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    Clinical Trial Results:
    A Phase III, randomised, partially-blind, controlled, multi-centric, multi-country study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ MenACWY-TT conjugate vaccine co-administered with Boostrix® administered intramuscularly versus MenACWY-TT alone administered intramuscularly, in healthy adolescents and young adults between 11 and 25 years of age.

    Summary
    EudraCT number
    		 2012-002737-11
    Trial protocol
    		 DE  
    Global end of trial date
    16 Jan 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    19 Aug 2017
    First version publication date
    06 Mar 2015
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Addition to primary and secondary outcomes

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    116705
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01767376
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, 1330
    Public contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    11 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To demonstrate the non-inferiority of MenACWY-TT co-administered with Boostrix compared to MenACWY-TT administered alone with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titres (GMTs) for serogroups A, C, W-135 and Y one month after MenACWY-TT vaccination. •To demonstrate the non-inferiority of Boostrix co-administered with MenACWY-TT compared to Boostrix administered alone in terms of anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibody concentrations one month after Boostrix vaccination. •To demonstrate the non-inferiority of Boostrix co-administered with MenACWY-TT compared to Boostrix administered alone with respect to geometric mean concentrations (GMCs) to each discrete pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]) one month after Boostrix vaccination.
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jan 2013
    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
    Germany: 181
    Country: Number of subjects enrolled
    Dominican Republic: 180
    Country: Number of subjects enrolled
    Korea, Republic of: 331
    Worldwide total number of subjects
    692
    EEA total number of subjects
    181
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    78
    Adolescents (12-17 years)
    211
    Adults (18-64 years)
    403
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Out of the 692 subjects enrolled in this study, one subject was eliminated due to not receiving vaccination, hence only 691 subject started the study.

    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.

    Pre-assignment period milestones
    Number of subjects started
    		 692
    Number of subjects completed
    		 691

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccination reveiced: 1
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nimenrix+Boostrix Group
    Arm description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine at Month 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid muscle of the arm at Month 0.

    Investigational medicinal product name
    Boostrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid of the right arm at Month 0.

    Arm title
    		 Nimenrix Group
    Arm description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid muscle of the arm at Month 0.

    Investigational medicinal product name
    Boostrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid of the left arm at Month 1.

    Arm title
    		 Boostrix Group
    Arm description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Meningococcal vaccine GSK134612
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid muscle of the arm at Month 1.

    Investigational medicinal product name
    Boostrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose administered intramuscularly (IM) in the deltoid of the left arm at Month 0.

    Number of subjects in period 1 [1]
    		Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Started
    231
    228
    232
    Completed
    227
    225
    232
    Not completed
    4
    3
    0
         Consent withdrawn by subject
    1
    1
    -
         Lost to follow-up
    3
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of the 692 subjects enrolled in this study, one subject was eliminated due to not receiving vaccination, hence only 691 subject started the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nimenrix+Boostrix Group
    Reporting group description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine at Month 0.

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1.

    Reporting group title
    Boostrix Group
    Reporting group description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1.

    Reporting group values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group Total
    Number of subjects
    		 231 228 232 691
    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)
    		 18.1 ( 4.2 ) 18.2 ( 4.5 ) 18.3 ( 4.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 128 126 146 400
        Male
    		 103 102 86 291

    End points

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    End points reporting groups
    Reporting group title
    Nimenrix+Boostrix Group
    Reporting group description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine at Month 0.

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1.

    Reporting group title
    Boostrix Group
    Reporting group description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1.

    Primary: Anti-Meningitis antibody titers by serum bactericidal assay using rabbit complement (rSBA)

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    End point title
    		 Anti-Meningitis antibody titers by serum bactericidal assay using rabbit complement (rSBA) [1]
    End point description
    The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement.
    End point type
    Primary
    End point timeframe
    At one month after Nimenrix vaccination
    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: Because of splitting into primary/secondary end points for some of the groups, the results were presented separately.
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group
    Number of subjects analysed
    226
    222
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA (N=225;222)
    3415.3 (2917.8 to 3997.6)
    2860.4 (2478.6 to 3300.9)
        rSBA-MenC (N=226;222)
    5092.5 (4268.7 to 6075.3)
    4597.6 (3703.1 to 5708.2)
        rSBA-MenW-135 (N=226;222)
    9608.5 (8522.5 to 10832.8)
    9052.8 (7510.3 to 10912)
        rSBA-MenY (N=226;222)
    7775.8 (6862.3 to 8811)
    6032.6 (5025.7 to 7241.2)
    Statistical analysis title
    		 Difference in adjusted GMT ratio for rSBA-MenA
    Statistical analysis description
    To demonstrate that the immunogenicity of Nimenrix vaccine co-administered with Boostrix vaccine (Nimenrix+Boostrix Group) was non-inferior to that of Nimenrix vaccine administered alone (Nimenrix Group) at Month 0, with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup A, at one month after the Nimenrix vaccination.
    Comparison groups
    Nimenrix+Boostrix Group v Nimenrix Group
    Number of subjects included in analysis
    448
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.48
    Notes
    [2] - Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup A between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.
    Statistical analysis title
    		 Difference in adjusted GMT ratio for rSBA-MenC
    Statistical analysis description
    To demonstrate that the immunogenicity of Nimenrix vaccine co-administered with Boostrix vaccine (Nimenrix+Boostrix Group) was non-inferior to that of Nimenrix vaccine administered alone (Nimenrix Group) at Month 0, with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup C, at one month after the Nimenrix vaccination.
    Comparison groups
    Nimenrix+Boostrix Group v Nimenrix Group
    Number of subjects included in analysis
    448
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.47
    Notes
    [3] - Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup C between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal (≥) to the pre-defined limit of 0.5.
    Statistical analysis title
    		 Difference in adjusted GMT ratio for rSBA-MenW-135
    Statistical analysis description
    To demonstrate that the immunogenicity of Nimenrix vaccine co-administered with Boostrix vaccine (Nimenrix+Boostrix Group) was non-inferior to that of Nimenrix vaccine administered alone (Nimenrix Group) at Month 0, with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup W-135, at one month after the Nimenrix vaccination.
    Comparison groups
    Nimenrix+Boostrix Group v Nimenrix Group
    Number of subjects included in analysis
    448
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.32
    Notes
    [4] - Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup W-135 between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal (≥) to the pre-defined limit of 0.5.
    Statistical analysis title
    		 Difference in adjusted GMT ratio for rSBA-MenY
    Statistical analysis description
    To demonstrate that the immunogenicity of Nimenrix vaccine co-administered with Boostrix vaccine (Nimenrix+Boostrix Group) was non-inferior to that of Nimenrix vaccine administered alone (Nimenrix Group) at Month 0, with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup Y, at one month after the Nimenrix vaccination.
    Comparison groups
    Nimenrix+Boostrix Group v Nimenrix Group
    Number of subjects included in analysis
    448
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.59
    Notes
    [5] - Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup Y between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal (≥) to the pre-defined limit of 0.5.

    Primary: Number of subjects with anti-D and anti-T concentrations ≥ 1.0 International Units per milliliter (IU/mL)

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    End point title
    		 Number of subjects with anti-D and anti-T concentrations ≥ 1.0 International Units per milliliter (IU/mL) [6]
    End point description
    The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    At one month after Boostrix vaccination
    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: Because of splitting into primary/secondary end points for some of the groups, the results were presented separately.
    End point values
    		 Nimenrix+Boostrix Group Boostrix Group
    Number of subjects analysed
    225
    223
    Units: Subjects
        Anti-D
    200
    224
        Anti-T
    203
    223
    Statistical analysis title
    		 Difference in percentage for anti-D antibodies
    Statistical analysis description
    To demonstrate that the immunogenicity of Boostrix vaccine co-administered with Nimenrix vaccine (Nimenrix+Boostrix Group) was non-inferior to that of Boostrix vaccine administered alone (Boostrix Group) at Month 0, in terms of percentage of subjects with anti-D antibody concentrations ≥ 1.0 International Units/mL (IU/mL), at one month after the Boostrix vaccination.
    Comparison groups
    Nimenrix+Boostrix Group v Boostrix Group
    Number of subjects included in analysis
    448
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -2.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.88
         upper limit
    		 3.53
    Notes
    [7] - Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-D concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.
    Statistical analysis title
    		 Difference in percentage for anti-T antibodies
    Statistical analysis description
    To demonstrate that the immunogenicity of Boostrix vaccine co-administered with Nimenrix vaccine (Nimenrix+Boostrix Group) was non-inferior to that of Boostrix vaccine administered alone (Boostrix Group) at Month 0, in terms of percentage of subjects with anti-T antibody concentrations ≥ 1.0 IU/mL, at one month after the Boostrix vaccination.
    Comparison groups
    Nimenrix+Boostrix Group v Boostrix Group
    Number of subjects included in analysis
    448
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.48
         upper limit
    		 1.26
    Notes
    [8] - Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-T concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.

    Primary: 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 [9]
    End point description
    The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    At one month after Boostrix vaccination
    Notes
    [9] - 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: Because of splitting into primary/secondary end points for some of the groups, the results were presented separately.
    End point values
    		 Nimenrix+Boostrix Group Boostrix Group
    Number of subjects analysed
    225
    223
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-PT (N=225;223)
    53.6 (47.2 to 60.8)
    68 (59.9 to 77.3)
        Anti-FHA (N=225;223)
    316.9 (288 to 348.6)
    545 (493.2 to 602.4)
        Anti-PRN (N=224;221)
    348.3 (293.8 to 412.9)
    499 (419.4 to 593.6)
    Statistical analysis title
    		 Difference in adjusted GMC ratios for anti-PT
    Statistical analysis description
    To demonstrate that the immunogenicity of Boostrix vaccine co-administered with Nimenrix vaccine (Nimenrix+Boostrix Group) was non-inferior to that of Boostrix vaccine administered alone (Boostrix Group) at Month 0, with respect to geometric mean concentrations (GMCs) to pertussis antigen (PT), at one month after the Boostrix vaccination.
    Comparison groups
    Nimenrix+Boostrix Group v Boostrix Group
    Number of subjects included in analysis
    448
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.89
    Notes
    [10] - Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertussis (PT) antigen, being greater than or equal to (≥) the pre-defined limit of 0.67.
    Statistical analysis title
    		 Difference in adjusted GMC ratios for anti-FHA
    Statistical analysis description
    To demonstrate that the immunogenicity of Boostrix vaccine co-administered with Nimenrix vaccine (Nimenrix+Boostrix Group) was non-inferior to that of Boostrix vaccine administered alone (Boostrix Group) at Month 0, with respect to geometric mean concentrations (GMCs) to filamentous haemagglutinin (FHA) antigen, at one month after the Boostrix vaccination.
    Comparison groups
    Nimenrix+Boostrix Group v Boostrix Group
    Number of subjects included in analysis
    448
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 0.65
    Notes
    [11] - Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the filamentous haemagglutinin (FHA) antigen, being greater than or equal to (≥) the pre-defined limit of 0.67.
    Statistical analysis title
    		 Difference in adjusted GMC ratios for anti-PRN
    Statistical analysis description
    To demonstrate that the immunogenicity of Boostrix vaccine co-administered with Nimenrix vaccine (Nimenrix+Boostrix Group) was non-inferior to that of Boostrix vaccine administered alone (Boostrix Group) at Month 0, with respect to geometric mean concentrations (GMCs) to pertactin (PRN) antigen, at one month after the Boostrix vaccination.
    Comparison groups
    Nimenrix+Boostrix Group v Boostrix Group
    Number of subjects included in analysis
    448
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [12]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.88
    Notes
    [12] - Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertactin (PRN) antigen, being greater than or equal to (≥) the pre-defined limit of 0.67.

    Secondary: Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥ 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 antibody titres ≥ 1:8 and ≥ 1:128
    End point description
    The number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8 and ≥ 1:128 is reported.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month (POST) after Nimenrix vaccination
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Number of subjects analysed
    226
    222
    223
    Units: Subjects
        rSBA-MenA ≥ 1:8, PRE (N=226;222;223)
    92
    92
    76
        rSBA-MenA ≥ 1:8, POST (N=225;222;223)
    225
    221
    222
        rSBA-MenC ≥ 1:8, PRE (N=226;222;223)
    35
    47
    43
        rSBA-MenC ≥ 1:8, POST (N=226;222;223)
    225
    220
    222
        rSBA-MenW-135 ≥ 1:8, PRE (N=226;222;223)
    34
    36
    26
        rSBA-MenW-135 ≥ 1:8, POST (N=226;222;223)
    226
    220
    216
        rSBA-MenY ≥ 1:8, PRE (N=226;222;223)
    93
    67
    74
        rSBA-MenY ≥ 1:8, POST (N=226;222;223)
    226
    220
    222
        rSBA-MenA ≥ 1:128, PRE (N=226;222;223)
    48
    46
    33
        rSBA-MenA ≥ 1:128, POST (N=225;222;223)
    224
    220
    220
        rSBA-MenC ≥ 1:128, PRE (N=226;222;223)
    13
    33
    30
        rSBA-MenC ≥ 1:128, POST (N=226;222;223)
    225
    218
    220
        rSBA-MenW-135 ≥ 1:128, PRE (N=226;222;223)
    31
    29
    23
        rSBA-MenW-135 ≥ 1:128, POST (N=226;222;223)
    226
    220
    216
        rSBA-MenY ≥ 1:128, PRE (N=226;222;223)
    80
    56
    70
        rSBA-MenY ≥ 1:128, POST (N=226;222;223)
    226
    219
    222
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-PT, anti-FHA and anti-PRN antibody concentrations above the cut-off values

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    End point title
    		 Number of subjects with anti-PT, anti-FHA and anti-PRN antibody concentrations above the cut-off values
    End point description
    The cut-off values assessed were greater than or equal (≥) to 5 International units per milliliter (IU/mL) in the sera of subjects seronegative before vaccination.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after (POST) Boostrix vaccination
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Number of subjects analysed
    225
    222
    223
    Units: Subjects
        Anti-PT, PRE (N=223;222;221)
    162
    156
    153
        Anti-PT, POST (N=225;220;223)
    221
    220
    223
        Anti-FHA, PRE (N=223;222;223)
    222
    221
    220
        Anti-FHA, POST (N=225;220;223)
    225
    220
    223
        Anti-PRN, PRE (N=223;222;221)
    200
    200
    207
        Anti-PRN, POST (N=224;218;221)
    223
    218
    221
    No statistical analyses for this end point

    Secondary: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY vaccine response

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    End point title
    		 rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY vaccine response
    End point description
    rSBA vaccine response for serogroups A, C, W-135 and Y is defined as: For initially seronegative subjects (pre-vaccination titer below the cut-off of 1:8): number of subjects with rSBA antibody titers ≥ 1:32 one month after vaccination. For initially seropositive subjects (pre-vaccination titer ≥ 1:8): number of subjects with rSBA antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination.
    End point type
    Secondary
    End point timeframe
    At one month after Nimenrix vaccination
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Number of subjects analysed
    226
    222
    223
    Units: Subjects
        rSBA-MenA (N=225;222;223)
    217
    207
    214
        rSBA-MenC (N=226;222;223)
    225
    210
    215
        rSBA-MenW-135 (N=226;222;223)
    225
    216
    211
        rSBA-MenY (N=226;222;223)
    220
    214
    212
    No statistical analyses for this end point

    Secondary: Booster responses for anti-PT, anti-FHA and anti-PRN concentrations

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    End point title
    		 Booster responses for anti-PT, anti-FHA and anti-PRN concentrations
    End point description
    Booster responses to the PT, FHA and PRN antigens, defined as: For initially seronegative subjects (antibody concentration < 2.046 IU/ml for anti-FHA, concentration < 2.187 IU/ml for anti- PRN, concentration < 2.693 IU/ml for anti-PT) prior to vaccination: antibody concentration ≥ 4 fold cut-off at one month after the vaccination. For initially seropositive subjects (antibody concentration ≥ 2.046 IU/ml for anti-FHA, concentration ≥ 2.187 IU/ml for anti- PRN, concentration ≥ 2.693 IU/ml for anti-PT) prior to vaccination, with pre-vaccination antibody concentration < 4 fold cut-off: antibody concentration ≥ 4 fold the pre-vaccination antibody concentration at one month after the vaccination. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 4 fold cut-off: antibody concentration ≥ 2 fold the pre-vaccination antibody concentration at one month after the vaccination.
    End point type
    Secondary
    End point timeframe
    One month after Boostrix vaccination
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Number of subjects analysed
    222
    220
    223
    Units: Subjects
        Anti-PT (N=222;220;221)
    201
    188
    201
        Anti-FHA (N=222;220;223)
    208
    210
    213
        Anti-PRN (N=221;218;219)
    209
    198
    207
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and Grade 3 solicited local symptoms

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    End point title
    		 Number of subjects reporting any and Grade 3 solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) following each vaccination
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Number of subjects analysed
    231
    228
    232
    Units: Subjects
        Any Pain (N=231;228;232)
    176
    148
    167
        Grade 3 Pain (N=231;228;232)
    15
    19
    8
        Any Pain after Boostrix (N=231;225;232)
    155
    121
    156
        Grade 3 Pain after Boostrix (N=231;225;232)
    13
    12
    8
        Any Pain after Nimenrix (N=231;228;232)
    121
    101
    92
        Grade 3 Pain after Nimenrix (N=231;228;232)
    7
    8
    0
        Any Redness (N=231;228;232)
    81
    75
    76
        Grade 3 Redness (N=231;228;232)
    4
    10
    6
        Any Redness after Boostrix (N=231;225;232)
    64
    56
    65
        Grade 3 Redness after Boostrix (N=231;225;232)
    3
    5
    5
        Any Redness after Nimenrix (N=231;228;232)
    61
    54
    39
        Grade 3 Redness after Nimenrix (N=231;228;232)
    1
    6
    4
        Any Swelling (N=231;228;232)
    71
    71
    68
        Grade 3 Swelling (N=231;228;232)
    5
    9
    7
        Any Swelling after Boostrix (N=231;225;232)
    57
    51
    54
        Grade 3 Swelling after Boostrix (N=231;225;232)
    3
    4
    7
        Any Swelling after Nimenrix (N=231;228;232)
    48
    47
    33
        Grade 3 Swelling after Nimenrix (N=231;228;232)
    3
    5
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, Grade 3 and related general symptoms

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    End point title
    		 Number of subjects reporting any, Grade 3 and related general symptoms
    End point description
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Number of subjects analysed
    231
    228
    232
    Units: Subjects
        Any Fatigue
    75
    77
    81
        Grade 3 Fatigue
    2
    5
    4
        Related Fatigue
    70
    67
    70
        Any Gastrointestinal symptoms
    23
    31
    25
        Grade 3 Gastrointestinal symptoms
    2
    2
    1
        Related Gastrointestinal symptoms
    20
    25
    18
        Any Headache
    51
    76
    65
        Grade 3 Headache
    2
    5
    2
        Related Headache
    49
    67
    53
        Any Fever
    14
    17
    11
        Grade 3 Fever
    0
    0
    0
        Related Fever
    10
    15
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events SAE(s)

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    End point title
    		 Number of subjects with serious adverse events SAE(s)
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    Throughout the whole study period (from Month 0 up to Month 2)
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Number of subjects analysed
    231
    228
    232
    Units: Subjects
        Subjects with any SAEs
    0
    0
    3
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with new onset of chronic illnesses (NOCIs)
    End point description
    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
    End point type
    Secondary
    End point timeframe
    Throughout the whole study period (from Month 0 up to Month 2)
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Number of subjects analysed
    231
    228
    232
    Units: Subjects
        Subjects with any NOCIs
    1
    5
    3
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events AE(s)

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    End point title
    		 Number of subjects with unsolicited adverse events AE(s)
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Days 0-30 following each vaccination
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Number of subjects analysed
    231
    228
    232
    Units: Subjects
        Subjects with any AEs
    36
    44
    58
    No statistical analyses for this end point

    Secondary: Anti-Meningitis antibody titers by serum bactericidal assay using rabbit complement (rSBA)

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    End point title
    		 Anti-Meningitis antibody titers by serum bactericidal assay using rabbit complement (rSBA) [13]
    End point description
    The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement.
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after (POST) Nimenrix vaccination
    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: Because of splitting into primary/secondary end points for some of the groups, the results were presented separately.
    End point values
    		 Boostrix Group
    Number of subjects analysed
    223
    Units: Titers
    geometric mean (confidence interval 95%)
        rSBA-MenA, PRE
    10.7 (8.5 to 13.4)
        rSBA-MenA, POST
    1577.4 (1354.4 to 1837.1)
        rSBA-MenC, PRE
    8.3 (6.7 to 10.4)
        rSBA-MenC, POST
    1912.6 (1593.9 to 2295.1)
        rSBA-MenW-135, PRE
    6.9 (5.6 to 8.5)
        rSBA-MenW-135, POST
    3164.6 (2534 to 3952.1)
        rSBA-MenY, PRE
    18.2 (13.6 to 24.5)
        rSBA-MenY, POST
    4134.4 (3582.3 to 4771.5)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-D and anti-T concentrations ≥ 1.0 IU/mL

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    End point title
    		 Number of subjects with anti-D and anti-T concentrations ≥ 1.0 IU/mL [14]
    End point description
    The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At one month after Boostrix 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: Because of splitting into primary/secondary end points for some of the groups, the results were presented separately.
    End point values
    		 Nimenrix Group
    Number of subjects analysed
    220
    Units: Subjects
        Anti-D
    200
        Anti-T
    220
    No statistical analyses for this end point

    Secondary: Anti-D antibody concentrations

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    End point title
    		 Anti-D antibody concentrations
    End point description
    The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    Prior to (PRE) and one month after (POST) Boostrix vaccination
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Number of subjects analysed
    225
    220
    223
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D, PRE (N=217;220;218)
    0.3 (0.3 to 0.4)
    0.3 (0.3 to 0.4)
    0.3 (0.3 to 0.4)
        Anti-D, POST (N=225;220;223)
    4 (3.4 to 4.6)
    4.6 (3.9 to 5.4)
    4.7 (4 to 5.4)
    No statistical analyses for this end point

    Secondary: Anti-T antibody concentrations

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    End point title
    		 Anti-T antibody concentrations
    End point description
    The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At Month 0, Month 1 and Month 2
    End point values
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Number of subjects analysed
    225
    222
    223
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-T, Month 0 (N=222;222;223)
    0.6 (0.5 to 0.8)
    0.6 (0.5 to 0.7)
    0.7 (0.5 to 0.8)
        Anti-T, Month 1 (N=225;222;223)
    23.5 (20.8 to 26.5)
    18.5 (16 to 21.3)
    16.3 (14.6 to 18.2)
        Anti-T, Month 2 (N=0;220;223)
    0 (0 to 0)
    13 (11.7 to 14.5)
    13.5 (12.3 to 14.8)
    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 [15]
    End point description
    The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At one month after Boostrix 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: Because of splitting into primary/secondary end points for some of the groups, the results were presented separately.
    End point values
    		 Nimenrix Group
    Number of subjects analysed
    220
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-PT (N=220)
    56.7 (49.9 to 64.3)
        Anti-FHA (N=220)
    447.3 (403.4 to 496)
        Anti-PRN (N=218)
    291.2 (239.1 to 354.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: Days 0-30 following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 2).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Nimenrix+Boostrix Group
    Reporting group description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine at Month 0.

    Reporting group title
    Nimenrix Group
    Reporting group description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1.

    Reporting group title
    Boostrix Group
    Reporting group description
    		 Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1.

    Serious adverse events
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 228 (0.00%)
    3 / 232 (1.29%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Nervous system disorders
    Orthostatic intolerance
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 228 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 228 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 231 (0.00%)
    0 / 228 (0.00%)
    1 / 232 (0.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nimenrix+Boostrix Group Nimenrix Group Boostrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    190 / 231 (82.25%)
    166 / 228 (72.81%)
    180 / 232 (77.59%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    176 / 231 (76.19%)
    148 / 228 (64.91%)
    167 / 232 (71.98%)
         occurrences all number
    176
    222
    248
    Redness
         subjects affected / exposed
    81 / 231 (35.06%)
    75 / 228 (32.89%)
    76 / 232 (32.76%)
         occurrences all number
    81
    75
    76
    Swelling
         subjects affected / exposed
    71 / 231 (30.74%)
    71 / 228 (31.14%)
    68 / 232 (29.31%)
         occurrences all number
    71
    71
    68
    Fatigue
         subjects affected / exposed
    75 / 231 (32.47%)
    77 / 228 (33.77%)
    81 / 232 (34.91%)
         occurrences all number
    75
    77
    81
    Gastrointestinal symptoms
         subjects affected / exposed
    23 / 231 (9.96%)
    31 / 228 (13.60%)
    25 / 232 (10.78%)
         occurrences all number
    23
    31
    25
    Headache
         subjects affected / exposed
    51 / 231 (22.08%)
    76 / 228 (33.33%)
    65 / 232 (28.02%)
         occurrences all number
    51
    76
    65
    Fever(Oral)
         subjects affected / exposed
    14 / 231 (6.06%)
    17 / 228 (7.46%)
    11 / 232 (4.74%)
         occurrences all number
    14
    17
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 231 (2.60%)
    6 / 228 (2.63%)
    12 / 232 (5.17%)
         occurrences all number
    6
    6
    12

    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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