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    Clinical Trial Results:
    Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers

    Summary
    EudraCT number
    2017-001993-40
    Trial protocol
    FI  
    Global end of trial date
    10 Sep 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Jan 2020
    First version publication date
    05 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MET62
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03476135
    WHO universal trial number (UTN)
    U1111-1183-5988
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    Discovery Drive, Swiftwater, PA, United States, 18370
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001930-PIP01-16
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Immunogenicity: 1) To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a booster dose in children who received either Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW) or Nimenrix® 3 years earlier as toddlers. 2) To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers. 3) To describe the antibody responses against tetanus toxoid 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers. Safety: To describe the safety profile of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Feb 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 91
    Worldwide total number of subjects
    91
    EEA total number of subjects
    91
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    91
    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
    Study subjects were enrolled at 8 sites in Finland from 27 February 2018 to 7 August 2018.

    Pre-assignment
    Screening details
    A total of 91 subjects who received a single dose of MenACYW conjugate vaccine or Nimenrix® vaccine in previous study MET54 (EudraCT ID: 2014-004367-20/NCT03205358) were enrolled in this study (MET62).

    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
    MET62 was an open-label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW)
    Arm description
    Subjects who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
    Arm type
    Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 millilitre (mL), intramuscular, single dose on Day 0.

    Arm title
    Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Arm description
    Subjects who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
    Arm type
    Experimental

    Investigational medicinal product name
    MenACYW conjugate vaccine: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular, single dose on Day 0.

    Number of subjects in period 1
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Started
    42
    49
    Completed
    42
    49

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW)
    Reporting group description
    Subjects who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).

    Reporting group title
    Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Reporting group description
    Subjects who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).

    Reporting group values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) Total
    Number of subjects
    42 49 91
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    3.9 ± 0.35 3.9 ± 0.33 -
    Gender categorical
    Units: Subjects
        Female
    16 30 46
        Male
    26 19 45

    End points

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    End points reporting groups
    Reporting group title
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW)
    Reporting group description
    Subjects who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).

    Reporting group title
    Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Reporting group description
    Subjects who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).

    Primary: Antibody Titers (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine

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    End point title
    Antibody Titers (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine [1]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Analysis was performed on Per-Protocol Analysis Set (PPAS) which included all subjects who received at least 1 dose of the study vaccine, had a valid post-vaccination blood sample results and had no protocol deviations.
    End point type
    Primary
    End point timeframe
    Day 0
    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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    40
    44
    Units: titers (1/dilution)
    geometric mean (confidence interval 95%)
        Serogroup A
    12.1 (8.15 to 18.1)
    16.5 (11.9 to 22.9)
        Serogroup C
    106 (73.2 to 153)
    11.7 (7.03 to 19.4)
        Serogroup Y
    30.9 (24.2 to 39.5)
    17.6 (13.1 to 23.7)
        Serogroup W
    48.5 (34.4 to 68.4)
    21.9 (14.7 to 32.7)
    No statistical analyses for this end point

    Primary: Antibody Titers (hSBA) Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine

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    End point title
    Antibody Titers (hSBA) Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine [2]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Analysis was performed on PPAS.
    End point type
    Primary
    End point timeframe
    Day 30 (post-booster 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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    40
    44
    Units: titers (1/dilution)
    geometric mean (confidence interval 95%)
        Serogroup A
    763 (521 to 1117)
    659 (427 to 1017)
        Serogroup C
    5894 (4325 to 8031)
    1592 (1165 to 2174)
        Serogroup Y
    2013 (1451 to 2792)
    2806 (2066 to 3813)
        Serogroup W
    2656 (1601 to 4406)
    3444 (2387 to 4970)
    No statistical analyses for this end point

    Primary: Antibody Titers (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine

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    End point title
    Antibody Titers (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine [3]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using baby rabbit complement (rSBA). Analysis was performed on PPAS. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Day 0
    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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    39
    44
    Units: titers (1/dilution)
    geometric mean (confidence interval 95%)
        Serogroup A
    135 (58.0 to 314)
    281 (131 to 606)
        Serogroup C
    102 (60.9 to 169)
    11.9 (6.14 to 22.9)
        Serogroup Y
    119 (65.0 to 219)
    126 (69.1 to 230)
        Serogroup W
    113 (54.6 to 234)
    126 (63.6 to 250)
    No statistical analyses for this end point

    Primary: Antibody Titers (rSBA) Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine

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    End point title
    Antibody Titers (rSBA) Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine [4]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA. Analysis was performed on PPAS.
    End point type
    Primary
    End point timeframe
    Day 30 (post-booster vaccination)
    Notes
    [4] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    40
    44
    Units: titers (1/dilution)
    geometric mean (confidence interval 95%)
        Serogroup A
    4240 (3352 to 5365)
    5702 (4575 to 7107)
        Serogroup C
    8629 (6573 to 11328)
    4871 (3750 to 6327)
        Serogroup Y
    5499 (4502 to 6717)
    7814 (6465 to 9445)
        Serogroup W
    16103 (12691 to 20431)
    19793 (15538 to 25214)
    No statistical analyses for this end point

    Primary: Antibody Titers (hSBA) Against Meningococcal Serogroups A, C, Y, and W for Priming Vaccination in MET54 and Booster Vaccination in MET62

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    End point title
    Antibody Titers (hSBA) Against Meningococcal Serogroups A, C, Y, and W for Priming Vaccination in MET54 and Booster Vaccination in MET62 [5]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Analysis was performed on Full Analysis Set for Persistence (FASP) which included all subjects who had a valid pre-vaccination blood sample result. Here 'n' signifies number of subjects with available data for specified category and "-99999" & "99999" signifies no data calculated for 95% confidence interval field, because everyone’s baseline value in MET54 was 2 for the specified category.
    End point type
    Primary
    End point timeframe
    Day 0 from study MET54, Day 30 (post-priming vaccination) from study MET54, Day 0 from study MET62 and Day 30 (post booster-vaccination) from study MET62
    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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    42
    49
    Units: titers (1/dilution)
    geometric mean (confidence interval 95%)
        Serogroup A: Day 0 (MET54) (n=41,49)
    3.68 (3.12 to 4.33)
    3.67 (3.15 to 4.29)
        Serogroup A: Day 30 (MET54) (n=42,49)
    83.3 (63.9 to 109)
    49.6 (32.1 to 76.7)
        Serogroup A: Day 0 (MET62) (n=42,49)
    11.9 (8.11 to 17.4)
    14.7 (10.7 to 20.2)
        Serogroup A: Day 30 (MET62) (n=41,47)
    755 (520 to 1097)
    629 (418 to 948)
        Serogroup C: Day 0 (MET54) (n=42,49)
    2.48 (2.04 to 3.01)
    2.30 (2.12 to 2.50)
        Serogroup C: Day 30 (MET54) (n=42,49)
    594 (445 to 793)
    29.4 (20.1 to 43.1)
        Serogroup C: Day 0 (MET62) (n=42,49)
    103 (71.7 to 149)
    11.6 (7.28 to 18.3)
        Serogroup C: Day 30 (MET62) (n=41,47)
    5744 (4230 to 7800)
    1618 (1204 to 2172)
        Serogroup Y: Day 0 (MET54) (n=42,49)
    2.17 (1.95 to 2.42)
    2.27 (2.05 to 2.52)
        Serogroup Y: Day 30 (MET54) (n=42,49)
    105 (73.9 to 149)
    75.8 (54.2 to 106)
        Serogroup Y: Day 0 (MET62) (n=42,49)
    32.5 (24.8 to 42.7)
    18.2 (13.8 to 24.0)
        Serogroup Y: Day 30 (MET62) (n=41,47)
    2048 (1486 to 2823)
    2710 (2022 to 3633)
        Serogroup W: Day 0 (MET54) (n=42,49)
    2.00 (-99999 to 99999)
    2.12 (2.00 to 2.24)
        Serogroup W: Day 30 (MET54) (n=42,49)
    71.8 (53.3 to 96.7)
    40.1 (30.6 to 52.6)
        Serogroup W: Day 0 (MET62) (n=42,49)
    50.0 (35.9 to 69.5)
    21.2 (14.6 to 30.9)
        Serogroup W: Day 30 (MET62) (n=41,47)
    2776 (1682 to 4584)
    3235 (2278 to 4594)
    No statistical analyses for this end point

    Primary: Antibody Titers (rSBA) Against Meningococcal Serogroups A, C, Y, and W for Priming Vaccination in MET54 and Booster Vaccination in MET62

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    End point title
    Antibody Titers (rSBA) Against Meningococcal Serogroups A, C, Y, and W for Priming Vaccination in MET54 and Booster Vaccination in MET62 [6]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA. Analysis was performed on FASP. Here 'n' signifies number of subjects with available data for specified category and "-99999" &"99999" signifies no data calculated for 95% confidence interval field, because everyone’s baseline value in MET54 was 2 for the specified category.
    End point type
    Primary
    End point timeframe
    Day 0 from study MET54, Day 30 (post-priming vaccination) from study MET54, Day 0 from study MET62 and Day 30 (post booster-vaccination) from study MET62
    Notes
    [6] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    42
    49
    Units: titers (1/dilution)
    geometric mean (confidence interval 95%)
        Serogroup A: Day 0 (MET54) (n=42,49)
    12.3 (5.25 to 28.8)
    4.88 (2.74 to 8.69)
        Serogroup A: Day 30 (MET54) (n=42,49)
    3198 (2559 to 3996)
    7633 (5879 to 9909)
        Serogroup A: Day 0 (MET62) (n=41,49)
    124 (54.0 to 283)
    239 (113 to 503)
        Serogroup A: Day 30 (MET62) (n=41,47)
    4096 (3223 to 5205)
    5341 (4275 to 6674)
        Serogroup C: Day 0 (MET54) (n=42,49)
    2.21 (1.81 to 2.70)
    2.15 (1.86 to 2.47)
        Serogroup C: Day 30 (MET54) (n=42,49)
    2711 (2156 to 3409)
    414 (283 to 607)
        Serogroup C: Day 0 (MET62) (n=41,49)
    94.4 (55.9 to 160)
    11.2 (6.11 to 20.6)
        Serogroup C: Day 30 (MET62) (n=41,47)
    8474 (6483 to 11075)
    4817 (3759 to 6175)
        Serogroup Y: Day 0 (MET54) (n=42,49)
    2.88 (1.87 to 4.42)
    4.29 (2.48 to 7.44)
        Serogroup Y: Day 30 (MET54) (n=42,49)
    2667 (2063 to 3447)
    2836 (2127 to 3781)
        Serogroup Y: Day 0 (MET62) (n=41,49)
    120 (67.1 to 213)
    123 (67.6 to 223)
        Serogroup Y: Day 30 (MET62) (n=41,47)
    5553 (4565 to 6755)
    7498 (6213 to 9049)
        Serogroup W: Day 0 (MET54) (n=42,49)
    2.00 (-99999 to 99999)
    2.24 (1.78 to 2.81)
        Serogroup W: Day 30 (MET54) (n=42,49)
    5793 (4346 to 7720)
    4214 (3162 to 5616)
        Serogroup W: Day 0 (MET62) (n=41,49)
    106 (51.6 to 219)
    113 (57.9 to 219)
        Serogroup W: Day 30 (MET62) (n=41,47)
    15839 (12530 to 20023)
    18710 (14737 to 23753)
    No statistical analyses for this end point

    Primary: Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine

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    End point title
    Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine [7]
    End point description
    Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay. Analysis was performed on PPAS. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Day 0
    Notes
    [7] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    39
    44
    Units: International Unit per millilitre(IU/mL)
        geometric mean (confidence interval 95%)
    3.12 (2.05 to 4.75)
    3.02 (2.11 to 4.31)
    No statistical analyses for this end point

    Primary: Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine

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    End point title
    Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine [8]
    End point description
    Anti-tetanus antibodies were measured by ECL assay. Analysis was performed on PPAS.
    End point type
    Primary
    End point timeframe
    Day 30 (post-booster vaccination)
    Notes
    [8] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    40
    44
    Units: IU/mL
        geometric mean (confidence interval 95%)
    10.4 (8.41 to 12.8)
    9.36 (7.61 to 11.5)
    No statistical analyses for this end point

    Primary: Number of Subjects With Immediate Adverse Event After Vaccination

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    End point title
    Number of Subjects With Immediate Adverse Event After Vaccination [9]
    End point description
    Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions. Analysis was performed on safety analysis set which included subjects who had received at least one dose of the study vaccine and had any safety data available.
    End point type
    Primary
    End point timeframe
    Within 30 minutes after vaccination
    Notes
    [9] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    42
    49
    Units: subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Solicited Injection Site Reactions and Systemic Reactions

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    End point title
    Number of Subjects With Solicited Injection Site Reactions and Systemic Reactions [10]
    End point description
    A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia. Analysis was performed on safety analysis set.
    End point type
    Primary
    End point timeframe
    Within 7 days after vaccination
    Notes
    [10] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    42
    49
    Units: subjects
    number (not applicable)
        Pain
    26
    35
        Erythema
    22
    27
        Swelling
    16
    19
        Fever
    3
    4
        Headache
    8
    14
        Malaise
    13
    15
        Myalgia
    14
    21
    No statistical analyses for this end point

    Primary: Number of Subjects with Unsolicited Adverse Event After Vaccination

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    End point title
    Number of Subjects with Unsolicited Adverse Event After Vaccination [11]
    End point description
    An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
    End point type
    Primary
    End point timeframe
    Within 30 days after vaccination
    Notes
    [11] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    42
    49
    Units: subjects
        number (not applicable)
    22
    15
    No statistical analyses for this end point

    Primary: Number of Subjects with a Serious Adverse Event (SAE) During the Study

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    End point title
    Number of Subjects with a Serious Adverse Event (SAE) During the Study [12]
    End point description
    A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event. Analysis was performed on safety analysis set.
    End point type
    Primary
    End point timeframe
    Within 30 days after vaccination
    Notes
    [12] - 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: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Number of subjects analysed
    42
    49
    Units: subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).
    Adverse event reporting additional description
    SR was an AR observed and reported under the conditions (nature and onset) prelisted in the protocol and CRB. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Analysis was performed on safety analysis set.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW)
    Reporting group description
    Subjects who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).

    Reporting group title
    Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Reporting group description
    Subjects who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).

    Serious adverse events
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 49 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Group 1:MenACYW Conjugate Vaccine(Previous exposed to MenACYW) Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 42 (85.71%)
    43 / 49 (87.76%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 42 (23.81%)
    14 / 49 (28.57%)
         occurrences all number
    11
    14
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    22 / 42 (52.38%)
    27 / 49 (55.10%)
         occurrences all number
    22
    27
    Injection Site Pain
         subjects affected / exposed
    26 / 42 (61.90%)
    35 / 49 (71.43%)
         occurrences all number
    26
    35
    Injection Site Swelling
         subjects affected / exposed
    16 / 42 (38.10%)
    19 / 49 (38.78%)
         occurrences all number
    16
    19
    Malaise
         subjects affected / exposed
    13 / 42 (30.95%)
    15 / 49 (30.61%)
         occurrences all number
    13
    15
    Pyrexia
         subjects affected / exposed
    3 / 42 (7.14%)
    4 / 49 (8.16%)
         occurrences all number
    3
    4
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    14 / 42 (33.33%)
    21 / 49 (42.86%)
         occurrences all number
    14
    21
    Infections and infestations
    Otitis Media
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 49 (6.12%)
         occurrences all number
    1
    3
    Upper Respiratory Tract Infection
         subjects affected / exposed
    7 / 42 (16.67%)
    4 / 49 (8.16%)
         occurrences all number
    7
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2018
    Following changes were made: Updated department name for the Pharmacovigilance Global Safety Expert; updated the planned trial period and planned trial calendar information; updated description of the need for a physical examination or assessment of health in the case of a rescheduled Visit 1; clarified concomitant medications and other therapies; updated the assay method used to measure anti-tetanus antibodies; addition of references to the Adverse event of special interest (AESI) of generalised seizures and to the AESI of Kawasaki disease.

    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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