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    Clinical Trial Results:
    A phase III, randomized, open, active-controlled study to evaluate the safety and immunogenicity of a prime-boost schedule of the H5N1 candidate vaccine adjuvanted with AS03B administered to children aged 3 to 17 years.

    Summary
    EudraCT number
    		 2011-004751-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    05 Oct 2012

    Results information
    Results version number
    		 v3(current)
    This version publication date
    16 Mar 2023
    First version publication date
    24 May 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    115115
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01379937
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 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
    05 Oct 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Co-primary Immunogenicity Objective • To assess the superiority of the haemagglutination inhibition (HI) antibody response against A/turkey/Turkey/01/2005 (H5N1) 10 days following H5N1 vaccination at Day 182 [1.9 µg A/turkey/Turkey/01/2005 (H5N1) HA antigen adjuvanted with AS03B] in subjects previously primed with 2 doses of heterologous A/Indonesia/5/2005 (H5N1) vaccine (Group H5N1_H5N1) versus non primed subjects (Group Havrix_H5N1). Co-primary Safety Objective • To evaluate the safety of the paediatric H5N1 vaccine when administered as a 2-dose primary vaccination to subjects 3 to 17 years of age in terms of occurrence of medically attended adverse events (MAEs) from Day 0 to Day 182 and to the Day 364 visit.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jul 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
    Philippines: 520
    Worldwide total number of subjects
    520
    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)
    0
    Children (2-11 years)
    320
    Adolescents (12-17 years)
    200
    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
    		 The study was of an overall duration 364 days for all subjects.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
    Arm description
    		 Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.
    Arm type
    		 Experimental

    Investigational medicinal product name
    H5N1 A/Indonesia/5/2005 with AS03B (Formulation 1)
    Investigational medicinal product code
    GSK1562902A
    Other name
    Pharmaceutical forms
    Emulsion and suspension for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.

    Investigational medicinal product name
    H5N1 A/turkey/Turkey/01/2005 with AS03B (Formulation 2)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion and suspension for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group.

    Investigational medicinal product name
    Havrix 1440 Adult
    Investigational medicinal product code
    Other name
    Havrix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group.

    Investigational medicinal product name
    Havrix 720 Junior
    Investigational medicinal product code
    Other name
    Havrix Junior
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group.

    Arm title
    		 GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
    Arm description
    		 Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.
    Arm type
    		 Experimental

    Investigational medicinal product name
    H5N1 A/Indonesia/05/2005 with AS03B (Formulation 1)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion and suspension for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.

    Investigational medicinal product name
    Havrix 1440 Adult
    Investigational medicinal product code
    Other name
    Havrix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group.

    Investigational medicinal product name
    Havrix 720 Junior
    Investigational medicinal product code
    Other name
    Havrix Junior
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group.

    Arm title
    		 GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
    Arm description
    		 Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    H5N1 A/turkey/Turkey/01/2005 with AS03B (Formulation 2)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion and suspension for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group.

    Investigational medicinal product name
    Havrix 1440 Adult
    Investigational medicinal product code
    Other name
    Havrix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group.

    Investigational medicinal product name
    Havrix 720 Junior
    Investigational medicinal product code
    Other name
    Havrix Junior
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group.

    Arm title
    		 Havrix / Havrix Jr Group
    Arm description
    		 Subjects in this group received 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Havrix 1440 Adult
    Investigational medicinal product code
    Other name
    Havrix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group.

    Investigational medicinal product name
    Havrix 720 Junior
    Investigational medicinal product code
    Other name
    Havrix Junior
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group.

    Number of subjects in period 1
    		GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Started
    156
    156
    104
    104
    Completed
    155
    153
    102
    103
    Not completed
    1
    3
    2
    1
         Consent withdrawn by subject
    -
    1
    -
    -
         Protocol violation
    -
    -
    -
    1
         Migrated/moved from study area
    1
    2
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Reporting group title
    GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Reporting group title
    GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Reporting group title
    Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Reporting group values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group Total
    Number of subjects
    		 156 156 104 104 520
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 9.7 ( 4.26 ) 9.4 ( 3.88 ) 9.3 ( 3.87 ) 9.6 ( 4.23 ) -
    Gender categorical
    Units: Subjects
        Female
    		 81 81 52 52 266
        Male
    		 75 75 52 52 254

    End points

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    End points reporting groups
    Reporting group title
    GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Reporting group title
    GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Reporting group title
    GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Reporting group title
    Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Subject analysis set title
    GSK1562902A Formulation 1 & 2 - Havrix/Havrix Jr pooled Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Pooled group of subjects who received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, no or 1 booster dose of vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 or 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Subject analysis set title
    GSK1562902A Formulation 2 - Havrix/Havrix Jr pooled Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Pooled group of subjects who received no or 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Primary: Haemagglutination Inhibition (HI) antibody titers for the A/Turkey/Turkey/01/2005 (H5N1) vaccine strain

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    End point title
    		 Haemagglutination Inhibition (HI) antibody titers for the A/Turkey/Turkey/01/2005 (H5N1) vaccine strain [1] [2]
    End point description
    Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
    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 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: This endpoint is only reporting values for the participants from the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and the GSK1562902A Formulation 2 - Havrix / Havrix Jr Group.
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
    Number of subjects analysed
    127
    84
    Units: Titer
    geometric mean (confidence interval 95%)
        Haemagglutination Inhibition (HI) antibody titers
    737.6 (646.8 to 841.1)
    24.7 (19.7 to 31)
    No statistical analyses for this end point

    Primary: Number of subjects with any medically attended adverse events (MAEs)

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    End point title
    		 Number of subjects with any medically attended adverse events (MAEs) [3]
    End point description
    Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
    End point type
    Primary
    End point timeframe
    From Day 0 to Day 182
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK1562902A Formulation 1 & 2 - Havrix/Havrix Jr pooled Group GSK1562902A Formulation 2 - Havrix/Havrix Jr pooled Group
    Number of subjects analysed
    312
    208
    Units: Subjects
        Any MAEs
    115
    64
    No statistical analyses for this end point

    Primary: Number of subjects with any medically attended adverse events (MAEs)

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    End point title
    		 Number of subjects with any medically attended adverse events (MAEs) [4]
    End point description
    Any = occurrence of the symptom regardless of intensity grade.
    End point type
    Primary
    End point timeframe
    From Day 0 to Day 364
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    156
    156
    104
    104
    Units: Subjects
        Any MAEs
    65
    84
    41
    41
    No statistical analyses for this end point

    Secondary: H5N1 HI antibody titres against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 virus) strains

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    End point title
    		 H5N1 HI antibody titres against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 virus) strains
    End point description
    The antibody titres were given as Geometric Mean Titer (GMT). A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK. For D192 , antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. For D364, antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
    End point type
    Secondary
    End point timeframe
    At Days 0, 42, 182, 192, 364
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    155
    152
    103
    101
    Units: Titer
    geometric mean (confidence interval 95%)
        A/INDO, Day 0 [N=155,152,103,101]
    5.7 (5.4 to 6)
    5.5 (5.2 to 5.8)
    5.4 (5.1 to 5.8)
    5.8 (5.3 to 6.3)
        A/INDO, Day 42 [N=155,152,103,101]
    553.5 (490.9 to 624.1)
    595 (522.1 to 678.2)
    5.6 (5.2 to 6)
    6.2 (5.6 to 7)
        A/INDO, Day 182 [N=155,152,103,101]
    52.2 (47.7 to 57.1)
    54.1 (49.5 to 59.1)
    5.1 (5 to 5.2)
    5.6 (5.3 to 6)
        A/INDO, Day 192 [N=127,NA,45,NA]
    674.1 (595 to 763.8)
    0 (0 to 0)
    7.6 (6.7 to 8.5)
    0 (0 to 0)
        A/INDO, Day 364 [N=151,147,100,NA]
    205.5 (183.3 to 230.4)
    40.4 (36.8 to 44.5)
    8.5 (7.6 to 9.4)
    0 (0 to 0)
        A/TURK, Day 0 [N=155,152,103,101]
    7 (6.3 to 7.7)
    6.4 (5.9 to 7)
    6.1 (5.6 to 6.8)
    7.2 (6.3 to 8.2)
        A/TURK, Day 42 [N=155,152,103,101]
    193 (172.1 to 216.5)
    240.3 (188.1 to 240.3)
    6.9 (6.9 to 7.9)
    8.5 (7.2 to 10)
        A/TURK, Day 182 [N=127,152,84,101]
    39.6 (35.8 to 43.8)
    42.5 (38.9 to 46.4)
    6 (5.5 to 6.5)
    7 (6.1 to 8)
        A/TURK, Day 364 [N=151,147,100,NA]
    215.1 (190.3 to 243.3)
    35.4 (32.2 to 39)
    18.4 (16.3 to 20.9)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: H5N1 HI neutralizing antibody titres against the A/Indonesia/5/2005 and A/turkey/Turkey/01/2005 (H5N1 virus) strains

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    End point title
    		 H5N1 HI neutralizing antibody titres against the A/Indonesia/5/2005 and A/turkey/Turkey/01/2005 (H5N1 virus) strains
    End point description
    Antibody titers were given as GMTs. A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK. For D192 , antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. For D364, antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
    End point type
    Secondary
    End point timeframe
    At Days 0, 42, 182, 192, 364
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    151
    147
    100
    102
    Units: Titer
    geometric mean (confidence interval 95%)
        A/INDO, Day 0 [N=149,145,98,99]
    16.6 (15.4 to 17.9)
    16 (15 to 17)
    15.3 (14.4 to 16.3)
    16 (14.9 to 17.3)
        A/INDO,Day 42 [N=150,146,99,100]
    726.8 (646.1 to 817.6)
    804.1 (710.8 to 909.5)
    15.3 (14.4 to 16.4)
    17 (15.1 to 19.1)
        A/INDO, Day 182 [N=151,147,100,102]
    133.3 (125.2 to 142)
    140.7 (132.1 to 149.8)
    15 (14.2 to 15.8)
    14.7 (14 to 15.5)
        A/INDO, Day 192 [N=149,NA,99,NA]
    2128 (1864 to 2429.5)
    0 (0 to 0)
    38.6 (33.7 to 44.1)
    0 (0 to 0)
        A/INDO, Day 364 [N=149,147,100,NA]
    523.1 (452.9 to 604.2)
    132.7 (123.9 to 142.2)
    30.4 (26.8 to 34.4)
    0 (0 to 0)
        A/TURK, Day 0, [N=149,145,98,100]
    16.4 (15.3 to 17.6)
    15.9 (15 to 16.9)
    15.6 (14.5 to 16.8)
    17.3 (15.8 to 19)
        A/TURK, Day 42, [N=150,146,98,100]
    155.7 (141.9 to 171)
    162.7 (147.8 to 179.2)
    16 (14.7 to 17.5)
    17.6 (15.9 to 19.5)
        A/TURK, Day 182, [N=151,147,100,101]
    85.3 (79.7 to 91.2)
    85.1 (79.2 to 91.3)
    15.7 (14.6 to 16.8)
    15.5 (14.5 to 16.5)
        A/TURK, Day 192, [N=150,NA,100,NA]
    1420.4 (1229.6 to 1640.8)
    0 (0 to 0)
    68.3 (58.2 to 80.2)
    0 (0 to 0)
        A/TURK, Day 364, [N=149,145,98,NA]
    415.2 (359.2 to 479.9)
    99.9 (92.6 to 107.9)
    67.1 (59.6 to 75.5)
    0 (0 to 0)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any, grade 3 and related solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
    End point type
    Secondary
    End point timeframe
    During a 7-day (Day 0-6) follow-up period after each vaccination
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    156
    156
    104
    104
    Units: Subjects
        Any Pain, D1 [N=156,156,104,104]
    106
    112
    45
    43
        Grade 3 Pain, D1 [N=156,156,104,104]
    2
    3
    1
    1
        Any Redness, D1 [N=156,156,104,104]
    0
    1
    0
    1
        Grade 3 Redness, D1 [N=156,156,104,104]
    0
    0
    0
    0
        Any Swelling, D1 [N=156,156,104,104]
    9
    9
    0
    1
        Grade 3 Swelling, D1 [N=156,156,104,104]
    0
    0
    0
    0
        Any Pain, D2 [N=156,156,104,103]
    93
    103
    65
    29
        Grade 3 Pain, D2 [N=156,156,104,103]
    3
    0
    0
    0
        Any Redness, D2 [N=156,156,104,103]
    3
    1
    1
    1
        Grade 3 Redness, D2 [N=156,156,104,103]
    0
    0
    0
    0
        Any Swelling, D2 [N=156,156,104,103]
    7
    7
    2
    1
        Grade 3 Swelling, D2 [N=156,156,104,103]
    0
    0
    0
    0
        Any Pain, D3 [N=156,154,0,0]
    105
    52
    0
    0
        Grade 3 Pain, D3 [N=156,154,0,0]
    0
    0
    0
    0
        Any Redness, D3 [N=156,154,0,0]
    1
    0
    0
    0
        Grade 3 Redness, D3 [N=156,154,0,0]
    0
    0
    0
    0
        Any Swelling, D3 [N=156,154,0,0]
    4
    0
    0
    0
        Grade 3 Swelling, D3 [N=156,1540,0]
    0
    0
    0
    0
        Any Pain, Across [N=156,156,104,104]
    127
    129
    73
    53
        Grade 3 Pain, Across [N=156,156,104,104]
    5
    3
    1
    1
        Any Redness, Across [N=156,156,104,104]
    4
    2
    1
    1
        Grade 3 Redness, Across [N=156,156,104,104]
    0
    0
    0
    0
        Any Swelling, Across [N=156,156,104,104]
    15
    13
    2
    1
        Grade 3 Swelling, Across [N=156,156,104,104]
    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
    Assessed solicited general symptoms were diarrhea/vomiting, drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged less than 6 years.
    End point type
    Secondary
    End point timeframe
    During a 7-day (Day 0-6) follow-up period after each vaccination
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    30
    31
    22
    24
    Units: Subjects
        Any diarrhoea/vomiting
    2
    3
    2
    0
        Grade 3 diarrhoea/vomiting
    0
    0
    0
    0
        Related diarrhoea/vomiting
    2
    3
    2
    0
        Any drowsiness
    5
    8
    3
    2
        Grade 3 drowsiness
    0
    2
    0
    0
        Related drowsiness
    5
    8
    3
    2
        Any irritability / fussiness
    8
    10
    3
    1
        Grade 3 irritability / fussiness
    0
    0
    0
    0
        Related irritability / fussiness
    8
    10
    3
    1
        Any loss of appetite
    8
    9
    3
    1
        Grade 3 loss of appetite
    0
    0
    0
    0
        Related loss of appetite
    8
    8
    3
    1
        Any temperature
    12
    11
    1
    0
        Grade 3 temperature
    2
    4
    1
    0
        Related temperature
    11
    10
    1
    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 arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia and temperature[defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged 6 years or more.
    End point type
    Secondary
    End point timeframe
    During a 7-day (Day 0-6) follow-up period after vaccination
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    126
    125
    82
    80
    Units: Subjects
        Any Arthralgia, D1
    13
    20
    7
    8
        Grade 3 Arthralgia, D1
    0
    0
    0
    0
        Related Arthralgia, D1
    12
    19
    7
    7
        Any Fatigue,D1
    16
    16
    8
    8
        Grade 3 Fatigue,D1
    0
    0
    0
    0
        Related Fatigue,D1
    15
    16
    8
    7
        Any Gastrointestinal symptoms, D1
    9
    5
    6
    7
        Grade 3 Gastrointestinal symptoms, D1
    0
    0
    0
    1
        Related Gastrointestinal symptoms, D1
    7
    5
    6
    6
        Any Headache, D1
    31
    24
    14
    19
        Grade 3 Headache, D1
    1
    1
    0
    0
        Related Headache, D1
    30
    23
    12
    17
        Any Myalgia, D1
    14
    23
    8
    11
        Grade 3 Myalgia, D1
    0
    0
    0
    0
        Related Myalgia, D1
    14
    22
    8
    10
        Any Temperature/(Axillary), D1
    10
    2
    6
    7
        Grade 3 Temperature/(Axillary), D1
    1
    1
    2
    1
        Related Temperature/(Axillary), D1
    8
    1
    3
    5
        Any Arthralgia, D2
    11
    18
    5
    3
        Grade 3 Arthralgia, D2
    0
    0
    0
    0
        Related Arthralgia, D2
    11
    18
    5
    3
        Any Fatigue, D2
    12
    7
    5
    3
        Grade 3 Fatigue, D2
    0
    0
    0
    0
        Related Fatigue, D2
    12
    7
    5
    3
        Any Gastrointestinal symptoms, D2
    6
    7
    3
    1
        Grade 3 Gastrointestinal symptoms, D2
    0
    0
    0
    0
        Related Gastrointestinal symptoms, D2
    6
    7
    3
    1
        Any Headache, D2
    40
    37
    8
    12
        Grade 3 Headache, D2
    4
    0
    0
    1
        Related Headache, D2
    39
    37
    8
    12
        Any Myalgia, D2
    13
    20
    7
    3
        Grade 3 Myalgia, D2
    0
    0
    0
    0
        Related Myalgia, D2
    13
    19
    7
    3
        Any Temperature/(Axillary), D2
    11
    17
    4
    0
        Grade 3 Temperature/(Axillary), D2
    2
    5
    0
    0
        Related Temperature/(Axillary), D2
    10
    15
    4
    0
        Any Arthralgia, D3
    19
    3
    0
    0
        Grade 3 Arthralgia, D3
    0
    0
    0
    0
        Related Arthralgia, D3
    19
    3
    0
    0
        Any Fatigue, D3
    15
    8
    0
    0
        Grade 3 Fatigue, D3
    0
    0
    0
    0
        Related Fatigue, D3
    15
    8
    0
    0
        Any Gastrointestinal symptoms, D3
    4
    6
    0
    0
        Grade 3 Gastrointestinal symptoms, D3
    0
    0
    0
    0
        Related Gastrointestinal symptoms, D3
    4
    6
    0
    0
        Any Headache, D3
    39
    17
    0
    0
        Grade 3 Headache, D3
    1
    0
    0
    0
        Related Headache, D3
    39
    17
    0
    0
        Any Myalgia, D3
    15
    2
    0
    0
        Grade 3 Myalgia, D3
    0
    0
    0
    0
        Related Myalgia, D3
    15
    2
    0
    0
        Any Temperature/(Axillary), D3
    7
    2
    0
    0
        Grade 3 Temperature/(Axillary), D3
    0
    0
    0
    0
        Related Temperature/(Axillary), D3
    7
    2
    0
    0
        Any Arthralgia, Across
    33
    31
    11
    11
        Grade 3 Arthralgia, Across
    0
    0
    0
    0
        Related Arthralgia, Across
    32
    30
    11
    10
        Any Fatigue, Across
    28
    22
    10
    10
        Grade 3 Fatigue, Across
    0
    0
    0
    0
        Related Fatigue, Across
    28
    22
    10
    9
        Any Gastrointestinal symptoms, Across
    16
    12
    8
    7
        Grade 3 Gastrointestinal symptoms, Across
    0
    0
    0
    1
        Related Gastrointestinal symptoms, Across
    15
    12
    8
    6
        Any Headache, Across
    63
    52
    20
    24
        Grade 3 Headache, Across
    5
    1
    0
    1
        Related Headache, Across
    62
    51
    18
    22
        Any Myalgia, Across
    29
    33
    13
    13
        Grade 3 Myalgia, Across
    0
    0
    0
    0
        Related Myalgia, Across
    29
    31
    13
    12
        Any Temperature/(Axillary), Across
    23
    19
    10
    7
        Grade 3 Temperature/(Axillary), Across
    3
    6
    2
    1
        Related Temperature/(Axillary), Across
    20
    16
    7
    5
    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 clinical investigation 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During a 21-day (Days 0 – 20) follow-up period after vaccination
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    156
    156
    104
    104
    Units: Subjects
        Any AEs
    60
    82
    35
    20
        Grade 3 AEs
    1
    1
    0
    0
        Related AEs
    12
    7
    7
    3
    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 clinical investigation 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During Day 0 to Telephone Contact (TC) Day 84 overall.
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    156
    156
    104
    104
    Units: Subjects
        Any AEs
    75
    92
    59
    50
        Grade 3 AEs
    2
    0
    1
    1
        Related AEs
    7
    6
    3
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with any potential Immune-Mediated Diseases (pIMDs)

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    End point title
    		 Number of subjects with any potential Immune-Mediated Diseases (pIMDs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 to 364)
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    156
    156
    104
    104
    Units: Subjects
        Any pIMDs
    0
    0
    0
    0
    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
    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.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 to 364)
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    156
    156
    104
    104
    Units: Subjects
        (SAEs).
    4
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-H5N1 antibodies above the cut off values greater than or equal to (≥) 1:10

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    End point title
    		 Number of subjects with anti-H5N1 antibodies above the cut off values greater than or equal to (≥) 1:10
    End point description
    Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 182, 192 and 364.
    End point type
    Secondary
    End point timeframe
    At Days 0, 42, 182, 192 and 364
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    155
    152
    103
    101
    Units: Subjects
        A/INDO, Day 0 [N=155,152,103,101]
    22
    15
    8
    14
        A/INDO, Day 42 [N=155,152,103,101]
    155
    151
    9
    19
        A/INDO, Day 182 [N=155,152,103,101]
    154
    152
    2
    12
        A/INDO, Day 192 [N=127,0,45,0]
    127
    0
    37
    0
        A/INDO, Day 364 [N=151,147,100,0]
    151
    147
    57
    0
        A/TURK, Day 182 [N=127,152,84,101]
    126
    152
    17
    26
        A/TURK, Day 364 [N=151,147,100,0]
    151
    147
    95
    0
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects against the A/Indonesia/05/2005 strains of H5N1 influenza disease

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    End point title
    		 Number of seroconverted subjects against the A/Indonesia/05/2005 strains of H5N1 influenza disease
    End point description
    A seroconverted subject was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Seroconversion rates against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.
    End point type
    Secondary
    End point timeframe
    At Days 42, 182, 192 and 364
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    155
    152
    103
    101
    Units: Subjects
        A/INDO, Day 42 [N=155,152,103,101]
    154
    151
    1
    1
        A/INDO, Day 182 [N=155,152,103,101]
    122
    121
    0
    0
        A/INDO, Day 192 [N=127,0,84,0]
    127
    0
    3
    0
        A/INDO, Day 364 [N=151,147,100,0]
    151
    100
    1
    0
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against the A/Indonesia/05/2005 and A/turkey/Turkey/01/2005 strains of H5N1 influenza disease

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    End point title
    		 Number of seroprotected subjects against the A/Indonesia/05/2005 and A/turkey/Turkey/01/2005 strains of H5N1 influenza disease
    End point description
    A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Seroprotection rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 -Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seroprotection rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182 and 192.
    End point type
    Secondary
    End point timeframe
    At Days 0,42, 182, 192 and 364
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    155
    152
    103
    101
    Units: Subjects
        A/INDO, Day 0 [N=155,152,103,101]
    0
    0
    2
    1
        A/INDO, Day 42 [N=155,152,103,101]
    154
    151
    2
    1
        A/INDO, Day 182 [N=155,152,103,101]
    125
    122
    0
    0
        A/INDO, Day 192 [N=127,0,84,0]
    127
    0
    3
    0
        A/INDO, Day 364 [N=151,147,100,0]
    151
    102
    1
    0
        A/TURK, Day 182 [N=127,0,84,0]
    73
    0
    1
    0
        A/TURK, Day 192 [N=127,0,84,0]
    127
    0
    28
    0
    No statistical analyses for this end point

    Secondary: Mean geometric increase for anti-H5N1 antibody titers

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    End point title
    		 Mean geometric increase for anti-H5N1 antibody titers
    End point description
    MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. MGI against the A/turkey/Turkey/01/2005 (H5N1 virus) strain were tabulated on Days 42, 182 and 364.
    End point type
    Secondary
    End point timeframe
    At Days 42, 182, 192 and 364
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    155
    152
    103
    101
    Units: Titer
    geometric mean (confidence interval 95%)
        A/INDO, Day 42 [N=155,152,103,101]
    96.9 (84.9 to 110.4)
    108.4 (94.2 to 124.7)
    1 (1 to 1.1)
    1.1 (0.9 to 1.2)
        A/INDO, Day 182 [N=155,152,103,101]
    9.1 (8.3 to 10.1)
    9.8 (9 to 10.8)
    0.9 (0.9 to 1)
    1 (0.9 to 1.1)
        A/INDO, Day 192 [N=127,0,84,0]
    117.7 (103 to 134.5)
    0 (0 to 0)
    1.4 (1.2 to 1.6)
    0 (0 to 0)
        A/INDO, Day 364 [N=151,147,100,0]
    36.2 (32 to 40.9)
    7.4 (6.7 to 8.2)
    1.6 (1.4 to 1.7)
    0 (0 to 0)
        A/TURK, Day 42 [N=155,152,103,101]
    27.7 (24 to 31.9)
    33.1 (28.6 to 38.3)
    1.1 (1 to 1.3)
    1.2 (1.1 to 1.3)
        A/TURK, Day 182 [N=155,152,103,101]
    5.6 (5 to 6.3)
    6.6 (6 to 7.4)
    1 (0.9 to 1.1)
    1 (0.9 to 1.1)
        A/TURK, Day 364 [N=151,147,100,0]
    31.4 (26.9 to 36.7)
    5.6 (5 to 6.3)
    3 (2.6 to 3.4)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects against the A/turkey/Turkey/01/2005 strains of H5N1 influenza disease

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    End point title
    		 Number of seroconverted subjects against the A/turkey/Turkey/01/2005 strains of H5N1 influenza disease [5]
    End point description
    Booster seroconversion rates against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated on Days 192 and 364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
    End point type
    Secondary
    End point timeframe
    At Days 192 and 364
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the participants from the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and the GSK1562902A Formulation 2 - Havrix / Havrix Jr Group.
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
    Number of subjects analysed
    151
    100
    Units: Subjects
        A/TURK, Day 192 [N=127,0,84,0]
    127
    27
        A/TURK, Day 364 [N=151,0,100,0]
    105
    18
    No statistical analyses for this end point

    Secondary: Booster factor for Hemagglutination Inhibition (HI) antibodies against the A/turkey/Turkey/01/2005 strain of H5N1 influenza disease

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    End point title
    		 Booster factor for Hemagglutination Inhibition (HI) antibodies against the A/turkey/Turkey/01/2005 strain of H5N1 influenza disease [6]
    End point description
    Boooster factor against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated 95% CI on Days 192,364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
    End point type
    Secondary
    End point timeframe
    At Days 192 and 364
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the participants from the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and the GSK1562902A Formulation 2 - Havrix / Havrix Jr Group.
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
    Number of subjects analysed
    151
    100
    Units: Titer
    geometric mean (confidence interval 95%)
        A/TURK, Day 192 [N=127,0,84,0]
    18.6 (16.3 to 21.3)
    4.1 (3.3 to 5.2)
        A/TURK, Day 364 [N=151,0,100,0]
    5.6 (5 to 6.3)
    3 (2.7 to 3.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with neutralizing anti-H5N1 antibody titers

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    End point title
    		 Number of subjects with neutralizing anti-H5N1 antibody titers
    End point description
    Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated 95 % CI on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group. Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 0, 42,182, 192 and 364.
    End point type
    Secondary
    End point timeframe
    At Days 0, 42, 182 192 and 364
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    151
    147
    100
    102
    Units: Subjects
        A/INDO, Day 0 [N=149,145,98,99]
    22
    17
    8
    14
        A/INDO,Day 42 [N=150,146,99,100]
    150
    146
    9
    15
        A/INDO, Day 182 [N=151,147,100,102]
    150
    147
    7
    4
        A/INDO, Day 192 [N=149,0,99,0]
    149
    0
    75
    0
        A/INDO, Day 364 [N=149,147,100,0]
    149
    147
    73
    0
        A/TURK, Day 0, [N=149,145,98,100]
    21
    18
    8
    19
        A/TURK, Day 42, [N=150,146,98,100]
    150
    145
    10
    20
        A/TURK, Day 182, [N=151,147,100,101]
    150
    145
    11
    10
        A/TURK, Day 192, [N=150,0,100,0]
    150
    0
    90
    0
        A/TURK, Day 364, [N=149,145,98,0]
    149
    145
    95
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine response rates (VRR) for H5N1 neutralizing antibodies

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    End point title
    		 Number of subjects with vaccine response rates (VRR) for H5N1 neutralizing antibodies
    End point description
    VRR was defined as the number of vaccinees who have at least a 4-fold increase in post-vaccination titre relative to pre-vaccination titre (Day 0). For D192 , antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol. For D364, antibody titers were tabulated for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
    End point type
    Secondary
    End point timeframe
    At Days 42, 182 192 and 364
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group
    Number of subjects analysed
    149
    145
    98
    98
    Units: Subjects
        A/INDO,Day 42 [N=149,144,98,98]
    147
    142
    0
    2
        A/INDO, Day 182 [N=149,145,98,98]
    127
    115
    0
    0
        A/INDO, Day 192 [N=147,0,97,0]
    147
    0
    5
    0
        A/INDO, Day 364 [N=148,145,98,0]
    144
    126
    8
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with booster vaccine response for H5N1 neutralizing antibodies

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    End point title
    		 Number of subjects with booster vaccine response for H5N1 neutralizing antibodies [7]
    End point description
    This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.
    End point type
    Secondary
    End point timeframe
    At Days 192 and 364
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only reporting values for the participants from the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and the GSK1562902A Formulation 2 - Havrix / Havrix Jr Group.
    End point values
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
    Number of subjects analysed
    150
    100
    Units: Subjects
        A/TURK, Day 192, [N=150,0,100,0]
    141
    38
        A/TURK, Day 364, [N=149,0,98,0]
    86
    36
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Systematically-assessed symptoms: during the 7 days after each vaccination; unsolicited AEs: within 21 days after each vaccination and from Day 0 to Day 84. SAEs were collected throughout the study from Day 0 to Day 364.
    Adverse event reporting additional description
    Solicited general symptoms were assessed in subjects aged less than 6 years and in subjects aged 6 years and more as required by the protocol.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Reporting group title
    GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Reporting group title
    Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Reporting group title
    GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
    Reporting group description
    		 Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix or Havrix Junior vaccine, administered intramuscularly in the deltoid region.

    Serious adverse events
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 156 (2.56%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 156 (0.64%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Open wound
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Typhoid fever
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group GSK1562902A Formulation 2 - Havrix / Havrix Jr Group Havrix / Havrix Jr Group GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    138 / 156 (88.46%)
    87 / 104 (83.65%)
    77 / 104 (74.04%)
    145 / 156 (92.95%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    127 / 156 (81.41%)
    73 / 104 (70.19%)
    53 / 104 (50.96%)
    129 / 156 (82.69%)
         occurrences all number
    127
    73
    53
    129
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    15 / 156 (9.62%)
    2 / 104 (1.92%)
    1 / 104 (0.96%)
    13 / 156 (8.33%)
         occurrences all number
    15
    2
    1
    13
    Diarrhoea/vomiting
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    2 / 30 (6.67%)
    2 / 22 (9.09%)
    0 / 24 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    2
    3
    0
    3
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    5 / 30 (16.67%)
    3 / 22 (13.64%)
    2 / 24 (8.33%)
    8 / 31 (25.81%)
         occurrences all number
    5
    3
    2
    8
    Irritability / fussiness
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    8 / 30 (26.67%)
    3 / 22 (13.64%)
    1 / 24 (4.17%)
    10 / 31 (32.26%)
         occurrences all number
    8
    3
    1
    10
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    8 / 30 (26.67%)
    3 / 22 (13.64%)
    1 / 24 (4.17%)
    9 / 31 (29.03%)
         occurrences all number
    8
    3
    1
    9
    Temperature (subjects aged less than 6 years)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    12 / 30 (40.00%)
    1 / 22 (4.55%)
    0 / 24 (0.00%)
    11 / 31 (35.48%)
         occurrences all number
    12
    1
    0
    11
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    33 / 126 (26.19%)
    11 / 82 (13.41%)
    11 / 80 (13.75%)
    31 / 125 (24.80%)
         occurrences all number
    33
    11
    11
    31
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    28 / 126 (22.22%)
    10 / 82 (12.20%)
    10 / 80 (12.50%)
    22 / 125 (17.60%)
         occurrences all number
    28
    10
    10
    22
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    16 / 126 (12.70%)
    8 / 82 (9.76%)
    7 / 80 (8.75%)
    12 / 125 (9.60%)
         occurrences all number
    16
    8
    7
    12
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    63 / 126 (50.00%)
    20 / 82 (24.39%)
    24 / 80 (30.00%)
    52 / 125 (41.60%)
         occurrences all number
    63
    20
    24
    52
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    29 / 126 (23.02%)
    13 / 82 (15.85%)
    13 / 80 (16.25%)
    33 / 125 (26.40%)
         occurrences all number
    29
    13
    13
    33
    Temperature (subjects aged 6 years or more)
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    23 / 126 (18.25%)
    10 / 82 (12.20%)
    7 / 80 (8.75%)
    19 / 125 (15.20%)
         occurrences all number
    23
    10
    7
    19
    Infections and infestations
    Upper respiratory tract infection (within 21 days post-vaccination)
         subjects affected / exposed
    31 / 156 (19.87%)
    9 / 104 (8.65%)
    9 / 104 (8.65%)
    54 / 156 (34.62%)
         occurrences all number
    31
    9
    9
    54
    Viral infection (within 21 days post-vaccination)
         subjects affected / exposed
    2 / 156 (1.28%)
    7 / 104 (6.73%)
    2 / 104 (1.92%)
    10 / 156 (6.41%)
         occurrences all number
    2
    7
    2
    10
    Rhinitis
         subjects affected / exposed
    5 / 156 (3.21%)
    6 / 104 (5.77%)
    2 / 104 (1.92%)
    5 / 156 (3.21%)
         occurrences all number
    5
    6
    2
    5
    Upper respiratory tract infection (Day 0 up to Day 84 post-vaccination)
         subjects affected / exposed
    45 / 156 (28.85%)
    31 / 104 (29.81%)
    27 / 104 (25.96%)
    63 / 156 (40.38%)
         occurrences all number
    45
    31
    27
    63
    Nasopharyngitis
         subjects affected / exposed
    3 / 156 (1.92%)
    3 / 104 (2.88%)
    6 / 104 (5.77%)
    8 / 156 (5.13%)
         occurrences all number
    3
    3
    6
    8
    Viral infection (Day 0 up to Day 84 post-vaccination)
         subjects affected / exposed
    10 / 156 (6.41%)
    18 / 104 (17.31%)
    10 / 104 (9.62%)
    20 / 156 (12.82%)
         occurrences all number
    10
    18
    10
    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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
    [10] - 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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.
    [11] - 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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.

    More information

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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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