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    Clinical Trial Results:
    Estudio fase II, aleatorizado, abierto, multicéntrico para evaluar la seguridad e inmunogenicidad de la vacuna experimental adyuvada de gripe pandémica H1N1 administrada como primovacunación y booster en niños entre 6 y 35 meses de edad.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2009-013783-39
    Trial protocol
    		 ES  
    Global end of trial date
    24 Nov 2010

    Results information
    Results version number
    		 v2
    This version publication date
    07 Apr 2016
    First version publication date
    18 Apr 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; Correction of errors

    Trial information

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    Trial identification
    Sponsor protocol code
    113462
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00971321
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Glaxo Smith Kline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, Glaxo Smith Kline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, Glaxo Smith Kline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000725-PIP01-09
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Mar 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Nov 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate whether the haemagglutination-inhibition (HI) immune response to the vaccine-homologous virus of Flu 1 vaccine meets or exceeds the European Medicines Agency, EMEA (Committee for Medicinal Products for Human Use, CHMP) criteria* 21 days post dose 2 vaccination.
    Protection of trial subjects
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Sep 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
    Spain: 157
    Worldwide total number of subjects
    157
    EEA total number of subjects
    157
    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)
    157
    Children (2-11 years)
    0
    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
    Final Analysis (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK2340272A Formulation 1 Group
    Arm description
    		 Subjects received two doses of GSK2340272A Formulation 1 vaccine according to a 0, 21-day schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2340272A Formulation 1
    Investigational medicinal product code
    Other name
    Pandemic influenza vaccine GSK2340272A
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary intramuscular (IM) doses administered in the deltoid region of the arm or in the anterolateral part of the thigh if the subject was < 12 months at study entry, at days 0 and 21.

    Arm title
    		 GSK2340272A Formulation 2 Group
    Arm description
    		 Subjects received two doses of GSK2340272A Formulation 2 vaccine according to a 0, 21-day schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2340272A Formulation 2
    Investigational medicinal product code
    Other name
    Pandemic influenza vaccine GSK2340272A
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary intramuscular (IM) doses administered in the deltoid region of the arm or in the anterolateral part of the thigh if the subject was < 12 months at study entry, at days 0 and 21.

    Number of subjects in period 1
    		GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Started
    104
    53
    Completed
    99
    50
    Not completed
    5
    3
         Consent withdrawn by subject
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2340272A Formulation 1 Group
    Reporting group description
    		 Subjects received two doses of GSK2340272A Formulation 1 vaccine according to a 0, 21-day schedule.

    Reporting group title
    GSK2340272A Formulation 2 Group
    Reporting group description
    		 Subjects received two doses of GSK2340272A Formulation 2 vaccine according to a 0, 21-day schedule.

    Reporting group values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group Total
    Number of subjects
    		 104 53 157
    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)
    		 19.3 ( 9.33 ) 19.7 ( 8.81 ) -
    Gender categorical
    Units: Subjects
        Female
    		 43 26 69
        Male
    		 61 27 88

    End points

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    End points reporting groups
    Reporting group title
    GSK2340272A Formulation 1 Group
    Reporting group description
    		 Subjects received two doses of GSK2340272A Formulation 1 vaccine according to a 0, 21-day schedule.

    Reporting group title
    GSK2340272A Formulation 2 Group
    Reporting group description
    		 Subjects received two doses of GSK2340272A Formulation 2 vaccine according to a 0, 21-day schedule.

    Primary: Haemagglutination inhibition HI antibody titers against Fluarix vaccine containing H1N1 strain

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    End point title
    		 Haemagglutination inhibition HI antibody titers against Fluarix vaccine containing H1N1 strain [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    At Day 0 and Day 42
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Following the primary outcome measure of this study, the analysis was performed on the GSK2340272A Formulation 1 Group only.
    End point values
    		 GSK2340272A Formulation 1 Group
    Number of subjects analysed
    101
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/2009, Day 0 [N=101]
    5.75 (5 to 6.63)
        Flu A/CAL/7/2009, Day 42 [N=97]
    2007.7 (1805.24 to 2232.87)
    No statistical analyses for this end point

    Primary: Number of subjects with HI antibody titers ≥ 1:10

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    End point title
    		 Number of subjects with HI antibody titers ≥ 1:10 [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    At Day 0 and Day 42
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Following the primary outcome measure of this study, the analysis was performed on the GSK2340272A Formulation 1 Group only.
    End point values
    		 GSK2340272A Formulation 1 Group
    Number of subjects analysed
    101
    Units: Subjects
        Flu A/CAL/7/2009, Day 0 [N=101]
    5
        Flu A/CAL/7/2009, Day 42 [N=97]
    97
    No statistical analyses for this end point

    Primary: Number of seroconverted subjects in terms of HI antibodies

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    End point title
    		 Number of seroconverted subjects in terms of HI antibodies [5] [6]
    End point description
    Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre for GSK2340272A Formulation 1 Group
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Following the primary outcome measure of this study, the analysis was performed on the GSK2340272A Formulation 1 Group only.
    End point values
    		 GSK2340272A Formulation 1 Group
    Number of subjects analysed
    97
    Units: Subjects
        Flu A/CAL/7/2009 [Day 42]
    97
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for HI antibodies

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    End point title
    		 Number of seroprotected subjects for HI antibodies [7] [8]
    End point description
    Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Following the primary outcome measure of this study, the analysis was performed on the GSK2340272A Formulation 1 Group only.
    End point values
    		 GSK2340272A Formulation 1 Group
    Number of subjects analysed
    97
    Units: Subjects
        Flu A/CAL/7/2009 [Day 42]
    97
    No statistical analyses for this end point

    Primary: Seroconvertion factor for HI antibody titre

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    End point title
    		 Seroconvertion factor for HI antibody titre [9] [10]
    End point description
    Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A Seroconverted subject was a subject with a serum HI GMTs post-vaccination compared to pre-vaccination. The criterion is fulfilled if the point estimate for SCF was > 2.5 in subjects 18 to 60 years of age for GSK2340272A Formulation 1 Group
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Following the primary outcome measure of this study, the analysis was performed on the GSK2340272A Formulation 1 Group only.
    End point values
    		 GSK2340272A Formulation 1 Group
    Number of subjects analysed
    97
    Units: Fold increase
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/2009 [Day 42]
    346.86 (287.54 to 418.42)
    No statistical analyses for this end point

    Secondary: HI antibody titers

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    End point title
    		 HI antibody titers
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21, Day 42 and Months 11-12
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    83
    37
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/2009 Day 0 [N=83,37]
    5.8 (5 to 6.8)
    6.2 (5 to 7.8)
        Flu A/CAL/7/2009 Day 21 [N=83,37]
    234 (202.9 to 269.8)
    255.5 (205.4 to 317.9)
        Flu A/CAL/7/2009 Day 42 [N=83,37]
    1758 (1553.8 to 1989.1)
    1879.2 (1504.2 to 2347.7)
        Flu A/CAL/7/2009 Months 11-12 [N=83,37]
    212.5 (182.8 to 247)
    239.3 (201.6 to 284)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-HIs antibody concentrations ≥ 1:10

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    End point title
    		 Number of subjects with anti-HIs antibody concentrations ≥ 1:10
    End point description
    End point type
    Secondary
    End point timeframe
    At Days 0, 21, 42 and Months 11-12
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    83
    37
    Units: Subjects
        Flu A/CAL/7/2009 Day 0 [N=83,37]
    4
    4
        Flu A/CAL/7/2009 Day 21 [N=83,37]
    83
    37
        Flu A/CAL/7/2009 Day 42 [N=83,37]
    83
    37
        Flu A/CAL/7/2009, Month 11-12 [N=83,37]
    83
    37
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for HI antibodies

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    End point title
    		 Number of seroconverted subjects for HI antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 21, Day 42 and Month 11-12
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    83
    37
    Units: Subjects
        Flu A/CAL/7/2009 Day 21 [N=83,37]
    82
    37
        Flu A/CAL/7/2009 Day 42 [N=83,37]
    83
    37
        Flu A/CAL/7/2009 Months 11-12 [N=83,37]
    81
    36
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for HI antibodies

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    End point title
    		 Number of seroprotected subjects for HI antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    At Days 0, 21, 42 and Month 11-12
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    83
    37
    Units: Subjects
        Flu A/CAL/7/2009 Day 0 [N=83,37]
    3
    3
        Flu A/CAL/7/2009 Day 21 [N=83,37]
    83
    37
        Flu A/CAL/7/2009 Day 42 [N=83,37]
    83
    37
        Flu A/CAL/7/2009 Months 11-12 [N=83,37]
    83
    37
    No statistical analyses for this end point

    Secondary: Seroconversion factor for HI antibody titre

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    End point title
    		 Seroconversion factor for HI antibody titre
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 21, Day 42 and Month 11-12
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    83
    37
    Units: Fold increase
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/2009 Day 21 [N=37;83]
    40.3 (34.3 to 47.2)
    41.2 (32.2 to 52.7)
        Flu A/CAL/7/2009 Day 42 [N=37;83]
    302.5 (248.2 to 368.7)
    302.8 (211.8 to 432.9)
        Flu A/CAL/7/2009 Month 11-12 [N=37;83]
    36.6 (30 to 44.6)
    38.6 (29.5 to 50.4)
    No statistical analyses for this end point

    Secondary: Serum neutralising antibody titres

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    End point title
    		 Serum neutralising antibody titres
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21, Day 42 and Month 11-12
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    57
    24
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/Neth/602/09 Day 0 [N=57,24]
    5.6 (3.9 to 7.9)
    5.7 (3.6 to 8.9)
        Flu A/Neth/602/09 Day 21 [N=53,23]
    36.9 (24.5 to 55.4)
    50.8 (25.6 to 100.7)
        Flu A/Neth/602/09 Day 42 [N=54,23]
    1416.1 (1048.1 to 1913.3)
    1960.6 (1097 to 3504)
        Flu A/Neth/602/09 Months 11-12 [N=49,22]
    312.8 (223.1 to 438.6)
    444.4 (286.5 to 689.3)
    No statistical analyses for this end point

    Secondary: Vaccine response for neutralising antibodies

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    End point title
    		 Vaccine response for neutralising antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 21, Day 42 and Month 11-12
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    25
    12
    Units: Subjects
        Flu A/Neth/602/2009 Day 21 [N=25,12]
    14
    8
        Flu A/Neth/602/2009 Day 42 [N=25,12]
    24
    12
        Flu A/Neth/602/2009 Months 11-12 [N=22,10]
    19
    10
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    During a 7-day follow-up period, i.e., day of vaccination and six subsequent days after each vaccination.
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    104
    53
    Units: Subjects
        Pain Any Dose 1 [N=104,53]
    37
    31
        Pain Grade 3 Dose 1 [N=104,53]
    1
    0
        Redness Any Dose 1 [N=104,53]
    19
    17
        Redness Grade 3 Dose 1 [N=104,53]
    0
    2
        Swelling Any Dose 1 [N=104,53]
    12
    11
        Swelling Grade 3 Dose 1 [N=104,53]
    0
    1
        Pain Any Dose 2 [N=104,52]
    43
    27
        Pain Grade 3 Dose 2 [N=104,52]
    3
    2
        Redness Any Dose 2 [N=104,52]
    34
    23
        Redness Grade 3 Dose 2 [N=104,52]
    1
    6
        Swelling Any Dose 2 [N=104,52]
    30
    17
        Swelling Grade 3 Dose 2 [N=104,52]
    1
    4
        Pain Any Across Doses [N=104,53]
    54
    37
        Pain Grade 3 Across Doses [N=104,53]
    4
    2
        Redness Any Across Doses [N=104,53]
    41
    27
        Redness Grade 3 Across Doses [N=104,53]
    1
    6
        Swelling Any Across Doses [N=104,53]
    38
    21
        Swelling Grade 3 Across Doses [N=104,53]
    1
    5
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    During a 7-day follow-up period, i.e. day of vaccination and six subsequent days after each vaccination.
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    104
    53
    Units: Subjects
        Drowsiness Any Dose 1 [N=104,53]
    24
    14
        Drowsiness Grade 3 Dose 1 [N=104,53]
    0
    2
        Drowsiness Related Dose 1 [N=104,53]
    17
    11
        Irritability Any Dose 1 [N=104,53]
    33
    17
        Irritability Grade 3 Dose 1 [N=104,53]
    2
    5
        Irritability Related Dose 1 [N=104,53]
    28
    12
        Loss of appetite Any Dose 1 [N=104,53]
    25
    17
        Loss of appetite Grade 3 Dose 1 [N=104,53]
    1
    1
        Loss of appetite Related Dose 1 [N=104,53]
    18
    11
        Temperature Any Dose 1 [N=104,53]
    21
    13
        Temperature Grade 3 Dose 1 [N=104,53]
    1
    1
        Temperature Related Dose 1 [N=104,53]
    16
    10
        Drowsiness Any Dose 2 [N=104,52]
    36
    25
        Drowsiness Grade 3 Dose 2 [N=104,52]
    0
    2
        Drowsiness Related Dose 2 [N=104,52]
    35
    22
        Irritability Any Dose 2 [N=104,52]
    48
    31
        Irritability Grade 3 Dose 2 [N=104,52]
    3
    4
        Irritability Related Dose 2 [N=104,52]
    45
    27
        Loss of appetite Any Dose 2 [N=104,52]
    44
    30
        Loss of appetite Grade 3 Dose 2 [N=104,52]
    4
    4
        Loss of appetite Related Dose 2 [N=104,52]
    41
    26
        Temperature Any Dose 2 [N=104,52]
    70
    37
        Temperature Grade 3 Dose 2 [N=104,52]
    4
    9
        Temperature Related Dose 2 [N=104,52]
    64
    34
        Drowsiness Any Across Doses [N=104,53]
    47
    31
        Drowsiness Grade 3 Across Doses [N=104,53]
    0
    3
        Drowsiness Related Across Doses [N=104,53]
    43
    26
        Irritability Any Across Doses [N=104,53]
    60
    38
        Irritability Grade 3 Across Doses [N=104,53]
    5
    8
        Irritability Related Across Doses [N=104,53]
    54
    31
        Loss of appetite Any Across Doses [N=104,53]
    54
    35
        Loss of appetite Grade 3 Across Doses [N=104,53]
    5
    5
        Loss of appetite Related Across Doses [N=104,53]
    49
    29
        Temperature Any Across Doses [N=104,53]
    79
    41
        Temperature Grade 3 Across Doses [N=104,53]
    5
    10
        Temperature Related Across Doses [N=104,53]
    70
    37
    No statistical analyses for this end point

    Secondary: Number of subjects with medically-attended events (MAEs)

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    End point title
    		 Number of subjects with medically-attended events (MAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    104
    53
    Units: Subjects
        MAEs
    94
    45
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events of specific interest (AESIs)/potential immune-mediated disease (pIMDs)

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    End point title
    		 Number of subjects with adverse events of specific interest (AESIs)/potential immune-mediated disease (pIMDs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    104
    53
    Units: Subjects
        AESI(s)/pIMD(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with normal or abnormal values of biochemical parameters

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    End point title
    		 Number of subjects with normal or abnormal values of biochemical parameters
    End point description
    Biochemical parameters assessed were Alanine Amino Trasferase (ALAT), Aspartate Amino Transferase (ASAT), Bilirubin, Creatinine and Blood Urea Nitrogen (BUN).
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21 and Day 42.
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    104
    53
    Units: Subjects
        ALAT Day 0 [N=104,53]
    3
    4
        ALAT Day 21 [N=104,52]
    1
    1
        ALAT Day 42 [N=103,53]
    1
    0
        ASAT Day 0 [N=104,53]
    3
    3
        ASAT Day 21 [N=104,52]
    4
    3
        ASAT Day 42 [N=103,53]
    1
    0
        Bilirubin Total Day 0 [N=104,53]
    3
    4
        Bilirubin Direct Day 0 [N=104,53]
    3
    4
        Bilirubin Total Day 21 [N=104,52]
    2
    1
        Bilirubin Direct Day 21 [N=104,52]
    1
    1
        Bilirubin Total Day 42 [N=103,53]
    1
    0
        Bilirubin Direct Day 42 [N=103,53]
    1
    0
        Creatinine Day 0 [N=104,53]
    3
    3
        Creatinine Day 21 [N=104,52]
    1
    2
        Creatinine Day 42 [N=103,53]
    1
    0
        BUN Day 0 [N=104,53]
    3
    4
        BUN Day 21 [N=104,52]
    1
    1
        BUN Day 42 [N=103,53]
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the 83-day period following first vaccination and the 62-day period following second vaccination
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    104
    53
    Units: Subjects
        Any 3 AE(s)
    98
    47
        Grade 3 AE(s)
    18
    8
        Related AE(s)
    12
    8
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Number of subjects analysed
    104
    53
    Units: Subjects
        SAEs
    2
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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
    13.1
    Reporting groups
    Reporting group title
    GSK2340272A Formulation 1 Group
    Reporting group description
    		 -

    Reporting group title
    GSK2340272A Formulation 2 Group
    Reporting group description
    		 -

    Serious adverse events
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 104 (1.92%)
    6 / 53 (11.32%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Traumatic brain injury
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Viral rash
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 53 (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
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    98 / 104 (94.23%)
    47 / 53 (88.68%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    8 / 104 (7.69%)
    4 / 53 (7.55%)
         occurrences all number
    8
    4
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    6 / 104 (5.77%)
    0 / 53 (0.00%)
         occurrences all number
    6
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    15 / 104 (14.42%)
    7 / 53 (13.21%)
         occurrences all number
    15
    7
    Vomiting
         subjects affected / exposed
    6 / 104 (5.77%)
    9 / 53 (16.98%)
         occurrences all number
    6
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    13 / 104 (12.50%)
    7 / 53 (13.21%)
         occurrences all number
    13
    7
    Asthma
         subjects affected / exposed
    0 / 104 (0.00%)
    6 / 53 (11.32%)
         occurrences all number
    0
    6
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    7 / 104 (6.73%)
    0 / 53 (0.00%)
         occurrences all number
    7
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    59 / 104 (56.73%)
    24 / 53 (45.28%)
         occurrences all number
    59
    24
    Gastroenteritis
         subjects affected / exposed
    12 / 104 (11.54%)
    8 / 53 (15.09%)
         occurrences all number
    12
    8
    Bronchitis
         subjects affected / exposed
    11 / 104 (10.58%)
    6 / 53 (11.32%)
         occurrences all number
    11
    6
    Pharyngitis
         subjects affected / exposed
    11 / 104 (10.58%)
    0 / 53 (0.00%)
         occurrences all number
    11
    0
    Laryngitis
         subjects affected / exposed
    6 / 104 (5.77%)
    3 / 53 (5.66%)
         occurrences all number
    6
    3
    Otitis media
         subjects affected / exposed
    6 / 104 (5.77%)
    3 / 53 (5.66%)
         occurrences all number
    6
    3
    Otitis media acute
         subjects affected / exposed
    8 / 104 (7.69%)
    0 / 53 (0.00%)
         occurrences all number
    8
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 104 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    Rhinitis
         subjects affected / exposed
    0 / 104 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Apr 2010
    Amendment 5 Due to recent developments in the pandemic situation and following the feedback from the European authorities, the follow-up study FLU D-PAN H1N1-037 is no longer planned to be conducted. Therefore the protocol was amended to delete all references to this planned follow-up study.

    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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