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    Clinical Trial Results:
    A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence Compared to Naive Children and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received a Three-Dose Series of the Novartis Vaccine as Infants in Study V72P9.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2009-013075-21
    Trial protocol
    		 GB  
    Global end of trial date
    23 May 2012

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

    Trial information

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    Trial identification
    Sponsor protocol code
    V72P9E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01026974
    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, RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines, 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
    21 Nov 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 May 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity Objective: To explore bactericidal antibody persistence in children at 40 months of age who previously received three doses of rMenB (recombinant Meningococcal B) or Meningococcal B Recombinant Vaccine ± Outer Membrane Vesicles (OMV) (rMenB+OMV NZ) as infants in parent study V72P9. Safety Objectives: To assess the safety and tolerability of a booster dose of rMenB or rMenB+OMV NZ administered to children at 40 months of age who previously received three doses of the same vaccine as infants in parent study V72P9.
    Protection of trial subjects
    The trial was conducted in compliance with the protocol, ethical principles that have their origin in the Declaration of Helsinki, that are consistent with good clinical practice (GCP) according to International Conference on Harmonisation (ICH) guidelines and the applicable regulatory requirements. A comprehensive review of rMenB±OMV NZ was contained in the investigator’s brochure (IB) supplied by Novartis Vaccines and Diagnostics; this document had to be reviewed prior to initiating the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 20 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    120
    Adolescents (12-17 years)
    0
    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 a single center.

    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
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 4rMenB
    Arm description
    		 Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study V72P9 and one booster dose of rMenB vaccine at 40 months of age in the present study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    rMenB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose 0.5 mL of injectable solution was administered intramuscularly.

    Arm title
    		 4rMenB+OMV NZ
    Arm description
    		 Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
    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
    Each dose 0.5 mL of injectable solution was administered intramuscularly.

    Arm title
    		 Naive_4042
    Arm description
    		 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
    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
    Each dose 0.5 mL of injectable solution was administered intramuscularly.

    Arm title
    		 Naive_6062
    Arm description
    		 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    rMenB+OMV NZ
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose 0.5 mL of injectable solution was administered intramuscularly.

    Number of subjects in period 1
    		4rMenB 4rMenB+OMV NZ Naive_4042 Naive_6062
    Started
    16
    14
    41
    49
    Completed
    15
    12
    29
    46
    Not completed
    1
    2
    12
    3
         Consent withdrawn by subject
    -
    1
    7
    2
         Inappropriate enrollment
    -
    -
    1
    -
         Adverse event
    -
    -
    -
    1
         Lost to follow-up
    1
    1
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    4rMenB
    Reporting group description
    		 Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study V72P9 and one booster dose of rMenB vaccine at 40 months of age in the present study.

    Reporting group title
    4rMenB+OMV NZ
    Reporting group description
    		 Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.

    Reporting group title
    Naive_4042
    Reporting group description
    		 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

    Reporting group title
    Naive_6062
    Reporting group description
    		 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

    Reporting group values
    		 4rMenB 4rMenB+OMV NZ Naive_4042 Naive_6062 Total
    Number of subjects
    		 16 14 41 49 120
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 16 14 41 49 120
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 42.8 ( 1.1 ) 43.1 ( 0.9 ) 41.7 ( 1.7 ) 61.3 ( 0.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 11 22 21 62
        Male
    		 8 3 19 28 58

    End points

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    End points reporting groups
    Reporting group title
    4rMenB
    Reporting group description
    		 Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study V72P9 and one booster dose of rMenB vaccine at 40 months of age in the present study.

    Reporting group title
    4rMenB+OMV NZ
    Reporting group description
    		 Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.

    Reporting group title
    Naive_4042
    Reporting group description
    		 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

    Reporting group title
    Naive_6062
    Reporting group description
    		 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

    Subject analysis set title
    Full Analysis Set (FAS) population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the enrolled population who are randomized and actually receive at least one rMenB±OMV NZ, and provided at least one evaluable serum sample both before and after baseline with exception of the analysis of persistence data, where only a sample before rMenB±OMV NZ vaccination is required.

    Subject analysis set title
    Modified Intention-to-treat (MITT) population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All subjects in the enrolled population who are randomized and actually receive at least one rMenB±OMV NZ, and provide at least one evaluable serum sample both before and after baseline with exception of the analysis of persistence data, where only a sample before rMenB±OMV NZ vaccination is required.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received at least one rMenB±OMV NZ vaccination and provided post-baseline safety data.

    Primary: 1.Persistence of human complement Serum Bactericidal Assay antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination.

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    End point title
    		 1.Persistence of human complement Serum Bactericidal Assay antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. [1] [2]
    End point description
    The geometric mean antibody titers (GMTs) against Neisseria meningitidis serogroup B in children (at 40 months of age); twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ vaccines, are compared with the GMTs in vaccine-naïve children.
    End point type
    Primary
    End point timeframe
    28 months after primary vaccination; Baseline for Naïve
    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 with this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_4042
    Number of subjects analysed
    15
    14
    40
    Units: Titers
    geometric mean (confidence interval 95%)
        44/76-SL strain (N = 14,14,39)
    1.26 (0.9 to 1.76)
    2.55 (1.15 to 5.66)
    1.08 (0.97 to 1.2)
        5/99 strain (N = 14,14,40)
    41 (18 to 95)
    29 (18 to 47)
    1 (1 to 1)
        NZ98/254 strain (N = 15,14,39)
    1 (1 to 1)
    1.74 (0.91 to 3.33)
    1 (1 to 1)
        M10713 strain ( N = 14,14,40)
    3.6 (1.32 to 9.84)
    7.11 (3.61 to 14)
    4.82 (2.9 to 8)
    No statistical analyses for this end point

    Primary: 2. Percentage of Subjects With Persisting hSBA antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination.

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    End point title
    		 2. Percentage of Subjects With Persisting hSBA antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. [3] [4]
    End point description
    The percentages of subjects with persisting hSBA titers ≥4, against N meningitidis serogroup B at 40 months of age; twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ as compared to the vaccine-naive children are reported.The serum bactericidal antibodies directed against serogroup B meningococci, are measured by hSBA. Analysis was done on MITT population.
    End point type
    Primary
    End point timeframe
    28 months after primary vaccination; Baseline for Naive
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is associated with this endpoint.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_4042
    Number of subjects analysed
    15
    14
    40
    Units: Percentage of Subjects
    number (confidence interval 95%)
        44/76-SL strain (N = 14,14,39)
    14 (2 to 43)
    36 (13 to 65)
    3 (0.065 to 13)
        5/99 strain (N = 14,14,40)
    93 (66 to 100)
    100 (77 to 100)
    0 (0 to 9)
        NZ98/254 strain (N = 15,14,39)
    0 (0 to 22)
    14 (2 to 43)
    0 (0 to 9)
        M10713 strain (N = 14,14,40)
    29 (8 to 58)
    79 (49 to 95)
    53 (36 to 68)
    No statistical analyses for this end point

    Primary: 3. Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age.

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    End point title
    		 3. Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. [5] [6]
    End point description
    The safety and tolerability of a single booster dose of rMenB or rMenB+OMV NZ vaccine in 40 month old children who had previously received three primary doses of the same vaccine as infants in parent study was assessed in terms of number of subjects with solicited local and systemic reactions following vaccination and compared to tolerability in vaccine-naive children who received first catch-up dose of rMenB+OMV NZ at 40 months of age. Analysis was done on the Safety population.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 7 [after booster vaccination /post dose 1 for naive]
    Notes
    [5] - 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 with this endpoint.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_4042
    Number of subjects analysed
    16
    14
    39
    Units: Number of Subjects
        Any Local
    14
    14
    38
        Injection-site pain
    10
    12
    34
        Injection-site erythema
    13
    14
    36
        Injection-site swelling
    9
    6
    10
        Injection-site induration
    11
    5
    17
        Any Systemic
    12
    11
    30
        Change in eating habits
    5
    5
    13
        Sleepiness
    6
    6
    20
        Vomiting
    0
    2
    1
        Diarrhea
    2
    1
    2
        Irritability
    8
    11
    24
        Headache
    2
    1
    4
        Arthralgia
    2
    3
    9
        Rash
    2
    1
    2
        Fever (≥38°C)
    4
    1
    6
        Other
    6
    10
    21
        Temperature (≥40°C)
    0
    0
    1
        Antipyretic preventive medication used
    4
    9
    19
        Antipyretic treatment medication used
    3
    1
    5
        Medically attended fever
    0
    0
    0
    No statistical analyses for this end point

    Secondary: 4. HSBA antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age

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    End point title
    		 4. HSBA antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age [7]
    End point description
    The serum bacterial antibody response one month after a booster dose of rMenB or rMenB+OMV NZ vaccine was given to children at 40 months of age and was compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects and reported as GMTs. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    1 month post booster /1 month post dose 1 for Naïve
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_4042
    Number of subjects analysed
    14
    14
    39
    Units: Titers
    geometric mean (confidence interval 95%)
        44/76-SL strain (N = 13,14,39)
    100 (50 to 200)
    114 (59 to 222)
    8.89 (5.83 to 14)
        5/99 strain
    1007 (445 to 2277)
    926 (432 to 1988)
    27 (16 to 44)
        NZ98/254 strain
    2.15 (0.88 to 5.23)
    32 (14 to 71)
    1.91 (1.35 to 2.71)
        M10713 strain (N = 13,14,39)
    10 (3.43 to 30)
    23 (13 to 41)
    6.04 (3.73 to 9.79)
    No statistical analyses for this end point

    Secondary: 5. Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age

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    End point title
    		 5. Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age [8]
    End point description
    The percentages of subjects with hSBA titers ≥4 against N meningitidis serogroup B one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, is compared with hSBA response following one catch-up. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    1 month post-booster/ 1 month post-dose 1 for Naïve
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_4042
    Number of subjects analysed
    14
    14
    39
    Units: Percentage of Subjects
    number (confidence interval 95%)
        44/76-SL strain (N = 13, 14, 39)
    100 (75 to 100)
    100 (77 to 100)
    72 (55 to 85)
        5/99 strain
    100 (77 to 100)
    100 (77 to 100)
    87 (73 to 96)
        NZ98/254 strain
    21 (5 to 51)
    93 (66 to 100)
    23 (11 to 39)
        M10713 strain (N = 13, 14, 39)
    69 (39 to 91)
    93 (66 to 100)
    62 (45 to 77)
    No statistical analyses for this end point

    Secondary: 6. Percentage of Subjects With a four-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age

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    End point title
    		 6. Percentage of Subjects With a four-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age [9]
    End point description
    The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B, one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, and compared with four-fold increase in hSBA titers following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects. Baseline was defined as either the time that the (first) booster dose was given (i.e. at 40 months of age) or the time of the first vaccination (i.e. at 40 months of age) for Naive_4042 group. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    1 month post booster / 1 month post dose 1 for Naive
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_4042
    Number of subjects analysed
    13
    14
    38
    Units: Percentage of Subjects
    number (confidence interval 95%)
        44/76-SL strain (N = 11,14,37)
    100 (72 to 100)
    93 (66 to 100)
    54 (37 to 71)
        5/99 strain (N = 12,14,38)
    100 (74 to 100)
    100 (77 to 100)
    76 (60 to 89)
        NZ98/254 strain (N = 13,14,37)
    23 (5 to 54)
    71 (42 to 92)
    11 (3 to 25)
        M10713 strain (N = 11,14,38)
    18 (2 to 52)
    36 (13 to 65)
    5 (1 to 18)
    No statistical analyses for this end point

    Secondary: 7. Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine

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    End point title
    		 7. Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine [10]
    End point description
    The persisting serum bactericidal antibody titers in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) is compared with the antibody titers in vaccine -naïve subjects of the same age and reported as GMTs. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    20 months post booster/ Baseline for Naive
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_6062
    Number of subjects analysed
    10
    12
    46
    Units: Titers
    geometric mean (confidence interval 95%)
        44/76-SL strain (N = 9,12,46)
    9.37 (2.47 to 36)
    4.69 (1.98 to 11)
    1.09 (0.96 to 1.25)
        5/99 strain (N = 9,11,46)
    334 (186 to 599)
    119 (56 to 252)
    1.17 (0.96 to 1.42)
        NZ98/254 strain (N = 10,12,46)
    1 (1 to 1)
    1.63 (0.86 to 3.08)
    1 (1 to 1)
        M10713 strain (N = 8,11,45)
    4.96 (1.03 to 24)
    5.51 (2.19 to 14)
    8.09 (5.13 to 13)
    No statistical analyses for this end point

    Secondary: 8. Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine.

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    End point title
    		 8. Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine. [11]
    End point description
    The percentage of subjects (60 months of age) with persisting hSBA titers ≥4, twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) are compared with hSBA response in vaccine-naïve subjects of the same age. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    20 months post booster/ Baseline for Naive
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_6062
    Number of subjects analysed
    10
    12
    46
    Units: Percentage of Subjects
    number (confidence interval 95%)
        44/76-SL strain (N = 9,12,46)
    67 (30 to 93)
    67 (35 to 90)
    4 (1 to 15)
        5/99 strain (N = 9,11,46)
    100 (66 to 100)
    100 (72 to 100)
    4 (1 to 15)
        NZ98/254 strain
    0 (0 to 31)
    17 (2 to 48)
    0 (0 to 8)
        M10713 strain (N = 8,11,45)
    50 (16 to 84)
    45 (17 to 77)
    67 (51 to 80)
    No statistical analyses for this end point

    Secondary: 9. Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given two Months Apart, Either at 40 or 60 Months of Age

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    End point title
    		 9. Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given two Months Apart, Either at 40 or 60 Months of Age [12]
    End point description
    The percentage of subjects with hSBA titers ≥4 after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age is reported. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    1 month post vaccine dose two
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 Naive_4042 Naive_6062
    Number of subjects analysed
    31
    35
    Units: Percentage of Subjects
    number (confidence interval 95%)
        44/76-SL strain (N = 30,34)
    100 (88 to 100)
    100 (90 to 100)
        5/99 strain (N = 31,34)
    100 (89 to 100)
    100 (90 to 100)
        NZ98/254 strain
    90 (74 to 98)
    89 (73 to 97)
        M10713 strain (N = 29,33)
    72 (53 to 87)
    97 (84 to 100)
    No statistical analyses for this end point

    Secondary: 10. Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given two Months Apart, Either at 40 or 60 Months of Age.

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    End point title
    		 10. Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given two Months Apart, Either at 40 or 60 Months of Age. [13]
    End point description
    The serum bactericidal antibody response in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age are reported as GMTs. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    1 month post -vaccine dose two
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 Naive_4042 Naive_6062
    Number of subjects analysed
    31
    35
    Units: Titers
    geometric mean (confidence interval 95%)
        44/76-SL strain (N = 30,34)
    74 (57 to 94)
    83 (67 to 103)
        5/99 strain (N = 31,34)
    247 (188 to 323)
    331 (254 to 432)
        NZ98/254 strain (N = 30,35)
    16 (11 to 23)
    14 (9.81 to 21)
        M10713 strain (N = 29,33)
    8.91 (5.19 to 15)
    44 (33 to 57)
    No statistical analyses for this end point

    Secondary: 11. Percentage of Subjects With a four-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given two Months Apart Either at 40 or 60 Months of Age

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    End point title
    		 11. Percentage of Subjects With a four-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given two Months Apart Either at 40 or 60 Months of Age [14]
    End point description
    The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 and 42 months or 60 and 62 months of age. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    1 month post vaccine dose two
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 Naive_4042 Naive_6062
    Number of subjects analysed
    31
    35
    Units: Percentage of Subjects
    number (confidence interval 95%)
        44/76-SL strain (N = 29,34)
    100 (88 to 100)
    100 (90 to 100)
        5/99 strain (N = 31,34)
    100 (89 to 100)
    100 (90 to 100)
        NZ98/254 strain (N = 30,35)
    73 (54 to 88)
    69 (51 to 83)
        M10713 strain (N = 29,32)
    24 (10 to 44)
    53 (35 to 71)
    No statistical analyses for this end point

    Secondary: 12. Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.

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    End point title
    		 12. Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. [15]
    End point description
    The serum bactericidal antibody response in children at 60 months of age who had received two catch-up doses of rMenB+OMV NZ vaccine at- 40 & 42 months age is reported as GMTs. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    18 months post vaccination dose two
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 Naive_4042
    Number of subjects analysed
    24
    Units: Titers
    geometric mean (confidence interval 95%)
        44/76-SL strain
    2.73 (1.54 to 4.84)
        5/99 strain
    24 (16 to 35)
        NZ98/254 strain
    1 (1 to 1)
        M10713 strain (N=23)
    14 (6.78 to 27)
    No statistical analyses for this end point

    Secondary: 13. Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.

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    End point title
    		 13. Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. [16]
    End point description
    Persisting hSBA titers ≥4 in children at 60 months of age, who had received two catchup doses of rMenB+OMV NZ vaccine at 40 & 42 months age is reported. Analysis was done on MITT population
    End point type
    Secondary
    End point timeframe
    18 months post vaccine dose two
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 Naive_4042
    Number of subjects analysed
    24
    Units: Titers
    geometric mean (confidence interval 95%)
        44/76-SL strain
    38 (19 to 59)
        5/99 strain
    100 (86 to 100)
        NZ98/254 strain
    0 (0 to 14)
        M10713 strain (N=23)
    83 (61 to 95)
    No statistical analyses for this end point

    Secondary: 14. Persistence of Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination.

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    End point title
    		 14. Persistence of Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination. [17]
    End point description
    The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age), twenty-eight months after completion of primary vaccination with either rMenB or rMen+OMV NZ vaccines, are compared with the GMCs in vaccine-naive children. GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA). Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    28 months after primary vaccination/ Baseline for Naive
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_4042
    Number of subjects analysed
    14
    14
    39
    Units: Concentration (IU/mL)
    geometric mean (confidence interval 95%)
        287-953 Strain
    86 (43 to 173)
    103 (61 to 174)
    27 (22 to 35)
    No statistical analyses for this end point

    Secondary: 15. Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age.

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    End point title
    		 15. Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age. [18]
    End point description
    The GMCs against vaccine antigen 287-953, in children one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine , is compared with GMCs following one catch-up dose of rMenB+ OMV NZ in children at 40 months. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    1 month post booster /1 month post dose 1 for Naive
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_4042
    Number of subjects analysed
    15
    14
    39
    Units: Concentration (IU/mL)
    geometric mean (confidence interval 95%)
        287-953 Strain
    5187 (2924 to 9204)
    3662 (2065 to 6491)
    83 (52 to 133)
    No statistical analyses for this end point

    Secondary: 16. Geometric Mean Antibody Concentrations (GMCs) in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine

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    End point title
    		 16. Geometric Mean Antibody Concentrations (GMCs) in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine [19]
    End point description
    The persisting GMCs against vaccine antigen 287-953 in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months), are compared with GMCs in vaccine-naïve children of same age. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    20 months post booster/ Baseline for Naive
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_6062
    Number of subjects analysed
    10
    12
    46
    Units: Concentration (IU/mL)
    geometric mean (confidence interval 95%)
        287-953 Strain
    772 (395 to 1512)
    358 (201 to 640)
    25 (19 to 33)
    No statistical analyses for this end point

    Secondary: 17. Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given Two Months Apart, Either at 40 Months or 60 Months of Age.

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    End point title
    		 17. Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given Two Months Apart, Either at 40 Months or 60 Months of Age. [20]
    End point description
    The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age are reported. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    1 month post vaccine dose two
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 Naive_4042 Naive_6062
    Number of subjects analysed
    31
    35
    Units: Concentration (IU/mL)
    geometric mean (confidence interval 95%)
        287-953 Strain
    612 (329 to 1139)
    2164 (1663 to 2817)
    No statistical analyses for this end point

    Secondary: 18. Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.

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    End point title
    		 18. Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. [21]
    End point description
    Persistence of GMCs against vaccine antigen 287-953 in children (60 months of age), eighteen months after two catch-up doses of rMenB+OMV NZ vaccine given at 40 months of age. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    18 months post vaccine dose two
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 Naive_4042
    Number of subjects analysed
    24
    Units: Concentration (IU/mL)
    geometric mean (confidence interval 95%)
        287-953 Strain
    87 (63 to 120)
    No statistical analyses for this end point

    Secondary: 19. Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age.

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    End point title
    		 19. Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age. [22]
    End point description
    The percentage of subjects with four fold increase in GMCs over baseline against vaccine antigen 287-953 one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine, is compared with responses following one catch-up dose of rMenB+OMV NZ in children at 40 months. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    1 month post booster /1 month post dose 1 for Naive
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 4rMenB 4rMenB+OMV NZ Naive_4042
    Number of subjects analysed
    14
    14
    38
    Units: Percentage of Subjects
    number (confidence interval 95%)
        287-953 Strain
    100 (77 to 100)
    100 (77 to 100)
    21 (10 to 37)
    No statistical analyses for this end point

    Secondary: 20. Percentage of Subjects With four-fold Increase in GMCs of Antibody, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given Two Months Apart Either at 40 or 60 Months of Age.

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    End point title
    		 20. Percentage of Subjects With four-fold Increase in GMCs of Antibody, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given Two Months Apart Either at 40 or 60 Months of Age. [23]
    End point description
    The percentages of subjects with four-fold increase in GMCs over baseline against vaccine antigen 287-953, one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age. Analysis was done on MITT population.
    End point type
    Secondary
    End point timeframe
    1 month post vaccine dose two
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 Naive_4042 Naive_6062
    Number of subjects analysed
    31
    35
    Units: Percentage of Subjects
    geometric mean (confidence interval 95%)
        287-953 Strain
    77 (59 to 90)
    97 (85 to 100)
    No statistical analyses for this end point

    Secondary: 21. Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine two Months Apart, Either at 40 or 60 Months of Age.

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    End point title
    		 21. Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine two Months Apart, Either at 40 or 60 Months of Age. [24]
    End point description
    The safety and tolerability of a two doses of rMenB+OMV NZ vaccine in children when given either at 40 & 42 months or 60 & 62 months of age is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination. Analysis was done on the Safety population
    End point type
    Secondary
    End point timeframe
    Day 1 to Day 7 after each vaccination
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis is associated with this endpoint.
    End point values
    		 Naive_4042 Naive_6062
    Number of subjects analysed
    39
    48
    Units: Number of subjects
        Any Local
    39
    48
        Injection-site pain
    38
    46
        Injection-site erythema
    38
    46
        Injection-site swelling
    19
    32
        Injection-site induration
    26
    28
        Any Systemic
    35
    44
        Change in eating habits
    20
    15
        Sleepiness
    26
    26
        Vomiting
    4
    7
        Diarrhea
    4
    4
        Irritability
    29
    29
        Headache
    8
    12
        Arthralgia
    13
    24
        Rash
    3
    5
        Fever (≥38°C)
    10
    10
        Antipyretic Preventive medication used
    24
    29
        Antipyretic Treatment medication used
    8
    12
        Temperature(≥40°C)
    1
    0
        Medically attended fever
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study
    Adverse event reporting additional description
    Solicited Adverse Events (AEs) were collected from Day 1 to Day 7 after each vaccination, Serious Adverse Events (SAEs) and other unsolicited AEs were collected throughout the study [approximately 20 months for Groups rMenB; rMenB+OMV NZ and Naive_4042 and Day 1 to Day 91 for Naive_6062 group].
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    4rMenB
    Reporting group description
    		 Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.

    Reporting group title
    4rMenB+OMV NZ
    Reporting group description
    		 Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.

    Reporting group title
    Naive_4042
    Reporting group description
    		 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.

    Reporting group title
    Naive_6062
    Reporting group description
    		 Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.

    Serious adverse events
    		 4rMenB 4rMenB+OMV NZ Naive_4042 Naive_6062
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 14 (7.14%)
    4 / 41 (9.76%)
    1 / 48 (2.08%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Nervous system disorders
    Febrile convulsion
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15.0 and AE occurences number all & related, fatalaties number all & related were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15.0 and AE occurences number all & related, fatalaties number all & related were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15.0 and AE occurences number all & related, fatalaties number all & related were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15.0 and AE occurences number all & related, fatalaties number all & related were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Croup infectious
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15.0 and AE occurences number all & related, fatalaties number all & related were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15.0 and AE occurences number all & related, fatalaties number all & related were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15.0 and AE occurences number all & related, fatalaties number all & related were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15.0 and AE occurences number all & related, fatalaties number all & related were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 4rMenB 4rMenB+OMV NZ Naive_4042 Naive_6062
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 16 (93.75%)
    14 / 14 (100.00%)
    41 / 41 (100.00%)
    48 / 48 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hair follicle tumor benign
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Surgical and medical procedures
    Ear tube insertion
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    2
    0
    0
    General disorders and administration site conditions
    Induration
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    2 / 41 (4.88%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Injection site erythema
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    13 / 16 (81.25%)
    14 / 14 (100.00%)
    40 / 41 (97.56%)
    46 / 48 (95.83%)
         occurrences all number
    13
    14
    74
    92
    Injection site induration
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    11 / 16 (68.75%)
    5 / 14 (35.71%)
    26 / 41 (63.41%)
    28 / 48 (58.33%)
         occurrences all number
    14
    6
    39
    42
    Pain
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Swelling
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Injection site pain
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    10 / 16 (62.50%)
    12 / 14 (85.71%)
    38 / 41 (92.68%)
    46 / 48 (95.83%)
         occurrences all number
    13
    13
    73
    94
    Injection site swelling
    Additional description: Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    9 / 16 (56.25%)
    6 / 14 (42.86%)
    20 / 41 (48.78%)
    32 / 48 (66.67%)
         occurrences all number
    9
    6
    27
    45
    Pyrexia
    Additional description: Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 16 (25.00%)
    1 / 14 (7.14%)
    11 / 41 (26.83%)
    10 / 48 (20.83%)
         occurrences all number
    4
    1
    11
    11
    Respiratory, thoracic and mediastinal disorders
    Asthma
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cough
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    3 / 41 (7.32%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Respiratory disorder
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Irritability
    Additional description: Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    8 / 16 (50.00%)
    11 / 14 (78.57%)
    29 / 41 (70.73%)
    29 / 48 (60.42%)
         occurrences all number
    8
    14
    50
    43
    Eating disorder
    Additional description: Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 16 (31.25%)
    5 / 14 (35.71%)
    20 / 41 (48.78%)
    15 / 48 (31.25%)
         occurrences all number
    5
    5
    26
    22
    Injury, poisoning and procedural complications
    Skin Abrasion (Excoriation)
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Laceration
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Headache
    Additional description: Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 14 (7.14%)
    8 / 41 (19.51%)
    13 / 48 (27.08%)
         occurrences all number
    2
    1
    9
    17
    Somnolence
    Additional description: Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 16 (37.50%)
    6 / 14 (42.86%)
    26 / 41 (63.41%)
    26 / 48 (54.17%)
         occurrences all number
    6
    8
    38
    36
    Blood and lymphatic system disorders
    Lymphadenopathy
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain upper
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    0
    1
    Gastritis
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea
    Additional description: Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 14 (7.14%)
    4 / 41 (9.76%)
    4 / 48 (8.33%)
         occurrences all number
    2
    1
    4
    5
    Vomiting
    Additional description: Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    2 / 14 (14.29%)
    6 / 41 (14.63%)
    7 / 48 (14.58%)
         occurrences all number
    0
    2
    7
    8
    Skin and subcutaneous tissue disorders
    Erythema
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Rash macular
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rash
    Additional description: Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 14 (7.14%)
    5 / 41 (12.20%)
    5 / 48 (10.42%)
         occurrences all number
    2
    1
    5
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 16 (12.50%)
    3 / 14 (21.43%)
    13 / 41 (31.71%)
    24 / 48 (50.00%)
         occurrences all number
    2
    3
    18
    32
    Infections and infestations
    Conjunctivitis
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lower respiratory tract infection
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 14 (7.14%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Ear infection
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 16 (12.50%)
    1 / 14 (7.14%)
    3 / 41 (7.32%)
    1 / 48 (2.08%)
         occurrences all number
    3
    1
    7
    1
    Rhinitis
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 14 (0.00%)
    3 / 41 (7.32%)
    2 / 48 (4.17%)
         occurrences all number
    0
    0
    3
    2
    Tonsillitis
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 14 (7.14%)
    4 / 41 (9.76%)
    0 / 48 (0.00%)
         occurrences all number
    0
    6
    5
    0
    Urinary tract infection
    Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1 for all the reported events.
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    1 / 41 (2.44%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Varicella
    Additional description: Additional description: Subject affected number for the reporting group 4rMenB, 4rMenB+OMV, Naive_4042, Naive_6062 were generated through MedDRA version 15 and the corresponding AE occurences all number were generated using MedDRA version 17.1
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 14 (0.00%)
    0 / 41 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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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.
    Not specified

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24722351
    http://www.ncbi.nlm.nih.gov/pubmed/23958808
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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