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    Clinical Trial Results:
    A Phase 2b, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose of GlaxoSmithKline Biologicals Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.

    Summary
    EudraCT number
    2015-001030-16
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    11 Jun 2015

    Results information
    Results version number
    v3(current)
    This version publication date
    07 Sep 2018
    First version publication date
    24 Jun 2016
    Other versions
    v1 , v2
    Version creation reason
    • New data added to full data set
    Endpoints for LLQ data are updated.

    Trial information

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    Trial identification
    Sponsor protocol code
    205232
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02285777
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart,, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effectiveness of the MenABCWY vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity at 1:4 dilution using enc-hSBA at one month after the 3-dose series, when compared to a single dose of MenACWY.
    Protection of trial subjects
    Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine is not injected into a blood vessel. The measures of safety used in this study are routine clinical procedures. They include a close vigilance for, and stringent reporting of, selected local and systemic adverse events routinely monitored in vaccine clinical studies as indicators of reactogenicity. The period of observation for AEs extends from the time the subject signs informed consent until he or she completes the final study visit (Visit Month 4) or terminates the study early (whichever comes first).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 189
    Worldwide total number of subjects
    189
    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)
    81
    Adolescents (12-17 years)
    97
    Adults (18-64 years)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    189 subjects were enrolled from 1 center in United States

    Pre-assignment
    Screening details
    An Interactive Response Technology (IRT) was used in the study. At Month 6 Visit of the parent study, IRT allocated the study vaccines (either MenABCWY or placebo) to the subject. Subject received either a 3rd dose of MenABCWY or one dose of a placebo, depending on their assigned vaccine group in parent 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, Assessor
    Blinding implementation details
    Trial is observer-blinded. Observer-blind means that during the course of study, the subject, the parents/guardians of the subjects and the study personnel responsible for the evaluation of any study endpoint (e.g. safety and reactogenicity) will be unaware which vaccine was administered. The vaccine preparation and administration will be done by designated medical personnel who will not participate in any of the clinical study evaluations.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    MenABCWY Group
    Arm description
    Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.
    Arm type
    Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of 0.5 millilitres

    Arm title
    MenACWY Group
    Arm description
    Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.
    Arm type
    Active comparator

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of 0.5 millilitres

    Number of subjects in period 1
    MenABCWY Group MenACWY Group
    Started
    95
    94
    Completed
    90
    91
    Not completed
    5
    3
         Consent withdrawn by subject
             1
             1
         Lost to follow-up
             4
             2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenABCWY Group
    Reporting group description
    Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.

    Reporting group title
    MenACWY Group
    Reporting group description
    Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.

    Reporting group values
    MenABCWY Group MenACWY Group Total
    Number of subjects
    95 94 189
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants(gestational age <37 weeks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Children (2-11 years)
    36 45 81
        Adolescents (12-17 years)
    53 44 97
        Adults (18-64 years)
    6 5 11
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    12.8 ± 2.36 12.4 ± 2.4 -
    Gender categorical
    Units: Subjects
        Female
    40 33 73
        Male
    55 61 116
    Race/Ethnicity, Customized
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    0 2 2
        ASIAN
    1 0 1
        BLACK OR AFRICAN AMERICAN
    16 21 37
        NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
    0 0 0
        WHITE
    74 66 140
        OTHER
    4 5 9

    End points

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    End points reporting groups
    Reporting group title
    MenABCWY Group
    Reporting group description
    Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.

    Reporting group title
    MenACWY Group
    Reporting group description
    Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.

    Primary: Percentages of subjects without bactericidal activity at 1:4 dilution against each US Neisseria meningitides (N. meningitidis) serogroup B strain at 1 month after the 3-dose vaccination series.

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    End point title
    Percentages of subjects without bactericidal activity at 1:4 dilution against each US Neisseria meningitides (N. meningitidis) serogroup B strain at 1 month after the 3-dose vaccination series.
    End point description
    The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.Analysis was performed on FAS-Effectiveness (Month 7)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination,& who provided evaluable serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 7.
    End point type
    Primary
    End point timeframe
    At Month 7 (1 month after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    93
    93
    Units: Percentages of subjects
    number (not applicable)
        Month 7
    21.1
    73.7
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)] x 100.The combined VE across all strains was computed by mean of a generalized linear model.
    Comparison groups
    MenABCWY Group v MenACWY Group
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.0001
    Method
    Generalized Linear Model
    Parameter type
    Vaccine Effectiveness
    Point estimate
    71
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    69
         upper limit
    73
    Notes
    [1] - Pre-specified.

    Secondary: Percentages of subjects without bactericidal activity at 1:4 dilution against each US N. meningitidis serogroup B strain at 4 months after the 3-dose vaccination series.

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    End point title
    Percentages of subjects without bactericidal activity at 1:4 dilution against each US N. meningitidis serogroup B strain at 4 months after the 3-dose vaccination series.
    End point description
    The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 4 months after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.Analysis was performed on FAS-Effectiveness (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 10
    End point type
    Secondary
    End point timeframe
    At Month 10 (4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    90
    90
    Units: Percentages of subjects
    number (not applicable)
        Month 10
    33.9
    69.9
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)] x 100. The combined VE across all strains was computed by mean of a generalized linear model.
    Comparison groups
    MenABCWY Group v MenACWY Group
    Number of subjects included in analysis
    180
    Analysis specification
    Pre-specified
    Analysis type
    other [2]
    P-value
    = 0.0001
    Method
    Generalized Linear Model
    Parameter type
    Vaccine Effectiveness
    Point estimate
    51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    48
         upper limit
    55
    Notes
    [2] - Pre-specified.

    Secondary: Percentages of subjects without bactericidal activity at 1:8 dilution against each US N. meningitidis serogroup B strain at 1 and 4 months after the 3-dose vaccination series.

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    End point title
    Percentages of subjects without bactericidal activity at 1:8 dilution against each US N. meningitidis serogroup B strain at 1 and 4 months after the 3-dose vaccination series.
    End point description
    The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 and 4 months after the 3-dose vaccination series were evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:8 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:8 dilution across all 110 strains.Analysis was performed on FAS-Effectiveness (Months 7 & 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received subject ID & vaccination, & provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Months 7 & 10.
    End point type
    Secondary
    End point timeframe
    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    93
    93
    Units: Percentages of subjects
    number (not applicable)
        Combined Serogroup B Strains (Month 7) (N-93, 93)
    36.9
    75.8
        Combined Serogroup B Strains (Month 10)(N-90,90)
    60.3
    79.6
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)] x 100. The combined VE across all strains was computed by mean of a generalized linear model.
    Comparison groups
    MenACWY Group v MenABCWY Group
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    P-value
    = 0.0001
    Method
    Generalized Linear Model
    Parameter type
    Vaccine Effectiveness
    Point estimate
    51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    48
         upper limit
    54
    Notes
    [3] - Pre-specified.
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)] x 100. The combined VE across all strains was computed by mean of a generalized linear model.
    Comparison groups
    MenACWY Group v MenABCWY Group
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    other [4]
    P-value
    = 0.0001
    Method
    Generalized Linear Model
    Parameter type
    Vaccine Effectiveness
    Point estimate
    24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    20
         upper limit
    28
    Notes
    [4] - Pre-specified.

    Secondary: Percentages of US N. meningitidis serogroup B strains killed at 1:4 and 1:8 dilutions at 1 and 4 months after the 3-dose vaccination series

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    End point title
    Percentages of US N. meningitidis serogroup B strains killed at 1:4 and 1:8 dilutions at 1 and 4 months after the 3-dose vaccination series
    End point description
    The mean percentage of US N. meningitidis serogroup B strains killed by each subject, at 1:4 and 1:8 dilutions before the 3-dose vaccination series, at Month 6 (PRE) and at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).Analysis was performed on FAS-Effectiveness (Months 6, 7 & 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, got subject ID & vaccination, & provided serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain before Month 6 & at Months 7 & 10
    End point type
    Secondary
    End point timeframe
    At Month 6 (before the 3-dose vaccination series) and at Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    93
    93
    Units: Percentage
    arithmetic mean (standard deviation)
        1:4, PRE (N-93, 93)
    56.97 ± 18.134
    22.94 ± 17.764
        1:4, Month 7 (N-93, 93)
    77.78 ± 10.041
    21.91 ± 16.885
        1:4, Month 10 (N-93, 93)
    62.37 ± 15.976
    22.49 ± 17.094
        1:8, PRE (N-93, 93)
    28.81 ± 17.086
    11.53 ± 11.705
        1:8, Month 7 (N-93, 93)
    56.95 ± 14.389
    11.4 ± 11.266
        1:8, Month 10 (N-90, 90)
    31.46 ± 19.434
    11.15 ± 10.774
    No statistical analyses for this end point

    Secondary: Percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA ≥1:8 at 1 and 4 months after the 3-dose vaccination series

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    End point title
    Percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA ≥1:8 at 1 and 4 months after the 3-dose vaccination series
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA ≥ 1:8 against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.
    End point type
    Secondary
    End point timeframe
    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    92
    91
    Units: Percentages of subjects
    number (confidence interval 95%)
        M14459 (≥ 1:4, Month 7) (N-91, 90)
    98 (92.3 to 99.73)
    12 (6.3 to 20.8)
        M14459 (≥ 1:4, Month 10)(N-87, 90)
    72 (61.8 to 81.5)
    12 (6.3 to 20.8)
        M14459 (≥ 1:8, Month 7)(N-91, 90)
    67 (56.4 to 76.5)
    2 (0.27 to 7.8)
        M14459 (≥ 1:8, Month 10)(N-87, 90)
    21 (12.7 to 30.7)
    1 (0.03 to 6)
        M07-0241084 (≥ 1:4, Month 7)(N-90, 85)
    81 (71.5 to 88.6)
    21 (13.1 to 31.4)
        M07-0241084 (≥ 1:4, Month 10)(N-79, 78)
    46 (34.3 to 57.2)
    22 (13.2 to 32.6)
        M07-0241084 (≥ 1:8, Month 7)(N-90, 85)
    38 (27.8 to 48.6)
    5 (1.3 to 11.6)
        M07-0241084 (≥ 1:8, Month 10)(N-79, 78)
    11 (5.3 to 20.5)
    6 (2.1 to 14.3)
        96217 (≥ 1:4, Month 7)(N-89, 88)
    99 (93.9 to 99.97)
    48 (37 to 58.6)
        96217 (≥ 1:4, Month 10)(N-87,88)
    100 (95.8 to 100)
    41 (30.5 to 51.9)
        96217 (≥ 1:8, Month 7)(N-89, 88)
    99 (93.9 to 99.97)
    17 (9.9 to 26.6)
        96217 (≥ 1:8, Month 10)(N-87,88)
    99 (93.8 to 99.97)
    16 (9 to 25.2)
        NZ98/254 (≥ 1:4, Month 7)(N-84, 87)
    76 (65.7 to 84.8)
    1 (0.03 to 6.2)
        NZ98/254 (≥ 1:4, Month 10)(N-80, 83)
    34 (23.6 to 45.2)
    1 (0.03 to 6.5)
        NZ98/254 (≥ 1:8, Month 7)(N-84,87)
    39 (28.8 to 50.5)
    1 (0.03 to 6.2)
        NZ98/254 (≥ 1:8, Month 10)(N-80, 83)
    4 (0.8 to 10.6)
    0 (0 to 4.3)
    No statistical analyses for this end point

    Secondary: HT-hSBA Geometric Mean Titers (GMTs) against the N. meningitidis serogroup B test strains

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    End point title
    HT-hSBA Geometric Mean Titers (GMTs) against the N. meningitidis serogroup B test strains
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.
    End point type
    Secondary
    End point timeframe
    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    91
    91
    Units: Titers
    geometric mean (confidence interval 95%)
        M14459, Month 7(N-91,88)
    23.12 (20 to 27)
    1.1 (0.94 to 1.29)
        M14459, Month 10(N-88, 91)
    3.93 (3.14 to 4.91)
    1.18 (0.95 to 1.46)
        M07-0241084, Month 7(N-89,90)
    12.26 (9.59 to 16)
    1.74 (1.37 to 2.2)
        M07-0241084, Month 10(N-86, 90)
    3.04 (2.36 to 3.92)
    1.68 (1.31 to 2.14)
        96217, Month 7(N-90, 87)
    367.29 (277 to 486)
    4.02 (3.03 to 5.32)
        96217, Month 10(N-87, 85)
    142.06 (105 to 191)
    3.32 (2.46 to 4.48)
        NZ98/254, Month 7(N-89,89)
    19.69 (16 to 24)
    1.02 (0.85 to 1.23)
        NZ98/254, Month 10(N-87, 90)
    3.75 (3.01 to 4.68)
    1.04 (0.84 to 1.29)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with HT-hSBA titers against N. meningitidis serogroup B test strains ≥ Lower Limit of Quantitation (LLQ) at 1 month after the 3-dose vaccination series.

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    End point title
    Percentages of subjects with HT-hSBA titers against N. meningitidis serogroup B test strains ≥ Lower Limit of Quantitation (LLQ) at 1 month after the 3-dose vaccination series.
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (96217, M07-0241084,M14459 and NZ98/254), at 1 month after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup B test strain. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.
    End point type
    Secondary
    End point timeframe
    At Month 7 (1 month after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    91
    90
    Units: Percentages of subjects
    number (confidence interval 95%)
        96217(N-90, 87)
    100 (96.0 to 100.0)
    37 (26.7 to 47.8)
        M07-0241084(N-89, 90)
    63 (52.0 to 72.9)
    12 (6.3 to 20.8)
        M14459(N-91, 88)
    90 (82.1 to 95.4)
    1 (0.03 to 6.2)
        NZ98/254(N-89, 89)
    79 (68.7 to 86.6)
    1 (0.03 to 6.1)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with HT-hSBA titers against N. meningitidis serogroup B test strains ≥ LLQ at 4 months after the 3-dose vaccination series

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    End point title
    Percentages of subjects with HT-hSBA titers against N. meningitidis serogroup B test strains ≥ LLQ at 4 months after the 3-dose vaccination series
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 and whose immunogenicity assay result was available for at least one serogroup strain.The LLQ cut off values for the strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6,8.9, 8 and 8.2 respectively.
    End point type
    Secondary
    End point timeframe
    At Month 10 (4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    88
    91
    Units: Percentages of subjects
    number (confidence interval 95%)
        96217(N-87, 85)
    99 (93.8 to 99.97)
    32 (22.1 to 42.8)
        M07-0241084(N-86,90)
    23 (14.8 to 33.6)
    12 (6.3 to 20.8)
        M14459(N-88,91)
    36 (26.4 to 46.0)
    3 (0.7 to 9.3)
        NZ98/254(N-87,90)
    33 (23.6 to 44.3)
    1 (0.03 to 6.0)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series.

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    End point title
    Percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series.
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subjects D & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
    End point type
    Secondary
    End point timeframe
    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    90
    90
    Units: Percentage of subjects
    number (confidence interval 95%)
        96217 (Month 7) (N-87,86)
    87 (78.5 to 93.5)
    12 (5.7 to 20.4)
        M07-0241084 (Month 7)(N-84,85)
    38 (27.7 to 49.3)
    1 (0.03 to 6.4)
        M14459 (Month 7)(N-90,87)
    67 (56.0 to 76.3)
    0 (0 to 4.1)
        NZ98/254 (Month 7)(N-88,88)
    56 (44.7 to 66.3)
    0 (0 to 4.1)
        96217 (Month 10)(N-84,84)
    54 (42.4 to 64.5)
    7 (2.7 to 14.9)
        M07-0241084 (Month 10)(N-81, 85)
    0 (0 to 4.4)
    4 (0.7 to 10.0)
        M14459 (Month 10)(N-87,90)
    7 (2.6 to 14.4)
    0 (0 to 4)
        NZ98/254 (Month 10)(N-86, 89)
    13 (6.6 to 21.7)
    0 (0 to 4.1)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series.

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    End point title
    Percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series.
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subjects D & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
    End point type
    Secondary
    End point timeframe
    At months 7 and 10 (1 and 4 months after 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    90
    90
    Units: Percentage of subjects
    number (confidence interval 95%)
        96217 (Month 7)(N-87, 86)
    79 (69.3 to 87.3)
    5 (1.3 to 11.5)
        M07-0241084 (Month 7)(N-84, 85)
    23 (14.2 to 33.1)
    1 (0.03 to 6.4)
        M14459 (Month 7)(N-90,87)
    41 (30.8 to 52.0)
    0 (0 to 4.1)
        NZ98/254 (Month 7)(N-88,88)
    41 (30.5 to 51.9)
    0 (0 to 4.1)
        96217 (Month 10)(N-84, 84)
    27 (18.2 to 38.2)
    5 (1.3 to 11.8)
        M07-0241084 (Month 10)(N-81, 85)
    0 (0 to 4.4)
    2 (0.29 to 8.2)
        M14459 (Month 10)(N-87,90)
    3 (0.7 to 9.8)
    0 (0 to 4)
        NZ98/254 (Month 10)(N-86, 89)
    5 (1.3 to 11.5)
    0 (0 to 4.1)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series.

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    End point title
    Percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series.
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subjects D & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
    End point type
    Secondary
    End point timeframe
    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    90
    90
    Units: Percentages of subjects
    number (confidence interval 95%)
        96217 (Month 7)(N-87, 86)
    63 (52.2 to 73.3)
    3 (0.7 to 9.9)
        M07-0241084 (Month 7)(N-84, 85)
    12 (5.9 to 20.8)
    0 (0 to 4.2)
        M14459 (Month 7)(N-90, 87)
    23 (15.1 to 33.4)
    0 (0.0 to 4.1)
        NZ98/254 (Month 7)(N-88,88)
    33 (23.3 to 43.8)
    0 (0.0 to 4.1)
        96217 (Month 10)(N-84,84)
    15 (8.5 to 25.0)
    5 (1.3 to 11.8)
        M07-0241084 (Month 10)(N-81, 85)
    0 (0 to 4.4)
    1 (0.03 to 6.4)
        M14459 (Month 10)(N-87, 90)
    3 (0.7 to 9.8)
    0 (0 to 4)
        NZ98/254 (Month 10)(N-86,89)
    2 (0.28 to 8.2)
    0 (0 to 4.1)
    No statistical analyses for this end point

    Secondary: HT-hSBA GMTs against N. meningitidis serogroups A, C, W and Y.

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    End point title
    HT-hSBA GMTs against N. meningitidis serogroups A, C, W and Y.
    End point description
    The immunogenicity of three doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at 1 and 4 months after the 3-dose vaccination series.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subjects D & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
    End point type
    Secondary
    End point timeframe
    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    91
    91
    Units: Titers
    geometric mean (confidence interval 95%)
        Men A, Month 7(N-91,87)
    127.92 (91 to 179)
    3.37 (2.41 to 4.73)
        Men A, Month 10(N-85,88)
    36.5 (25 to 53)
    2.73 (1.89 to 3.94)
        Men C, Month 7(N-85, 86)
    521.64 (365 to 745)
    18.34 (13 to 26)
        Men C, Month 10(N-86, 89)
    291.19 (201 to 421)
    15.4 (11 to 22)
        Men W, Month 7(N-83,88)
    424.8 (310 to 581)
    40.22 (30 to 54)
        Men W, Month 10(N-85,83)
    147.4 (104 to 209)
    23.01 (16 to 33)
        Men Y, Month 7(N-91,88)
    204.84 (142 to 296)
    13.27 (9.21 to 19)
        Men Y, Month 10(N-86,91)
    83.42 (55 to 126)
    11.85 (7.93 to 18)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with HT-hSBA titers against the N. meningitidis serogroup A, C, W and Y ≥ LLQ at 1 month after the 3- dose vaccination series

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    End point title
    Percentages of subjects with HT-hSBA titers against the N. meningitidis serogroup A, C, W and Y ≥ LLQ at 1 month after the 3- dose vaccination series
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2, 39.6 and 14.7 respectively. Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.
    End point type
    Secondary
    End point timeframe
    At Month 7 (1 month after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    91
    88
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A(N-91, 87)
    98 (92.3 to 99.73)
    24 (15.6 to 34.5)
        Men C(N-85,86)
    100 (95.8 to 100.0)
    73 (62.6 to 82.2)
        Men W(N-83,88)
    99 (93.5 to 99.97)
    60 (49.2 to 70.5)
        Men Y(N-91,88)
    100 (96.0 to 100)
    57 (45.8 to 67.3)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with HT-hSBA titers against the N. meningitidis serogroup A, C, W and Y ≥ LLQ at 4 months after the 3-dose vaccination series

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    End point title
    Percentages of subjects with HT-hSBA titers against the N. meningitidis serogroup A, C, W and Y ≥ LLQ at 4 months after the 3-dose vaccination series
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series.The LLQ cut off values for serogroups A, C, W and Y were 22.7,5.2,39.6 and 14.7 respectively.Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 and whose immunogenicity assay result was available for at least one serogroup B strain
    End point type
    Secondary
    End point timeframe
    At Month 10 (4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    86
    91
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A(N-85,88)
    81 (71.2 to 88.8)
    18 (10.8 to 27.8)
        Men C(N-86,89)
    100 (95.8 to 100.0)
    69 (57.8 to 78.0)
        Men W(N-85,83)
    89 (80.9 to 95.0)
    51 (39.4 to 61.8)
        Men Y(N-86,91)
    86 (76.9 to 92.6)
    53 (42.0 to 63.3)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with two-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C,W and Y at 1 and 4 months after the 3-dose vaccination series.

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    End point title
    Percentage of subjects with two-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C,W and Y at 1 and 4 months after the 3-dose vaccination series.
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
    End point type
    Secondary
    End point timeframe
    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    89
    88
    Units: Percentage of subjects
    number (confidence interval 95%)
        Men A, Month 7(N-83,85)
    88 (79.0 to 94.1)
    2 (0.29 to 8.2)
        Men C, Month 7(N-84,84)
    87 (77.8 to 93.3)
    2 (0.29 to 8.3)
        Men W, Month 7(N-81, 84)
    83 (72.7 to 90.2)
    5 (1.3 to 11.8)
        Men Y, Month 7(N-89, 85)
    57 (46.4 to 67.7)
    2 (0.29 to 8.2)
        Men A, Month 10(N-77, 86)
    32 (22.2 to 44.1)
    1 (0.03 to 6.3)
        Men C, Month 10(N-85, 87)
    56 (45.3 to 67.2)
    8 (3.3 to 15.9)
        Men W, Month 10(N-83,79)
    24 (15.4 to 34.7)
    1 (0.03 to 6.9)
        Men Y, Month 10(N-84, 88)
    26 (17.2 to 36.9)
    3 (0.7 to 9.6)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with three-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series.

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    End point title
    Percentage of subjects with three-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series.
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
    End point type
    Secondary
    End point timeframe
    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    89
    88
    Units: Percentage of subjects
    number (confidence interval 95%)
        Men A, Month 7(N-83,85)
    69 (57.6 to 78.4)
    0 (0 to 4.2)
        Men C, Month 7(N-84, 84)
    60 (48.3 to 70.1)
    1 (0.03 to 6.5)
        Men W, Month 7(N-81, 84)
    67 (55.3 to 76.8)
    0 (0 to 4.3)
        Men Y, Month 7(N-89, 85)
    39 (29.1 to 50.3)
    0 (0 to 4.2)
        Men A, Month 10(N-77,86)
    16 (8.3 to 25.6)
    1 (0.03 to 6.3)
        Men C, Month 10(N-85,87)
    29 (20.0 to 40.3)
    5 (1.3 to 11.4)
        Men W, Month 10(N-83, 79)
    13 (6.8 to 22.5)
    0 (0 to 4.6)
        Men Y, Month 10(N-84,88)
    15 (8.5 to 25.0)
    2 (0.28 to 8.0)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series.

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    End point title
    Percentage of subjects with four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series.
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
    End point type
    Secondary
    End point timeframe
    At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    89
    88
    Units: Percentage of subjects
    number (confidence interval 95%)
        Men A, Month 7(N-83,85)
    53 (41.7 to 64.1)
    0 (0 to 4.2)
        Men C, Month 7(N-84,84)
    49 (37.7 to 60.0)
    1 (0.03 to 6.5)
        Men W, Month 7(N-81, 84)
    49 (38.1 to 60.7)
    0 (0 to 4.3)
        Men Y, Month 7(N-89, 85)
    28 (19.1 to 38.6)
    0 (0 to 4.2)
        Men A, Month 10(N-77, 86)
    6 (2.1 to 14.5)
    1 (0.03 to 6.3)
        Men C, Month 10(N-85, 87)
    21 (13.1 to 31.4)
    2 (0.28 to 8.1)
        Men W, Month 10(N-83,79)
    8 (3.5 to 16.6)
    0 (0 to 4.6)
        Men Y, Month 10(N-84, 88)
    6 (2.0 to 13.4)
    1 (0.03 to 6.2)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series

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    End point title
    Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup B test strain.
    End point type
    Secondary
    End point timeframe
    At Month 7 (1 month after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    91
    90
    Units: Percentage of subjects
    number (confidence interval 95%)
        96217, ≥ 5 (N-90, 87)
    100 (96 to 100)
    38 (27.7 to 49)
        96217, ≥ 8 (N-90, 87)
    100 (96 to 100)
    37 (26.7 to 47.8)
        96217, ≥ 16 (N-90, 87)
    100 (96 to 100)
    25 (16.6 to 35.7)
        96217, ≥ 32 (N-90, 87)
    100 (96 to 100)
    15 (8.2 to 24.2)
        96217, ≥ 64 (N-90, 87)
    99 (94 to 99.97)
    8 (3.3 to 15.9)
        96217, ≥ 128 (N-90, 87)
    93 (86.1 to 97.5)
    3 (0.7 to 9.7)
        M07-0241084, ≥ 5 (N-89,90)
    82 (72.5 to 89.4)
    16 (8.8 to 24.7)
        M07-0241084, ≥ 8(N-89,90)
    67 (56.7 to 77)
    12 (6.3 to 20.8)
        M07-0241084, ≥ 16(N-89,90)
    46 (35.4 to 57)
    8 (3.2 to 15.4)
        M07-0241084, ≥ 32(N-89,90)
    20 (12.4 to 30.1)
    3 (0.7 to 9.4)
        M07-0241084, ≥ 64(N-89,90)
    6 (1.8 to 12.6)
    2 (0.27 to 7.8)
        M07-0241084, ≥ 128(N-89,90)
    0 (0 to 4.1)
    0 (0 to 4)
        M14459, ≥ 5 (N-91,88)
    95 (87.6 to 98.2)
    1 (0.03 to 6.2)
        M14459, ≥ 8(N-91,88)
    90 (82.1 to 95.4)
    1 (0.03 to 6.2)
        M14459, ≥ 16(N-91,88)
    71 (61 to 80.4)
    1 (0.03 to 6.2)
        M14459, ≥ 32(N-91,88)
    34 (24.5 to 44.7)
    1 (0.03 to 6.2)
        M14459, ≥ 64(N-91,88)
    11 (5.4 to 19.3)
    0 (0 to 4.1)
        M14459, ≥ 128(N-91,88)
    3 (0.7 to 9.3)
    0 (0 to 4.1)
        NZ98/254, ≥ 5 (N-89,89)
    89 (80.3 to 94.5)
    1 (0.03 to 6.1)
        NZ98/254, ≥ 8(N-89,89)
    79 (68.7 to 86.6)
    1 (0.03 to 6.1)
        NZ98/254, ≥ 16(N-89,89)
    61 (49.7 to 70.9)
    0 (0 to 4.1)
        NZ98/254, ≥ 32(N-89,89)
    37 (27.1 to 48)
    0 (0 to 4.1)
        NZ98/254, ≥ 64(N-89,89)
    10 (4.7 to 18.3)
    0 (0 to 4.1)
        NZ98/254, ≥ 128(N-89,89)
    4 (1.2 to 11.1)
    0 (0 to 4.1)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series

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    End point title
    Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.
    End point type
    Secondary
    End point timeframe
    At Month 10 (4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    88
    91
    Units: Percentage of subjects
    number (confidence interval 95%)
        96217, ≥ 5 (N-87, 85)
    99 (93.8 to 99.97)
    35 (25.2 to 46.4)
        96217, ≥ 8(N-87, 85)
    99 (93.8 to 99.97)
    33 (23.1 to 44)
        96217, ≥ 16(N-87, 85)
    98 (91.9 to 99.72)
    21 (13.1 to 31.4)
        96217, ≥ 32(N-87, 85)
    94 (87.1 to 98.1)
    16 (9.3 to 26.1)
        96217, ≥64(N-87, 85)
    85 (75.8 to 91.8)
    6 (1.9 to 13.2)
        96217, ≥ 128(N-87, 85)
    56 (45.3 to 66.9)
    2 (0.29 to 8.2)
        M07-0241084, ≥ 5 (N-86, 90)
    38 (28.1 to 49.5)
    17 (9.6 to 26)
        M07-0241084, ≥ 8 (N-86, 90)
    24 (15.8 to 34.9)
    12 (6.3 to 20.8)
        M07-0241084, ≥ 16 (N-86, 90)
    9 (4.1 to 17.5)
    9 (3.9 to 16.8)
        M07-0241084, ≥ 32 (N-86, 90)
    1 (0.03 to 6.3)
    3 (0.7 to 9.4)
        M07-0241084, ≥ 64 (N-86, 90)
    1 (0.03 to 6.3)
    2 (0.27 to 7.8)
        M07-0241084, ≥ 128 (N-86, 90)
    0 (0 to 4.2)
    1 (0.03 to 6)
        M14459, ≥ 5(N-88, 91)
    49 (38.1 to 59.8)
    4 (1.2 to 10.9)
        M14459, ≥ 8(N-88, 91)
    36 (26.4 to 47.3)
    3 (0.7 to 9.3)
        M14459, ≥ 16(N-88, 91)
    17 (9.9 to 26.6)
    1 (0.03 to 6)
        M14459, ≥ 32(N-88, 91)
    6 (1.9 to 12.8)
    0 (0 to 4)
        M14459, ≥ 64(N-88, 91)
    1 (0.03 to 6.2)
    0 (0 to 4)
        M14459, ≥ 128(N-88, 91)
    0 (0 to 4.1)
    0 (0 to 4)
        NZ98/254, ≥ 5 (N-87, 90)
    44 (33.1 to 54.7)
    1 (0.03 to 6)
        NZ98/254, ≥ 8 (N-87, 90)
    34 (24.6 to 45.4)
    1 (0.03 to 6)
        NZ98/254, ≥ 16 (N-87, 90)
    16 (9.1 to 25.5)
    0 (0 to 4)
        NZ98/254, ≥ 32 (N-87, 90)
    5 (1.3 to 11.4)
    0 (0 to 4)
        NZ98/254, ≥ 64 (N-87, 90)
    2 (0.28 to 8.1)
    0 (0 to 4)
        NZ98/254, ≥ 128 (N-87, 90)
    2 (0.28 to 8.1)
    0 (0 to 4)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series

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    End point title
    Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.
    End point type
    Secondary
    End point timeframe
    At Month 7 (1 month after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    91
    88
    Units: Percentage of subjects
    number (confidence interval 95%)
        Men A, ≥ 8 (N-91, 87)
    98 (92.3 to 99.73)
    30 (20.5 to 40.6)
        Men A, ≥ 16(N-91, 87)
    98 (92.3 to 99.73)
    26 (17.6 to 37)
        Men A, ≥ 32(N-91, 87)
    98 (92.3 to 99.73)
    22 (13.7 to 32)
        Men A, ≥ 64(N-91, 88)
    86 (76.8 to 92.2)
    13 (6.5 to 21.5)
        Men A, ≥ 128(N-91, 87)
    56 (45.2 to 66.4)
    8 (3.3 to 15.9)
        Men C, ≥ 8(N-85, 86)
    100 (95.8 to 100)
    71 (60.1 to 80.2)
        Men C, ≥ 16(N-85, 86)
    99 (93.6 to 99.97)
    51 (40.1 to 62.1)
        Men C, ≥ 32(N-85, 86)
    99 (93.6 to 99.97)
    33 (22.8 to 43.5)
        Men C, ≥ 64(N-85, 86)
    99 (93.6 to 99.97)
    26 (16.8 to 36.1)
        Men C, ≥ 128(N-85, 86)
    91 (82.3 to 95.8)
    19 (11 to 28.4)
        Men W, ≥ 8(N-83, 88)
    100 (95.7 to 100)
    86 (77.4 to 92.8)
        Men W, ≥ 16(N-83, 88)
    100 (95.7 to 100)
    77 (67.1 to 85.5)
        Men W, ≥ 32(N-83, 88)
    99 (93.5 to 99.97)
    61 (50.4 to 71.6)
        Men W, ≥ 64(N-83, 88)
    99 (93.5 to 99.97)
    45 (34.8 to 56.4)
        Men W, ≥ 128(N-83, 88)
    89 (80.4 to 94.9)
    24 (15.4 to 34.1)
        Men Y, ≥ 8(N-91, 88)
    100 (96 to 100)
    61 (50.4 to 71.6)
        Men Y, ≥ 16(N-91, 88)
    100 (96 to 100)
    56 (44.7 to 66.3)
        Men Y, ≥ 32(N-91, 88)
    95 (87.6 to 98.2)
    44 (33.7 to 55.3)
        Men Y, ≥ 64(N-91, 88)
    81 (71.8 to 88.7)
    27 (18.3 to 37.8)
        Men Y, ≥ 128(N-91, 88)
    65 (54.1 to 74.6)
    14 (7.2 to 22.6)
    No statistical analyses for this end point

    Secondary: Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series

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    End point title
    Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series
    End point description
    The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.
    End point type
    Secondary
    End point timeframe
    At Month 10 (4 months after the 3-dose vaccination series)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    86
    91
    Units: Percentage of subjects
    number (confidence interval 95%)
        Men A, ≥ 8 (N-85,88)
    86 (76.6 to 92.5)
    25 (16.4 to 35.4)
        Men A, ≥ 16(N-85,88)
    84 (73.9 to 90.7)
    23 (14.5 to 32.9)
        Men A, ≥ 32(N-85,88)
    72 (61 to 81)
    18 (10.8 to 27.8)
        Men A, ≥ 64(N-85,88)
    46 (35 to 57)
    8 (3.3 to 15.7)
        Men A, ≥ 128(N-85,88)
    14 (7.5 to 23.4)
    7 (2.5 to 14.3)
        Men C, ≥ 8(N-86,89)
    100 (95.8 to 100)
    65 (54.3 to 75)
        Men C, ≥ 16(N-86,89)
    98 (91.9 to 99.72)
    48 (37.6 to 59.2)
        Men C, ≥ 32(N-86,89)
    97 (90.1 to 99.3)
    34 (24 to 44.5)
        Men C, ≥ 64(N-86,91)
    86 (76.9 to 92.6)
    26 (17.1 to 36.2)
        Men C, ≥ 128(N-86,91)
    74 (63.9 to 83.2)
    16 (8.9 to 25)
        Men W, ≥ 8(N-85,83)
    99 (93.6 to 99.97)
    75 (64 to 83.6)
        Men W, ≥ 16(N-85,83)
    98 (91.8 to 99.71)
    66 (55.1 to 76.3)
        Men W, ≥ 32(N-85,83)
    94 (86.8 to 98.1)
    58 (46.5 to 68.6)
        Men W, ≥ 64(N-85,83)
    75 (64.7 to 84)
    36 (25.9 to 47.4)
        Men W, ≥ 128(N-85,83)
    52 (40.7 to 62.7)
    18 (10.5 to 28)
        Men Y, ≥ 8(N-86,91)
    91 (82.5 to 95.9)
    58 (47.4 to 68.5)
        Men Y, ≥ 16(N-86,91)
    86 (76.9 to 92.6)
    51 (39.9 to 61.2)
        Men Y, ≥ 32(N-86,91)
    77 (66.4 to 85.2)
    38 (28.4 to 49.2)
        Men Y, ≥ 64(N-86,91)
    62 (50.5 to 71.9)
    20 (12.2 to 29.4)
        Men Y, ≥ 128(N-86,91)
    40 (29.2 to 50.7)
    9 (3.9 to 16.6)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any solicited local or systemic Adverse Events (AEs)

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    End point title
    Number of subjects reporting any solicited local or systemic Adverse Events (AEs)
    End point description
    Number of subjects reporting any solicited local or systemic AEs from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported. Assessed solicited local symptoms were induration, erythema and pain. Assessed solicited general symptoms were fatigue, myalgia, arthralgia, headache, fever, chills and loss of appetite. Other solicited data included prevention of pain/fever and treatment of pain/fever. Any = occurrence of the symptom regardless of intensity grade.Analysis was performed on Safety Set (solicited AEs & other solicited reactions)-included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & a study vaccination, & provided post-vaccination reactogenicity data.
    End point type
    Secondary
    End point timeframe
    Day 1 (6 hours) to Day 7 after vaccination
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    90
    87
    Units: Participants
        Any (Vacc.1, N=90,87)
    62
    25
        Any Local Reactions(Vacc.1, N=90,87)
    60
    15
        Any Systemic Reactions(Vacc.1, N=90,87)
    27
    15
        Induration (mm)(Vacc.1, N=88,87)
    6
    0
        Erythema (mm)(Vacc.1, N=87,86)
    6
    0
        Pain(Vacc.1, N=88,87)
    59
    15
        Nausea(Vacc.1, N=87,87)
    5
    5
        Fatigue(Vacc.1, N=87,87)
    14
    11
        Myalgia(Vacc.1, N=87,85)
    13
    3
        Arthralgia (Vacc.1, N=86,85)
    9
    0
        Headache(Vacc.1, N=88,87)
    13
    9
        Fever(Vacc.1, N=90,85)
    0
    1
        Chills(Vacc.1, N=88,87)
    2
    3
        Loss of appetite(Vacc.1, N=88,87)
    3
    3
        Prevention of pain/fever (Vacc.1, N=85,84)
    0
    0
        Treatment of pain/fever(Vacc.1, N=85,84)
    12
    3
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited AEs

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    End point title
    Number of subjects reporting any unsolicited AEs
    End point description
    The number of subjects reporting unsolicited AEs after any vaccination is reported. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.Analysis was performed on Safety set (unsolicited AEs)- included all screened subjects who provided informed consent & demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and had post-vaccination unsolicited adverse event records.
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 30 after any vaccination
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    93
    93
    Units: Participants
        Participants
    14
    11
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any serious adverse events (SAEs), medically-attended AEs and AEs leading to premature withdrawal.

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    End point title
    Number of subjects reporting any serious adverse events (SAEs), medically-attended AEs and AEs leading to premature withdrawal.
    End point description
    The number of subjects reporting any SAEs, medically-attended AEs and AEs leading to premature withdrawal during the entire study period is reported. SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as the occurrence of any unsolicited AE regardless of intensitygrade or relation to vaccination.Analysis was performed on Safety Set (overall)- included all screened subjects who provide informed consent and demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and have either post-vaccination reactogenicity data or post-vaccination unsolicited adverse event records.
    End point type
    Secondary
    End point timeframe
    During the entire study period (from Day 0 up to Month 10)
    End point values
    MenABCWY Group MenACWY Group
    Number of subjects analysed
    95
    94
    Units: Participants
        Any SAEs(N=93,93)
    0
    0
        Any Medically Attended AEs(N=93,93)
    14
    20
        Any AEs leading to premature withdrawal(N=95,94)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10)
    Adverse event reporting additional description
    Total number of subjects at risk for the frequent AEs were analysed from the exposed set & the number of subjects at risk for each of the individual adverse event were analysed from overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than total number of subjects at risk
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    MenACWY Group
    Reporting group description
    Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study.

    Reporting group title
    MenABCWY Group
    Reporting group description
    Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study.

    Serious adverse events
    MenACWY Group MenABCWY Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 94 (0.00%)
    0 / 95 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    MenACWY Group MenABCWY Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 94 (28.72%)
    63 / 95 (66.32%)
    Nervous system disorders
    Headache
         subjects affected / exposed [1]
    9 / 93 (9.68%)
    14 / 93 (15.05%)
         occurrences all number
    27
    25
    General disorders and administration site conditions
    Injection site induration
         subjects affected / exposed [2]
    3 / 93 (3.23%)
    16 / 93 (17.20%)
         occurrences all number
    10
    57
    Injection site erythema
         subjects affected / exposed [3]
    4 / 93 (4.30%)
    16 / 93 (17.20%)
         occurrences all number
    12
    44
    Fatigue
         subjects affected / exposed [4]
    11 / 93 (11.83%)
    14 / 93 (15.05%)
         occurrences all number
    24
    32
    Injection site pain
         subjects affected / exposed [5]
    15 / 93 (16.13%)
    60 / 93 (64.52%)
         occurrences all number
    23
    155
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed [6]
    5 / 93 (5.38%)
    5 / 93 (5.38%)
         occurrences all number
    7
    9
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed [7]
    3 / 93 (3.23%)
    13 / 93 (13.98%)
         occurrences all number
    10
    33
    Arthralgia
         subjects affected / exposed [8]
    1 / 93 (1.08%)
    9 / 93 (9.68%)
         occurrences all number
    1
    21
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed [9]
    1 / 93 (1.08%)
    6 / 93 (6.45%)
         occurrences all number
    1
    6
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Feb 2015
    Rationale-As per CBER feedback on HT-hSBA validation plan, CBRE agreed to replace strain M01-0240364 with 96217. The minimum required safety follow-up after last vaccination was specified.In addition, need to obtain safety information at the planned last study contact was justified. Footnote for compostion of intervention was added for consistency.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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