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    Clinical Trial Results:
    A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, when Administered to Healthy Infants 6-8 months old

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2006-005589-38
    Trial protocol
    GB  
    Global end of trial date
    15 Jul 2008

    Results information
    Results version number
    v2(current)
    This version publication date
    15 Jun 2016
    First version publication date
    08 Jan 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data points need to be updated.

    Trial information

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    Trial identification
    Sponsor protocol code
    V72P9
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00433914
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics S.r.l
    Sponsor organisation address
    S.r.l. - via Fiorentina 1, Siena, Italy, 53100
    Public contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.com
    Scientific contact
    Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000139-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Feb 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore the immunogenicity of Novartis rMenB Vaccine +/- OMV when administered to healthy infants, at 30 days after the second and the third dose, by evaluation of the breadth of bactericidal activity (BCA) response against a panel of genetically distinct meningococcal strains. To explore the safety and tolerability of Novartis rMenB with or without OMV throughout the clinical study.
    Protection of trial subjects
    Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. An oral temperature ≥38.0°C (≥100.4°F) or serious active infection was a reason for delaying vaccination. Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine is not injected into a blood vessel.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Feb 2007
    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?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    Children (2-11 years)
    0
    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 enrolled at one study center in the UK.

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

    Period 1
    Period 1 title
    Per arm in the baseline period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject
    Blinding implementation details
    The trial was designed as a single-blind study with the study personnel being aware of the vaccine administered, but the enrolled subjects and their parents unaware of the vaccine received.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    rMenB
    Arm description
    6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
    Arm type
    Experimental

    Investigational medicinal product name
    Novartis rMenB vaccine
    Investigational medicinal product code
    Other name
    Serogroup B meningococcal recombinant vaccine without OMV-NZ
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of three 0.5 mL doses of rMenB vaccine administered IM into anterolateral area of the right thigh

    Arm title
    rMenB + OMV
    Arm description
    6-8 month-old infants were administered 3 doses of Novartis rMenB with OMV-NZ vaccine at 6-8 months of age, 2 months later and at 12 months of age.
    Arm type
    Experimental

    Investigational medicinal product name
    Novartis rMenB + OMV
    Investigational medicinal product code
    Other name
    Serogroup B meningococcal recombinant vaccine with OMV-NZ
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Vaccination consisted of three 0.5 mL doses of rMenB + OMV vaccine administered IM into anterolateral area of the right thigh

    Number of subjects in period 1
    rMenB rMenB + OMV
    Started
    30
    30
    Completed
    30
    27
    Not completed
    0
    3
         Consent withdrawn by subject
             -
             2
         Lost to follow-up
             -
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    rMenB
    Reporting group description
    6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.

    Reporting group title
    rMenB + OMV
    Reporting group description
    6-8 month-old infants were administered 3 doses of Novartis rMenB with OMV-NZ vaccine at 6-8 months of age, 2 months later and at 12 months of age.

    Reporting group values
    rMenB rMenB + OMV Total
    Number of subjects
    30 30 60
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    30 30 60
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine with or without OMV-NZ at 6-8, 2 months later and at 12 months of age.
    Units: months
        arithmetic mean (standard deviation)
    228.1 ± 18 230.1 ± 19.4 -
    Gender categorical
    6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine with or without OMV-NZ at 6-8, 2 months later and at 12 months of age.
    Units: Subjects
        Female
    14 18 32
        Male
    16 12 28

    End points

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    End points reporting groups
    Reporting group title
    rMenB
    Reporting group description
    6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.

    Reporting group title
    rMenB + OMV
    Reporting group description
    6-8 month-old infants were administered 3 doses of Novartis rMenB with OMV-NZ vaccine at 6-8 months of age, 2 months later and at 12 months of age.

    Subject analysis set title
    All enrolled population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All subjects who had data in the DEMOG panel.

    Subject analysis set title
    Per-protocol Populatoin
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All enrolled subjects who correctly received the vaccine, provided evaluable serum samples at the relevant time points (Visit 3), and had no major protocol violation as defined prior to the end of the study.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All subjects who received the study vaccine and provided some post-vaccination safety data

    Primary: Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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    End point title
    Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ [1]
    End point description
    Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.
    End point type
    Primary
    End point timeframe
    Baseline and one month after second and third 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: No statistical analyses for this end point.
    End point values
    rMenB rMenB + OMV
    Number of subjects analysed
    25
    24
    Units: Percentage of subjects
    number (confidence interval 95%)
        Strain 44/76-SL - Baseline
    8 (1 to 26)
    29 (13 to 51)
        Strain 44/76-SL - Post- 2nd vaccination (N=25,23)
    100 (86 to 100)
    100 (85 to 100)
        Strain 44/76-SL - Post-3rd vaccination (N=24,24)
    100 (86 to 100)
    100 (86 to 100)
        Strain 5/99 - Baseline
    0 (0 to 14)
    0 (0 to 14)
        Strain 5/99 - Post-2nd vaccination (N=25,23)
    100 (86 to 100)
    100 (85 to 100)
        Strain 5/99 - Post-3rd vaccination (N=24,24)
    100 (86 to 100)
    100 (86 to 100)
        Strain NZ98/254 - Baseline
    0 (0 to 14)
    0 (0 to 14)
        Strain NZ98/254 - Post-2nd vaccination (N=24,22)
    4 (0 to 21)
    95 (77 to 100)
        Strain NZ98/254 - Post-3rd vaccination (N=22,24)
    9 (1 to 29)
    96 (79 to 100)
        Strain UK P1.7-2,4 -Baseline (N=24,21)
    0 (0 to 14)
    0 (0 to 16)
        Strain UKP1.7-2,4 - Post-2nd vaccination (N=23,19)
    0 (0 to 15)
    100 (82 to 100)
        Strain UKP1.7-2,4 - Post-3rd vaccination (N=21,22)
    5 (0 to 24)
    100 (85 to 100)
        Strain GB101 - Baseline (N=24,21)
    0 (0 to 14)
    10 (1 to 30)
        Strain GB101 - Post-2nd vaccination (N=22,21)
    23 (8 to 45)
    67 (43 to 85)
        Strain GB101 - Post-3rd vaccination (N=22,22)
    27 (11 to 50)
    73 (50 to 89)
        Strain GB355 - Baseline (N=12,11)
    0 (0 to 26)
    0 (0 to 28)
        Strain GB355 - Post-2nd vaccination (N=11,14)
    0 (0 to 28)
    7 (0 to 34)
        Strain GB355 – Post 3rd vaccination (N=12,11)
    0 (0 to 26)
    18 (2 to 52)
        Strain GB364 - Baseline (N=22,17)
    9 (1 to 29)
    12 (1 to 36)
        Strain GB364 - Post-2nd vaccination (N=19,16)
    95 (74 to 100)
    88 (62 to 98)
        Strain GB364 - Post-3rd vaccination (N=17,19)
    88 (64 to 99)
    95 (74 to 100)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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    End point title
    Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ [2]
    End point description
    Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.
    End point type
    Primary
    End point timeframe
    Baseline and one month after second and third vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point.
    End point values
    rMenB rMenB + OMV
    Number of subjects analysed
    25
    24
    Units: Percentage of subjects
    number (confidence interval 95%)
        Strain 44/76-SL - Baseline
    0 (0 to 14)
    4 (0 to 21)
        Strain 44/76-SL - Post- 2nd Vaccination (N=25,23)
    96 (80 to 100)
    100 (85 to 100)
        Strain 44/76-SL - Post-3rd Vaccination (N=24,24)
    100 (86 to 100)
    100 (86 to 100)
        Strain 5/99 - Baseline
    0 (0 to 14)
    0 (0 to 14)
        Strain 5/99 - Post-2nd Vaccination (N=25,23)
    100 (86 to 100)
    100 (85 to 100)
        Strain 5/99 - Post-3rd Vaccination (N=24,24)
    100 (86 to 100)
    100 (86 to 100)
        Strain NZ98/254 - Baseline
    0 (0 to 14)
    0 (0 to 14)
        Strain NZ98/254 - Post- 2nd Vaccination (N=24,22)
    0 (0 to 14)
    91 (71 to 99)
        Strain NZ98/254 - Post- 3rd Vaccination (N=22,24)
    5 (0 to 23)
    96 (79 to 100)
        Strain UK P1.7-2,4 - Baseline (N=24,21)
    0 (0 to 14)
    0 (0 to 16)
        Strain UKP1.7-2,4 - Post- 2nd Vaccination (N=23,19
    0 (0 to 15)
    84 (60 to 97)
        Strain UKP1.7-2,4 - Post- 3rd Vaccination (N=21,22
    0 (0 to 16)
    95 (77 to 100)
        Strain GB101 – Baseline (N=24,21)
    0 (0 to 14)
    10 (1 to 30)
        Strain GB101 - Post-2nd Vaccination (N=22,21)
    9 (1 to 29)
    33 (15 to 57)
        Strain GB101 - Post-3rd Vaccination (N=22,22)
    14 (3 to 35)
    45 (24 to 68)
        Strain GB355 – Baseline (N=12,11)
    0 (0 to 26)
    0 (0 to 28)
        Strain GB355 - Post-2nd Vaccination (N=11,14)
    0 (0 to 28)
    0 (0 to 23)
        Strain GB355 – Post 3rd Vaccination (N=12,11)
    0 (0 to 26)
    0 (0 to 28)
        Strain GB364 – Baseline (N=22,17)
    0 (0 to 15)
    0 (0 to 20)
        Strain GB364 - Post-2nd Vaccination (N=19,16)
    74 (49 to 91)
    69 (41 to 89)
        Strain GB364 - Post-3rd Vaccination (N=17,19)
    71 (44 to 90)
    84 (60 to 97)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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    End point title
    Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
    End point description
    Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.
    End point type
    Secondary
    End point timeframe
    One month after second and third vaccination
    End point values
    rMenB rMenB + OMV
    Number of subjects analysed
    25
    24
    Units: Percentage of subjects
    number (confidence interval 95%)
        Strain 44/76-SL - Post- 2nd Vaccination (N=25,23)
    96 (80 to 100)
    100 (85 to 100)
        Strain 44/76-SL - Post-3rd Vaccination
    100 (86 to 100)
    100 (86 to 100)
        Strain 5/99 - Post-2nd Vaccination (N=25,23)
    100 (86 to 100)
    100 (85 to 100)
        Strain 5/99 - Post-3rd Vaccination
    100 (86 to 100)
    100 (86 to 100)
        Strain NZ98/254 - Post-2nd Vaccination (N=24,22)
    0 (0 to 14)
    91 (71 to 99)
        Strain NZ98/254 - Post- 3rd Vaccination (N=22,24)
    5 (0 to 23)
    96 (79 to 100)
        Strain UKP1.7-2,4 - Post-2nd Vaccination (N=22,17)
    0 (0 to 15)
    88 (64 to 99)
        Strain UKP1.7-2,4 - Post-3rd Vaccination (N=20,20)
    0 (0 to 17)
    95 (75 to 100)
        Strain GB101 - Post-2nd Vaccination (N=21,18)
    10 (1 to 30)
    22 (6 to 48)
        Strain GB101 - Post-3rd Vaccination (N=21,19)
    14 (3 to 36)
    32 (13 to 57)
        Strain GB355 - Post-2nd Vaccination (N=5,7)
    0 (0 to 52)
    0 (0 to 41)
        Strain GB355 - Post-3rd Vaccination (N=7,6)
    0 (0 to 41)
    0 (0 to 46)
        Strain GB364 - Post-2nd Vaccination (N=17,14)
    76 (50 to 93)
    64 (35 to 87)
        Strain GB364 - Post-3rd Vaccination (N=15,15)
    80 (52 to 96)
    80 (52 to 96)
        287-953proteinantigen-Post-2ndVaccination(N=25,23)
    100 (86 to 100)
    100 (85 to 100)
        287-953proteinantigen-Post-3rdVaccination(N=24,25)
    100 (86 to 100)
    100 (86 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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    End point title
    Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
    End point description
    The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254, before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.
    End point type
    Secondary
    End point timeframe
    Baseline and one month after second and third vaccination
    End point values
    rMenB rMenB + OMV
    Number of subjects analysed
    25
    24
    Units: Titers
    geometric mean (confidence interval 95%)
        Strain 44/76-SL - Baseline
    1.16 (0.89 to 1.52)
    1.7 (1.29 to 2.24)
        Strain 44/76-SL - Post- 2nd Vaccination (N=25,23)
    94 (66 to 134)
    250 (173 to 361)
        Strain 44/76-SL - Post-3rd Vaccination (N=24,24)
    109 (79 to 153)
    189 (136 to 263)
        Strain 5/99 - Baseline
    1 (0.94 to 1.07)
    1.05 (0.98 to 1.12)
        Strain 5/99 - Post-2nd Vaccination (N=25,23)
    710 (532 to 947)
    534 (395 to 721)
        Strain 5/99 - Post-3rd Vaccination (N=24,24)
    1202 (929 to 1555)
    906 (700 to 1172)
        Strain NZ98/254 - Baseline
    1 (1 to 1)
    1 (1 to 1)
        Strain NZ98/254 - Post- 2nd Vaccination (N=24,22)
    1.06 (0.82 to 1.38)
    27 (21 to 36)
        Strain NZ98/254 - Post- 3rd Vaccination (N=22,24)
    1.21 (0.86 to 1.72)
    44 (32 to 62)
        Strain UK P1.7-2,4 - Baseline (N=24,21)
    1 (1 to 1)
    1 (1 to 1)
        Strain UKP1.7-2,4 - Post- 2nd Vaccination (N=23,19
    1 (0.75 to 1.34)
    17 (12 to 24)
        Strain UKP1.7-2,4 - Post- 3rd Vaccination (N=21,22
    1.07 (0.72 to 1.58)
    34 (23 to 50)
        Strain GB101 - Baseline (N=24,21)
    1.12 (0.81 to 1.56)
    1.49 (1.05 to 2.11)
        Strain GB101 - Post-2nd Vaccination (N=22,21)
    1.82 (1.14 to 2.9)
    4.56 (2.83 to 7.35)
        Strain GB101 - Post-3rd Vaccination (N=22,22)
    2.2 (1.14 to 4.23)
    9.36 (4.87 to 18)
        Strain GB355 - Baseline (N=12,11)
    1 (1 to 1)
    1 (1 to 1)
        Strain GB355 - Post-2nd Vaccination (N=11,14)
    1 (0.83 to 1.21)
    1.16 (0.98 to 1.37)
        Strain GB355 – Post 3rd Vaccination (N=12,11)
    1.06 (0.82 to 1.36)
    1.46 (1.12 to 1.9)
        Strain GB364 - Baseline (N=22,17)
    1.46 (1.19 to 1.79)
    1.5 (1.19 to 1.9)
        Strain GB364 - Post-2nd Vaccination (N=19,16)
    11 (6.39 to 19)
    12 (6.75 to 23)
        Strain GB364 - Post-3rd Vaccination (N=17,19)
    12 (6.17 to 22)
    21 (11 to 37)
    No statistical analyses for this end point

    Secondary: Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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    End point title
    Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
    End point description
    The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbant assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.
    End point type
    Secondary
    End point timeframe
    Baseline and one month after second and third vaccination
    End point values
    rMenB rMenB + OMV
    Number of subjects analysed
    25
    25
    Units: Titers
    geometric mean (confidence interval 95%)
        Antigen 287-953 - Baseline
    24 (21 to 28)
    21 (18 to 24)
        Antigen 287-953 - Post-2nd Vaccination (N=25,23)
    1759 (1331 to 2324)
    2912 (2178 to 3894)
        Antigen 287-953 - Post-3rd Vaccination (N=24,25)
    2298 (1778 to 2970)
    3521 (2739 to 4527)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

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    End point title
    Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
    End point description
    Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). The analysis was performed on the per-protocol population.
    End point type
    Secondary
    End point timeframe
    One month after second and third vaccination
    End point values
    rMenB rMenB + OMV
    Number of subjects analysed
    25
    25
    Units: Percentage of subjects
    number (confidence interval 95%)
        Antigen 287-953 - Post-2nd Vaccination (N=25,23)
    100 (86 to 100)
    100 (85 to 100)
        Antigen 287-953 - Post-3rd Vaccination (N=24,25)
    100 (86 to 100)
    100 (86 to 100)
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ

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    End point title
    Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ
    End point description
    Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3). Analysis was done on safety set.
    End point type
    Secondary
    End point timeframe
    Day 1 through day 7 after each vaccination
    End point values
    rMenB rMenB + OMV
    Number of subjects analysed
    30
    30
    Units: Number of subjects
        Local reactions
    29
    29
        Tenderness - Vaccination 1
    4
    9
        Tenderness - Vaccination 2 (N=30,28)
    5
    11
        Tenderness - Vaccination 3 (N=30,27)
    12
    10
        Erythema - Vaccination 1
    26
    26
        Erythema - Vaccination 2 (N=30,28)
    22
    25
        Erythema - Vaccination 3 (N=30,27)
    24
    26
        Induration - Vaccination 1
    15
    18
        Induration - Vaccination 2 (N=30,28)
    12
    16
        Induration - Vaccination 3 (N=30,27)
    15
    18
        Swelling - Vaccination 1
    4
    11
        Swelling - Vaccination 2 (N=30,28)
    9
    10
        Swelling - Vaccination 3 (N=30,27)
    11
    9
        Systemic reactions
    22
    28
        Change in eating habits - Vaccination 1 (N=30,29)
    6
    8
        Change in eating habits - Vaccination 2 (N=30,27)
    1
    7
        Change in eating habits - Vaccination 3 (N=30,27)
    8
    5
        Sleepiness - Vaccination 1
    7
    11
        Sleepiness - Vaccination 2 (N=30,28)
    7
    8
        Sleepiness - Vaccination 3 (N=30,27)
    7
    4
        Vomiting - Vaccination 1
    6
    4
        Vomiting - Vaccination 2 (N=30,28)
    1
    3
        Vomiting - Vaccination 3 (N=30,27)
    6
    2
        Diarrhea - Vaccination 1
    2
    5
        Diarrhea - Vaccination 2 (N=30,28)
    4
    1
        Diarrhea - Vaccination 3 (N=30,27)
    5
    5
        Unusual crying - Vaccination 1
    2
    3
        Unusual crying - Vaccination 2 (N=30,28)
    2
    2
        Unusual crying - Vaccination 3 (N=30,27)
    4
    7
        Irritability - Vaccination 1
    14
    14
        Irritability - Vaccination 2 (N=30,28)
    10
    17
        Irritability - Vaccination 3 (N=30,28)
    13
    18
        Rash - Vaccination 1
    3
    3
        Rash - Vaccination 2 (N=30,28)
    5
    4
        Rash - Vaccination 3 (N=30,27)
    5
    4
        Fever (≥38 °C) - Vaccination 1
    1
    3
        Fever (≥38 °C) - Vaccination 2 (N=30,28)
    2
    3
        Fever (≥38 °C) - Vaccination 3 (N=30,27)
    4
    1
        Analg/Antipyr medications used - Vaccination 1
    10
    18
        Analg/Antipyr medications used - Vaccination 2
    12
    17
        Analg/Antipyr medications used - Vaccination 3
    15
    16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    rMenB + OMV
    Reporting group description
    6-8 month-old infants were administered 3 doses of Novartis rMenB with OMV-NZ vaccine at 6-8, 2 months later and at 12 months of age.

    Reporting group title
    rMenB
    Reporting group description
    6-8 month-old infants were administered 3 doses of Novartis rMenB vaccine without OMV-NZ at 6-8, 2 months later and at 12 months of age.

    Serious adverse events
    rMenB + OMV rMenB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
    5 / 30 (16.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    rMenB + OMV rMenB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 30 (100.00%)
    30 / 30 (100.00%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 30 (20.00%)
    3 / 30 (10.00%)
         occurrences all number
    6
    3
    Rhinorrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    16 / 30 (53.33%)
    14 / 30 (46.67%)
         occurrences all number
    27
    27
    General disorders and administration site conditions
    Induration
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 30 (3.33%)
         occurrences all number
    4
    2
    Injection site erythema
         subjects affected / exposed
    28 / 30 (93.33%)
    28 / 30 (93.33%)
         occurrences all number
    82
    73
    Injection site induration
         subjects affected / exposed
    26 / 30 (86.67%)
    20 / 30 (66.67%)
         occurrences all number
    54
    43
    Injection site swelling
         subjects affected / exposed
    17 / 30 (56.67%)
    14 / 30 (46.67%)
         occurrences all number
    30
    26
    Pyrexia
         subjects affected / exposed
    6 / 30 (20.00%)
    7 / 30 (23.33%)
         occurrences all number
    7
    10
    Swelling
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    5
    0
    Crying
         subjects affected / exposed
    10 / 30 (33.33%)
    5 / 30 (16.67%)
         occurrences all number
    13
    8
    Injection site pain
         subjects affected / exposed
    18 / 30 (60.00%)
    13 / 30 (43.33%)
         occurrences all number
    30
    21
    Vaccination site erythema
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    25 / 30 (83.33%)
    18 / 30 (60.00%)
         occurrences all number
    58
    53
    Eating disorder
         subjects affected / exposed
    14 / 30 (46.67%)
    13 / 30 (43.33%)
         occurrences all number
    27
    20
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 30 (33.33%)
    9 / 30 (30.00%)
         occurrences all number
    13
    16
    Teething
         subjects affected / exposed
    8 / 30 (26.67%)
    8 / 30 (26.67%)
         occurrences all number
    13
    11
    Vomiting
         subjects affected / exposed
    7 / 30 (23.33%)
    11 / 30 (36.67%)
         occurrences all number
    10
    16
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Erythema
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 30 (3.33%)
         occurrences all number
    7
    2
    Rash
         subjects affected / exposed
    9 / 30 (30.00%)
    8 / 30 (26.67%)
         occurrences all number
    16
    19
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    5 / 30 (16.67%)
    1 / 30 (3.33%)
         occurrences all number
    6
    1
    Gastroenteritis
         subjects affected / exposed
    4 / 30 (13.33%)
    0 / 30 (0.00%)
         occurrences all number
    4
    0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 30 (6.67%)
         occurrences all number
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    Otitis media
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Rhinitis
         subjects affected / exposed
    3 / 30 (10.00%)
    5 / 30 (16.67%)
         occurrences all number
    4
    5
    Tonsillitis
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    3
    0
    Varicella
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Viral rash
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    4 / 30 (13.33%)
         occurrences all number
    0
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jul 2008
    The amendment was done to include the following: 1. An additional laboratory was included in the study where serology tests for this trial could be performed. 2. The laboratory related procedures for both laboratories involved in the study were drafted and aligned with the protocol accordingly. 3. Additionally, an immune response by ELISA testing was further explored for the subject’s immune response in the trial and this was to demonstrate the possibility of performing additional future tests for future vaccine related projects according to subject’s consent. 4. The sponsor’s administrative structure, the cover page and the sponsor signature page were updated. 5. Blood draws were delayed for subjects taking antibiotics until 3 days after completion of antibiotic therapy. 6. Additional 30 minutes data on the Local & Systemic reaction page, was to be reported directly on the CRFs and are considered to be source data along with: demographics, medical history, pre-immunization axillary temperature, sites of immunizations. In addition to this, it was planned to categorize the measurements of body temperature as <38°C, 38-<39°C, 39-<40°C and ≥40°C, but was instead categorized as <38°C, 38-<38.5, 38.5-<39°C, 39-<39.5, 39.5-<40°C and ≥40°C. The root MSE from the PROC GLM output was used in the calculation of the 95% confidence intervals for each vaccine group associated with the geometric mean titers (GMTs) and geometric mean ratios (GMRs) for each visit and meningococcal strain, instead of the within group estimate of error at that visit, as specified in the AP.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/20844462
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