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    Clinical Trial Results:
    A Phase II, non-randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted (pre-) pandemic H5N1 influenza candidate vaccine following a heterologous prime-boost schedule (six months apart) in children aged 6 to 35 months.

    Summary
    EudraCT number
    		 2011-004734-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    02 Nov 2012

    Results information
    Results version number
    		 v1
    This version publication date
    13 May 2016
    First version publication date
    24 May 2015
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    109825
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01323946
    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 Disclosure Advisor, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000160-PIP01-07
    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
    14 Feb 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jun 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether a heterologous booster dose of H5N1 (A/turkey/Turkey/1/2005) haemagglutinin (HA) given 6 months following a 2-dose primary vaccination series with H5N1 (A/Indonesia/05/2005) HA elicits an antibody response that meets the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) guidance targets for pre-pandemic vaccine seroconversion rate (SCR)*, seroprotection rate (SPR)* and mean geometric increase (MGI)* based on haemagglutination inhibition (HI) responses to A/turkey/Turkey/1/2005 (H5N1) ten days following booster 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
    18 Apr 2011
    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
    Australia: 29
    Country: Number of subjects enrolled
    Singapore: 84
    Worldwide total number of subjects
    113
    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)
    80
    Children (2-11 years)
    33
    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
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK1562902A 6<12 M Group
    Arm description
    		 Subjects between 6 and 12 months of age, who received 2 primary doses of A/Indonesia/05/2005 H5N1 vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1562902A vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the anterolateral thigh

    Arm title
    		 GSK1562902A 12<24 M Group
    Arm description
    		 Subjects between 12 and 24 months of age, who received 2 primary doses of A/Indonesia/05/2005 H5N1 vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1562902A vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid region of arm

    Investigational medicinal product name
    GSK1562902A vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid region of arm

    Arm title
    		 GSK1562902A 24<36 M Group
    Arm description
    		 Subjects between 24 and 36 months of age, who received 2 primary doses of A/Indonesia/05/2005 H5N1 vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1562902A vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid region of arm

    Number of subjects in period 1
    		GSK1562902A 6<12 M Group GSK1562902A 12<24 M Group GSK1562902A 24<36 M Group
    Started
    46
    34
    33
    Completed
    43
    31
    33
    Not completed
    3
    3
    0
         Consent withdrawn by subject
    3
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK1562902A 6<12 M Group
    Reporting group description
    		 Subjects between 6 and 12 months of age, who received 2 primary doses of A/Indonesia/05/2005 H5N1 vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.

    Reporting group title
    GSK1562902A 12<24 M Group
    Reporting group description
    		 Subjects between 12 and 24 months of age, who received 2 primary doses of A/Indonesia/05/2005 H5N1 vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.

    Reporting group title
    GSK1562902A 24<36 M Group
    Reporting group description
    		 Subjects between 24 and 36 months of age, who received 2 primary doses of A/Indonesia/05/2005 H5N1 vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.

    Reporting group values
    		 GSK1562902A 6<12 M Group GSK1562902A 12<24 M Group GSK1562902A 24<36 M Group Total
    Number of subjects
    		 46 34 33 113
    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)
    		 8.3 ± 1.56 16.1 ± 3.44 29.6 ± 3.38 -
    Gender categorical
    Units: Subjects
        Female
    		 25 19 19 63
        Male
    		 21 15 14 50
    Subject analysis sets

    Subject analysis set title
    GSK1562902A Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 2 primary doses of A/Indonesia/05/2005 H5N1 vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.

    Subject analysis sets values
    		 GSK1562902A Group
    Number of subjects
    113
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    16.9 ± 9.29
    Gender categorical
    Units: Subjects
        Female
    63
        Male
    50

    End points

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    End points reporting groups
    Reporting group title
    GSK1562902A 6<12 M Group
    Reporting group description
    		 Subjects between 6 and 12 months of age, who received 2 primary doses of A/Indonesia/05/2005 H5N1 vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.

    Reporting group title
    GSK1562902A 12<24 M Group
    Reporting group description
    		 Subjects between 12 and 24 months of age, who received 2 primary doses of A/Indonesia/05/2005 H5N1 vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.

    Reporting group title
    GSK1562902A 24<36 M Group
    Reporting group description
    		 Subjects between 24 and 36 months of age, who received 2 primary doses of A/Indonesia/05/2005 H5N1 vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.

    Subject analysis set title
    GSK1562902A Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 2 primary doses of A/Indonesia/05/2005 H5N1 vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 H5N1 vaccine on Day 182.

    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 [1]
    End point description
    HI antibody concentration against A/turkey/Turkey/01/2005
    End point type
    Primary
    End point timeframe
    At Day 192
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    83
    Units: Subjects
        A/turkey/Turkey/01/2005.HA [Day 192]
    83
    No statistical analyses for this end point

    Primary: Geometric mean of the within-subject ratios

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    End point title
    		 Geometric mean of the within-subject ratios [2]
    End point description
    HI antibody concentration against Flu A/Turk/01/05 (H5N1)
    End point type
    Primary
    End point timeframe
    At Day 192
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    83
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/Turk/01/05 (H5N1).HA [Day 192]
    357.7 (302.4 to 423.2)
    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 [3]
    End point description
    HI antibody concentration against A/turkey/Turkey/01/2005
    End point type
    Primary
    End point timeframe
    At Day 192
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    83
    Units: Subjects
        A/turkey/Turkey/01/2005.HA [Day192]
    83
    No statistical analyses for this end point

    Secondary: HI antibody titers

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    End point title
    		 HI antibody titers
    End point description
    HI antibody concentration against A/Indonezia/05/2005
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 42, Day 182, Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    100
    Units: Titers
    geometric mean (confidence interval 95%)
        A/Indonesia/05/2005.HA [Day 0]
    5 (5 to 5)
        A/Indonesia/05/2005.HA [Day 42]
    1078.6 (935.3 to 1243.7)
        A/Indonesia/05/2005.HA [Day 182]
    147.2 (129.6 to 167.1)
        A/Indonesia/05/2005.HA [Day 192]
    1787.6 (1552.4 to 2058.3)
        A/Indonesia/05/2005.HA [Day 364]
    1043.3 (886.1 to 1228.4)
    No statistical analyses for this end point

    Secondary: HI antibody titers

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    End point title
    		 HI antibody titers
    End point description
    HI antibody concentration against A/turkey/Turkey/01/2005
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 182, Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    100
    Units: Titers
    geometric mean (confidence interval 95%)
        A/turkey/Turkey/01/2005.HA [Day 0]
    5.7 (5.2 to 6.2)
        A/turkey/Turkey/01/2005.HA [Day 182]
    89.3 (79.1 to 100.7)
        A/turkey/Turkey/01/2005.HA [Day 192]
    2026.2 (1731.3 to 2371.3)
        A/turkey/Turkey/01/2005.HA [Day 364]
    1266.8 (1080.6 to 1485)
    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
    HI antibody concentration against A/Indonezia/05/2005
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 42, Day 182, Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    100
    Units: Subjects
        A/Indonesia/05/2005.HA [Day 0]
    0
        A/Indonesia/05/2005.HA [Day 42]
    85
        A/Indonesia/05/2005.HA [Day 182]
    83
        A/Indonesia/05/2005.HA [Day 192]
    83
        A/Indonesia/05/2005.HA [Day 364]
    100
    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
    HI antibody concentration against A/turkey/Turkey/01/2005
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 182, Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    100
    Units: Subjects
        A/turkey/Turkey/01/2005.HA [Day 0]
    11
        A/turkey/Turkey/01/2005.HA [Day 182]
    83
        A/turkey/Turkey/01/2005.HA [Day 192]
    83
        A/turkey/Turkey/01/2005.HA [Day 364]
    100
    No statistical analyses for this end point

    Secondary: 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
    End point description
    HI antibody concentration against A/Indonezia/05/2005
    End point type
    Secondary
    End point timeframe
    At Day 42, Day 182, Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    100
    Units: Subjects
        A/Indonesia/05/2005.HA [Day 42]
    85
        A/Indonesia/05/2005.HA [Day 182]
    83
        A/Indonesia/05/2005.HA [Day 192]
    83
        A/Indonesia/05/2005.HA [Day 364]
    100
    No statistical analyses for this end point

    Secondary: 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
    End point description
    HI antibody concentration against Flu A/Turk/01/05 (H5N1)
    End point type
    Secondary
    End point timeframe
    At Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    99
    Units: Subjects
        Flu A/Turk/01/05 (H5N1).HA [Day 364]
    95
    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 Day 0 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    100
    Units: Subjects
        Flu A/Ind/05/05 (H5N1).HA [Day 0]
    0
        Flu A/Ind/05/05 (H5N1).HA [Day 364]
    100
        Flu A/Turk/01/05 (H5N1).HA [Day 0]
    1
        Flu A/Turk/01/05 (H5N1).HA [Day 364]
    100
    No statistical analyses for this end point

    Secondary: Geometric mean of the within-subject ratios for the assessed H5N1 strains

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    End point title
    		 Geometric mean of the within-subject ratios for the assessed H5N1 strains
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    100
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/Ind/05/05 (H5N1).HA [Day 364]
    208.7 (177.2 to 245.7)
        Flu A/Turk/01/05 (H5N1).HA [Day 364]
    14.9 (12.6 to 17.6)
    No statistical analyses for this end point

    Secondary: 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
    End point description
    HI antibody concentration against A/turkey/Turkey/01/2005.HA
    End point type
    Secondary
    End point timeframe
    At Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    99
    Units: Subjects
        A/turkey/Turkey/01/2005.HA [Day 192]
    82
        A/turkey/Turkey/01/2005.HA [Day 364]
    95
    No statistical analyses for this end point

    Secondary: Booster Factor

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    End point title
    		 Booster Factor
    End point description
    Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titre to the pre-booster (Day 182) reciprocal titre.
    End point type
    Secondary
    End point timeframe
    At Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    99
    Units: Titers
    geometric mean (confidence interval 95%)
        A/turkey/Turkey/01/2005.HA [Day 192]
    22.7 (19.3 to 26.8)
        A/turkey/Turkey/01/2005.HA [Day 364]
    14.9 (12.6 to 17.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with serum neutralising antibody titers ≥ 1:28

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    End point title
    		 Number of subjects with serum neutralising antibody titers ≥ 1:28
    End point description
    HI antibody concentration against Flu A/Ind/05/05 (H5N1)
    End point type
    Secondary
    End point timeframe
    Day 0, Day 42, Day 182, Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    95
    Units: Subjects
        Flu A/Ind/05/05 (H5N1) [Day 0]
    1
        Flu A/Ind/05/05 (H5N1) [Day 42]
    70
        Flu A/Ind/05/05 (H5N1) [Day 182]
    81
        Flu A/Ind/05/05 (H5N1) [Day 192]
    83
        Flu A/Ind/05/05 (H5N1) [Day 364]
    95
    No statistical analyses for this end point

    Secondary: Number of subjects with serum neutralising antibody titers ≥ 1:28

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    End point title
    		 Number of subjects with serum neutralising antibody titers ≥ 1:28
    End point description
    HI antibody concentration against Flu A/Turk/01/05 (H5N1)
    End point type
    Secondary
    End point timeframe
    Day 0, Day 182, Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    95
    Units: Subjects
        Flu A/Turk/01/05 (H5N1) [Day 0]
    0
        Flu A/Turk/01/05 (H5N1) [Day 182]
    81
        Flu A/Turk/01/05 (H5N1) [Day 192]
    83
        Flu A/Turk/01/05 (H5N1) [Day 364]
    95
    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
    Antibody titers against Flu A/Ind/05/05 (H5N1)
    End point type
    Secondary
    End point timeframe
    Day 0, Day 42, Day 182, Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    95
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/Ind/05/05 (H5N1) [Day 0]
    14.1 (13.9 to 14.4)
        Flu A/Ind/05/05 (H5N1) [Day 42]
    1858 (1491.3 to 2315)
        Flu A/Ind/05/05 (H5N1) [Day 182]
    448.7 (379 to 531.2)
        Flu A/Ind/05/05 (H5N1) [Day 192]
    11215.7 (9797.4 to 12839.2)
        Flu A/Ind/05/05 (H5N1) [Day 364]
    4283.3 (3485.8 to 5263.2)
    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
    HI antibody concentration against Flu A/Turk/01/05 (H5N1)
    End point type
    Secondary
    End point timeframe
    Day 0, Day 182, Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    95
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/Turk/01/05 (H5N1) [Day 0]
    14 (14 to 14)
        Flu A/Turk/01/05 (H5N1) [Day 182]
    125.4 (111.6 to 140.8)
        Flu A/Turk/01/05 (H5N1) [Day 192]
    5192.9 (4101.3 to 6575.1)
        Flu A/Turk/01/05 (H5N1) [Day 364]
    2610.2 (2085.3 to 3267.2)
    No statistical analyses for this end point

    Secondary: Vaccine response rate for neutralising antibodies

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    End point title
    		 Vaccine response rate for neutralising antibodies
    End point description
    Vaccine response rate against Flu A/Ind/05/05 (H5N1)
    End point type
    Secondary
    End point timeframe
    At Day 42, Day 182, Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    83
    Units: Subjects
        Flu A/Ind/05/05 (H5N1) [Day 42]
    62
        Flu A/Ind/05/05 (H5N1) [Day 182]
    69
        Flu A/Ind/05/05 (H5N1) [Day 192]
    72
        Flu A/Ind/05/05 (H5N1) [Day 364]
    83
    No statistical analyses for this end point

    Secondary: Vaccine response rate for neutralising antibodies

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    End point title
    		 Vaccine response rate for neutralising antibodies
    End point description
    Vaccine response rate against Flu A/Turk/01/05 (H5N1)
    End point type
    Secondary
    End point timeframe
    At Day 182, Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    83
    Units: Subjects
        Flu A/Turk/01/05 (H5N1) Ab [Day 182]
    58
        Flu A/Turk/01/05 (H5N1) Ab [Day 192]
    72
        Flu A/Turk/01/05 (H5N1) Ab [Day 364]
    83
    No statistical analyses for this end point

    Secondary: Booster vaccine response for neutralising antibodies

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    End point title
    		 Booster vaccine response for neutralising antibodies
    End point description
    Booster vaccine response against Flu A/Turk/01/05 (H5N1)
    End point type
    Secondary
    End point timeframe
    At Day 192 and Day 364
    End point values
    		 GSK1562902A Group
    Number of subjects analysed
    79
    Units: Subjects
        Flu A/Turk/01/05 (H5N1) [Day 192]
    69
        Flu A/Turk/01/05 (H5N1) [Day 364]
    76
    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
    End point type
    Secondary
    End point timeframe
    During a 7-day follow-up period, i.e. day of vaccination and 6 subsequent days after each vaccination on Day 0, Day 21 and Day 182
    End point values
    		 GSK1562902A 6<12 M Group GSK1562902A 12<24 M Group GSK1562902A 24<36 M Group GSK1562902A Group
    Number of subjects analysed
    46
    33
    33
    112
    Units: Subjects
        Any Pain Dose 1
    14
    5
    13
    32
        Grade 3 Pain Dose 1
    2
    0
    1
    3
        Any Redness Dose 1
    2
    0
    2
    4
        Grade 3 Redness Dose 1
    0
    0
    0
    0
        Any Swelling Dose 1
    1
    1
    1
    3
        Grade 3 Swelling Dose 1
    0
    0
    0
    0
        Any Pain Dose 2
    10
    13
    14
    37
        Grade 3 Pain Dose 2
    0
    0
    1
    1
        Any Redness Dose 2
    3
    2
    1
    6
        Grade 3 Redness Dose 2
    0
    0
    0
    0
        Any Swelling Dose 2
    2
    2
    0
    4
        Grade 3 Swelling Dose 2
    0
    0
    0
    0
        Any Pain Dose 3
    20
    15
    18
    53
        Grade 3 Pain Dose 3
    3
    1
    3
    7
        Any Redness Dose 3
    11
    5
    2
    18
        Grade 3 Redness Dose 3
    0
    0
    0
    0
        Any Swelling Dose 3
    5
    5
    1
    11
        Grade 3 Swelling Dose 3
    0
    0
    0
    0
        Any Pain Across doses
    26
    19
    21
    66
        Grade 3 Pain Across doses
    4
    1
    5
    10
        Any Redness Across doses
    13
    6
    3
    22
        Grade 3 Redness Across doses
    0
    0
    0
    0
        Any Swelling Across doses
    6
    6
    1
    13
        Grade 3 Swelling Across doses
    0
    0
    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
    End point type
    Secondary
    End point timeframe
    During a 7-day follow-up period, i.e. day of vaccination and 6 subsequent days after each vaccination on Day 0, Day 21 and Day 182
    End point values
    		 GSK1562902A 6<12 M Group GSK1562902A 12<24 M Group GSK1562902A 24<36 M Group GSK1562902A Group
    Number of subjects analysed
    46
    33
    33
    112
    Units: Subjects
        Any Diarrhoea/vomiting Dose 1
    10
    6
    3
    19
        Grade 3 Diarrhoea/vomiting Dose 1
    1
    1
    0
    2
        Related Diarrhoea/vomiting Dose 1
    6
    1
    2
    9
        Any Drowsiness Dose 1
    10
    9
    5
    24
        Grade 3 Drowsiness Dose 1
    1
    0
    0
    1
        Related Drowsiness Dose 1
    8
    7
    5
    20
        Any Irritability/fussiness Dose 1
    21
    14
    9
    44
        Grade 3 Irritability/fussiness Dose 1
    3
    0
    0
    3
        Related Irritability/fussiness Dose 1
    19
    10
    8
    37
        Any Loss of appetite Dose 1
    9
    12
    6
    27
        Grade 3 Loss of appetite Dose 1
    0
    1
    0
    1
        Related Loss of appetite Dose 1
    5
    8
    5
    18
        Any Fever (Axillary) Dose 1
    4
    6
    4
    14
        Grade 3 Fever (Axillary) Dose 1
    0
    2
    0
    2
        Related Fever (Axillary) Dose 1
    3
    5
    3
    11
        Any Diarrhoea/vomiting Dose 2
    8
    3
    2
    13
        Grade 3 Diarrhoea/vomiting Dose 2
    0
    0
    0
    0
        Related Diarrhoea/vomiting Dose 2
    7
    2
    1
    10
        Any Drowsiness Dose 2
    8
    12
    7
    27
        Grade 3 Drowsiness Dose 2
    1
    1
    1
    3
        Related Drowsiness Dose 2
    8
    10
    7
    25
        Any Irritability/fussiness Dose 2
    14
    17
    10
    41
        Grade 3 Irritability/fussiness Dose 2
    1
    3
    0
    4
        Related Irritability/fussiness Dose 2
    13
    15
    10
    38
        Any Loss of appetite Dose 2
    8
    6
    9
    23
        Grade 3 Loss of appetite Dose 2
    0
    1
    0
    1
        Related Loss of appetite Dose 2
    8
    5
    8
    21
        Any Fever (Axillary) Dose 2
    14
    12
    10
    36
        Grade 3 Fever (Axillary) Dose 2
    2
    3
    1
    6
        Related Fever (Axillary) Dose 2
    14
    12
    10
    36
        Any Diarrhoea/vomiting Dose 3
    10
    3
    3
    16
        Grade 3 Diarrhoea/vomiting Dose 3
    1
    0
    0
    1
        Related Diarrhoea/vomiting Dose 3
    9
    2
    1
    12
        Any Drowsiness Dose 3
    16
    6
    10
    32
        Grade 3 Drowsiness Dose 3
    2
    0
    1
    3
        Related Drowsiness Dose 3
    16
    6
    7
    29
        Any Irritability/fussiness Dose 3
    28
    15
    11
    54
        Grade 3 Irritability/fussiness Dose 3
    7
    0
    2
    9
        Related Irritability/fussiness Dose 3
    26
    15
    10
    51
        Any Loss of appetite Dose 3
    16
    12
    9
    37
        Grade 3 Loss of appetite Dose 3
    2
    0
    2
    4
        Related Loss of appetite Dose 3
    15
    12
    7
    34
        Any Fever (Axillary) Dose 3
    20
    15
    19
    54
        Grade 3 Fever (Axillary) Dose 3
    3
    5
    3
    11
        Related Fever (Axillary) Dose 3
    19
    15
    18
    52
        Any Diarrhoea/vomiting Across doses
    17
    11
    7
    35
        Grade 3 Diarrhoea/vomiting Across doses
    1
    1
    0
    2
        Related Diarrhoea/vomiting Across doses
    14
    5
    3
    22
        Any Drowsiness Across doses
    22
    18
    12
    52
        Grade 3 Drowsiness Across doses
    3
    1
    2
    6
        Related Drowsiness Across doses
    21
    17
    12
    50
        Any Irritability/fussiness Across doses
    35
    23
    15
    73
        Grade 3 Irritability/fussiness Across doses
    10
    3
    2
    15
        Related Irritability/fussiness Across doses
    35
    23
    14
    72
        Any Loss of appetite Across doses
    22
    18
    14
    54
        Grade 3 Loss of appetite Across doses
    2
    2
    2
    6
        Related Loss of appetite Across doses
    19
    17
    14
    50
        Any Fever (Axillary) Across doses
    29
    19
    21
    69
        Grade 3 Fever (Axillary) Across doses
    5
    8
    4
    17
        Related Fever (Axillary) Across doses
    28
    19
    20
    67
    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
    		 GSK1562902A 6<12 M Group GSK1562902A 12<24 M Group GSK1562902A 24<36 M Group GSK1562902A Group
    Number of subjects analysed
    46
    34
    33
    113
    Units: Subjects
        Any MAE(s)
    29
    19
    20
    68
    No statistical analyses for this end point

    Secondary: Number of subjects with potential immune-mediated disease (pIMDs)

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    End point title
    		 Number of subjects with potential immune-mediated disease (pIMDs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 GSK1562902A 6<12 M Group GSK1562902A 12<24 M Group GSK1562902A 24<36 M Group GSK1562902A Group
    Number of subjects analysed
    46
    34
    33
    113
    Units: Subjects
        Any pIMDs
    0
    0
    0
    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 a 21 day follow-up period after each vaccination
    End point values
    		 GSK1562902A 6<12 M Group GSK1562902A 12<24 M Group GSK1562902A 24<36 M Group GSK1562902A Group
    Number of subjects analysed
    46
    34
    33
    113
    Units: Subjects
        Any AE(s)
    29
    19
    24
    72
        Grade 3 AE(s)
    5
    3
    2
    10
        Related AE(s)
    13
    5
    7
    25
    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
    Up to Day 84 follow-up period after each vaccination
    End point values
    		 GSK1562902A 6<12 M Group GSK1562902A 12<24 M Group GSK1562902A 24<36 M Group GSK1562902A Group
    Number of subjects analysed
    46
    34
    33
    113
    Units: Subjects
        Any AE(s)
    32
    23
    22
    77
        Grade 3 AE(s)
    4
    4
    2
    10
        Related AE(s)
    9
    3
    6
    18
    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
    		 GSK1562902A 6<12 M Group GSK1562902A 12<24 M Group GSK1562902A 24<36 M Group GSK1562902A Group
    Number of subjects analysed
    46
    34
    33
    113
    Units: Subjects
        SAEs
    5
    4
    0
    9
    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
    15.1
    Reporting groups
    Reporting group title
    GSK1562902A 6<12 M Group
    Reporting group description
    		 -

    Reporting group title
    GSK1562902A 12<24 M Group
    Reporting group description
    		 -

    Reporting group title
    GSK1562902A 24<36 M Group
    Reporting group description
    		 -

    Serious adverse events
    		 GSK1562902A 6<12 M Group GSK1562902A 12<24 M Group GSK1562902A 24<36 M Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 46 (10.87%)
    4 / 34 (11.76%)
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (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
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (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
    Asthma
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 34 (0.00%)
    0 / 33 (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
    Wheezing
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 34 (0.00%)
    0 / 33 (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
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 46 (2.17%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 34 (2.94%)
    0 / 33 (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
    Gastritis viral
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (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
    Gastroenteritis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (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
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 34 (0.00%)
    0 / 33 (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
    Gastroenteritis viral
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (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
    Lobar pneumonia
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 34 (2.94%)
    0 / 33 (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
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 34 (0.00%)
    0 / 33 (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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 34 (5.88%)
    0 / 33 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK1562902A 6<12 M Group GSK1562902A 12<24 M Group GSK1562902A 24<36 M Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 46 (76.09%)
    23 / 34 (67.65%)
    24 / 33 (72.73%)
    Investigations
    Body temperature increased (Day 0-20 following vaccination)
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
         occurrences all number
    1
    1
    0
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    26 / 46 (56.52%)
    19 / 33 (57.58%)
    21 / 33 (63.64%)
         occurrences all number
    26
    19
    21
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    13 / 46 (28.26%)
    6 / 33 (18.18%)
    3 / 33 (9.09%)
         occurrences all number
    13
    6
    3
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    6 / 46 (13.04%)
    6 / 33 (18.18%)
    1 / 33 (3.03%)
         occurrences all number
    6
    6
    1
    Diarrhoea/vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    17 / 46 (36.96%)
    11 / 33 (33.33%)
    7 / 33 (21.21%)
         occurrences all number
    17
    11
    7
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    22 / 46 (47.83%)
    18 / 33 (54.55%)
    12 / 33 (36.36%)
         occurrences all number
    22
    18
    12
    Irritability/fussiness
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    35 / 46 (76.09%)
    23 / 33 (69.70%)
    15 / 33 (45.45%)
         occurrences all number
    35
    23
    15
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    22 / 46 (47.83%)
    18 / 33 (54.55%)
    14 / 33 (42.42%)
         occurrences all number
    22
    18
    14
    Fever (Axillary)
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    29 / 46 (63.04%)
    19 / 33 (57.58%)
    21 / 33 (63.64%)
         occurrences all number
    29
    19
    21
    Pyrexia (Day 0-20 following vaccination)
         subjects affected / exposed
    3 / 46 (6.52%)
    3 / 34 (8.82%)
    5 / 33 (15.15%)
         occurrences all number
    3
    3
    5
    Pyrexia (Day 0-84 following vaccination)
         subjects affected / exposed
    6 / 46 (13.04%)
    4 / 34 (11.76%)
    4 / 33 (12.12%)
         occurrences all number
    6
    4
    4
    Gastrointestinal disorders
    Vomiting (Day 0-20 following vaccination)
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 34 (5.88%)
    4 / 33 (12.12%)
         occurrences all number
    0
    2
    4
    Teething (Day 0-20 following vaccination)
         subjects affected / exposed
    4 / 46 (8.70%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
         occurrences all number
    4
    1
    0
    Diarrhoea (Day 0-20 following vaccination)
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
         occurrences all number
    0
    1
    2
    Vomiting (Day 0-84 following vaccination)
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 34 (8.82%)
    1 / 33 (3.03%)
         occurrences all number
    2
    3
    1
    Teething (Day 0-84 following vaccination)
         subjects affected / exposed
    4 / 46 (8.70%)
    1 / 34 (2.94%)
    0 / 33 (0.00%)
         occurrences all number
    4
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough (Day 0-20 following vaccination)
         subjects affected / exposed
    8 / 46 (17.39%)
    5 / 34 (14.71%)
    2 / 33 (6.06%)
         occurrences all number
    8
    5
    2
    Rhinorrhoea (Day 0-20 following vaccination)
         subjects affected / exposed
    10 / 46 (21.74%)
    2 / 34 (5.88%)
    2 / 33 (6.06%)
         occurrences all number
    10
    2
    2
    Wheezing (Day 0-20 following vaccination)
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    Cough (Day 0-84 following vaccination)
         subjects affected / exposed
    7 / 46 (15.22%)
    6 / 34 (17.65%)
    2 / 33 (6.06%)
         occurrences all number
    7
    6
    2
    Rhinorrhoea (Day 0-84 following vaccination)
         subjects affected / exposed
    6 / 46 (13.04%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
         occurrences all number
    6
    1
    2
    Skin and subcutaneous tissue disorders
    Urticaria (Day 0-20 following vaccination)
         subjects affected / exposed
    0 / 46 (0.00%)
    0 / 34 (0.00%)
    3 / 33 (9.09%)
         occurrences all number
    0
    0
    3
    Dermatitis diaper (Day 0-20 following vaccination)
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    Eczema (Day 0-20 following vaccination)
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 34 (5.88%)
    0 / 33 (0.00%)
         occurrences all number
    0
    2
    0
    Rash (Day 0-20 following vaccination)
         subjects affected / exposed
    3 / 46 (6.52%)
    0 / 34 (0.00%)
    1 / 33 (3.03%)
         occurrences all number
    3
    0
    1
    Dermatitis diaper (Day 0-84 following vaccination)
         subjects affected / exposed
    0 / 46 (0.00%)
    3 / 34 (8.82%)
    0 / 33 (0.00%)
         occurrences all number
    0
    3
    0
    Eczema (Day 0-84 following vaccination)
         subjects affected / exposed
    1 / 46 (2.17%)
    3 / 34 (8.82%)
    0 / 33 (0.00%)
         occurrences all number
    1
    3
    0
    Infections and infestations
    Upper respiratory tract infection (Day 0-20 following vaccination)
         subjects affected / exposed
    7 / 46 (15.22%)
    5 / 34 (14.71%)
    11 / 33 (33.33%)
         occurrences all number
    7
    5
    11
    Nasopharyngitis (Day 0-20 following vaccination)
         subjects affected / exposed
    2 / 46 (4.35%)
    4 / 34 (11.76%)
    2 / 33 (6.06%)
         occurrences all number
    2
    4
    2
    Rhinitis (Day 0-20 following vaccination)
         subjects affected / exposed
    4 / 46 (8.70%)
    0 / 34 (0.00%)
    2 / 33 (6.06%)
         occurrences all number
    4
    0
    2
    Upper respiratory tract infection (Day 0-84 following vaccination)
         subjects affected / exposed
    9 / 46 (19.57%)
    4 / 34 (11.76%)
    11 / 33 (33.33%)
         occurrences all number
    9
    4
    11
    Nasopharyngitis (Day 0-84 following vaccination)
         subjects affected / exposed
    2 / 46 (4.35%)
    5 / 34 (14.71%)
    2 / 33 (6.06%)
         occurrences all number
    2
    5
    2
    Rhinitis (Day 0-84 following vaccination)
         subjects affected / exposed
    5 / 46 (10.87%)
    1 / 34 (2.94%)
    2 / 33 (6.06%)
         occurrences all number
    5
    1
    2
    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 the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jan 2011
    Amendment 1 The former version of the protocol was published in two versions, due to a tehnical problem. The first version contained errors in the tables of intensity (Table 15). This version was submitted in Singapore. The second version contained errors in the vaccine tables (Tables 7 and 10), where commas where left out in the volumes. This version was submitted in Australia. This Amendment is based on the latter version of the final protocol. Therefore, track changes on Table 15 will not be found in the amendment, although a difference exists with the version submitted in Singapore. The changes have been brought to the tables as explained under Section 8.2.2.2.1. Additional changes have been brought to clarify the contents of the vials and vaccine doses.
    16 Jun 2011
    Amendment 2 The protocol was amended to exclude subjects who had a past medical history of infection with a H5N1 virus or vaccination with a H5N1 vaccine. Exclusion criteria were updated accordingly. In addition, procedures for collection of medically-attended adverse events between Day 203 and Day 364 have been clarified.
    04 Nov 2011
    Amendment 3 With Amendment 3, the protocol was adjusted to document that the age stratification ratio of 2:1:1 for children 6 to 11 months, 12 to 23 months, and 24 to 35 months of age, respectively, will not be maintained due to recruitment difficulties. The overall subjects enrolment goal will not change.

    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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