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    Clinical Trial Results:
    A PHASE 3, MULTI-CENTER, OPEN-LABEL STUDY TO EVALUATE IMMUNOGENICITY AND SAFETY OF NOVARTIS MENINGOCOCCAL ACWY CONJUGATE VACCINE (MENACWY-CRM) IN HEALTHY SUBJECTS FROM 2 TO 75 YEARS OF AGE IN INDIA.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-004477-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Apr 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    V59_43
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01547715
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines
    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)
    No
    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
    13 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects with human serum bactericidal assay (hSBA) seroresponse, directed against N.meningitidis serogroups A, C, W and Y.
    Protection of trial subjects
    Study vaccine were not administered to individuals with known hypersensitivity to any component of the vaccine. 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 or locally approved medications were available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine was not injected into a blood vessel.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Mar 2012
    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
    India: 180
    Worldwide total number of subjects
    180
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    69
    Adolescents (12-17 years)
    51
    Adults (18-64 years)
    55
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled from 3 study sites.

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

    Pre-assignment period milestones
    Number of subjects started
    		 180
    Number of subjects completed
    		 180

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 2 - 10 years
    Arm description
    		 Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Novartis MenACWY Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose 0.5 mL of injectable solution was administered intramuscularly.

    Arm title
    		 11 - 18 years
    Arm description
    		 Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Novartis MenACWY Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose 0.5 mL of injectable solution was administered intramuscularly.

    Arm title
    		 19 - 75 years
    Arm description
    		 Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Novartis MenACWY Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose 0.5 mL of injectable solution was administered intramuscularly.

    Arm title
    		 Overall (≥2 years)
    Arm description
    		 Subjects between 2 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Novartis MenACWY Conjugate Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose 0.5 mL of injectable solution was administered intramuscularly.

    Number of subjects in period 1
    		2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Started
    60
    60
    60
    180
    Completed
    60
    60
    60
    180

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    2 - 10 years
    Reporting group description
    		 Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1.

    Reporting group title
    11 - 18 years
    Reporting group description
    		 Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1.

    Reporting group title
    19 - 75 years
    Reporting group description
    		 Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.

    Reporting group values
    		 2 - 10 years 11 - 18 years 19 - 75 years Total
    Number of subjects
    		 60 60 60
    Age Group
    Units: AGE_UNITS.years
    Age Continuous
    Units: AGE_UNITS.years
        arithmetic mean (standard deviation)
    		 5.77 ( 2.5 ) 14.03 ( 1.931 ) 32.67 ( 12.297 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 33 33 21 87
        Male
    		 27 27 39 93
    Subject analysis sets

    Subject analysis set title
    All Enrolled Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who signed an informed consent, underwent screening procedure(s), and had a subject number assigned.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the exposed population who provided at least one evaluable serum sample whose assay result is available for at least one serogroup.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed population who provided any post-baseline safety data.

    Subject analysis set title
    All Exposed Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All enrolled subjects who actually received study vaccination.

    Subject analysis set title
    Per-Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the FAS who provided evaluable serum samples at day 1 and day 29, and had no major protocol violations.

    Subject analysis sets values
    		 All Enrolled Set Full Analysis Set Safety Set All Exposed Set Per-Protocol Set
    Number of subjects
    180
    180
    180
    180
    175
    Age Group
    Units: AGE_UNITS.years
    Age Continuous
    Units: AGE_UNITS.years
        arithmetic mean (standard deviation)
    17.49 ( 13.432 )
    ( )
    ( )
    ( )
    ( )
    Gender Categorical
    Units: Subjects
        Female
    87
        Male
    93

    End points

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    End points reporting groups
    Reporting group title
    2 - 10 years
    Reporting group description
    		 Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1.

    Reporting group title
    11 - 18 years
    Reporting group description
    		 Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1.

    Reporting group title
    19 - 75 years
    Reporting group description
    		 Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.

    Reporting group title
    Overall (≥2 years)
    Reporting group description
    		 Subjects between 2 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.

    Subject analysis set title
    All Enrolled Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who signed an informed consent, underwent screening procedure(s), and had a subject number assigned.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects in the exposed population who provided at least one evaluable serum sample whose assay result is available for at least one serogroup.

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects in the exposed population who provided any post-baseline safety data.

    Subject analysis set title
    All Exposed Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All enrolled subjects who actually received study vaccination.

    Subject analysis set title
    Per-Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the FAS who provided evaluable serum samples at day 1 and day 29, and had no major protocol violations.

    Primary: 1) Percentages of subjects with human Serum Bactericidal Assay (hSBA) seroresponse against N.meningitidis serogroup A at day 29

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    End point title
    		 1) Percentages of subjects with human Serum Bactericidal Assay (hSBA) seroresponse against N.meningitidis serogroup A at day 29 [1]
    End point description
    The immunogenicity of a single injection of MenACWY-CRM vaccine was assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Analysis was done on the Full Analysis Set.
    End point type
    Primary
    End point timeframe
    Day 29 (1 month post 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 analysis is associated to this endpoint. Analyses were run descriptively.
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    60
    59
    58
    177
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Overall Seroresponse
    75 (62 to 85)
    76 (63 to 86)
    66 (52 to 78)
    72 (65 to 79)
    No statistical analyses for this end point

    Primary: 2) Percentages of subjects with hSBA seroresponse against N.meningitidis serogroup C at day 29

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    End point title
    		 2) Percentages of subjects with hSBA seroresponse against N.meningitidis serogroup C at day 29 [2]
    End point description
    The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C. Analysis was done on the FAS.
    End point type
    Primary
    End point timeframe
    Day 29 (1 month post vaccination)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is associated to this endpoint. Analyses were run descriptively.
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    58
    59
    58
    175
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Overall Seroresponse
    84 (73 to 93)
    90 (79 to 96)
    90 (79 to 96)
    88 (82 to 92)
    No statistical analyses for this end point

    Primary: 3) Percentages of subjects with hSBA seroresponse against N.meningitidis serogroup W at day 29

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    End point title
    		 3) Percentages of subjects with hSBA seroresponse against N.meningitidis serogroup W at day 29 [3]
    End point description
    The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W. Analysis was done on the Full Analysis Set.
    End point type
    Primary
    End point timeframe
    Day 29 (1 month post 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: No statistical analysis is associated to this endpoint. Analyses were run descriptively.
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    60
    59
    57
    176
    Units: Number of Subjects
    number (confidence interval 95%)
        Overall Seroresponse
    58 (45 to 71)
    51 (37 to 64)
    54 (41 to 68)
    55 (47 to 62)
    No statistical analyses for this end point

    Primary: 4) Percentages of Subjects With hSBA Seroresponse Against N. meningitidis Serogroup Y at day 29

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    End point title
    		 4) Percentages of Subjects With hSBA Seroresponse Against N. meningitidis Serogroup Y at day 29 [4]
    End point description
    The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y. Analysis was done on the FAS.
    End point type
    Primary
    End point timeframe
    Day 29 (1 month post 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: No statistical analysis is associated to this endpoint. Analyses were run descriptively.
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    58
    59
    57
    174
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Overall Seroresponse
    69 (55 to 80)
    69 (56 to 81)
    75 (62 to 86)
    71 (64 to 78)
    No statistical analyses for this end point

    Secondary: 5) Percentages of Subjects With hSBA ≥1:8 Directed Against N. meningitidis Serogroup A at day 1 and day 29

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    End point title
    		 5) Percentages of Subjects With hSBA ≥1:8 Directed Against N. meningitidis Serogroup A at day 1 and day 29
    End point description
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 1 and day 29. Analysis was done on the FAS.
    End point type
    Secondary
    End point timeframe
    Day 1 and day 29
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    60
    60
    58
    178
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Day 1 N= 60, 59, 60, 179
    0 (0 to 6)
    2 (0 to 9)
    2 (0 to 9)
    1 (0 to 4)
        Day 29
    75 (62 to 85)
    77 (64 to 87)
    66 (52 to 78)
    72 (65 to 79)
    No statistical analyses for this end point

    Secondary: 6) Percentages of Subjects With hSBA ≥1:8 Directed Against N. meningitidis Serogroup C at day 1 and day 29

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    End point title
    		 6) Percentages of Subjects With hSBA ≥1:8 Directed Against N. meningitidis Serogroup C at day 1 and day 29
    End point description
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 1 and day 29. Analysis was done on the FAS.
    End point type
    Secondary
    End point timeframe
    Day 1 and day 29
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    60
    60
    58
    178
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Day 1 N= 58, 59, 60, 177
    14 (6 to 25)
    24 (14 to 37)
    25 (15 to 38)
    21 (15 to 28)
        Day 29
    92 (82 to 97)
    97 (88 to 100)
    97 (88 to 100)
    95 (91 to 98)
    No statistical analyses for this end point

    Secondary: 7) Percentages of Subjects With hSBA ≥1:8 Directed Against N. meningitidis Serogroup W at day 1 and day 29

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    End point title
    		 7) Percentages of Subjects With hSBA ≥1:8 Directed Against N. meningitidis Serogroup W at day 1 and day 29
    End point description
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W at day 1 and day 29. Analysis was done on the FAS.
    End point type
    Secondary
    End point timeframe
    Day 1 and day 29
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    60
    60
    58
    178
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Day 1 N= 60, 59, 59, 178
    52 (38 to 65)
    63 (49 to 75)
    59 (46 to 72)
    58 (50 to 65)
        Day 29
    95 (86 to 99)
    95 (86 to 99)
    93 (83 to 98)
    94 (90 to 97)
    No statistical analyses for this end point

    Secondary: 8) Percentages of Subjects With hSBA ≥1:8 Directed Against N. meningitidis Serogroup Y at day 1 and day 29

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    End point title
    		 8) Percentages of Subjects With hSBA ≥1:8 Directed Against N. meningitidis Serogroup Y at day 1 and day 29
    End point description
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. Meningitidis serogroup Y at day 1 and day 29. Analysis was done on the FAS.
    End point type
    Secondary
    End point timeframe
    day 1 and day 29
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    59
    60
    58
    177
    Units: Percentages of Subjects
    number (confidence interval 95%)
        Day 1 N= 59, 59, 59, 177
    22 (12 to 35)
    53 (39 to 66)
    53 (39 to 66)
    42 (35 to 50)
        Day 29
    83 (71 to 92)
    95 (86 to 99)
    93 (83 to 98)
    90 (85 to 94)
    No statistical analyses for this end point

    Secondary: 9) hSBA Geometric Mean Titers (GMTs) Directed Against N. meningitidis Serogroup A at day 1 and day 29

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    End point title
    		 9) hSBA Geometric Mean Titers (GMTs) Directed Against N. meningitidis Serogroup A at day 1 and day 29
    End point description
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 1 and day 29. Analysis was done on the FAS.
    End point type
    Secondary
    End point timeframe
    Day 1 and day 29
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    60
    60
    58
    178
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 29
    30 (19 to 47)
    50 (30 to 84)
    29 (16 to 51)
    35 (26 to 47)
        Day 1 N= 60, 59, 60, 179
    ( to )
    ( to )
    ( to )
    ( to )
    No statistical analyses for this end point

    Secondary: 10) hSBA GMTs Directed Against N. meningitidis Serogroups C at day 1 and day 29

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    End point title
    		 10) hSBA GMTs Directed Against N. meningitidis Serogroups C at day 1 and day 29
    End point description
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 1 and day 29.
    End point type
    Secondary
    End point timeframe
    Day 1 and day 29
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    60
    60
    58
    178
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 1 N= 58, 59, 60, 177
    2.88 (2.26 to 3.65)
    4.01 (3 to 5.35)
    4.14 (3.12 to 5.49)
    3.63 (3.11 to 4.25)
        Day 29
    67 (44 to 101)
    191 (117 to 310)
    287 (191 to 431)
    153 (117 to 199)
    No statistical analyses for this end point

    Secondary: 11) hSBA GMTs Directed Against N. meningitidis Serogroup W at day 1 and day 29

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    End point title
    		 11) hSBA GMTs Directed Against N. meningitidis Serogroup W at day 1 and day 29
    End point description
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 1. Analysis was done on the FAS.
    End point type
    Secondary
    End point timeframe
    Day 1 and day 29
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    60
    60
    58
    178
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 29
    60 (44 to 81)
    75 (54 to 105)
    116 (71 to 187)
    80 (64 to 100)
        Day 1 N= 60, 59, 59, 178
    ( to )
    ( to )
    ( to )
    ( to )
    No statistical analyses for this end point

    Secondary: 12) hSBA GMTs Directed Against N. meningitidis Serogroup Y at day 1 and day 29

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    End point title
    		 12) hSBA GMTs Directed Against N. meningitidis Serogroup Y at day 1 and day 29
    End point description
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 1 and day 29. Analysis was done on the FAS.
    End point type
    Secondary
    End point timeframe
    Day 1 and day 29
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    59
    60
    58
    177
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 29
    45 (29 to 69)
    105 (72 to 155)
    173 (97 to 309)
    93 (70 to 123)
        Day 1 N= 59, 59, 59, 177
    3.59 (2.75 to 4.7)
    7.87 (5.48 to 11)
    8.69 (5.98 to 13)
    6.26 (5.13 to 7.65)
    No statistical analyses for this end point

    Secondary: 13) Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination

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    End point title
    		 13) Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination
    End point description
    The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting any solicited local and systemic reactions post vaccination. The analysis was performed on the safety analysis set.
    End point type
    Secondary
    End point timeframe
    From day 1 to Day 7 post vaccination
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    60
    60
    60
    180
    Units: Number of Subjects
        INJECTION SITE REACTIONS
    5
    17
    5
    27
        SYSTEMIC REACTIONS
    3
    7
    9
    19
    No statistical analyses for this end point

    Secondary: 14) Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination

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    End point title
    		 14) Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination
    End point description
    The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting solicited local and systemic reactions post vaccination. The analysis was performed on the safety analysis set.
    End point type
    Secondary
    End point timeframe
    From day 1 to Day 7 post vaccination
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    60
    60
    60
    180
    Units: Number of Subjects
        ANALGESIC ANTIPYRETIC
    2
    5
    2
    9
        Body Temperature >=40C
    0
    0
    0
    0
        ERYTHEMA (mm)
    0
    0
    0
    0
        INDURATION (mm)
    0
    0
    0
    0
        PAIN
    4
    17
    5
    26
        TENDERNESS
    1
    0
    0
    1
        ARTHRALGIA
    1
    1
    0
    2
        BODY TEMPERATURE >=38C
    1
    1
    1
    3
        CHANGE IN EATING HABITS
    0
    0
    0
    0
        CHILLS
    0
    4
    2
    6
        DIARRHEA
    0
    0
    0
    0
        HEADACHE
    2
    5
    7
    14
        IRRITABILITY
    0
    0
    0
    0
        MALAISE
    2
    2
    2
    6
        MYALGIA
    1
    0
    2
    3
        NAUSEA
    0
    1
    1
    2
        RASH
    0
    0
    0
    0
        SLEEPINESS
    0
    0
    0
    0
        VOMITING
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: 15) Number of Subjects With Unsolicited Adverse Events

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    End point title
    		 15) Number of Subjects With Unsolicited Adverse Events
    End point description
    The safety of one dose of MenACWY -CRM was assessed in terms of the number of subjects reporting unsolicited adverse events. All AEs were recorded from day 1 to day 7; SAE, medically attended AEs and AEs Leading to premature withdrawal were recorded throughout the entire study period. The analysis was performed on the safety analysis set.
    End point type
    Secondary
    End point timeframe
    Day 1 through day 29
    End point values
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (≥2 years)
    Number of subjects analysed
    60
    60
    60
    180
    Units: Number of Subjects
        Any Unsolicited AE
    9
    6
    4
    19
        Any SAE
    0
    0
    1
    1
        Medically Attended AEs
    8
    5
    4
    17
        AEs Leading to premature withdrawal
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1-7 after vaccination for Solicited Adverse; Unsolicited AEs were collected throughout the study period.
    Adverse event reporting additional description
    Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    2 - 10 years
    Reporting group description
    		 Subjects between 2 and 10 years of age who received one injection of MenACWY - CRM vaccine on day 1.

    Reporting group title
    11 - 18 years
    Reporting group description
    		 Subjects between 11 and 18 years of age who received one injection of MenACWY - CRM vaccine on day 1.

    Reporting group title
    19 - 75 years
    Reporting group description
    		 Subjects between 19 and 75 years of age who received one injection of MenACWY - CRM vaccine on day 1.

    Reporting group title
    Overall (>2 years)
    Reporting group description
    		 Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.

    Serious adverse events
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (>2 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    1 / 180 (0.56%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    General disorders and administration site conditions
    PYREXIA
         subjects affected / exposed
    0 / 60 (0.00%)
    0 / 60 (0.00%)
    1 / 60 (1.67%)
    1 / 180 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 2 - 10 years 11 - 18 years 19 - 75 years Overall (>2 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 60 (16.67%)
    21 / 60 (35.00%)
    10 / 60 (16.67%)
    41 / 180 (22.78%)
    Nervous system disorders
    HEADACHE
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 60 (3.33%)
    5 / 60 (8.33%)
    7 / 60 (11.67%)
    14 / 180 (7.78%)
         occurrences all number
    3
    5
    8
    16
    General disorders and administration site conditions
    CHILLS
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 60 (0.00%)
    4 / 60 (6.67%)
    2 / 60 (3.33%)
    6 / 180 (3.33%)
         occurrences all number
    0
    4
    2
    6
    INJECTION SITE PAIN
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 60 (8.33%)
    17 / 60 (28.33%)
    5 / 60 (8.33%)
    27 / 180 (15.00%)
         occurrences all number
    5
    17
    6
    28
    Infections and infestations
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    4 / 60 (6.67%)
    1 / 60 (1.67%)
    0 / 60 (0.00%)
    5 / 180 (2.78%)
         occurrences all number
    4
    1
    0
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2012
    Protocol title; protocol synopsis, methodology section; protocol synopsis, medical history section; protocol synopsis, number of subjects planned section; new section: 4.3 Criteria for Delay of Blood Sampling; A new text: Subjects who are withdrawn from study should be encouraged to continue in the study for safety and immunogenicity assessments; Clarification for Serious Adverse Event definition.
    06 Feb 2012
    New text: Enrollment will commence with approximately 60 subjects 19 up to 75 years of age. Following safety evaluation in this cohort, younger subjects will be enrolled. New text: All adult subjects’ (19-75 years of age) safety data collected through Day 1 until Day 29 will be analyzed before subjects from 2 up to 18 years of age are enrolled into the study. Inclusion of one interim safety analysis planned for the study.
    09 Jan 2013
    Clarification of an ambiguity as regard to the subject numbering and identification. Clarification of the process for subject’s identification and the definition of ‘subject number’.
    22 May 2013
    Inclusion of a second planned interim safety analysis of all subjects age 11 to 18 years will be analyzed before subjects aged 2 to 10 years are enrolled. Further stratification of pediatric population to enroll approximately 30 subjects each in age groups 2 to 5, 6 to 10, 11 to 14 and 15 to 18. Deletion of the phrase: ‘The analysis of the serologic specimens by the lab will be done in a blinded fashion’.
    26 Mar 2014
    Inclusion of "End of Trial" definition

    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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