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    Clinical Trial Results:
    A phase III, observer-blind, multi-centre, multi-country, randomized study to evaluate the immunogenicity and safety of thimerosal-free (TF) Fluarix (GSK Biologicals) compared with Fluzone (Sanofi Pasteur) administered intramuscularly in children (6 to 35 months of age)

    Summary
    EudraCT number
    		 2015-001258-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    01 Jun 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Apr 2023
    First version publication date
    18 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    111751
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00764790
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 8664357343, GSKClinicalSupportHD@gsk.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
    30 Sep 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Mar 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To demonstrate the immunological non-inferiority (in terms of GMTs and seroconversion rates) of TF Fluarix (0.5mL) versus Fluzone (0.25mL) in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial IM vaccination. •To demonstrate the immunological non-inferiority (in terms of GMTs and seroconversion rates) of TF Fluarix (0.25mL) versus Fluzone (0.25mL) in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial IM vaccination
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1289
    Country: Number of subjects enrolled
    Taiwan: 177
    Country: Number of subjects enrolled
    Thailand: 275
    Country: Number of subjects enrolled
    Mexico: 1297
    Country: Number of subjects enrolled
    Hong Kong: 280
    Worldwide total number of subjects
    3318
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    2212
    Children (2-11 years)
    1106
    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
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fluarix Dose A Group
    Arm description
    		 Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluarix
    Investigational medicinal product code
    Other name
    TRIVALENT INACTIVATED INFLUENZA VACCINE
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses were tested.

    Arm title
    		 Fluarix Dose B Group
    Arm description
    		 Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluarix
    Investigational medicinal product code
    Other name
    TRIVALENT INACTIVATED INFLUENZA VACCINE
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses were tested.

    Arm title
    		 Fluzone Group
    Arm description
    		 Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluzone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: This is an observer-blind study which means that during the course of the study, the vaccine recipient (subject) and those responsible for the evaluation of any study endpoint, were all unaware of which vaccine was administered to a particular subject. To do so, vaccine preparation and vaccination were done by authorized medical personnel who did not participate in any of the study clinical evaluations (i.e. carer and assessor).
    Number of subjects in period 1 [2]
    		Fluarix Dose A Group Fluarix Dose B Group Fluzone Group
    Started
    1107
    1106
    1104
    Completed
    1069
    1065
    1074
    Not completed
    38
    41
    30
         Consent withdrawn by subject
    10
    12
    6
         Protocol violation
    -
    -
    1
         Migrated/moved from study area
    4
    3
    5
         Lost to follow-up
    24
    26
    18
    Notes
    [2] - 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: 1 subject enrolled in the study was allocated a subject number but the study vaccine dose was not administered.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluarix Dose A Group
    Reporting group description
    		 Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

    Reporting group title
    Fluarix Dose B Group
    Reporting group description
    		 Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

    Reporting group title
    Fluzone Group
    Reporting group description
    		 Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

    Reporting group values
    		 Fluarix Dose A Group Fluarix Dose B Group Fluzone Group Total
    Number of subjects
    		 1107 1106 1104 3317
    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: months
        arithmetic mean (standard deviation)
    		 20.9 ( 8.07 ) 20.9 ( 8.42 ) 21 ( 8.23 ) -
    Gender categorical
    Units: Subjects
        Female
    		 539 517 560 1616
        Male
    		 568 589 544 1701

    End points

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    End points reporting groups
    Reporting group title
    Fluarix Dose A Group
    Reporting group description
    		 Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

    Reporting group title
    Fluarix Dose B Group
    Reporting group description
    		 Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

    Reporting group title
    Fluzone Group
    Reporting group description
    		 Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

    Primary: Geometric Mean Titer (GMT) of serum anti-hemagglutinin (HA) antibodies against each of the influenza vaccine strains

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    End point title
    		 Geometric Mean Titer (GMT) of serum anti-hemagglutinin (HA) antibodies against each of the influenza vaccine strains
    End point description
    GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
    End point type
    Primary
    End point timeframe
    Day 0 (PRE), Day 28 or Day 56 (POST)
    End point values
    		 Fluarix Dose A Group Fluarix Dose B Group Fluzone Group
    Number of subjects analysed
    1018
    1016
    1031
    Units: titre
    geometric mean (confidence interval 95%)
        A/Brisbane (PRE) (N=1017; 1013; 1030)
    10.4 (9.7 to 11.1)
    10.6 (9.8 to 11.4)
    10.9 (10.1 to 11.7)
        A/Brisbane (POST) (N=1018; 1016; 1031)
    106.1 (93.8 to 120.1)
    131.6 (116.3 to 148.9)
    232.4 (214 to 252.3)
        A/Uruguay (PRE) (N=1017; 1013; 1030)
    12.1 (11.1 to 13.2)
    11.2 (10.2 to 12.2)
    11.6 (10.7 to 12.7)
        A/Uruguay (POST) (N=1018; 1016; 1031)
    125.6 (113.3 to 139.3)
    158.7 (143.9 to 175.2)
    280.3 (260.3 to 301.9)
        B/Florida (PRE) (N=1017; 1013; 1030)
    8.4 (7.9 to 9)
    8.9 (8.3 to 9.6)
    8.3 (7.7 to 8.8)
        B/Florida (POST) (N=1018; 1016; 1031)
    113 (103.4 to 123.4)
    164.4 (150.2 to 180.1)
    176.4 (162.3 to 191.7)
    Statistical analysis title
    		 Adjusted GMT ratio anti-A/Brisbane Fluzone/Fluarix
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of geometric mean titers [GMTs] of Fluarix (Dose B) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluarix Dose B Group v Fluzone Group
    Number of subjects included in analysis
    2047
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.54
         upper limit
    		 1.98
    Notes
    [1] - The non-inferiority of the Fluarix Dose B Group as compared to the Fluzone Group was concluded if the upper limit of two-sided 95% CI of the GMT ratio (Fluzone Group over Fluarix Dose B Group) was ≤ 1.50 in terms of anti-A/Brisbane titers.
    Statistical analysis title
    		 Adjusted GMT ratio anti-A/Uruguay Fluzone/Fluarix
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of geometric mean titers [GMTs] of Fluarix (Dose B) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluarix Dose B Group v Fluzone Group
    Number of subjects included in analysis
    2047
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.57
         upper limit
    		 1.89
    Notes
    [2] - The non-inferiority of the Fluarix Dose B Group as compared to the Fluzone Group was concluded if the upper limit of two-sided 95% CI of the GMT ratio (Fluzone Group over Fluarix Dose B Group) was ≤ 1.50 in terms of anti-A/Uruguay titers.
    Statistical analysis title
    		 Adjusted GMT ratio anti-B/Florida Fluzone/Fluarix
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of geometric mean titers [GMTs] of Fluarix (Dose B) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluzone Group v Fluarix Dose B Group
    Number of subjects included in analysis
    2047
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.25
    Notes
    [3] - The non-inferiority of the Fluarix Dose B Group as compared to the Fluzone Group was concluded if the upper limit of two-sided 95% CI of the GMT ratio (Fluzone Group over Fluarix Dose B Group) was ≤ 1.50 in terms of anti-B/Florida titers.
    Statistical analysis title
    		 Adjusted GMT ratio anti-A/Brisbane Fluzone/Fluarix
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of geometric mean titers [GMTs] of Fluarix (Dose A) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluzone Group v Fluarix Dose A Group
    Number of subjects included in analysis
    2049
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    2.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.86
         upper limit
    		 2.4
    Notes
    [4] - The non-inferiority of the Fluarix Dose A Group as compared to the Fluzone Group was concluded if the upper limit of two-sided 95% CI of the GMT ratio (Fluzone Group over Fluarix Dose A Group) was ≤ 1.50 in terms of anti-A/Brisbane titers.
    Statistical analysis title
    		 Adjusted GMT ratio anti-A/Uruguay Fluzone/Fluarix
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of geometric mean titers [GMTs] of Fluarix (Dose A) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluzone Group v Fluarix Dose A Group
    Number of subjects included in analysis
    2049
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    2.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.08
         upper limit
    		 2.52
    Notes
    [5] - The non-inferiority of the Fluarix Dose A Group as compared to the Fluzone Group was concluded if the upper limit of two-sided 95% CI of the GMT ratio (Fluzone Group over Fluarix Dose A Group) was ≤ 1.50 in terms of anti-A/Uruguay titers.
    Statistical analysis title
    		 Adjusted GMT ratio anti-B/Florida Fluzone/Fluarix
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of geometric mean titers [GMTs] of Fluarix (Dose A) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluzone Group v Fluarix Dose A Group
    Number of subjects included in analysis
    2049
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.42
         upper limit
    		 1.76
    Notes
    [6] - The non-inferiority of the Fluarix Dose A Group as compared to the Fluzone Group was concluded if the upper limit of two-sided 95% CI of the GMT ratio (Fluzone Group over Fluarix Dose A Group) was ≤ 1.50 in terms of anti-B/Florida titers.

    Primary: Number of subjects who seroconverted

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    End point title
    		 Number of subjects who seroconverted
    End point description
    Seroconversion rate was defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
    End point type
    Primary
    End point timeframe
    Day 28 or Day 56
    End point values
    		 Fluarix Dose A Group Fluarix Dose B Group Fluzone Group
    Number of subjects analysed
    1017
    1013
    1030
    Units: Subjects
        A/Brisbane
    636
    699
    929
        A/Uruguay
    747
    808
    988
        B/Florida
    812
    864
    904
    Statistical analysis title
    		 SCR difference A/Brisbane Fluzone/Fluarix Dose B
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of seroconversion rates [SCRs]) of Fluarix (Dose B) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluarix Dose B Group v Fluzone Group
    Number of subjects included in analysis
    2043
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 SCR difference
    Point estimate
    21.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.82
         upper limit
    		 24.58
    Notes
    [7] - The non-inferiority of the Fluarix Dose B Group as compared to the Fluzone Group was concluded if the upper limit of the two-sided 95% CI for the difference (Fluzone Group minus Fluarix Dose B Group) in SCR was ≤ 10% for the 3 strains.
    Statistical analysis title
    		 SCR difference A/Uruguay Fluzone/Fluarix Dose B
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of seroconversion rates [SCRs]) of Fluarix (Dose B) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluarix Dose B Group v Fluzone Group
    Number of subjects included in analysis
    2043
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 SCR difference
    Point estimate
    16.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.46
         upper limit
    		 18.98
    Notes
    [8] - The non-inferiority of the Fluarix Dose B Group as compared to the Fluzone Group was concluded if the upper limit of the two-sided 95% CI for the difference (Fluzone Group minus Fluarix Dose B Group) in SCR was ≤ 10% for the 3 strains.
    Statistical analysis title
    		 SCR difference B/Florida Fluzone/Fluarix Dose B
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of seroconversion rates [SCRs]) of Fluarix (Dose B) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluarix Dose B Group v Fluzone Group
    Number of subjects included in analysis
    2043
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 SCR difference
    Point estimate
    2.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 5.45
    Notes
    [9] - The non-inferiority of the Fluarix Dose B Group as compared to the Fluzone Group was concluded if the upper limit of the two-sided 95% CI for the difference (Fluzone Group minus Fluarix Dose B Group) in SCR was ≤ 10% for the 3 strains.
    Statistical analysis title
    		 SCR difference A/Brisbane Fluzone/Fluarix Dose A
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of seroconversion rates [SCRs]) of Fluarix (Dose A) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluzone Group v Fluarix Dose A Group
    Number of subjects included in analysis
    2047
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 SCR difference
    Point estimate
    27.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.16
         upper limit
    		 31.14
    Notes
    [10] - The non-inferiority of the Fluarix Dose A Group as compared to the Fluzone Group was concluded if the upper limit of the two-sided 95% CI for the difference (Fluzone Group minus Fluarix Dose A Group) in SCR was ≤ 10% for the 3 strains.
    Statistical analysis title
    		 SCR difference A/Uruguay Fluzone/Fluarix Dose A
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of seroconversion rates [SCRs]) of Fluarix (Dose A) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluzone Group v Fluarix Dose A Group
    Number of subjects included in analysis
    2047
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    Parameter type
    		 SCR difference
    Point estimate
    22.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.54
         upper limit
    		 25.49
    Notes
    [11] - The non-inferiority of the Fluarix Dose A Group as compared to the Fluzone Group was concluded if the upper limit of the two-sided 95% CI for the difference (Fluzone Group minus Fluarix Dose A Group) in SCR was ≤ 10% for the 3 strains.
    Statistical analysis title
    		 SCR difference B/Florida Fluzone/Fluarix Dose A
    Statistical analysis description
    To demonstrate the immunological non-inferiority (in terms of seroconversion rates [SCRs]) of Fluarix (Dose A) vaccine versus Fluzone vaccine in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial intramuscular vaccination.
    Comparison groups
    Fluarix Dose A Group v Fluzone Group
    Number of subjects included in analysis
    2047
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [12]
    Method
    Parameter type
    		 SCR difference
    Point estimate
    7.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.75
         upper limit
    		 11.12
    Notes
    [12] - The non-inferiority of the Fluarix Dose A Group as compared to the Fluzone Group was concluded if the upper limit of the two-sided 95% CI for the difference (Fluzone Group minus Fluarix Dose A Group) in SCR was ≤ 10% for the 3 strains.

    Secondary: Number of Seroprotected Subjects

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    End point title
    		 Number of Seroprotected Subjects
    End point description
    A seroprotected subject is a subject with a serum anti-HA titer ≥ 1:40 Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
    End point type
    Secondary
    End point timeframe
    Day 0 (PRE), Day 28 or Day 56 (POST)
    End point values
    		 Fluarix Dose A Group Fluarix Dose B Group Fluzone Group
    Number of subjects analysed
    1018
    1016
    1031
    Units: Subjects
        A/Brisbane (PRE) (N=1017; 1013; 1030)
    185
    186
    206
        A/Brisbane (POST) (N=1018; 1016; 1031)
    699
    754
    986
        A/Uruguay (PRE) (N=1017; 1013; 1030)
    222
    193
    214
        A/Uruguay (POST) (N=1018; 1016; 1031)
    788
    846
    1012
        B/Florida (PRE) (N=1017; 1013; 1030)
    171
    181
    166
        B/Florida (POST) (N=1018; 1016; 1031)
    872
    902
    935
    No statistical analyses for this end point

    Secondary: Seroconversion factor

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    End point title
    		 Seroconversion factor
    End point description
    Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0). Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
    End point type
    Secondary
    End point timeframe
    Day 28 or Day 56
    End point values
    		 Fluarix Dose A Group Fluarix Dose B Group Fluzone Group
    Number of subjects analysed
    1017
    1013
    1030
    Units: fold increase
    geometric mean (confidence interval 95%)
        A/Brisbane
    10.2 (9.2 to 11.4)
    12.4 (11.2 to 13.7)
    21.4 (19.9 to 23.1)
        A/Uruguay
    10.4 (9.6 to 11.3)
    14.2 (13.1 to 15.4)
    24.1 (22.6 to 25.7)
        B/Florida
    13.4 (12.4 to 14.5)
    18.4 (17 to 20)
    21.4 (19.7 to 23.1)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local symptoms

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    End point title
    		 Number of subjects reporting solicited local symptoms
    End point description
    Solicited local symptoms assessed included pain, redness and swelling.
    End point type
    Secondary
    End point timeframe
    During a 4-day follow-up period after vaccination
    End point values
    		 Fluarix Dose A Group Fluarix Dose B Group Fluzone Group
    Number of subjects analysed
    1081
    1086
    1090
    Units: Subjects
        Pain
    403
    406
    363
        Redness
    259
    249
    253
        Swelling
    152
    170
    129
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general symptoms

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    End point title
    		 Number of subjects reporting solicited general symptoms
    End point description
    Solicited general symptoms assessed included drowsiness, irritability, loss of appetitie, and temperature.
    End point type
    Secondary
    End point timeframe
    During a 4-day follow-up period after vaccination
    End point values
    		 Fluarix Dose A Group Fluarix Dose B Group Fluzone Group
    Number of subjects analysed
    1080
    1086
    1090
    Units: Subjects
        Drowsiness
    293
    317
    298
        Irritability
    386
    387
    375
        Loss of appetite
    281
    273
    270
        Temperature
    67
    69
    72
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events (AE)

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    End point title
    		 Number of subjects reporting unsolicited adverse events (AE)
    End point description
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
    End point type
    Secondary
    End point timeframe
    During a 28-day follow-up period after vaccination
    End point values
    		 Fluarix Dose A Group Fluarix Dose B Group Fluzone Group
    Number of subjects analysed
    1107
    1106
    1104
    Units: Subjects
        Unsolicited adverse events (AE)
    565
    541
    562
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAE) and new onset of chronic diseases (NOCD)

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    End point title
    		 Number of subjects reporting serious adverse events (SAE) and new onset of chronic diseases (NOCD)
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders
    End point type
    Secondary
    End point timeframe
    During the entire study (Day 0 until Month 6)
    End point values
    		 Fluarix Dose A Group Fluarix Dose B Group Fluzone Group
    Number of subjects analysed
    1107
    1106
    1104
    Units: Subjects
        SAE
    35
    29
    31
        NOCD
    10
    8
    9
    No statistical analyses for this end point

    Secondary: Number of subjects reporting rare serious events

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    End point title
    		 Number of subjects reporting rare serious events
    End point description
    Rare serious events have an occurrence rate of 1/300 (0.3%).
    End point type
    Secondary
    End point timeframe
    During the entire study (Day 0 until Month 6)
    End point values
    		 Fluarix Dose A Group Fluarix Dose B Group Fluzone Group
    Number of subjects analysed
    1107
    1106
    1104
    Units: Subjects
        Pneumonia
    0
    0
    3
        Bronchiolitis
    0
    3
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs: Day 0 to Month 6; Unsolicted AEs: During the 28-day post-vaccination period; Solicited local and general symptoms: During the 4-day post-vaccination period.
    Adverse event reporting additional description
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Fluarix Dose A Group
    Reporting group description
    		 Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

    Reporting group title
    Fluzone Group
    Reporting group description
    		 Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

    Reporting group title
    Fluarix Dose B Group
    Reporting group description
    		 Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

    Serious adverse events
    		 Fluarix Dose A Group Fluzone Group Fluarix Dose B Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 1107 (3.16%)
    31 / 1104 (2.81%)
    29 / 1106 (2.62%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electric shock
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body trauma
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury corneal
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    2 / 1107 (0.18%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 1107 (0.00%)
    2 / 1104 (0.18%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Coarctation of the aorta
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cyanosis
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enterocolitis
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    2 / 1107 (0.18%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    2 / 1106 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 1107 (0.18%)
    2 / 1104 (0.18%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Idiopathic urticaria
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    4 / 1107 (0.36%)
    3 / 1104 (0.27%)
    3 / 1106 (0.27%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 1107 (0.09%)
    1 / 1104 (0.09%)
    2 / 1106 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    6 / 1107 (0.54%)
    2 / 1104 (0.18%)
    4 / 1106 (0.36%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 1107 (0.18%)
    4 / 1104 (0.36%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 1107 (0.09%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 1107 (0.00%)
    2 / 1104 (0.18%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 1107 (0.36%)
    3 / 1104 (0.27%)
    4 / 1106 (0.36%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia primary atypical
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 1107 (0.09%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 1107 (0.00%)
    2 / 1104 (0.18%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 1107 (0.63%)
    4 / 1104 (0.36%)
    4 / 1106 (0.36%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    0 / 1107 (0.00%)
    2 / 1104 (0.18%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 1107 (0.00%)
    1 / 1104 (0.09%)
    0 / 1106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 1107 (0.00%)
    0 / 1104 (0.00%)
    1 / 1106 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Fluarix Dose A Group Fluzone Group Fluarix Dose B Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    565 / 1107 (51.04%)
    562 / 1104 (50.91%)
    541 / 1106 (48.92%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    53 / 1107 (4.79%)
    62 / 1104 (5.62%)
    52 / 1106 (4.70%)
         occurrences all number
    53
    62
    52
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    403 / 1107 (36.40%)
    363 / 1104 (32.88%)
    406 / 1106 (36.71%)
         occurrences all number
    403
    363
    406
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    259 / 1107 (23.40%)
    253 / 1104 (22.92%)
    249 / 1106 (22.51%)
         occurrences all number
    259
    253
    249
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    152 / 1107 (13.73%)
    129 / 1104 (11.68%)
    170 / 1106 (15.37%)
         occurrences all number
    152
    129
    170
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    293 / 1107 (26.47%)
    298 / 1104 (26.99%)
    317 / 1106 (28.66%)
         occurrences all number
    293
    298
    317
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    386 / 1107 (34.87%)
    375 / 1104 (33.97%)
    387 / 1106 (34.99%)
         occurrences all number
    386
    375
    387
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    281 / 1107 (25.38%)
    270 / 1104 (24.46%)
    273 / 1106 (24.68%)
         occurrences all number
    281
    270
    273
    Temperature
    alternative assessment type: Systematic
         subjects affected / exposed
    67 / 1107 (6.05%)
    72 / 1104 (6.52%)
    69 / 1106 (6.24%)
         occurrences all number
    67
    72
    69
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    62 / 1107 (5.60%)
    60 / 1104 (5.43%)
    42 / 1106 (3.80%)
         occurrences all number
    62
    60
    42
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    59 / 1107 (5.33%)
    60 / 1104 (5.43%)
    70 / 1106 (6.33%)
         occurrences all number
    59
    60
    70
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    135 / 1107 (12.20%)
    139 / 1104 (12.59%)
    116 / 1106 (10.49%)
         occurrences all number
    135
    139
    116
    Nasopharyngitis
         subjects affected / exposed
    139 / 1107 (12.56%)
    123 / 1104 (11.14%)
    119 / 1106 (10.76%)
         occurrences all number
    139
    123
    119
    Pharyngitis
         subjects affected / exposed
    49 / 1107 (4.43%)
    52 / 1104 (4.71%)
    60 / 1106 (5.42%)
         occurrences all number
    49
    52
    60

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Aug 2008
    The rationale for this amendment was to include respiratory rate and heart rate measures at visit Day 0, change in the number of subjects planned (from 150 to 300) for interim analyses and recruitment plan was changed as enrollment plan was not available.

    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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