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    Clinical Trial Results:
    A phase IV, open label, randomized, multicountry study to evaluate immunogenicity and safety of GSK Biologicals' seasonal (2010-2011) influenza vaccine FluarixTM in children previously vaccinated with GSK Biologicals' H1N1 vaccine (PandemrixTM)

    Summary
    EudraCT number
    2010-020330-26
    Trial protocol
    SE   NL  
    Global end of trial date
    26 May 2011

    Results information
    Results version number
    v2(current)
    This version publication date
    05 May 2016
    First version publication date
    30 Jan 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Information edited in the primary outcomes pertaining to MGI and SCR and for the SAE outcomes

    Trial information

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    Trial identification
    Sponsor protocol code
    114451
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01196026
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, 1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000725-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
    29 Sep 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate HI immune response against the H1N1 strain 28 days following vaccination with the first dose of trivalent inactivated influenza virus (TIV) vaccine (Fluarix) in subjects previously vaccinated with 2 doses of H1N1 adjuvanted vaccine (Pandemrix).
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Only eligible subjects that had no contraindications to any components of the vaccines were vaccinated.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Sep 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 80
    Country: Number of subjects enrolled
    Sweden: 82
    Worldwide total number of subjects
    162
    EEA total number of subjects
    162
    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)
    54
    Children (2-11 years)
    108
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Primed subjects =subjects who had been previously vaccinated with a seasonal influenza vaccine whereas unprimed subjects had not. - children ≥ 9 years + primed children < 9 years=1 dose of Fluarix - unprimed children < 9 years=2 doses of Fluarix. To complete the vaccination schedule, a 2nd dose of Havrix vaccine was given outside the study setting

    Pre-assignment
    Screening details
    162 subjects were enrolled in the study but only 154 subjects were vaccinated. The remaining 8 subjects gave their consent withdrawal and were not included in the study.Enrollment was stratified according to the age at first Pandemrix vaccination: 6-11 months, 12-35 months, 3-9 years. Also, subjects were grouped from 3-5 and from 6-9 years.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Fluarix 6-11 Months Group
    Arm description
    Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
    Arm type
    Experimental

    Investigational medicinal product name
    Havrix™ Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two intramuscular injections

    Investigational medicinal product name
    Fluarix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two intramuscular injections

    Arm title
    Fluarix 12-35 Months Group
    Arm description
    Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
    Arm type
    Experimental

    Investigational medicinal product name
    Fluarix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One or two intramuscular injections.

    Investigational medicinal product name
    Havrix™ Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two intramuscular injections.

    Arm title
    Fluarix 3-9 Years Group
    Arm description
    Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
    Arm type
    Experimental

    Investigational medicinal product name
    Fluarix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One or two intramuscular injections.

    Investigational medicinal product name
    Havrix™ Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two intramuscular injections.

    Arm title
    Havrix Junior 6-11 Months Group
    Arm description
    Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
    Arm type
    Active comparator

    Investigational medicinal product name
    Havrix™ Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two intramuscular injections.

    Arm title
    Havrix Junior 12-35 Months Group
    Arm description
    Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
    Arm type
    Active comparator

    Investigational medicinal product name
    Havrix™ Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two intramuscular injections.

    Arm title
    Havrix Junior 3-9 Years Group
    Arm description
    Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
    Arm type
    Active comparator

    Investigational medicinal product name
    Havrix™ Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two intramuscular injections.

    Number of subjects in period 1 [1]
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Started
    10
    44
    23
    10
    43
    24
    Completed
    9
    36
    23
    10
    42
    24
    Not completed
    1
    8
    0
    0
    1
    0
         Unspecified
    -
    1
    -
    -
    -
    -
         Consent withdrawn by subject
    1
    4
    -
    -
    -
    -
         Lost to follow-up
    -
    3
    -
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 8 subjects were enrolled but not vaccinated due to consent withdrawal after randomization.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluarix 6-11 Months Group
    Reporting group description
    Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.

    Reporting group title
    Fluarix 12-35 Months Group
    Reporting group description
    Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.

    Reporting group title
    Fluarix 3-9 Years Group
    Reporting group description
    Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.

    Reporting group title
    Havrix Junior 6-11 Months Group
    Reporting group description
    Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.

    Reporting group title
    Havrix Junior 12-35 Months Group
    Reporting group description
    Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.

    Reporting group title
    Havrix Junior 3-9 Years Group
    Reporting group description
    Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.

    Reporting group values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Total
    Number of subjects
    10 44 23 10 43 24 154
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    1 ± 0 2.3 ± 0.52 6.4 ± 1.99 1 ± 0 2.4 ± 0.58 7.5 ± 1.53 -
    Gender categorical
    Units: Subjects
        Female
    5 21 13 4 16 13 72
        Male
    5 23 10 6 27 11 82

    End points

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    End points reporting groups
    Reporting group title
    Fluarix 6-11 Months Group
    Reporting group description
    Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.

    Reporting group title
    Fluarix 12-35 Months Group
    Reporting group description
    Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.

    Reporting group title
    Fluarix 3-9 Years Group
    Reporting group description
    Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.

    Reporting group title
    Havrix Junior 6-11 Months Group
    Reporting group description
    Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.

    Reporting group title
    Havrix Junior 12-35 Months Group
    Reporting group description
    Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.

    Reporting group title
    Havrix Junior 3-9 Years Group
    Reporting group description
    Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.

    Subject analysis set title
    Fluarix All Ages Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.

    Subject analysis set title
    Havrix Junior All Ages Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.

    Primary: Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine

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    End point title
    Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine [1]
    End point description
    Antibody titers were expressed as Geometric mean titers (GMTs).
    End point type
    Primary
    End point timeframe
    Day 0 and 28
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Fluarix All Ages Group
    Number of subjects analysed
    65
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 0
    120.7 (100.8 to 144.4)
        Day 28
    1079.3 (915.8 to 1272)
    No statistical analyses for this end point

    Primary: Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine

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    End point title
    Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine [2]
    End point description
    Seropositivity was defined as antibody titers greater than or equal to 1:10.
    End point type
    Primary
    End point timeframe
    Day 0-28
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Fluarix All Ages Group
    Number of subjects analysed
    65
    Units: Subjects
        Day 0
    65
        Day 28
    65
    No statistical analyses for this end point

    Primary: Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine

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    End point title
    Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine [3]
    End point description
    A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
    End point type
    Primary
    End point timeframe
    Day 0-28
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Fluarix All Ages Group
    Number of subjects analysed
    65
    Units: Subjects
        Day 0
    63
        Day 28
    65
    No statistical analyses for this end point

    Primary: Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine

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    End point title
    Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine [4]
    End point description
    A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
    End point type
    Primary
    End point timeframe
    Day 28
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Fluarix All Ages Group
    Number of subjects analysed
    65
    Units: Subjects
        H1N1
    55
    No statistical analyses for this end point

    Primary: Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine

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    End point title
    Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine [5]
    End point description
    MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
    End point type
    Primary
    End point timeframe
    Day 28
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Fluarix All Ages Group
    Number of subjects analysed
    65
    Units: Ratio
    geometric mean (confidence interval 95%)
        H1N1
    8.9 (7.1 to 11.2)
    No statistical analyses for this end point

    Secondary: HI Antibody Titers Against All Fluarix Vaccine Strains

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    End point title
    HI Antibody Titers Against All Fluarix Vaccine Strains
    End point description
    Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were Flu A/CAL/7/09 H1N1 , FluB/Bri/60/08 Victoria, and Flu A/Vic/210/09 H3N2, further in this summary denoted as H1N1, Victoria and H3N2 strains, respectively.
    End point type
    Secondary
    End point timeframe
    Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
    Number of subjects analysed
    7
    35
    23
    10
    43
    24
    65
    77
    Units: Titer
    geometric mean (confidence interval 95%)
        H1N1 Day 0
    176.6 (79.3 to 393.4)
    124.9 (97.1 to 160.5)
    102 (77.2 to 134.9)
    171.4 (118.9 to 247.2)
    186.5 (148.8 to 233.8)
    105.3 (75.4 to 147)
    120.7 (100.8 to 144.4)
    154.4 (129.8 to 183.7)
        H1N1 Day 28
    1810.2 (775.2 to 4226.8)
    1345 (1141.9 to 1584.1)
    659.7 (524.1 to 830.3)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    1079.3 (915.8 to 1272)
    0 (0 to 0)
        Victoria Day 0
    16.4 (3.7 to 71.9)
    15.1 (10.6 to 21.5)
    21.9 (14 to 34.1)
    13.6 (7.6 to 24.6)
    19.1 (14.4 to 25.4)
    19.1 (12.3 to 29.6)
    17.4 (13.2 to 22.8)
    18.3 (14.8 to 22.7)
        Victoria Day 28
    176.8 (28.1 to 1111.2)
    142.2 (93.5 to 216.2)
    188.8 (103.7 to 343.8)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    160.9 (115 to 225.2)
    0 (0 to 0)
        H3N2 Day 0
    5 (5 to 5)
    21.2 (13.7 to 32.8)
    31 (19 to 50.5)
    5 (5 to 5)
    8.9 (6.4 to 12.4)
    26.7 (16.6 to 42.9)
    20.8 (15.2 to 28.3)
    11.7 (8.9 to 15.2)
        H3N2 Day 28
    88.4 (35.9 to 217.6)
    448.3 (265.9 to 755.8)
    518.6 (304.1 to 884.3)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    396.3 (276.3 to 568.5)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine

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    End point title
    HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
    End point description
    Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
    End point type
    Secondary
    End point timeframe
    Day 0 and Month 6
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
    Number of subjects analysed
    6
    28
    22
    9
    38
    23
    56
    70
    Units: Titer
    geometric mean (confidence interval 95%)
        H1N1 Day 0 (N=6;28;22;9;38;23;56;70)
    201.6 (81.1 to 501.1)
    126.4 (93.2 to 171.4)
    96.9 (73.9 to 126.9)
    172.8 (113.9 to 262.1)
    195.6 (155.1 to 246.6)
    100.3 (71.8 to 140.1)
    119.7 (97.9 to 146.3)
    154.6 (128.8 to 185.5)
        H1N1 Month 6 (N=6;28;22;9;38;23;56;70)
    1437 (595.7 to 3466.6)
    565.5 (458.1 to 698.2)
    335.5 (253.1 to 444.7)
    93.4 (48.6 to 179.5)
    172 (127.9 to 231.4)
    74.3 (55.4 to 99.6)
    509 (416.9 to 621.5)
    120.7 (97.2 to 149.8)
        Victoria Day 0 (N=6;28;22;0;0;0;56;0)
    17.8 (2.9 to 110)
    16.2 (10.6 to 24.6)
    21.6 (13.6 to 34.5)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    18.3 (13.5 to 24.8)
    0 (0 to 0)
        Victoria Month 6 (N=6;28;22;0;0;0;56;0)
    302 (115.6 to 788.8)
    148.4 (97.9 to 225.1)
    134.5 (82.2 to 220.1)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    154.1 (115.3 to 205.9)
    0 (0 to 0)
        H3N2 Day 0 (N=6;28;22;0;0;0;56;0)
    5 (5 to 5)
    20.3 (12.4 to 33)
    29.7 (17.9 to 49.2)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    20.3 (14.5 to 28.2)
    0 (0 to 0)
        H3N2 Month 6 (N=6;28;22;0;0;0;56;0)
    127 (70.1 to 230)
    160 (119.1 to 214.8)
    252.7 (186.3 to 342.8)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    186.8 (152.9 to 228.2)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains

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    End point title
    Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
    End point description
    Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
    End point type
    Secondary
    End point timeframe
    Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
    Number of subjects analysed
    7
    35
    23
    10
    43
    24
    65
    77
    Units: Subjects
        H1N1 Day 0
    7
    35
    23
    10
    43
    24
    65
    77
        H1N1 Day 28
    7
    35
    23
    0
    0
    0
    65
    0
        Victoria Day 0
    4
    25
    20
    9
    39
    20
    49
    68
        Victoria Day 28
    7
    35
    23
    0
    0
    0
    65
    0
        H3N2 Day 0
    0
    22
    19
    0
    11
    19
    41
    30
        H3N2 Day 28
    7
    35
    23
    0
    0
    0
    65
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine

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    End point title
    Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
    End point description
    Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
    End point type
    Secondary
    End point timeframe
    Day 0 and Month 6
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
    Number of subjects analysed
    6
    28
    22
    9
    38
    23
    56
    70
    Units: Subjects
        H1N1 Day 0 (N=6;28;22;9;38;23;56;70)
    6
    28
    22
    9
    38
    23
    56
    70
        H1N1 Month 6 (N=6;28;22;9;38;23;56;70)
    6
    28
    22
    9
    38
    23
    56
    70
        Victoria Day 0 (N=6;28;22;0;0;0;56;0)
    3
    21
    19
    0
    0
    0
    43
    0
        Victoria Month 6 (N=6;28;22;0;0;0;56;0)
    6
    28
    22
    0
    0
    0
    56
    0
        H3N2 Day 0 (N=6;28;22;0;0;0;56;0)
    0
    17
    18
    0
    0
    0
    35
    0
        H3N2 Month 6 (N=6;28;22;0;0;0;56;0)
    6
    28
    22
    0
    0
    0
    56
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine

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    End point title
    Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine [6]
    End point description
    A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
    End point type
    Secondary
    End point timeframe
    Day 28
    Notes
    [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: This endpoint was analysed only for the Fluarix groups i.e. Fluarix 6-11 Months Group, Fluarix 12-35 Months Group, Fluarix 3-9 Years Group and Fluarix All Ages Group.
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Fluarix All Ages Group
    Number of subjects analysed
    7
    35
    23
    65
    Units: Subjects
        H1N1
    5
    31
    19
    55
        Victoria
    7
    30
    18
    55
        H3N2
    7
    35
    22
    64
    No statistical analyses for this end point

    Secondary: Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine

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    End point title
    Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
    End point description
    A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
    Number of subjects analysed
    6
    28
    22
    9
    38
    23
    56
    70
    Units: Subjects
        H1N1(N=6;28;22;9;38;23;56;70)
    5
    18
    12
    0
    1
    0
    35
    1
        Victoria (N=6;28;22;0;0;0;56;0)
    5
    22
    15
    0
    0
    0
    42
    0
        H3N2 (N=6;28;22;0;0;0;56;0)
    6
    22
    18
    0
    0
    0
    46
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains

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    End point title
    Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
    End point description
    A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
    End point type
    Secondary
    End point timeframe
    Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
    Number of subjects analysed
    7
    35
    23
    10
    43
    24
    65
    77
    Units: Subjects
        H1N1 Day 0
    7
    33
    23
    10
    43
    24
    63
    77
        H1N1 Day 28
    7
    35
    23
    0
    0
    0
    65
    0
        Victoria Day 0
    2
    5
    7
    1
    9
    7
    14
    17
        Victoria Day 28
    7
    35
    21
    0
    0
    0
    63
    0
        H3N2 Day 0
    0
    17
    13
    0
    6
    12
    30
    18
        H3N2 Day 28
    7
    35
    23
    0
    0
    0
    65
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine

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    End point title
    Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
    End point description
    A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
    End point type
    Secondary
    End point timeframe
    Day 0 and Month 6
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
    Number of subjects analysed
    6
    28
    22
    9
    38
    23
    56
    70
    Units: Subjects
        H1N1 Day 0 (N=6;28;22;9;38;23;56;70)
    6
    26
    22
    9
    38
    23
    54
    70
        H1N1 Month 6 (N=6;28;22;9;38;23;56;70)
    6
    28
    22
    8
    36
    21
    56
    65
        Victoria Day 0 (N=6;28;22;0;0;0;56;0)
    2
    5
    7
    0
    0
    0
    14
    0
        Victoria Month 6 (N=6;28;22;0;0;0;56;0)
    6
    26
    20
    0
    0
    0
    52
    0
        H3N2 Day 0 (N=6;28;22;0;0;0;56;0)
    0
    13
    12
    0
    0
    0
    25
    0
        H3N2 Month 6 (N=6;28;22;0;0;0;56;0)
    6
    28
    22
    0
    0
    0
    56
    0
    No statistical analyses for this end point

    Secondary: Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine

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    End point title
    Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine [7]
    End point description
    MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
    End point type
    Secondary
    End point timeframe
    Day 28
    Notes
    [7] - 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: This endpoint was analysed only for the Fluarix groups i.e. Fluarix 6-11 Months Group, Fluarix 12-35 Months Group, Fluarix 3-9 Years Group and Fluarix All Ages Group.
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Fluarix All Ages Group
    Number of subjects analysed
    7
    35
    23
    65
    Units: Ratio
    geometric mean (confidence interval 95%)
        H1N1
    10.2 (3 to 34.8)
    10.8 (7.9 to 14.7)
    6.5 (4.7 to 8.8)
    8.9 (7.1 to 11.2)
        Victoria
    10.8 (5.9 to 19.6)
    9.4 (6.8 to 12.9)
    8.6 (5.5 to 13.6)
    9.3 (7.3 to 11.7)
        H3N2
    17.7 (7.2 to 43.5)
    21.1 (16.3 to 27.4)
    16.7 (11.4 to 24.6)
    19.1 (15.6 to 23.4)
    No statistical analyses for this end point

    Secondary: Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine

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    End point title
    Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
    End point description
    MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Month 6) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
    Number of subjects analysed
    6
    28
    22
    9
    38
    23
    56
    70
    Units: Ratio
    geometric mean (confidence interval 95%)
        H1N1 (N=6;28;22;9;38;23;56;70)
    7.1 (2 to 25.5)
    4.5 (3.3 to 6)
    3.5 (2.6 to 4.7)
    0.5 (0.4 to 0.8)
    0.9 (0.7 to 1.1)
    0.7 (0.7 to 0.8)
    4.3 (3.4 to 5.3)
    0.8 (0.7 to 0.9)
        Victoria (N=6;28;22;0;0;0;56;0)
    17 (3.1 to 93.9)
    9.2 (5.9 to 14.2)
    6.2 (3.8 to 10.2)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    8.4 (6.1 to 11.6)
    0 (0 to 0)
        H3N2 (N=6;28;22;0;0;0;56;0)
    25.4 (14 to 46)
    7.9 (5.5 to 11.4)
    8.5 (5.9 to 12.3)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    9.2 (7.2 to 11.8)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains

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    End point title
    Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains [8]
    End point description
    Antibody titers were expressed as Geometric Mean Titers (GMTs).
    End point type
    Secondary
    End point timeframe
    Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
    Notes
    [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: This endpoint was analysed only for the Fluarix groups i.e. Fluarix 6-11 Months Group, Fluarix 12-35 Months Group, Fluarix 3-9 Years Group and Fluarix All Ages Group.
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Fluarix All Ages Group
    Number of subjects analysed
    7
    35
    23
    65
    Units: Titer
    geometric mean (confidence interval 95%)
        H1N1 Day 0 (N=7;34;23;0;0;0;64;0)
    359.1 (159.7 to 807.4)
    235.4 (180.5 to 307)
    237.6 (154.7 to 364.8)
    247.3 (199.6 to 306.5)
        H1N1 Day 28 (N=7;34;23;0;0;0;64;0)
    5706.2 (3382.6 to 9626)
    5860.4 (5072.5 to 6770.7)
    2052.3 (1395.1 to 3019)
    4007.7 (3274.8 to 4904.6)
        Victoria Day 0 (N=7;35;23;0;0;0;65;0)
    20.2 (8.3 to 49.2)
    19.1 (13.9 to 26.2)
    25.4 (16.6 to 38.9)
    21.3 (16.8 to 26.9)
        Victoria Day 28 (N=7;34;23;0;0;0;64;0)
    49.3 (6.9 to 349.5)
    42.3 (20.9 to 85.5)
    80.8 (34.8 to 187.9)
    54.3 (33 to 89.3)
        H3N2 Day 0 (N=7;35;23;0;0;0;65;0)
    30 (13.5 to 66.9)
    84.9 (53.7 to 134.5)
    139.5 (100.8 to 193)
    90.5 (67.4 to 121.6)
        H3N2 Day 28 (N=7;34;23;0;0;0;64;0)
    90.1 (50.1 to 162)
    1011.6 (509.5 to 2008.6)
    1229.9 (586.5 to 2579.3)
    832.9 (514.7 to 1347.8)
    No statistical analyses for this end point

    Secondary: Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine

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    End point title
    Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
    End point description
    Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
    End point type
    Secondary
    End point timeframe
    Day 0 and Month 6
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
    Number of subjects analysed
    6
    28
    22
    9
    38
    23
    56
    70
    Units: Titer
    geometric mean (confidence interval 95%)
        H1N1 Day 0 (N=6;27;22;9;38;23;55;70)
    419.1 (172 to 1021.2)
    254.8 (184 to 352.8)
    221.2 (145 to 337.6)
    292 (170.8 to 499.1)
    441.3 (317.5 to 613.5)
    212.8 (142.3 to 318.1)
    254.2 (200.2 to 322.9)
    329.3 (260 to 417.2)
        H1N1 Month 6 (N=6;28;22;9;38;23;56;70)
    5080.1 (2169.7 to 11894.4)
    2359.7 (1852 to 3006.4)
    892.2 (585.7 to 1359)
    292.6 (173.6 to 493)
    528.9 (377.5 to 741)
    221.6 (155 to 316.8)
    1748.2 (1347.3 to 2268.4)
    368.3 (290.1 to 467.5)
        Victoria Day 0 (6;28;22;0;0;0;56;0)
    21.4 (7.2 to 64)
    20.7 (13.9 to 30.7)
    26.1 (16.8 to 40.6)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    22.7 (17.4 to 29.7)
    0 (0 to 0)
        Victoria Month 6 (N=6;28;22;0;0;0;56;0)
    284.5 (89.4 to 905.6)
    140 (81.7 to 240)
    113.1 (58.2 to 219.7)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    138.9 (95.2 to 202.6)
    0 (0 to 0)
        H3N2 Day 0 (N=6;28;22;0;0;0;56;0)
    34.1 (13.6 to 85.3)
    78.4 (47 to 131.1)
    136.5 (97.4 to 191.3)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    89.2 (65.5 to 121.5)
    0 (0 to 0)
        H3N2 Month 6 (N=6;28;22;0;0;0;56;0)
    264.1 (136 to 512.9)
    618.2 (435.1 to 878.5)
    638.2 (381.1 to 1068.8)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    571.5 (435.5 to 749.8)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains

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    End point title
    Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains [9]
    End point description
    Seropositivity was defined as antibody titers greater than or equal to 1:28.
    End point type
    Secondary
    End point timeframe
    Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)
    Notes
    [9] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Fluarix All Ages Group
    Number of subjects analysed
    7
    35
    23
    65
    Units: Subjects
        H1N1 Day 0 (N=7;34;23;0;0;0;64;0)
    7
    34
    23
    64
        H1N1 Day 28 (N=7;34;23;0;0;0;64;0)
    7
    34
    23
    64
        Victoria Day 0 (N=7;35;23;0;0;0;65;0)
    1
    5
    7
    13
        Victoria Day 28 (N=7;34;23;0;0;0;64;0)
    3
    15
    12
    30
        H3N2 Day 0 (N=7;35;23;0;0;0;65;0)
    4
    26
    22
    52
        H3N2 Day28 (N=7;34;23;0;0;0;64;0)
    7
    34
    23
    64
    No statistical analyses for this end point

    Secondary: Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine

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    End point title
    Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
    End point description
    Seropositivity was defined as antibody titers greater than or equal to 1:28. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
    End point type
    Secondary
    End point timeframe
    Day 0 and Month 6
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
    Number of subjects analysed
    6
    28
    22
    9
    38
    23
    56
    70
    Units: Subjects
        H1N1 Day 0 (N=6;27;22;9;38;23;55;70)
    6
    27
    22
    9
    38
    23
    55
    70
        H1N1 Month 6 (N=6;28;22;9;38;23;56;70)
    6
    28
    22
    9
    38
    23
    56
    70
        Victoria Day 0 (6;28;22;0;0;0;56;0)
    1
    5
    7
    0
    0
    0
    13
    0
        Victoria Month 6 (N=6;28;22;0;0;0;56;0)
    6
    28
    18
    0
    0
    0
    52
    0
        H3N2 Day 0 (N=6;28;22;0;0;0;56;0)
    4
    20
    21
    0
    0
    0
    45
    0
        H3N2 Month 6 (N=6;28;22;0;0;0;56;0)
    6
    28
    22
    0
    0
    0
    56
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix

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    End point title
    Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix [10]
    End point description
    Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.
    End point type
    Secondary
    End point timeframe
    Day 28
    Notes
    [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: This endpoint was analysed only for the Fluarix groups i.e. Fluarix 6-11 Months Group, Fluarix 12-35 Months Group, Fluarix 3-9 Years Group and Fluarix All Ages Group.
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Fluarix All Ages Group
    Number of subjects analysed
    7
    34
    23
    64
    Units: Subjects
        H1N1 (N=7;33;23;0;0;0;63;0)
    6
    33
    17
    56
        Victoria (N=7;34;23;0;0;0;64;0)
    3
    11
    11
    25
        H3N2 (N=7;34;23;0;0;0;64;0)
    4
    32
    16
    52
    No statistical analyses for this end point

    Secondary: Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine

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    End point title
    Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
    End point description
    Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group Fluarix All Ages Group Havrix Junior All Ages Group
    Number of subjects analysed
    6
    28
    22
    9
    38
    23
    56
    70
    Units: Subjects
        H1N1 (N=6;27;22;9;38;23;55;70)
    5
    22
    10
    0
    2
    0
    37
    2
        Victoria (N=6;28;22;0;0;0;56;0)
    6
    23
    13
    0
    0
    0
    42
    0
        H3N2 (N=6;28;22;0;0;0;56;0)
    5
    21
    13
    0
    0
    0
    39
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

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    End point title
    Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
    End point description
    Solicited local symptoms assessed included: pain, redness and swelling. Any symptom was defined as regardless of intensity. Grade 3 pain was defined as a symptom that prevented normal activity.Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
    End point type
    Secondary
    End point timeframe
    During the 7 days (Day 0 – 6) after vaccination
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Number of subjects analysed
    10
    43
    23
    10
    43
    24
    Units: Subjects
        Any Pain
    3
    28
    21
    5
    19
    14
        Grade 3 Pain
    0
    1
    1
    0
    1
    0
        Any Redness
    7
    33
    19
    2
    15
    9
        Grade 3 Redness
    2
    8
    6
    0
    0
    0
        Any Swelling
    5
    23
    11
    1
    10
    5
        Grade 3 Swelling
    1
    3
    2
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Any Solicited Local Symptom

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    End point title
    Duration of Any Solicited Local Symptom
    End point description
    Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed included: pain, redness and swelling.
    End point type
    Secondary
    End point timeframe
    During the 7 days (Days 0 – 6) after vaccination
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Number of subjects analysed
    6
    30
    20
    5
    19
    14
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Pain [Dose 1] (N= 3;23;20;5;19;14)
    1 (1 to 2)
    2 (1 to 5)
    2 (1 to 5)
    1 (1 to 5)
    1 (1 to 7)
    2 (1 to 4)
        Redness [Dose 1] (N= 6;30;16;2;15;9)
    4 (1 to 6)
    3 (1 to 7)
    3 (1 to 6)
    1.5 (1 to 2)
    3 (1 to 7)
    2 (1 to 5)
        Swelling [Dose 1] (N=5;18;9;1;10;5)
    2 (1 to 5)
    3 (1 to 6)
    2 (1 to 6)
    1 (1 to 1)
    2 (1 to 7)
    2 (1 to 3)
        Pain [Dose 2] (N= 2;21;14;0;0;0)
    1.5 (1 to 2)
    1 (1 to 3)
    2 (1 to 3)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Redness [Dose 2] (N= 4;23;13;0;0;0)
    3 (3 to 7)
    3 (1 to 6)
    2 (1 to 5)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        Swelling [Dose 2] (N=2;16;8;0;0;0)
    3 (2 to 4)
    2 (1 to 6)
    2 (1 to 4)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms

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    End point title
    Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
    End point description
    Solicited general symptoms assessed included diarrhoea, drowsiness, irritability, loss of appetite and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 loss of appetite was not eating at all; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 7 days (Days 0–6) after vaccination
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Number of subjects analysed
    10
    43
    11
    10
    43
    2
    Units: Subjects
        Any Diarrhoea
    5
    8
    2
    2
    7
    0
        Grade 3 Diarrhoea
    0
    0
    0
    0
    1
    0
        Related Diarrhoea
    5
    3
    1
    2
    3
    0
        Any Drowsiness
    6
    16
    2
    2
    15
    0
        Grade 3 Drowsiness
    0
    3
    1
    0
    2
    0
        Related Drowsiness
    5
    10
    2
    2
    9
    0
        Any Irritability
    6
    20
    4
    5
    14
    0
        Grade 3 Irritability
    0
    1
    0
    0
    2
    0
        Related Irritability
    5
    14
    3
    4
    10
    0
        Any Loss of Appetite
    6
    14
    4
    3
    6
    0
        Grade 3 Loss of Appetite
    0
    1
    0
    0
    0
    0
        Related Loss of Appetite
    4
    8
    4
    2
    3
    0
        Any Fever
    5
    14
    4
    3
    11
    0
        Grade 3 Fever
    1
    1
    1
    0
    0
    0
        Related Fever
    4
    11
    3
    0
    4
    0
    No statistical analyses for this end point

    Secondary: Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old

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    End point title
    Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
    End point description
    Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever.
    End point type
    Secondary
    End point timeframe
    During a 7-day follow-up period (Day 0-6) after vaccination
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Number of subjects analysed
    5
    14
    3
    5
    15
    0 [11]
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Diarrhoea [Dose 1] (N=3;6;1;2;7;0)
    2 (2 to 3)
    2 (1 to 4)
    1 (1 to 1)
    3.5 (1 to 6)
    1 (1 to 3)
    ( to )
        Drowsiness [Dose 1] (N=4;11;1;2;15;0)
    1.5 (1 to 6)
    1 (1 to 4)
    3 (3 to 3)
    2 (2 to 2)
    2 (1 to 6)
    ( to )
        Irritability [Dose 1] (N=4;14;3;5;14;0)
    2.5 (1 to 4)
    2 (1 to 5)
    1 (1 to 2)
    2 (1 to 6)
    1 (1 to 5)
    ( to )
        Loss of Appetite [Dose 1] (N=5;11;3;3;6;0)
    2 (1 to 6)
    3 (1 to 5)
    1 (1 to 3)
    2 (1 to 7)
    1.5 (1 to 3)
    ( to )
        Fever [Dose 1] (N=3;10;2;3;11;0)
    4 (1 to 6)
    1.5 (1 to 3)
    1.5 (1 to 2)
    2 (2 to 2)
    2 (1 to 6)
    ( to )
        Diarrhoea [Dose 2] (N=4;4;1;0;0;0)
    1 (1 to 3)
    1 (1 to 4)
    1 (1 to 1)
    0 (0 to 0)
    0 (0 to 0)
    ( to )
        Drowsiness [Dose 2] (N=4;9;2;0;0;0)
    1.5 (1 to 3)
    1 (1 to 2)
    1 (1 to 1)
    0 (0 to 0)
    0 (0 to 0)
    ( to )
        Irritability [Dose 2] (N=5;12;2;0;0;0)
    2 (2 to 7)
    2 (1 to 4)
    2 (1 to 3)
    0 (0 to 0)
    0 (0 to 0)
    ( to )
        Loss of Appetite [Dose 2] (N=4;9;2;0;0;0)
    2 (1 to 5)
    2 (1 to 4)
    1 (1 to 1)
    0 (0 to 0)
    0 (0 to 0)
    ( to )
        Fever [Dose 2] (N=3;9;2;0;0;0)
    2 (1 to 2)
    1 (1 to 7)
    1 (1 to 1)
    0 (0 to 0)
    0 (0 to 0)
    ( to )
    Notes
    [11] - This group was not analysed.
    No statistical analyses for this end point

    Secondary: Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms

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    End point title
    Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
    End point description
    Solicited general symptoms assessed included arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During a 7-day follow-up period (Day 0-6) after vaccination
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Number of subjects analysed
    0 [12]
    0 [13]
    12
    0 [14]
    0 [15]
    22
    Units: Subjects
        Any Arthralgia
    0
    0
        Grade 3 Arthralgia
    0
    0
        Related Arthralgia
    0
    0
        Any Fatigue
    5
    8
        Grade 3 Fatigue
    0
    0
        Related Fatigue
    4
    6
        Any Gastrointestinal Symptoms
    1
    1
        Grade 3 Gastrointestinal Symptoms
    0
    0
        Related Gastrointestinal Symptoms
    1
    1
        Any Headache
    4
    4
        Grade 3 Headache
    0
    0
        Related Headache
    3
    3
        Any Myalgia
    1
    2
        Grade 3 Myalgia
    0
    0
        Related Myalgia
    1
    2
        Any Shivering
    2
    0
        Grade 3 Shivering
    0
    0
        Related Shivering
    2
    0
        Any Sweating
    0
    0
        Grade 3 Sweating
    0
    0
        Related Sweating
    0
    0
        Any Fever
    3
    0
        Grade 3 Fever
    0
    0
        Related Fever
    2
    0
    Notes
    [12] - This group was not analysed
    [13] - This group was not analysed
    [14] - This group was not analysed.
    [15] - This group was not analysed
    No statistical analyses for this end point

    Secondary: Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old

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    End point title
    Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
    End point description
    Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed included fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever.
    End point type
    Secondary
    End point timeframe
    During a 7-day follow-up period (Day 0-6) after vaccination
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Number of subjects analysed
    0 [16]
    0 [17]
    4
    0 [18]
    0 [19]
    8
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Fatigue [Dose 1] (N=0;0;4;0;0;8)
    ( to )
    ( to )
    1.5 (1 to 5)
    ( to )
    ( to )
    1 (1 to 2)
        Fatigue [Dose 2] (N=0;0;2;0;0;0)
    ( to )
    ( to )
    4 (1 to 7)
    ( to )
    ( to )
    0 (0 to 0)
        Gastrointestinal Symptoms [Dose 1] (N=0;0;1;0;0;1)
    ( to )
    ( to )
    2 (2 to 2)
    ( to )
    ( to )
    1 (1 to 1)
        Gastrointestinal symptoms [Dose 2] (N=0;0;0;0;0;0)
    ( to )
    ( to )
    0 (0 to 0)
    ( to )
    ( to )
    0 (0 to 0)
        Headache [Dose 1] (N=0;0;2;0;0;4)
    ( to )
    ( to )
    3 (2 to 4)
    ( to )
    ( to )
    3 (1 to 7)
        Headache [Dose 2] (N=0;0;2;0;0;0)
    ( to )
    ( to )
    3.5 (3 to 4)
    ( to )
    ( to )
    0 (0 to 0)
        Myalgia [Dose 1] (N=0;0;0;0;0;2)
    ( to )
    ( to )
    0 (0 to 0)
    ( to )
    ( to )
    1 (1 to 1)
        Myalgia [Dose 2] (N=0;0;1;0;0;0)
    ( to )
    ( to )
    1 (1 to 1)
    ( to )
    ( to )
    0 (0 to 0)
        Shivering [Dose 1] (N=0;0;2;0;0;0)
    ( to )
    ( to )
    1 (1 to 1)
    ( to )
    ( to )
    0 (0 to 0)
        Shivering [Dose 2] (N=0;0;0;0;0;0)
    ( to )
    ( to )
    0 (0 to 0)
    ( to )
    ( to )
    0 (0 to 0)
        Fever [Dose 1] (N=0;0;3;0;0;0)
    ( to )
    ( to )
    1 (1 to 1)
    ( to )
    ( to )
    0 (0 to 0)
        Fever [Dose2] (N=0;0;1;0;0;0)
    ( to )
    ( to )
    1 (1 to 1)
    ( to )
    ( to )
    0 (0 to 0)
    Notes
    [16] - This group was not analysed.
    [17] - This group was not analysed.
    [18] - This group was not analysed.
    [19] - This group was not analysed.
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)

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    End point title
    Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
    End point description
    Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination. Grade 3 was a symptom preventing normal everyday activity. Related was any symptom assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During a 28 day follow-up period (Day 0-27) after vaccination
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Number of subjects analysed
    10
    44
    23
    10
    43
    24
    Units: Subjects
        Any AEs
    6
    20
    7
    3
    15
    7
        Grade 3 AEs
    3
    4
    1
    0
    1
    1
        Related AEs
    2
    1
    2
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest

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    End point title
    Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest
    End point description
    MAEs: subject received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. AESIs/pIMD: includes both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Adverse events of special interest include both convulsion and anaphylaxis.
    End point type
    Secondary
    End point timeframe
    During the entire study period (up to Month 6)
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Number of subjects analysed
    10
    44
    23
    10
    43
    24
    Units: Subjects
        Any AEs
    4
    11
    2
    3
    7
    1
        Grade 3 AEs
    0
    0
    0
    0
    0
    0
        Related AEs
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects Reporting Serious Adverse Events (SAEs)
    End point description
    SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Number of subjects analysed
    10
    44
    23
    10
    43
    24
    Units: Subjects
        Any SAE(s)
    0
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects Reporting Serious Adverse Events (SAEs)
    End point description
    SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    Up to Month 6
    End point values
    Fluarix 6-11 Months Group Fluarix 12-35 Months Group Fluarix 3-9 Years Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Number of subjects analysed
    10
    44
    23
    10
    43
    24
    Units: Subjects
        Any SAE(s)
    1
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
    Adverse event reporting additional description
    The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Fluarix Group
    Reporting group description
    Subjects received 1 or doses of Fluarix vaccine based on age and priming status

    Reporting group title
    Havrix Junior Group
    Reporting group description
    Subjects received 1 dose of Havrix Junior vacine. The second dose was administered outside the study setting.

    Reporting group title
    Fluarix 6-11 Months Group
    Reporting group description
    Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.

    Reporting group title
    Fluarix 3-9 Years Group
    Reporting group description
    Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.

    Reporting group title
    Fluarix 12-35 Months Group
    Reporting group description
    Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.

    Reporting group title
    Havrix Junior 6-11 Months Group
    Reporting group description
    Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.

    Reporting group title
    Havrix Junior 12-35 Months Group
    Reporting group description
    Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.

    Reporting group title
    Havrix Junior 3-9 Years Group
    Reporting group description
    Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.

    Serious adverse events
    Fluarix Group Havrix Junior Group Fluarix 6-11 Months Group Fluarix 3-9 Years Group Fluarix 12-35 Months Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 23 (0.00%)
    1 / 44 (2.27%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 23 (0.00%)
    1 / 44 (2.27%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Fluarix Group Havrix Junior Group Fluarix 6-11 Months Group Fluarix 3-9 Years Group Fluarix 12-35 Months Group Havrix Junior 6-11 Months Group Havrix Junior 12-35 Months Group Havrix Junior 3-9 Years Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 12 (41.67%)
    8 / 22 (36.36%)
    7 / 10 (70.00%)
    21 / 23 (91.30%)
    33 / 44 (75.00%)
    5 / 10 (50.00%)
    19 / 43 (44.19%)
    14 / 24 (58.33%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 23 (4.35%)
    0 / 44 (0.00%)
    1 / 10 (10.00%)
    2 / 43 (4.65%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    2
    1
    Dysphonia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    1 / 10 (10.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    1 / 23 (4.35%)
    0 / 44 (0.00%)
    1 / 10 (10.00%)
    0 / 43 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    1
    Asthma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    1 / 10 (10.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    3 / 10 (30.00%)
    21 / 23 (91.30%)
    28 / 43 (65.12%)
    5 / 10 (50.00%)
    19 / 43 (44.19%)
    14 / 24 (58.33%)
         occurrences all number
    0
    0
    3
    21
    28
    5
    19
    14
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    7 / 10 (70.00%)
    19 / 23 (82.61%)
    33 / 43 (76.74%)
    2 / 10 (20.00%)
    15 / 43 (34.88%)
    9 / 24 (37.50%)
         occurrences all number
    0
    0
    7
    19
    33
    2
    15
    9
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    5 / 10 (50.00%)
    11 / 23 (47.83%)
    23 / 43 (53.49%)
    1 / 10 (10.00%)
    10 / 43 (23.26%)
    5 / 24 (20.83%)
         occurrences all number
    0
    0
    5
    11
    23
    1
    10
    5
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    5 / 10 (50.00%)
    2 / 11 (18.18%)
    8 / 43 (18.60%)
    2 / 10 (20.00%)
    7 / 43 (16.28%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    5
    2
    8
    2
    7
    0
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    6 / 10 (60.00%)
    2 / 11 (18.18%)
    16 / 43 (37.21%)
    2 / 10 (20.00%)
    15 / 43 (34.88%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    6
    2
    16
    2
    15
    0
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    6 / 10 (60.00%)
    4 / 11 (36.36%)
    20 / 43 (46.51%)
    5 / 10 (50.00%)
    14 / 43 (32.56%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    6
    4
    20
    5
    14
    0
    Loss of Appetite
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    6 / 10 (60.00%)
    4 / 11 (36.36%)
    14 / 43 (32.56%)
    3 / 10 (30.00%)
    6 / 43 (13.95%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    6
    4
    14
    3
    6
    0
    Fever (Solicited Symptom)
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    3 / 12 (25.00%)
    0 / 22 (0.00%)
    5 / 10 (50.00%)
    4 / 11 (36.36%)
    14 / 43 (32.56%)
    3 / 10 (30.00%)
    11 / 43 (25.58%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    5
    4
    14
    3
    11
    0
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 12 (41.67%)
    8 / 22 (36.36%)
    0 / 10 (0.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    5
    8
    0
    0
    0
    0
    0
    0
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 22 (4.55%)
    0 / 10 (0.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 12 (33.33%)
    4 / 22 (18.18%)
    0 / 10 (0.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    4
    4
    0
    0
    0
    0
    0
    0
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 22 (9.09%)
    0 / 10 (0.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    2 / 12 (16.67%)
    0 / 22 (0.00%)
    0 / 6 (0.00%)
    0 / 22 (0.00%)
    0 / 28 (0.00%)
    0 / 9 (0.00%)
    0 / 38 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 23 (0.00%)
    1 / 44 (2.27%)
    0 / 10 (0.00%)
    2 / 43 (4.65%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    2
    0
    Gastrointestinal disorders
    Lip haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    1 / 10 (10.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Tooth discolouration
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 23 (0.00%)
    1 / 44 (2.27%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    1 / 23 (4.35%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    1 / 43 (2.33%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    1
    0
    Infections and infestations
    Fever (AE)
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    2 / 10 (20.00%)
    0 / 23 (0.00%)
    9 / 44 (20.45%)
    0 / 10 (0.00%)
    6 / 43 (13.95%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    2
    0
    9
    0
    6
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    0 / 10 (0.00%)
    0 / 23 (0.00%)
    4 / 44 (9.09%)
    0 / 10 (0.00%)
    1 / 43 (2.33%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    2 / 23 (8.70%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    1 / 43 (2.33%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    1
    2
    Ear infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Varicella
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 22 (0.00%)
    1 / 10 (10.00%)
    0 / 23 (0.00%)
    0 / 44 (0.00%)
    0 / 10 (0.00%)
    0 / 43 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet/screen completed).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet/screen completed).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet/screen completed).
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet/screen completed).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet/screen completed).
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet/screen completed).
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet/screen completed).
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet/screen completed).
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the solicited local and general symptoms, not all subjects had their symptom sheet completed therefore, the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom sheet/screen completed).

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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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