point timeframe
    Day 22
    End point values
    		 MF59-eTIV_F (6 – <96 months ) eTIV_a _ F (6 – <96 months) MF59-eTIV_ I (6 – <96 months) eTIV_a _ I (6 – <96 months) MF59-eTIV_ M/E (6 – <96 months)
    Number of subjects analysed
    48
    30
    57
    31
    27
    Units: Percentages of subjects
    geometric mean (confidence interval 95%)
        A/Brisbane/59/2007(A/H1N1)/ (SC or SI)
    25 (14 to 40)
    3 (0.084 to 17)
    16 (7 to 28)
    10 (2 to 26)
    11 (2 to 29)
        A/Brisbane/10/2007(A/H3N2)/ (SC or SI)
    71 (56 to 83)
    57 (37 to 75)
    82 (70 to 91)
    74 (55 to 88)
    93 (76 to 99)
        B/Malaysia/2506/2004 (SC or SI)
    77 (63 to 88)
    63 (44 to 80)
    37 (24 to 51)
    13 (4 to 30)
    19 (6 to 38)
        B/Florida/2006 (SC or SI)
    73 (58 to 85)
    47 (28 to 66)
    53 (39 to 66)
    42 (25 to 61)
    30 (14 to 50)
        A/Brisbane/59/2007(A/H1N1)/ (HI titer≥40)
    100 (93 to 100)
    100 (88 to 100)
    63 (49 to 76)
    61 (42 to 78)
    48 (29 to 68)
        A/Brisbane/10/2007(A/H3N2)/ (HI titer≥40)
    100 (93 to 100)
    100 (88 to 100)
    100 (94 to 100)
    94 (79 to 99)
    96 (81 to 100)
        B/Malaysia/2506/2004(HI titer≥40)
    79 (65 to 90)
    67 (47 to 83)
    39 (26 to 52)
    13 (4 to 30)
    19 (6 to 38)
        B/Florida/2006(HI titer≥40)
    100 (93 to 100)
    100 (88 to 100)
    81 (68 to 90)
    74 (55 to 88)
    37 (19 to 58)
    No statistical analyses for this end point

    Secondary: Number of children reporting solicited local and systemic adverse events after receiving single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur

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    End point title
    		 Number of children reporting solicited local and systemic adverse events after receiving single dose of MF59-eTIV/eTIV_a, previously primed with MF59-eTIV/ Influsplit SSW/ Menjugate/Encepur
    End point description
    The safety and tolerability of the single dose of MF59-eTIV/eTIV_a vaccine in children (6-<96 months age) 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-eTIV_Half _F_(6-<36 months) eTIV_a _Half _F_(6-<36 months) MF59-eTIV_Half _I_(6-<36 months) eTIV_a_Half_I_(6-<36 months) MF59-eTIV_Half_M/E_(6-<36 months) MF59-eTIV_Full_F_(36 -< 96 months) MF59-eTIV_Half _F_(36 -< 96 months) eTIV_a_Full _F_(36 -< 96 months) MF59-eTIV_Full_I_(36 -< 96 months) MF59-eTIV_Half_I_(36 -< 96 months) eTIV_a _Full_I_(36 -< 96 months) MF59-eTIV_Full_M/E_(36 -< 96 months) MF59-eTIV_Half_M/E_(36 -< 96 months) MF59-eTIV_Full_F (6-<36 months)
    Number of subjects analysed
    9
    7
    7
    3
    2
    22
    18
    23
    22
    28
    28
    16
    11
    1
    Units: Number of subjects
        Any
    9
    7
    7
    1
    2
    21
    17
    21
    20
    26
    24
    15
    9
    1
        Any local
    9
    5
    5
    1
    2
    20
    16
    21
    19
    25
    21
    15
    6
    1
        Injection site Ecchymosis
    0
    0
    1
    0
    0
    2
    1
    1
    1
    3
    2
    3
    2
    0
        Injection site Erythema
    3
    3
    4
    0
    1
    14
    10
    13
    9
    13
    15
    8
    5
    0
        Injection site Induration
    4
    2
    3
    0
    0
    8
    7
    7
    3
    4
    8
    4
    1
    1
        Injection site Swelling
    1
    3
    2
    0
    0
    10
    9
    7
    4
    2
    6
    3
    1
    0
        Tenderness
    8
    4
    3
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
        Injection site pain
    0
    0
    0
    0
    0
    19
    14
    17
    19
    23
    20
    15
    6
    0
        Any Systemic
    6
    5
    5
    0
    1
    16
    13
    9
    11
    10
    15
    9
    7
    0
        Change in eating habits
    3
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Sleepiness
    3
    2
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Unusual Crying
    5
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Irritability
    4
    3
    3
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Vomiting
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Diarrhea
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Chills/Shivering
    1
    1
    0
    0
    0
    4
    3
    2
    3
    2
    1
    3
    2
    0
        Malaise
    0
    0
    0
    0
    0
    8
    2
    1
    3
    3
    1
    4
    4
    0
        Myalgia
    0
    0
    0
    0
    0
    10
    3
    4
    2
    6
    6
    3
    1
    0
        Arthralagia
    0
    0
    0
    0
    0
    5
    0
    3
    2
    2
    1
    1
    1
    0
        Headache
    0
    0
    0
    0
    0
    8
    2
    3
    4
    2
    4
    4
    2
    0
        Fatigue
    0
    0
    0
    0
    0
    11
    9
    8
    9
    5
    7
    8
    3
    0
        Fever (≥ 37.3 °C)
    1
    1
    0
    0
    0
    6
    1
    0
    5
    1
    4
    2
    1
    0
        Any Other
    5
    4
    1
    0
    2
    9
    6
    5
    9
    5
    7
    6
    3
    0
        Temp. (°C) (< 37.2°C)
    0
    0
    0
    0
    0
    16
    17
    23
    17
    27
    24
    13
    10
    0
        Analg. Antipyr. Med.
    2
    2
    0
    0
    0
    7
    3
    3
    6
    4
    2
    2
    3
    0
    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
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    MF59-eTIV_Half _F_(6-<36 months)
    Reporting group description
    		 Subjects aged 6-<36 months who received half dose of MF59-eTIV, previously primed with MF59-eTIV in the parent study.

    Reporting group title
    eTIV_a _Half _F_(6-<36 months)
    Reporting group description
    		 Subjects aged 6 – <36 months who received half dose of eTIV_a, previously primed with MF59-eTIV in the parent study.

    Reporting group title
    eTIV_a_Half_I_(6-<36 months)
    Reporting group description
    		 Subjects aged 6 – <36 months who received half dose of eTIV_a, previously primed with Influsplit SSW in the parent study.

    Reporting group title
    MF59-eTIV_Half _I_(6-<36 months)
    Reporting group description
    		 Subjects aged 6-<36 months who received half dose of MF59-eTIV, previously primed with Influsplit SSW in the parent study.

    Reporting group title
    MF59-eTIV_Full_F_(36 -< 96 months)
    Reporting group description
    		 Subjects aged 36 – <96 months who received full dose of MF59-eTIV, previously primed with MF59-eTIV in the parent study.

    Reporting group title
    MF59-eTIV_Half_M/E_(6-<36 months)
    Reporting group description
    		 Subjects aged 6 – <36 months who received half dose of MF59-eTIV, previously primed with Menjugate/Encepur in the parent study.

    Reporting group title
    MF59-eTIV_Half _F_(36 -< 96 months)
    Reporting group description
    		 Subjects aged 36 – <96 months who received half dose of MF59-eTIV, previously primed with MF59-eTIV in the parent study.

    Reporting group title
    eTIV_a_Full _F_(36 -< 96 months)
    Reporting group description
    		 Subjects aged 36 – <96 months who received full dose of eTIV_a, previously primed with MF59-eTIV in the parent study.

    Reporting group title
    MF59-eTIV_Full_I_(36 -< 96 months)
    Reporting group description
    		 Subjects aged 36 – <96 months who received full dose of MF59-eTIV, previously primed with Influsplit SSW in the parent study.

    Reporting group title
    MF59-eTIV_Half_I_(36 -< 96 months)
    Reporting group description
    		 Subjects aged 36 – <96 months who received half dose of MF59-eTIV, previously primed with Influsplit SSW in the parent study.

    Reporting group title
    MF59-eTIV_Full_F_(6-<36 months)
    Reporting group description
    		 Subjects aged 6-<36 months who received full dose of MF59-eTIV, previously primed with MF59-eTIV in the parent study.

    Reporting group title
    eTIV_a _Full_I_(36 -< 96 months)
    Reporting group description
    		 Subjects aged 36 – <96 months who received full dose of eTIV_a, previously primed with Influsplit SSW in the parent study.

    Reporting group title
    MF59-eTIV_Full_M/E_(36 -< 96 months)
    Reporting group description
    		 Subjects aged 36 – <96 months who received full dose of MF59-eTIV, previously primed with Menjugate/Encepur in the parent study.

    Reporting group title
    MF59-eTIV_Half_M/E_(36 -< 96 months)
    Reporting group description
    		 Subjects aged 36 – <96 months who received half dose of MF59-eTIV, previously primed with Menjugate/Encepur in the parent study.

    Serious adverse events
    		 MF59-eTIV_Half _F_(6-<36 months) eTIV_a _Half _F_(6-<36 months) eTIV_a_Half_I_(6-<36 months) MF59-eTIV_Half _I_(6-<36 months) MF59-eTIV_Full_F_(36 -< 96 months) MF59-eTIV_Half_M/E_(6-<36 months) MF59-eTIV_Half _F_(36 -< 96 months) eTIV_a_Full _F_(36 -< 96 months) MF59-eTIV_Full_I_(36 -< 96 months) MF59-eTIV_Half_I_(36 -< 96 months) MF59-eTIV_Full_F_(6-<36 months) eTIV_a _Full_I_(36 -< 96 months) MF59-eTIV_Full_M/E_(36 -< 96 months) MF59-eTIV_Half_M/E_(36 -< 96 months)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 16 (6.25%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Snake bite
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 16 (6.25%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    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-eTIV_Half _F_(6-<36 months) eTIV_a _Half _F_(6-<36 months) eTIV_a_Half_I_(6-<36 months) MF59-eTIV_Half _I_(6-<36 months) MF59-eTIV_Full_F_(36 -< 96 months) MF59-eTIV_Half_M/E_(6-<36 months) MF59-eTIV_Half _F_(36 -< 96 months) eTIV_a_Full _F_(36 -< 96 months) MF59-eTIV_Full_I_(36 -< 96 months) MF59-eTIV_Half_I_(36 -< 96 months) MF59-eTIV_Full_F_(6-<36 months) eTIV_a _Full_I_(36 -< 96 months) MF59-eTIV_Full_M/E_(36 -< 96 months) MF59-eTIV_Half_M/E_(36 -< 96 months)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    7 / 7 (100.00%)
    2 / 3 (66.67%)
    7 / 7 (100.00%)
    21 / 22 (95.45%)
    2 / 2 (100.00%)
    17 / 18 (94.44%)
    22 / 23 (95.65%)
    21 / 22 (95.45%)
    27 / 28 (96.43%)
    1 / 1 (100.00%)
    27 / 28 (96.43%)
    16 / 16 (100.00%)
    10 / 11 (90.91%)
    Investigations
    Influenza B virus test positive
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    1 / 2 (50.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Foreign body
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Humerus fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 16 (6.25%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Ligament sprain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 16 (6.25%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Wound
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Surgical and medical procedures
    Tonsillectomy
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    8 / 22 (36.36%)
    0 / 2 (0.00%)
    2 / 18 (11.11%)
    3 / 23 (13.04%)
    5 / 22 (22.73%)
    3 / 28 (10.71%)
    0 / 1 (0.00%)
    5 / 28 (17.86%)
    4 / 16 (25.00%)
    3 / 11 (27.27%)
         occurrences all number
    0
    0
    0
    0
    11
    0
    2
    3
    5
    5
    0
    5
    4
    4
    Migraine
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    3 / 9 (33.33%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    0 / 22 (0.00%)
    1 / 2 (50.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    4
    2
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    4 / 22 (18.18%)
    0 / 2 (0.00%)
    3 / 18 (16.67%)
    2 / 23 (8.70%)
    3 / 22 (13.64%)
    2 / 28 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
    3 / 16 (18.75%)
    2 / 11 (18.18%)
         occurrences all number
    1
    1
    0
    0
    4
    0
    3
    2
    3
    2
    0
    1
    4
    2
    Crying
         subjects affected / exposed
    5 / 9 (55.56%)
    3 / 7 (42.86%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    5
    3
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    11 / 22 (50.00%)
    0 / 2 (0.00%)
    9 / 18 (50.00%)
    8 / 23 (34.78%)
    9 / 22 (40.91%)
    5 / 28 (17.86%)
    0 / 1 (0.00%)
    7 / 28 (25.00%)
    8 / 16 (50.00%)
    3 / 11 (27.27%)
         occurrences all number
    0
    0
    0
    0
    12
    0
    11
    10
    10
    10
    0
    7
    12
    4
    Injection site erythema
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 7 (42.86%)
    0 / 3 (0.00%)
    4 / 7 (57.14%)
    14 / 22 (63.64%)
    1 / 2 (50.00%)
    10 / 18 (55.56%)
    13 / 23 (56.52%)
    9 / 22 (40.91%)
    13 / 28 (46.43%)
    0 / 1 (0.00%)
    15 / 28 (53.57%)
    8 / 16 (50.00%)
    5 / 11 (45.45%)
         occurrences all number
    3
    3
    0
    4
    14
    1
    10
    14
    10
    13
    0
    16
    11
    5
    Injection site haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    2 / 22 (9.09%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    1 / 23 (4.35%)
    1 / 22 (4.55%)
    3 / 28 (10.71%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
    3 / 16 (18.75%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    1
    1
    1
    4
    0
    2
    3
    2
    Injection site induration
         subjects affected / exposed
    4 / 9 (44.44%)
    2 / 7 (28.57%)
    0 / 3 (0.00%)
    3 / 7 (42.86%)
    8 / 22 (36.36%)
    0 / 2 (0.00%)
    7 / 18 (38.89%)
    7 / 23 (30.43%)
    3 / 22 (13.64%)
    4 / 28 (14.29%)
    1 / 1 (100.00%)
    8 / 28 (28.57%)
    4 / 16 (25.00%)
    1 / 11 (9.09%)
         occurrences all number
    4
    2
    0
    3
    9
    0
    7
    8
    4
    4
    1
    9
    4
    1
    Injection site pain
         subjects affected / exposed
    8 / 9 (88.89%)
    4 / 7 (57.14%)
    1 / 3 (33.33%)
    3 / 7 (42.86%)
    19 / 22 (86.36%)
    2 / 2 (100.00%)
    14 / 18 (77.78%)
    17 / 23 (73.91%)
    19 / 22 (86.36%)
    23 / 28 (82.14%)
    1 / 1 (100.00%)
    20 / 28 (71.43%)
    15 / 16 (93.75%)
    6 / 11 (54.55%)
         occurrences all number
    8
    4
    1
    4
    19
    2
    15
    17
    19
    25
    1
    21
    15
    6
    Injection site pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    2 / 28 (7.14%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Injection site swelling
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 7 (42.86%)
    0 / 3 (0.00%)
    2 / 7 (28.57%)
    10 / 22 (45.45%)
    0 / 2 (0.00%)
    9 / 18 (50.00%)
    7 / 23 (30.43%)
    4 / 22 (18.18%)
    2 / 28 (7.14%)
    0 / 1 (0.00%)
    6 / 28 (21.43%)
    3 / 16 (18.75%)
    1 / 11 (9.09%)
         occurrences all number
    1
    3
    0
    2
    11
    0
    9
    8
    4
    2
    0
    7
    3
    1
    Injection site warmth
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 16 (6.25%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Malaise
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    8 / 22 (36.36%)
    0 / 2 (0.00%)
    2 / 18 (11.11%)
    1 / 23 (4.35%)
    3 / 22 (13.64%)
    3 / 28 (10.71%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
    4 / 16 (25.00%)
    4 / 11 (36.36%)
         occurrences all number
    0
    0
    0
    0
    9
    0
    2
    1
    3
    3
    0
    1
    5
    5
    Pyrexia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    6 / 22 (27.27%)
    0 / 2 (0.00%)
    2 / 18 (11.11%)
    0 / 23 (0.00%)
    7 / 22 (31.82%)
    3 / 28 (10.71%)
    1 / 1 (100.00%)
    5 / 28 (17.86%)
    2 / 16 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    1
    2
    0
    0
    8
    0
    2
    0
    9
    4
    1
    5
    3
    1
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    2 / 23 (8.70%)
    0 / 22 (0.00%)
    1 / 28 (3.57%)
    0 / 1 (0.00%)
    3 / 28 (10.71%)
    0 / 16 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    2
    0
    2
    0
    3
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 22 (0.00%)
    1 / 2 (50.00%)
    0 / 18 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    2
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    0 / 23 (0.00%)
    2 / 22 (9.09%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    2 / 11 (18.18%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    2
    0
    0
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    2 / 23 (8.70%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    4 / 22 (18.18%)
    0 / 2 (0.00%)
    2 / 18 (11.11%)
    1 / 23 (4.35%)
    2 / 22 (9.09%)
    3 / 28 (10.71%)
    1 / 1 (100.00%)
    4 / 28 (14.29%)
    2 / 16 (12.50%)
    1 / 11 (9.09%)
         occurrences all number
    2
    1
    0
    1
    4
    0
    2
    1
    2
    3
    1
    4
    2
    2
    Oropharyngeal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
    3 / 28 (10.71%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    5
    0
    2
    0
    0
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    1 / 23 (4.35%)
    2 / 22 (9.09%)
    1 / 28 (3.57%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    1
    2
    1
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    1 / 28 (3.57%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Psychiatric disorders
    Eating disorder
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 7 (42.86%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    3
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Irritability
         subjects affected / exposed
    4 / 9 (44.44%)
    3 / 7 (42.86%)
    0 / 3 (0.00%)
    3 / 7 (42.86%)
    0 / 22 (0.00%)
    1 / 2 (50.00%)
    1 / 18 (5.56%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    4
    3
    0
    3
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Restlessness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 16 (6.25%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    5 / 22 (22.73%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    3 / 23 (13.04%)
    2 / 22 (9.09%)
    2 / 28 (7.14%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
    1 / 16 (6.25%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    5
    0
    0
    3
    2
    3
    0
    1
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    10 / 22 (45.45%)
    0 / 2 (0.00%)
    3 / 18 (16.67%)
    4 / 23 (17.39%)
    2 / 22 (9.09%)
    6 / 28 (21.43%)
    0 / 1 (0.00%)
    6 / 28 (21.43%)
    3 / 16 (18.75%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    10
    0
    3
    4
    2
    6
    0
    8
    3
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    1 / 23 (4.35%)
    1 / 22 (4.55%)
    2 / 28 (7.14%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 16 (6.25%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    0
    1
    1
    2
    0
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    1 / 3 (33.33%)
    2 / 7 (28.57%)
    2 / 22 (9.09%)
    1 / 2 (50.00%)
    0 / 18 (0.00%)
    3 / 23 (13.04%)
    1 / 22 (4.55%)
    1 / 28 (3.57%)
    1 / 1 (100.00%)
    2 / 28 (7.14%)
    1 / 16 (6.25%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    1
    2
    2
    1
    0
    3
    1
    1
    1
    2
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    1 / 7 (14.29%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    0 / 23 (0.00%)
    1 / 22 (4.55%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    Enterobiasis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    1 / 28 (3.57%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    1 / 23 (4.35%)
    1 / 22 (4.55%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 16 (6.25%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    1
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 16 (6.25%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Impetigo
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    2 / 18 (11.11%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Laryngitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 16 (6.25%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    1 / 22 (4.55%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    1 / 23 (4.35%)
    1 / 22 (4.55%)
    1 / 28 (3.57%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    1
    1
    1
    2
    0
    1
    0
    0
    Otitis media
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 7 (42.86%)
    2 / 3 (66.67%)
    4 / 7 (57.14%)
    4 / 22 (18.18%)
    1 / 2 (50.00%)
    6 / 18 (33.33%)
    4 / 23 (17.39%)
    3 / 22 (13.64%)
    6 / 28 (21.43%)
    0 / 1 (0.00%)
    8 / 28 (28.57%)
    2 / 16 (12.50%)
    3 / 11 (27.27%)
         occurrences all number
    5
    4
    3
    7
    6
    1
    8
    8
    5
    9
    0
    14
    2
    5
    Paronychia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pertussis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    1 / 2 (50.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 16 (6.25%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    1 / 23 (4.35%)
    1 / 22 (4.55%)
    1 / 28 (3.57%)
    1 / 1 (100.00%)
    0 / 28 (0.00%)
    2 / 16 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    1
    1
    2
    1
    1
    0
    2
    0
    Sinusitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
    2 / 28 (7.14%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
    2 / 16 (12.50%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    2 / 3 (66.67%)
    1 / 7 (14.29%)
    3 / 22 (13.64%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    3 / 23 (13.04%)
    3 / 22 (13.64%)
    4 / 28 (14.29%)
    0 / 1 (0.00%)
    6 / 28 (21.43%)
    1 / 16 (6.25%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    3
    1
    4
    0
    1
    5
    5
    4
    0
    6
    1
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    2 / 22 (9.09%)
    0 / 2 (0.00%)
    1 / 18 (5.56%)
    1 / 23 (4.35%)
    0 / 22 (0.00%)
    1 / 28 (3.57%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
    0 / 16 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    1
    1
    0
    1
    0
    1
    0
    0
    Varicella
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 22 (0.00%)
    0 / 2 (0.00%)
    0 / 18 (0.00%)
    0 / 23 (0.00%)
    0 / 22 (0.00%)
    1 / 28 (3.57%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 16 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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