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    Clinical Trial Results:
    A phase III, open, randomized, controlled study to demonstrate the immunogenicity, reactogenicity and safety of GSK Biologicals meningococcal serogroup ACWY conjugate vaccine (GSK134612, MenACWY-TT) co-administered with Infanrix hexa compared to individual administration of each vaccine, in healthy 12- through 23-month-old children

    Summary
    EudraCT number
    		 2006-006680-23
    Trial protocol
    		 GR   DE   AT  
    Global end of trial date
    27 Oct 2008

    Results information
    Results version number
    		 v1
    This version publication date
    11 May 2016
    First version publication date
    06 Mar 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    109835
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00508261
    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
    07 Apr 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In subjects of the MenACWY-TT + Infanrix hexa and MenACWY-TT groups: To demonstrate the non-inferiority of the MenACWY-TT conjugate vaccine co-administered with combined DTPa-HBV-IPV/Hib vaccine to the MenACWY-TT conjugate vaccine given alone in terms of serum bactericidal antibodies (rSBA) for N. meningitidis serogroups A, C, W-135, and Y. In subjects of the MenACWY-TT + Infanrix hexa and Infanrix hexa groups: To demonstrate the non-inferiority of the combined DTPa-HBV-IPV/Hib vaccine co-administered with MenACWY-TT conjugate vaccine to DTPa-HBV-IPV/Hib vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), percentages of subjects with antibody concentrations to PRP >= 1.0µg/ml and to HBsAg >= 10mIU/ml.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 30 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2007
    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
    Austria: 120
    Country: Number of subjects enrolled
    Germany: 598
    Country: Number of subjects enrolled
    Greece: 75
    Worldwide total number of subjects
    793
    EEA total number of subjects
    793
    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)
    793
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Overal 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
    		 Nimenrix + Infanrix-hexa Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection into the left thigh at Day 0.

    Investigational medicinal product name
    Infanrix™ Hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection into the right thigh at Day 0.

    Arm title
    		 Nimenrix Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection into the left thigh at Day 0.

    Investigational medicinal product name
    Infanrix-hexa™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection into the right thigh at Month 1.

    Arm title
    		 Infanrix-Hexa Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix-hexa™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection into the right thigh at Day 0.

    Investigational medicinal product name
    Nimenrix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection into the left thigh at Month 1.

    Arm title
    		 Meningitec Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningitec™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection into the left thigh at Day 0.

    Number of subjects in period 1
    		Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Started
    222
    220
    224
    127
    Completed
    219
    212
    218
    126
    Not completed
    3
    8
    6
    1
         Consent withdrawn by subject
    3
    4
    4
    -
         'Migrated/moved from study area '
    -
    1
    -
    -
         Others
    -
    1
    1
    -
         Lost to follow-up
    -
    1
    1
    1
         Serious Adverse Event
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix + Infanrix-hexa Group
    Reporting group description
    		 -

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix-Hexa Group
    Reporting group description
    		 -

    Reporting group title
    Meningitec Group
    Reporting group description
    		 -

    Reporting group values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group Total
    Number of subjects
    		 222 220 224 127 793
    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
        arithmetic mean (standard deviation)
    		 14.6 ( 3.01 ) 15 ( 3.33 ) 14.9 ( 3.17 ) 14.6 ( 2.99 ) -
    Gender categorical
    Units: Subjects
        Female
    		 109 106 119 61 395
        Male
    		 113 114 105 66 398

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix + Infanrix-hexa Group
    Reporting group description
    		 -

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix-Hexa Group
    Reporting group description
    		 -

    Reporting group title
    Meningitec Group
    Reporting group description
    		 -

    Primary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥1:8.

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥1:8. [1]
    End point description
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination with Nimenrix vaccine (Month 1)
    Notes
    [1] - 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: The analysis was based only on subjects receiving Nimenrix vaccination at Day 0.
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group
    Number of subjects analysed
    193
    186
    Units: Subjects
        rSBA-MenA, M1 (N=193; 183)
    193
    180
        rSBA-MenC, M1 (N=191; 183)
    191
    178
        rSBA-MenW-135, M1 (N=193; 186)
    193
    183
        rSBA-MenY, M1 (N=192, 185)
    192
    180
    Statistical analysis title
    		 Difference in subjects with rSBA-MenA titres ≥ 1:8
    Statistical analysis description
    To demonstrate the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine to the Nimenrix vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroups A, C, W-135, and Y.
    Comparison groups
    Nimenrix + Infanrix-hexa Group v Nimenrix Group
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 4.71
    Notes
    [2] - Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.
    Statistical analysis title
    		 Difference in subjects with rSAB-MenC titres ≥1:8
    Statistical analysis description
    To demonstrate the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix hexa vaccine to the Nimenrix vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroups A, C, W-135, and Y.
    Comparison groups
    Nimenrix + Infanrix-hexa Group v Nimenrix Group
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    2.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 6.24
    Notes
    [3] - Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.
    Statistical analysis title
    		 Difference in subjects with rSAB-MenW titres ≥1:8
    Statistical analysis description
    To demonstrate the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix hexa vaccine to the Nimenrix vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroups A, C, W-135, and Y.
    Comparison groups
    Nimenrix + Infanrix-hexa Group v Nimenrix Group
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    1.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.36
         upper limit
    		 4.64
    Notes
    [4] - Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.
    Statistical analysis title
    		 Difference in subjects with rSAB-MenY titres ≥1:8
    Statistical analysis description
    To demonstrate the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix hexa vaccine to the Nimenrix vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroups A, C, W-135, and Y.
    Comparison groups
    Nimenrix + Infanrix-hexa Group v Nimenrix Group
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 6.18
    Notes
    [5] - Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.

    Primary: Anti-PT, anti-FHA and anti-PRN concentrations

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    End point title
    		 Anti-PT, anti-FHA and anti-PRN concentrations [6]
    End point description
    End point type
    Primary
    End point timeframe
    At 1 month after the first vaccination (Month 1)
    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: The analysis was based only on subjects receiving Infanrix-hexa vaccination.
    End point values
    		 Nimenrix + Infanrix-hexa Group Infanrix-Hexa Group
    Number of subjects analysed
    191
    179
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT, M1 (N=191; 178)
    86 (77 to 95)
    85 (75 to 96)
        Anti-FHA, M1 (N=191; 178)
    542 (492 to 597)
    544 (485 to 611)
        Anti-PRN, M1 (N=190; 179)
    470 (411 to 537)
    450 (387 to 522)
    Statistical analysis title
    		 GMC ratio for anti-PT concentrations
    Statistical analysis description
    To demonstrate the non-inferiority of the combined Infanrix hexa vaccine co-administered with Nimenrix vaccine to Infanrix hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT) ≥1.0 g/mL.
    Comparison groups
    Nimenrix + Infanrix-hexa Group v Infanrix-Hexa Group
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Adjusted GMC ratios
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.12
    Notes
    [7] - Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PT (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.
    Statistical analysis title
    		 GMC ratio for anti-FHA concentrations
    Statistical analysis description
    To demonstrate the non-inferiority of the combined Infanrix hexa vaccine co-administered with Nimenrix vaccine to Infanrix hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to filamentous haemagglutinin (FHA) ≥1.0 g/mL.
    Comparison groups
    Nimenrix + Infanrix-hexa Group v Infanrix-Hexa Group
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Adjusted GMC ratios
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.13
    Notes
    [8] - Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-FHA (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.
    Statistical analysis title
    		 GMC ratio for anti-PRN concentrations
    Statistical analysis description
    To demonstrate the non-inferiority of the combined Infanrix hexa vaccine co-administered with Nimenrix vaccine to Infanrix hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertactin (PRN) ≥1.0 g/mL.
    Comparison groups
    Nimenrix + Infanrix-hexa Group v Infanrix-Hexa Group
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Adjusted GMC ratios
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.1
    Notes
    [9] - Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PRN (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.

    Primary: Number of subjects with anti-HBs concentrations ≥10 mIU/mL

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    End point title
    		 Number of subjects with anti-HBs concentrations ≥10 mIU/mL [10]
    End point description
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination with Nimenrix vaccine (Month 1)
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The analysis was based only on subjects receiving Infanrix-hexa vaccination.
    End point values
    		 Nimenrix + Infanrix-hexa Group Infanrix-Hexa Group
    Number of subjects analysed
    181
    169
    Units: Subjects
        Anti-PT, M1 (N=181; 169)
    180
    166
    Statistical analysis title
    		 Difference in subjects with anti-HBs ≥10mIU/mL
    Statistical analysis description
    To demonstrate the non-inferiority of the combined Infanrix hexa vaccine co-administered with Nimenrix vaccine to Infanrix hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to hepatitis B surface antigen (HBsAg) ≥1.0 g/mL.
    Comparison groups
    Nimenrix + Infanrix-hexa Group v Infanrix-Hexa Group
    Number of subjects included in analysis
    350
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.47
         upper limit
    		 4.6
    Notes
    [11] - Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentages of subjects with anti-HBs antibody concentrations ≥10 mIU/ml is greater than or equal to the pre-defined clinical limit of -10%.

    Primary: Number of subjects with anti-PRP concentrations ≥1μg/mL

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    End point title
    		 Number of subjects with anti-PRP concentrations ≥1μg/mL [12]
    End point description
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination with Nimenrix vaccine (Month 1)
    Notes
    [12] - 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: The analysis was based only on subjects receiving Infanrix-hexa vaccination.
    End point values
    		 Nimenrix + Infanrix-hexa Group Infanrix-Hexa Group
    Number of subjects analysed
    184
    173
    Units: Subjects
        Anti-PRP, M1 (N=184; 173)
    183
    170
    Statistical analysis title
    		 Difference in subjects with anti-PRP ≥1.0 μg/mL
    Statistical analysis description
    To demonstrate the non-inferiority of the combined Infanrix hexa vaccine co-administered with Nimenrix vaccine to Infanrix hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to polyribosyl-ribitol-phosphate (PRP) ≥1.0 μg/mL
    Comparison groups
    Nimenrix + Infanrix-hexa Group v Infanrix-Hexa Group
    Number of subjects included in analysis
    357
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [13]
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.45
         upper limit
    		 4.5
    Notes
    [13] - Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentage of subjects with anti-PRP concentrations (ELISA) ≥1.0 μg/mL is greater than or equal to the pre-defined clinical limit of -10%.

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥1:8 and ≥1:128

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers ≥1:8 and ≥1:128
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    193
    186
    179
    114
    Units: Subjects
        rSBA-MenA [M 0], ≥1:8 (N=84,77,72,46)
    30
    32
    34
    18
        rSBA-MenA [M 1], ≥1:8 (N=193,183,163,100)
    193
    180
    71
    43
        rSBA-MenA [M 2], ≥1:8 (N=0,90,178,0)
    0
    90
    178
    0
        rSBA-MenA [M 0], ≥1:128 (N=84,77,72,46)
    18
    21
    24
    11
        rSBA-MenA [M 1], ≥1:128 (N=193,183,163,100)
    193
    179
    57
    30
        rSBA-MenA [M 2], ≥1:128 (N=0,90,178,0)
    0
    90
    178
    0
        rSBA-MenC [M 0], ≥1:8 (N=93,91,92,54)
    20
    25
    13
    11
        rSBA-MenC [M 1], ≥1:8 (N=191,183,177,114)
    191
    178
    34
    112
        rSBA-MenC [M 2], ≥1:8 (N=0,94,178,0)
    0
    91
    178
    0
        rSBA-MenC [M 0], ≥1:128 (N=93,91,92,54)
    5
    8
    5
    3
        rSBA-MenC [M 1], ≥1:128 (N=191,183,177,114)
    189
    172
    14
    102
        rSBA-MenC [M 2], ≥1:128 (N=0,94,178,0)
    0
    85
    157
    0
        rSBA-MenW-135 [M 0], ≥1:8 (N=91,84,85,55)
    43
    42
    46
    22
        rSBA-MenW-135 [M 1], ≥1:8 (N=193,186,173,112)
    193
    183
    86
    41
        rSBA-MenW-135 [M 2], ≥1:8 (N=0,91,179,0)
    0
    91
    179
    0
        rSBA-MenW-135 [M 0], ≥1:128 (N=91,84,85,55)
    17
    11
    23
    10
        rSBA-MenW-135 [M 1] ≥1:128 (N=193,186,173,112)
    193
    180
    49
    23
        rSBA-MenW-135 [M 2], ≥1:128 (N=0,91,179,0)
    0
    90
    178
    0
        rSBA-MenY [M 0], ≥1:8 (N=94,87,87,55)
    57
    53
    53
    30
        rSBA-MenY [M 1], ≥1:8 (N=192,185,174,110)
    192
    180
    103
    71
        rSBA-MenY [M 2], ≥1:8 (N=0,92,179,0)
    0
    91
    178
    0
        rSBA-MenY [M 0], ≥1:128 (N=94,87,87,55)
    38
    37
    34
    20
        rSBA-MenY [M 1], ≥1:128 (N=192,185,174,110)
    192
    178
    79
    38
        rSBA-MenY [M 2], ≥1:128 (N=0,92,179,0)
    0
    91
    178
    0
    No statistical analyses for this end point

    Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers

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    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    193
    186
    179
    114
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA [M 0], (N=84,77,72,46)
    15 (10 to 22.4)
    19 (12.2 to 29.5)
    24 (15 to 38.4)
    15.9 (9.2 to 27.5)
        rSBA-MenA [M 1], (N=193,183,163,100)
    3152.9 (2752.5 to 3611.4)
    3169.9 (2577.2 to 3898.8)
    24.2 (17.4 to 33.7)
    21.5 (14.5 to 32.1)
        rSBA-MenA [M 2], (N=0,90,178,0)
    0 (0 to 0)
    2881.9 (2292 to 3623.6)
    1938.3 (1699.1 to 2211.2)
    0 (0 to 0)
        rSBA-MenC [M 0], (N=93,91,92,54)
    7.4 (5.7 to 9.6)
    9.1 (6.7 to 12.2)
    6.1 (4.9 to 7.7)
    7.6 (5.2 to 11.2)
        rSBA-MenC [M 1], (N=191,183,177,114)
    879.7 (763.1 to 1014)
    828.7 (672.4 to 1021.4)
    7.5 (6.1 to 9.3)
    691.4 (520.8 to 917.9)
        rSBA-MenC [M 2], (N=0,94,178,0)
    0 (0 to 0)
    519.6 (391.7 to 689.2)
    386 (333.9 to 446.2)
    0 (0 to 0)
        rSBA-MenW-135 [M 0], (N=91,84,85,55)
    19 (13.1 to 27.6)
    19.2 (13.3 to 27.7)
    24.8 (16.7 to 36.8)
    15.6 (9.8 to 25)
        rSBA-MenW-135 [M 1], (N=193,186,173,112)
    4147 (3670.1 to 4685.8)
    4022.3 (3269.2 to 4948.8)
    25.2 (18.6 to 34.2)
    14.2 (10.2 to 19.7)
        rSBA-MenW-135 [M 2], (N=0,91,179,0)
    0 (0 to 0)
    3630.1 (2899.1 to 4545.4)
    2466.4 (2175.4 to 2796.4)
    0 (0 to 0)
        rSBA-MenY [M 0], (N=94,87,87,55)
    36.8 (24.7 to 54.8)
    45.4 (29.1 to 71)
    41.2 (26.7 to 63.4)
    32 (18.3 to 55.9)
        rSBA-MenY [M 1], (N=192,185,174,110)
    3461.8 (2990.1 to 4007.9)
    3167.7 (2521.9 to 3978.9)
    45.9 (33 to 63.9)
    47.2 (32.1 to 69.3)
        rSBA-MenY [M 2], (N=0,92,179,0)
    0 (0 to 0)
    3010.4 (2325.3 to 3897.3)
    2446.9 (2088.5 to 2866.8)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥0.3μg/mL and ≥2.0μg/mL

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    End point title
    		 Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY ≥0.3μg/mL and ≥2.0μg/mL
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    51
    47
    47
    29
    Units: Subjects
        Anti-PSA [Month 0], ≥0.3 (N=45,45,41,27)
    4
    1
    1
    1
        Anti-PSA [Month 1], ≥0.3 (N=46,46,37,25)
    46
    45
    1
    1
        Anti-PSA [Month 2], ≥0.3 (N=0,44,42,0)
    0
    44
    42
    0
        Anti-PSA [Month 0], ≥2.0 (N=45,45,41,27)
    0
    0
    0
    0
        Anti-PSA [Month 1], ≥2.0 (N=45,45,41,27)
    46
    44
    1
    0
        Anti-PSA [Month 2], ≥2.0 (N=45,45,41,27)
    0
    43
    40
    0
        Anti-PSC [Month 0], ≥0.3 (N=48,43,46,29)
    1
    1
    2
    0
        Anti-PSC [Month 1], ≥0.3 (N=51,41,47,28)
    51
    41
    2
    28
        Anti-PSC [Month 2], ≥0.3 (N=0,41,47,0)
    0
    41
    47
    0
        Anti-PSC [Month 0], ≥2.0 (N=48,43,46,29)
    1
    0
    0
    0
        Anti-PSC [Month 1], ≥2.0 (N=51,41,47,28)
    50
    41
    0
    26
        Anti-PSC [Month 2], ≥2.0 (N=0,41,47,0)
    0
    41
    43
    0
        Anti-PSW-135 [Month 0], ≥0.3 (N=44,43,40,26)
    1
    1
    2
    0
        Anti-PSW-135 [Month 1], ≥0.3 (N=44,47,41,26)
    44
    43
    2
    0
        Anti-PSW-135 [Month 2], ≥0.3 (N=0,44,41,0)
    0
    43
    41
    0
        Anti-PSW-135 [Month 0], ≥2.0 (N=44,43,40,26)
    0
    0
    1
    0
        Anti-PSW-135 [Month 1], ≥2.0 (N=44,47,41,26)
    40
    39
    2
    0
        Anti-PSW-135 [Month 2], ≥2.0 (N=0,41,41,0)
    0
    36
    29
    0
        Anti-PSY [Month 0], ≥0.3 (N=45,44,42,29)
    1
    1
    0
    0
        Anti-PSY [Month 1], ≥0.3 (N=45,45,37,23)
    45
    43
    1
    0
        Anti-PSY [Month 2], ≥0.3 (N=0,44,41,0)
    0
    44
    41
    0
        Anti-PSY [Month 0], ≥2.0 (N=45,44,42,29)
    0
    0
    0
    0
        Anti-PSY [Month 1], ≥2.0 (N=45,45,37,23)
    40
    42
    1
    0
        Anti-PSY [Month 2], ≥2.0 (N=0,44,41,0)
    0
    40
    34
    0
    No statistical analyses for this end point

    Secondary: Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY antibody concentrations

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    End point title
    		 Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    48
    47
    47
    29
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA [M 0], (N=45,45,41,27)
    0.17 (0.15 to 0.19)
    0.15 (0.15 to 0.16)
    0.16 (0.14 to 0.18)
    0.16 (0.14 to 0.18)
        Anti-PSA [M 1], (N=46,46,37,25)
    31.01 (23.73 to 40.52)
    33.15 (21.89 to 50.18)
    0.17 (0.13 to 0.22)
    0.16 (0.14 to 0.18)
        Anti-PSA [M 2], (N=0,44,42,0)
    0 (0 to 0)
    16.93 (12.39 to 23.13)
    12.28 (9.38 to 16.06)
    0 (0 to 0)
        Anti-PSC [M 0], (N=48,43,46,29)
    0.16 (0.14 to 0.2)
    0.16 (0.14 to 0.17)
    0.16 (0.15 to 0.17)
    0.15 (0.15 to 0.15)
        Anti-PSC [M 1], (N=51,41,47,28)
    13.74 (10.68 to 17.67)
    23.52 (18.91 to 29.25)
    0.16 (0.15 to 0.17)
    7.99 (5.57 to 11.46)
        Anti-PSC [M 2], (N=0,41,47,0)
    0 (0 to 0)
    9.73 (7.82 to 12.12)
    5.84 (4.66 to 7.32)
    0 (0 to 0)
        Anti-PSW-135 [M 0], (N=44,43,40,26)
    0.16 (0.14 to 0.17)
    0.15 (0.15 to 0.16)
    0.17 (0.14 to 0.22)
    0.15 (0.15 to 0.15)
        Anti-PSW-135 [M 1], (N=44,47,41,26)
    6.43 (4.92 to 8.4)
    4.15 (2.82 to 6.11)
    0.18 (0.14 to 0.22)
    0.15 (0.15 to 0.15)
        Anti-PSW-135 [M 2], (N=0,44,41,0)
    0 (0 to 0)
    3.99 (2.91 to 5.48)
    3.4 (2.52 to 4.59)
    0 (0 to 0)
        Anti-PSY [M 0], (N=45,44,42,29)
    0.15 (0.15 to 0.16)
    0.15 (0.15 to 0.16)
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.15)
        Anti-PSY [M 1], (N=45,45,37,23)
    6.52 (4.91 to 8.65)
    9.42 (6.49 to 13.66)
    0.17 (0.13 to 0.21)
    0.15 (0.15 to 0.15)
        Anti-PSY [M 2], (N=0,44,41,0)
    0 (0 to 0)
    7.86 (6.04 to 10.23)
    4.76 (3.73 to 6.09)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for Anti-tetanus toxoid (anti-TT)

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    End point title
    		 Number of seroprotected subjects for Anti-tetanus toxoid (anti-TT)
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    186
    180
    176
    110
    Units: Subjects
        anti-TT [M 0], ≥0.1 (N=186,177,171,108)
    177
    161
    155
    99
        anti-TT [M 1], ≥0.1 (N=184,180,174,110)
    184
    177
    173
    99
        anti-TT [M 2], ≥0.1 (N=0,177,176,0)
    0
    177
    176
    0
    No statistical analyses for this end point

    Secondary: Anti-tetanus toxoid (anti-TT) antibody concentrations

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    End point title
    		 Anti-tetanus toxoid (anti-TT) antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    186
    180
    176
    110
    Units: IU/mL
    geometric mean (confidence interval 95%)
        anti-TT [M 0], (N=186,177,171,108)
    0.481 (0.417 to 0.554)
    0.39 (0.332 to 0.457)
    0.416 (0.354 to 0.489)
    0.393 (0.325 to 0.475)
        anti-TT [M 1], (N=184,180,174,110)
    10.47 (9.131 to 12.007)
    7.941 (6.517 to 9.677)
    6.189 (5.404 to 7.089)
    0.374 (0.306 to 0.457)
        anti-TT [M 2], (N=0,177,176,0)
    0 (0 to 0)
    13.966 (12.199 to 15.987)
    8.236 (7.348 to 9.231)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of subjects seroprotected for anti-diphtheria (anti-D)

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    End point title
    		 Number of subjects seroprotected for anti-diphtheria (anti-D)
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    185
    178
    176
    110
    Units: Subjects
        anti-D [M 0], ≥0.1 (N=185,174,170,106)
    169
    157
    154
    94
        anti-D [M 1], ≥0.1 (N=184,178,174,110)
    184
    156
    173
    109
        anti-D [M 2], ≥0.1 (N=0,177,176,0)
    0
    176
    176
    0
    No statistical analyses for this end point

    Secondary: Anti-diphtheria (anti-D) antibody concentrations

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    End point title
    		 Anti-diphtheria (anti-D) antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    185
    178
    176
    110
    Units: IU/mL
    geometric mean (confidence interval 95%)
        anti-D [M 0], (N=185,174,170,106)
    0.477 (0.407 to 0.559)
    0.476 (0.397 to 0.57)
    0.437 (0.367 to 0.521)
    0.452 (0.355 to 0.574)
        anti-D [M 1], (N=184,178,174,110)
    7.636 (6.889 to 8.465)
    0.404 (0.335 to 0.487)
    7.292 (6.362 to 8.358)
    5.201 (4.243 to 6.376)
        anti-D [M 2], (N=0,177,176,0)
    0 (0 to 0)
    8.561 (7.553 to 9.703)
    5.21 (4.623 to 5.872)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of subjects seroprotected for anti-polio type 1, 2 & 3

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    End point title
    		 Number of subjects seroprotected for anti-polio type 1, 2 & 3
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    168
    164
    164
    100
    Units: Subjects
        anti-p1 [M 0] (N=168,161,156,100)
    158
    143
    142
    90
        anti-p1 [M 1] (N=167,164,164,99)
    166
    149
    163
    89
        anti-p1 [M 2] (N=0,160,162,0)
    0
    159
    161
    0
        anti-p2 [M 0] (N=168,161,156,98)
    153
    141
    145
    80
        anti-p2 [M 1] (N=167,164,163,98)
    166
    147
    161
    80
        anti-p2 [M 2] (N=0,159,162,0)
    0
    159
    161
    0
        anti-p3 [M 0] (N=168,161,157,100)
    155
    148
    143
    88
        anti-p3 [M 1] (N=167,163,163,100)
    167
    150
    160
    87
        anti-p3 [M 2] (N=0,160,161,0)
    0
    159
    159
    0
    No statistical analyses for this end point

    Secondary: Anti-polio type 1, 2 & 3 titers

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    End point title
    		 Anti-polio type 1, 2 & 3 titers
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    168
    164
    164
    100
    Units: Titers
    geometric mean (confidence interval 95%)
        anti-p1 [M 0] (N=168,161,156,100)
    84.2 (67.2 to 105.4)
    72.5 (55.6 to 94.5)
    83.6 (65.5 to 106.6)
    71.7 (51.7 to 99.6)
        anti-p1 [M 1] (N=167,164,164,99)
    984.4 (830.4 to 1167)
    74.2 (56.7 to 97.3)
    1308.5 (1073.2 to 1595.5)
    66.3 (46.6 to 94.4)
        anti-p1 [M 2] (N=0,160,162,0)
    0 (0 to 0)
    1288.2 (1052.5 to 1576.6)
    1108.4 (913.5 to 1344.8)
    0 (0 to 0)
        anti-p2 [M 0] (N=168,161,156,98)
    76.8 (60.8 to 97)
    66.3 (50.9 to 86.5)
    65.6 (51.2 to 84.2)
    49.3 (34.9 to 69.6)
        anti-p2 [M 1] (N=167,164,163,98)
    1372 (1153.5 to 1631.9)
    70.3 (53.4 to 92.6)
    1540.4 (1253.2 to 1893.2)
    49.8 (34.5 to 71.9)
        anti-p2 [M 2] (N=0,159,162,0)
    0 (0 to 0)
    1650.5 (1358.5 to 2005.3)
    1174.5 (961.4 to 1434.8)
    0 (0 to 0)
        anti-p3 [M 0] (N=168,161,157,100)
    104.4 (81.1 to 134.4)
    99.8 (77.5 to 128.5)
    113.2 (86.9 to 147.5)
    102.9 (72.8 to 145.4)
        anti-p3 [M 1] (N=167,163,163,100)
    2295.6 (1952.1 to 2699.4)
    96.6 (74.2 to 125.8)
    2034.3 (1594.9 to 2594.8)
    85.3 (58.7 to 124.1)
        anti-p3 [M 2] (N=0,160,161,0)
    0 (0 to 0)
    2478 (2049.2 to 2996.4)
    1655.1 (1308.9 to 2092.9)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Numbers of seroprotected subjects for anti-PRP

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    End point title
    		 Numbers of seroprotected subjects for anti-PRP
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    185
    179
    176
    110
    Units: Subjects
        anti-PRP [M 0] ≥1.0 (N=185,175,171,108)
    73
    64
    65
    36
        anti-PRP [M 1] ≥1.0 (N=184,179,173,110)
    183
    70
    170
    34
        anti-PRP [M 2] ≥1.0 (N=0,177,176,0)
    0
    172
    170
    0
    No statistical analyses for this end point

    Secondary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    185
    179
    176
    110
    Units: µg/mL
    geometric mean (confidence interval 95%)
        anti-PRP [M 0] (N=185,175,171,108)
    0.806 (0.658 to 0.987)
    0.665 (0.528 to 0.839)
    0.766 (0.596 to 0.986)
    0.585 (0.449 to 0.762)
        anti-PRP [M 1] (N=184,179,173,110)
    25.556 (21.358 to 30.579)
    0.711 (0.56 to 0.904)
    31.165 (25.142 to 38.631)
    0.55 (0.42 to 0.72)
        anti-PRP [M 2] (N=0,177,176,0)
    0 (0 to 0)
    12.239 (10.392 to 14.414)
    21.023 (17.036 to 25.942)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for anti-HBs

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    End point title
    		 Number of seroprotected subjects for anti-HBs
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    181
    174
    169
    106
    Units: Subjects
        anti-HBS [M 0] ≥10 (N=180,169,166,102)
    173
    158
    155
    95
        anti-HBS [M 1] ≥10 (N=181,174,169,106)
    180
    160
    166
    100
        anti-HBS [M 2] ≥10 (N=0,173,168,0)
    0
    172
    167
    0
        anti-HBS [M 0] ≥100 (N=180,169,166,102)
    92
    80
    75
    46
        anti-HBS [M 1] ≥100 (N=181,174,169,106)
    169
    85
    155
    46
        anti-HBS [M 2] ≥100 (N=0,173,168,0)
    0
    168
    158
    0
    No statistical analyses for this end point

    Secondary: Anti-HBs antibody concentrations

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    End point title
    		 Anti-HBs antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    181
    174
    169
    106
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        anti-HBS [M 0] (N=180,169,166,102)
    111.6 (90.9 to 136.9)
    92.8 (75.3 to 114.4)
    101.2 (81.5 to 125.7)
    85.6 (65.7 to 111.5)
        anti-HBS [M 1] (N=181,174,169,106)
    2048.4 (1589.3 to 2640)
    95 (74.8 to 120.6)
    1711.6 (1292.7 to 2266.3)
    101.6 (75.5 to 136.7)
        anti-HBS [M 2] (N=0,173,168,0)
    0 (0 to 0)
    2392.3 (1841.7 to 3107.4)
    1241 (976.2 to 1577.7)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of subjects with a vaccine response to PT, FHA and PRN antigens

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    End point title
    		 Number of subjects with a vaccine response to PT, FHA and PRN antigens [14]
    End point description
    Vaccine response to these antigens is defined as appearance of antibodies in subjects who were seronegative (antibody concentration < 5 EL.U/mL) at pre-vaccination or as at least a 2-fold increase in post-over pre-vaccination antibody concentrations in subjects seropositive at pre-vaccination.
    End point type
    Secondary
    End point timeframe
    At 1 month after vaccination
    Notes
    [14] - 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: The analysis was based only on subjects receiving experimental vaccination.
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group
    Number of subjects analysed
    30
    47
    44
    Units: Subjects
        PT (N=30,47,44)
    30
    47
    44
        FHA (N=3,1,1)
    3
    1
    1
        PRN (N=13,10,18)
    13
    10
    18
    No statistical analyses for this end point

    Secondary: Anti-PT, anti-FHA and anti-PRN antibody concentrations

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    End point title
    		 Anti-PT, anti-FHA and anti-PRN antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At month 0, 1 and 2
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    194
    188
    182
    114
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT [M 0] (N=193,187,182,112)
    11 (10 to 12)
    10 (8 to 11)
    10 (9 to 12)
    11 (9 to 13)
        Anti-PT [M 1] (N=191,180,178,109)
    86 (77 to 95)
    8 (7 to 9)
    85 (75 to 96)
    9 (7 to 10)
        Anti-PT [M 2] (N=0,177,179,0)
    0 (0 to 0)
    91 (80 to 102)
    63 (55 to 71)
    0 (0 to 0)
        Anti-FHA [M 0] (N=193,183,181,111)
    51 (44 to 59)
    55 (46 to 66)
    49 (41 to 57)
    55 (44 to 68)
        Anti-FHA [M 1] (N=191,183,178,110)
    542 (492 to 597)
    48 (40 to 58)
    544 (485 to 611)
    55 (42 to 71)
        Anti-FHA [M 2] (N=0,178,176,0)
    0 (0 to 0)
    664 (664 to 750)
    413 (366 to 465)
    0 (0 to 0)
        Anti-PRN [M 0] (N=194,188,182,114)
    26 (23 to 31)
    26 (22 to 31)
    21 (17 to 24)
    23 (18 to 28)
        Anti-PRN [M 1] (N=190,184,179,112)
    470 (411 to 537)
    23 (19 to 27)
    450 (387 to 522)
    21 (16 to 26)
        Anti-PRN [M 2] (N=0,178,178,0)
    0 (0 to 0)
    583 (502 to 676)
    336 (286 to 395)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and Grade 3 solicited local symptoms post-meningococcal vaccination

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    End point title
    		 Number of subjects reporting any and Grade 3 solicited local symptoms post-meningococcal vaccination
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) follow-up period after Nimenrix vaccination
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    220
    217
    219
    126
    Units: Subjects
        Any Pain
    49
    30
    35
    16
        Grade 3 Pain
    3
    0
    1
    1
        Any Redness
    70
    74
    56
    36
        Grade 3 Redness
    3
    8
    8
    2
        Any Swelling
    42
    36
    36
    23
        Grade 3 Swelling
    2
    3
    7
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and Grade 3 solicited local symptoms post-combined diphtheria vaccination

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    End point title
    		 Number of subjects reporting any and Grade 3 solicited local symptoms post-combined diphtheria vaccination [15]
    End point description
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) follow-up period after Infanrix-hexa vaccination
    Notes
    [15] - 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: The analysis was based only on subjects receiving combined-diphtheria vaccination.
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group
    Number of subjects analysed
    220
    209
    221
    Units: Subjects
        Any Pain
    60
    65
    64
        Grade 3 Pain
    6
    5
    10
        Any Redness
    70
    77
    99
        Grade 3 Redness
    11
    14
    27
        Any Swelling
    48
    53
    74
        Grade 3 Swelling
    12
    14
    22
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited general symptoms following each dose

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    End point title
    		 Number of subjects reporting any solicited general symptoms following each dose
    End point description
    Subjects in the Nimenrix + Infanrix-hexa Group did not receive a second dose of vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    220
    218
    221
    126
    Units: Subjects
        Drowsiness, D1
    85
    56
    80
    29
        Fever, D1
    80
    41
    71
    15
        Irritability, D1
    83
    63
    75
    25
        Loss of appetite, D1
    51
    46
    51
    15
        Drowsiness, D2
    0
    63
    56
    0
        Fever, D2
    0
    60
    37
    0
        Irritability, D2
    0
    75
    50
    0
        Loss of appetite, D2
    0
    54
    38
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any rash

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    End point title
    		 Number of subjects reporting any rash
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    222
    220
    224
    127
    Units: Subjects
        Any rash
    13
    25
    22
    12
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any new onset of chronic illnesses (NOCIs)

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    End point title
    		 Number of subjects reporting any new onset of chronic illnesses (NOCIs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    222
    220
    224
    127
    Units: Subjects
        Any NOCIs
    1
    2
    6
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any conditions prompting emergency room visits (ER)

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    End point title
    		 Number of subjects reporting any conditions prompting emergency room visits (ER)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    222
    220
    224
    127
    Units: Subjects
        Any ER visits
    5
    3
    14
    6
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse events (AEs) after the first dose

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    End point title
    		 Number of subjects reporting any unsolicited adverse events (AEs) after the first dose
    End point description
    End point type
    Secondary
    End point timeframe
    Occurring within Day 0-30 following vaccination
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    222
    220
    224
    127
    Units: Subjects
        Any AE(s)
    71
    81
    83
    42
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse events (AEs) after the second dose

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    End point title
    		 Number of subjects reporting any unsolicited adverse events (AEs) after the second dose [16]
    End point description
    End point type
    Secondary
    End point timeframe
    Occurring within Day 0-30 following vaccination
    Notes
    [16] - 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: The analysis was based only on subjects receiving a second dose of vaccination.
    End point values
    		 Nimenrix Group Infanrix-Hexa Group
    Number of subjects analysed
    215
    221
    Units: Subjects
        Any AE(s)
    87
    79
    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
    End point type
    Secondary
    End point timeframe
    From dose 1 up to study end
    End point values
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Number of subjects analysed
    222
    220
    224
    127
    Units: Subjects
        Any SAE(s)
    10
    8
    11
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs were reported throughout the entire study period. Solicited symptoms were reported during a 4-day period (Day 0-Day 3) after any vaccine dose, while unsolicited AEs were collected within 31 days (Days 0-30) after vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Nimenrix + Infanrix-hexa Group
    Reporting group description
    		 -

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 -

    Reporting group title
    Infanrix-Hexa Group
    Reporting group description
    		 -

    Reporting group title
    Meningitec Group
    Reporting group description
    		 -

    Serious adverse events
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 222 (4.50%)
    8 / 220 (3.64%)
    11 / 224 (4.91%)
    6 / 127 (4.72%)
         number of deaths (all causes)
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 222 (0.45%)
    1 / 220 (0.45%)
    0 / 224 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 224 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 224 (0.00%)
    0 / 127 (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
    Skull fracture
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 224 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    2 / 222 (0.90%)
    0 / 220 (0.00%)
    1 / 224 (0.45%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 224 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Cyst
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 224 (0.45%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 224 (0.45%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 224 (0.00%)
    0 / 127 (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
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 224 (0.00%)
    1 / 127 (0.79%)
         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
    Gastrointestinal disorders
    Aphthous stomatitis
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 224 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 224 (0.45%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 224 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 222 (0.45%)
    1 / 220 (0.45%)
    2 / 224 (0.89%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 222 (0.45%)
    1 / 220 (0.45%)
    2 / 224 (0.89%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 224 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    1 / 224 (0.45%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    1 / 224 (0.45%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 224 (0.45%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coxsackie viral infection
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 224 (0.00%)
    0 / 127 (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
    Croup infectious
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 224 (0.45%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 224 (0.45%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 224 (0.00%)
    0 / 127 (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
    Subcutaneous abscess
         subjects affected / exposed
    0 / 222 (0.00%)
    1 / 220 (0.45%)
    0 / 224 (0.00%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 224 (0.00%)
    0 / 127 (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
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 222 (0.45%)
    0 / 220 (0.00%)
    0 / 224 (0.00%)
    0 / 127 (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
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    1 / 224 (0.45%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    0 / 222 (0.00%)
    0 / 220 (0.00%)
    0 / 224 (0.00%)
    1 / 127 (0.79%)
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix + Infanrix-hexa Group Nimenrix Group Infanrix-Hexa Group Meningitec Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 222 (38.29%)
    87 / 220 (39.55%)
    99 / 224 (44.20%)
    42 / 127 (33.07%)
    General disorders and administration site conditions
    Pain (after meningococcal vaccination )
    alternative assessment type: Systematic
         subjects affected / exposed
    49 / 222 (22.07%)
    30 / 220 (13.64%)
    35 / 224 (15.63%)
    16 / 127 (12.60%)
         occurrences all number
    49
    30
    35
    16
    Redness (after meningococcal vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    70 / 222 (31.53%)
    74 / 220 (33.64%)
    56 / 224 (25.00%)
    36 / 127 (28.35%)
         occurrences all number
    70
    74
    56
    36
    Swelling (after meningococcal vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    42 / 222 (18.92%)
    36 / 220 (16.36%)
    36 / 224 (16.07%)
    23 / 127 (18.11%)
         occurrences all number
    42
    36
    36
    23
    Pain (after Infanrix-hexa vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    60 / 222 (27.03%)
    65 / 220 (29.55%)
    64 / 224 (28.57%)
    0 / 127 (0.00%)
         occurrences all number
    60
    65
    64
    0
    Redness (after infanrix-hexa vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    70 / 222 (31.53%)
    77 / 220 (35.00%)
    99 / 224 (44.20%)
    0 / 127 (0.00%)
         occurrences all number
    70
    77
    99
    0
    Swelling (after infanrix-hexa vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed
    48 / 222 (21.62%)
    53 / 220 (24.09%)
    74 / 224 (33.04%)
    0 / 127 (0.00%)
         occurrences all number
    48
    53
    74
    0
    Drowsiness (after the first dose)
    alternative assessment type: Systematic
         subjects affected / exposed
    85 / 222 (38.29%)
    56 / 220 (25.45%)
    80 / 224 (35.71%)
    29 / 127 (22.83%)
         occurrences all number
    85
    56
    80
    29
    Fever - Rectally (after the first dose)
    alternative assessment type: Systematic
         subjects affected / exposed
    80 / 222 (36.04%)
    41 / 220 (18.64%)
    71 / 224 (31.70%)
    15 / 127 (11.81%)
         occurrences all number
    80
    41
    71
    15
    Irritability (after the first dose)
    alternative assessment type: Systematic
         subjects affected / exposed
    83 / 222 (37.39%)
    63 / 220 (28.64%)
    75 / 224 (33.48%)
    25 / 127 (19.69%)
         occurrences all number
    83
    63
    75
    25
    Loss of appetite (after the first dose)
    alternative assessment type: Systematic
         subjects affected / exposed
    51 / 222 (22.97%)
    46 / 220 (20.91%)
    51 / 224 (22.77%)
    15 / 127 (11.81%)
         occurrences all number
    51
    46
    51
    15
    Drowsiness (after the second dose)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 222 (0.00%)
    63 / 220 (28.64%)
    56 / 224 (25.00%)
    0 / 127 (0.00%)
         occurrences all number
    0
    63
    56
    0
    Fever - Rectally (after the second dose)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 222 (0.00%)
    60 / 220 (27.27%)
    37 / 224 (16.52%)
    0 / 127 (0.00%)
         occurrences all number
    0
    60
    37
    0
    Irritability (after the second dose)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 222 (0.00%)
    75 / 220 (34.09%)
    50 / 224 (22.32%)
    0 / 127 (0.00%)
         occurrences all number
    0
    75
    50
    0
    Loss of appetite (after the second dose)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 222 (0.00%)
    54 / 220 (24.55%)
    38 / 224 (16.96%)
    0 / 127 (0.00%)
         occurrences all number
    0
    54
    38
    0
    Infections and infestations
    Upper respiratory tract infection (after the first dose)
         subjects affected / exposed
    12 / 222 (5.41%)
    13 / 220 (5.91%)
    12 / 224 (5.36%)
    8 / 127 (6.30%)
         occurrences all number
    12
    13
    12
    8
    Rhinitis (after the first dose)
         subjects affected / exposed
    9 / 222 (4.05%)
    11 / 220 (5.00%)
    0 / 224 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    9
    11
    0
    0
    Upper respiratory tract infection (after the second dose)
         subjects affected / exposed
    4 / 222 (1.80%)
    17 / 220 (7.73%)
    14 / 224 (6.25%)
    0 / 127 (0.00%)
         occurrences all number
    4
    17
    14
    0
    Gastroenteritis (after the second dose)
         subjects affected / exposed
    0 / 222 (0.00%)
    12 / 220 (5.45%)
    8 / 224 (3.57%)
    0 / 127 (0.00%)
         occurrences all number
    0
    12
    8
    0
    Bronchitis (after the second dose)
         subjects affected / exposed
    0 / 222 (0.00%)
    11 / 220 (5.00%)
    7 / 224 (3.13%)
    0 / 127 (0.00%)
         occurrences all number
    0
    11
    7
    0
    Bronchitis (after the first dose)
         subjects affected / exposed
    7 / 222 (3.15%)
    0 / 220 (0.00%)
    6 / 224 (2.68%)
    7 / 127 (5.51%)
         occurrences all number
    7
    0
    6
    7

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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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