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    Clinical Trial Results:
    Immunogenicity & safety study of GSK Biologicals’ meningococcal vaccine GSK134612 when co-administered with GSK Biologicals’ MMRV vaccine (Priorix-Tetra™) in healthy 12 to 23-month-old children.

    Summary
    EudraCT number
    		 2006-006580-23
    Trial protocol
    		 FI  
    Global end of trial date
    26 Mar 2008

    Results information
    Results version number
    		 v3(current)
    This version publication date
    30 Sep 2020
    First version publication date
    06 Mar 2015
    Other versions
    		 v1 (removed from public view) , v2
    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
    109670
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00474266
    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 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000429-PIP01-08
    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
    27 Jan 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    42 days after the first vaccine dose •To demonstrate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to Meningitec, the licensed conjugate vaccine for N. meningitidis serogroup C, in terms of serogroup C serum bactericidal antibodies (rSBA-MenC). •To demonstrate the immunogenicity induced by the MenACWY-TT conjugate vaccine for N. meningitidis serogroups A, W-135, and Y in terms of bactericidal antibodies to N. meningitidis serogroups A, W-135, and Y. •To demonstrate the non-inferiority of MenACWY-TT conjugate vaccine co-administered with MMRV compared to MenACWY-TT conjugate vaccine alone in terms of bactericidal antibodies to N. meningitidis serogroups A, C, W-135, and Y. •To demonstrate the non-inferiority of the immunogenicity of the first dose of MMRV vaccine co-administered with MenACWY-TT conjugate vaccine compared to the first dose of MMRV vaccine alone with respect to anti-measles, anti-mumps, anti-rubella, and anti-varicella seroconversion rates.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up for any solicited, unsolicited, and specified categories of AEs and SAEs that might have occurred during the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jun 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
    Finland: 1000
    Worldwide total number of subjects
    1000
    EEA total number of subjects
    1000
    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)
    1000
    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
    Overall Study Period (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 + Priorix-Tetra Group
    Arm description
    		 Subjects received 1 dose of Nimenrix vaccine & 1 dose of Priorix-Tetra vaccine on Day 0 and a second dose of Priorix-Tetra vaccine on Day 84.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    MeMuRu-OKA
    Other name
    MMRV, GSK Biologicals’ combined measles, mumps, rubella and varicella vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2-dose subcutaneous injection in the right upper arm

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    MenACWY-TT conjugate vaccine, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection in the left thigh

    Arm title
    		 Nimenrix Group
    Arm description
    		 Subjects received 1 dose of Nimenrix vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    MeMuRu-OKA
    Other name
    MMRV, GSK Biologicals’ combined measles, mumps, rubella and varicella vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2-dose subcutaneous injection in the right upper arm

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    MenACWY-TT conjugate vaccine, GSK Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection in the left thigh

    Arm title
    		 Priorix-Tetra Group
    Arm description
    		 Subjects received 1 dose of Priorix-Tetra vaccine on Day 0, 1 dose of Meningitec vaccine on Day 42 and a second dose of Priorix-Tetra vaccine on Day 84.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    MenC-CRM, Pfizer`s (formerly Wyeth) meningococcal serogroup C oligosaccharide conjugate
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection in the left thigh

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    MeMuRu-OKA
    Other name
    MMRV, GSK Biologicals’ combined measles, mumps, rubella and varicella vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2-dose subcutaneous injection in the right upper arm

    Arm title
    		 Meningitec Group
    Arm description
    		 Subjects received 1 dose of Meningitec vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    MeMuRu-OKA
    Other name
    MMRV, GSK Biologicals’ combined measles, mumps, rubella and varicella vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2-dose subcutaneous injection in the right upper arm

    Investigational medicinal product name
    Meningitec
    Investigational medicinal product code
    Other name
    MenC-CRM, Pfizer`s (formerly Wyeth) meningococcal serogroup C oligosaccharide conjugate
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose intramuscular injection in the left thigh

    Number of subjects in period 1
    		Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Started
    375
    374
    126
    125
    Completed
    368
    354
    122
    118
    Not completed
    7
    20
    4
    7
         Consent withdrawn by subject
    7
    20
    4
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix + Priorix-Tetra Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix vaccine & 1 dose of Priorix-Tetra vaccine on Day 0 and a second dose of Priorix-Tetra vaccine on Day 84.

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.

    Reporting group title
    Priorix-Tetra Group
    Reporting group description
    		 Subjects received 1 dose of Priorix-Tetra vaccine on Day 0, 1 dose of Meningitec vaccine on Day 42 and a second dose of Priorix-Tetra vaccine on Day 84.

    Reporting group title
    Meningitec Group
    Reporting group description
    		 Subjects received 1 dose of Meningitec vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.

    Reporting group values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group Total
    Number of subjects
    		 375 374 126 125 1000
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 14.7 ( 1.5 ) 14.6 ( 1.49 ) 14.6 ( 1.41 ) 14.4 ( 1.47 ) -
    Gender categorical
    Units: Subjects
        Female
    		 180 174 68 60 482
        Male
    		 195 200 58 65 518
    Race/Ethnicity
    Units: Subjects
        White - Caucasian/European heritage
    		 369 372 123 123 987
        White - Arabic/North African heritage
    		 4 2 2 2 10
        Unspecified
    		 2 0 1 0 3

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix + Priorix-Tetra Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix vaccine & 1 dose of Priorix-Tetra vaccine on Day 0 and a second dose of Priorix-Tetra vaccine on Day 84.

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.

    Reporting group title
    Priorix-Tetra Group
    Reporting group description
    		 Subjects received 1 dose of Priorix-Tetra vaccine on Day 0, 1 dose of Meningitec vaccine on Day 42 and a second dose of Priorix-Tetra vaccine on Day 84.

    Reporting group title
    Meningitec Group
    Reporting group description
    		 Subjects received 1 dose of Meningitec vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.

    Subject analysis set title
    Pooled group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Nimenrix + Priorix-Tetra and Nimenrix groups

    Primary: Number of subjects with rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY titers greater than or equal to the cut-off values

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    End point title
    		 Number of subjects with rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY titers greater than or equal to the cut-off values [1]
    End point description
    The cut-off values for the rSBA titers were ≥ 1:8.
    End point type
    Primary
    End point timeframe
    42 days after the first vaccine dose (Post vaccination I, study Day 42)
    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 performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Meningitec Group
    Number of subjects analysed
    360
    354
    121
    Units: Subjects
        rSBA-MenA, D42 [N=360;354;51]
    360
    353
    23
        rSBA-MenC, D42 [N=357;354;121]
    357
    353
    118
        rSBA-MenW-135, D42 [N=360;354;58]
    360
    354
    29
        rSBA-MenY, D42 [N=359;354;59]
    359
    354
    32
    Statistical analysis title
    		 Difference in % of subjects with rSBA-MenC ≥1:8
    Comparison groups
    Nimenrix Group v Meningitec Group
    Number of subjects included in analysis
    475
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 6.78
    Notes
    [2] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%
    Statistical analysis title
    		 Difference in % of subjects for rSBA-MenA ≥1:8
    Comparison groups
    Nimenrix + Priorix-Tetra Group v Nimenrix Group
    Number of subjects included in analysis
    714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.78
         upper limit
    		 1.58
    Notes
    [3] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥ -10%
    Statistical analysis title
    		 Difference in % of subjects for rSBA-MenC ≥1:8
    Comparison groups
    Nimenrix + Priorix-Tetra Group v Nimenrix Group
    Number of subjects included in analysis
    714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.79
         upper limit
    		 1.58
    Notes
    [4] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥ -10%
    Statistical analysis title
    		 Difference in % of subjects for rSBA-MenW-135 ≥1:8
    Comparison groups
    Nimenrix + Priorix-Tetra Group v Nimenrix Group
    Number of subjects included in analysis
    714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 1.07
    Notes
    [5] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥ -10%
    Statistical analysis title
    		 Difference in % of subjects for rSBA-MenY ≥1:8
    Comparison groups
    Nimenrix Group v Nimenrix + Priorix-Tetra Group
    Number of subjects included in analysis
    714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference in %
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 1.07
    Notes
    [6] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥ -10%

    Primary: Number of subjects with anti-measles antibody concentrations greater than or equal to the cut-off values

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    End point title
    		 Number of subjects with anti-measles antibody concentrations greater than or equal to the cut-off values
    End point description
    The cut-off values for anti-measles antibody concentrations were ≥ 150 mIU/mL.
    End point type
    Primary
    End point timeframe
    42 days after the first vaccine dose (Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    361
    354
    118
    120
    Units: Subjects
        Anti-measles, D42
    361
    0
    118
    0
    Statistical analysis title
    		 Difference in %, seroconversion for anti-measles
    Comparison groups
    Nimenrix + Priorix-Tetra Group v Priorix-Tetra Group
    Number of subjects included in analysis
    479
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 3.17
    Notes
    [7] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥ -10%

    Primary: Number of subjects with anti-mumps antibody concentrations greater than or equal to the cut-off values

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    End point title
    		 Number of subjects with anti-mumps antibody concentrations greater than or equal to the cut-off values
    End point description
    The cut-off values for anti-mumps antibody concentrations were ≥ 231 U/mL.
    End point type
    Primary
    End point timeframe
    42 days after the first vaccine dose (Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    349
    354
    116
    120
    Units: Subjects
        Anti-mumps, D42
    306
    0
    97
    0
    Statistical analysis title
    		 Difference in %, seroconversion for anti-mumps
    Comparison groups
    Nimenrix + Priorix-Tetra Group v Priorix-Tetra Group
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    4.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.82
         upper limit
    		 12.46
    Notes
    [8] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%

    Primary: Number of subjects with anti-rubella antibody concentrations greater than or equal to the cut-off values

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    End point title
    		 Number of subjects with anti-rubella antibody concentrations greater than or equal to the cut-off values
    End point description
    The cut-off values for anti-rubella antibody concentrations were ≥4 IU/mL.
    End point type
    Primary
    End point timeframe
    42 days after the first vaccine dose (Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    361
    354
    118
    120
    Units: Subjects
        Anti-rubella, D42
    361
    1
    118
    1
    Statistical analysis title
    		 Difference in %, seroconversion for anti-rubella
    Comparison groups
    Nimenrix + Priorix-Tetra Group v Priorix-Tetra Group
    Number of subjects included in analysis
    479
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 3.18
    Notes
    [9] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥ -10%

    Primary: Number of subjects with anti-varicella antibody concentrations greater than or equal to the cut-off values

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    End point title
    		 Number of subjects with anti-varicella antibody concentrations greater than or equal to the cut-off values
    End point description
    The cut-off values for anti-varicella antibody concentrations were ≥1:4.
    End point type
    Primary
    End point timeframe
    42 days after the first vaccine dose (Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    333
    335
    111
    116
    Units: Subjects
        Anti-varicella, D42
    326
    6
    105
    2
    Statistical analysis title
    		 Difference in %, seroconversion for anti-varicella
    Comparison groups
    Nimenrix + Priorix-Tetra Group v Priorix-Tetra Group
    Number of subjects included in analysis
    444
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    3.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 9.5
    Notes
    [10] - Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers greater than or equal to the cut-off values

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    End point title
    		 Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers greater than or equal to the cut-off values
    End point description
    The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. At pre-vaccination for all groups, half of the subjects had sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups had sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
    End point type
    Secondary
    End point timeframe
    Prior to and 42 days after the first vaccine dose (Pre vaccination, study Day 0 and Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    360
    354
    117
    121
    Units: Subjects
        rSBA-MenA ≥ 1:8, D0 [N=158;171;53;53]
    57
    77
    24
    18
        rSBA-MenA ≥ 1:128, D0 [N=158;171;53;53]
    32
    50
    18
    10
        rSBA-MenA ≥ 1:128, D42 [N=360;354;55;51]
    359
    353
    22
    17
        rSBA-MenC ≥ 1:8, D0 [N=178;174;60;60]
    48
    47
    16
    13
        rSBA-MenC ≥ 1:128, D0 [N=178;174;60;60]
    19
    22
    4
    4
        rSBA-MenC ≥ 1:128, D42 [N=357;354;117;121]
    337
    339
    13
    85
        rSBA-MenW-135 ≥ 1:8, D0 [N=177;177;60;61]
    76
    81
    29
    30
        rSBA-MenW-135 ≥ 1:128, D0 [N=177;177;60;61]
    30
    28
    14
    12
        rSBA-MenW-135 ≥ 1:128, D42 [N=360;354;58;58]
    360
    352
    16
    15
        rSBA-MenY ≥ 1:8, D0 [N=179;181;60;62]
    103
    112
    41
    34
        rSBA-MenY ≥ 1:128, D0 [N=179;181;60;62]
    75
    79
    30
    23
        rSBA-MenY ≥ 1:128, D42 [N=359;354;58;59]
    358
    353
    30
    21
    No statistical analyses for this end point

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

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    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers
    End point description
    Antibody titers were expressed as geometric mean titers (GMTs). At pre-vaccination for all groups, half of the subjects had sera tested for rSBA-MenC while the other half was tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY. At Post vaccination I (Day 42), all subjects from Nimenrix + Priorix-Tetra and Nimenrix groups had sera tested for each rSBA. For Meningitec and Priorix-Tetra groups, all subjects were tested for rSBA-MenC while half of subjects were tested for rSBA-MenA, rSBA-MenW-135 and rSBA-MenY.
    End point type
    Secondary
    End point timeframe
    Prior to and 42 days after the first vaccine dose (Pre vaccination, study Day 0 and Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    360
    354
    117
    121
    Units: Titer
    geometric mean (confidence interval 95%)
        rSBA-MenA, D0 [N=158;171;53;53]
    14.6 (10.9 to 19.4)
    22.8 (16.8 to 31)
    24.4 (13.7 to 43.4)
    14.3 (8.5 to 24)
        rSBA-MenA, D42 [N=360;354;55;51]
    2085.9 (1905.3 to 2283.6)
    2205 (2007.8 to 2421.6)
    33.1 (19.1 to 57.4)
    24.3 (13.4 to 44.1)
        rSBA-MenC, D0 [N=178;174;60;60]
    9.2 (7.4 to 11.4)
    10 (7.8 to 12.6)
    8.5 (6 to 12.2)
    7.6 (5.5 to 10.6)
        rSBA-MenC, D42 [N=357;354;117;121]
    519 (470.9 to 571.9)
    477.6 (437.3 to 521.6)
    11.2 (8.3 to 15.2)
    212.3 (170 to 265.2)
        rSBA-MenW-135, D0 [N=177;177,60,61]
    16.2 (12.6 to 20.7)
    16.7 (13.1 to 21.4)
    21.9 (13.5 to 35.4)
    20.8 (13.1 to 33.2)
        rSBA-MenW-135, D42 [N=360;354;58;58]
    2055.8 (1871 to 2258.9)
    2681.7 (2453.1 to 2931.6)
    25.6 (15.6 to 42.1)
    25.1 (14.6 to 43.1)
        rSBA-MenY, D0 [N=179;181;60;62]
    41.4 (30.2 to 56.6)
    50.1 (36.7 to 68.2)
    71 (40.9 to 123.2)
    31.7 (18.9 to 53.2)
        rSBA-MenY, D42 [N=359;354;58;59]
    2282.4 (2051.3 to 2539.5)
    2729.4 (2472.7 to 3012.8)
    70 (39.3 to 124.7)
    31.4 (18.4 to 53.6)
    No statistical analyses for this end point

    Secondary: Anti-PSA (anti-polysaccharide A), anti-PSC, anti-PSW-135 and anti-PSY antibodies concentrations

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    End point title
    		 Anti-PSA (anti-polysaccharide A), anti-PSC, anti-PSW-135 and anti-PSY antibodies concentrations
    End point description
    Anti-PS antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as µg/mL. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.
    End point type
    Secondary
    End point timeframe
    Prior to and 42 days after the first vaccine dose (Pre vaccination, study Day 0 and Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    90
    93
    30
    31
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-PSA, D0 [N=90;93;29;31]
    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 0.17)
        Anti-PSA, D42 [N=90;90;29;30]
    28.74 (24.01 to 34.4)
    15.71 (12.91 to 19.12)
    0.16 (0.15 to 0.17)
    0.15 (0.15 to 0.17)
        Anti-PSC, D0 [N=89;90;30;30]
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.15)
        Anti-PSC, D42 [N=89;87;29;29]
    9.26 (7.73 to 11.1)
    7.44 (6.43 to 8.6)
    0.15 (0.15 to 0.15)
    4.89 (3.69 to 6.47)
        Anti-PSW-135, D0 [N=90;92;29;31]
    0.16 (0.15 to 0.17)
    0.15 (0.15 to 0.16)
    0.16 (0.14 to 0.18)
    0.15 (0.15 to 0.15)
        Anti-PSW-135, D42 [N=90;90;29;30]
    6.5 (5.52 to 7.65)
    4.5 (3.77 to 5.37)
    0.16 (0.14 to 0.17)
    0.15 (0.15 to 0.15)
        Anti-PSY, D0 [N=89;93;29;31]
    0.15 (0.15 to 0.15)
    0.16 (0.15 to 0.16)
    0.15 (0.15 to 0.15)
    0.15 (0.15 to 0.15)
        Anti-PSY, D42 [N=90;90;29;30]
    8.56 (7.26 to 10.11)
    6.37 (5.13 to 7.92)
    0.16 (0.14 to 0.17)
    0.15 (0.15 to 0.15)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies concentrations greater than or equal to the cut-off values

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    End point title
    		 Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies concentrations greater than or equal to the cut-off values
    End point description
    The cut-off values for anti-PS antibody concentrations were ≥ 0.3 µg/mL and ≥ 2.0 µg/mL respectively. At pre-vaccination (Day 0) and Post-vaccination I (Day 42), a quarter of the subjects were tested for anti-PSC and another quarter for anti-PSA, anti-PSW-135 and anti-PSY.
    End point type
    Secondary
    End point timeframe
    Prior to and 42 days after the first vaccine dose (Pre vaccination, study Day 0 and Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    90
    93
    30
    31
    Units: Subjects
        Anti-PSA ≥ 0.3 µg/mL, D0 [N=90;93;29;31]
    6
    1
    1
    1
        Anti-PSA ≥ 0.3 μg/mL, D42 [N=90;90;29;30]
    90
    89
    2
    1
        Anti-PSA ≥ 2 µg/mL, D0 [N=90;93;29;31]
    0
    0
    0
    0
        Anti-PSA ≥ 2 μg/mL, D42 [N=90;90;29;30]
    90
    88
    0
    0
        Anti-PSC ≥ 0.3 µg/mL, D0 [N=89;90;30;30]
    0
    0
    0
    0
        Anti-PSC ≥ 0.3 µg/mL, D42 [N=89;87;29;29]
    89
    87
    0
    29
        Anti-PSC ≥ 2 µg/mL, D0 [N=89;90;30;30]
    0
    0
    0
    0
        Anti-PSC ≥ 2 µg/mL, D42 [N=89;87;29;29]
    85
    85
    0
    26
        Anti-PSW-135 ≥ 0.3 µg/mL, D0 [N=90;92;29;31]
    4
    2
    1
    0
        Anti-PSW-135 ≥ 0.3 µg/mL, D42 [N=90;90;29;30]
    90
    89
    1
    0
        Anti-PSW-135 ≥ 2 µg/mL, D0 [N=90;92;29;31]
    0
    0
    0
    0
        Anti-PSW-135 ≥ 2 µg/mL, D42 [N=90;90;29;30]
    82
    80
    0
    0
        Anti-PSY ≥ 0.3 µg/mL, D0 [N=89;93;29;31]
    0
    4
    0
    0
        Anti-PSY ≥ 0.3 µg/mL, D42 [N=90;90;29;30]
    90
    89
    1
    0
        Anti-PSY ≥ 2 µg/mL, D0 [N=89;93;29;31]
    0
    0
    0
    0
        Anti-PSY ≥ 2 µg/mL, D42 [N=90;90;29;30]
    87
    79
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with hSBA-MenA (meningococcal polysaccharide A serum bactericidal antibodies using human complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers greater than or equal to the cut-off values

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    End point title
    		 Number of subjects with hSBA-MenA (meningococcal polysaccharide A serum bactericidal antibodies using human complement), hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titers greater than or equal to the cut-off values [11]
    End point description
    The cut-off values for hSBA antibody titers were ≥1:4 and ≥1:8 for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively.
    End point type
    Secondary
    End point timeframe
    Prior to and 42 days after the first vaccine dose (Pre vaccination, study Day 0 and Post vaccination I, study Day 42)
    Notes
    [11] - 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 performed only on subjects receiving meningitis vaccination (Nimenrix or Meningitec) at Day 0.
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Meningitec Group Pooled group
    Number of subjects analysed
    359
    363
    123
    722
    Units: Subjects
        hSBA-MenA ≥1:4, D0 [N=357;356;122;713]
    14
    8
    2
    22
        hSBA-MenA ≥1:4, D42 [N=348;338;117;686]
    305
    273
    1
    578
        hSBA-MenA ≥1:8, D0 [N=357;356;122;713]
    7
    7
    1
    14
        hSBA-MenA ≥1:8, D42 [N=348;338;117;686]
    292
    261
    1
    553
        hSBA-MenC ≥1:4, D0 [N=359;363;122;722]
    1
    3
    1
    4
        hSBA-MenC ≥1:4, D42 [N=346;341;116;687]
    339
    338
    95
    677
        hSBA-MenC ≥1:8, D0 [N=359;363;122;722]
    1
    3
    1
    4
        hSBA-MenC ≥1:8, D42 [N=346;341;116;687]
    339
    336
    95
    675
        hSBA-MenW-135 ≥1:4, D0 [N=353;357;123;710]
    4
    3
    0
    7
        hSBA-MenW-135 ≥1:4, D42 [N=337;336;114;673]
    280
    295
    1
    575
        hSBA-MenW-135 ≥1:8, D0 [N=353;357;123;710]
    4
    2
    0
    6
        hSBA-MenW-135 ≥1:8, D42 [N=337;336;114;673]
    279
    294
    1
    573
        hSBA-MenY ≥1:4, D0 [N=344;349;122;693]
    4
    5
    1
    9
        hSBA-MenY ≥1:4, D42 [N=333;329;117;662]
    273
    261
    2
    534
        hSBA-MenY ≥1:8, D0 [N=344;349;122;693]
    4
    5
    1
    9
        hSBA-MenY ≥1:8, D42 [N=333;329;117;662]
    271
    261
    2
    532
    No statistical analyses for this end point

    Secondary: hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers

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    End point title
    		 hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titers [12]
    End point description
    Anti-hSBA antibody titers were expressed as geometric mean titers (GMTs) for Nimenrix + Priorix-Tetra group, Nimenrix group, Meningitec group and Pooled group (Nimenrix + Priorix-Tetra and Nimenrix groups), respectively.
    End point type
    Secondary
    End point timeframe
    Prior to and 42 days after the first vaccine dose (Pre vaccination, study Day 0 and Post vaccination I, study Day 42)
    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 performed only on subjects receiving meningitis vaccination (Nimenrix) at Day 0.
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Meningitec Group Pooled group
    Number of subjects analysed
    359
    363
    123
    722
    Units: Titer
    geometric mean (confidence interval 95%)
        hSBA- MenA, D0 [N=357;356;122;713]
    2.1 (2.1 to 2.2)
    2.1 (2 to 2.1)
    2 (2 to 2.1)
    2.1 (2.1 to 2.2)
        hSBA- MenA, D42 [N=348;338;117;686]
    33.7 (28.9 to 39.2)
    19 (16.4 to 22.1)
    2 (2 to 2.1)
    25.4 (22.8 to 28.4)
        hSBA-MenC, D0 [N=359;363;122;722]
    2 (2 to 2)
    2 (2 to 2.1)
    2 (2 to 2.1)
    2 (2 to 2.1)
        hSBA-MenC, D42 [N=346;341;116;687]
    209.1 (183.8 to 238)
    196 (175.4 to 219)
    40.3 (29.5 to 55.1)
    202.5 (186 to 220.5)
        hSBA-MenW-135, D0 [N=353;357;123;710]
    2.1 (2 to 2.1)
    2.1 (2 to 2.1)
    2 (2 to 2)
    2.1 (2 to 2.1)
        hSBA-MenW-135, D42 [N=337;336;114;673]
    57.3 (47 to 69.9)
    48.9 (41.2 to 58)
    2 (2 to 2.2)
    52.9 (46.4 to 60.3)
        hSBA-MenY, D0 [N=344;349;122;693]
    2.1 (2 to 2.1)
    2.1 (2 to 2.1)
    2.1 (1.9 to 2.2)
    2.1 (2 to 2.1)
        hSBA-MenY, D42 [N=333;329;117;662]
    38.7 (32.2 to 46.7)
    30.9 (25.8 to 37.1)
    2.1 (1.9 to 2.3)
    34.6 (30.4 to 39.4)
    No statistical analyses for this end point

    Secondary: Anti-measles antibody concentrations

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    End point title
    		 Anti-measles antibody concentrations
    End point description
    Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in milli-international units per millilitre (mIU/mL) in all groups.
    End point type
    Secondary
    End point timeframe
    42 days after the first vaccine dose (Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    361
    354
    118
    120
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-measles, D42
    4273.4 (4018.4 to 4544.6)
    75 (75 to 75)
    4457.3 (3976.3 to 4996.6)
    75 (75 to 75)
    No statistical analyses for this end point

    Secondary: Anti-measles antibody concentrations

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    End point title
    		 Anti-measles antibody concentrations [13]
    End point description
    Anti-measles antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in mIU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only.
    End point type
    Secondary
    End point timeframe
    42 days after the second Priorix-Tetra vaccine dose (Post vaccination III, study Day 126)
    Notes
    [13] - 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 performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
    End point values
    		 Nimenrix + Priorix-Tetra Group Priorix-Tetra Group
    Number of subjects analysed
    37
    7
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    7113.8 (5335.6 to 9484.7)
    8699.8 (4865.3 to 15556.2)
    No statistical analyses for this end point

    Secondary: Anti-mumps antibody concentrations

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    End point title
    		 Anti-mumps antibody concentrations
    End point description
    Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in units per millilitre (U/mL) in all groups.
    End point type
    Secondary
    End point timeframe
    42 days after the first vaccine dose (Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    349
    354
    116
    120
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-mumps, D42
    662.9 (598.4 to 734.4)
    115.5 (115.5 to 115.5)
    710.1 (583.8 to 863.8)
    115.5 (115.5 to 115.5)
    No statistical analyses for this end point

    Secondary: Anti-mumps antibody concentrations

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    End point title
    		 Anti-mumps antibody concentrations [14]
    End point description
    Anti-mumps antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in U/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only.
    End point type
    Secondary
    End point timeframe
    42 days after the second Priorix-Tetra vaccine dose (Post vaccination III, study Day 126)
    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 performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
    End point values
    		 Nimenrix + Priorix-Tetra Group Priorix-Tetra Group
    Number of subjects analysed
    37
    7
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-mumps, D126
    3351.2 (2658.2 to 4224.7)
    3334.1 (1933.1 to 5750.5)
    No statistical analyses for this end point

    Secondary: Anti-rubella antibody concentrations

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    End point title
    		 Anti-rubella antibody concentrations
    End point description
    Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in all groups.
    End point type
    Secondary
    End point timeframe
    42 days after the first vaccine dose (Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    361
    354
    118
    120
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-rubella, D42
    43.1 (40 to 46.5)
    2 (2 to 2)
    53.2 (46.6 to 60.7)
    2 (2 to 2.1)
    No statistical analyses for this end point

    Secondary: Anti-rubella antibody concentrations

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    End point title
    		 Anti-rubella antibody concentrations [15]
    End point description
    Anti-rubella antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in IU/mL in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only.
    End point type
    Secondary
    End point timeframe
    42 days after the second Priorix-Tetra vaccine dose (Post vaccination III, study Day 126)
    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 performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
    End point values
    		 Nimenrix + Priorix-Tetra Group Priorix-Tetra Group
    Number of subjects analysed
    37
    7
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-rubella, D126
    87.2 (74.8 to 101.6)
    117 (73.8 to 185.5)
    No statistical analyses for this end point

    Secondary: Anti-varicella antibody titers

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    End point title
    		 Anti-varicella antibody titers
    End point description
    Anti-varicella antibody titers were given as geometric mean titers (GMTs) for all groups.
    End point type
    Secondary
    End point timeframe
    42 days after the first vaccine dose (Post vaccination I, study Day 42)
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    333
    335
    111
    116
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-varicella, D42
    152.8 (133.5 to 174.8)
    2.2 (2 to 2.3)
    128.8 (99.1 to 167.4)
    2.2 (1.9 to 2.5)
    No statistical analyses for this end point

    Secondary: Anti-varicella antibody titers

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    End point title
    		 Anti-varicella antibody titers [16]
    End point description
    Anti-varicella antibody titers were given as geometric mean titers (GMTs) in a subset (30%) of the Nimenrix + Priorix-Tetra and Priorix-Tetra groups only.
    End point type
    Secondary
    End point timeframe
    42 days after the second Priorix-Tetra vaccine dose (Post vaccination III, study Day 126)
    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 performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
    End point values
    		 Nimenrix + Priorix-Tetra Group Priorix-Tetra Group
    Number of subjects analysed
    36
    7
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-varicella, D126
    4175.6 (3064 to 5690.6)
    3360.1 (1646.5 to 6857)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local symptoms specific for Priorix-Tetra vaccination

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    End point title
    		 Number of subjects reporting solicited local symptoms specific for Priorix-Tetra vaccination [17]
    End point description
    Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group and Priorix-Tetra Group, respectively.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) after vaccination with first dose of Priorix-Tetra vaccine at Day 0
    Notes
    [17] - 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 performed only on subjects receiving varicella vaccination (Priorix-Tetra) at Day 0.
    End point values
    		 Nimenrix + Priorix-Tetra Group Priorix-Tetra Group
    Number of subjects analysed
    375
    124
    Units: Subjects
        Pain
    75
    22
        Redness
    126
    48
        Swelling
    28
    7
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local symptoms after Nimenrix or Meningitec vaccination

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    End point title
    		 Number of subjects reporting solicited local symptoms after Nimenrix or Meningitec vaccination [18]
    End point description
    Solicited local symptoms assessed were pain, redness and swelling for the Nimenrix + Priorix-Tetra Group, Nimenrix Group and Meningitec Group, respectively.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) after vaccination with Nimenrix or Meningitec at Day 0
    Notes
    [18] - 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 performed only on subjects receiving meningitis vaccination (Nimenrix or Meningitec) at Day 0.
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Meningitec Group
    Number of subjects analysed
    375
    367
    123
    Units: Subjects
        Pain
    91
    107
    31
        Redness
    133
    136
    39
        Swelling
    52
    69
    10
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general symptoms

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    End point title
    		 Number of subjects reporting solicited general symptoms
    End point description
    Solicited general symptoms assessed were drowsiness, fever (measured rectally and temperature ≥ 38.0°C ), irritability and loss of appetite, meningismus, parotiditis and rash.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) follow-up period after Dose1 vaccination in all groups
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    375
    367
    124
    124
    Units: Subjects
        Drowsiness
    122
    103
    29
    40
        Fever≥38.0˚C
    56
    34
    14
    16
        Irritability
    190
    150
    48
    54
        Loss of appetite
    107
    84
    29
    33
        Meningismus
    0
    0
    0
    0
        Parotiditis
    0
    0
    0
    0
        Rash
    22
    23
    10
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with Priorix-Tetra-specific solicited general symptoms

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    End point title
    		 Number of subjects with Priorix-Tetra-specific solicited general symptoms
    End point description
    Solicited general symptoms assessed were fever (measured rectally and temperature ≥ 38.0°C ), meningismus, parotiditis and rash.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) after Dose1 vaccination period
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    375
    367
    124
    124
    Units: Subjects
        Fever ≥ 38.0˚C
    295
    164
    99
    56
        Meningismus
    1
    0
    0
    1
        Parotiditis
    0
    0
    0
    0
        Rash
    119
    66
    36
    24
    No statistical analyses for this end point

    Secondary: Number of subjects reporting specific adverse events (AEs)

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    End point title
    		 Number of subjects reporting specific adverse events (AEs)
    End point description
    Specific AEs include: − rash (hives, idiopathic thrombocytopenic purpura, petechiae), − New Onset of Chronic Illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), and/or: − conditions prompting emergency room (ER) visits or or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis).
    End point type
    Secondary
    End point timeframe
    From Day 0 up to 6 months after first vaccine dose
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    375
    374
    126
    125
    Units: Subjects
        Rash (es)
    13
    10
    2
    6
        NOCI (s)
    6
    3
    1
    1
        ER visit (s)
    28
    29
    3
    7
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited symptoms

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    End point title
    		 Number of subjects reporting unsolicited symptoms
    End point description
    Unsolicited symptom covers any symptom 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.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post Dose 1 vaccination period
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    375
    374
    126
    125
    Units: Subjects
        Any (AE’s)
    243
    225
    86
    68
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited symptoms

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    End point title
    		 Number of subjects reporting unsolicited symptoms
    End point description
    Unsolicited symptom covers any symptom 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.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) follow-up period after each vaccination
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    375
    374
    126
    125
    Units: Subjects
        Any (AE’s)
    252
    233
    90
    75
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From Day 0 up to 6 months after vaccination
    End point values
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Priorix-Tetra Group Meningitec Group
    Number of subjects analysed
    375
    374
    126
    125
    Units: Subjects
        Any (SAE’s)
    13
    10
    3
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs: Day 0 up to 6 months. Solicited local and general symptoms: during the 4-day (Day 0-Day 3) period after vaccination. Unsolicited symptoms (AEs): during the 43-day (Days 0-42) period after vaccination.
    Adverse event reporting additional description
    This is specific for each SAE/AE that is entered. The occurrence of reported AEs (all/related) was not available and it is encoded as equal to the number of affected subjects.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Nimenrix + Priorix-Tetra Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix vaccine & 1 dose of Priorix-Tetra vaccine on Day 0 and a second dose of Priorix-Tetra vaccine on Day 84.

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Subjects received 1 dose of Nimenrix vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.

    Reporting group title
    Meningitec Group
    Reporting group description
    		 Subjects received 1 dose of Meningitec vaccine on Day 0 followed by 2 doses of Priorix-Tetra vaccine, respectively 42 and 84 days later.

    Reporting group title
    Priorix-Tetra Group
    Reporting group description
    		 Subjects received 1 dose of Priorix-Tetra vaccine on Day 0, 1 dose of Meningitec vaccine on Day 42 and a second dose of Priorix-Tetra vaccine on Day 84.

    Serious adverse events
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Meningitec Group Priorix-Tetra Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 375 (3.47%)
    10 / 374 (2.67%)
    2 / 125 (1.60%)
    3 / 126 (2.38%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Medical observation
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 374 (0.00%)
    0 / 125 (0.00%)
    0 / 126 (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
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    2 / 375 (0.53%)
    0 / 374 (0.00%)
    0 / 125 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug toxicity
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 374 (0.00%)
    0 / 125 (0.00%)
    0 / 126 (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
    Poisoning
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 374 (0.27%)
    0 / 125 (0.00%)
    0 / 126 (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
    0 / 375 (0.00%)
    1 / 374 (0.27%)
    1 / 125 (0.80%)
    0 / 126 (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
    Skin and subcutaneous tissue disorders
    Henoch-schonlein purpura
         subjects affected / exposed
    0 / 375 (0.00%)
    0 / 374 (0.00%)
    1 / 125 (0.80%)
    0 / 126 (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
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 375 (0.53%)
    3 / 374 (0.80%)
    0 / 125 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 374 (0.27%)
    0 / 125 (0.00%)
    0 / 126 (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
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 375 (0.53%)
    0 / 374 (0.00%)
    0 / 125 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 374 (0.00%)
    0 / 125 (0.00%)
    0 / 126 (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
    Laryngitis
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 374 (0.27%)
    0 / 125 (0.00%)
    0 / 126 (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
    Otitis media
         subjects affected / exposed
    1 / 375 (0.27%)
    1 / 374 (0.27%)
    0 / 125 (0.00%)
    0 / 126 (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
    Pneumococcal sepsis
         subjects affected / exposed
    0 / 375 (0.00%)
    0 / 374 (0.00%)
    1 / 125 (0.80%)
    0 / 126 (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
    2 / 375 (0.53%)
    1 / 374 (0.27%)
    0 / 125 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 374 (0.27%)
    0 / 125 (0.00%)
    1 / 126 (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
    Pyelonephritis acute
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 374 (0.00%)
    0 / 125 (0.00%)
    0 / 126 (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
    Sepsis
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 374 (0.00%)
    0 / 125 (0.00%)
    0 / 126 (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
    0 / 375 (0.00%)
    1 / 374 (0.27%)
    0 / 125 (0.00%)
    0 / 126 (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
    Viral infection
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 374 (0.00%)
    0 / 125 (0.00%)
    0 / 126 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix + Priorix-Tetra Group Nimenrix Group Meningitec Group Priorix-Tetra Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    340 / 375 (90.67%)
    313 / 374 (83.69%)
    103 / 125 (82.40%)
    108 / 126 (85.71%)
    Nervous system disorders
    Febrile convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    38 / 375 (10.13%)
    37 / 374 (9.89%)
    11 / 125 (8.80%)
    16 / 126 (12.70%)
         occurrences all number
    38
    37
    11
    16
    General disorders and administration site conditions
    Irritability
    alternative assessment type: Non-systematic
         subjects affected / exposed
    51 / 375 (13.60%)
    19 / 374 (5.08%)
    9 / 125 (7.20%)
    17 / 126 (13.49%)
         occurrences all number
    51
    19
    9
    17
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    53 / 375 (14.13%)
    40 / 374 (10.70%)
    16 / 125 (12.80%)
    14 / 126 (11.11%)
         occurrences all number
    53
    40
    16
    14
    Teething
    alternative assessment type: Non-systematic
         subjects affected / exposed
    39 / 375 (10.40%)
    38 / 374 (10.16%)
    13 / 125 (10.40%)
    14 / 126 (11.11%)
         occurrences all number
    39
    38
    13
    14
    Infections and infestations
    Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    54 / 375 (14.40%)
    66 / 374 (17.65%)
    23 / 125 (18.40%)
    21 / 126 (16.67%)
         occurrences all number
    54
    66
    23
    21
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    38 / 375 (10.13%)
    35 / 374 (9.36%)
    11 / 125 (8.80%)
    16 / 126 (12.70%)
         occurrences all number
    38
    35
    11
    16
    Otitis media
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 375 (0.00%)
    29 / 374 (7.75%)
    0 / 125 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    29
    0
    0
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    54 / 375 (14.40%)
    66 / 374 (17.65%)
    23 / 125 (18.40%)
    21 / 126 (16.67%)
         occurrences all number
    54
    66
    23
    21
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    53 / 375 (14.13%)
    40 / 374 (10.70%)
    16 / 125 (12.80%)
    14 / 126 (11.11%)
         occurrences all number
    53
    40
    16
    14
    Concussion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    39 / 375 (10.40%)
    38 / 374 (10.16%)
    13 / 125 (10.40%)
    14 / 126 (11.11%)
         occurrences all number
    39
    38
    13
    14
    Gastroenteritis rotavirus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    51 / 375 (13.60%)
    0 / 374 (0.00%)
    9 / 125 (7.20%)
    17 / 126 (13.49%)
         occurrences all number
    51
    0
    9
    17

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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