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    Clinical Trial Results:
    Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents and Young Adults to Evaluate Safety and Immunogenicity of Two Different rMenB with OMV + MenACWY Combination Vaccination Formulations

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2010-023523-23
    Trial protocol
    		 PL  
    Global end of trial date
    08 Sep 2012

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Jun 2016
    First version publication date
    03 May 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    re-QC of study needed because of EudraCT system glitch and updates to results are required.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V102_03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01272180
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics
    Sponsor organisation address
    Via Fiorentina, 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000139-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To demonstrate immunologic noninferiority of 2 doses of 2 different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine, as measured by the percentage of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W-135, and Y, at 30 days after the second vaccination, in healthy adolescents and young adults aged 10 through 25 years. 2. To identify the optimal formulation of MenABCWY vaccine compared with a single dose of Menveo (MenACWY) and with 2 doses of rMenB+OMV in healthy adolescents and young adults aged 10 through 25 years, based on the overall desirability index. The overall desirability index is based on immunogenicity parameters (GMT ratios against N. meningitidis serogroups A, C, W-135, and Y and serogroup B test strains at 30 days after the second vaccination) and reactogenicity parameters (percentages of doses associated with severe local and severe systemic solicited AEs following any vaccination).
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with Good Clinical Practice (GCP), and the applicable regulatory requirement(s) for the country in which the trial was conducted according to International Conference on Harmonisation (ICH) guidelines, and applicable Standard Operating Procedures (SOPs)..
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Aug 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 132
    Country: Number of subjects enrolled
    United States: 352
    Worldwide total number of subjects
    484
    EEA total number of subjects
    132
    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)
    169
    Adolescents (12-17 years)
    163
    Adults (18-64 years)
    152
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 8 sites in US, 5 sites in Poland

    Pre-assignment
    Screening details
    		 All enrolled subjects were included in the trial

    Period 1
    Period 1 title
    Enrolled (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ABCWY+OMV
    Arm description
    		 Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABCWY+OMV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml

    Arm title
    		 ABCWY+qOMV
    Arm description
    		 Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABCWY+qOMV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml

    Arm title
    		 rMenB +OMV
    Arm description
    		 Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart
    Arm type
    		 Active comparator

    Investigational medicinal product name
    rMenB+OMV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml

    Arm title
    		 PBO/ACWY
    Arm description
    		 Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PBO/ACWY
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml

    Number of subjects in period 1
    		ABCWY+OMV ABCWY+qOMV rMenB +OMV PBO/ACWY
    Started
    120
    121
    122
    121
    Completed
    103
    100
    109
    107
    Not completed
    17
    21
    13
    14
         Consent withdrawn by subject
    2
    6
    3
    2
         Adverse event, non-fatal
    -
    -
    1
    -
         Inappropriate enrollment
    -
    -
    1
    1
         Lost to follow-up
    15
    14
    8
    10
         Protocol deviation
    -
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABCWY+OMV
    Reporting group description
    		 Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart

    Reporting group title
    ABCWY+qOMV
    Reporting group description
    		 Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart

    Reporting group title
    rMenB +OMV
    Reporting group description
    		 Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart

    Reporting group title
    PBO/ACWY
    Reporting group description
    		 Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.

    Reporting group values
    		 ABCWY+OMV ABCWY+qOMV rMenB +OMV PBO/ACWY Total
    Number of subjects
    		 120 121 122 121 484
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.7 ( 4.7 ) 15.1 ( 4.9 ) 15.3 ( 4.9 ) 15 ( 5.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 61 68 60 64 253
        Male
    		 59 53 62 57 231

    End points

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    End points reporting groups
    Reporting group title
    ABCWY+OMV
    Reporting group description
    		 Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart

    Reporting group title
    ABCWY+qOMV
    Reporting group description
    		 Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart

    Reporting group title
    rMenB +OMV
    Reporting group description
    		 Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart

    Reporting group title
    PBO/ACWY
    Reporting group description
    		 Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.

    Primary: 1.Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.

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    End point title
    		 1.Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. [1]
    End point description
    Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y. Seroresponse is defined as: 1. For subjects with a pre-vaccination hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8; 2. For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer. Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA).
    End point type
    Primary
    End point timeframe
    One month after the second vaccination (Day 91)
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 ABCWY+OMV ABCWY+qOMV PBO/ACWY
    Number of subjects analysed
    90
    85
    76
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A (N=88, 83, 75)
    90 (81 to 95)
    92 (83 to 97)
    73 (62 to 83)
        Men C (N=86, 84, 76)
    95 (89 to 99)
    93 (85 to 97)
    63 (51 to 74)
        Men W-135 (N=75, 73, 60)
    80 (69 to 88)
    84 (73 to 91)
    65 (52 to 77)
        Men Y (N=65, 70, 59)
    92 (83 to 97)
    90 (80 to 96)
    75 (62 to 85)
    Statistical analysis title
    		 Non-inferiority seroresponse against N.meningitis
    Statistical analysis description
    Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine
    Comparison groups
    ABCWY+OMV v PBO/ACWY
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Group Difference % (ABCWY+OMV -ACWY)
    Point estimate
    16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 29
    Notes
    [2] - The immune response of ABCWY+OMV group was considered to be non-inferior to that of PBO/ACWY group if the lower limit of the two-sided 95% confidence interval of the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135 and Y serogroups, at 30 days after the last vaccination
    Statistical analysis title
    		 Non-inferiority seroresponse against N.meningitis
    Statistical analysis description
    Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine
    Comparison groups
    ABCWY+OMV v PBO/ACWY
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Group Difference % (ABCWY+OMV -ACWY)
    Point estimate
    32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21
         upper limit
    		 44
    Notes
    [3] - The immune response of ABCWY+OMV group was considered to be non-inferior to that of PBO/ACWY group if the lower limit of the two-sided 95% confidence interval of the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135 and Y serogroups, at 30 days after the last vaccination
    Statistical analysis title
    		 Non-inferiority seroresponse against N.meningitis
    Statistical analysis description
    Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine
    Comparison groups
    ABCWY+OMV v PBO/ACWY
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Group Difference % (ABCWY+OMV -ACWY)
    Point estimate
    15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 30
    Notes
    [4] - The immune response of ABCWY+OMV group was considered to be non-inferior to that of PBO/ACWY group if the lower limit of the two-sided 95% confidence interval of the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135 and Y serogroups, at 30 days after the last vaccination.
    Statistical analysis title
    		 Non-inferiority seroresponse against N.meningitis
    Statistical analysis description
    Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine
    Comparison groups
    ABCWY+OMV v PBO/ACWY
    Number of subjects included in analysis
    166
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Group Difference % (ABCWY+OMV -ACWY)
    Point estimate
    18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 31
    Notes
    [5] - The immune response of ABCWY+OMV group was considered to be non-inferior to that of PBO/ACWY group if the lower limit of the two-sided 95% confidence interval of the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135 and Y serogroups, at 30 days after the last vaccination.
    Statistical analysis title
    		 Non-inferiority seroresponse against N.meningitis
    Statistical analysis description
    Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine
    Comparison groups
    ABCWY+qOMV v PBO/ACWY
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Group Difference % (ABCWY+OMV -ACWY)
    Point estimate
    18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7
         upper limit
    		 30
    Notes
    [6] - The immune response of ABCWY+qOMV group was considered to be non-inferior to that of PBO/ACWY group if the lower limit of the two-sided 95% confidence interval of the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135 and Y serogroups, at 30 days after the last vaccination.
    Statistical analysis title
    		 Non-inferiority seroresponse against N.meningitis
    Statistical analysis description
    Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine
    Comparison groups
    ABCWY+qOMV v PBO/ACWY
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Group Difference % (ABCWY+OMV -ACWY)
    Point estimate
    30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18
         upper limit
    		 42
    Notes
    [7] - The immune response of ABCWY+qOMV group was considered to be non-inferior to that of PBO/ACWY group if the lower limit of the two-sided 95% confidence interval of the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135 and Y serogroups, at 30 days after the last vaccination.
    Statistical analysis title
    		 Non-inferiority seroresponse against N.meningitis
    Statistical analysis description
    Non-inferiority of seroresponse against N.meningitidis serogroup W of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine
    Comparison groups
    ABCWY+qOMV v PBO/ACWY
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Group Difference % (ABCWY+OMV -ACWY)
    Point estimate
    19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4
         upper limit
    		 33
    Notes
    [8] - The immune response of ABCWY+qOMV group was considered to be non-inferior to that of PBO/ACWY group if the lower limit of the two-sided 95% confidence interval of the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135 and Y serogroups, at 30 days after the last vaccination
    Statistical analysis title
    		 Non-inferiority seroresponse against N.meningitis
    Statistical analysis description
    Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine
    Comparison groups
    ABCWY+qOMV v PBO/ACWY
    Number of subjects included in analysis
    161
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Group Difference % (ABCWY+OMV -ACWY)
    Point estimate
    15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3
         upper limit
    		 29
    Notes
    [9] - The immune response of ABCWY+qOMV group was considered to be non-inferior to that of PBO/ACWY group if the lower limit of the two-sided 95% confidence interval of the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135 and Y serogroups, at 30 days after the last vaccination.

    Primary: 2.Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters

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    End point title
    		 2.Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters [10] [11]
    End point description
    The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation
    End point type
    Primary
    End point timeframe
    One month after the second vaccination (Day 91)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is associated to this endpoint.
    [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: No statistical analysis is associated to this endpoint.
    End point values
    		 ABCWY+OMV ABCWY+qOMV
    Number of subjects analysed
    86
    82
    Units: Ratio
    number (not applicable)
        Desirability index (50/50 Immuno/ Reactogenicity)
    0.306
    0.325
    No statistical analyses for this end point

    Secondary: 3. Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.

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    End point title
    		 3. Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. [12]
    End point description
    Percentages of subjects with hSBA titers ≥ 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY vaccine.
    End point type
    Secondary
    End point timeframe
    Day 1 and one month after second vaccination (Day 91)
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 ABCWY+OMV ABCWY+qOMV PBO/ACWY
    Number of subjects analysed
    90
    85
    76
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A (Day 1;N=90, 85, 76)
    8 (3 to 15)
    6 (2 to 13)
    1 (0.033 to 7)
        Men A (Day 91; N=88, 83, 75)
    93 (86 to 97)
    95 (88 to 99)
    73 (62 to 83)
        Men C (Day 1; N=88, 85,76)
    35 (25 to 46)
    35 (25 to 46)
    32 (21 to 43)
        Men C (Day 91; N=86, 84,76)
    99 (94 to 100)
    100 (96 to 100)
    83 (73 to 91)
        Men W-135 (Day 1; N=86, 79, 68)
    66 (55 to 76)
    58 (47 to 69)
    51 (39 to 64)
        Men W-135 (Day 91;N=77, 75, 65)
    100 (95 to 100)
    100 (95 to 100)
    89 (79 to 96)
        Men Y (Day 1; N=89, 85, 74)
    18 (11 to 28)
    15 (8 to 25)
    8 (3 to 17)
        Men Y (Day 91; N=65, 70,60)
    97 (89 to 100)
    97 (90 to 100)
    82 (70 to 90)
    No statistical analyses for this end point

    Secondary: 4. The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.

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    End point title
    		 4. The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. [13]
    End point description
    The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY vaccine.
    End point type
    Secondary
    End point timeframe
    Day 1 and one month after the second vaccination (Day 91)
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 ABCWY+OMV ABCWY+qOMV PBO/ACWY
    Number of subjects analysed
    90
    85
    76
    Units: Titers
    geometric mean (confidence interval 95%)
        Men A (Day 1; N=90, 85, 76)
    1.57 (1.28 to 1.92)
    1.32 (1.07 to 1.63)
    1.33 (1.08 to 1.65)
        Men A (Day 91; N=88, 83,75)
    71 (49 to 102)
    77 (53 to 111)
    45 (31 to 65)
        Men C (Day 1; N=88, 85,76)
    4.15 (3.02 to 5.69)
    3.72 (2.69 to 5.12)
    3.93 (2.84 to 5.45)
        Men C (Day 91; N=86, 84, 76)
    214 (148 to 309)
    187 (129 to 272)
    55 (38 to 80)
        Men W-135 (Day 1; N=86,79, 68)
    14 (8.88 to 22)
    10 (6.45 to 16)
    6.58 (4.11 to 11)
        Men W-135 (Day 91;N=77, 75, 65)
    239 (178 to 322)
    288 (214 to 389)
    65 (48 to 90)
        Men Y (Day 1; N=89, 85,74)
    2.01 (1.52 to 2.66)
    1.91 (1.43 to 2.53)
    1.52 (1.14 to 2.04)
        Men Y (Day 91; N=65, 70,60)
    149 (95 to 234)
    129 (83 to 201)
    46 (29 to 72)
    No statistical analyses for this end point

    Secondary: 5. Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B Test Strains, After Vaccination With Different Formulations of MenABCWY Combination Vaccine

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    End point title
    		 5. Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B Test Strains, After Vaccination With Different Formulations of MenABCWY Combination Vaccine [14]
    End point description
    The percentages of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
    End point type
    Secondary
    End point timeframe
    Day 1 and one month after the second vaccination (Day 91)
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 ABCWY+OMV ABCWY+qOMV rMenB +OMV
    Number of subjects analysed
    90
    85
    92
    Units: Percentages of subjects
    number (confidence interval 95%)
        M14459 (Day 1; hSBA ≥1:5;N=90, 85, 92)
    9 (4 to 17)
    4 (1 to 10)
    5 (2 to 12)
        M14459 (Day 91; hSBA ≥1:5; N=89, 85, 92)
    64 (53 to 74)
    71 (60 to 80)
    82 (72 to 89)
        M07-0241084 (Day 1; hSBA ≥1:5; N=89, 84, 92)
    26 (17 to 36)
    27 (18 to 38)
    23 (15 to 33)
        M07-0241084 (Day 91; hSBA ≥1:5; N=88, 85, 92)
    64 (53 to 74)
    55 (44 to 66)
    73 (63 to 82)
        M01-0240364 (Day 1; hSBA ≥1:5; N=90, 84, 91)
    3 (1 to 9)
    14 (8 to 24)
    4 (1 to 11)
        M01-0240364 (Day 91;hSBA ≥1:5; N=86, 84, 90)
    80 (70 to 88)
    80 (70 to 88)
    93 (86 to 98)
        NZ 98/254 (Day 1; hSBA ≥1:5; N=89, 85, 92)
    3 (1 to 10)
    1 (0 to 6)
    3 (1 to 9)
        NZ 98/254 (Day 91; hSBA ≥1:5; N=89, 84, 92)
    62 (51 to 72)
    56 (45 to 67)
    88 (80 to 94)
        M14459 (Day 1; hSBA ≥1:8; N=90, 85, 92)
    6 (2 to 12)
    2 (0 to 8)
    4 (1 to 11)
        M14459 (Day 91; hSBA ≥1:8; N=89, 85, 92)
    58 (47 to 69)
    66 (55 to 76)
    77 (67 to 85)
        M07-0241084 (Day 1; hSBA ≥1:8; N=89, 84, 92)
    18 (11 to 28)
    20 (12 to 30)
    14 (8 to 23)
        M07-0241084 (Day 91; hSBA ≥1:8; N=88, 85, 92)
    49 (38 to 60)
    47 (36 to 58)
    60 (49 to 70)
        M01-0240364 (Day 1; hSBA ≥1:8; N=90, 84, 91)
    2 (0 to 8)
    13 (7 to 22)
    4 (1 to 11)
        M01-0240364 (Day 91;hSBA ≥1:8; N=86, 84, 90)
    79 (69 to 87)
    79 (68 to 87)
    91 (83 to 96)
        NZ 98/254 (Day 1; hSBA ≥ 8; N=89, 85, 92)
    3 (1 to 10)
    0 (0 to 4)
    3 (1 to 9)
        NZ 98/254 (Day 91; hSBA ≥1:8; N=89, 84, 92)
    47 (37 to 58)
    49 (38 to 60)
    77 (67 to 85)
    No statistical analyses for this end point

    Secondary: 6.Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B Test Strains, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.

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    End point title
    		 6.Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B Test Strains, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. [15]
    End point description
    The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine 4-fold increase is defined as follows; for subjects with a prevaccination hSBA < 1:2, a postvaccination hSBA ≥ 1:8, for subjects with a prevaccination hSBA ≥ 1:2, at least a 4-fold increase
    End point type
    Secondary
    End point timeframe
    One month after the second vaccination (Day 91)
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 ABCWY+OMV ABCWY+qOMV rMenB +OMV
    Number of subjects analysed
    90
    85
    92
    Units: Percentages of subjects
    number (confidence interval 95%)
        M14459 (N=89, 85, 92)
    56 (45 to 67)
    62 (51 to 73)
    75 (65 to 83)
        M07-0241084 (N=87, 84,92)
    28 (19 to 38)
    25 (16 to 36)
    42 (32 to 53)
        M01-0240364 (N=86, 83, 89)
    79 (69 to 87)
    70 (59 to 79)
    88 (79 to 94)
        NZ98/254 (N=88, 84, 92)
    47 (36 to 58)
    48 (37 to 59)
    76 (66 to 84)
    No statistical analyses for this end point

    Secondary: 7. The hSBA GMTs Against N.Meningitidis serogroup B Test Strains, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.

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    End point title
    		 7. The hSBA GMTs Against N.Meningitidis serogroup B Test Strains, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. [16]
    End point description
    The hSBA GMTs against N.meningitidis serogroup B test strains after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
    End point type
    Secondary
    End point timeframe
    Day 1 and one month after the second vaccination (Day 91)
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 ABCWY+OMV ABCWY+qOMV rMenB +OMV
    Number of subjects analysed
    90
    85
    92
    Units: Titers
    geometric mean (confidence interval 95%)
        M14459 (Day 1; N=90,85,92)
    1.32 (1.09 to 1.59)
    1.15 (0.95 to 1.4)
    1.26 (1.04 to 1.53)
        M14459 (Day 91; N= 89, 85, 92)
    9.24 (6.19 to 14)
    11 (7.51 to 17)
    17 (11 to 25)
        M07-0241084 (Day 1; N= 89, 84, 92)
    2.55 (1.86 to 3.49)
    2.45 (1.76 to 3.4)
    2.13 (1.54 to 2.94)
        M07-0241084 (Day 91; N= 88, 85, 92)
    7.24 (5.4 to 9.71)
    6.26 (4.63 to 8.46)
    12 (8.83 to 16)
        M01-0240364 (Day 1; N=90, 84, 91)
    1.08 (0.82 to 1.42)
    1.72 (1.29 to 2.28)
    1.14 (0.86 to 1.51)
        M01-0240364 (Day 91; N= 86, 84, 90)
    55 (33 to 93)
    48 (28 to 83)
    118 (69 to 202)
        NZ 98/254 (Day 1; N= 89, 85, 92)
    1.2 (1.03 to 1.39)
    1.1 (0.94 to 1.28)
    1.21 (1.04 to 1.42)
        NZ 98/254 (Day 91; N= 89, 84, 92)
    8.68 (5.91 to 13)
    7.88 (5.3 to 12)
    19 (13 to 27)
    No statistical analyses for this end point

    Secondary: 8. The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B Test Strains, After Vaccination With Different Formulations of MenABCWY Combination Vaccine

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    End point title
    		 8. The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B Test Strains, After Vaccination With Different Formulations of MenABCWY Combination Vaccine [17]
    End point description
    The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B test strains after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
    End point type
    Secondary
    End point timeframe
    One month after the second vaccination/prevaccination (Day 91/day 1)
    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: No statistical analysis is associated to this endpoint.
    End point values
    		 ABCWY+OMV ABCWY+qOMV rMenB +OMV
    Number of subjects analysed
    90
    85
    92
    Units: Ratio
    geometric mean (confidence interval 95%)
        M14459 (N=89, 85, 92)
    7.32 (4.89 to 11)
    9.41 (6.19 to 14)
    14 (9.01 to 21)
        M07-0241084 (N=87,84,92)
    2.94 (2.15 to 4.02)
    2.59 (1.88 to 3.58)
    5.16 (3.76 to 7.08)
        M01-0240364 (N=86, 83, 89)
    48 (27 to 83)
    30 (17 to 54)
    98 (56 to 173)
        NZ98/254 (N=88,84,92)
    7.44 (5.06 to 11)
    6.91 (4.64 to 10)
    16 (11 to 23)
    No statistical analyses for this end point

    Secondary: 9. Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study

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    End point title
    		 9. Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study
    End point description
    The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY
    End point type
    Secondary
    End point timeframe
    Day 1 through day 7 after any vaccination
    End point values
    		 ABCWY+OMV ABCWY+qOMV rMenB +OMV PBO/ACWY
    Number of subjects analysed
    120
    120
    120
    109
    Units: Subjects
        Erythema (N=107, 110, 115, 99)
    0
    1
    0
    2
        Induration (N=107, 110, 115, 99)
    1
    0
    0
    2
        Pain (N=108, 110, 115, 99)
    29
    29
    44
    9
        Chills (N=108, 110, 115, 99)
    2
    4
    1
    0
        Myalgia(N=108, 110, 115, 99)
    16
    13
    24
    4
        Arthralgia(N=108, 110, 115, 99)
    4
    5
    4
    0
        Headache (N=108, 110, 115, 99)
    6
    4
    10
    4
        Fatigue (N=108, 110, 115, 99)
    4
    9
    9
    2
        Nausea(N=108, 110, 115, 99)
    2
    5
    7
    0
        Rash (N=108, 110, 115, 99)
    2
    3
    2
    4
        Loss of appetite (N=108, 110, 115, 99)
    3
    4
    3
    0
        Fever ( >= 38C ) (N=108, 111, 115, 99)
    7
    5
    6
    1
        Medically attended fever (N=108, 110, 115, 99)
    2
    0
    0
    0
        Prophylactic use antipyretic (N=108, 110, 115, 99)
    17
    14
    16
    7
        Therapeutic use antipyretic (N=108, 110, 115, 99)
    18
    26
    27
    10
    No statistical analyses for this end point

    Secondary: 10. The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study

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    End point title
    		 10. The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study
    End point description
    The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY
    End point type
    Secondary
    End point timeframe
    Throughout the study ( Day 1 to Day 241)
    End point values
    		 ABCWY+OMV ABCWY+qOMV rMenB +OMV PBO/ACWY
    Number of subjects analysed
    120
    120
    120
    109
    Units: Subjects
        Any AE within 30days first vaccination (days 1-30)
    21
    28
    33
    20
        Any AE within 30days second vaccination(day 61–91)
    9
    5
    9
    7
        Any AE from days 1–91
    51
    55
    66
    50
        Any AE from days 1–241
    56
    60
    71
    60
        Medically attended AEs from days 92–241
    26
    24
    30
    31
        SAEs (days 1–241)
    2
    2
    1
    3
        AEs leading to premature withdrawal (days 1–241)
    0
    0
    2
    0
        Deaths (days 1–241)
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs were collected from Day 1 to Day 7; unsolicited AEs and SAEs were collected throughout the study period (Day 1 to Day 241)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    ABCWY+OMV
    Reporting group description
    		 Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart

    Reporting group title
    ABCWY+qOMV
    Reporting group description
    		 Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart

    Reporting group title
    rMenB +OMV
    Reporting group description
    		 Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart

    Reporting group title
    PBO/ACWY
    Reporting group description
    		 Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.

    Serious adverse events
    		 ABCWY+OMV ABCWY+qOMV rMenB +OMV PBO/ACWY
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 119 (1.68%)
    2 / 121 (1.65%)
    1 / 121 (0.83%)
    3 / 108 (2.78%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 121 (0.00%)
    1 / 121 (0.83%)
    0 / 108 (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
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 121 (0.00%)
    0 / 121 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Spermatocele
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 121 (0.00%)
    0 / 121 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Sleep Apnoea syndrome
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 121 (0.00%)
    0 / 121 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 121 (0.83%)
    0 / 121 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 121 (0.00%)
    0 / 121 (0.00%)
    0 / 108 (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
    Pertussis
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 121 (0.83%)
    0 / 121 (0.00%)
    0 / 108 (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
    Pneumonia
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 121 (0.00%)
    0 / 121 (0.00%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 121 (0.83%)
    0 / 121 (0.00%)
    0 / 108 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ABCWY+OMV ABCWY+qOMV rMenB +OMV PBO/ACWY
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    104 / 119 (87.39%)
    104 / 121 (85.95%)
    110 / 121 (90.91%)
    86 / 108 (79.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    38 / 119 (31.93%)
    41 / 121 (33.88%)
    53 / 121 (43.80%)
    32 / 108 (29.63%)
         occurrences all number
    57
    71
    100
    57
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    19 / 119 (15.97%)
    22 / 121 (18.18%)
    29 / 121 (23.97%)
    12 / 108 (11.11%)
         occurrences all number
    22
    29
    43
    17
    Fatigue
         subjects affected / exposed
    33 / 119 (27.73%)
    47 / 121 (38.84%)
    51 / 121 (42.15%)
    32 / 108 (29.63%)
         occurrences all number
    52
    80
    91
    55
    Injection Site Erythema
         subjects affected / exposed
    59 / 119 (49.58%)
    53 / 121 (43.80%)
    71 / 121 (58.68%)
    31 / 108 (28.70%)
         occurrences all number
    92
    74
    108
    40
    Injection Site Induration
         subjects affected / exposed
    47 / 119 (39.50%)
    52 / 121 (42.98%)
    45 / 121 (37.19%)
    24 / 108 (22.22%)
         occurrences all number
    74
    78
    68
    32
    Injection Site Pain
         subjects affected / exposed
    100 / 119 (84.03%)
    97 / 121 (80.17%)
    106 / 121 (87.60%)
    55 / 108 (50.93%)
         occurrences all number
    187
    180
    208
    74
    Pyrexia
         subjects affected / exposed
    14 / 119 (11.76%)
    8 / 121 (6.61%)
    7 / 121 (5.79%)
    7 / 108 (6.48%)
         occurrences all number
    16
    9
    8
    8
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 119 (3.36%)
    2 / 121 (1.65%)
    2 / 121 (1.65%)
    6 / 108 (5.56%)
         occurrences all number
    4
    2
    2
    6
    Nausea
         subjects affected / exposed
    15 / 119 (12.61%)
    25 / 121 (20.66%)
    30 / 121 (24.79%)
    9 / 108 (8.33%)
         occurrences all number
    23
    28
    50
    12
    Respiratory, thoracic and mediastinal disorders
    Rhinitis Allergic
         subjects affected / exposed
    5 / 119 (4.20%)
    4 / 121 (3.31%)
    3 / 121 (2.48%)
    7 / 108 (6.48%)
         occurrences all number
    5
    4
    3
    8
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    6 / 119 (5.04%)
    9 / 121 (7.44%)
    4 / 121 (3.31%)
    6 / 108 (5.56%)
         occurrences all number
    7
    11
    5
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    22 / 119 (18.49%)
    24 / 121 (19.83%)
    25 / 121 (20.66%)
    8 / 108 (7.41%)
         occurrences all number
    28
    30
    39
    11
    Myalgia
         subjects affected / exposed
    65 / 119 (54.62%)
    67 / 121 (55.37%)
    66 / 121 (54.55%)
    38 / 108 (35.19%)
         occurrences all number
    109
    104
    117
    51
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 119 (2.52%)
    8 / 121 (6.61%)
    6 / 121 (4.96%)
    5 / 108 (4.63%)
         occurrences all number
    3
    8
    8
    5
    Otitis Media Acute
         subjects affected / exposed
    2 / 119 (1.68%)
    0 / 121 (0.00%)
    2 / 121 (1.65%)
    6 / 108 (5.56%)
         occurrences all number
    2
    0
    2
    6
    Pharyngitis
         subjects affected / exposed
    7 / 119 (5.88%)
    8 / 121 (6.61%)
    7 / 121 (5.79%)
    5 / 108 (4.63%)
         occurrences all number
    8
    10
    7
    6
    Pharyngitis Stretococcal
         subjects affected / exposed
    4 / 119 (3.36%)
    5 / 121 (4.13%)
    1 / 121 (0.83%)
    9 / 108 (8.33%)
         occurrences all number
    4
    7
    1
    10
    Upper Respiratory Tract infection
         subjects affected / exposed
    5 / 119 (4.20%)
    8 / 121 (6.61%)
    11 / 121 (9.09%)
    8 / 108 (7.41%)
         occurrences all number
    6
    9
    12
    9
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    17 / 119 (14.29%)
    22 / 121 (18.18%)
    24 / 121 (19.83%)
    12 / 108 (11.11%)
         occurrences all number
    21
    28
    40
    18

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 May 2011
    - replacement of study formulation MenABx2CWY (i.e., MenABCWY vaccine formulation containing a ‘double’ dose of rMenB, without OMV) with the MenABCWY+OMV formulation; - addition of rMenB+OMV as a reference vaccine, thus adding a fourth study group and increasing the sample size from 360 to 480 subjects; - addition of the third secondary objective (comparison with rMenB+OMV vaccine); - broadening subjects’ age range from 11 through 18 years to 10 through 25 years - a Data Monitoring Commitee (DMC) was formed
    06 Jul 2012
    - clarification that the purpose of the study was to select a MenABCWY formulation for further clinical development; - secondary immunogenicity endpoints to include hSBA titers of ≥1:8 and 4-fold increase in hSBA titer for serogroup B strains
    08 Sep 2012
    - addition of desirability model as the second primary immunogenicity objective

    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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