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    Clinical Trial Results:
    A phase II, double-blind, multicenter, randomized study to evaluate the immunogenicity and safety of GSK Biologicals’ quadrivalent influenza candidate vaccine GSK2321138A compared with GSK Biologicals’ trivalent influenza vaccine, Fluarix™, administered intramuscularly in children (18-47 months of age) in both unprimed subjects and in primed subjects who previously participated in the 111751 study

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2012-002587-27
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 May 2010

    Results information
    Results version number
    		 v2
    This version publication date
    22 May 2016
    First version publication date
    15 Jul 2015
    Other versions
    		 v1 (removed from public view) , v3
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT – Results (Primary endpoint) Data (typos) were corrected for 1 secondary endpoint

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    113237
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00985790
    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 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, 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
    13 Sep 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 May 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    21 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To assess the immunological non-inferiority in terms of Geometric Mean Titers (GMTs) of the quadrivalent influenza study vaccine (FLU D-QIV) compared to the trivalent influenza vaccine (Fluarix™) in primed and unprimed subjects for the three recommended seasonal strains, 28 days after the last 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
    08 Oct 2009
    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
    Mexico: 599
    Worldwide total number of subjects
    599
    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)
    299
    Children (2-11 years)
    300
    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
    		 A total of 599 subjects were enrolled in the study, and assigned to either the GSK2321138A Group (298 subjects) or the Fluarix Group (301 subjects). Duration of study was of approximately 6 months for each subject.

    Pre-assignment
    Screening details
    		 For demography and safety, results are presented as per the main study groups. For some outcome measures and where relevant, subjects as in these 2 main groups are split according to their priming status at study entry.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK2321138A Group
    Arm description
    		 Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FLU D-QIV
    Investigational medicinal product code
    GSK2321138A
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccines were given intramuscularly in the deltoid of the right arm

    Arm title
    		 Fluarix Group
    Arm description
    		 Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
    Arm type
    		 Active comparator

    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
    The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.

    Number of subjects in period 1
    		GSK2321138A Group Fluarix Group
    Started
    298
    301
    Completed
    291
    293
    Not completed
    7
    8
         Consent withdrawn by subject
    1
    1
         Lost to follow-up
    6
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2321138A Group
    Reporting group description
    		 Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.

    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.

    Reporting group values
    		 GSK2321138A Group Fluarix Group Total
    Number of subjects
    		 298 301 599
    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)
    		 31.4 ± 8.46 31.6 ± 8.29 -
    Gender categorical
    Units: Subjects
        Female
    		 138 147 285
        Male
    		 160 154 314

    End points

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    End points reporting groups
    Reporting group title
    GSK2321138A Group
    Reporting group description
    		 Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.

    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.

    Subject analysis set title
    GSK2321138A-Primed Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.

    Subject analysis set title
    GSK2321138A-Unprimed Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.

    Subject analysis set title
    Fluarix-Primed Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.

    Subject analysis set title
    Fluarix-Unprimed Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.

    Primary: Titers for serum Hemagglutination Inhibition (HI) antibodies against the 3 Fluarix vaccine strains.

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    End point title
    		 Titers for serum Hemagglutination Inhibition (HI) antibodies against the 3 Fluarix vaccine strains.
    End point description
    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.
    End point type
    Primary
    End point timeframe
    At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]
    End point values
    		 GSK2321138A Group Fluarix Group
    Number of subjects analysed
    193
    193
    Units: titers
    geometric mean (confidence interval 95%)
        H1N1, PRE [N=189;192]
    22.2 (17.2 to 28.7)
    21.6 (16.7 to 28)
        H1N1, POST [N=193;193]
    173.8 (141.4 to 213.5)
    176.9 (143.3 to 218.5)
        H3N2, PRE [N=190;192]
    18.6 (14.9 to 23.2)
    20.8 (16.5 to 26.2)
        H3N2, POST [N=193;193]
    120.7 (101.2 to 143.9)
    130.4 (108 to 157.5)
        VICT, PRE [N=190;192]
    8.7 (7.3 to 10.2)
    9 (7.7 to 10.6)
        VICT, POST [N=192;193]
    61.9 (48.7 to 78.6)
    66.6 (52.4 to 84.7)
    Statistical analysis title
    		 Adjusted GMT ratio for FLU A/Bri/59/07 H1N1
    Statistical analysis description
    To assess the immunological non-inferiority in terms of Geometric Mean Titers (GMTs) of the GSK2321138A vaccine compared to the Fluarix vaccine in primed and unprimed subjects for the three recommended seasonal strains, 28 days after the last vaccination.
    Comparison groups
    GSK2321138A Group v Fluarix Group
    Number of subjects included in analysis
    386
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.33
    Notes
    [1] - Non-inferiority criterion: UL of the two-sided 95% CI on GMT ratio < 2.
    Statistical analysis title
    		 Adjusted GMT ratio for Flu A/Uru/716/07 H3N2
    Statistical analysis description
    To assess the immunological non-inferiority in terms of Geometric Mean Titers (GMTs) of the GSK2321138A vaccine compared to the Fluarix vaccine in primed and unprimed subjects for the three recommended seasonal strains, 28 days after the last vaccination.
    Comparison groups
    GSK2321138A Group v Fluarix Group
    Number of subjects included in analysis
    386
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.23
    Notes
    [2] - Non-inferiority criterion: UL of the two-sided 95% CI on GMT ratio < 2.
    Statistical analysis title
    		 Adjusted GMT ratio for FluB/Bri/60/08 Victoria
    Statistical analysis description
    To assess the immunological non-inferiority in terms of Geometric Mean Titers (GMTs) of the GSK2321138A vaccine compared to the Fluarix vaccine in primed and unprimed subjects for the three recommended seasonal strains, 28 days after the last vaccination.
    Comparison groups
    GSK2321138A Group v Fluarix Group
    Number of subjects included in analysis
    386
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.37
    Notes
    [3] - Non-inferiority criterion: UL of the two-sided 95% CI on GMT ratio < 2.

    Secondary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

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    End point title
    		 Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.
    End point description
    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
    End point type
    Secondary
    End point timeframe
    At Days 0 and 28.
    End point values
    		 GSK2321138A-Primed Group Fluarix-Primed Group
    Number of subjects analysed
    94
    95
    Units: titers
    geometric mean (confidence interval 95%)
        H1N1, Day 0
    40.3 (27 to 60.2)
    36.5 (24.3 to 54.9)
        H1N1, Day 28
    117 (83.2 to 164.5)
    124.4 (89.8 to 172.4)
        H3N2, Day 0
    22.8 (16.7 to 31.2)
    21.7 (16 to 29.5)
        H3N2, Day 28
    85.2 (64.8 to 112)
    83 (63.6 to 108.2)
        VICT, Day 0
    8.9 (7.2 to 11)
    9.7 (7.7 to 12.4)
        VICT, Day 28
    38.7 (26.2 to 57.1)
    44 (29.6 to 65.2)
        YAMA, Day 0
    29.3 (23 to 37.4)
    37.7 (29.8 to 47.8)
        YAMA, Day 28
    243.6 (198.1 to 299.6)
    127.2 (106.1 to 152.3)
    No statistical analyses for this end point

    Secondary: Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

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    End point title
    		 Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.
    End point description
    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
    End point type
    Secondary
    End point timeframe
    At Days 0, 28 and Day 56
    End point values
    		 GSK2321138A-Unprimed Group Fluarix-Unprimed Group
    Number of subjects analysed
    192
    198
    Units: titers
    geometric mean (confidence interval 95%)
        H1N1, Day 0 [N=190;198]
    14.7 (11.8 to 18.4)
    12.8 (10.5 to 15.7)
        H1N1, Day 28 [N=97;101]
    173.1 (113.1 to 264.8)
    161.6 (103.9 to 251.4)
        H1N1, Day 56 [N=99;98]
    253.1 (203.4 to 314.8)
    249 (192.5 to 321.9)
        H3N2, Day 0 [N=192;197]
    17.7 (14.1 to 22.1)
    17.9 (14.1 to 22.6)
        H3N2, Day 28 [N=96;101]
    99.3 (64.8 to 152.2)
    84.2 (54.1 to 131.2)
        H3N2, Day 56 [N=99;98]
    168.1 (136.6 to 206.7)
    202.1 (158.6 to 257.5)
        VICT, Day 0 [N=190;198]
    7.8 (6.7 to 9.2)
    8.7 (7.5 to 10.3)
        VICT, Day 28 [N=95;101]
    26.5 (17.7 to 39.7)
    34.6 (22.4 to 53.6)
        VICT, Day 56 [N=98;98]
    97.2 (74.9 to 126.1)
    99.6 (76.7 to 129.4)
        YAMA, Day 0 [N=188;198]
    9.1 (7.7 to 10.7)
    9.9 (8.4 to 11.8)
        YAMA, Day 28 [N=97;102]
    97 (64.7 to 145.4)
    30 (21.3 to 42.1)
        YAMA, Day 56 [N=99;98]
    311.1 (255.4 to 379.1)
    42.2 (30.6 to 58.1)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects against 4 strains of influenza disease.

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    End point title
    		 Number of seropositive subjects against 4 strains of influenza disease.
    End point description
    A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
    End point type
    Secondary
    End point timeframe
    At Days 0 and 28
    End point values
    		 GSK2321138A-Primed Group Fluarix-Primed Group
    Number of subjects analysed
    94
    95
    Units: Subjects
        H1N1, Day 0
    58
    54
        H1N1, Day 28
    83
    87
        H3N2, Day 0
    60
    59
        H3N2, Day 28
    88
    87
        VICT, Day 0
    26
    28
        VICT, Day 28
    62
    66
        YAMA, Day 0
    73
    80
        YAMA, Day 28
    93
    94
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects against 4 strains of influenza disease.

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    End point title
    		 Number of seropositive subjects against 4 strains of influenza disease.
    End point description
    A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
    End point type
    Secondary
    End point timeframe
    At Days 0, 28 and 56
    End point values
    		 GSK2321138A-Unprimed Group Fluarix-Unprimed Group
    Number of subjects analysed
    192
    198
    Units: Subjects
        H1N1, Day 0 [N=190;198]
    75
    71
        H1N1, Day 28 [N=97;101]
    83
    84
        H1N1, Day 56 [N=99;98]
    99
    96
        H3N2, Day 0 [N=192;197]
    85
    82
        H3N2, Day 28 [N=96;101]
    74
    78
        H3N2, Day 56 [N=99;98]
    99
    98
        VICT, Day 0 [N=190; 198]
    30
    42
        VICT, Day 28 [N=95; 101]
    51
    61
        VICT, Day 56 [N=98; 98]
    96
    94
        YAMA, Day 0 [N=188;198]
    45
    57
        YAMA, Day 28 [N=97;102]
    75
    57
        YAMA, Day 56 [N=99;98]
    98
    70
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects against 4 strains of influenza disease.

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    End point title
    		 Number of seroconverted subjects against 4 strains of influenza disease.
    End point description
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
    End point type
    Secondary
    End point timeframe
    At Day 28
    End point values
    		 GSK2321138A-Primed Group Fluarix-Primed Group
    Number of subjects analysed
    94
    95
    Units: Subjects
        H1N1, Day 28
    30
    39
        H3N2, Day 28
    48
    46
        VICT, Day 28
    46
    42
        YAMA, Day 28
    82
    40
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects against 4 strains of influenza disease.

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    End point title
    		 Number of seroconverted subjects against 4 strains of influenza disease.
    End point description
    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
    End point type
    Secondary
    End point timeframe
    At Days 28 and 56
    End point values
    		 GSK2321138A-Unprimed Group Fluarix-Unprimed Group
    Number of subjects analysed
    96
    101
    Units: Subjects
        H1N1, Day 28 [N=95;101]
    63
    74
        H1N1, Day 56 [N=95;97]
    81
    89
        H3N2, Day 28 [N=96;100]
    55
    54
        H3N2, Day 56 [N=96;97]
    79
    75
        VICT, Day 28 [N=94;101]
    34
    40
        VICT, Day 56 [N=95;97]
    77
    85
        YAMA, Day 28 [N=93;101]
    59
    40
        YAMA, Day 56 [N=95;97]
    90
    42
    No statistical analyses for this end point

    Secondary: Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

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    End point title
    		 Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.
    End point description
    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
    End point type
    Secondary
    End point timeframe
    At Day 28
    End point values
    		 GSK2321138A-Primed Group Fluarix-Primed Group
    Number of subjects analysed
    94
    95
    Units: fold increase
    geometric mean (confidence interval 95%)
        H1N1, Day 28
    2.9 (2.3 to 3.6)
    3.4 (2.7 to 4.2)
        H3N2, Day 28
    3.7 (3.1 to 4.5)
    3.8 (3.1 to 4.7)
        VICT, Day 28
    4.4 (3.3 to 5.8)
    4.5 (3.4 to 6)
        YAMA, Day 28
    8.3 (6.8 to 10.1)
    3.4 (2.8 to 4)
    No statistical analyses for this end point

    Secondary: Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

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    End point title
    		 Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.
    End point description
    The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
    End point type
    Secondary
    End point timeframe
    At Days 28 and 56
    End point values
    		 GSK2321138A-Unprimed Group Fluarix-Unprimed Group
    Number of subjects analysed
    96
    101
    Units: fold increase
    geometric mean (confidence interval 95%)
        H1N1, Day 28 [N=95;101]
    9.9 (7 to 14.1)
    12.7 (9.1 to 17.7)
        H1N1, Day 56 [N=95;97]
    19.8 (15.4 to 25.6)
    19.2 (15.2 to 24.2)
        H3N2, Day 28 [N=96;100]
    4.9 (3.7 to 6.3)
    5.1 (3.9 to 6.7)
        H3N2, Day 56 [N=96;97]
    11.1 (9 to 13.7)
    10.3 (8.3 to 12.9)
        VICT, Day 28 [N=94;101]
    3.6 (2.7 to 5)
    3.8 (2.9 to 5)
        VICT, Day 56 [N=95;97]
    11.3 (9.4 to 13.6)
    12.1 (9.8 to 14.8)
        YAMA, Day 28 [N=93;101]
    9.9 (6.9 to 14)
    3.4 (2.5 to 4.5)
        YAMA, Day 56 [N=95;97]
    35.1 (27.6 to 44.6)
    3.7 (2.9 to 4.8)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against 4 strains of influenza disease.

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    End point title
    		 Number of seroprotected subjects against 4 strains of influenza disease.
    End point description
    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
    End point type
    Secondary
    End point timeframe
    At Days 0 and 28
    End point values
    		 GSK2321138A-Primed Group Fluarix-Primed Group
    Number of subjects analysed
    94
    95
    Units: Subjects
        H1N1, Day 0
    48
    45
        H1N1, Day 28
    73
    78
        H3N2, Day 0
    39
    36
        H3N2, Day 28
    75
    80
        VICT, Day 0
    16
    20
        VICT, Day 28
    50
    52
        YAMA, Day 0
    56
    62
        YAMA, Day 28
    91
    90
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against 4 strains of influenza disease.

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    End point title
    		 Number of seroprotected subjects against 4 strains of influenza disease.
    End point description
    A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
    End point type
    Secondary
    End point timeframe
    At Days 0, 28 and 56
    End point values
    		 GSK2321138A-Unprimed Group Fluarix-Unprimed Group
    Number of subjects analysed
    192
    198
    Units: Subjects
        H1N1, Day 0 [N=190;198]
    58
    54
        H1N1, Day 28 [N=97;101]
    76
    78
        H1N1, Day 56 [N=99;98]
    95
    94
        H3N2, Day 0 [N=192;197]
    74
    70
        H3N2, Day 28 [N=96;101]
    64
    61
        H3N2, Day 56 [N=99;98]
    96
    94
        VICT, Day 0 [N=190;198]
    25
    35
        VICT, Day 28 [N=95;101]
    36
    41
        VICT, Day 56 [N=98;98]
    84
    88
        YAMA, Day 0 [N=188;198]
    37
    40
        YAMA, Day 28 [N=97;102]
    67
    53
        YAMA, Day 56 [N=99;98]
    98
    59
    No statistical analyses for this end point

    Secondary: Number of subjects with any and grade 3 solicited local symptoms.

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    End point title
    		 Number of subjects with any and grade 3 solicited local symptoms.
    End point description
    Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 7-day follow-up period (Days 0 to 6) after any vaccination
    End point values
    		 GSK2321138A Group Fluarix Group
    Number of subjects analysed
    293
    298
    Units: Subjects
        Any Pain
    125
    116
        Grade 3 Pain
    4
    1
        Any Redness
    31
    34
        Redness >50 mm
    0
    0
        Any Swelling
    27
    24
        Swelling >50 mm
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related solicited general symptoms.

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    End point title
    		 Number of subjects with any, grade 3 and related solicited general symptoms.
    End point description
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms assessed by the investigator as related to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 temperature: ≥ 39.0°C.
    End point type
    Secondary
    End point timeframe
    During the 7-day follow-up period (Days 0 to 6) after any vaccination
    End point values
    		 GSK2321138A Group Fluarix Group
    Number of subjects analysed
    293
    298
    Units: Subjects
        Any Drowsiness
    70
    62
        Grade 3 Drowsiness
    2
    0
        Related Drowsiness
    64
    57
        Any Irritability
    90
    87
        Grade 3 Irritability
    4
    2
        Related Irritability
    83
    78
        Any Loss of appetite
    89
    86
        Grade 3 Loss of appetite
    4
    3
        Related Loss of appetite
    79
    68
        Temperature ≥ 37.5°C
    74
    79
        Temperature > 39.0°C
    3
    3
        Related Temperature
    63
    62
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related unsolicited adverse events (AEs).

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    End point title
    		 Number of subjects with any, grade 3 and related unsolicited adverse events (AEs).
    End point description
    An unsolicited AE covers any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 28-day follow-up period (Days 0 to 27) after vaccination
    End point values
    		 GSK2321138A Group Fluarix Group
    Number of subjects analysed
    298
    301
    Units: Subjects
        Subjects with any AE(s)
    116
    118
        Subjects with Grade 3 AE(s)
    10
    12
        Subjects with related AE(s)
    7
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with any and related serious adverse events (SAEs).

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    End point title
    		 Number of subjects with any and related serious adverse events (SAEs).
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Day 180 (study conclusion)
    End point values
    		 GSK2321138A Group Fluarix Group
    Number of subjects analysed
    298
    301
    Units: Subjects
        Any SAE(s)
    0
    2
        Related SAE(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any adverse events of specific interest (AESIs).

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    End point title
    		 Number of subjects with any adverse events of specific interest (AESIs).
    End point description
    An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Day 180 (study conclusion)
    End point values
    		 GSK2321138A Group Fluarix Group
    Number of subjects analysed
    298
    301
    Units: Subjects
        Subjects with any AESI(s)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
    Adverse event reporting additional description
    The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.

    Reporting group title
    GSK2321138A Group
    Reporting group description
    		 Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.

    Serious adverse events
    		 Fluarix Group GSK2321138A Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 301 (0.66%)
    0 / 298 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    1 / 301 (0.33%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Fluarix Group GSK2321138A Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 301 (38.54%)
    125 / 298 (41.95%)
    General disorders and administration site conditions
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    62 / 298 (20.81%)
    70 / 293 (23.89%)
         occurrences all number
    62
    70
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    87 / 298 (29.19%)
    90 / 293 (30.72%)
         occurrences all number
    87
    90
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    86 / 298 (28.86%)
    89 / 293 (30.38%)
         occurrences all number
    86
    89
    Temperature
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    79 / 298 (26.51%)
    74 / 293 (25.26%)
         occurrences all number
    79
    74
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    116 / 298 (38.93%)
    125 / 293 (42.66%)
         occurrences all number
    116
    125
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    34 / 298 (11.41%)
    31 / 293 (10.58%)
         occurrences all number
    34
    31
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    24 / 298 (8.05%)
    27 / 293 (9.22%)
         occurrences all number
    24
    27
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    69 / 301 (22.92%)
    72 / 298 (24.16%)
         occurrences all number
    69
    72
    Pharyngitis
         subjects affected / exposed
    21 / 301 (6.98%)
    20 / 298 (6.71%)
         occurrences all number
    21
    20
    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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).

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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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