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    Clinical Trial Results:
    Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study Vaccines

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-005014-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Jul 2012

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Jun 2016
    First version publication date
    22 Mar 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    V102_02E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01367158
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics S.r.l.
    Sponsor organisation address
    Via Fiorentina 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001260-PIP01-11
    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
    15 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jul 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study vaccines.
    Protection of trial subjects
    This clinical study was designed, implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jul 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Chile: 44
    Country: Number of subjects enrolled
    Colombia: 104
    Country: Number of subjects enrolled
    Panama: 292
    Worldwide total number of subjects
    440
    EEA total number of subjects
    0
    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)
    18
    Adolescents (12-17 years)
    374
    Adults (18-64 years)
    48
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled from 6 study centres in Panama, 3 in Columbia and 2 in Chile

    Pre-assignment
    Screening details
    		 Subjects previously allocated to groups I–V of the primary study were to be randomized in a 1:2 ratio to receive, either a third dose of the same vaccine as in the primary study (NCT number: NCT01210885) or a dose of tetanus, diphtheria and acellular pertussis vaccine (Tdap) respectively. Subjects in group VI received only Tdap in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer
    Blinding implementation details
    Study subjects and personnel assessing the safety and eligibility of subjects will remain blinded to the treatment assigned in this study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 3ABCWY
    Arm description
    		 Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Combined MenABCWY vaccine (rMenB (no OMV)+MenACWY lyophilized)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of injectable solution

    Arm title
    		 2ABCWY
    Arm description
    		 Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tdap
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of injectable solution.

    Arm title
    		 3ABx2CWY
    Arm description
    		 Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Combined MenABCWY vaccine (rMenBx2doses (no OMV)+MenACWY lyophilized)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1.0 mL of injectable solution.

    Arm title
    		 2ABx2CWY
    Arm description
    		 Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tdap
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of injectable solution.

    Arm title
    		 3ABCWY+OMV
    Arm description
    		 Two doses of MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Combined MenABCWY vaccine (rMenB + OMV liquid suspension + MenACWY lyophilized)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of injectable solution.

    Arm title
    		 2ABCWY+OMV
    Arm description
    		 Two doses of MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tdap
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of injectable solution.

    Arm title
    		 3ABCWYqOMV
    Arm description
    		 Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Combined MenABCWY vaccine (rMenB + 1/4 OMV liquid suspension +MenACWY lyophilized)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of injectable solution

    Arm title
    		 2ABCWYqOMV
    Arm description
    		 Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tdap
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of injectable solution

    Arm title
    		 Men 3B
    Arm description
    		 Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Novartis rMenB vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of injectable solution.

    Arm title
    		 Men 2B
    Arm description
    		 Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tdap
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of injectable solution

    Arm title
    		 1ACWY
    Arm description
    		 One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tdap
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL of injectable solution

    Number of subjects in period 1
    		3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV Men 3B Men 2B 1ACWY
    Started
    25
    49
    24
    49
    25
    48
    25
    49
    23
    50
    73
    Completed
    25
    46
    23
    48
    23
    46
    25
    47
    23
    50
    72
    Not completed
    0
    3
    1
    1
    2
    2
    0
    2
    0
    0
    1
         Consent withdrawn by subject
    -
    2
    1
    -
    2
    -
    -
    1
    -
    -
    -
         Lost to follow-up
    -
    -
    -
    1
    -
    2
    -
    1
    -
    -
    1
         Protocol deviation
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    3ABCWY
    Reporting group description
    		 Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    2ABCWY
    Reporting group description
    		 Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study.

    Reporting group title
    3ABx2CWY
    Reporting group description
    		 Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    2ABx2CWY
    Reporting group description
    		 Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study.

    Reporting group title
    3ABCWY+OMV
    Reporting group description
    		 Two doses of MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    2ABCWY+OMV
    Reporting group description
    		 Two doses of MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study.

    Reporting group title
    3ABCWYqOMV
    Reporting group description
    		 Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    2ABCWYqOMV
    Reporting group description
    		 Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study.

    Reporting group title
    Men 3B
    Reporting group description
    		 Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    Men 2B
    Reporting group description
    		 Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study.

    Reporting group title
    1ACWY
    Reporting group description
    		 One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study.

    Reporting group values
    		 3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV Men 3B Men 2B 1ACWY Total
    Number of subjects
    		 25 49 24 49 25 48 25 49 23 50 73 440
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0 0 0 0 0 0
        Children (2-11 years)
    		 1 0 1 2 1 2 1 4 3 2 1 18
        Adolescents (12-17 years)
    		 21 44 22 42 18 44 22 41 16 42 62 374
        Adults (18-64 years)
    		 3 5 1 5 6 2 2 4 4 6 10 48
        From 65-84 years
    		 0 0 0 0 0 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.3 ± 2.2 14.2 ± 2 14.4 ± 2.1 14.4 ± 2.1 14.9 ± 2.6 14.2 ± 2.1 14.3 ± 2 14.4 ± 2.1 14.8 ± 2.5 15 ± 2 14.8 ± 2.1 -
    Gender categorical
    Units: Subjects
        Female
    		 16 29 14 27 12 26 14 19 11 25 39 232
        Male
    		 9 20 10 22 13 22 11 30 12 25 34 208

    End points

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    End points reporting groups
    Reporting group title
    3ABCWY
    Reporting group description
    		 Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    2ABCWY
    Reporting group description
    		 Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study.

    Reporting group title
    3ABx2CWY
    Reporting group description
    		 Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    2ABx2CWY
    Reporting group description
    		 Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study.

    Reporting group title
    3ABCWY+OMV
    Reporting group description
    		 Two doses of MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    2ABCWY+OMV
    Reporting group description
    		 Two doses of MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study.

    Reporting group title
    3ABCWYqOMV
    Reporting group description
    		 Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    2ABCWYqOMV
    Reporting group description
    		 Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study.

    Reporting group title
    Men 3B
    Reporting group description
    		 Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    Men 2B
    Reporting group description
    		 Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study.

    Reporting group title
    1ACWY
    Reporting group description
    		 One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study.

    Subject analysis set title
    Enrolled Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who signed an informed consent, underwent screening procedures, and were randomized.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All exposed subjects with adverse event data.

    Subject analysis set title
    MITT Set- Month 6
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; had no major protocol deviations .

    Subject analysis set title
    MITT Set- Month 7
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; had no major protocol deviations.

    Subject analysis set title
    MITT Set- Month 12
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; had no major protocol deviations.

    Primary: Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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    End point title
    		 Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo [1] [2]
    End point description
    Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7). MITT Month 7.
    End point type
    Primary
    End point timeframe
    At month 6 and month 7
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point.
    [2] - 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 analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    25
    24
    25
    25
    23
    72
    Units: Percentage of subjects
    number (confidence interval 95%)
        Ser. A - month 6 (N=23,24,24,25,23,69)
    52 (31 to 73)
    79 (58 to 93)
    75 (53 to 90)
    68 (46 to 85)
    35 (16 to 57)
    55 (43 to 67)
        Ser. A - month 7 (N=24,24,21,25,22,71)
    100 (86 to 100)
    100 (86 to 100)
    100 (84 to 100)
    100 (86 to 100)
    91 (71 to 99)
    58 (45 to 69)
        Ser. C - month 6 (N=22,24,24,24,21,70)
    100 (85 to 100)
    96 (79 to 100)
    100 (86 to 100)
    100 (86 to 100)
    33 (15 to 57)
    76 (64 to 85)
        Ser. C - month 7 (N=23,24,23,25,22,72)
    100 (85 to 100)
    100 (86 to 100)
    100 (85 to 100)
    100 (86 to 100)
    73 (50 to 89)
    68 (56 to 79)
        Ser. W - month 6 (N=24,24,25,24,22,69)
    100 (86 to 100)
    96 (79 to 100)
    100 (86 to 100)
    100 (86 to 100)
    55 (32 to 76)
    97 (90 to 100)
        Ser. W - month 7 (N=23,24,21,25,21,72)
    100 (85 to 100)
    100 (86 to 100)
    100 (84 to 100)
    100 (86 to 100)
    90 (70 to 99)
    96 (88 to 99)
        Ser. Y - month 6 (N=24,24,24,25,23,72)
    96 (79 to 100)
    100 (86 to 100)
    96 (79 to 100)
    92 (74 to 99)
    4 (0 to 22)
    85 (74 to 92)
        Ser. Y - month 7 (N=25,24,24,25,22,72)
    100 (86 to 100)
    96 (79 to 100)
    100 (86 to 100)
    100 (86 to 100)
    14 (3 to 35)
    85 (74 to 92)
    No statistical analyses for this end point

    Primary: Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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    End point title
    		 Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo [3] [4]
    End point description
    Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).
    End point type
    Primary
    End point timeframe
    At month 6 and month 7
    Notes
    [3] - 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 analyses for this end point.
    [4] - 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 analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    25
    24
    25
    25
    23
    73
    Units: Percentage of subjects
    number (confidence interval 95%)
        H44/76 (fHbp) - month 6 (N=25,24,25,24,23,72)
    40 (21 to 61)
    46 (26 to 67)
    52 (31 to 72)
    29 (13 to 51)
    35 (16 to 57)
    3 (0 to 10)
        H44/76 (fHbp) - month 7 (N=25,24,24,25,22,73)
    92 (74 to 99)
    96 (79 to 100)
    96 (79 to 100)
    92 (74 to 99)
    91 (71 to 99)
    4 (1 to 12)
        5/99 (NadA) - month 6 (N=25,24,24,25,23,72)
    96 (80 to 100)
    100 (86 to 100)
    96 (79 to 100)
    100 (86 to 100)
    100 (85 to 100)
    15 (8 to 26)
        5/99 (NadA) - month 7 (N=25,24,24,25,23,73)
    100 (86 to 100)
    100 (86 to 100)
    100 (86 to 100)
    100 (86 to 100)
    100 (85 to 100)
    16 (9 to 27)
        NZ98/254(PorA) - month 6 (N=25,24,24,25,23,72)
    12 (3 to 31)
    8 (1 to 27)
    29 (13 to 51)
    12 (3 to 31)
    9 (1 to 28)
    0 (0 to 5)
        NZ98/254(PorA) - month 7 (N=25,24,24,25,23,73)
    20 (7 to 41)
    29 (13 to 51)
    88 (68 to 97)
    76 (55 to 91)
    17 (5 to 39)
    1 (0.035 to 7)
        M14459(fHBP) - month 6 (N=25,24,25,25,23,71)
    24 (9 to 45)
    25 (10 to 47)
    32 (15 to 54)
    16 (5 to 36)
    17 (5 to 39)
    6 (2 to 14)
        M14459(fHBP) - month 7 (N=25,24,23,25,22,73)
    80 (59 to 93)
    79 (58 to 93)
    87 (66 to 97)
    88 (69 to 97)
    64 (41 to 83)
    8 (3 to 17)
        M07-0241084(NHBA) - month 6 (N=25,23,23,25,23,70)
    20 (7 to 41)
    35 (16 to 57)
    39 (20 to 61)
    52 (31 to 72)
    30 (13 to 53)
    30 (20 to 42)
        M07-0241084(NHBA) - month 7 (N=25,23,22,25,21,72)
    68 (46 to 85)
    61 (39 to 80)
    95 (77 to 100)
    92 (74 to 99)
    62 (38 to 82)
    29 (19 to 41)
        M01-0240364(NadA) - month 6 (N=25,21,24,24,21,71)
    16 (5 to 36)
    38 (18 to 62)
    25 (10 to 47)
    33 (16 to 55)
    33 (15 to 57)
    4 (1 to 12)
        M01-0240364(NadA) - month 7 (N=24,23,24,25,23,71)
    96 (79 to 100)
    100 (85 to 100)
    100 (86 to 100)
    96 (80 to 100)
    96 (78 to 100)
    4 (1 to 12)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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    End point title
    		 Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo [5]
    End point description
    Antibody response was measured as Geometric Mean hSBA Titers against N meningitidis Serogroups A, C, W and Y at One of Four MenABCWY Formulations or rMenB at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).
    End point type
    Secondary
    End point timeframe
    At month 6 and month 7
    Notes
    [5] - 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 analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    25
    24
    25
    25
    23
    72
    Units: Titers
    geometric mean (confidence interval 95%)
        Ser. A - month 6 (N=23,24,24,25,23,69)
    15 (6.66 to 33)
    44 (20 to 96)
    31 (14 to 68)
    21 (9.53 to 44)
    4.52 (2.02 to 10)
    21 (13 to 34)
        Ser. A - month 7 (N=24,24,21,25,22,71)
    247 (120 to 509)
    322 (157 to 659)
    242 (113 to 521)
    274 (136 to 553)
    135 (64 to 287)
    22 (14 to 33)
        Ser. C - month 6 (N=22,24,24,24,21,70)
    211 (125 to 355)
    153 (93 to 251)
    168 (102 to 278)
    137 (83 to 224)
    4.54 (2.66 to 7.75)
    25 (18 to 34)
        Ser. C - month 7 (N=23,24,23,25,22,72)
    796 (472 to 1343)
    716 (430 to 1193)
    670 (397 to 1130)
    634 (385 to 1044)
    31 (18 to 53)
    19 (14 to 26)
        Ser. W - month 6 (N=24,24,25,24,22,69)
    189 (116 to 305)
    184 (144 to 296)
    202 (127 to 324)
    164 (102 to 263)
    11 (6.67 to 18)
    128 (95 to 173)
        Ser. W - month 7 (N=23,24,21,25,21,72)
    710 (442 to 1143)
    695 (441 to 1096)
    929 (570 to 1512)
    684 (438 to 1069)
    126 (77 to 207)
    130 (98 to 172)
        Ser. Y - month 6 (N=24,24,24,25,23,72)
    203 (111 to 372)
    233 (128 to 425)
    158 (86 to 289)
    129 (72 to 233)
    1.72 (0.93 to 3.18)
    97 (67 to 140)
        Ser. Y - month 7 (N=25,24,24,25,22,72)
    695 (385 to 1255)
    629 (346 to 1144)
    619 (339 to 1129)
    432 (241 to 776)
    2.64 (1.41 to 4.96)
    85 (59 to 122)
    No statistical analyses for this end point

    Secondary: Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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    End point title
    		 Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo [6]
    End point description
    Antibody response was measured as Geometric Mean Ratio (95% CI), against N meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination (month 7) With One of Four MenABCWY Formulations or rMenB.
    End point type
    Secondary
    End point timeframe
    At month 7
    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: No statistical analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    25
    24
    25
    25
    23
    72
    Units: Ratio
    geometric mean (confidence interval 95%)
        Ser. A (N=22,24,21,25,22,68)
    15 (8.88 to 25)
    7.53 (4.58 to 12)
    10 (6.1 to 18)
    14 (8.37 to 22)
    34 (20 to 57)
    1.05 (0.77 to 1.43)
        Ser. C (N=21,24,22,24,20,70)
    3.43 (2.59 to 4.54)
    4.63 (3.56 to 6.02)
    3.85 (2.92 to 5.06)
    5.01 (3.85 to 6.5)
    8.41 (6.31 to 11)
    0.75 (0.64 to 0.89)
        Ser. W (N=23,24,21,24,20,69)
    3.42 (2.41 to 4.85)
    3.66 (2.62 to 5.12)
    3.98 (2.78 to 5.69)
    4.05 (2.9 to 5.66)
    11 (7.55 to 16)
    1.01 (0.82 to 1.24)
        Ser. Y (N=24,24,23,25,22,71)
    3.33 (2.31 to 4.79)
    2.68 (1.87 to 3.85)
    4.45 (3.06 to 6.45)
    3.32 (2.33 to 4.73)
    1.46 (1 to 2.14)
    0.81 (0.65 to 1.02)
    No statistical analyses for this end point

    Secondary: GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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    End point title
    		 GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo [7]
    End point description
    Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo.
    End point type
    Secondary
    End point timeframe
    At month 6 and month 7
    Notes
    [7] - 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 analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    25
    24
    25
    25
    23
    73
    Units: Titers
    geometric mean (confidence interval 95%)
        H44/76 (fHbp) - month 6 (N=25,24,25,24,23,72)
    5.9 (3.07 to 11)
    6.88 (3.56 to 13)
    12 (6.14 to 23)
    5.25 (2.71 to 10)
    6.42 (3.27 to 13)
    1.18 (1.01 to 1.37)
        H44/76 (fHbp) - month 7 (N=25,24,24,24,25,22,73)
    109 (60 to 201)
    154 (83 to 285)
    181 (97 to 336)
    114 (62 to 208)
    109 (57 to 209)
    1.21 (1.04 to 1.4)
        5/99 (NadA) - month 6 (N=25,24,24,25,23,72)
    78 (52 to 118)
    122 (80 to 186)
    46 (30 to 71)
    84 (56 to 127)
    152 (99 to 234)
    1.74 (1.36 to 2.22)
        5/99 (NadA) - month 7 (N=25,24,24,25,23,73)
    546 (365 to 817)
    740 (492 to 1112)
    665 (441 to 1002)
    527 (354 to 786)
    832 (548 to 1263)
    1.93 (1.5 to 2.48)
        NZ98/254(PorA) - month 6 (N=25,24,24,25,23,72)
    1.96 (1.29 to 3)
    1.85 (1.21 to 2.85)
    3.47 (2.26 to 5.35)
    1.89 (1.24 to 2.88)
    1.81 (1.17 to 2.81)
    1.15 (1.05 to 1.25)
        NZ98/254(PorA) - month 7 (N=25,24,24,25,23,73)
    2.37 (1.5 to 3.74)
    3.26 (2.06 to 5.17)
    24 (15 to 37)
    12 (7.57 to 19)
    2.64 (1.65 to 4.23)
    1.2 (1.07 to 1.33)
        M14459(fHBP) - month 6 (N=25,24,25,25,23,71)
    2.71 (1.72 to 4.27)
    3.29 (2.08 to 5.21)
    4.49 (2.85 to 7.06)
    2.34 (1.49 to 3.67)
    2.48 (1.55 to 3.97)
    1.28 (1.11 to 1.49)
        M14459(fHBP) - month 7 (N=25,24,23,25,22,73)
    16 (10 to 27)
    27 (17 to 44)
    45 (27 to 75)
    20 (13 to 33)
    12 (7.07 to 20)
    1.28 (1.1 to 1.49)
        M07-0241084(NHBA) - month 6 (N=25,23,23,25,23,70)
    3.37 (1.98 to 5.73)
    3.66 (2.12 to 6.34)
    6.92 (3.99 to 12)
    6.45 (3.81 to 11)
    3.32 (1.91 to 5.75)
    2.99 (2.16 to 4.14)
        M07-0241084(NHBA) - month 7 (N=25,23,22,25,21,72)
    12 (7.07 to 21)
    9.48 (5.37 to 17)
    38 (21 to 69)
    25 (15 to 44)
    9.73 (5.33 to 18)
    3.03 (2.22 to 4.15)
        M01-0240364(NadA) - month 6 (N=25,21,24,24,21,71)
    4.62 (2.15 to 9.95)
    9.98 (4.37 to 23)
    6.95 (3.19 to 15)
    7.44 (3.44 to 16)
    7.21 (3.15 to 17)
    1.18 (1 to 1.39)
        M01-0240364(NadA) - month 7 (N=24,23,24,25,23,71)
    311 (152 to 637)
    533 (259 to 1098)
    385 (188 to 786)
    286 (143 to 573)
    474 (229 to 980)
    1.18 (1 to 1.39)
    No statistical analyses for this end point

    Secondary: GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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    End point title
    		 GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo [8]
    End point description
    Antibody response was measured as Geometric Mean Ratio (95% CI), against Serogroup B Test Strains at One Month After the Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo.
    End point type
    Secondary
    End point timeframe
    At month 7
    Notes
    [8] - 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 analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    25
    24
    25
    25
    23
    73
    Units: Ratio
    geometric mean (confidence interval 95%)
        H44/76 (fHbp) (N=25,24,24,24,22,72)
    18 (12 to 29)
    22 (14 to 36)
    14 (8.88 to 23)
    22 (14 to 36)
    16 (9.83 to 26)
    1.03 (0.98 to 1.08)
        5/99 (NadA) (N=25,24,23,25,23,72)
    6.96 (5.15 to 9.42)
    6.04 (4.45 to 8.21)
    14 (11 to 20)
    6.25 (4.63 to 8.44)
    5.47 (4 to 7.48)
    1.12 (0.93 to 1.36)
        NZ98/254 (PorA) (N=25,24,23,25,23,72)
    1.21 (0.87 to 1.67)
    1.76 (1.26 to 2.45)
    6.56 (4.67 to 9.2)
    6.29 (4.55 to 8.69)
    1.45 (1.04 to 2.04)
    1.05 (0.95 to 1.15)
        M14459 (fHBP) (N=25,24,23,25,22,71)
    5.99 (4.11 to 8.73)
    8.1 (5.54 to 12)
    9.08 (6.14 to 13)
    8.58 (5.91 to 12)
    4.37 (2.93 to 6.53)
    1.01 (0.91 to 1.11)
        M07-0241084 (NHBA) (N=25,22,20,25,21,69)
    3.61 (2.57 to 5.09)
    2.46 (1.71 to 3.54)
    5.18 (3.53 to 7.58)
    3.92 (2.8 to 5.51)
    2.75 (1.89 to 4.01)
    1.01 (0.91 to 1.12)
        M01-0240364 (NadA) (N=24,20,23,24,21,69)
    65 (37 to 114)
    50 (27 to 92)
    65 (37 to 116)
    40 (23 to 71)
    66 (36 to 120)
    1 (0.97 to 1.04)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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    End point title
    		 Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo [9]
    End point description
    Antibody response was measured as the percentage of subjects with seroresponse Against N meningitidis Serogroups A, C, W and Y, after the third vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo. Seroresponse to N meningitidis serogroups A, C, W and Y is defined as: For subjects with a prevaccination (month 6) hSBA <1:4, a postvaccination hSBA ≥1:8;For subjects with a prevaccination (month 6) hSBA ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
    End point type
    Secondary
    End point timeframe
    At month 7
    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: No statistical analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    24
    24
    23
    25
    22
    71
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Ser. A (N=22,24,21,25,22,68)
    59 (36 to 79)
    67 (45 to 84)
    67 (43 to 85)
    72 (51 to 88)
    82 (60 to 95)
    3 (0 to 10)
        Ser. C (N=21,24,22,24,20,70)
    48 (26 to 70)
    54 (33 to 74)
    59 (36 to 79)
    67 (45 to 84)
    60 (36 to 81)
    0 (0 to 5)
        Ser. W (N=23,24,21,24,20,69)
    35 (16 to 57)
    38 (19 to 59)
    48 (26 to 70)
    58 (37 to 78)
    60 (36 to 81)
    3 (0 to 10)
        Ser. Y (N=24,24,23,25,22,71)
    29 (13 to 51)
    38 (19 to 59)
    43 (23 to 66)
    32 (15 to 54)
    5 (0 to 23)
    0 (0 to 5)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

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    End point title
    		 Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo [10]
    End point description
    Antibody response was measured as the percentage of subjects with 4-fold Increase in human serum bactericidal assay (hSBA) titers and associated 95% CI, Against Serogroup B Test Strains at One Month After Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo (compared to month 6 values).
    End point type
    Secondary
    End point timeframe
    At month 7
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    25
    24
    24
    25
    23
    72
    Units: Percentage of subjects
    number (confidence interval 95%)
        H44/76 (fHbp) (N=25,24,24,24,22,72)
    80 (59 to 93)
    88 (68 to 97)
    83 (63 to 95)
    88 (68 to 97)
    73 (50 to 89)
    0 (0 to 5)
        5/99 (NadA) (N=25,24,23,25,23,72)
    80 (59 to 93)
    67 (45 to 84)
    83 (61 to 95)
    76 (55 to 91)
    57 (34 to 77)
    3 (0 to 10)
        NZ98/254 (PorA) (N=25,24,23,25,23,72)
    4 (0 to 20)
    17 (5 to 37)
    61 (39 to 80)
    44 (24 to 65)
    17 (5 to 39)
    1 (0.035 to 7)
        M14459 (fHBP) (N=25,24,23,25,22,71)
    56 (35 to 76)
    54 (33 to 74)
    65 (43 to 84)
    52 (31 to 72)
    50 (28 to 72)
    1 (0.036 to 8)
        M07-0241084 (NHBA) (N=25,22,20,25,21,69)
    36 (18 to 57)
    23 (8 to 45)
    60 (36 to 81)
    44 (24 to 65)
    29 (11 to 52)
    0 (0 to 5)
        M01-0240364 (NadA) (N=24,20,23,24,21,69)
    88 (68 to 97)
    80 (56 to 94)
    83 (61 to 95)
    79 (58 to 93)
    90 (70 to 99)
    0 (0 to 5)
    No statistical analyses for this end point

    Secondary: GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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    End point title
    		 GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo [11]
    End point description
    Antibody response was measured as Geometric Mean hSBA Titers Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, and after 6, 7 and 12 months of the first vaccination in the parent study (months 6, 7 and 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.
    End point type
    Secondary
    End point timeframe
    At months 0, 1, 3, 6, 7 and 12
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point.
    End point values
    		 2ABCWY 2ABx2CWY 2ABCWY+OMV 2ABCWYqOMV Men 2B 1ACWY
    Number of subjects analysed
    49
    48
    48
    49
    50
    73
    Units: Titers
    geometric mean (confidence interval 95%)
        Ser. A – month 0 (N=49,49,48,48,50,73)
    1.65 (1.32 to 2.07)
    1.41 (1.13 to 1.76)
    1.38 (1.1 to 1.73)
    1.2 (0.96 to 1.51)
    1.34 (1.07 to 1.67)
    1.43 (1.18 to 1.72)
        Ser. A - month 1 (N=48,48,47,49,50,70)
    61 (35 to 107)
    61 (35 to 107)
    49 (28 to 86)
    37 (21 to 65)
    2.96 (1.71 to 5.13)
    107 (66 to 172)
        Ser. A - month 3 (N=49,48,47,48,50,72)
    162 (106 to 249)
    206 (134 to 316)
    183 (118 to 282)
    169 (109 to 262)
    44 (29 to 68)
    36 (25 to 52)
        Ser. A - month 6 (N=46,46,48,44,49,69)
    28 (16 to 49)
    44 (25 to 78)
    21 (12 to 36)
    24 (14 to 44)
    4.22 (2.43 to 7.33)
    20 (12 to 32)
        Ser. A - month 7 (N=48,47,46,49,50,71)
    24 (14 to 39)
    28 (17 to 46)
    17 (9.94 to 28)
    17 (10 to 29)
    3.18 (1.95 to 5.19)
    21 (13 to 31)
        Ser. A - month 12 (N=43,44,45,46,50,71)
    10 (5.69 to 18)
    9.73 (5.6 to 17)
    8.88 (5.09 to 15)
    8.08 (4.64 to 14)
    2.21 (1.31 to 3.75)
    14 (9.03 to 22)
        Ser C – month 0 (N=49,49,48,47,50,72)
    4.9 (3.37 to 7.13)
    4.66 (3.21 to 6.75)
    6.08 (4.17 to 8.86)
    5.75 (3.92 to 8.43)
    8 (5.53 to 12)
    4.96 (3.61 to 6.81)
        Ser. C - month 1 (N=48,48,48,48,50,71)
    51 (33 to 80)
    116 (75 to 180)
    99 (64 to 155)
    101 (64 to 159)
    8.76 (5.63 to 14)
    75 (51 to 109)
        Ser. C - month 3 (N=49,47,46,48,50,71)
    340 (252 to 460)
    501 (370 to 680)
    338 (248 to 461)
    380 (278 to 520)
    17 (12 to 22)
    45 (35 to 58)
        Ser. C - month 6 (N=46,48,47,48,49,70)
    133 (94 to 189)
    186 (133 to 261)
    117 (83 to 165)
    157 (111 to 223)
    6.77 (4.82 to 9.52)
    23 (17 to 31)
        Ser. C - month 7 (N=48,47,46,49,50,72)
    110 (78 to 156)
    153 (108 to 217)
    88 (61 to 126)
    128 (90 to 183)
    5.53 (3.9 to 7.84)
    18 (13 to 24)
        Ser. C - month 12 (N=44,46,46,46,50,72)
    55 (38 to 81)
    66 (45 to 95)
    45 (31 to 65)
    72 (49 to 105)
    6.03 (4.19 to 8.69)
    14 (10 to 19)
        Ser W – month 0 (N=49,48,48,47,50,73)
    19 (11 to 33)
    21 (12 to 36)
    29 (17 to 50)
    24 (14 to 42)
    31 (18 to 52)
    24 (15 to 38)
        Ser. W - month 1 (N=48,48,47,48,49,72)
    163 (113 to 237)
    243 (168 to 352)
    173 (119 to 252)
    233 (160 to 341)
    29 (20 to 42)
    210 (154 to 287)
        Ser. W - month 3 (N=49,46,47,48,50,72)
    370 (290 to 472)
    514 (400 to 661)
    349 (272 to 448)
    435 (338 to 559)
    140 (110 to 179)
    166 (135 to 204)
        Ser. W - month 6 (N=44,47,45,45,43,69)
    202 (144 to 284)
    196 (141 to 272)
    143 (102 to 200)
    194 (138 to 274)
    15 (11 to 21)
    117 (88 to 154)
        Ser. W - month 7 (N=46,47,45,47,45,72)
    173 (125 to 240)
    167 (121 to 230)
    118 (85 to 164)
    168 (121 to 234)
    13 (9.72 to 19)
    121 (93 to 159)
        Ser. W - month 12 (N=45,45,45,43,46,69)
    119 (82 to 174)
    113 (77 to 164)
    83 (57 to 120)
    109 (73 to 161)
    11 (7.81 to 17)
    75 (55 to 103)
        Ser Y – month 0 (N=49,48,48,49,50,73)
    5.1 (3.69 to 7.05)
    4.84 (3.5 to 6.7)
    5.6 (4.04 to 7.77)
    4.98 (3.6 to 6.91)
    6.52 (4.73 to 8.99)
    7.07 (5.38 to 9.29)
        Ser. Y - month 1 (N=48,48,48,49,49,73)
    98 (66 to 145)
    119 (80 to 177)
    76 (51 to 113)
    92 (62 to 136)
    5.6 (3.77 to 8.32)
    92 (66 to 128)
        Ser. Y - month 3 (N=49,48,47,49,50,73)
    214 (162 to 281)
    283 (215 to 374)
    195 (147 to 258)
    226 (172 to 298)
    4.7 (3.58 to 6.18)
    72 (57 to 91)
        Ser. Y - month 6 (N=48,48,48,48,49,72)
    206 (134 to 315)
    249 (162 to 382)
    138 (90 to 212)
    154 (100 to 237)
    1.93 (1.26 to 2.95)
    84 (58 to 120)
        Ser. Y - month 7 (N=46,48,46,49,50,72)
    180 (116 to 278)
    213 (139 to 327)
    100 (65 to 155)
    127 (83 to 194)
    2.05 (1.34 to 3.13)
    75 (52 to 108)
        Ser. Y - month 12 (N=45,47,45,46,50,70)
    88 (55 to 141)
    112 (71 to 178)
    55 (34 to 88)
    75 (47 to 121)
    1.59 (1.01 to 2.5)
    47 (31 to 69)
    No statistical analyses for this end point

    Secondary: GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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    End point title
    		 GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo [12]
    End point description
    Antibody response was measured as Geometric Mean Ratios (95%CI) Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6, 7 and 12 months of the first vaccination (months 6, 7 and 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.
    End point type
    Secondary
    End point timeframe
    At month 1, 3, 6, 7 and 12
    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 analyses for this end point.
    End point values
    		 2ABCWY 2ABx2CWY 2ABCWY+OMV 2ABCWYqOMV Men 2B 1ACWY
    Number of subjects analysed
    49
    48
    48
    49
    50
    73
    Units: Ratio
    geometric mean (confidence interval 95%)
        Ser. A - month 1 (N=48,48,47,48,50,70)
    41 (23 to 73)
    45 (26 to 80)
    36 (20 to 65)
    30 (17 to 53)
    2.25 (1.28 to 3.93)
    78 (48 to 127)
        Ser. A - month 3 (N=49,48,47,47,50,72)
    107 (68 to 168)
    150 (95 to 235)
    135 (85 to 214)
    137 (86 to 217)
    34 (21 to 52)
    26 (18 to 38)
        Ser. A - month 6 (N=46,46,48,44,49,69)
    19 (11 to 34)
    32 (18 to 57)
    15 (8.77 to 27)
    20 (11 to 35)
    3.19 (1.82 to 5.59)
    15 (9.12 to 24)
        Ser. A - month 7 (N=48,47,46,48,50,71)
    16 (9.83 to 27)
    21 (12 to 34)
    12 (7.36 to 21)
    14 (8.22 to 23)
    2.41 (1.47 to 3.97)
    15 (9.87 to 23)
        Ser. A - month 12 (N=43,44,45,45,50,71)
    6.97 (3.93 to 12)
    7.18 (4.11 to 13)
    6.61 (3.77 to 12)
    6.42 (3.67 to 11)
    1.68 (0.99 to 2.85)
    11 (6.65 to 17)
        Ser. C - month 1 (N=48,48,48,47,50,70)
    11 (6.83 to 19)
    26 (16 to 43)
    19 (12 to 31)
    20 (12 to 33)
    1.42 (0.87 to 2.32)
    16 (11 to 25)
        Ser. C - month 3 (N=49,47,46,46,50,70)
    72 (47 to 110)
    114 (74 to 175)
    60 (39 to 93)
    71 (45 to 110)
    2.36 (1.54 to 3.59)
    9.54 (6.61 to 14)
        Ser. C - month 6 (N=46,48,47,46,49,69)
    29 (19 to 45)
    41 (27 to 63)
    22 (14 to 34)
    31 (20 to 47)
    1.07 (0.7 to 1.63)
    5.14 (3.57 to 7.39)
        Ser. C - month 7 (N=48,47,46,47,50,71)
    24 (16 to 37)
    33 (21 to 51)
    16 (10 to 25)
    25 (16 to 38)
    0.85 (0.55 to 1.3)
    3.9 (2.7 to 5.64)
        Ser. C - month 12 (N=44,46,46,44,50,71)
    12 (7.82 to 19)
    16 (10 to 24)
    8.88 (5.7 to 14)
    15 (9.57 to 24)
    0.99 (0.65 to 1.52)
    3.06 (2.12 to 4.4)
        Ser. W - month 1 (N=48,47,47,46,49,72)
    9.2 (5.41 to 16)
    13 (7.42 to 21)
    7.41 (4.34 to 13)
    10 (6.1 to 18)
    1.15 (0.68 to 1.95)
    10 (6.49 to 16)
        Ser. W - month 3 (N=49,45,47,46,50,72)
    20 (11 to 34)
    27 (15 to 48)
    12 (6.7 to 21)
    19 (11 to 35)
    4.83 (2.76 to 8.46)
    7.32 (4.53 to 12)
        Ser. W - month 6 (N=44,46,45,43,43,69)
    11 (6.33 to 20)
    9.75 (5.64 to 17)
    5.44 (3.11 to 9.52)
    9.75 (5.51 to 17)
    0.58 (0.33 to 1.02)
    5.17 (3.25 to 8.24)
        Ser. W - month 7 (N=46,46,45,45,45,72)
    9.21 (5.2 to 16)
    8.17 (4.64 to 14)
    4.84 (2.72 to 8.62)
    7.94 (4.44 to 14)
    0.55 (0.31 to 0.97)
    5.47 (3.4 to 8.8)
        Ser. W - month 12 (N=45,44,45,42,46,69)
    7.33 (4.08 to 13)
    6.54 (3.62 to 12)
    3.52 (1.95 to 6.33)
    4.83 (2.62 to 8.92)
    0.49 (0.27 to 0.89)
    3.62 (2.21 to 5.94)
        Ser. Y - month 1 (N=48,47,48,49,49,73)
    21 (13 to 32)
    26 (17 to 40)
    15 (9.89 to 24)
    20 (13 to 31)
    1.02 (0.66 to 1.58)
    16 (11 to 23)
        Ser. Y - month 3 (N=49,47,47,49,50,73)
    44 (30 to 63)
    59 (41 to 85)
    37 (25 to 54)
    47 (33 to 68)
    0.8 (0.56 to 1.15)
    12 (8.54 to 16)
        Ser. Y - month 6 (N=48,47,48,48,49,72)
    44 (27 to 71)
    56 (34 to 91)
    27 (16 to 44)
    33 (20 to 54)
    0.35 (0.21 to 0.56)
    14 (9.04 to 21)
        Ser. Y - month 7 (N=46,47,46,49,50,72)
    37 (22 to 61)
    45 (27 to 74)
    19 (11 to 31)
    26 (16 to 43)
    0.35 (0.21 to 0.56)
    12 (7.76 to 18)
        Ser. Y - month 12 (N=45,46,45,46,50,70)
    18 (11 to 31)
    25 (15 to 42)
    10 (6.14 to 18)
    16 (9.64 to 28)
    0.27 (0.16 to 0.45)
    7.27 (4.68 to 11)
    No statistical analyses for this end point

    Secondary: GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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    End point title
    		 GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo [13]
    End point description
    Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, and 6, 7 and 12 months after the first vaccination with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.
    End point type
    Secondary
    End point timeframe
    At month 0, 1, 3, 6, 7 and 12
    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 analyses for this end point.
    End point values
    		 2ABCWY 2ABx2CWY 2ABCWY+OMV 2ABCWYqOMV Men 2B 1ACWY
    Number of subjects analysed
    49
    49
    48
    49
    50
    73
    Units: Titers
    geometric mean (confidence interval 95%)
        H44/76 (fHbp) - month 0 (N=49,48,47,48,50,73)
    1.19 (0.93 to 1.53)
    1.39 (1.08 to 1.79)
    1.31 (1.01 to 1.69)
    1.3 (1.01 to 1.68)
    1.42 (1.1 to 1.82)
    1.31 (1.05 to 1.65)
        H44/76 (fHbp) - month 1 (N=48,48,48,49,50,73)
    5.56 (3.44 to 8.99)
    10 (6.38 to 17)
    15 (9.5 to 25)
    11 (6.93 to 18)
    4.56 (2.84 to 7.3)
    1.51 (1.19 to 1.92)
        H44/76 (fHbp) - month 3 (N=49,48,46,48,50,72)
    74 (53 to 102)
    114 (82 to 158)
    114 (81 to 159)
    133 (96 to 186)
    44 (32 to 61)
    1.27 (1.07 to 1.5)
        H44/76 (fHbp) - month 6 (N=47,48,48,48,50,72)
    7.87 (5.04 to 12)
    7.76 (4.98 to 12)
    9.44 (6.04 to 15)
    14 (9.2 to 23)
    4.34 (2.81 to 6.71)
    1.18 (1.01 to 1.37)
        H44/76 (fHbp) - month 7 (N=48,48,47,49,49,73)
    4.62 (3.04 to 7.02)
    5.75 (3.79 to 8.73)
    6.12 (4 to 9.37)
    11 (7.15 to 17)
    3.55 (2.35 to 5.37)
    1.21 (1.04 to 1.4)
        H44/76 (fHbp) - month 12 (N=45,47,45,46,50,71)
    3.24 (2.18 to 4.8)
    2.31 (1.57 to 3.39)
    4 (2.69 to 5.97)
    4.31 (2.91 to 6.4)
    2.42 (1.66 to 3.52)
    1.13 (1 to 1.29)
        5/99 (NadA) - month 0 (N=49,49,48,48,50,73)
    2.48 (1.81 to 3.39)
    2.17 (1.59 to 2.96)
    1.87 (1.36 to 2.56)
    2.02 (1.47 to 2.78)
    3.16 (2.32 to 4.32)
    2.25 (1.77 to 2.85)
        5/99 (NadA) - month 1 (N=48,48,47,49,50,72)
    44 (29 to 65)
    91 (62 to 135)
    23 (15 to 34)
    34 (23 to 51)
    58 (39 to 85)
    2.27 (1.82 to 2.85)
        5/99 (NadA) - month 3 (N=49,48,47,47,50,71)
    257 (203 to 324)
    401 (318 to 507)
    337 (266 to 427)
    363 (285 to 462)
    322 (255 to 406)
    2.11 (1.65 to 2.7)
        5/99 (NadA) - month 6 (N=47,49,48,48,48,72)
    69 (51 to 93)
    122 (91 to 163)
    55 (41 to 74)
    72 (53 to 97)
    73 (54 to 98)
    1.74 (1.36 to 2.22)
        5/99 (NadA) - month 7 (N=47,48,47,49,50,73)
    55 (42 to 73)
    96 (72 to 127)
    44 (33 to 58)
    59 (45 to 79)
    68 (51 to 90)
    1.93 (1.5 to 2.48)
        5/99 (NadA) - month 12 (N=45,47,46,46,50,72)
    31 (22 to 44)
    46 (33 to 64)
    30 (21 to 42)
    35 (25 to 49)
    32 (23 to 44)
    1.53 (1.25 to 1.88)
        NZ98/254 (PorA) - month 0 (N=49,49,48,48,50,73)
    1.76 (1.42 to 2.19)
    1.62 (1.3 to 2.01)
    1.77 (1.42 to 2.2)
    1.76 (1.41 to 2.2)
    2.37 (1.91 to 2.94)
    1.5 (1.3 to 1.73)
        NZ98/254 (PorA) - month 1 (N=48,48,48,49,50,72)
    2.14 (1.58 to 2.9)
    2.42 (1.8 to 3.26)
    4.95 (3.66 to 6.7)
    4.26 (3.15 to 5.77)
    2.01 (1.49 to 2.71)
    1.51 (1.32 to 1.74)
        NZ98/254 (PorA) - month 3 (N=49,48,47,48,50,72)
    2.98 (2.18 to 4.06)
    3.86 (2.83 to 5.26)
    14 (10 to 19)
    12 (8.96 to 17)
    2.81 (2.06 to 3.84)
    1.49 (1.29 to 1.72)
        NZ98/254 (PorA) - month 6 (N=48,49,48,48,49,72)
    1.7 (1.28 to 2.26)
    1.88 (1.42 to 2.48)
    3.19 (2.4 to 4.25)
    3.09 (2.31 to 4.13)
    1.47 (1.1 to 1.95)
    1.15 (1.05 to 1.25)
        NZ98/254 (PorA) - month 7 (N=47,48,47,49,50,73)
    1.45 (1.05 to 2)
    1.76 (1.29 to 2.41)
    2.62 (1.9 to 3.62)
    2.49 (1.81 to 3.43)
    1.45 (1.06 to 2)
    1.2 (1.07 to 1.33)
        NZ98/254 (PorA) - month 12 (N=45,47,46,46,50,72)
    1.57 (1.2 to 2.06)
    1.6 (1.23 to 2.09)
    2.47 (1.89 to 3.24)
    2.18 (1.66 to 2.86)
    1.21 (0.93 to 1.57)
    1.15 (1.05 to 1.25)
        M14459 (fHBP) - month 0 (N=49,48,45,45,50,72)
    1.29 (1.05 to 1.59)
    1.43 (1.16 to 1.75)
    1.43 (1.16 to 1.78)
    1.38 (1.11 to 1.72)
    1.89 (1.54 to 2.32)
    1.33 (1.08 to 1.62)
        M14459 (fHBP) - month 1 (N=48,48,47,49,50,72)
    1.99 (1.44 to 2.75)
    2.66 (1.92 to 3.68)
    4.59 (3.28 to 6.44)
    3.47 (2.47 to 4.89)
    2.02 (1.46 to 2.8)
    1.26 (1.08 to 1.47)
        M14459 (fHBP) - month 3 (N=49,48,45,43,50,70)
    6.31 (4.28 to 9.32)
    13 (8.91 to 20)
    17 (11 to 26)
    20 (13 to 30)
    5.04 (3.39 to 7.47)
    1.29 (1.1 to 1.51)
        M14459 (fHBP) - month 6 (N=47,47,48,48,50,71)
    2.1 (1.59 to 2.79)
    2.63 (1.99 to 3.49)
    3.33 (2.49 to 4.44)
    3.15 (2.35 to 4.24)
    2.05 (1.55 to 2.71)
    1.28 (1.11 to 1.49)
        M14459 (fHBP) - month 7 (N=47,48,47,49,50,73)
    1.79 (1.29 to 2.49)
    2.4 (1.74 to 3.33)
    2.75 (1.96 to 3.86)
    3.59 (2.55 to 5.06)
    1.87 (1.35 to 2.59)
    1.28 (1.1 to 1.49)
        M14459 (fHBP) - month 12 (N=45,47,45,47,50,72)
    1.73 (1.31 to 2.27)
    1.64 (1.25 to 2.14)
    2.43 (1.83 to 3.23)
    2.53 (1.91 to 3.36)
    1.44 (1.1 to 1.87)
    1.37 (1.15 to 1.64)
        M07-0241084 (NHBA) - month 0 (N=48,46,37,44,50,67)
    2.9 (1.97 to 4.27)
    4.04 (2.74 to 5.97)
    3.57 (2.3 to 5.56)
    3.19 (2.13 to 4.78)
    5.63 (3.85 to 8.22)
    2.67 (1.88 to 3.79)
        M07-0241084 (NHBA) - month 1 (N=48,48,48,48,50,72)
    2.88 (2.17 to 3.81)
    3.17 (2.39 to 4.21)
    7.11 (5.18 to 9.76)
    5.51 (4.12 to 7.36)
    3.76 (2.85 to 4.97)
    2.68 (1.93 to 3.7)
        M07-0241084 (NHBA) - month 3 (N=48,48,42,45,49,68)
    4.34 (3.27 to 5.75)
    6.27 (4.71 to 8.33)
    12 (8.71 to 17)
    14 (10 to 19)
    6.25 (4.71 to 8.28)
    2.85 (2.08 to 3.91)
        M07-0241084 (NHBA) - month 6 (N=47,48,48,48,49,70)
    3.78 (2.88 to 4.95)
    3.3 (2.51 to 4.34)
    5.43 (4 to 7.37)
    6.93 (5.23 to 9.19)
    3.36 (2.56 to 4.4)
    2.99 (2.16 to 4.14)
        M07-0241084 (NHBA) - month 7 (N=47,48,47,48,50,72)
    3.51 (2.54 to 4.85)
    3.19 (2.3 to 4.41)
    5.18 (3.58 to 7.48)
    6.58 (4.7 to 9.22)
    3.78 (2.74 to 5.2)
    3.03 (2.22 to 4.15)
        M07-0241084(NHBA) - month 12 (N=45,46,45,47,50,70)
    3.71 (2.74 to 5.03)
    2.82 (2.08 to 3.83)
    4.92 (3.51 to 6.89)
    6.16 (4.53 to 8.38)
    3.09 (2.31 to 4.14)
    2.91 (2.06 to 4.12)
        M01-0240364 (NadA) - month 0 (N=49,47,44,45,50,72)
    1.15 (0.9 to 1.46)
    1.37 (1.08 to 1.75)
    1.25 (0.97 to 1.61)
    1.45 (1.12 to 1.86)
    1.47 (1.16 to 1.86)
    1.12 (1.01 to 1.24)
        M01-0240364 (NadA) - month 1 (N=48,44,46,48,50,72)
    5.46 (3.1 to 9.61)
    6.42 (3.54 to 12)
    4.7 (2.58 to 8.58)
    4.24 (2.33 to 7.71)
    4.25 (2.44 to 7.41)
    1.12 (0.98 to 1.29)
        M01-0240364 (NadA) - month 3 (N=48,48,44,42,49,70)
    67 (38 to 118)
    192 (109 to 339)
    133 (72 to 245)
    125 (67 to 233)
    88 (50 to 154)
    1.41 (1.07 to 1.85)
        M01-0240364 (NadA) - month 6 (N=46,48,48,48,48,71)
    8.59 (4.95 to 15)
    17 (9.65 to 29)
    11 (6.48 to 20)
    6.27 (3.52 to 11)
    7.02 (4.07 to 12)
    1.18 (1 to 1.39)
        M01-0240364 (NadA) - month 7 (N=44,48,48,48,50,71)
    5.38 (3.2 to 9.03)
    9.65 (5.83 to 16)
    7.51 (4.45 to 13)
    4.13 (2.43 to 7.01)
    5.72 (3.49 to 9.35)
    1.18 (1 to 1.39)
        M01-0240364 (NadA) - month12 (N=43,45,44,44,50,72)
    3.85 (2.16 to 6.84)
    4.79 (2.72 to 8.44)
    5.76 (3.19 to 10)
    3.23 (1.78 to 5.87)
    2.88 (1.68 to 4.92)
    1.15 (0.97 to 1.37)
    No statistical analyses for this end point

    Secondary: GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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    End point title
    		 GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo [14]
    End point description
    Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, and after 6, 7 and 12 months of the first vaccination with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.
    End point type
    Secondary
    End point timeframe
    At month 1, 3, 6, 7 and 12
    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 analyses for this end point.
    End point values
    		 2ABCWY 2ABx2CWY 2ABCWY+OMV 2ABCWYqOMV Men 2B 1ACWY
    Number of subjects analysed
    49
    49
    48
    49
    50
    73
    Units: Ratio
    geometric mean (confidence interval 95%)
        H44/76 (fHbp) - month 1 (N=48,47,47,48,50,73)
    4.42 (2.73 to 7.16)
    7.99 (4.95 to 13)
    12 (7.44 to 20)
    8.82 (5.43 to 14)
    3.53 (2.2 to 5.65)
    1.15 (0.98 to 1.35)
        H44/76 (fHbp) - month 3 (N=49,47,45,47,50,72)
    61 (42 to 87)
    84 (58 to 121)
    87 (60 to 127)
    103 (71 to 150)
    32 (22 to 46)
    1.05 (0.89 to 1.24)
        H44/76 (fHbp) - month 6 (N=47,47,47,47,50,72)
    6.3 (4.01 to 9.9)
    5.94 (3.79 to 9.3)
    7.37 (4.69 to 12)
    11 (7.14 to 18)
    3.31 (2.13 to 5.14)
    0.89 (0.78 to 1.02)
        H44/76 (fHbp) - month 7 (N=48,47,46,48,49,73)
    3.73 (2.43 to 5.75)
    4.34 (2.82 to 6.68)
    4.75 (3.06 to 7.37)
    8.48 (5.49 to 13)
    2.66 (1.73 to 4.08)
    0.92 (0.79 to 1.06)
        H44/76 (fHbp) - month 12 (N=45,46,44,45,50,71)
    2.58 (1.73 to 3.84)
    1.77 (1.2 to 2.61)
    3.11 (2.08 to 4.66)
    3.41 (2.29 to 5.09)
    1.85 (1.27 to 2.71)
    0.86 (0.73 to 1.01)
        5/99 (NadA) - month 1 (N=48,48,47,48,50,72)
    18 (12 to 29)
    42 (27 to 65)
    12 (7.41 to 18)
    16 (10 to 26)
    21 (13 to 33)
    1 (0.85 to 1.18)
        5/99 (NadA) - month 3 (N=49,48,47,46,50,71)
    106 (74 to 151)
    184 (129 to 263)
    176 (122 to 253)
    174 (120 to 252)
    107 (75 to 153)
    1 (0.8 to 1.26)
        5/99 (NadA) - month 6 (N=47,49,48,47,48,72)
    28 (19 to 41)
    56 (39 to 82)
    29 (20 to 42)
    35 (24 to 51)
    25 (17 to 37)
    0.78 (0.61 to 0.99)
        5/99 (NadA) - month 7 (N=47,48,47,48,50,73)
    23 (16 to 34)
    44 (30 to 63)
    23 (16 to 33)
    29 (20 to 42)
    23 (16 to 34)
    0.86 (0.68 to 1.08)
        5/99 (NadA) - month 12 (N=45,47,46,46,50,72)
    13 (8.78 to 20)
    21 (14 to 31)
    15 (10 to 23)
    18 (12 to 28)
    11 (7.48 to 16)
    0.7 (0.59 to 0.83)
        NZ98/254 (PorA) - month 1 (N=48,48,48,48,50,72)
    1.27 (0.93 to 1.73)
    1.46 (1.07 to 1.98)
    2.91 (2.14 to 3.96)
    2.51 (1.84 to 3.42)
    1.08 (0.8 to 1.46)
    1 (0.87 to 1.16)
        NZ98/254 (PorA) - month 3 (N=49,48,47,47,50,72)
    1.74 (1.26 to 2.4)
    2.33 (1.69 to 3.21)
    8.25 (5.95 to 11)
    7.17 (5.16 to 9.96)
    1.46 (1.06 to 2.01)
    0.99 (0.83 to 1.17)
        NZ98/254 (PorA) - month 6 (N=48,49,48,47,49,72)
    0.99 (0.73 to 1.33)
    1.14 (0.85 to 1.53)
    1.86 (1.38 to 2.52)
    1.79 (1.32 to 2.44)
    0.75 (0.56 to 1.02)
    0.76 (0.65 to 0.89)
        NZ98/254 (PorA) - month 7 (N=47,48,47,48,50,73)
    0.85 (0.61 to 1.19)
    1.07 (0.76 to 1.49)
    1.53 (1.09 to 2.15)
    1.45 (1.03 to 2.03)
    0.73 (0.52 to 1.01)
    0.8 (0.67 to 0.94)
        NZ98/254 (PorA) - month 12 (N=45,47,46,45,50,72)
    0.91 (0.68 to 1.22)
    0.97 (0.73 to 1.29)
    1.41 (1.05 to 1.88)
    1.25 (0.93 to 1.68)
    0.6 (0.46 to 0.8)
    0.77 (0.66 to 0.9)
        M14459 (fHBP) - month 1 (N=48,47,44,45,50,71)
    1.57 (1.13 to 2.17)
    2.09 (1.51 to 2.89)
    3.61 (2.58 to 5.06)
    2.73 (1.95 to 3.84)
    1.57 (1.14 to 2.16)
    0.95 (0.87 to 1.03)
        M14459 (fHBP) - month 3 (N=49,47,42,41,50,69)
    4.96 (3.35 to 7.36)
    10 (6.77 to 15)
    13 (8.66 to 20)
    15 (9.83 to 23)
    3.54 (2.4 to 5.23)
    1.04 (0.9 to 1.2)
        M14459 (fHBP) - month 6 (N=47,46,45,44,50,70)
    1.65 (1.25 to 2.19)
    2.04 (1.54 to 2.71)
    2.58 (1.94 to 3.45)
    2.46 (1.83 to 3.31)
    1.53 (1.16 to 2.02)
    0.99 (0.87 to 1.12)
        M14459 (fHBP) - month 7 (N=47,47,44,45,50,72)
    1.4 (1 to 1.96)
    1.82 (1.31 to 2.54)
    2.08 (1.48 to 2.94)
    2.75 (1.95 to 3.9)
    1.3 (0.94 to 1.8)
    0.97 (0.83 to 1.13)
        M14459 (fHBP) - month 12 ( n=45,46,42,43,50,71)
    1.35 (1.02 to 1.77)
    1.26 (0.96 to 1.65)
    1.86 (1.4 to 2.47)
    1.96 (1.48 to 2.61)
    1.05 (0.81 to 1.37)
    1.03 (0.87 to 1.24)
        M07-0241084 (NHBA) - month 1 (N=47,45,37,44,50,66)
    1.07 (0.81 to 1.42)
    1.14 (0.86 to 1.52)
    2.6 (1.89 to 3.57)
    2.03 (1.52 to 2.73)
    1.31 (1 to 1.72)
    1.02 (0.87 to 1.19)
        M07-0241084 (NHBA) - month 3 (N=47,45,33,40,49,65)
    1.62 (1.19 to 2.19)
    2.1 (1.55 to 2.85)
    4.46 (3.11 to 6.39)
    4.94 (3.56 to 6.84)
    1.91 (1.42 to 2.56)
    1.13 (0.89 to 1.44)
        M07-0241084 (NHBA) - month 6 (N=46,45,37,43,49,65)
    1.39 (1.04 to 1.85)
    1.13 (0.85 to 1.5)
    1.91 (1.39 to 2.64)
    2.53 (1.88 to 3.4)
    1.07 (0.81 to 1.42)
    1.2 (0.97 to 1.49)
        M07-0241084 (NHBA) - month 7 (N=46,45,36,43,50,66)
    1.29 (0.91 to 1.82)
    1.05 (0.74 to 1.48)
    1.81 (1.22 to 2.68)
    2.41 (1.68 to 3.46)
    1.12 (0.8 to 1.57)
    1.21 (0.96 to 1.51)
        M07-0241084(NHBA) - month 12 (N=44,43,36,43,50,64)
    1.38 (0.99 to 1.9)
    0.94 (0.68 to 1.3)
    1.7 (1.18 to 2.43)
    2.24 (1.61 to 3.12)
    0.94 (0.69 to 1.28)
    1.19 (0.9 to 1.58)
        M01-0240364 (NadA) - month 1 (N=48,42,42,44,50,71)
    4.42 (2.51 to 7.77)
    5.08 (2.8 to 9.2)
    3.77 (2.07 to 6.88)
    3.35 (1.84 to 6.08)
    3.35 (1.93 to 5.83)
    1 (0.86 to 1.16)
        M01-0240364 (NadA) - month 3 (N=48,46,40,40,49,63)
    57 (32 to 102)
    145 (80 to 261)
    105 (56 to 199)
    89 (47 to 170)
    64 (36 to 113)
    1.28 (1.01 to 1.63)
        M01-0240364 (NadA) - month 6 (N=46,46,44,44,48,70)
    7.07 (4.05 to 12)
    13 (7.46 to 22)
    9.18 (5.17 to 16)
    4.78 (2.68 to 8.54)
    5.32 (3.08 to 9.19)
    1.05 (0.9 to 1.23)
        M01-0240364 (NadA) - month 7 (N=44,46,44,44,50,70)
    4.46 (2.63 to 7.56)
    7.43 (4.45 to 12)
    6.03 (3.54 to 10)
    3.11 (1.81 to 5.33)
    4.29 (2.6 to 7.08)
    1.07 (0.92 to 1.25)
        M01-0240364 (NadA) - month12 (N=43,43,41,40,50,71)
    3.17 (1.77 to 5.69)
    3.77 (2.12 to 6.69)
    4.65 (2.55 to 8.47)
    2.52 (1.38 to 4.62)
    2.17 (1.26 to 3.72)
    1.03 (0.87 to 1.22)
    No statistical analyses for this end point

    Secondary: GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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    End point title
    		 GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo [15]
    End point description
    Antibody response was measured as Geometric Mean hSBA Titers Against Serogroups A, C, W and Y at baseline (month 0), after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.
    End point type
    Secondary
    End point timeframe
    At month 0. 1, 3, 6, 7 and 12
    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 analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    25
    24
    25
    25
    23
    73
    Units: Titers
    geometric mean (confidence interval 95%)
        Ser. A - month 0 (N=25,24,25,25,23,73)
    1.34 (0.99 to 1.83)
    1.5 (1.1 to 2.06)
    1.19 (0.88 to 1.63)
    1.47 (1.08 to 1.99)
    1.21 (0.88 to 1.67)
    1.43 (1.18 to 1.72)
        Ser. A - month 1 (N=24,24,24,25,23,70)
    42 (19 to 92)
    98 (45 to 213)
    44 (20 to 95)
    46 (21 to 98)
    4.35 (1.97 to 9.6)
    107 (66 to 172)
        Ser. A - month 3 (N=25,24,25,25,23,72)
    132 (73 to 237)
    252 (139 to 456)
    185 (103 to 333)
    153 (86 to 275)
    98 (53 to 181)
    36 (25 to 52)
        Ser. A - month 6 (N=23,24,24,25,23,69)
    14 (6.54 to 32)
    40 (19 to 86)
    32 (15 to 69)
    19 (8.99 to 41)
    4.65 (2.12 to 10)
    20 (12 to 32)
        Ser. A - month 7 (N=24,24,21,25,22,71)
    247 (124 to 495)
    296 (149 to 591)
    253 (121 to 530)
    256 (130 to 503)
    140 (68 to 289)
    21 (13 to 31)
        Ser. A - month 12 (N=25,23,21,25,22,71)
    33 (16 to 68)
    58 (27 to 123)
    47 (21 to 103)
    38 (18 to 78)
    11 (5.1 to 24)
    14 (9.03 to 22)
        Ser. C - month 0 (N=25,24,25,25,23,72)
    6.67 (3.99 to 11)
    4.9 (2.91 to 8.25)
    4.75 (2.84 to 7.96)
    6.3 (3.78 to 11)
    3.82 (2.24 to 6.52)
    4.96 (3.61 to 6.81)
        Ser. C - month 1 (N=25,24,24,25,23,71)
    125 (68 to 230)
    87 (47 to 161)
    112 (61 to 208)
    74 (41 to 136)
    5.93 (3.16 to 11)
    75 (51 to 109)
        Ser. C - month 3 (N=25,24,25,24,23,71)
    482 (318 to 731)
    384 (252 to 585)
    346 (228 to 523)
    381 (250 to 580)
    20 (13 to 31)
    45 (35 to 58)
        Ser. C - month 6 (N=22,24,24,24,21,70)
    182 (111 to 297)
    143 (90 to 229)
    157 (98 to 251)
    118 (74 to 189)
    4.58 (2.77 to 7.57)
    23 (17 to 31)
        Ser. C - month 7 (N=23,24,23,25,22,72)
    676 (410 to 1114)
    676 (416 to 1097)
    636 (387 to 1046)
    553 (344 to 891)
    33 (20 to 55)
    18 (13 to 24)
        Ser. C - month 12 (N=25,23,21,25,23,72)
    202 (123 to 334)
    185 (110 to 309)
    153 (89 to 263)
    157 (96 to 258)
    7.8 (4.65 to 13)
    14 (10 to 19)
        Ser. W - month 0 (N=25,24,25,25,23,73)
    28 (13 to 59)
    20 (9.17 to 42)
    21 (9.83 to 44)
    27 (13 to 56)
    27 (12 to 58)
    24 (15 to 38)
        Ser. W - month 1 (N=25,24,24,25,23,72)
    152 (92 to 253)
    180 (108 to 300)
    237 (141 to 396)
    144 (87 to 238)
    19 (11 to 32)
    210 (154 to 287)
        Ser. W - month 3 (N=25,24,25,24,23,72)
    398 (285 to 557)
    455 (324 to 639)
    499 (357 to 697)
    406 (289 to 570)
    139 (98 to 197)
    166 (135 to 204)
        Ser. W - month 6 (N=24,24,25,24,22,69)
    166 (105 to 261)
    176 (112 to 275)
    191 (123 to 297)
    148 (94 to 231)
    10 (6.28 to 16)
    117 (88 to 154)
        Ser. W - month 7 (N=23,24,21,25,21,72)
    640 (405 to 1014)
    670 (432 to 1039)
    876 (548 to 1402)
    627 (407 to 965)
    116 (72 to 187)
    121 (93 to 159)
        Ser. W - month 12(N=24,22,19,24,23,69)
    264 (159 to 438)
    258 (153 to 433)
    257 (147 to 449)
    212 (128 to 349)
    17 (10 to 29)
    75 (55 to 103)
        Ser. Y - month 0 (N=25,24,25,25,23,73)
    5.6 (3.58 to 8.74)
    5.45 (3.47 to 8.57)
    5.2 (3.33 to 8.13)
    5.27 (3.38 to 8.2)
    4.4 (2.77 to 6.99)
    7.07 (5.38 to 9.29)
        Ser. Y - month 1 (N=25,24,23,25,23,73)
    75 (44 to 129)
    48 (28 to 82)
    62 (36 to 109)
    71 (42 to 121)
    4.38 (2.51 to 7.67)
    92 (66 to 128)
        Ser. Y - month 3 (N=25,24,25,25,23,73)
    225 (154 to 328)
    179 (122 to 262)
    214 (147 to 312)
    170 (117 to 247)
    4.91 (3.32 to 7.26)
    72 (57 to 91)
        Ser. Y - month 6 (N=24,24,24,25,23,72)
    185 (102 to 336)
    216 (119 to 390)
    147 (81 to 267)
    121 (68 to 216)
    1.69 (0.92 to 3.09)
    84 (58 to 120)
        Ser. Y - month 7 (N=25,24,24,25,22,72)
    648 (362 to 1162)
    590 (327 to 1066)
    599 (331 to 1085)
    408 (229 to 728)
    2.56 (1.38 to 4.77)
    75 (52 to 108)
        Ser. Y - month 12 (N=25,23,21,25,23,70)
    295 (158 to 550)
    351 (184 to 670)
    210 (107 to 413)
    205 (110 to 381)
    1.46 (0.76 to 2.78)
    47 (31 to 69)
    No statistical analyses for this end point

    Secondary: GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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    End point title
    		 GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo [16]
    End point description
    Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.
    End point type
    Secondary
    End point timeframe
    At month 1, 3, 6, 7 and 12
    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 analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    25
    24
    25
    25
    23
    73
    Units: Ratio
    geometric mean (confidence interval 95%)
        Ser. A - month 1 (N=24,24,24,25,23,70)
    32 (15 to 71)
    71 (32 to 155)
    35 (16 to 77)
    33 (15 to 72)
    3.45 (1.54 to 7.73)
    78 (48 to 127)
        Ser. A - month 3 (N=25,24,25,25,23,72)
    99 (53 to 185)
    176 (94 to 330)
    150 (81 to 280)
    109 (59 to 202)
    79 (42 to 150)
    26 (18 to 38)
        Ser. A - month 6 (N=23,24,24,25,23,69)
    11 (4.86 to 24)
    29 (13 to 63)
    25 (12 to 56)
    14 (6.47 to 30)
    3.69 (1.66 to 8.2)
    15 (9.12 to 24)
        Ser. A - month 7 (N=24,24,21,25,22,71)
    190 (94 to 385)
    214 (106 to 432)
    201 (95 to 425)
    187 (94 to 372)
    110 (53 to 230)
    15 (9.87 to 23)
        Ser. A - month 12 (N=25,23,21,25,22,71)
    25 (12 to 52)
    42 (20 to 90)
    36 (16 to 81)
    28 (13 to 57)
    8.75 (4.01 to 19)
    11 (6.65 to 17)
        Ser. C - month 1 (N=25,24,24,25,23,70)
    23 (11 to 45)
    19 (9.55 to 38)
    26 (13 to 52)
    14 (7.09 to 28)
    1.51 (0.74 to 3.07)
    16 (11 to 25)
        Ser. C - month 3 (N=25,24,25,24,23,70)
    80 (44 to 143)
    81 (45 to 148)
    75 (42 to 135)
    63 (35 to 114)
    5.17 (2.81 to 9.52)
    9.54 (6.61 to 14)
        Ser. C - month 6 (N=22,24,24,24,21,69)
    33 (18 to 61)
    31 (17 to 56)
    33 (19 to 60)
    22 (12 to 39)
    1.16 (0.62 to 2.18)
    5.14 (3.57 to 7.39)
        Ser. C - month 7 (N=23,24,23,25,22,71)
    115 (62 to 214)
    146 (80 to 266)
    139 (75 to 258)
    100 (56 to 181)
    9.09 (4.84 to 17)
    3.9 (2.7 to 5.64)
        Ser. C - month 12 (N=25,23,21,25,23,71)
    37 (21 to 67)
    41 (22 to 75)
    33 (18 to 63)
    30 (17 to 53)
    2.01 (1.09 to 3.69)
    3.06 (2.12 to 4.4)
        Ser. W - month 1 (N=25,24,24,25,23,72)
    6.44 (3.12 to 13)
    9.65 (4.64 to 20)
    13 (6.09 to 27)
    6.3 (3.07 to 13)
    0.81 (0.38 to 1.72)
    10 (6.49 to 16)
        Ser. W - month 3 (N=25,24,25,24,23,72)
    15 (6.85 to 33)
    24 (11 to 52)
    24 (11 to 53)
    14 (6.51 to 31)
    5.42 (2.42 to 12)
    7.32 (4.53 to 12)
        Ser. W - month 6 (N=24,24,25,24,22,69)
    6.45 (3.03 to 14)
    9.27 (4.4 to 20)
    9.6 (4.6 to 20)
    6.36 (3.02 to 13)
    0.45 (0.21 to 0.98)
    5.17 (3.25 to 8.24)
        Ser. W - month 7 (N=23,24,21,25,21,72)
    24 (11 to 54)
    35 (16 to 76)
    41 (18 to 94)
    26 (12 to 55)
    4.78 (2.08 to 11)
    5.47 (3.4 to 8.8)
        Ser. W - month 12(N=24,22,19,24,23,69)
    11 (4.99 to 24)
    15 (6.76 to 34)
    15 (6.38 to 37)
    9.44 (4.32 to 21)
    0.75 (0.34 to 1.67)
    3.62 (2.21 to 5.94)
        Ser. Y - month 1 (N=25,24,23,25,23,73)
    15 (8.32 to 28)
    9.78 (5.33 to 18)
    13 (6.88 to 24)
    15 (8.2 to 27)
    1.02 (0.55 to 1.9)
    16 (11 to 23)
        Ser. Y - month 3 (N=25,24,25,25,23,73)
    43 (26 to 71)
    35 (21 to 58)
    43 (26 to 72)
    34 (21 to 56)
    1.13 (0.67 to 1.9)
    12 (8.54 to 16)
        Ser. Y - month 6 (N=24,24,24,25,23,72)
    36 (18 to 70)
    43 (22 to 84)
    30 (15 to 59)
    25 (13 to 48)
    0.39 (0.2 to 0.78)
    14 (9.04 to 21)
        Ser. Y - month 7 (N=25,24,24,25,22,72)
    123 (63 to 242)
    115 (58 to 227)
    129 (65 to 257)
    81 (42 to 159)
    0.55 (0.27 to 1.14)
    12 (7.76 to 18)
        Ser. Y - month 12 (N=25,23,21,25,23,70)
    56 (28 to 114)
    67 (32 to 139)
    43 (20 to 93)
    41 (20 to 83)
    0.33 (0.16 to 0.69)
    7.27 (4.68 to 11)
    No statistical analyses for this end point

    Secondary: GMT against N Meningitidis Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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    End point title
    		 GMT against N Meningitidis Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo [17]
    End point description
    Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at baseline (month 0), after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.
    End point type
    Secondary
    End point timeframe
    At month 0, 1, 3, 6, 7 and 12
    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 analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    25
    24
    25
    25
    23
    73
    Units: Titers
    geometric mean (confidence interval 95%)
        H44/76 (fHbp) - month 0 (N=25,24,25,25,23,73)
    1.32 (0.93 to 1.87)
    1.36 (0.96 to 1.93)
    1.43 (1.01 to 2.02)
    1.2 (0.85 to 1.7)
    1.37 (0.96 to 1.96)
    1.31 (1.05 to 1.65)
        H44/76 (fHbp) - month 1 (N=25,24,24,24,23,73)
    4.84 (2.52 to 9.3)
    14 (7 to 26)
    22 (11 to 42)
    11 (5.83 to 22)
    5.03 (2.55 to 9.9)
    1.51 (1.19 to 1.92)
        H44/76 (fHbp) - month 3 (N=25,24,24,25,23,72)
    62 (40 to 97)
    115 (73 to 180)
    153 (97 to 241)
    110 (71 to 171)
    71 (45 to 112)
    1.27 (1.07 to 1.5)
        H44/76 (fHbp) - month 6 (N=25,24,25,24,23,72)
    5.75 (3.15 to 11)
    6.56 (3.56 to 12)
    11 (5.95 to 20)
    5.41 (2.93 to 9.98)
    6.1 (3.27 to 11)
    1.18 (1.01 to 1.37)
        H44/76 (fHbp) - month 7 (N=25,24,24,25,22,73)
    108 (61 to 190)
    149 (84 to 264)
    169 (95 to 302)
    118 (67 to 208)
    104 (57 to 191)
    1.21 (1.04 to 1.4)
        H44/76 (fHbp) - month 12 (N=25,23,21,25,23,71)
    5.42 (3.22 to 9.11)
    9.63 (5.64 to 16)
    22 (12 to 38)
    8.09 (4.84 to 14)
    9.02 (5.26 to 15)
    1.13 (1 to 1.29)
        5/99 (NadA) - month 0 (N=25,24,25,25,23,73)
    2.48 (1.61 to 3.82)
    2.16 (1.4 to 3.34)
    2 (1.3 to 3.07)
    2.17 (1.42 to 3.33)
    1.92 (1.23 to 3)
    2.25 (1.77 to 2.85)
        5/99 (NadA) - month 1 (N=25,24,24,25,23,72)
    54 (31 to 93)
    128 (74 to 222)
    29 (17 to 51)
    42 (24 to 71)
    157 (90 to 276)
    2.27 (1.82 to 2.85)
        5/99 (NadA) - month 3 (N=24,24,25,24,23,71)
    328 (237 to 455)
    426 (308 to 589)
    367 (267 to 506)
    382 (277 to 528)
    454 (326 to 632)
    2.11 (1.65 to 2.7)
        5/99 (NadA) - month 6 (N=25,24,24,25,23,72)
    75 (50 to 112)
    122 (81 to 183)
    48 (32 to 72)
    84 (56 to 125)
    156 (103 to 237)
    1.74 (1.36 to 2.22)
        5/99 (NadA) - month 7 (N=25,24,24,25,23,73)
    530 (361 to 779)
    741 (502 to 1092)
    674 (456 to 996)
    527 (360 to 771)
    856 (575 to 1274)
    1.93 (1.5 to 2.48)
        5/99 (NadA) - month 12 (N=25,23,21,25,23,72)
    140 (89 to 220)
    202 (127 to 322)
    126 (77 to 206)
    127 (81 to 199)
    274 (172 to 439)
    1.53 (1.25 to 1.88)
        NZ98/254 (PorA) - month 0 (N=25,24,25,25,23,73)
    1.78 (1.32 to 2.4)
    1.69 (1.25 to 2.29)
    1.77 (1.32 to 2.39)
    1.78 (1.33 to 2.4)
    1.66 (1.22 to 2.27)
    1.5 (1.3 to 1.73)
        NZ98/254 (PorA) - month 1 (N=25,24,24,25,23,72)
    2.13 (1.41 to 3.21)
    2.22 (1.46 to 3.36)
    6.22 (4.09 to 9.45)
    2.92 (1.95 to 4.39)
    1.76 (1.15 to 2.7)
    1.51 (1.32 to 1.74)
        NZ98/254 (PorA) - month 3 (N=25,24,25,24,23,72)
    2.87 (1.87 to 4.4)
    3.14 (2.04 to 4.83)
    18 (12 to 27)
    8.95 (5.82 to 14)
    2.75 (1.77 to 4.28)
    1.49 (1.29 to 1.72)
        NZ98/254 (PorA) - month 6 (N=25,24,24,25,23,72)
    1.9 (1.29 to 2.81)
    1.85 (1.25 to 2.74)
    3.33 (2.24 to 4.96)
    1.83 (1.24 to 2.69)
    1.83 (1.22 to 2.73)
    1.15 (1.05 to 1.25)
        NZ98/254 (PorA) - month 7 (N=25,24,24,25,23,73)
    2.3 (1.49 to 3.54)
    3.24 (2.09 to 5.02)
    23 (15 to 35)
    12 (7.5 to 18)
    2.65 (1.69 to 4.14)
    1.2 (1.07 to 1.33)
        NZ98/254 (PorA) - month 12 (N=25,23,21,25,23,72)
    1.41 (0.98 to 2.02)
    1.94 (1.34 to 2.81)
    5.01 (3.4 to 7.39)
    2.39 (1.68 to 3.42)
    1.79 (1.23 to 2.59)
    1.15 (1.05 to 1.25)
        M14459 (fHBP) - month 0 (N=25,24,25,22,23,72)
    1.57 (1.19 to 2.09)
    1.64 (1.23 to 2.18)
    1.45 (1.09 to 1.93)
    1.32 (0.98 to 1.78)
    1.41 (1.05 to 1.9)
    1.33 (1.08 to 1.62)
        M14459 (fHBP) - month 1 (N=25,24,24,25,23,72)
    1.87 (1.2 to 2.91)
    2.78 (1.78 to 4.36)
    4.4 (2.8 to 6.91)
    2.69 (1.69 to 4.29)
    2.08 (1.32 to 3.3)
    1.26 (1.08 to 1.47)
        M14459 (fHBP) - month 3 (N=25,24,25,24,23,70)
    5.94 (3.47 to 10)
    15 (8.59 to 25)
    22 (13 to 38)
    11 (6.03 to 19)
    9.66 (5.55 to 17)
    1.29 (1.1 to 1.51)
        M14459 (fHBP) - month 6 (N=25,24,25,25,23,71)
    2.25 (1.54 to 3.3)
    2.64 (1.8 to 3.89)
    4 (2.73 to 5.86)
    2.11 (1.42 to 3.15)
    2.27 (1.53 to 3.37)
    1.28 (1.11 to 1.49)
        M14459 (fHBP) - month 7 (N=25,24,23,25,22,73)
    14 (9.12 to 22)
    23 (14 to 36)
    41 (26 to 65)
    17 (11 to 27)
    11 (6.77 to 17)
    1.28 (1.1 to 1.49)
        M14459 (fHBP) - month 12 (N=25,23,21,25,23,72)
    1.79 (1.25 to 2.57)
    2.663 (1.81 to 3.81)
    5.99 (4.06 to 8.85)
    2.35 (1.61 to 3.43)
    2.8 (1.93 to 4.07)
    1.37 (1.15 to 1.64)
        M07-0241084(NHBA) - month 0 (N=24,23,23,21,23,67)
    2.79 (1.64 to 4.76)
    3.33 (1.94 to 5.72)
    3.24 (1.88 to 5.58)
    3.46 (1.95 to 6.12)
    2.42 (1.41 to 4.16)
    2.67 (1.88 to 3.79)
        M07-0241084(NHBA) - month 1 (N=25,24,23,23,23,72)
    3.42 (2.33 to 5.02)
    3.23 (2.19 to 4.75)
    6.8 (4.57 to 10)
    5.73 (3.76 to 8.71)
    4.07 (2.76 to 6.01)
    2.68 (1.93 to 3.7)
        M07-0241084 (NHBA) - month 3 (N=25,24,22,21,22,68)
    4.04 (2.75 to 5.93)
    5.1 (3.46 to 7.53)
    12 (8.04 to 19)
    8.09 (5.18 to 13)
    6.48 (4.35 to 9.66)
    2.85 (2.08 to 3.91)
        M07-0241084 (NHBA) - month 6 (N=25,23,23,25,23,70)
    3.27 (2.26 to 4.73)
    3.21 (2.19 to 4.69)
    5.91 (3.99 to 8.74)
    4.57 (3.08 to 6.78)
    3.67 (2.52 to 5.34)
    2.99 (2.16 to 4.14)
        M07-0241084 (NHBA) - month 7 (N=25,23,22,25,21,72)
    12 (7.85 to 19)
    8.91 (5.64 to 14)
    33 (20 to 53)
    22 (14 to 35)
    11 (6.65 to 17)
    3.03 (2.22 to 4.15)
        M07-0241084(NHBA) - month 12 (N=25,23,21,25,23,70)
    2.77 (1.85 to 4.13)
    3.05 (2.01 to 4.61)
    9.99 (6.39 to 16)
    4.92 (3.2 to 7.56)
    5.74 (3.82 to 8.64)
    2.91 (2.06 to 4.12)
        M01-0240364 (NadA) - month 0 (N=25,24,24,22,23,72)
    1.37 (0.99 to 1.91)
    1.32 (0.95 to 1.84)
    1.18 (0.84 to 1.65)
    1.11 (0.79 to 1.57)
    1.11 (0.79 to 1.56)
    1.12 (1.01 to 1.24)
        M01-0240364 (NadA) - month 1 (N=23,24,24,25,23,72)
    2.94 (1.32 to 6.58)
    10 (4.75 to 22)
    6 (2.71 to 13)
    5.52 (2.46 to 12)
    3.84 (1.74 to 8.52)
    1.12 (0.98 to 1.29)
        M01-0240364 (NadA) - month 3 (N=25,24,24,24,23,70)
    41 (19 to 88)
    245 (113 to 532)
    126 (57 to 280)
    205 (91 to 459)
    226 (102 to 501)
    1.41 (1.07 to 1.85)
        M01-0240364 (NadA) - month 6 (N=25,21,24,24,21,71)
    4.39 (2.09 to 9.19)
    9.54 (4.3 to 21)
    7.3 (3.44 to 15)
    9.08 (4.1 to 20)
    7.87 (3.54 to 18)
    1.18 (1 to 1.39)
        M01-0240364 (NadA) - month 7 (N=24,23,24,25,23,71)
    294 (147 to 589)
    513 (255 to 1035)
    409 (202 to 829)
    280 (137 to 572)
    507 (251 to 1027)
    1.18 (1 to 1.39)
        M01-0240364(NadA) - month 12 (N=23,21,20,25,22,72)
    7.32 (3.4 to 16)
    24 (11 to 54)
    17 (7.37 to 38)
    19 (8.71 to 41)
    41 (19 to 88)
    1.15 (0.97 to 1.37)
    No statistical analyses for this end point

    Secondary: GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo

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    End point title
    		 GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo [18]
    End point description
    Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.
    End point type
    Secondary
    End point timeframe
    At month 6 and month 7
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses for this end point.
    End point values
    		 3ABCWY 3ABx2CWY 3ABCWY+OMV 3ABCWYqOMV Men 3B 1ACWY
    Number of subjects analysed
    25
    24
    25
    25
    23
    73
    Units: Ratio
    geometric mean (confidence interval 95%)
        H44/76 (fHbp) - month 1 (N=25,24,24,24,23,73)
    3.79 (1.97 to 7.29)
    11 (5.45 to 20)
    17 (8.59 to 33)
    8.95 (4.62 to 17)
    3.92 (1.99 to 7.72)
    1.15 (0.98 to 1.35)
        H44/76 (fHbp) - month 3 (N=25,24,24,25,23,72)
    48 (29 to 78)
    86 (52 to 143)
    111 (67 to 185)
    90 (55 to 147)
    53 (32 to 89)
    1.05 (0.89 to 1.24)
        H44/76 (fHbp) - month 6 (N=25,24,25,24,23,72)
    4.47 (2.43 to 8.23)
    5.06 (2.73 to 9.37)
    8.28 (4.5 to 15)
    4.31 (2.32 to 8.01)
    4.7 (2.5 to 8.85)
    0.89 (0.78 to 1.02)
        H44/76 (fHbp) - month 7 (N=25,24,24,25,22,73)
    83 (46 to 150)
    113 (63 to 206)
    126 (69 to 229)
    95 (53 to 170)
    79 (42 to 147)
    0.92 (0.79 to 1.06)
        H44/76 (fHbp) - month 12 (N=25,23,21,25,23,71)
    4.22 (2.49 to 7.14)
    7.44 (4.33 to 13)
    16 (9.28 to 29)
    6.45 (3.83 to 11)
    6.97 (4.04 to 12)
    0.86 (0.73 to 1.01)
        5/99 (NadA) - month 1 (N=25,24,24,25,23,72)
    23 (12 to 42)
    60 (32 to 110)
    14 (7.59 to 26)
    19 (11 to 35)
    79 (42 to 148)
    1 (0.85 to 1.18)
        5/99 (NadA) - month 3 (N=24,24,25,24,23,71)
    131 (79 to 216)
    197 (120 to 324)
    182 (112 to 298)
    182 (111 to 299)
    233 (140 to 387)
    1 (0.8 to 1.26)
        5/99 (NadA) - month 6 (N=25,24,24,25,23,72)
    31 (19 to 53)
    56 (34 to 95)
    24 (14 to 41)
    39 (23 to 64)
    79 (46 to 134)
    0.78 (0.61 to 0.99)
        5/99 (NadA) - month 7 (N=25,24,24,25,23,73)
    221 (133 to 368)
    344 (206 to 574)
    325 (194 to 545)
    244 (147 to 403)
    435 (257 to 736)
    0.86 (0.68 to 1.08)
        5/99 (NadA) - month 12 (N=25,23,21,25,23,72)
    58 (34 to 101)
    95 (54 to 167)
    62 (34 to 111)
    58 (34 to 100)
    138 (78 to 243)
    0.7 (0.59 to 0.83)
        NZ98/254 (PorA) - month 1 (N=25,24,24,25,23,72)
    1.25 (0.82 to 1.9)
    1.32 (0.86 to 2.02)
    3.63 (2.37 to 5.57)
    1.71 (1.13 to 2.6)
    1.06 (0.68 to 1.63)
    1 (0.87 to 1.16)
        NZ98/254 (PorA) - month 3 (N=25,24,25,24,23,72)
    1.67 (1.07 to 2.6)
    1.86 (1.19 to 2.91)
    10 (6.67 to 16)
    5.16 (3.31 to 8.06)
    1.64 (1.04 to 2.6)
    0.99 (0.83 to 1.17)
        NZ98/254 (PorA) - month 6 (N=25,24,24,25,23,72)
    1.11 (0.73 to 1.67)
    1.1 (0.73 to 1.67)
    1.93 (1.27 to 2.92)
    1.06 (0.71 to 1.59)
    1.09 (0.71 to 1.67)
    0.76 (0.65 to 0.89)
        NZ98/254 (PorA) - month 7 (N=25,24,24,25,23,73)
    1.33 (0.84 to 2.1)
    1.93 (1.21 to 3.07)
    13 (8.14 to 21)
    6.66 (4.23 to 10)
    1.59 (0.99 to 2.55)
    0.8 (0.67 to 0.94)
        NZ98/254 (PorA) - month 12 (N=25,23,21,25,23,72)
    0.81 (0.55 to 1.19)
    1.13 (0.76 to 1.69)
    2.81 (1.85 to 4.27)
    1.37 (0.94 to 2.02)
    1.06 (0.71 to 1.58)
    0.77 (0.66 to 0.9)
        M14459 (fHBP) - month 1 (N=25,24,24,22,23,71)
    1.46 (0.94 to 2.27)
    2.18 (1.39 to 3.4)
    3.46 (2.2 to 5.42)
    2.12 (1.33 to 3.38)
    1.64 (1.04 to 2.59)
    0.95 (0.87 to 1.03)
        M14459 (fHBP) - month 3 (N=25,24,25,22,23,69)
    4.41 (2.57 to 7.57)
    11 (6.28 to 19)
    17 (9.77 to 29)
    8.26 (4.68 to 15)
    7.4 (4.22 to 13)
    1.04 (0.9 to 1.2)
        M14459 (fHBP) - month 6 (N=25,24,25,22,23,70)
    1.73 (1.18 to 2.53)
    2.02 (1.37 to 2.96)
    3.1 (2.12 to 4.54)
    1.66 (1.11 to 2.48)
    1.77 (1.19 to 2.63)
    0.99 (0.87 to 1.12)
        M14459 (fHBP) - month 7 (N=25,24,23,22,22,72)
    10 (6.66 to 16)
    16 (10 to 26)
    31 (19 to 49)
    13 (8.26 to 21)
    8.18 (5.06 to 13)
    0.97 (0.83 to 1.13)
        M14459 (fHBP) - month 12 (N=25,23,21,22,23,71)
    1.35 (0.94 to 1.94)
    1.97 (1.35 to 2.86)
    4.57 (3.09 to 6.77)
    1.83 (1.25 to 2.68)
    2.16 (1.48 to 3.14)
    1.03 (0.87 to 1.24)
        M07-0241084 (NHBA) - month 1 (N=24,23,22,20,23,66)
    1.28 (0.87 to 1.89)
    1.19 (0.8 to 1.75)
    2.5 (1.67 to 3.74)
    2.1 (1.38 to 3.21)
    1.55 (1.05 to 2.29)
    1.02 (0.87 to 1.19)
        M07-0241084 (NHBA) - month 3 (N=24,23,20,18,22,65)
    1.52 (1 to 2.3)
    1.82 (1.2 to 2.77)
    4.54 (2.89 to 7.11)
    2.81 (1.74 to 4.54)
    2.56 (1.67 to 3.93)
    1.13 (0.89 to 1.44)
        M07-0241084 (NHBA) - month 6 (N=24,22,21,21,23,65)
    1.22 (0.83 to 1.8)
    1.14 (0.76 to 1.7)
    2.14 (1.42 to 3.23)
    1.62 (1.07 to 2.46)
    1.42 (0.95 to 2.1)
    1.2 (0.97 to 1.49)
        M07-0241084 (NHBA) - month 7 (N=24,22,20,21,21,66)
    4.55 (2.84 to 7.29)
    3.1 (1.9 to 5.05)
    12 (6.98 to 20)
    7.7 (4.65 to 13)
    4.15 (2.49 to 6.9)
    1.21 (0.96 to 1.51)
        M07-0241084 (NHBA) - month 12(N=24,22,19,21,23,64)
    1.03 (0.67 to 1.59)
    1.07 (0.68 to 1.66)
    3.56 (2.21 to 5.75)
    1.73 (1.09 to 2.74)
    2.24 (1.44 to 3.46)
    1.19 (0.9 to 1.58)
        M01-0240364 (NadA) - month 1 (N=23,24,23,22,23,71)
    2.33 (1.04 to 5.2)
    8.23 (3.79 to 18)
    4.84 (2.19 to 11)
    4.48 (2 to 10)
    3.12 (1.41 to 6.91)
    1 (0.86 to 1.16)
        M01-0240364 (NadA) - month 3 (N=25,24,23,22,23,69)
    31 (14 to 68)
    190 (85 to 424)
    105 (46 to 239)
    177 (77 to 408)
    196 (86 to 446)
    1.28 (1.01 to 1.63)
        M01-0240364 (NadA) - month 6 (N=25,21,24,21,21,70)
    3.41 (1.62 to 7.2)
    7.46 (3.33 to 17)
    5.97 (2.79 to 13)
    7.56 (3.39 to 17)
    6.57 (2.93 to 15)
    1.05 (0.9 to 1.23)
        M01-0240364 (NadA) - month 7 (N=24,23,23,22,23,70)
    226 (111 to 459)
    401 (196 to 820)
    336 (164 to 690)
    236 (114 to 488)
    428 (209 to 879)
    1.07 (0.92 to 1.25)
        M01-0240364 (NadA) - month 12(N=23,21,20,22,22,71)
    5.61 (2.58 to 12)
    19 (8.45 to 42)
    14 (6.13 to 32)
    16 (7.28 to 35)
    34 (16 to 76)
    1.03 (0.87 to 1.22)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Unsolicited Adverse Events After Vaccination

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    End point title
    		 Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
    End point description
    Unsolicited AEs were collected with onset from Day 1 through Day 7 After Vaccination.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 7 after vaccination
    End point values
    		 3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV Men 3B Men 2B 1ACWY
    Number of subjects analysed
    24
    49
    24
    49
    25
    48
    24
    49
    23
    50
    73
    Units: Number of Subjects
    number (not applicable)
        Any AEs
    3
    6
    1
    4
    2
    3
    3
    2
    2
    6
    6
        At least possibly related AEs
    1
    4
    0
    2
    1
    1
    3
    0
    1
    3
    3
        SAEs
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        At least possibly related SAEs
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Numbers of Subjects With Other Unsolicited AEs

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    End point title
    		 Numbers of Subjects With Other Unsolicited AEs
    End point description
    Unsolicited AEs were collected from Day 8 After vaccination Through Study Termination.
    End point type
    Secondary
    End point timeframe
    Day 8 After vaccination Through Study Termination
    End point values
    		 3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV Men 3B Men 2B 1ACWY
    Number of subjects analysed
    24
    48
    24
    49
    25
    48
    24
    49
    23
    50
    73
    Units: Number of Subjects
    number (not applicable)
        Medically attended AEs
    5
    7
    4
    10
    6
    7
    2
    5
    4
    14
    15
        AEs leading to Withdrawal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        At least possibly related AEs
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
        SAEs
    0
    0
    1
    1
    0
    0
    0
    1
    0
    1
    0
        At least possibly related SAEs
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination

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    End point title
    		 Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
    End point description
    Solicited local and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 7 after vaccination.
    End point values
    		 3ABCWY 2ABCWY 3ABx2CWY 2ABx2CWY 3ABCWY+OMV 2ABCWY+OMV 3ABCWYqOMV 2ABCWYqOMV Men 3B Men 2B 1ACWY
    Number of subjects analysed
    24
    48
    24
    49
    25
    48
    24
    49
    23
    50
    73
    Units: Number of Subjects
    number (not applicable)
        Any Solicited Local AEs
    18
    33
    18
    35
    23
    36
    20
    30
    17
    38
    53
        Injection site erythema
    5
    13
    7
    12
    12
    11
    13
    3
    9
    13
    19
        Injection site induration
    7
    14
    11
    12
    10
    17
    11
    6
    7
    14
    18
        Injection site pain
    18
    33
    15
    35
    23
    35
    19
    30
    17
    36
    52
        Injection site Swelling
    5
    11
    9
    10
    10
    14
    13
    5
    7
    14
    14
        Any Solicited Systemic AEs
    10
    33
    14
    25
    20
    23
    18
    24
    14
    34
    43
        Chills
    3
    10
    4
    2
    7
    7
    4
    5
    5
    5
    8
        Malaise
    6
    12
    7
    14
    8
    9
    7
    8
    5
    13
    13
        Myalgia
    6
    23
    9
    20
    6
    18
    14
    19
    9
    21
    32
        Arthralgia
    2
    6
    5
    7
    6
    5
    8
    3
    2
    8
    9
        Headache
    5
    20
    6
    17
    9
    11
    10
    15
    6
    18
    27
        Fatigue
    3
    9
    3
    9
    5
    11
    4
    7
    3
    10
    9
        Nausea
    4
    6
    2
    3
    4
    6
    6
    3
    2
    4
    6
        Rash
    1
    2
    2
    1
    0
    1
    1
    0
    1
    1
    2
        Fever (≥38°C)
    3
    5
    0
    3
    3
    0
    3
    1
    2
    2
    4
        Any other indicators of reactogenicity
    4
    8
    3
    5
    6
    3
    7
    4
    3
    5
    11
        Stay home
    0
    5
    0
    2
    1
    0
    3
    1
    0
    0
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety was assessed up to 6 months after vaccination.
    Adverse event reporting additional description
    The analyses for serious unsolicited adverse events (SAEs) and adverse events (AEs) were done on the safety population.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    1ACWY
    Reporting group description
    		 One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study

    Reporting group title
    Men 3B
    Reporting group description
    		 Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study

    Reporting group title
    Men 2B
    Reporting group description
    		 Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study.

    Reporting group title
    3ABCWYqOMV
    Reporting group description
    		 Two doses of MenABCWY +1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    2ABCWY+OMV
    Reporting group description
    		 Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study.

    Reporting group title
    2ABCWYqOMV
    Reporting group description
    		 Two doses of MenABCWY+ 1/4OMV vaccine in the primary study and one dose of Tdap in the current study.

    Reporting group title
    3ABx2CWY
    Reporting group description
    		 Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    3ABCWY+OMV
    Reporting group description
    		 Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    2ABx2CWY
    Reporting group description
    		 Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study

    Reporting group title
    3ABCWY
    Reporting group description
    		 Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study.

    Reporting group title
    2ABCWY
    Reporting group description
    		 Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study.

    Serious adverse events
    		 1ACWY Men 3B Men 2B 3ABCWYqOMV 2ABCWY+OMV 2ABCWYqOMV 3ABx2CWY 3ABCWY+OMV 2ABx2CWY 3ABCWY 2ABCWY
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 23 (0.00%)
    1 / 50 (2.00%)
    1 / 24 (4.17%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    1 / 49 (2.04%)
    0 / 24 (0.00%)
    0 / 49 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Burns Second Degree
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 23 (0.00%)
    1 / 50 (2.00%)
    0 / 24 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
    0 / 24 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaccination Complication
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 23 (0.00%)
    0 / 50 (0.00%)
    1 / 24 (4.17%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
    0 / 24 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendiceal Abscess
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 23 (0.00%)
    0 / 50 (0.00%)
    0 / 24 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    1 / 24 (4.17%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
    0 / 24 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 23 (0.00%)
    0 / 50 (0.00%)
    0 / 24 (0.00%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    0 / 49 (0.00%)
    0 / 24 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar Abscess
         subjects affected / exposed
    0 / 73 (0.00%)
    0 / 23 (0.00%)
    0 / 50 (0.00%)
    0 / 24 (0.00%)
    0 / 48 (0.00%)
    0 / 50 (0.00%)
    0 / 24 (0.00%)
    0 / 25 (0.00%)
    1 / 49 (2.04%)
    0 / 24 (0.00%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 1ACWY Men 3B Men 2B 3ABCWYqOMV 2ABCWY+OMV 2ABCWYqOMV 3ABx2CWY 3ABCWY+OMV 2ABx2CWY 3ABCWY 2ABCWY
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 73 (76.71%)
    19 / 23 (82.61%)
    40 / 50 (80.00%)
    22 / 24 (91.67%)
    37 / 48 (77.08%)
    38 / 50 (76.00%)
    20 / 24 (83.33%)
    23 / 25 (92.00%)
    36 / 49 (73.47%)
    20 / 24 (83.33%)
    38 / 49 (77.55%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    27 / 73 (36.99%)
    7 / 23 (30.43%)
    18 / 50 (36.00%)
    10 / 24 (41.67%)
    11 / 48 (22.92%)
    15 / 50 (30.00%)
    6 / 24 (25.00%)
    9 / 25 (36.00%)
    17 / 49 (34.69%)
    5 / 24 (20.83%)
    20 / 49 (40.82%)
         occurrences all number
    35
    8
    23
    14
    13
    15
    6
    11
    21
    7
    25
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    8 / 73 (10.96%)
    5 / 23 (21.74%)
    5 / 50 (10.00%)
    4 / 24 (16.67%)
    8 / 48 (16.67%)
    5 / 50 (10.00%)
    4 / 24 (16.67%)
    7 / 25 (28.00%)
    2 / 49 (4.08%)
    3 / 24 (12.50%)
    10 / 49 (20.41%)
         occurrences all number
    8
    5
    5
    5
    8
    7
    4
    7
    3
    4
    11
    Fatigue
         subjects affected / exposed
    9 / 73 (12.33%)
    3 / 23 (13.04%)
    10 / 50 (20.00%)
    4 / 24 (16.67%)
    11 / 48 (22.92%)
    7 / 50 (14.00%)
    3 / 24 (12.50%)
    5 / 25 (20.00%)
    9 / 49 (18.37%)
    3 / 24 (12.50%)
    9 / 49 (18.37%)
         occurrences all number
    12
    3
    11
    4
    13
    9
    3
    6
    9
    3
    10
    Injection Site Erythema
         subjects affected / exposed
    20 / 73 (27.40%)
    10 / 23 (43.48%)
    14 / 50 (28.00%)
    16 / 24 (66.67%)
    12 / 48 (25.00%)
    5 / 50 (10.00%)
    7 / 24 (29.17%)
    13 / 25 (52.00%)
    14 / 49 (28.57%)
    5 / 24 (20.83%)
    16 / 49 (32.65%)
         occurrences all number
    21
    10
    14
    17
    12
    5
    7
    14
    15
    6
    16
    Injection Site Pain
         subjects affected / exposed
    52 / 73 (71.23%)
    17 / 23 (73.91%)
    36 / 50 (72.00%)
    19 / 24 (79.17%)
    35 / 48 (72.92%)
    31 / 50 (62.00%)
    15 / 24 (62.50%)
    23 / 25 (92.00%)
    35 / 49 (71.43%)
    18 / 24 (75.00%)
    33 / 49 (67.35%)
         occurrences all number
    56
    19
    38
    20
    39
    32
    15
    24
    38
    19
    36
    Injection Site Swelling
         subjects affected / exposed
    16 / 73 (21.92%)
    8 / 23 (34.78%)
    14 / 50 (28.00%)
    14 / 24 (58.33%)
    14 / 48 (29.17%)
    6 / 50 (12.00%)
    9 / 24 (37.50%)
    11 / 25 (44.00%)
    11 / 49 (22.45%)
    5 / 24 (20.83%)
    11 / 49 (22.45%)
         occurrences all number
    17
    8
    14
    15
    16
    6
    9
    12
    13
    6
    11
    Malaise
         subjects affected / exposed
    13 / 73 (17.81%)
    5 / 23 (21.74%)
    13 / 50 (26.00%)
    8 / 24 (33.33%)
    9 / 48 (18.75%)
    8 / 50 (16.00%)
    7 / 24 (29.17%)
    8 / 25 (32.00%)
    14 / 49 (28.57%)
    6 / 24 (25.00%)
    12 / 49 (24.49%)
         occurrences all number
    15
    5
    13
    9
    11
    9
    7
    8
    15
    6
    14
    Pyrexia
         subjects affected / exposed
    4 / 73 (5.48%)
    2 / 23 (8.70%)
    3 / 50 (6.00%)
    5 / 24 (20.83%)
    0 / 48 (0.00%)
    1 / 50 (2.00%)
    0 / 24 (0.00%)
    3 / 25 (12.00%)
    3 / 49 (6.12%)
    3 / 24 (12.50%)
    6 / 49 (12.24%)
         occurrences all number
    4
    2
    5
    5
    0
    1
    0
    3
    3
    3
    8
    Injection Site Induration
         subjects affected / exposed
    19 / 73 (26.03%)
    8 / 23 (34.78%)
    15 / 50 (30.00%)
    13 / 24 (54.17%)
    17 / 48 (35.42%)
    8 / 50 (16.00%)
    11 / 24 (45.83%)
    12 / 25 (48.00%)
    13 / 49 (26.53%)
    7 / 24 (29.17%)
    16 / 49 (32.65%)
         occurrences all number
    22
    8
    15
    14
    18
    8
    12
    13
    14
    7
    16
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 73 (8.22%)
    2 / 23 (8.70%)
    4 / 50 (8.00%)
    6 / 24 (25.00%)
    7 / 48 (14.58%)
    3 / 50 (6.00%)
    2 / 24 (8.33%)
    4 / 25 (16.00%)
    3 / 49 (6.12%)
    4 / 24 (16.67%)
    6 / 49 (12.24%)
         occurrences all number
    6
    3
    4
    8
    7
    4
    2
    4
    3
    4
    7
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 73 (2.74%)
    1 / 23 (4.35%)
    1 / 50 (2.00%)
    1 / 24 (4.17%)
    1 / 48 (2.08%)
    0 / 50 (0.00%)
    2 / 24 (8.33%)
    0 / 25 (0.00%)
    1 / 49 (2.04%)
    1 / 24 (4.17%)
    2 / 49 (4.08%)
         occurrences all number
    2
    1
    2
    1
    1
    0
    2
    0
    1
    1
    2
    Musculoskeletal and connective tissue disorders
    Athralgia
         subjects affected / exposed
    9 / 73 (12.33%)
    2 / 23 (8.70%)
    8 / 50 (16.00%)
    8 / 24 (33.33%)
    5 / 48 (10.42%)
    3 / 50 (6.00%)
    5 / 24 (20.83%)
    6 / 25 (24.00%)
    7 / 49 (14.29%)
    2 / 24 (8.33%)
    6 / 49 (12.24%)
         occurrences all number
    11
    2
    8
    8
    5
    3
    5
    6
    8
    2
    6
    Myalgia
         subjects affected / exposed
    32 / 73 (43.84%)
    9 / 23 (39.13%)
    21 / 50 (42.00%)
    14 / 24 (58.33%)
    18 / 48 (37.50%)
    19 / 50 (38.00%)
    9 / 24 (37.50%)
    15 / 25 (60.00%)
    20 / 49 (40.82%)
    6 / 24 (25.00%)
    23 / 49 (46.94%)
         occurrences all number
    37
    9
    23
    14
    18
    20
    9
    18
    22
    7
    27
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 73 (5.48%)
    1 / 23 (4.35%)
    3 / 50 (6.00%)
    1 / 24 (4.17%)
    1 / 48 (2.08%)
    2 / 50 (4.00%)
    0 / 24 (0.00%)
    1 / 25 (4.00%)
    4 / 49 (8.16%)
    2 / 24 (8.33%)
    2 / 49 (4.08%)
         occurrences all number
    4
    1
    3
    1
    1
    2
    0
    1
    4
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Aug 2011
    After study completion, once the database is locked and the study is unblinded, subjects randomized in study Group V will be offered the Menveo vaccination (in countries where it is licensed), out of the scope of the trial.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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