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    Clinical Trial Results:
    A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged 11-17 Years According to Different Vaccination Schedules.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-004410-29
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Dec 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Jun 2016
    First version publication date
    27 Dec 2014
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    re-QC of this study is needed because of EudraCT system glitch and updates to results are required.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V72P10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00661713
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics S.r.l
    Sponsor organisation address
    Via Fiorentina 1,, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l, RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000139-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Jun 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunogenicity, safety and tolerability of one, two (0,1 or 0,2 schedule) or three doses (0, 1, 2 schedule) of Novartis rMenB+OMV NZ in healthy adolescents, by evaluation of the serum bactericidal activity using human complement (SBA) response at one month after the last rMenB+OMV NZ dose.
    Protection of trial subjects
    Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. An oral temperature ≥38.0°C (≥100.4°F) or serious active infection was a reason for delaying vaccination. 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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jun 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Chile: 1631
    Worldwide total number of subjects
    1631
    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)
    233
    Adolescents (12-17 years)
    1398
    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 enrolled at 10 study centers in Chile.

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

    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, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 rMenB06
    Arm description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
    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
    Single dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

    Arm title
    		 rMenB0
    Arm description
    		 Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
    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
    Single dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

    Arm title
    		 rMenB016
    Arm description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months
    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
    Single dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

    Arm title
    		 rMenB01
    Arm description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
    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
    Single dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

    Arm title
    		 rMenB026
    Arm description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
    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
    Single dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

    Arm title
    		 rMenB02
    Arm description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
    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
    Single dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

    Arm title
    		 rMenB012
    Arm description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
    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
    Single dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

    Arm title
    		 rMenB6
    Arm description
    		 Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
    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
    Single dose of 0.5mL vaccine or 0.5 mL placebo is administered at each schedule by IM injection into deltoid muscle of non-dominant arm.

    Number of subjects in period 1
    		rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Started
    128
    247
    128
    247
    127
    253
    373
    128
    Completed
    112
    208
    111
    219
    107
    216
    309
    117
    Not completed
    16
    39
    17
    28
    20
    37
    64
    11
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    -
    1
    -
         Consent withdrawn by subject
    11
    25
    12
    21
    12
    26
    45
    9
         Death
    1
    -
    -
    -
    1
    -
    -
    -
         Administrative Reason
    -
    1
    -
    2
    2
    2
    1
    -
         Unable to classify
    1
    -
    -
    -
    -
    -
    -
    -
         Lost to follow-up
    2
    7
    2
    2
    5
    7
    14
    1
         Inappropriate Enrollment
    -
    -
    -
    -
    -
    -
    1
    -
         Protocol deviation
    1
    6
    3
    3
    -
    2
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    rMenB06
    Reporting group description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.

    Reporting group title
    rMenB0
    Reporting group description
    		 Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.

    Reporting group title
    rMenB016
    Reporting group description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months

    Reporting group title
    rMenB01
    Reporting group description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.

    Reporting group title
    rMenB026
    Reporting group description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.

    Reporting group title
    rMenB02
    Reporting group description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.

    Reporting group title
    rMenB012
    Reporting group description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.

    Reporting group title
    rMenB6
    Reporting group description
    		 Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.

    Reporting group values
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6 Total
    Number of subjects
    		 128 247 128 247 127 253 373 128 1631
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.8 ± 1.9 13.7 ± 1.9 13.9 ± 1.9 13.9 ± 1.9 13.7 ± 1.9 13.7 ± 1.8 13.8 ± 1.9 13.8 ± 2 -
    Gender categorical
    Units: Subjects
        Female
    		 76 147 76 138 73 138 199 66 913
        Male
    		 52 100 52 109 54 115 174 62 718

    End points

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    End points reporting groups
    Reporting group title
    rMenB06
    Reporting group description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.

    Reporting group title
    rMenB0
    Reporting group description
    		 Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.

    Reporting group title
    rMenB016
    Reporting group description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months

    Reporting group title
    rMenB01
    Reporting group description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.

    Reporting group title
    rMenB026
    Reporting group description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.

    Reporting group title
    rMenB02
    Reporting group description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.

    Reporting group title
    rMenB012
    Reporting group description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.

    Reporting group title
    rMenB6
    Reporting group description
    		 Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.

    Subject analysis set title
    All Enrolled Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects who enrolled in this study.

    Subject analysis set title
    Per Protocol-month 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable post immunization serum samples at month 1.

    Subject analysis set title
    Per Protocol-month 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable post immunization serum samples at month 2.

    Subject analysis set title
    Per Protocol-month 0
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable post immunization serum samples at month 0.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects enrolled who received study vaccination and provide post-baseline safety data.

    Subject analysis set title
    Per Protocol-month 6
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable post immunization serum samples at 1 month after 4th dose.

    Subject analysis set title
    Per Protocol-month 7
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable post immunization serum samples at 1 month after 4th dose.

    Subject analysis set title
    Per Protocol-month 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the Full Analysis Set/MITT population who received all the relevant doses of vaccine correctly, and provided evaluable post immunization serum samples at 1 month after 4th dose

    Primary: 1. Percentages‘ of subjects with hSBA titer ≥1:4 after receiving one, two or three doses of rMenB+OMV NZ vaccine

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    End point title
    		 1. Percentages‘ of subjects with hSBA titer ≥1:4 after receiving one, two or three doses of rMenB+OMV NZ vaccine [1]
    End point description
    Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
    End point type
    Primary
    End point timeframe
    Month-1, 2, 3
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is associated to this endpoint. Analyses were run descriptively.
    End point values
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Number of subjects analysed
    112
    223
    113
    231
    110
    232
    334
    116
    Units: Percentage of Subjects
    number (confidence interval 95%)
        44/76-SL- Mo 0 N= 112,223,113,231,110,232,334,116
    42 (33 to 52)
    47 (40 to 54)
    41 (32 to 50)
    38 (32 to 45)
    37 (28 to 47)
    47 (40 to 53)
    46 (41 to 52)
    46 (36 to 55)
        44/76-SL- Mo 1 N= 112,223,113,231,110,232,333,115
    92 (85 to 96)
    92 (88 to 95)
    95 (89 to 98)
    93 (88 to 96)
    90 (83 to 95)
    92 (88 to 95)
    95 (92 to 97)
    43 (34 to 53)
        44/76-SL- Mo 2 N=108, 213,108,222,105,219,307,109
    88 (80 to 93)
    92 (88 to 95)
    100 (97 to 100)
    100 (98 to 100)
    88 (80 to 93)
    89 (85 to 93)
    100 (98 to 100)
    50 (40 to 59)
        44/76-SL- Mo 3 N=107,208,105,215,104,215,303,108
    84 (76 to 90)
    88 (82 to 92)
    99 (95 to 100)
    100 (97 to 100)
    100 (97 to 100)
    100 (98 to 100)
    100 (98 to 100)
    48 (38 to 58)
        5/99- Mo 0 N= 112,223,113,231,110,232,334,116
    29 (20 to 38)
    41 (35 to 48)
    28 (20 to 38)
    31 (25 to 38)
    30 (22 to 39)
    37 (31 to 44)
    36 (30 to 41)
    29 (21 to 38)
        5/99- Mo 1 N= 111,223,113,231,110,232,333,115
    97 (92 to 99)
    96 (93 to 98)
    96 (90 to 99)
    97 (94 to 99)
    97 (92 to 99)
    96 (93 to 98)
    97 (94 to 98)
    35 (26 to 44)
        5/99- Mo 2 N=108,213,108,222,105,219,308,109
    95 (90 to 98)
    94 (90 to 97)
    100 (97 to 100)
    100 (98 to 100)
    89 (81 to 94)
    95 (92 to 98)
    100 (98 to 100)
    31 (23 to 41)
        5/99- Mo 3 N=107,209,105,215,105,215,303,108
    92 (85 to 96)
    89 (84 to 93)
    99 (95 to 100)
    100 (98 to 100)
    98 (93 to 100)
    100 (98 to 100)
    100 (99 to 100)
    32 (24 to 42)
        NZ98/254-mo 0 N= 112,223,113,231,110,232,333,116
    32 (24 to 42)
    39 (33 to 46)
    33 (24 to 42)
    35 (29 to 41)
    34 (25 to 43)
    37 (31 to 44)
    33 (28 to 38)
    38 (29 to 47)
        NZ98/254-mo 1 N= 111,223,113,231,110,232,333,115
    90 (83 to 95)
    94 (90 to 97)
    95 (89 to 98)
    94 (90 to 96)
    90 (83 to 95)
    93 (89 to 96)
    95 (92 to 97)
    38 (29 to 48)
        NZ98/254-mo 2 N=107,213,108,222,105,218,308,109
    81 (73 to 88)
    84 (74 to 88)
    99 (95 to 100)
    100 (98 to 100)
    78 (69 to 86)
    85 (79 to 89)
    100 (98 to 100)
    39 (29 to 48)
        NZ98/254-mo 3 N=107,208,105,215,104,215,302,108
    80 (72 to 87)
    76 (70 to 82)
    97 (92 to 99)
    97 (94 to 99)
    100 (97 to 100)
    100 (98 to 100)
    99 (97 to 100)
    43 (33 to 52)
    No statistical analyses for this end point

    Primary: 9. Number of Subjects with Local Reactions and systemic reactions occurring in days 1 to 7 after vaccination

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    End point title
    		 9. Number of Subjects with Local Reactions and systemic reactions occurring in days 1 to 7 after vaccination [2]
    End point description
    Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after vaccination with rMenB+OMV
    End point type
    Primary
    End point timeframe
    1 to 7 days after each vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is associated to this endpoint. Analyses were run descriptively.
    End point values
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Number of subjects analysed
    128
    247
    128
    247
    127
    253
    373
    128
    Units: Number of Subjects
        erythema (local)
    93
    162
    95
    188
    94
    172
    282
    85
        Induration (Local)
    71
    130
    75
    151
    82
    121
    228
    57
        Swelling (Local)
    72
    132
    81
    144
    76
    115
    226
    54
        Pain (Local)
    122
    236
    124
    237
    113
    236
    345
    123
        Med.Att Fever (Systemic)
    1
    0
    2
    0
    1
    1
    1
    1
        Malaise (Systemic)
        Myalgia(Systemic)
    85
    141
    91
    156
    81
    160
    238
    91
        Arthralgia(Systemic)
    55
    76
    55
    80
    39
    105
    146
    43
        Headache(Systemic)
    79
    139
    88
    160
    73
    165
    244
    74
        Nausea(Systemic)
    41
    80
    51
    72
    42
    88
    143
    49
        Fever(Systemic)
    12
    8
    11
    21
    18
    26
    38
    18
    No statistical analyses for this end point

    Secondary: 2. Percentages ‘of subjects with hSBA titer ≥1:4 after receiving a booster dose of rMenB+OMV NZ vaccine at month 6.

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    End point title
    		 2. Percentages ‘of subjects with hSBA titer ≥1:4 after receiving a booster dose of rMenB+OMV NZ vaccine at month 6.
    End point description
    Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter >1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 6 & 7.
    End point type
    Secondary
    End point timeframe
    Month-6 & 7
    End point values
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Number of subjects analysed
    100
    188
    113
    231
    110
    232
    334
    116
    Units: Percentage of Subjects
    number (confidence interval 95%)
        44/76-SL- Mo 6 N= 100,188,100,198,99,201,278,100
    76 (66 to 84)
    72 (65 to 79)
    93 (86 to 97)
    92 (88 to 96)
    97 (91 to 99)
    98 (94 to 99)
    97 (94 to 99)
    46 (36 to 56)
        44/76-SL- Mo 7 N=86,173,95,186,91,179,255,95
    100 (96 to 100)
    71 (64 to 78)
    100 (96 to 100)
    90 (85 to 94)
    100 (96 to 100)
    95 (91 to 98)
    95 (92 to 98)
    93 (85 to 97)
        5/99- Mo 6 N=100,188,100,198,99,201,278,100
    79 (70 to 87)
    74 (67 to 80)
    99 (95 to 100)
    98 (96 to 100)
    99 (95 to 100)
    100 (97 to 100)
    100 (98 to 100)
    28 (19 to 38)
        5/99- Mo 7 N=86,173,95,187,91,179,255,95
    99 (94 to 100)
    67 (60 to 74)
    100 (96 to 100)
    98 (95 to 99)
    100 (96 to 100)
    99 (96 to 100)
    99 (97 to 100)
    93 (85 to 97)
        NZ98/254-mo 6 N=99,188100,198,99,200,278,100
    81 (72 to 88)
    69 (62 to 76)
    93 (86 to 97)
    89 (84 to 93)
    97 (91 to 99)
    96 (92 to 98)
    97 (94 to 99)
    45 (35 to 55)
        NZ98/254-mo 7 N=86,172,95,187,91,179,255,95
    100 (96 to 100)
    67 (60 to 74)
    100 (96 to 100)
    85 (79 to 90)
    100 (96 to 100)
    94 (89 to 97)
    95 (92 to 98)
    93 (85 to 97)
    No statistical analyses for this end point

    Secondary: 3. Percentage of subjects with hSBA titer ≥1:8 after primary and booster vaccination.

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    End point title
    		 3. Percentage of subjects with hSBA titer ≥1:8 after primary and booster vaccination.
    End point description
    Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter ≥1:8 against 44/76-SL, 5/99, NZ98/254 strains at baseline, month-1, month-2, month-3, month-6 and month-7.
    End point type
    Secondary
    End point timeframe
    Baseline, month-1, month-2, month-3, month-6 and month-7.
    End point values
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Number of subjects analysed
    112
    223
    113
    231
    110
    232
    334
    116
    Units: Percentage of Subjects
    number (confidence interval 95%)
        44/76-SL- Mo 0 N=112,223,113,231,110,232,334,116
    29 (21 to 39)
    37 (31 to 44)
    31 (23 to 40)
    32 (26 to 38)
    30 (22 to 39)
    35 (29 to 42)
    33 (28 to 38)
    33 (24 to 42)
        44/76-SL- Mo 1 N=112,223,113,231,110,232,333,115
    87 (79 to 92)
    87 (82 to 91)
    85 (77 to 91)
    85 (80 to 89)
    81 (72 to 88)
    87 (82 to 91)
    86 (82 to 90)
    30 (22 to 40)
        44/76-SL- Mo 2 N=108, 213,108,222,105,219,307,109
    79 (70 to 86)
    84 (78 to 89)
    99 (95 to 100)
    99 (97 to 100)
    80 (71 to 87)
    80 (74 to 85)
    99 (98 to 100)
    33 (24 to 43)
        44/76-SL- Mo 3 N=107,208,105,215,104,215,303,108
    74 (64 to 82)
    77 (71 to 83)
    99 (95 to 100)
    98 (95 to 99)
    99 (95 to 100)
    100 (98 to 100)
    99 (97 to 100)
    36 (27 to 46)
        44/76-SL- Mo 6 N= 100,188,100,198,99,201,278,100
    62 (52 to 72)
    62 (54 to 69)
    90 (82 to 95)
    83 (77 to 88)
    90 (82 to 95)
    91 (86 to 95)
    93 (90 to 96)
    34 (25 to 44)
        44/76-SL- Mo 7 N=86,173,95,186,91,179,255,95
    99 (94 to 100)
    57 (49 to 64)
    100 (96 to 100)
    82 (75 to 87)
    100 (96 to 100)
    88 (82 to 92)
    91 (86 to 94)
    89 (81 to 95)
        5/99- Mo 0 N=112,223,113,231,110,232,334,116
    18 (11 to 26)
    24 (19 to 30)
    20 (13 to 29)
    22 (17 to 28)
    23 (15 to 32)
    22 (17 to 28)
    22 (17 to 26)
    14 (8 to 21)
        5/99- Mo 1 N= 111,223,113,231,110,232,333,115
    96 (91 to 99)
    91 (87 to 95)
    89 (82 to 94)
    94 (90 to 96)
    91 (84 to 96)
    93 (89 to 96)
    94 (91 to 96)
    19 (12 to 28)
        5/99- Mo 2 N=108,213,108,222,105,219,308,109
    89 (81 to 94)
    85 (80 to 90)
    100 (97 to 100)
    100 (98 to 100)
    78 (69 to 86)
    88 (83 to 92)
    99 (98 to 100)
    17 (11 to 26)
        5/99- Mo 3 N=107,209,105,215,105,215,303,108
    81 (73 to 88)
    77 (71 to 83)
    99 (95 to 99)
    100 (97 to 100)
    98 (93 to 100)
    100 (98 to 100)
    100 (99 to 100)
    19 (12 to 27)
        5/99- Mo 6 N=100,188,100,198,99,201,278,100
    60 (50 to 70)
    57 (50 to 64)
    97 (91 to 100)
    98 (95 to 99)
    98 (93 to 100)
    99 (96 to 100)
    99 (97 to 100)
    16 (9 to 25)
        5/99- Mo 7 N=86,173,95,187,91,179,255,95
    99 (94 to 100)
    48 (40 to 56)
    100 (96 to 100)
    97 (93 to 99)
    100 (96 to 100)
    97 (94 to 99)
    98 (95 to 99)
    86 (78 to 93)
        NZ98/254 Mo 0 N=112,223,113,231,110,232,333,116
    22 (15 to 31)
    30 (24 to 36)
    27 (19 to 36)
    25 (20 to 31)
    24 (16 to 33)
    26 (21 to 32)
    25 (20 to 30)
    29 (21 to 38)
        NZ98/254 Mo 1 N=111,223,113,231,110,232,333,115
    84 (76 to 90)
    83 (77 to 87)
    82 (74 to 89)
    84 (79 to 88)
    75 (65 to 82)
    80 (74 to 85)
    86 (81 to 89)
    26 (18 to 35)
        NZ98/254 Mo 2 N=107,213,108,222,105,218,308,109
    72 (62 to 80)
    70 (64 to 76)
    98 (93 to 100)
    99 (97 to 100)
    65 (55 to 74)
    75 (68 to 80)
    99 (97 to 100)
    31 (23 to 41)
        NZ98/254 Mo 3 N=107,208,105,215,104,215,302,108
    70 (60 to 79)
    65 (58 to 71)
    90 (82 to 95)
    91 (86 to 94)
    98 (93 to 100)
    100 (97 to 100)
    98 (96 to 99)
    30 (21 to 39)
        NZ98/254 Mo 6 N=99,188,100,198,99,200,278,100
    60 (49 to 69)
    54 (47 to 62)
    80 (71 to 87)
    77 (70 to 82)
    86 (77 to 92)
    86 (80 to 90)
    91 (87 to 94)
    38 (28 to 48)
        NZ98/254 Mo 7 N=86,172,95,187,91,179,255,95
    99 (94 to 100)
    49 (42 to 57)
    99 (94 to 100)
    71 (64 to 78)
    100 (96 to 100)
    81 (74 to 86)
    84 (79 to 88)
    86 (78 to 93)
    No statistical analyses for this end point

    Secondary: 4. Percentages of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination

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    End point title
    		 4. Percentages of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination
    End point description
    Immunogenicity was evaluated by measuring the percentage of subjects with at least a fourfold rise in hSBA titer over the prevaccination and after booster vaccination against 44/76-SL, 5/99, NZ98/254 strains at month-1, month-2, month-3 and month-7.
    End point type
    Secondary
    End point timeframe
    Month-1, month-2, month-3 and month-7.
    End point values
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Number of subjects analysed
    112
    223
    113
    231
    110
    232
    334
    116
    Units: Percentage of Subjects
    number (confidence interval 95%)
        44/76-SL Mo 1 N= 112,223,113,231,110,232,333,115
    73 (64 to 81)
    75 (69 to 80)
    71 (61 to 79)
    77 (71 to 82)
    67 (58 to 76)
    73 (67 to 79)
    72 (67 to 77)
    3 (1 to 7)
        44/76-SL Mo 2 N=108,213,107,222,105,219,307,109
    62 (52 to 71)
    67 (60 to 73)
    94 (88 to 98)
    96 (92 to 98)
    65 (55 to 74)
    61 (54 to 67)
    94 (91 to 97)
    6 (2 to 12)
        44/76-SL Mo 3 N=107,208,105,215,104,215,303,108
    53 (43 to 63)
    59 (52 to 66)
    88 (81 to 94)
    91 (87 to 95)
    91 (84 to 96)
    95 (92 to 98)
    95 (92 to 97)
    3 (1 to 8)
        44/76-SL Mo 7 N=86,173,94,186,91,179,255,95
    95 (89 to 99)
    33 (26 to 40)
    98 (93 to 100)
    73 (66 to 79)
    93 (86 to 98)
    76 (69 to 82)
    80 (75 to 85)
    76 (66 to 84)
        5/99 Mo 1 N=111,223,113,231,110,232,333,115
    87 (80 to 93)
    79 (73 to 84)
    81 (72 to 87)
    85 (80 to 89)
    79 (70 to 86)
    85 (80 to 89)
    85 (80 to 88)
    3 (1 to 7)
        5/99 Mo 2 N=108,213,107,222,105,219,308,109
    78 (69 to 85)
    65 (58 to 72)
    98 (93 to 100)
    98 (95 to 100)
    63 (53 to 72)
    74 (68 to 80)
    98 (96 to 99)
    5 (2 to 10)
        5/99 Mo 3 N=107,209,104,215,105,215,303,108
    65 (56 to 74)
    53 (46 to 60)
    95 (89 to 98)
    99 (96 to 100)
    96 (91 to 99)
    99 (96 to 100)
    99 (98 to 100)
    6 (3 to 13)
        5/99- Mo 7 N=86,173,94,187,91,179,255,95
    98 (92 to 100)
    27 (21 to 34)
    99 (94 to 100)
    88 (82 to 92)
    99 (94 to 100)
    90 (85 to 94)
    94 (90 to 97)
    82 (73 to 89)
        NZ98/254 Mo 1 N=111,223,113,231,110,232,332,115
    72 (63 to 80)
    70 (63 to 76)
    65 (56 to 74)
    74 (67 to 79)
    59 (49 to 68)
    64 (58 to 70)
    73 (68 to 78)
    3 (1 to 7)
        NZ98/254 Mo 2 N=107,213,107,222,105,218,307,109
    57 (47 to 67)
    52 (45 to 59)
    89 (81 to 94)
    93 (89 to 96)
    51 (41 to 61)
    57 (50 to 64)
    93 (89 to 95)
    7 (3 to 14)
        NZ98/254 Mo 3 N=107,208,104,215,104,215,301,108
    50 (40 to 59)
    43 (36 to 50)
    78 (69 to 85)
    81 (76 to 86)
    91 (84 to 96)
    91 (86 to 94)
    93 (90 to 96)
    6 (3 to 13)
        NZ98/254 Mo 7 N=86,172,94,187,91,179,254,95
    94 (87 to 98)
    27 (21 to 35)
    95 (88 to 98)
    62 (55 to 69)
    92 (85 to 97)
    69 (62 to 76)
    75 (69 to 80)
    77 (67 to 85)
    No statistical analyses for this end point

    Secondary: 5. Geometric mean titers (GMTs) after primary and booster vaccination

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    End point title
    		 5. Geometric mean titers (GMTs) after primary and booster vaccination
    End point description
    Immunogenicity was evaluated by measuring the Geometric mean titers (GMTs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
    End point type
    Secondary
    End point timeframe
    month-1, month-2, month-3, month-6 and month-7
    End point values
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Number of subjects analysed
    112
    223
    113
    231
    110
    232
    334
    116
    Units: Titer
    geometric mean (confidence interval 95%)
        44/76 GMT Mo 0 N=112,223,113,231,110,232,334,116
    3.41 (2.54 to 4.58)
    4.24 (3.44 to 5.22)
    3.34 (2.49 to 4.48)
    3.35 (2.72 to 4.11)
    3.39 (2.52 to 4.56)
    3.99 (3.25 to 4.9)
    3.87 (3.26 to 4.6)
    3.89 (2.91 to 5.19)
        44/76 GMT Mo 1 N=112,223,113,231,110,232,333,115
    46 (33 to 63)
    58 (46 to 72)
    56 (40 to 77)
    52 (41 to 65)
    44 (32 to 61)
    57 (45 to 71)
    60 (49 to 72)
    3.39 (2.46 to 4.65)
        44/76 GMT Mo 2 N= 108,213,108,222,105,219,307,109
    31 (23 to 41)
    41 (34 to 50)
    182 (138 to 240)
    187 (154 to 228)
    28 (21 to 37)
    38 (31 to 46)
    193 (164 to 228)
    4.09 (3.11 to 5.38)
        44/76 GMT Mo 3 N= 107,208,105,215,104,215,303,108
    20 (16 to 26)
    31 (26 to 38)
    132 (101 to 172)
    114 (95 to 137)
    182 (139 to 236)
    230 (191 to 277)
    240 (205 to 280)
    4.04 (3.12 to 5.22)
        44/76 GMT Mo 6 N= 100,188,100,198,99,201,278,100
    13 (9.24 to 18)
    15 (12 to 19)
    59 (43 to 82)
    50 (39 to 63)
    54 (39 to 75)
    75 (60 to 95)
    86 (70 to 104)
    3.9 (2.82 to 5.4)
        44/76 GMT Mo 7 N= 86, 173,95,186,91,179,255,95
    218 (157 to 302)
    12 (9.69 to 15)
    324 (236 to 443)
    36 (29 to 45)
    259 (188 to 357)
    48 (38 to 60)
    59 (49 to 72)
    56 (41 to 77)
        5/99 GMT Mo 0 N= 112,223,113,231,110,232,334,116
    2.61 (2.03 to 3.34)
    3.15 (2.64 to 3.75)
    2.59 (2.02 to 3.32)
    2.52 (2.11 to 2.99)
    2.43 (1.89 to 3.12)
    2.72 (2.29 to 3.24)
    2.58 (2.23 to 2.98)
    2.27 (1.78 to 2.89)
        5/99 GMT Mo 1 N= 111,223,113,231,110,232,333,115
    81 (61 to 109)
    64 (52 to 79)
    66 (49 to 88)
    72 (59 to 88)
    57 (42 to 76)
    76 (62 to 93)
    71 (60 to 84)
    2.56 (1.93 to 3.4)
        5/99 GMT Mo 2 N= 108,213,108,222,105,219,308,109
    40 (31 to 51)
    34 (28 to 40)
    505 (396 to 644)
    451 (381 to 535)
    26 (20 to 33)
    40 (34 to 48)
    481 (415 to 556)
    2.48 (1.95 to 3.16)
        5/99 GMT Mo 3 N= 107,209,105,215,105,215,303,108
    25 (20 to 31)
    23 (20 to 27)
    303 (242 to 380)
    273 (233 to 320)
    540 (431 to 677)
    822 (702 to 964)
    584 (510 to 668)
    2.58 (2.07 to 3.22)
        5/99 GMT Mo 6 N= 100,188,100,198,99,201,278,100
    12 (9.56 to 16)
    11 (9.26 to 13)
    125 (98 to 160)
    113 (95 to 135)
    124 (97 to 158)
    147 (123 to 175)
    186 (160 to 216)
    2.03 (1.59 to 2.59)
        5/99 GMT Mo 7 N= 86,173,95,187,91,179,255,95
    880 (675 to 1147)
    8.61 (7.13 to 10)
    1094 (849 to 1410)
    99 (82 to 119)
    994 (767 to 1289)
    121 (101 to 146)
    164 (141 to 192)
    53 (41 to 68)
        NZ98/254 GMT Mo0 N=112,223,113,231,110,232,333,116
    2.87 (2.14 to 3.84)
    3.35 (2.72 to 4.13)
    3.43 (2.56 to 4.59)
    2.98 (2.43 to 3.66)
    3.07 (2.28 to 4.12)
    3.39 (2.76 to 4.16)
    2.83 (2.38 to 3.36)
    3.12 (2.34 to 4.15)
        NZ98/254 GMT Mo1 N=111,223,113,231,110,232,333,115
    42 (31 to 56)
    44 (36 to 55)
    47 (35 to 63)
    45 (36 to 55)
    37 (27 to 50)
    42 (34 to 52)
    49 (41 to 58)
    2.85 (2.11 to 3.84)
        NZ98/254 GMT Mo2 N=107,213,108,222,105,218,308,109
    23 (17 to 30)
    25 (20 to 31)
    98 (72 to 132)
    89 (72 to 110)
    19 (14 to 26)
    26 (21 to 32)
    92 (77 to 110)
    3.28 (2.43 to 4.41)
        NZ98/254 GMT Mo3 N=107,208,105,215,104,215,302,108
    17 (13 to 22)
    19 (16 to 24)
    61 (46 to 82)
    52 (42 to 64)
    117 (87 to 157)
    125 (102 to 154)
    122 (102 to 145)
    3.57 (2.68 to 4.75)
        NZ98/254 GMT Mo 6 N= 99,188,100,198,99,200,278,100
    12 (8.94 to 17)
    11 (8.63 to 14)
    31 (22 to 42)
    29 (23 to 36)
    44 (32 to 61)
    49 (39 to 61)
    52 (43 to 63)
    4.17 (3.04 to 5.72)
        NZ98/254 GMT Mo 7 N= 86,172,95,187,91,179,255,95
    140 (101 to 195)
    10 (8.01 to 13)
    181 (132 to 248)
    24 (19 to 30)
    168 (122 to 232)
    39 (31 to 49)
    41 (34 to 50)
    47 (34 to 64)
    No statistical analyses for this end point

    Secondary: 6. Geometric mean ratios (GMRs) after primary and booster vaccination.

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    End point title
    		 6. Geometric mean ratios (GMRs) after primary and booster vaccination.
    End point description
    Immunogenicity was evaluated by measuring the Geometric mean ratios (GMRs) after primary and booster vaccination against 44/76-SL, 5/99, NZ98/254.
    End point type
    Secondary
    End point timeframe
    month-1, month-2, month-3, month-6 and month-7
    End point values
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Number of subjects analysed
    112
    223
    113
    231
    110
    232
    334
    116
    Units: Ratio
    geometric mean (confidence interval 95%)
        44/76GMR Mo 1to0 N=112,223,113,231,110,232,333,115
    13 (10 to 18)
    14 (11 to 17)
    17 (12 to 22)
    16 (13 to 19)
    13 (9.71 to 18)
    14 (12 to 17)
    15 (13 to 18)
    0.89 (0.66 to 1.18)
        44/76GMR Mo 2to0 N=108,213,107,222,105,219,307,109
    8.92 (6.73 to 12)
    9.65 (7.88 to 12)
    53 (40 to 71)
    56 (46 to 69)
    8.43 (6.33 to 11)
    9.51 (7.79 to 12)
    50 (42 to 59)
    1.04 (0.79 to 1.38)
        44/76GMR Mo 3to0 N=107,208,104,215,104,215,303,108
    5.98 (4.51 to 7.92)
    7.31 (5.97 to 8.96)
    37 (28 to 50)
    34 (28 to 42)
    55 (41 to 73)
    58 (48 to 71)
    62 (52 to 73)
    0.98 (0.74 to 1.3)
        44/76GMR Mo 6to0 N=100,188,99,198,99,201,278,100
    3.98 (2.96 to 5.35)
    3.64 (2.93 to 4.52)
    17 (13 to 23)
    16 (13 to 19)
    16 (12 to 21)
    20 (16 to 25)
    23 (19 to 27)
    0.92 (0.69 to 1.24)
        44/76GMR Mo 7to0 N=86,173,94,186,91,179,255,95
    74 (54 to 103)
    3.09 (2.46 to 3.88)
    92 (67 to 125)
    12 (9.24 to 12)
    79 (58 to 109)
    13 (11 to 17)
    16 (13 to 19)
    13 (9.76 to 18)
        44/76GMR Mo 7to6 86,173,95,186,91,179,255,94
    18 (14 to 23)
    0.89 (0.76 to 1.05)
    5.36 (4.3 to 6.68)
    0.72 (0.61 to 0.84)
    5.08 (4.05 to 6.37)
    0.67 (0.57 to 0.79)
    0.67 (0.59 to 0.77)
    14 (11 to 17)
        5/99GMR Mo 1to0 N=111,223,113,231,110,232,333,115
    31 (23 to 42)
    20 (16 to 25)
    25 (19 to 34)
    29 (23 to 35)
    23 (17 to 32)
    28 (23 to 34)
    28 (23 to 33)
    1.13 (0.84 to 1.52)
        5/99GMR Mo 2to0 N=108,213,107,222,105,219,308,109
    15 (11 to 20)
    11 (8.65 to 13)
    198 (149 to 262)
    181 (149 to 220)
    11 (8.13 to 14)
    15 (12 to 18)
    186 (158 to 220)
    1.06 (0.8 to 1.4)
        5/99GMR Mo 3to0 N=107,209,104,215,105,215,303,108
    9.22 (6.94 to 12)
    7.37 (6.01 to 9.04)
    115 (86 to 153)
    109 (89 to 133)
    233 (175 to 311)
    306 (250 to 374)
    225 (190 to 267)
    1.09 (0.82 to 1.44)
        5/99GMR Mo 6to0 N=100,188,99,198,99,201,278,100
    4.65 (3.47 to 6.23)
    3.83 (3.09 to 4.75)
    49 (37 to 66)
    45 (36 to 55)
    52 (39 to 70)
    56 (45 to 69)
    74 (62 to 88)
    0.82 (0.61 to 1.1)
        5/99GMR Mo 7 to 0 N=86,173,95,187,91,179,255,94
    355 (254 to 497)
    3.07 (2.42 to 3.89)
    430 (312 to 594)
    40 (32 to 50)
    427 (307 to 593)
    46 (36 to 58)
    65 (53 to 79)
    21 (16 to 29)
        5/99GMR Mo 7to6 N=86,173,95,187,91,179,255,94
    71 (55 to 90)
    0.83 (0.7 to 0.99)
    8.98 (7.13 to 11)
    0.87 (0.74 to 1.03)
    7.92 (6.26 to 10)
    0.83 (0.71 to 0.99)
    0.86 (0.74 to 0.99)
    26 (20 to 32)
        NZ98/254GMR Mo 1to0 N=111,223,113,231,110,232,115
    14 (11 to 19)
    13 (11 to 16)
    14 (10 to 18)
    15 (12 to 18)
    12 (9 to 16)
    12 (10 to 15)
    17 (15 to 21)
    0.91 (0.68 to 1.2)
        NZ98/254GMR Mo 2to0 N=107,213,107,222,105,218,109,
    7.69 (5.86 to 10)
    7.24 (5.97 to 8.79)
    29 (22 to 38)
    30 (24 to 36)
    6.46 (4.91 to 8.5)
    7.96 (6.57 to 9.63)
    33 (28 to 39)
    1.06 (0.81 to 1.38)
        NZ98/254GMR Mo 3to0 N=107,208,104,215,104,215,108
    6.01 (4.54 to 7.96)
    5.5 (4.49 to 6.74)
    18 (14 to 24)
    18 (14 to 21)
    40 (30 to 54)
    38 (32 to 47)
    44 (37 to 52)
    1.13 (0.86 to 1.5)
        NZ98/254GMR Mo 6to0 N=99,188,99,198,99,200,277,100
    4.75 (3.62 to 6.24)
    3.49 (2.86 to 4.26)
    9.26 (7.05 to 12)
    10 (8.29 to 12)
    14 (11 to 19)
    15 (13 to 19)
    19 (16 to 22)
    1.28 (0.98 to 1.68)
        NZ98/254GMR Mo 7to0 N=86,172,94,187,91,179,254,95
    59 (44 to 80)
    3.32 (2.67 to 4.12)
    53 (40 to 71)
    8.94 (7.26 to 11)
    57 (42 to 77)
    13 (10 to 16)
    15 (12 to 18)
    15 (11 to 19)
        NZ98/254GMR Mo 7to6 N=85,172,95,187,91,179,255,94
    11 (8.73 to 14)
    0.99 (0.84 to 1.17)
    5.86 (4.7 to 7.3)
    0.85 (0.73 to 1)
    3.95 (3.15 to 4.95)
    0.84 (0.72 to 0.99)
    0.81 (0.7 to 0.92)
    11 (8.98 to 14)
    No statistical analyses for this end point

    Secondary: 7. GMCs of Antibodies Against 287-293 Antigen (ELISA) after primary and Booster Vaccination

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    End point title
    		 7. GMCs of Antibodies Against 287-293 Antigen (ELISA) after primary and Booster Vaccination
    End point description
    Immunogenicity was evaluated by measuring the Geometric mean Concentration (GMCs) after primary and booster vaccination against Antigen 287-293 Antigen.
    End point type
    Secondary
    End point timeframe
    month-1, month-2, month-3, month-6 and month-7
    End point values
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Number of subjects analysed
    34
    35
    35
    35
    35
    35
    35
    35
    Units: IU/mL
    geometric mean (confidence interval 95%)
        GMC Mo 0 N= 34,35,35,32,35,35,35,35,35
    35 (25 to 51)
    35 (25 to 50)
    43 (30 to 61)
    37 (26 to 54)
    44 (31 to 63)
    32 (23 to 46)
    32 (22 to 45)
    48 (34 to 68)
        GMC Mo 1 N= 34,35,35,35,35,35,35,35,35
    190 (113 to 318)
    204 (123 to 340)
    334 (200 to 555)
    217 (130 to 361)
    234 (140 to 389)
    220 (132 to 367)
    521 (313 to 868)
    50 (30 to 82)
        GMC Mo 2 N= 34,35,35,34,35,35,35,35,35
    173 (115 to 261)
    154 (102 to 231)
    3025 (2015 to 4543)
    3875 (2566 to 5854)
    175 (117 to 263)
    144 (96 to 216)
    3693 (2459 to 5545)
    42 (28 to 62)
        GMC Mo 3 N= 34,35,35,34,35,35,35,35,35
    102 (69 to 152)
    124 (84 to 183)
    1612 (1093 to 2378)
    1831 (1234 to 2716)
    3332 (2259 to 4916)
    2936 (1990 to 4332)
    5314 (3602 to 7839)
    42 (29 to 62)
        GMC Mo 6 N= 34,35,35,35,35,35,35,35,35
    91 (59 to 138)
    72 (48 to 110)
    565 (372 to 857)
    488 (322 to 741)
    807 (531 to 1224)
    628 (414 to 953)
    1602 (1055 to 2431)
    37 (24 to 56)
        GMC Mo 7 N= 34,34,35,34,35,35,35,35,35
    2240 (1385 to 3623)
    69 (43 to 112)
    3840 (2391 to 6168)
    383 (237 to 620)
    5492 (3419 to 8821)
    532 (331 to 855)
    1111 (692 to 1785)
    283 (176 to 454)
    No statistical analyses for this end point

    Secondary: 8. GMRs of Antibodies Against 287-293 Antigen (ELISA) after primary and Booster Vaccination

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    End point title
    		 8. GMRs of Antibodies Against 287-293 Antigen (ELISA) after primary and Booster Vaccination
    End point description
    Immunogenicity was evaluated by measuring the Geometric mean Ratios (GMRs) after primary and booster vaccination against 287-293 Antigen
    End point type
    Secondary
    End point timeframe
    month-1, month-2, month-3, month-6 and month-7
    End point values
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Number of subjects analysed
    34
    35
    35
    35
    35
    35
    35
    35
    Units: Ratio
    geometric mean (confidence interval 95%)
        GMR Mo 1 to 0 N= 34,35,35,32,35,35,35,35,35
    5.37 (3.19 to 9.05)
    5.82 (3.48 to 9.73)
    7.75 (4.64 to 13)
    5.34 (3.12 to 9.14)
    5.26 (3.14 to 8.79)
    6.85 (4.09 to 11)
    16 (9.77 to 27)
    1.03 (0.62 to 1.73)
        GMR Mo 2 to 0 N= 34,35,35,31,35,35,35,35,35
    4.9 (3.2 to 7.5)
    4.38 (2.88 to 6.66)
    70 (46 to 107)
    112 (72 to 175)
    3.94 (2.59 to 5.99)
    4.46 (2.93 to 6.79)
    116 (76 to 176)
    0.87 (0.57 to 1.32)
        GMR Mo 3 to 0 N= 34,35,35,31,35,35,35,35,35
    2.9 (1.82 to 4.61)
    3.54 (2.24 to 5.59)
    37 (24 to 59)
    55 (34 to 89)
    75 (47 to 118)
    91 (59 to 144)
    167 (105 to 263)
    0.88 (0.56 to 1.4)
        GMR Mo 6 to 0 N= 34,35,35,32,35,35,35,35,35
    2.56 (1.59 to 4.13)
    2.06 (1.29 to 3.3)
    13 (8.2 to 21)
    13 (7.86 to 21)
    18 (11 to 29)
    20 (12 to 31)
    50 (31 to 80)
    0.77 (0.48 to 1.23)
        GMR Mo 7 to 0 N= 34,34,35,31,35,35,35,35,35
    63 (34 to 119)
    1.94 (1.03 to 3.64)
    89 (48 to 166)
    11 (5.67 to 21)
    123 (66 to 229)
    17 (8.9 to 31)
    35 (19 to 65)
    5.9 (3.17 to 11)
    No statistical analyses for this end point

    Secondary: 10. Number of Subjects reporting unsolicited AEs throughout the study

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    End point title
    		 10. Number of Subjects reporting unsolicited AEs throughout the study
    End point description
    Safety was assessed as the number of subjects who reported unsolicited AEs throughout the study.
    End point type
    Secondary
    End point timeframe
    Throughout the study
    End point values
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Number of subjects analysed
    128
    247
    128
    247
    127
    253
    373
    128
    Units: Number of Subjects
        Any AE’s
    65
    137
    73
    143
    72
    148
    210
    80
        At least possibly related AEs
    22
    36
    30
    36
    24
    43
    76
    26
        Serious AEs
    5
    4
    2
    4
    2
    4
    11
    3
        At least possibly related SAEs
    0
    0
    0
    0
    0
    0
    2
    0
        AEs leading to discontinuation
    1
    0
    0
    0
    1
    0
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected throughout the study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    rMenB06
    Reporting group description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.

    Reporting group title
    rMenB0
    Reporting group description
    		 Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.

    Reporting group title
    rMenB016
    Reporting group description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.

    Reporting group title
    rMenB01
    Reporting group description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.

    Reporting group title
    rMenB026
    Reporting group description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.

    Reporting group title
    rMenB02
    Reporting group description
    		 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.

    Reporting group title
    rMenB012
    Reporting group description
    		 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.

    Reporting group title
    rMenB6
    Reporting group description
    		 Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.

    Serious adverse events
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 128 (3.91%)
    4 / 247 (1.62%)
    2 / 128 (1.56%)
    4 / 247 (1.62%)
    2 / 127 (1.57%)
    4 / 253 (1.58%)
    11 / 373 (2.95%)
    3 / 128 (2.34%)
         number of deaths (all causes)
    1
    0
    0
    0
    1
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ADENOMA BENIGN
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BENIGN OVARIAN TUMOUR
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    1 / 373 (0.27%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    JOINT INJURY
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    1 / 373 (0.27%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LIGAMENT RUPTURE
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    1 / 373 (0.27%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ROAD TRAFFIC ACCIDENT
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TOXICITY TO VARlOUS AGENTS
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    2 / 253 (0.79%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    ADENOIDECTOMY
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    1 / 247 (0.40%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    TONSILLECTOMY
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    1 / 247 (0.40%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    CONVULSION
         subjects affected / exposed
    1 / 128 (0.78%)
    1 / 247 (0.40%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    EPILEPSY
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 247 (0.40%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SYNCOPE
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    1 / 373 (0.27%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    PREMATURE LABOUR
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 247 (0.00%)
    1 / 128 (0.78%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    TESTICULAR TORSION
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    1 / 247 (0.40%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ASTHMATIC CRISIS
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    1 / 373 (0.27%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    URTICARIA
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    1 / 373 (0.27%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    MAJOR DEPRESSION
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    1 / 127 (0.79%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    PANIC ATTACK
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    1 / 127 (0.79%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SUICIDE ATTEMPT
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 247 (0.40%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    1 / 127 (0.79%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    GLOMERULONEPHRITIS MINIMAL LESION
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    1 / 247 (0.40%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    JUVENILE IDIOPATHIC ARTHRITIS
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    2 / 373 (0.54%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    APPENDICITIS
         subjects affected / exposed
    1 / 128 (0.78%)
    1 / 247 (0.40%)
    1 / 128 (0.78%)
    1 / 247 (0.40%)
    1 / 127 (0.79%)
    1 / 253 (0.40%)
    2 / 373 (0.54%)
    1 / 128 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DYSENTERY
         subjects affected / exposed
    0 / 128 (0.00%)
    1 / 247 (0.40%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MENINGITIS BACTERlAL
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    1 / 373 (0.27%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMONIA VIRAL
         subjects affected / exposed
    1 / 128 (0.78%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    0 / 253 (0.00%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SHIGELLA INFECTION
         subjects affected / exposed
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 128 (0.00%)
    0 / 247 (0.00%)
    0 / 127 (0.00%)
    1 / 253 (0.40%)
    0 / 373 (0.00%)
    0 / 128 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 rMenB06 rMenB0 rMenB016 rMenB01 rMenB026 rMenB02 rMenB012 rMenB6
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    123 / 128 (96.09%)
    238 / 247 (96.36%)
    126 / 128 (98.44%)
    242 / 247 (97.98%)
    118 / 127 (92.91%)
    240 / 253 (94.86%)
    354 / 373 (94.91%)
    125 / 128 (97.66%)
    Injury, poisoning and procedural complications
    LIGAMENT SPRAIN
         subjects affected / exposed
    4 / 128 (3.13%)
    6 / 247 (2.43%)
    3 / 128 (2.34%)
    7 / 247 (2.83%)
    7 / 127 (5.51%)
    7 / 253 (2.77%)
    15 / 373 (4.02%)
    4 / 128 (3.13%)
         occurrences all number
    4
    6
    3
    8
    7
    7
    15
    4
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    79 / 128 (61.72%)
    140 / 247 (56.68%)
    88 / 128 (68.75%)
    160 / 247 (64.78%)
    74 / 127 (58.27%)
    165 / 253 (65.22%)
    244 / 373 (65.42%)
    76 / 128 (59.38%)
         occurrences all number
    185
    346
    256
    444
    208
    452
    704
    209
    General disorders and administration site conditions
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    93 / 128 (72.66%)
    162 / 247 (65.59%)
    97 / 128 (75.78%)
    188 / 247 (76.11%)
    94 / 127 (74.02%)
    172 / 253 (67.98%)
    282 / 373 (75.60%)
    86 / 128 (67.19%)
         occurrences all number
    211
    338
    225
    428
    251
    389
    680
    169
    INJECTION SITE INDURATION
         subjects affected / exposed
    72 / 128 (56.25%)
    130 / 247 (52.63%)
    76 / 128 (59.38%)
    151 / 247 (61.13%)
    82 / 127 (64.57%)
    122 / 253 (48.22%)
    228 / 373 (61.13%)
    58 / 128 (45.31%)
         occurrences all number
    149
    240
    167
    328
    191
    234
    564
    116
    INJECTION SITE PAIN
         subjects affected / exposed
    122 / 128 (95.31%)
    236 / 247 (95.55%)
    124 / 128 (96.88%)
    237 / 247 (95.95%)
    113 / 127 (88.98%)
    236 / 253 (93.28%)
    345 / 373 (92.49%)
    123 / 128 (96.09%)
         occurrences all number
    378
    667
    396
    729
    398
    749
    1160
    398
    INJECTION SITE SWELLING
         subjects affected / exposed
    73 / 128 (57.03%)
    132 / 247 (53.44%)
    81 / 128 (63.28%)
    144 / 247 (58.30%)
    76 / 127 (59.84%)
    115 / 253 (45.45%)
    226 / 373 (60.59%)
    55 / 128 (42.97%)
         occurrences all number
    129
    244
    172
    310
    171
    242
    523
    92
    MALAISE
         subjects affected / exposed
    92 / 128 (71.88%)
    181 / 247 (73.28%)
    96 / 128 (75.00%)
    172 / 247 (69.64%)
    87 / 127 (68.50%)
    185 / 253 (73.12%)
    272 / 373 (72.92%)
    89 / 128 (69.53%)
         occurrences all number
    222
    371
    238
    405
    235
    444
    690
    205
    PYREXIA
         subjects affected / exposed
    12 / 128 (9.38%)
    8 / 247 (3.24%)
    13 / 128 (10.16%)
    21 / 247 (8.50%)
    18 / 127 (14.17%)
    26 / 253 (10.28%)
    38 / 373 (10.19%)
    20 / 128 (15.63%)
         occurrences all number
    17
    11
    18
    22
    20
    30
    50
    27
    Gastrointestinal disorders
    NAUSEA
         subjects affected / exposed
    41 / 128 (32.03%)
    80 / 247 (32.39%)
    51 / 128 (39.84%)
    72 / 247 (29.15%)
    42 / 127 (33.07%)
    89 / 253 (35.18%)
    143 / 373 (38.34%)
    49 / 128 (38.28%)
         occurrences all number
    80
    120
    109
    126
    72
    156
    276
    90
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    56 / 128 (43.75%)
    76 / 247 (30.77%)
    55 / 128 (42.97%)
    89 / 247 (36.03%)
    31 / 127 (24.41%)
    105 / 253 (41.50%)
    146 / 373 (39.14%)
    44 / 128 (34.38%)
         occurrences all number
    101
    131
    106
    175
    81
    215
    320
    77
    MYALGIA
         subjects affected / exposed
    85 / 128 (66.41%)
    141 / 247 (57.09%)
    91 / 128 (71.09%)
    158 / 247 (63.97%)
    82 / 127 (64.57%)
    160 / 253 (63.24%)
    238 / 373 (63.81%)
    91 / 128 (71.09%)
         occurrences all number
    170
    266
    187
    335
    193
    357
    568
    198
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    6 / 128 (4.69%)
    7 / 247 (2.83%)
    5 / 128 (3.91%)
    10 / 247 (4.05%)
    9 / 127 (7.09%)
    6 / 253 (2.37%)
    14 / 373 (3.75%)
    11 / 128 (8.59%)
         occurrences all number
    6
    7
    5
    10
    9
    6
    14
    14
    GASTROENTERITIS
         subjects affected / exposed
    4 / 128 (3.13%)
    7 / 247 (2.83%)
    2 / 128 (1.56%)
    15 / 247 (6.07%)
    2 / 127 (1.57%)
    14 / 253 (5.53%)
    23 / 373 (6.17%)
    3 / 128 (2.34%)
         occurrences all number
    4
    8
    2
    15
    2
    15
    27
    3
    NASOPHARYNGITIS
         subjects affected / exposed
    9 / 128 (7.03%)
    24 / 247 (9.72%)
    18 / 128 (14.06%)
    20 / 247 (8.10%)
    9 / 127 (7.09%)
    28 / 253 (11.07%)
    43 / 373 (11.53%)
    13 / 128 (10.16%)
         occurrences all number
    9
    26
    18
    21
    11
    30
    46
    15
    PHARYNGITIS
         subjects affected / exposed
    7 / 128 (5.47%)
    11 / 247 (4.45%)
    5 / 128 (3.91%)
    9 / 247 (3.64%)
    4 / 127 (3.15%)
    7 / 253 (2.77%)
    21 / 373 (5.63%)
    8 / 128 (6.25%)
         occurrences all number
    7
    11
    6
    10
    4
    7
    24
    9
    TONSILLITIS
         subjects affected / exposed
    3 / 128 (2.34%)
    5 / 247 (2.02%)
    4 / 128 (3.13%)
    7 / 247 (2.83%)
    3 / 127 (2.36%)
    6 / 253 (2.37%)
    16 / 373 (4.29%)
    7 / 128 (5.47%)
         occurrences all number
    4
    5
    5
    9
    3
    7
    18
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2008
    To include an external safety monitoring committee (Data Monitoring Committee- DMC) in the safety monitoring procedures of the trial. To clarify the procedure for stopping/pausing the trial
    26 Aug 2008
    To add, according to requests from Regulators, collection of medically attended fever for 7 days from vaccination To enlarge visit 5 window and to replace the final study phone contact by a final study office visit To include in exclusion criterion no. 7 sexual abstinence and the use of condom without spermicidal agent as additional acceptable birth control methods and to clarify that acceptable birth control measures must have been used for at least two months prior to study entry by female subjects of childbearing age. To clarify that urine pregnancy test will be required only for all females of childbearing potential To review the plan on the interim analysis To remove the duration of the enrolment period in order to avoid potential future amendments. To update the sponsor representative details and the contact number for trial related emergencies out of office hours.
    01 Sep 2009
    To describe the safety follow-up after subject withdrawal. To clarify that the scheduling of Visit 5 and Visit 7 should be based on the actual date of the preceding study vaccinations at Visit 3 and Visit 5
    03 Feb 2010
    To change the study objectives To change the study endpoints
    13 Apr 2010
    To change the study endpoints

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22260988
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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