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    Clinical Trial Results:
    A Phase 3, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of Novartis rMenB+OMV NZ Vaccine Formulated with Outer Membrane Vesicle (OMV) Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-004476-30
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    01 Dec 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    03 Jun 2016
    First version publication date
    26 Dec 2014
    Other versions
    		 v1 (removed from public view)
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    V72_41
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01423084
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics SRL
    Sponsor organisation address
    Via Fiorentina 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics SRL, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics SRL, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Mar 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by Enzymelinked immunosorbent assay (ELISA) geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.
    Protection of trial subjects
    This clinical study was designed, conducted and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for 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), with the ethical principles laid down in the Declaration of Helsinki, and with the applicable regulatory requirement(s) for the country in which the trial was conducted. Specifically, this trial was conducted under a protocol reviewed and approved by an EC; the trial was conducted by scientifically and medically qualified persons; the benefits of the study are in percentage to the risks; the rights and welfare of the subjects were respected; the physicians conducting the trial did not find the hazards to outweigh the potential benefits; each subject, or where applicable, each subject's legally acceptable representative(s) gave his or her written informed consent before any protocol-driven tests or evaluations were performed. A copy of the ICH GCP guidelines and of the Declaration of Helsinki was included in the investigator's study file.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Aug 2011
    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
    Australia: 75
    Country: Number of subjects enrolled
    Canada: 269
    Worldwide total number of subjects
    344
    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)
    48
    Adolescents (12-17 years)
    296
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 7 centres in Canada and 6 in Australia

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

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 4CMenB_Rosia
    Arm description
    		 Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
    Arm type
    		 Experimental

    Investigational medicinal product name
    rMenB+OMV NZ
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received two injections of 0.5 mL dose administered intra-muscularly (IM) into the deltoid area.

    Arm title
    		 4CMenB_Siena
    Arm description
    		 Subjects received two doses of rMenB+OMV NZ vaccinations from lot 2 manufactured at Siena facility.
    Arm type
    		 Experimental

    Investigational medicinal product name
    rMenB+OMV NZ
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received two injections of 0.5 mL dose administered intra-muscularly (IM) into the deltoid area.

    Number of subjects in period 1
    		4CMenB_Rosia 4CMenB_Siena
    Started
    170
    174
    Completed
    168
    170
    Not completed
    2
    4
         Consent withdrawn by subject
    2
    3
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    4CMenB_Rosia
    Reporting group description
    		 Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.

    Reporting group title
    4CMenB_Siena
    Reporting group description
    		 Subjects received two doses of rMenB+OMV NZ vaccinations from lot 2 manufactured at Siena facility.

    Reporting group values
    		 4CMenB_Rosia 4CMenB_Siena Total
    Number of subjects
    		 170 174 344
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.6 ( 1.9 ) 13.8 ( 1.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 72 82 154
        Male
    		 98 92 190

    End points

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    End points reporting groups
    Reporting group title
    4CMenB_Rosia
    Reporting group description
    		 Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.

    Reporting group title
    4CMenB_Siena
    Reporting group description
    		 Subjects received two doses of rMenB+OMV NZ vaccinations from lot 2 manufactured at Siena facility.

    Subject analysis set title
    All Enrolled Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who have signed an informed consent, undergone screening procedure(s) and were randomized.

    Subject analysis set title
    All Exposed Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All enrolled subjects who actually received a study vaccination.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the Exposed population who provided post vaccination safety data

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the Enrolled Set who correctly received the vaccine, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to un-blinding.

    Primary: 1) Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) against 3 Neisseria.meningitidis (N. meningitidis) serogroup B reference strains.

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    End point title
    		 1) Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) against 3 Neisseria.meningitidis (N. meningitidis) serogroup B reference strains.
    End point description
    Two different lots of rMenB+OMV NZ are evaluated in terms of hSBA GMTs against 3 different strains of serogroup B N. meningitidis antigens.
    End point type
    Primary
    End point timeframe
    Day 61
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    147 [1]
    151 [2]
    Units: Titers
    geometric mean (confidence interval 95%)
        H44/76 strain
    111 (96 to 129)
    111 (96 to 128)
        NZ98/254 strain
    9.27 (7.44 to 12)
    11 (9.22 to 14)
        5/99 strain
    183 (160 to 209)
    199 (174 to 227)
    Notes
    [1] - Analysis was done on the Per Protocol Set.
    [2] - Analysis was done on the Per Protocol Set. For strain 5/99, N=152 Stat. Analysis N=299
    Statistical analysis title
    		 Equivalence of 2 differents lots of rMenB+OMV NZ
    Statistical analysis description
    Equivalence of 2 differents lots of rMenB+OMV NZ in terms of hSBA GMTs against H44/76 strain
    Comparison groups
    4CMenB_Rosia v 4CMenB_Siena
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    Parameter type
    		 between groups ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.23
    Notes
    [3] - Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against H44/76 strain if t the two sided 95% Confidence Interval (CI) of the between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).
    Statistical analysis title
    		 Equivalence of 2 differents lots of rMenB+OMV NZ
    Statistical analysis description
    Equivalence of 2 differents lots of rMenB+OMV NZ in terms of hSBA GMTs against NZ98/254 strain
    Comparison groups
    4CMenB_Rosia v 4CMenB_Siena
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    Method
    Parameter type
    		 between groups ratio
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.09
    Notes
    [4] - Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against NZ 98/254 strain if t the two sided 95% Confidence Interval (CI) of the between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).
    Statistical analysis title
    		 Equivalence of 2 differents lots of rMenB+OMV NZ
    Statistical analysis description
    Equivalence of 2 differents lots of rMenB+OMV NZ in terms of hSBA GMTs against 5/99 strain
    Comparison groups
    4CMenB_Rosia v 4CMenB_Siena
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [5]
    Method
    Parameter type
    		 between groups ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.1
    Notes
    [5] - Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against 5/99 strain if the two sided 95% Confidence Interval (CI) of the between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).

    Primary: 2) Enzyme-linked immunosorbent assay (ELISA) geometric mean concentrations (GMCs) against vaccine antigen 287-953

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    End point title
    		 2) Enzyme-linked immunosorbent assay (ELISA) geometric mean concentrations (GMCs) against vaccine antigen 287-953
    End point description
    The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
    End point type
    Primary
    End point timeframe
    Day 61
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    147 [6]
    152 [7]
    Units: IU/mL
        geometric mean (confidence interval 95%)
    2729 (2338 to 3186)
    3291 (2829 to 3828)
    Notes
    [6] - Analysis was done on the Per Protocol Set.
    [7] - Analysis was done on the Per Protocol Set.
    Statistical analysis title
    		 Equivalence in terms of hSBA GMTs
    Statistical analysis description
    Equivalence of 2 differents lots of rMenB+OMV NZ in terms of ELISA GMCs
    Comparison groups
    4CMenB_Rosia v 4CMenB_Siena
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [8]
    Method
    Parameter type
    		 between groups ratio
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.02
    Notes
    [8] - Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of ELISA GMCs against vaccine antigen 287-953 if t the two sided 95% Confidence Interval (CI) of the between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).

    Secondary: 3) Percentage of Subjects with hSBA ≥1:5 against each of N. meningitidis serogroup B test strains.

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    End point title
    		 3) Percentage of Subjects with hSBA ≥1:5 against each of N. meningitidis serogroup B test strains.
    End point description
    The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of percentages of subjects with hSBA ≥1:5.
    End point type
    Secondary
    End point timeframe
    Day 61
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    147 [9]
    152 [10]
    Units: Percentages of Subjects
    number (confidence interval 95%)
        H44/76 strain
    99 (96 to 100)
    99 (96 to 100)
        NZ98/254 strain
    70 (62 to 77)
    79 (72 to 86)
        5/99 strain
    100 (98 to 100)
    100 (98 to 100)
    Notes
    [9] - Analysis was done on the Per Protocol Set.
    [10] - Analysis was done on the Per Protocol Set
    No statistical analyses for this end point

    Secondary: 4) Geometric Mean Ratio (GMR) of GMTs against each of N. meningitidis serogroup B reference strains.

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    End point title
    		 4) Geometric Mean Ratio (GMR) of GMTs against each of N. meningitidis serogroup B reference strains.
    End point description
    The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after 2nd vaccination vs baseline).
    End point type
    Secondary
    End point timeframe
    Day 61
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    147 [11]
    152 [12]
    Units: Ratio of GMTs
    geometric mean (confidence interval 95%)
        H44/76 strain (N=147, 151)
    104 (89 to 121)
    107 (92 to 124)
        NZ98/254 strain (N=147, 151)
    8.63 (6.99 to 11)
    11 (8.99 to 14)
        5/99 strain
    156 (133 to 183)
    167 (143 to 195)
    Notes
    [11] - Analysis was done on the Per Protocol Set.
    [12] - Analysis was done on the Per Protocol Set.
    No statistical analyses for this end point

    Secondary: 5) GMR of ELISA GMCs against antigen 287-953

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    End point title
    		 5) GMR of ELISA GMCs against antigen 287-953
    End point description
    The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).
    End point type
    Secondary
    End point timeframe
    Day 61
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    145 [13]
    152 [14]
    Units: Ratio of GMTs
        geometric mean (confidence interval 95%)
    122 (103 to 143)
    153 (131 to 179)
    Notes
    [13] - Analysis was done on the Per Protocol Set.
    [14] - Analysis was done on the Per Protocol Set.
    No statistical analyses for this end point

    Secondary: 6) hSBA GMT against 3 N. meningitidis serogroup B reference strains at day 45.

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    End point title
    		 6) hSBA GMT against 3 N. meningitidis serogroup B reference strains at day 45.
    End point description
    The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.
    End point type
    Secondary
    End point timeframe
    Day 45
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    76 [15]
    71 [16]
    Units: Titers
    geometric mean (confidence interval 95%)
        H44/76 strain (N=76,70)
    187 (152 to 229)
    171 (139 to 210)
        NZ98/254 strain
    14 (10 to 18)
    20 (15 to 27)
        5/99 strain
    254 (206 to 314)
    339 (273 to 420)
    Notes
    [15] - Analysis was done on the PPS, immunogenicity subset.
    [16] - Analysis was done on the PPS, immunogenicity subset.
    No statistical analyses for this end point

    Secondary: 7) GMRs of GMT against 3 N. meningitidis serogroup B reference strains at day 45.

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    End point title
    		 7) GMRs of GMT against 3 N. meningitidis serogroup B reference strains at day 45.
    End point description
    The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N. meningitidis serogroup B reference strains at two weeks after last vaccination.
    End point type
    Secondary
    End point timeframe
    Day 45
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    76 [17]
    71 [18]
    Units: Ratios of GMTs
    geometric mean (confidence interval 95%)
        H44/76 strain (N=76, 70)
    174 (138 to 219)
    157 (124 to 199)
        NZ98/254 strain
    13 (9.87 to 17)
    20 (15 to 26)
        5/99 strain
    214 (161 to 284)
    243 (183 to 325)
    Notes
    [17] - Analysis was done on the PPS, immunogenicity subset.
    [18] - Analysis was done on the PPS, immunogenicity subset.
    No statistical analyses for this end point

    Secondary: 8) Percentage of Subjects with hSBA ≥1:5 against each of N. meningitidis serogroup B reference strains at day 45.

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    End point title
    		 8) Percentage of Subjects with hSBA ≥1:5 against each of N. meningitidis serogroup B reference strains at day 45.
    End point description
    The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination.
    End point type
    Secondary
    End point timeframe
    Day 45
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    76 [19]
    71 [20]
    Units: Percentage of Subjects
    number (confidence interval 95%)
        H44/76 strain
    100 (95 to 100)
    100 (95 to 100)
        NZ98/254 strain
    84 (74 to 92)
    96 (88 to 99)
        5/99 strain
    100 (95 to 100)
    100 (95 to 100)
    Notes
    [19] - Analysis was done on the PPS, immunogenicity subset.
    [20] - Analysis was done on the PPS, immunogenicity subset.
    No statistical analyses for this end point

    Secondary: 9) ELISA GMCs against vaccine antigen 287-953 at day 45.

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    End point title
    		 9) ELISA GMCs against vaccine antigen 287-953 at day 45.
    End point description
    The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.
    End point type
    Secondary
    End point timeframe
    Day 45
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    74 [21]
    71 [22]
    Units: IU/mL
        geometric mean (confidence interval 95%)
    3782 (3011 to 4750)
    4824 (3839 to 6061)
    Notes
    [21] - Analysis was done on the PPS, immunogenicity subset.
    [22] - Analysis was done on the PPS, immunogenicity subset.
    No statistical analyses for this end point

    Secondary: 10) GMR of ELISA GMCs against antigen 287-953 at day 45.

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    End point title
    		 10) GMR of ELISA GMCs against antigen 287-953 at day 45.
    End point description
    The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day45 vs baseline).
    End point type
    Secondary
    End point timeframe
    Day 45
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    74 [23]
    71 [24]
    Units: Ratio of GMTs
        geometric mean (confidence interval 95%)
    166 (130 to 213)
    217 (169 to 279)
    Notes
    [23] - Analysis was done on the PPS, immunogenicity subset.
    [24] - Analysis was done on the PPS, immunogenicity subset.
    No statistical analyses for this end point

    Secondary: 11) Number of subjects reporting solicited local and systemic Adverse Events (AEs)

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    End point title
    		 11) Number of subjects reporting solicited local and systemic Adverse Events (AEs)
    End point description
    Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 7 after any vaccination.
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    169 [25]
    173 [26]
    Units: Number of subjects
        Any local
    163
    170
        Induration
    65
    74
        Pain
    162
    170
        Erythema
    110
    111
        Swelling
    80
    74
        Any systemic
    136
    150
        Nausea
    49
    56
        Fatigue
    75
    85
        Myalgia
    99
    118
        Arthralgia
    28
    44
        Headache
    75
    89
        Fever ( >= 38C )
    8
    5
        Rash
    11
    16
        Any other
    87
    96
        Use of Analgesics
    82
    92
    Notes
    [25] - Analysis was done on the Safety set.
    [26] - Analysis was done on the Safety set.
    No statistical analyses for this end point

    Secondary: 12) Number of subjects reporting Unsolicited AEs

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    End point title
    		 12) Number of subjects reporting Unsolicited AEs
    End point description
    Number of subjects reporting any Unsolicited AEs after any vaccination.
    End point type
    Secondary
    End point timeframe
    From day 1 to day 7 after any vaccination .
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    169 [27]
    173 [28]
    Units: Number of subjects
    56
    55
    Notes
    [27] - Analysis was done on the Safety set.
    [28] - Analysis was done on the Safety set.
    No statistical analyses for this end point

    Secondary: 13) Number of subjects reporting SAEs and AE leading to withdrawal

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    End point title
    		 13) Number of subjects reporting SAEs and AE leading to withdrawal
    End point description
    Number of subjects any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject’s withdrawal from the study after any vaccination.
    End point type
    Secondary
    End point timeframe
    Throughout the entire study period.
    End point values
    		 4CMenB_Rosia 4CMenB_Siena
    Number of subjects analysed
    169 [29]
    173 [30]
    Units: Number of subjects
        SAEs
    0
    0
        AEs leading to withdrawal
    0
    1
    Notes
    [29] - Analysis was done on the Safety set.
    [30] - Analysis was done on the Safety set.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs were collected from day 1 through study termination, other AEs were collected from day 1 to 7 after vaccination.
    Adverse event reporting additional description
    Solicited adverse events were collected through systematic assessment, unsolicited were collected through non-systematic assessment. Analysis was done on the Safety set.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    4CMenB_Siena
    Reporting group description
    		 Subjects received two doses of rMenB+OMV NZ vaccinations from lot 2 manufactured at Siena facility.

    Reporting group title
    4CMenB_Rosia
    Reporting group description
    		 Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.

    Serious adverse events
    		 4CMenB_Siena 4CMenB_Rosia
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 173 (0.00%)
    0 / 169 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 4CMenB_Siena 4CMenB_Rosia
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    171 / 173 (98.84%)
    165 / 169 (97.63%)
    Investigations
    Injection Site Swelling
         subjects affected / exposed
    74 / 173 (42.77%)
    80 / 169 (47.34%)
         occurrences all number
    107
    115
    Nervous system disorders
    Headache
         subjects affected / exposed
    89 / 173 (51.45%)
    75 / 169 (44.38%)
         occurrences all number
    159
    124
    General disorders and administration site conditions
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    85 / 173 (49.13%)
    75 / 169 (44.38%)
         occurrences all number
    138
    129
    Injection Site Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    111 / 173 (64.16%)
    111 / 169 (65.68%)
         occurrences all number
    177
    175
    Injection Site Induration
         subjects affected / exposed
    75 / 173 (43.35%)
    65 / 169 (38.46%)
         occurrences all number
    107
    96
    Injection Site Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    170 / 173 (98.27%)
    162 / 169 (95.86%)
         occurrences all number
    349
    337
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    56 / 173 (32.37%)
    49 / 169 (28.99%)
         occurrences all number
    77
    68
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    16 / 173 (9.25%)
    11 / 169 (6.51%)
         occurrences all number
    18
    13
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    45 / 173 (26.01%)
    28 / 169 (16.57%)
         occurrences all number
    66
    38
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    118 / 173 (68.21%)
    99 / 169 (58.58%)
         occurrences all number
    189
    169

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

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

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