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    Clinical Trial Results:
    A phase II, open-label, randomised, multicentre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine, when given to healthy infants at 2, 4 and 12 months of age.

    Summary
    EudraCT number
    2009-016635-36
    Trial protocol
    FR   DE  
    Global end of trial date
    11 Oct 2011

    Results information
    Results version number
    v2(current)
    This version publication date
    16 Sep 2018
    First version publication date
    06 Jun 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Minor corrections of the full study results.

    Trial information

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    Trial identification
    Sponsor protocol code
    113615
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01090453
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Sep 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Oct 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Oct 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate non-inferiority of the GSK2202083A vaccine when compared to the control group, in terms of immune response to Hib and MenC antigens, one month after the second vaccine dose.
    Protection of trial subjects
    Subjects that did not meet inclusion and exclusion criteria were not vaccinated. Vaccinations were performed by qualified and trained study personnel.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 May 2010
    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
    France: 163
    Country: Number of subjects enrolled
    Germany: 196
    Country: Number of subjects enrolled
    Canada: 121
    Worldwide total number of subjects
    480
    EEA total number of subjects
    359
    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)
    480
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 480 subjects were enrolled in the study.

    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
    GSK2202083A Group
    Arm description
    Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13 at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix was offered to the study participants at 2 and 4 months of age.
    Arm type
    Experimental

    Investigational medicinal product name
    Biological: GSK2202083A vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses given at 2, 4 and 12 months of age

    Investigational medicinal product name
    Biological: Prevenar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 co-administered doses

    Investigational medicinal product name
    Biological: Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, two doses

    Arm title
    Infanrix hexa Group
    Arm description
    Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa vaccine, co-administered with Prevenar 13 and Menjugate at 2, 4 and 12 months of age. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix was offered to the study participants at 2 and 4 months of age.
    Arm type
    Active comparator

    Investigational medicinal product name
    Biological: Prevenar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 co-administered doses

    Investigational medicinal product name
    Biological: Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses given at 2, 4 and 12 months of age

    Investigational medicinal product name
    Biological: Menjugate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 co-administered doses

    Investigational medicinal product name
    Biological: Rotarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, two doses

    Number of subjects in period 1
    GSK2202083A Group Infanrix hexa Group
    Started
    238
    242
    Completed
    225
    228
    Not completed
    13
    14
         Eligibility Criteria
    -
    1
         Non serious AEs
    1
    -
         Protocol Violation
    2
    -
         Unspecified
    2
    4
         Consent withdrawn by subject
    1
    2
         Lost to follow-up
    7
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2202083A Group
    Reporting group description
    Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13 at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix was offered to the study participants at 2 and 4 months of age.

    Reporting group title
    Infanrix hexa Group
    Reporting group description
    Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa vaccine, co-administered with Prevenar 13 and Menjugate at 2, 4 and 12 months of age. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix was offered to the study participants at 2 and 4 months of age.

    Reporting group values
    GSK2202083A Group Infanrix hexa Group Total
    Number of subjects
    238 242 480
    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: weeks
        arithmetic mean (standard deviation)
    9.1 ± 1.15 9.2 ± 1.17 -
    Gender categorical
    Units: Subjects
        Female
    108 111 219
        Male
    130 131 261
    Race/Ethnicity
    Units: Subjects
        African heritage/African American
    2 3 5
        American Indian or Alaskan Native
    2 0 2
        Asian-Central/South Asian heritage
    1 1 2
        Asian-East Asian heritage
    5 1 6
        Asian-South East Asian heritage
    2 1 3
        White-Arabic/North African heritage
    5 8 13
        White-Caucasian/European heritage
    210 216 426
        Unspecified
    11 12 23

    End points

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    End points reporting groups
    Reporting group title
    GSK2202083A Group
    Reporting group description
    Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13 at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix was offered to the study participants at 2 and 4 months of age.

    Reporting group title
    Infanrix hexa Group
    Reporting group description
    Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa vaccine, co-administered with Prevenar 13 and Menjugate at 2, 4 and 12 months of age. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix was offered to the study participants at 2 and 4 months of age.

    Primary: Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) above the cut-offs.

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    End point title
    Number of subjects with anti-polyribosylribitol phosphate (anti-PRP) above the cut-offs. [1]
    End point description
    The anti-PRP antibody concentrations cut-off was ≥ 0.15 and ≥ 1.0 micrograms per milliliter (µg/mL). The results for Month 3 ≥ 0.15 µg/mL were the primary efficacy variables.
    End point type
    Primary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    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 end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    216
    223
    Units: Subjects
        Anti-PRP at Month 3 ≥ 0.15 [N=216;223]
    204
    188
        Anti-PRP at Month 10 ≥ 0.15 [N=197;195]
    145
    123
        Anti-PRP at Month 11 ≥ 0.15 [N=200;196]
    200
    196
        Anti-PRP at Month 3 ≥ 1.0 [N=216;223]
    134
    82
        Anti-PRP at Month 10 ≥ 1.0 [N=197;195]
    32
    26
        Anti-PRP at Month 11 ≥ 1.0 [N=200;196]
    198
    185
    No statistical analyses for this end point

    Primary: Number of subjects with Neisseria meningitidis using baby rabbit complement (rSBA-MenC) antibodies above the cut-offs.

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    End point title
    Number of subjects with Neisseria meningitidis using baby rabbit complement (rSBA-MenC) antibodies above the cut-offs. [2]
    End point description
    The rSBA-MenC cut-offs were ≥ 1:8 and ≥ 1:128. The results for Month 3 ≥ 1:8 were the primary efficacy variables.
    End point type
    Primary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    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 end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    214
    220
    Units: Subjects
        rSBA-MenC at Month 3 ≥ 1:8 [N=214;220]
    210
    219
        rSBA-MenC at Month 10 ≥ 1:8 [N=194;191]
    178
    154
        rSBA-MenC at Month 11 ≥ 1:8 [N=199;196]
    198
    196
        rSBA-MenC at Month 3 ≥ 1:128 [N=214;220]
    201
    219
        rSBA-MenC at Month 10 ≥ 1:128 [N=194;191]
    119
    92
        rSBA-MenC at Month 11 ≥ 1:128 [N=199;196]
    192
    196
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PRP.

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    End point title
    Concentrations for anti-PRP.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off values were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    216
    223
    Units: Units:µg/mL
    geometric mean (confidence interval 95%)
        Anti-PRP at Month 3 [N=216;223]
    1.594 (1.306 to 1.946)
    0.671 (0.548 to 0.822)
        Anti-PRP at Month 10 [N=197;195]
    0.34 (0.283 to 0.407)
    0.26 (0.217 to 0.311)
        Anti-PRP at Month 11 [N=200;196]
    17.678 (15.058 to 20.753)
    13.737 (11.205 to 16.84)
    No statistical analyses for this end point

    Secondary: Titers for rSBA-MenC.

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    End point title
    Titers for rSBA-MenC.
    End point description
    Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off values were ≥ 1:8 and ≥ 1:128.
    End point type
    Secondary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    214
    220
    Units: Units:titers
    geometric mean (confidence interval 95%)
        rSBA-MenC at Month 3 [N=214;220]
    1119.5 (926.4 to 1353)
    3200.5 (2737.7 to 3741.6)
        rSBA-MenC at Month 10 [N=194;191]
    131.1 (105.4 to 163.1)
    73.7 (56.9 to 95.3)
        rSBA-MenC at Month 11 [N=199;196]
    2653.8 (2225.5 to 3164.6)
    6028.4 (5183.4 to 7011.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies above the cut-off.

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    End point title
    Number of subjects with anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies above the cut-off.
    End point description
    The anti-D and anti-T antibody cut-off was ≥ 0.1 international units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    216
    223
    Units: Subjects
        Anti-D at Month 3 [N=216;223]
    215
    222
        Anti-D at Month 10 [N=197;195]
    143
    169
        Anti-D at Month 11 [N=200;196]
    200
    196
        Anti-T at Month 3 [N=216;223]
    216
    223
        Anti-T at Month 10 [N=197;195]
    189
    176
        Anti-T at Month 11 [N=200;196]
    200
    196
    No statistical analyses for this end point

    Secondary: Concentrations for anti-T and anti-D.

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    End point title
    Concentrations for anti-T and anti-D.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 0.1 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    216
    223
    Units: Units:IU/mL
    geometric mean (confidence interval 95%)
        Anti-D at Month 3 [N=216;223]
    0.936 (0.825 to 1.062)
    1.197 (1.069 to 1.34)
        Anti-D at Month 10 [N=197;195]
    0.183 (0.159 to 0.211)
    0.241 (0.211 to 0.276)
        Anti-D at Month 11 [N=200;196]
    4.538 (4.127 to 4.99)
    5.307 (4.862 to 5.793)
        Anti-T at Month 3 [N=216;223]
    2.543 (2.332 to 2.774)
    1.38 (1.245 to 1.529)
        Anti-T at Month 10 [N=197;195]
    0.458 (0.407 to 0.515)
    0.249 (0.219 to 0.282)
        Anti-T at Month 11 [N=200;196]
    7.647 (7.063 to 8.279)
    4.72 (4.281 to 5.203)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-hepatitis B (anti-HBs) antibody concentration equal to or above (≥) 10 and 100 milli-International units per milliliter (mIU/mL)

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    End point title
    Number of subjects with anti-hepatitis B (anti-HBs) antibody concentration equal to or above (≥) 10 and 100 milli-International units per milliliter (mIU/mL)
    End point description
    A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
    End point type
    Secondary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    207
    216
    Units: Subjects
        Anti-HBs ≥ 10 mIU/mL at Month 3 [N=207;216]
    204
    215
        Anti-HBs ≥ 10 mIU/mL at Month 10 [N=197;195]
    182
    190
        Anti-HBs ≥ 10 mIU/mL at Month 11 [N=196;196]
    194
    196
        Anti-HBs ≥ 100 mIU/mL at Month 3 [N=207;216]
    190
    207
        Anti-HBs ≥ 100 mIU/mL at Month 10 [N=197;195]
    118
    146
        Anti-HBs ≥ 100 mIU/mL at Month 11 [N=196;196]
    187
    194
    No statistical analyses for this end point

    Secondary: Concentrations for anti-HBs.

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    End point title
    Concentrations for anti-HBs.
    End point description
    A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
    End point type
    Secondary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    207
    216
    Units: Units:mIU/mL
    geometric mean (confidence interval 95%)
        Anti-HBs at Month 3 [N=207;216]
    701.6 (578.4 to 851.1)
    897.8 (764.9 to 1053.9)
        Anti-HBs at Month 10 [N=197;195]
    134.9 (107.6 to 169.2)
    212.8 (176.7 to 256.2)
        Anti-HBs at Month 11 [N=196;196]
    3934.7 (3121.8 to 4959.3)
    4850.7 (4059 to 5796.9)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-poliovirus (anti-polio) types 1, 2 and 3 above the cut-off.

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    End point title
    Number of subjects with anti-poliovirus (anti-polio) types 1, 2 and 3 above the cut-off.
    End point description
    The anti-polio 1, 2 and 3 antibody concentrations cut-off value was ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    196
    208
    Units: Subjects
        Anti-polio 1 at Month 3 [N=196;208]
    168
    183
        Anti-polio 1 at Month 10 [N=183;188]
    82
    98
        Anti-polio 1 at Month 11 [N=191;189]
    182
    186
        Anti-polio 2 at Month 3 [N=196;208]
    159
    160
        Anti-polio 2 at Month 10 [N=183;188]
    87
    96
        Anti-polio 2 at Month 11 [N=191;189]
    188
    186
        Anti-polio 3 at Month 3 [N=196;208]
    169
    188
        Anti-polio 3 at Month 10 [N=183;188]
    96
    108
        Anti-polio 3 at Month 11 [N=191;189]
    188
    185
    No statistical analyses for this end point

    Secondary: Titers for anti-polio 1, 2 and 3.

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    End point title
    Titers for anti-polio 1, 2 and 3.
    End point description
    Titers were expressed as geometric mean titers (GMTs). The reference cut-off value was ≥ 1:8.
    End point type
    Secondary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    196
    208
    Units: Units:titers
    geometric mean (confidence interval 95%)
        Anti-polio 1 at Month 3 [N=196;208]
    37.5 (30.1 to 46.8)
    52.1 (42.1 to 64.5)
        Anti-polio 1 at Month 10 [N=183;188]
    9.3 (7.8 to 10.9)
    11.2 (9.4 to 13.4)
        Anti-polio 1 at Month 11 [N=191;189]
    268.4 (216.5 to 332.7)
    313.7 (258.7 to 380.4)
        Anti-polio 2 at Month 3 [N=196;208]
    28.1 (22.6 to 35)
    30.6 (24.5 to 38.2)
        Anti-polio 2 at Month 10 [N=183;188]
    10 (8.4 to 11.9)
    10.5 (8.8 to 12.4)
        Anti-polio 2 at Month 11 [N=191;189]
    379 (311 to 461.9)
    429.2 (357.6 to 515.2)
        Anti-polio 3 at Month 3 [N=196;208]
    70 (54 to 90.7)
    91.9 (71.8 to 117.6)
        Anti-polio 3 at Month 10 [N=183;188]
    13 (10.7 to 15.9)
    15.1 (12.4 to 18.4)
        Anti-polio 3 at Month 11 [N=191;189]
    506.5 (407.9 to 628.9)
    541.9 (443.6 to 661.9)
    No statistical analyses for this end point

    Secondary: Number subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) above the cut-off.

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    End point title
    Number subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) above the cut-off.
    End point description
    The reference cut-off for anti-PT, anti-FHA and anti-PRN antibody concentrations was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    217
    223
    Units: Subjects
        Anti-PT at Month 3 [N=217;223]
    217
    223
        Anti-PT at Month 10 [N=193;194]
    136
    153
        Anti-PT at Month 11 [N=200;196]
    199
    195
        Anti-FHA at Month 3 [N=216;222]
    216
    222
        Anti-FHA at Month 10 [N=197;196]
    196
    195
        Anti-FHA at Month 11 [N=199;196]
    199
    196
        Anti-PRN at Month 3 [N=217;223]
    216
    222
        Anti-PRN at Month 10 [N=197;196]
    129
    142
        Anti-PRN at Month 11 [N=200;198]
    200
    198
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PT, anti-FHA and anti-PRN.

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    End point title
    Concentrations for anti-PT, anti-FHA and anti-PRN.
    End point description
    Concentrations were expressed as geometric mean concentrations (GMCs). The reference cut-off value was ≥ 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3, Month 10 and Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    217
    223
    Units: Units:EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT at Month 3 [N=217;223]
    47.4 (43.3 to 51.9)
    49.3 (45.6 to 53.3)
        Anti-PT at Month 10 [N=193;194]
    8 (7 to 9.1)
    8.3 (7.4 to 9.3)
        Anti-PT at Month 11 [N=200;196]
    74.9 (67.2 to 83.5)
    86.1 (77.8 to 95.4)
        Anti-FHA at Month 3 [N=216;222]
    165.8 (151.5 to 181.5)
    172.3 (157.9 to 188.1)
        Anti-FHA at Month 10 [N=197;196]
    37.8 (33.3 to 43)
    39.7 (35.3 to 44.6)
        Anti-FHA at Month 11 [N=199;196]
    429.6 (388.4 to 475)
    451.2 (413.7 to 492.1)
        Anti-PRN at Month 3 [N=217;223]
    66.2 (56.9 to 77)
    74.5 (64.7 to 85.7)
        Anti-PRN at Month 10 [N=197;196]
    9.1 (7.7 to 10.8)
    11 (9.3 to 13.1)
        Anti-PRN at Month 11 [N=200;198]
    218 (188.5 to 252.2)
    242.9 (216.1 to 273.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with a booster response to anti-PT, anti-FHA and anti-PRN.

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    End point title
    Number of subjects with a booster response to anti-PT, anti-FHA and anti-PRN.
    End point description
    Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at Month 11; for initially seropositive subjects: antibody concentration at Month 11 ≥ 2 fold the pre-vaccination antibody concentration
    End point type
    Secondary
    End point timeframe
    At Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    193
    193
    Units: Subjects
        Anti-FHA [N=191;190]
    183
    185
        Anti-PRN [N=193;193]
    191
    190
        Anti-PT [N=189;189]
    185
    186
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-pneumococcal (anti-PNE) serotypes above the cut-offs.

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    End point title
    Number of subjects with anti-pneumococcal (anti-PNE) serotypes above the cut-offs.
    End point description
    The anti-PNE antibody concentrations reference cut-offs were ≥ 0.2 and ≥ 0.05 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
    End point type
    Secondary
    End point timeframe
    At Month 3 and Month 11
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    87
    94
    Units: Subjects
        Anti-PNE 1 at Month 3 ≥ 0.2 [N=87;94]
    86
    94
        Anti-PNE 1 at Month 11 ≥ 0.2 [N=86;83]
    86
    83
        Anti-PNE 3 at Month 3 ≥ 0.2 [N=83;93]
    82
    93
        Anti-PNE 3 at Month 11 ≥ 0.2 [N=86;83]
    83
    83
        Anti-PNE 4 at Month 3 ≥ 0.2 [N=82;94]
    78
    93
        Anti-PNE 4 at Month 11 ≥ 0.2 [N=86;83]
    85
    83
        Anti-PNE 5 at Month 3 ≥ 0.2 [N=80;91]
    75
    89
        Anti-PNE 5 at Month 11 ≥ 0.2 [N=86;83]
    86
    83
        Anti-PNE 6A at Month 3 ≥ 0.2 [N=80;92]
    70
    86
        Anti-PNE 6A at Month 11 ≥ 0.2 [N=86;83]
    84
    83
        Anti-PNE 6B at Month 3 ≥ 0.2 [N=80;92]
    20
    27
        Anti-PNE 6B at Month 11 ≥ 0.2 [N=86;83]
    83
    82
        Anti-PNE 7F at Month 3 ≥ 0.2 [N=84;93]
    83
    93
        Anti-PNE 7F at Month 11 ≥ 0.2 [N=86;83]
    86
    83
        Anti-PNE 9V at Month 3 ≥ 0.2 [N=82;91]
    77
    89
        Anti-PNE 9V at Month 11 ≥ 0.2 [N=86;83]
    85
    83
        Anti-PNE 14 at Month 3 ≥ 0.2 [N=85;93]
    85
    92
        Anti-PNE 14 at Month 11 ≥ 0.2 [N=86;83]
    86
    82
        Anti-PNE 18C at Month 3 ≥ 0.2 [N=83;93]
    79
    89
        Anti-PNE 18C at Month 11 ≥ 0.2 [N=86;83]
    86
    83
        Anti-PNE 19A at Month 3 ≥ 0.2 [N=83;93]
    74
    91
        Anti-PNE 19A at Month 11 ≥ 0.2 [N=86;83]
    85
    83
        Anti-PNE 19F at Month 3 ≥ 0.2 [N=81;92]
    79
    92
        Anti-PNE 19F at Month 11 ≥ 0.2 [N=85;82]
    84
    82
        Anti-PNE 23F at Month 3 ≥ 0.2 [N=77;92]
    52
    76
        Anti-PNE 23F at Month 11 ≥ 0.2 [N=86;83]
    84
    82
        Anti-PNE 1 at Month 3 ≥ 0.05 [N=87;94]
    87
    94
        Anti-PNE 1 at Month 11 ≥ 0.05 [N=86;83]
    86
    83
        Anti-PNE 3 at Month 3 ≥ 0.05 [N=83;93]
    83
    93
        Anti-PNE 3 at Month 11 ≥ 0.05 [N=86;83]
    85
    83
        Anti-PNE 4 at Month 3 ≥ 0.05 [N=82;94]
    82
    94
        Anti-PNE 4 at Month 11 ≥ 0.05 [N=86;83]
    86
    83
        Anti-PNE 5 at Month 3 ≥ 0.05 [N=80;91]
    79
    91
        Anti-PNE 5 at Month 11 ≥ 0.05 [N=86;83]
    86
    83
        Anti-PNE 6A at Month 3 ≥ 0.05 [N=80;92]
    79
    91
        Anti-PNE 6A at Month 11 ≥ 0.05 [N=86;83]
    86
    83
        Anti-PNE 6B at Month 3 ≥ 0.05 [N=80;92]
    54
    72
        Anti-PNE 6B at Month 11 ≥ 0.05 [N=86;83]
    85
    83
        Anti-PNE 7F at Month 3 ≥ 0.05 [N=84;93]
    84
    93
        Anti-PNE 7F at Month 11 ≥ 0.05 [N=86;83]
    86
    83
        Anti-PNE 9V at Month 3 ≥ 0.05 [N=82;91]
    80
    91
        Anti-PNE 9V at Month 11 ≥ 0.05 [N=86;83]
    86
    83
        Anti-PNE 14 at Month 3 ≥ 0.05 [N=85;93]
    85
    93
        Anti-PNE 14 at Month 11 ≥ 0.05 [N=86;83]
    86
    83
        Anti-PNE 18C at Month 3 ≥ 0.05 [N=83;93]
    83
    93
        Anti-PNE 18C at Month 11 ≥ 0.05 [N=86;83]
    86
    83
        Anti-PNE 19A at Month 3 ≥ 0.05 [N=83;93]
    83
    93
        Anti-PNE 19A at Month 11 ≥ 0.05 [N=86;83]
    86
    83
        Anti-PNE 19F at Month 3 ≥ 0.05 [N=81;92]
    81
    92
        Anti-PNE 19F at Month 11 ≥ 0.05 [N=85;82]
    85
    82
        Anti-PNE 23F at Month 3 ≥ 0.05 [N=77;92]
    73
    89
        Anti-PNE 23F at Month 11 ≥ 0.05 [N=86;83]
    85
    82
    No statistical analyses for this end point

    Secondary: Concentrations for anti-PNE serotypes.

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    End point title
    Concentrations for anti-PNE serotypes.
    End point description
    Concentrations were expressed as geometric mean concentreations (GMCs). The reference cut-off value was ≥ 0.2 µg/mL.
    End point type
    Secondary
    End point timeframe
    At Month 3 and Month 11
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    87
    94
    Units: Units:µg/mL
    geometric mean (confidence interval 95%)
        Anti-PNE 1 at Month 3 ≥ 0.2 [N=87;94]
    1.66 (1.37 to 2)
    1.89 (1.59 to 2.25)
        Anti-PNE 1 at Month 11 ≥ 0.2 [N=86;83]
    4.99 (4.13 to 6.02)
    4.79 (4.12 to 5.56)
        Anti-PNE 3 at Month 3 ≥ 0.2 [N=83;93]
    1.16 (0.99 to 1.35)
    1.15 (1.02 to 1.3)
        Anti-PNE 3 at Month 11 ≥ 0.2 [N=86;83]
    1.74 (1.41 to 2.16)
    1.82 (1.54 to 2.15)
        Anti-PNE 4 at Month 3 ≥ 0.2 [N=82;94]
    1.4 (1.14 to 1.73)
    1.55 (1.32 to 1.82)
        Anti-PNE 4 at Month 11 ≥ 0.2 [N=86;83]
    4.19 (3.46 to 5.06)
    4.43 (3.77 to 5.21)
        Anti-PNE 5 at Month 3 ≥ 0.2 [N=80;91]
    1.83 (1.38 to 2.43)
    2.17 (1.76 to 2.68)
        Anti-PNE 5 at Month 11 ≥ 0.2 [N=86;83]
    6.68 (5.47 to 8.17)
    6.75 (5.67 to 8.02)
        Anti-PNE 6A at Month 3 ≥ 0.2 [N=80;92]
    1.06 (0.82 to 1.39)
    1.2 (0.98 to 1.48)
        Anti-PNE 6A at Month 11 ≥ 0.2 [N=86;83]
    7.34 (5.87 to 9.16)
    7.96 (6.95 to 9.11)
        Anti-PNE 6B at Month 3 ≥ 0.2 [N=80;92]
    0.09 (0.07 to 0.12)
    0.12 (0.09 to 0.15)
        Anti-PNE 6B at Month 11 ≥ 0.2 [N=86;83]
    2.23 (1.68 to 2.97)
    2.78 (2.23 to 3.46)
        Anti-PNE 7F at Month 3 ≥ 0.2 [N=84;93]
    2.72 (2.3 to 3.21)
    2.75 (2.44 to 3.1)
        Anti-PNE 7F at Month 11 ≥ 0.2 [N=86;83]
    6.67 (5.82 to 7.65)
    6.47 (5.68 to 7.38)
        Anti-PNE 9V at Month 3 ≥ 0.2 [N=82;91]
    1.36 (1.02 to 1.82)
    1.42 (1.17 to 1.74)
        Anti-PNE 9V at Month 11 ≥ 0.2 [N=86;83]
    6.12 (4.99 to 7.5)
    6.8 (5.78 to 8)
        Anti-PNE 14 at Month 3 ≥ 0.2 [N=85;93]
    3.03 (2.42 to 3.8)
    2.96 (2.33 to 3.76)
        Anti-PNE 14 at Month 11 ≥ 0.2 [N=86;83]
    10.41 (8.56 to 12.65)
    7.5 (6.03 to 9.34)
        Anti-PNE 18C at Month 3 ≥ 0.2 [N=83;93]
    1.81 (1.4 to 2.34)
    2.08 (1.72 to 2.51)
        Anti-PNE 18C at Month 11 ≥ 0.2 [N=86;83]
    6.2 (5.06 to 7.59)
    5.91 (4.97 to 7.02)
        Anti-PNE 19A at Month 3 ≥ 0.2 [N=83;93]
    1.05 (0.81 to 1.36)
    1.3 (1.1 to 1.54)
        Anti-PNE 19A at Month 11 ≥ 0.2 [N=86;83]
    5.73 (4.55 to 7.2)
    5.22 (4.26 to 6.41)
        Anti-PNE 19F at Month 3 ≥ 0.2 [N=81;92]
    2.82 (2.25 to 3.53)
    3.36 (2.83 to 3.98)
        Anti-PNE 19F at Month 11 ≥ 0.2 [N=85;82]
    5.47 (4.36 to 6.86)
    5.7 (4.81 to 6.75)
        Anti-PNE 23F at Month 3 ≥ 0.2 [N=77;92]
    0.4 (0.29 to 0.54)
    0.54 (0.43 to 0.68)
        Anti-PNE 23F at Month 11 ≥ 0.2 [N=86;83]
    4.38 (3.33 to 5.77)
    4.51 (3.57 to 5.69)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PRP and rSBA-MenC fold increase distribution.

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    End point title
    Number of subjects with anti-PRP and rSBA-MenC fold increase distribution.
    End point description
    The fold increase distribution cut-offs were: ≥2, ≥4, ≥6, ≥8 and ≥10.
    End point type
    Secondary
    End point timeframe
    At Month 11.
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    197
    193
    Units: Subjects
        Anti-PRP ≥2 [N=197;193]
    195
    189
        Anti-PRP ≥4 [N=197;193]
    191
    186
        Anti-PRP ≥6 [N=197;193]
    189
    176
        Anti-PRP ≥8 [N=197;193]
    179
    170
        Anti-PRP ≥10 [N=197;193]
    173
    166
        rSBA-MenC ≥2 [N=193;189]
    189
    185
        rSBA-MenC ≥4 [N=193;189]
    177
    185
        rSBA-MenC ≥6 [N=193;189]
    160
    182
        rSBA-MenC ≥8 [N=193;189]
    148
    180
        rSBA-MenC ≥10 [N=193;189]
    135
    178
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited local symptoms.

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    End point title
    Number of subjects reporting any solicited local symptoms.
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) post-vaccination period
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    238
    241
    Units: Subjects
        Any pain
    155
    181
        Any redness
    171
    183
        Any swelling
    147
    163
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited general symptoms.

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    End point title
    Number of subjects reporting any solicited general symptoms.
    End point description
    Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 8-day (Days 0-7) post-vaccination period
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    238
    241
    Units: Subjects
        Any drowsiness
    188
    190
        Any irritability
    208
    207
        Any loss of appetite
    169
    154
        Any fever
    165
    167
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse events (AEs).

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    End point title
    Number of subjects reporting any unsolicited adverse events (AEs).
    End point description
    An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 31-day (Days 0-30) follow up period after vaccination
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    238
    242
    Units: Subjects
        Any AEs
    148
    158
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any serious adverse events (SAEs).

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    End point title
    Number of subjects reporting any serious adverse events (SAEs).
    End point description
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Month 0 to Month 11)
    End point values
    GSK2202083A Group Infanrix hexa Group
    Number of subjects analysed
    238
    242
    Units: Subjects
        Any SAEs
    12
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: 8-day (Days 0-7) follow-up period after vaccination; unsolicited AEs: 31-day (Days 0-30) follow-up period after vaccination; SAEs: during the entire study period (Months 0-11).
    Adverse event reporting additional description
    For solicited local and general symptoms, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    GSK2202083A Group
    Reporting group description
    Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13 at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix was offered to the study participants at 2 and 4 months of age.

    Reporting group title
    Infanrix hexa Group
    Reporting group description
    Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa vaccine, co-administered with Prevenar 13 and Menjugate at 2, 4 and 12 months of age. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix was offered to the study participants at 2 and 4 months of age.

    Serious adverse events
    GSK2202083A Group Infanrix hexa Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 238 (5.04%)
    15 / 242 (6.20%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Concussion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    3 / 242 (1.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental drug intake by child
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choking
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Tremor
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Crying
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Sandifer’s syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cow’s milk intolerance
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 242 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 242 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    GSK2202083A Group Infanrix hexa Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    232 / 238 (97.48%)
    237 / 242 (97.93%)
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    19 / 238 (7.98%)
    14 / 242 (5.79%)
         occurrences all number
    19
    14
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    155 / 238 (65.13%)
    181 / 241 (75.10%)
         occurrences all number
    155
    181
    Redness
         subjects affected / exposed [2]
    171 / 238 (71.85%)
    183 / 241 (75.93%)
         occurrences all number
    171
    183
    Swelling
         subjects affected / exposed [3]
    147 / 238 (61.76%)
    163 / 241 (67.63%)
         occurrences all number
    147
    163
    Drowsiness
         subjects affected / exposed [4]
    188 / 238 (78.99%)
    190 / 241 (78.84%)
         occurrences all number
    188
    190
    Irritability
         subjects affected / exposed [5]
    208 / 238 (87.39%)
    207 / 241 (85.89%)
         occurrences all number
    208
    207
    Loss of appetite
         subjects affected / exposed [6]
    169 / 238 (71.01%)
    154 / 241 (63.90%)
         occurrences all number
    169
    154
    Temperature
         subjects affected / exposed [7]
    165 / 238 (69.33%)
    167 / 241 (69.29%)
         occurrences all number
    165
    167
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    12 / 238 (5.04%)
    17 / 242 (7.02%)
         occurrences all number
    12
    17
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 238 (3.78%)
    14 / 242 (5.79%)
         occurrences all number
    9
    14
    Infections and infestations
    Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    31 / 238 (13.03%)
    27 / 242 (11.16%)
         occurrences all number
    31
    27
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    20 / 238 (8.40%)
    15 / 242 (6.20%)
         occurrences all number
    20
    15
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    10 / 238 (4.20%)
    16 / 242 (6.61%)
         occurrences all number
    10
    16
    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: This solicited local symptom was only collected from 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: This solicited local symptom was only collected from 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: This solicited local symptom was only collected from 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: This solicited general symptom was only collected from 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: This solicited general symptom was only collected from 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: This solicited general symptom was only collected from 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: This solicited general symptom was only collected from 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
    25 Jan 2010
    After the approval of Prevenar 13, it was recommended to use this one instead of Prevenar 7 according to the same vaccination schedule at 2, 4 and 12 months of age . Additionally, contraindications to the administration of Rotarix were added to the exclusion criteria.
    06 Apr 2010
    GSK Biologicals has identified the presence of material from PCV-1 in its Human Rotavirus vaccine (444563). PCV-1 is a well known virus that does not replicate in humans and is not known to cause illness in humans. GSK’s Vaccine Safety Monitoring Board has reviewed all data and has concluded that the benefit/risk profile of the vaccine remains unchanged and is favourable. However the subject informed consent form has been updated to include information about this finding, since it might affect the willingness of a subject’s parent / Legally Acceptable Representative (s) (LAR) to allow their child to participate or continue participation in the study.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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