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    Clinical Trial Results:
    Title of the trial: A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting at 12 Months of Age and to Evaluate the Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2009-018101-52
    Trial protocol
    FI   CZ  
    Global end of trial date
    08 Sep 2011

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

    Trial information

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    Trial identification
    Sponsor protocol code
    V72P13E2
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01139021
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics
    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
    02 May 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity: To explore antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ, administered at 12 months of age to toddlers enrolled in study V72P13E1 who previously received a three-dose primary series of rMenB+OMV NZ (administered at 2, 4, and 6 months of age) as infants in the original parent study V72P13.
    Protection of trial subjects
    This clinical study was designed, implemented and reported in accordance with the ICH Harmonized Tripartite Guidelines for GCP, with applicable local regulations, including the European Directive 2001/20/EC, the US CFR Title 21, and the Japanese Ministry of Health, Labor, and Welfare, Novartis codes on the protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Jun 2010
    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
    Czech Republic: 345
    Country: Number of subjects enrolled
    Finland: 163
    Worldwide total number of subjects
    508
    EEA total number of subjects
    508
    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)
    42
    Children (2-11 years)
    466
    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
    Participants were enrolled from two study centers.

    Pre-assignment
    Screening details
    The eligible subjects from V72P13E1 (NCT00847145) who originally participated in the open-label, immunogenicity subset of parent study V72P13 (NCT00657709) and a naïve group, at 24 months of age, who did not previously participate in V72P13 (or V72P13E1) were enrolled in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Not Applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    B246_12M12
    Arm description
    Subjects assessed one year post administration of rMenB+OMV NZ and Measles, Mumps, Rubella, Varicella (MMRV) at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
    Arm type
    Experimental

    Investigational medicinal product name
    Not Applicable
    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
    B246_12M13
    Arm description
    Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
    Arm type
    Experimental

    Investigational medicinal product name
    Not Applicable
    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
    B13_15_27
    Arm description
    Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
    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
    B12_14_26
    Arm description
    Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
    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
    B_24_26
    Arm description
    Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age
    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
    B12M13
    Arm description
    Subject was randomized in group B13_15_27 but treated as group B12_M13
    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.

    Number of subjects in period 1
    B246_12M12 B246_12M13 B13_15_27 B12_14_26 B_24_26 B12M13
    Started
    152
    153
    67
    19
    116
    1
    Completed
    151
    153
    67
    18
    107
    1
    Not completed
    1
    0
    0
    1
    9
    0
         Protocol deviation
             1
             -
             -
             -
             2
             -
         Consent withdrawn by subject
             -
             -
             -
             1
             4
             -
         Adverse Event
             -
             -
             -
             -
             1
             -
         Lost to follow-up
             -
             -
             -
             -
             2
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    B246_12M12
    Reporting group description
    Subjects assessed one year post administration of rMenB+OMV NZ and Measles, Mumps, Rubella, Varicella (MMRV) at 12th month after primary vaccination at 2nd ,4th and 6th months of age.

    Reporting group title
    B246_12M13
    Reporting group description
    Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.

    Reporting group title
    B13_15_27
    Reporting group description
    Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.

    Reporting group title
    B12_14_26
    Reporting group description
    Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.

    Reporting group title
    B_24_26
    Reporting group description
    Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

    Reporting group title
    B12M13
    Reporting group description
    Subject was randomized in group B13_15_27 but treated as group B12_M13

    Reporting group values
    B246_12M12 B246_12M13 B13_15_27 B12_14_26 B_24_26 B12M13 Total
    Number of subjects
    152 153 67 19 116 1 508
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    25 ± 1 25.3 ± 0.9 27.3 ± 0.9 26.6 ± 1.2 24.7 ± 1.4 26 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    65 85 30 10 55 1 246
        Male
    87 68 37 9 61 0 262

    End points

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    End points reporting groups
    Reporting group title
    B246_12M12
    Reporting group description
    Subjects assessed one year post administration of rMenB+OMV NZ and Measles, Mumps, Rubella, Varicella (MMRV) at 12th month after primary vaccination at 2nd ,4th and 6th months of age.

    Reporting group title
    B246_12M13
    Reporting group description
    Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.

    Reporting group title
    B13_15_27
    Reporting group description
    Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.

    Reporting group title
    B12_14_26
    Reporting group description
    Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.

    Reporting group title
    B_24_26
    Reporting group description
    Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

    Reporting group title
    B12M13
    Reporting group description
    Subject was randomized in group B13_15_27 but treated as group B12_M13

    Subject analysis set title
    Enrolled Population
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    All subjects who were enrolled in this study.

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

    Subject analysis set title
    Modified ITT (Primary)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    All subjects in the enrolled population who provided an evaluable serum sample (visit 1, i.e., 12 months after booster or 2 dose catch-up schedule or prior to vaccination naive controls). In case of randomization errors, subjects were to be analyzed as planned in MITT population

    Subject analysis set title
    Modified ITT (Secondary)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    All subjects in the enrolled population who: actually received a study vaccination, and provided at least an evaluable serum sample after vaccination (groups B13_15_27 and B12_14_26, visit 2), or at least an evaluable serum sample before vaccination and 30 days after the second vaccination (B24_26). In case of randomization errors, subjects were to be analyzed as planned in MITT population

    Subject analysis set title
    B246_12Tot
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age

    Subject analysis set title
    B12+B13Tot
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th or 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26th or 27th months of age.

    Primary: Geometric Mean Titers (GMTs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

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    End point title
    Geometric Mean Titers (GMTs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination [1] [2]
    End point description
    To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs, through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately). Analysis was done on Modified Intention-To-Treat (MITT) population (Primary).
    End point type
    Primary
    End point timeframe
    12 months post booster (4th) vaccination.
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    [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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    B246_12M12 B246_12M13 B246_12Tot
    Number of subjects analysed
    147
    153
    300
    Units: Titers
    geometric mean (confidence interval 95%)
        H44/76-SL (N=147,152,299)
    7.38 (5.55 to 9.83)
    8.3 (6.17 to 11)
    6.5 (5.63 to 7.5)
        5/99 (N=147,151,298)
    68 (52 to 91)
    90 (67 to 121)
    81 (71 to 94)
        NZ98/254 (N=147,153,300)
    1.57 (1.24 to 1.99)
    1.79 (1.4 to 2.29)
    1.91 (1.7 to 2.15)
        M10713 (N=143,148,291)
    4.37 (3.24 to 5.9)
    3.62 (2.65 to 4.94)
    3.35 (2.88 to 3.9)
    No statistical analyses for this end point

    Primary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

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    End point title
    Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination [3] [4]
    End point description
    To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 & hSBA ≥1:8 through antibody persistence at 1 year after a booster (4th) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2,4,6 months of age. Group B246_12M12 received MMRV at 12 months (concomitantly) & B246_12M13 received MMRV at 13 months of age (separately). Analysis was done on MITT population (Primary).
    End point type
    Primary
    End point timeframe
    12 months post booster (4th) vaccination.
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    [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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    B246_12M12 B246_12M13 B246_12Tot
    Number of subjects analysed
    147
    153
    300
    Units: Percentage of subjects
    number (confidence interval 95%)
        H44/76-SL (hSBA ≥1:5) (N=147, 152, 299)
    60 (51 to 68)
    64 (56 to 71)
    62 (56 to 67)
        5/99 (hSBA ≥1:5) (N=147, 151, 298)
    96 (91 to 98)
    99 (95 to 100)
    97 (95 to 99)
        NZ98/254 (hSBA ≥1:5) (N=147, 153, 300)
    18 (12 to 25)
    17 (11 to 24)
    17 (13 to 22)
        M10713 (hSBA ≥1:5) (N=143, 148, 291)
    40 (32 to 48)
    32 (25 to 41)
    36 (31 to 42)
        H44/76-SL (hSBA ≥1:8) (N=147, 152, 299)
    44 (35 to 52)
    47 (39 to 55)
    45 (39 to 51)
        5/99 (hSBA ≥1:8) (N=147, 151, 298)
    96 (91 to 98)
    98 (94 to 100)
    97 (94 to 99)
        NZ98/254 (hSBA ≥1:8) (N=147, 153, 300)
    12 (7 to 19)
    14 (9 to 21)
    13 (10 to 18)
        M10713 (hSBA ≥1:8) (N=143, 148, 291)
    31 (23 to 39)
    24 (17 to 31)
    27 (22 to 33)
    No statistical analyses for this end point

    Primary: Geometric Mean concentrations (GMCs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination

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    End point title
    Geometric Mean concentrations (GMCs) to assess antibody persistence at one year after a booster dose of rMenB+OMV NZ Vaccination [5] [6]
    End point description
    To assess the immunogenicity in terms of GMCs determined by ELISA through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246_12M12 received MMRV at 12 months of age (concomitantly) and group B246_12M13 received MMRV at 13 months of age (separately)against vaccine antigen 287-953. Analysis was done on MITT population (Primary).
    End point type
    Primary
    End point timeframe
    12 months post booster (4th) vaccination
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    [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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    B246_12M12 B246_12M13 B246_12Tot
    Number of subjects analysed
    148
    153
    301
    Units: Concentration
    geometric mean (confidence interval 95%)
        287-953
    360 (293 to 442)
    389 (314 to 482)
    352 (317 to 391)
    No statistical analyses for this end point

    Secondary: GMTs to assess antibody persistence at 12 months after two catch-up doses and 6 months after booster dose of rMenB+OMV NZ Vaccination

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    End point title
    GMTs to assess antibody persistence at 12 months after two catch-up doses and 6 months after booster dose of rMenB+OMV NZ Vaccination [7]
    End point description
    To assess the immunogenicity in terms of hSBA GMTs at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age.Both the groups received MMRV at 12 months of age. Analysis was done on MITT population (Secondary).
    End point type
    Secondary
    End point timeframe
    6 months or 12 months post two catch-up dose vaccination.
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    B13_15_27 B12_14_26 B12+B13Tot
    Number of subjects analysed
    67
    18
    85
    Units: Titers
    geometric mean (confidence interval 95%)
        H44/76-SL (12months) (N= 67, 18, 85)
    14 (9.01 to 23)
    8.4 (4.13 to 17)
    10 (8 to 13)
        5/99 (12months) (N= 67, 18, 85)
    73 (43 to 123)
    71 (32 to 154)
    65 (49 to 85)
        NZ98/254 (12months) (N= 67, 18, 85)
    1.67 (1.09 to 2.55)
    1.2 (0.64 to 2.27)
    1.75 (1.39 to 2.2)
        M10713 (12months) (N= 64, 18, 82)
    3.74 (2.14 to 6.54)
    3.29 (1.43 to 7.56)
    3.4 (2.5 to 4.61)
        H44/76-SL (6months) (N= 67, 17, 84)
    68 (41 to 113)
    70 (32 to 151)
    51 (38 to 68)
        5/99 (6months) (N= 67, 17, 84)
    524 (332 to 827)
    525 (263 to 1047)
    518 (405 to 664)
        NZ98/254 (6months) (N= 67, 17, 84)
    8.87 (5.23 to 15)
    16 (7.13 to 35)
    8.8 (6.63 to 12)
        M10713 (6months) (N= 66, 16, 82)
    30 (18 to 49)
    36 (17 to 78)
    26 (20 to 33)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at 12 months after two catch up doses and 6 months after a booster doses of rMenB+OMV NZ Vaccination.

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    End point title
    Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody persistence at 12 months after two catch up doses and 6 months after a booster doses of rMenB+OMV NZ Vaccination. [8]
    End point description
    To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age. Both the groups received MMRV at 12 months of age. Analysis was done on MITT population (Secondary).
    End point type
    Secondary
    End point timeframe
    6month and 12 months post two catch-up dose vaccination.
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    B13_15_27 B12_14_26 B12+B13Tot
    Number of subjects analysed
    67
    18
    85
    Units: Percentage of subjects
    number (confidence interval 95%)
        H44/76-SL (hSBA ≥1:5) (12months) (N= 67, 18, 85)
    75 (63 to 84)
    56 (31 to 78)
    71 (60 to 80)
        5/99 (hSBA ≥1:5) (12months) (N= 67, 18, 85)
    97 (90 to 100)
    94 (73 to 100)
    96 (90 to 99)
        NZ98/254 (hSBA ≥1:5) (12months) (N= 67, 18, 85)
    18 (10 to 29)
    6 (0 to 27)
    15 (8 to 25)
        M10713 (hSBA ≥1:5) (12months) (N= 64, 18, 82)
    39 (27 to 52)
    28 (10 to 53)
    37 (26 to 48)
        H44/76-SL (hSBA ≥1:5) (6months) (N= 67, 17, 84)
    99 (92 to 100)
    100 (80 to 100)
    99 (94 to 100)
        5/99 (hSBA ≥1:5) (6months) (N= 67, 18, 84)
    100 (95 to 100)
    100 (80 to 100)
    100 (96 to 100)
        NZ98/254 (hSBA ≥1:5) (6months) (N= 67, 18, 84)
    73 (61 to 83)
    82 (57 to 96)
    75 (64 to 84)
        M10713 (hSBA ≥1:5) (6months) (N= 66, 16, 82)
    92 (83 to 97)
    94 (70 to 100)
    93 (85 to 97)
        H44/76-SL (hSBA ≥1:8) (12months) (N= 67, 18, 85)
    63 (50 to 74)
    56 (31 to 78)
    61 (50 to 72)
        5/99 (hSBA ≥1:8) (12months) (N= 67, 18, 85)
    96 (87 to 99)
    94 (73 to 100)
    95 (88 to 99)
        NZ98/254 (hSBA ≥1:8) (12months) (N= 67, 18, 85)
    15 (7 to 26)
    6 (0 to 27)
    13 (7 to 22)
        M10713 (hSBA ≥1:8) (12months) (N= 64, 18, 82)
    27 (16 to 39)
    22 (6 to 48)
    26 (17 to 36)
        H44/76-SL (hSBA ≥1:8) (6months) (N= 67, 17, 84)
    91 (82 to 97)
    100 (80 to 100)
    93 (85 to 97)
        5/99 (hSBA ≥1:8) (6months) (N= 67, 18, 84)
    100 (95 to 100)
    94 (71 to 100)
    99 (94 to 100)
        NZ98/254 (hSBA ≥1:8) (6months) (N= 67, 18, 84)
    52 (40 to 65)
    65 (38 to 86)
    55 (44 to 66)
        M10713 (hSBA ≥1:8) (6months) (N= 66, 16, 82)
    86 (76 to 94)
    81 (54 to 96)
    85 (76 to 92)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with at least four fold increase in hSBA titers to evaluate antibody response 1 month post booster dose of rMenB+OMV NZ Vaccination

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    End point title
    Percentage of subjects with at least four fold increase in hSBA titers to evaluate antibody response 1 month post booster dose of rMenB+OMV NZ Vaccination [9]
    End point description
    To assess the immunogenicity in terms of percentage of subjects with at least four fold increase in hSBA titers 1 month post booster dose of rMenB+OMV NZ administered at 26 or 27 months of age, in children previously administered two catch-up doses of rMenB+OMV NZ at either 12 and 14 or 13 and 15 months of age. Both the groups received MMRV at 12 months of age. Analysis was done on MITT population (Secondary).
    End point type
    Secondary
    End point timeframe
    1 month post booster dose versus prebooster
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    B13_15_27 B12_14_26 B12+B13Tot
    Number of subjects analysed
    67
    18
    85
    Units: Percentage of Subjects
    number (confidence interval 95%)
        H44/76-SL (N= 66, 18, 84)
    100 (95 to 100)
    100 (81 to 100)
    100 (96 to 100)
        5/99 (N= 67, 18, 85)
    99 (92 to 100)
    100 (81 to 100)
    99 (94 to 100)
        NZ98/254 (N= 65, 18, 83)
    97 (89 to 100)
    94 (73 to 100)
    96 (90 to 99)
        M10713 (N= 62, 16, 78)
    82 (70 to 91)
    88 (62 to 98)
    83 (73 to 91)
    No statistical analyses for this end point

    Secondary: GMCs to assess antibody persistence at one year after two catch-up doses and 6 months after booster of rMenB+OMV NZ Vaccination against 287-953 strain.

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    End point title
    GMCs to assess antibody persistence at one year after two catch-up doses and 6 months after booster of rMenB+OMV NZ Vaccination against 287-953 strain. [10]
    End point description
    To assess the immunogenicity in terms of GMCs determined by ELISA at 12 months after two catch up doses previously administered to children at either 12 and 14 or 13 and 15 months of age and 6 months after a booster dose of rMenB+OMV NZ administered at 26 or 27 months of age. Both the groups received MMRV at 12 months of age. Analysis was done on MITT population (Secondary).
    End point type
    Secondary
    End point timeframe
    12 months post two catch-up dose vaccination and 6 months post booster dose
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    B13_15_27 B12_14_26 B12+B13Tot
    Number of subjects analysed
    67
    18
    85
    Units: Concentration
    geometric mean (confidence interval 95%)
        287-953 (12months) (N=67, 18, 85)
    219 (149 to 322)
    246 (138 to 437)
    227 (185 to 278)
        287-953 (6months) (N=67, 17, 84)
    2314 (1596 to 3355)
    3259 (1859 to 5712)
    2597 (2104 to 3205)
    No statistical analyses for this end point

    Secondary: GMTs to characterize antibody response at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

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    End point title
    GMTs to characterize antibody response at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. [11]
    End point description
    To assess the immunogenicity in terms of GMTs through antibody response at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. Analysis was done on MITT population (Secondary).
    End point type
    Secondary
    End point timeframe
    1 month and 6 months post two catch-up doses.
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    B_24_26
    Number of subjects analysed
    108
    Units: Titers
    geometric mean (confidence interval 95%)
        H44/76-SL (1 month) (N= 105)
    220 (186 to 261)
        5/99 (1 month) (N= 103)
    455 (372 to 556)
        NZ98/254 (1 month) (N=108 )
    27 (23 to 32)
        M10713 (1 month) (N=100)
    38 (32 to 45)
        H44/76-SL (6 months) (N=104)
    22 (18 to 27)
        5/99 (6 months) (N= 104)
    71 (57 to 89)
        NZ98/254 (6 months) (N= 104)
    1.88 (1.57 to 2.26)
        M10713 (6 months) (N= 104)
    8.04 (6.39 to 10)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

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    End point title
    Percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age [12]
    End point description
    To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody response at at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. Analysis was done on MITT population (Secondary).
    End point type
    Secondary
    End point timeframe
    1 month and 6 months post two catch-up doses
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    B_24_26
    Number of subjects analysed
    108
    Units: Percentage of subjects
    number (confidence interval 95%)
        H44/76-SL (hSBA ≥1:5) (1months) (N=105)
    100 (97 to 100)
        5/99 (hSBA ≥1:5) (1months) (N= 103)
    99 (95 to 100)
        NZ98/254 (hSBA ≥1:5) (1months) (N= 108)
    98 (93 to 100)
        M10713 (hSBA ≥1:5) (1months) (N= 100)
    97 (91 to 99)
        H44/76-SL (hSBA ≥1:5) (6months) (N=104)
    93 (87 to 97)
        5/99 (hSBA ≥1:5) (6months) (N= 104 )
    96 (90 to 99)
        NZ98/254 (hSBA ≥1:5) (6months) (N= 104)
    18 (11 to 27)
        M10713 (hSBA ≥1:5) (6months) (N= 104)
    70 (60 to 79)
        H44/76-SL (hSBA ≥1:8) (1months) (N=105)
    100 (97 to 100)
        5/99 (hSBA ≥1:8) (1months) (N= 103)
    99 (95 to 100)
        NZ98/254 (hSBA ≥1:8) (1months) (N= 108)
    96 (91 to 99)
        M10713 (hSBA ≥1:8) (1months) (N= 100)
    95 (89 to 98)
        H44/76-SL (hSBA ≥1:8) (6months) (N=104)
    88 (80 to 93)
        5/99 (hSBA ≥1:8) (6months) (N= 104)
    96 (90 to 99)
        NZ98/254 (hSBA ≥1:8) (6months) (N= 104)
    12 (6 to 19)
        M10713 (hSBA ≥1:8) (6months) (N= 104)
    52 (42 to 62)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with fourfold increases in hSBA to assess antibody response at 1 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age

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    End point title
    Percentage of subjects with fourfold increases in hSBA to assess antibody response at 1 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age [13]
    End point description
    To assess the immunogenicity in terms of percentage of subjects with fourfold increases in hSBA titers at 1 month post two catch-up doses of rMenB+OMV NZ in children previously administered to naive children at 24 and 26 months of age against 4 strains. Analysis was done on MITT population (Secondary).
    End point type
    Secondary
    End point timeframe
    1 month post two catch-up doses versus prevaccination
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    B_24_26
    Number of subjects analysed
    108
    Units: Percentage of subjects
    geometric mean (confidence interval 95%)
        H44/76-SL (N=105)
    100 (97 to 100)
        5/99 (N= 101)
    99 (95 to 100)
        NZ98/254 (N=108 )
    96 (91 to 99)
        M10713 (N= 99)
    85 (76 to 91)
    No statistical analyses for this end point

    Secondary: GMCs to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain.

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    End point title
    GMCs to assess antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain. [14]
    End point description
    To assess the immunogenicity in terms of GMCs to assess through antibody response at 1 month and 6 month post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age against 287-953 strain. Analysis was done on MITT population (Secondary).
    End point type
    Secondary
    End point timeframe
    1 month and 6 months post two catch-up doses
    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: There was no statistical null hypothesis associated with this immunogenicity objective.
    End point values
    B_24_26
    Number of subjects analysed
    112
    Units: Concentration
    geometric mean (confidence interval 95%)
        287-953 strain (1 month, N=108)
    5448 (4630 to 6411)
        287-953 strain (6 months, N=105)
    383 (319 to 459)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local and systemic AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1year after 2 catch-up doses of rMenB+OMV NZ, previously administered at either 12 & 14 or 13 & 15 months of age in V72P13E1

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    End point title
    Number of subjects reporting solicited local and systemic AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1year after 2 catch-up doses of rMenB+OMV NZ, previously administered at either 12 & 14 or 13 & 15 months of age in V72P13E1 [15]
    End point description
    To assess the safety and tolerability by reporting solicited local and systemic AEs of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1. The analysis was done on safety subset.
    End point type
    Secondary
    End point timeframe
    Up to 7 days after any vaccination
    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: All safety analyses were run in the safety population. EudraCT
    End point values
    B13_15_27 B12_14_26
    Number of subjects analysed
    67
    18
    Units: Number of Subjects
        Any Local
    64
    16
        Tenderness (N=67,17)
    63
    16
        Erythema (N=67,17)
    47
    13
        Induration (N=67,17)
    37
    9
        Swelling (N=67,17)
    35
    9
        Any Systemic
    53
    15
        Change Eat. Habits (N=67,17)
    25
    9
        Sleepiness (N=67,17)
    22
    7
        Vomiting (N=67,17)
    4
    0
        Diarrhoea (N=67,17)
    4
    1
        Irritability (N=67,17)
    40
    14
        Unusual Crying (N=67,17)
    16
    5
        Rash (N=67,17)
    1
    0
        Fever ( >= 38C )
    22
    6
        Temperature (>= 40 C) (N=67,17)
    0
    0
        Medical Attend. Fever (N=67,17)
    0
    0
        Antipyr. Med. Used Prev. (N=67,17)
    12
    5
        Antipyr. Med. Used Trt. (N=67,17)
    20
    6
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Unsolicited AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1 year after 2 catch-up doses of rMenB+OMV NZ,previously administered to children at either 12 & 14 or 13 &15 months of age in V72P13E2

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    End point title
    Number of Subjects Reporting Unsolicited AEs after receiving a booster (3rd) dose of rMenB+OMV NZ administered at 1 year after 2 catch-up doses of rMenB+OMV NZ,previously administered to children at either 12 & 14 or 13 &15 months of age in V72P13E2 [16]
    End point description
    To assess the safety and tolerability in terms of number of subjects reporting unsolicited AEs of a booster (third) dose of rMenB+OMV NZ administered at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 or 13 and 15 months of age in study V72P13E1. The analysis was done on safety subset.
    End point type
    Secondary
    End point timeframe
    Up to 7 days after any vaccination
    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: All safety analyses were run in the safety population. EudraCT
    End point values
    B13_15_27 B12_14_26
    Number of subjects analysed
    67
    18
    Units: Number of Subjects
        Any AE
    45
    10
        Serious AEs
    2
    1
        At least possibly related SAEs
    0
    0
        AEs leading to withdrawal
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local and systemic AEs after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

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    End point title
    Number of subjects reporting solicited local and systemic AEs after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. [17]
    End point description
    To assess the safety and tolerability by reporting solicited local and systemic AEs of two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. The analysis was done on safety subset.
    End point type
    Secondary
    End point timeframe
    Up to 7 days after any vaccination
    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: All safety analyses were run in the safety population. EudraCT
    End point values
    B_24_26
    Number of subjects analysed
    112
    Units: Number of subjects)
        Any Local
    110
        Tenderness
    109
        Erythema
    103
        Induration
    75
        Swelling
    58
        Any Systemic
    98
        Change Eat. Habits
    53
        Sleepiness
    70
        Vomiting
    14
        Diarrhea
    23
        Irritability
    84
        Unusual Crying
    47
        Rash
    14
        Fever ( >= 38C )
    44
        Temperature (>= 40 C)
    1
        Medical Attend. Fever
    2
        Antipyr. Med. Used Prev
    33
        Antipyr. Med. Used Trt
    38
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Unsolicited Adverse Events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

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    End point title
    Number of Subjects Reporting Unsolicited Adverse Events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. [18]
    End point description
    To assess the safety and tolerability in terms of number of subjects reporting unsolicited adverse events after receiving two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. The analysis was done on safety subset.
    End point type
    Secondary
    End point timeframe
    Up to 7 days after any vaccination
    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: All safety analyses were run in the safety population. EudraCT
    End point values
    B_24_26
    Number of subjects analysed
    112
    Units: Number of Subjects
        Any AE
    96
        Serious AEs
    6
        At least possibly related SAEs
    0
        AEs leading to withdrawal
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study (solicited and unsolicited from Day 1 to Day 209)
    Adverse event reporting additional description
    Any solicited and unsolicited adverse events were reported up to day 7 post vaccination. Unsolicited SAE, medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    B13_15_27
    Reporting group description
    Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.

    Reporting group title
    B24_26
    Reporting group description
    Subjects assessed for safety and tolerability after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.

    Reporting group title
    B12_14_26
    Reporting group description
    Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 months of age.

    Serious adverse events
    B13_15_27 B24_26 B12_14_26
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 67 (2.99%)
    6 / 112 (5.36%)
    1 / 18 (5.56%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cholesteatoma
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 112 (0.89%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal Hypertrophy
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 112 (0.89%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 112 (0.89%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 112 (0.89%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 112 (0.89%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 112 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral Herpes
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 112 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis Media
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 112 (0.89%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Respiratory Syncytial Viral
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 112 (0.89%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    B13_15_27 B24_26 B12_14_26
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 67 (100.00%)
    110 / 112 (98.21%)
    18 / 18 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Somnolence
         subjects affected / exposed
    22 / 67 (32.84%)
    70 / 112 (62.50%)
    7 / 18 (38.89%)
         occurrences all number
    22
    109
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 67 (4.48%)
    14 / 112 (12.50%)
    0 / 18 (0.00%)
         occurrences all number
    3
    18
    0
    Nervous system disorders
    Speech Disorder Developmental
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 112 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Crying
         subjects affected / exposed
    16 / 67 (23.88%)
    47 / 112 (41.96%)
    5 / 18 (27.78%)
         occurrences all number
    17
    70
    5
    Induration
         subjects affected / exposed
    1 / 67 (1.49%)
    4 / 112 (3.57%)
    1 / 18 (5.56%)
         occurrences all number
    1
    4
    1
    Injection Site Erythema
         subjects affected / exposed
    47 / 67 (70.15%)
    103 / 112 (91.96%)
    13 / 18 (72.22%)
         occurrences all number
    52
    177
    14
    Injection Site Induration
         subjects affected / exposed
    37 / 67 (55.22%)
    75 / 112 (66.96%)
    9 / 18 (50.00%)
         occurrences all number
    54
    156
    12
    Injection Site Pain
         subjects affected / exposed
    63 / 67 (94.03%)
    109 / 112 (97.32%)
    16 / 18 (88.89%)
         occurrences all number
    68
    208
    16
    Injection Site Swelling
         subjects affected / exposed
    35 / 67 (52.24%)
    58 / 112 (51.79%)
    9 / 18 (50.00%)
         occurrences all number
    39
    83
    11
    Pyrexia
         subjects affected / exposed
    22 / 67 (32.84%)
    46 / 112 (41.07%)
    6 / 18 (33.33%)
         occurrences all number
    23
    61
    6
    Tenderness
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 112 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    1
    0
    1
    Psychiatric disorders
    Eating Disorder
         subjects affected / exposed
    25 / 67 (37.31%)
    53 / 112 (47.32%)
    9 / 18 (50.00%)
         occurrences all number
    26
    80
    9
    Irritability
         subjects affected / exposed
    40 / 67 (59.70%)
    84 / 112 (75.00%)
    14 / 18 (77.78%)
         occurrences all number
    43
    140
    14
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 112 (1.79%)
    1 / 18 (5.56%)
         occurrences all number
    1
    2
    1
    Diarrhoea
         subjects affected / exposed
    5 / 67 (7.46%)
    24 / 112 (21.43%)
    1 / 18 (5.56%)
         occurrences all number
    5
    28
    2
    Vomiting
         subjects affected / exposed
    4 / 67 (5.97%)
    15 / 112 (13.39%)
    0 / 18 (0.00%)
         occurrences all number
    4
    17
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 67 (1.49%)
    18 / 112 (16.07%)
    0 / 18 (0.00%)
         occurrences all number
    1
    20
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 67 (5.97%)
    14 / 112 (12.50%)
    1 / 18 (5.56%)
         occurrences all number
    4
    16
    1
    Conjunctivitis
         subjects affected / exposed
    5 / 67 (7.46%)
    16 / 112 (14.29%)
    0 / 18 (0.00%)
         occurrences all number
    5
    19
    0
    Ear Infection
         subjects affected / exposed
    1 / 67 (1.49%)
    6 / 112 (5.36%)
    0 / 18 (0.00%)
         occurrences all number
    1
    6
    0
    Exanthema Subitum
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 112 (0.89%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 67 (0.00%)
    6 / 112 (5.36%)
    0 / 18 (0.00%)
         occurrences all number
    0
    6
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 67 (7.46%)
    9 / 112 (8.04%)
    2 / 18 (11.11%)
         occurrences all number
    5
    10
    2
    Otitis Media
         subjects affected / exposed
    7 / 67 (10.45%)
    18 / 112 (16.07%)
    1 / 18 (5.56%)
         occurrences all number
    9
    23
    1
    Pharyngitis
         subjects affected / exposed
    2 / 67 (2.99%)
    9 / 112 (8.04%)
    0 / 18 (0.00%)
         occurrences all number
    2
    10
    0
    Pneumonia
         subjects affected / exposed
    0 / 67 (0.00%)
    0 / 112 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    2 / 67 (2.99%)
    8 / 112 (7.14%)
    0 / 18 (0.00%)
         occurrences all number
    2
    10
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    5 / 67 (7.46%)
    20 / 112 (17.86%)
    1 / 18 (5.56%)
         occurrences all number
    6
    29
    2
    Viral Infection
         subjects affected / exposed
    7 / 67 (10.45%)
    14 / 112 (12.50%)
    1 / 18 (5.56%)
         occurrences all number
    8
    15
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2010
    To perform assessment of persistence data generated one year after the booster (fourth) dose of rMenB+OMV NZ (groups B246_12M12 and B246_12M13) and one year after the two catch-up doses of rMenB+OMV NZ (groups B13_15_27 and B12_14_26) with a comparison against baseline titers of naive subjects at 24 months of age (group B_24_26).

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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