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    Clinical Trial Results:
    A phase 3, multi-center, observer-blind, placebo-controlled, randomized study to evaluate the immunogenicity and safety of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 11 to 55 years of age in Korea.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2014-005055-11
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Mar 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    10 Jun 2016
    First version publication date
    02 Apr 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    V59_39
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01274897
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Vaccines and Diagnostics S.r.l
    Sponsor organisation address
    Via Fiorentina, 1, Siena, Italy, 53100
    Public contact
    Posting director, Novartis Vaccines 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)
    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
    04 Oct 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Mar 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Mar 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Immunogenicity objectives : To assess the immunogenicity of a single injection of MenACWY as measured by the percentage of subjects with hSBA seroresponse, directed against N meningitidis serogroups A, C, W and Y.
    Protection of trial subjects
    This trial was performed with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP) according to International Conference on Harmonisation (ICH) guidelines, the applicable regulatory requirements(s) for the country in which the study was conducted, and applicable standard operating procedures (SOPs).
    Background therapy
    		 -
    Evidence for comparator
    		 Placebo - One 0.5mL of saline placebo was administered by intramuscular (IM) injection in the deltoid area of the nondominant arm.
    Actual start date of recruitment
    20 Dec 2010
    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
    Korea, Democratic People's Republic of: 450
    Worldwide total number of subjects
    450
    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)
    37
    Adolescents (12-17 years)
    230
    Adults (18-64 years)
    183
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled from 8 centres in Korea.

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

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MenACWY-CRM
    Arm description
    		 Subjects received one dose of MenACWY-CRM conjugate vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 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
    One 0.5mL dose of MenACWY was administered by intramuscular (IM) injection in the deltoid area of nondominant arm.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received the saline placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL of saline placebo was administered by intramuscular (IM) injection in the deltoid area of the nondominant arm.

    Number of subjects in period 1
    		MenACWY-CRM Placebo
    Started
    297
    153
    Completed
    297
    153

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MenACWY-CRM
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM conjugate vaccine.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received the saline placebo.

    Reporting group values
    		 MenACWY-CRM Placebo Total
    Number of subjects
    		 297 153 450
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 19.6 ( 9.2 ) 19.3 ( 8.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 139 77 216
        Male
    		 158 76 234

    End points

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    End points reporting groups
    Reporting group title
    MenACWY-CRM
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM conjugate vaccine.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received the saline placebo.

    Subject analysis set title
    Modified Intention-to-treat (MITT) population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    All randomized subjects who received the vaccine, and provided at least one evaluable serum sample before and one after vaccination.

    Subject analysis set title
    Per protocol population - Immunogenicity
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects in the MITT Set who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant timepoints, and had no major protocol violation as defined prior to unblinding. A “major” deviation is defined as a protocol deviation that is considered to have a significant impact on the immunogenicity results of the subject compared to the result that would have possibly otherwise been obtained.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who were injected and who had post-injection safety data.

    Primary: To assess the immunogenicity of a single injection of MenACWY as measured by the percentage of subjects with hSBA seroresponse, directed against N. meningitidis serogroups A, C, W and Y.

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    End point title
    		 To assess the immunogenicity of a single injection of MenACWY as measured by the percentage of subjects with hSBA seroresponse, directed against N. meningitidis serogroups A, C, W and Y.
    End point description
    Seroresponse is defined as: • for subjects with a pre-vaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8. • for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
    End point type
    Primary
    End point timeframe
    At day 29 post-vaccination.
    End point values
    		 MenACWY-CRM Placebo
    Number of subjects analysed
    295
    152
    Units: Percentage of subjects
    number (confidence interval 95%)
        Men A Seroresponse -baseline < 4 (N=246,120)
    76 (70 to 81)
    2 (0 to 6)
        Men A Seroresponse -baseline >= 4 (N=49,32)
    76 (61 to 87)
    0 (0 to 11)
        Men A Overall Seroresponse (N=295,152)
    76 (71 to 81)
    1 (0 to 5)
        Men C Seroresponse -baseline < 4 (N=111,67)
    96 (91 to 99)
    3 (0 to 10)
        Men C Seroresponse -baseline >= 4 (N=182,83)
    80 (74 to 86)
    0 (0 to 4)
        Men C Overall Seroresponse (N=293,150)
    86 (82 to 90)
    1 (0 to 5)
        Men W Seroresponse -baseline < 4 (N=32,20)
    84 (67 to 95)
    30 (12 to 54)
        Men W Seroresponse -baseline >= 4 (N=261,131)
    21 (16 to 26)
    0 (0 to 3)
        Men W Overall Seroresponse (N=293,151)
    28 (23 to 33)
    4 (1 to 8)
        Men Y Seroresponse -baseline < 4 (N=119,62)
    89 (82 to 94)
    5 (1 to 13)
        Men Y Seroresponse -baseline >= 4 (N=175,90)
    55 (47 to 62)
    0 (0 to 4)
        Men Y Overall Seroresponse (N=294,152)
    69 (63 to 74)
    2 (0 to 6)
    Statistical analysis title
    		 Immune response in serogroup Men A
    Statistical analysis description
    Statistical Analysis 1 for Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
    Comparison groups
    MenACWY-CRM v Placebo
    Number of subjects included in analysis
    447
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Clopper Pearson
    Parameter type
    		 Vaccine group differences
    Point estimate
    75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 69
         upper limit
    		 79
    Variability estimate
    Standard deviation
    Statistical analysis title
    		 Immune response in serogroup Men C.
    Statistical analysis description
    Statistical Analysis 2 for Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
    Comparison groups
    MenACWY-CRM v Placebo
    Number of subjects included in analysis
    447
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Clopper Pearson
    Parameter type
    		 Vaccine group differences
    Point estimate
    85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 80
         upper limit
    		 89
    Statistical analysis title
    		 Immune response in serogroup Men W.
    Statistical analysis description
    Statistical Analysis 3 for Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
    Comparison groups
    MenACWY-CRM v Placebo
    Number of subjects included in analysis
    447
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Clopper Pearson
    Parameter type
    		 Vaccine group differences
    Point estimate
    24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18
         upper limit
    		 30
    Statistical analysis title
    		 Immune response in serogroup Men Y.
    Statistical analysis description
    Statistical Analysis 2 for Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
    Comparison groups
    MenACWY-CRM v Placebo
    Number of subjects included in analysis
    447
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Clopper Pearson
    Parameter type
    		 Vaccine group differences
    Point estimate
    67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 61
         upper limit
    		 72

    Primary: Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination

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    End point title
    		 Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination [1]
    End point description
    Numbers of subjects with reported local and systemic reactions and other AEs.
    End point type
    Primary
    End point timeframe
    During 7 days after vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was no statistical null hypothesis associated with this safety objective.
    End point values
    		 MenACWY-CRM Placebo
    Number of subjects analysed
    297
    153
    Units: Number of Subjects
        Any Local
    83
    14
        Pain
    69
    12
        Erythema
    30
    3
        Induration
    30
    0
        Systemic
    83
    43
        Chills
    17
    7
        Nausea
    22
    10
        Myalgia
    45
    13
        Arthralgia
    6
    4
        Headache
    39
    25
        Rash
    1
    0
        Fever ( ≥38°C )
    3
    1
        Stayed home due to reaction
    9
    2
        Analgesic/antipyretic medication use
    7
    3
    No statistical analyses for this end point

    Secondary: To assess the immunogenicity of MenACWY as measured by the percentage of subjects with hSBA ≥1:8 directed against N. meningitidis serogroups A, C, W and Y

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    End point title
    		 To assess the immunogenicity of MenACWY as measured by the percentage of subjects with hSBA ≥1:8 directed against N. meningitidis serogroups A, C, W and Y
    End point description
    Percentage of subjects with hSBA ≥ 1:8 to N. meningitidis serogroups A, C, W135 and Y.
    End point type
    Secondary
    End point timeframe
    At day 1 and day 29 post-vaccination.
    End point values
    		 MenACWY-CRM Placebo
    Number of subjects analysed
    295
    152
    Units: Percentages of subjects
    number (confidence interval 95%)
        Men A Day 1 (N=295,152)
    13 (9 to 17)
    15 (10 to 22)
        Men A Day 29 (N=295,152)
    79 (74 to 84)
    16 (10 to 23)
        Men C Day 1 (N=293,150)
    49 (44 to 55)
    39 (31 to 47)
        Men C Day 29 (N=293,150)
    99 (97 to 100)
    37 (30 to 46)
        Men W Day 1 (N=293,151)
    89 (85 to 92)
    87 (80 to 92)
        Men W Day 29 (N=293,151)
    98 (96 to 99)
    88 (82 to 93)
        Men Y Day 1 (N=294,152)
    54 (48 to 60)
    53 (44 to 61)
        Men Y Day 29 (N=294,152)
    94 (91 to 97)
    51 (42 to 59)
    No statistical analyses for this end point

    Secondary: To assess the immunogenicity of MenACWY as measured by the hSBA geometric mean titers (GMTs) directed against N. meningitidis serogroups A, C, W and Y.

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    End point title
    		 To assess the immunogenicity of MenACWY as measured by the hSBA geometric mean titers (GMTs) directed against N. meningitidis serogroups A, C, W and Y.
    End point description
    Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination).
    End point type
    Secondary
    End point timeframe
    At day 1 and day 29 post-vaccination.
    End point values
    		 MenACWY-CRM Placebo
    Number of subjects analysed
    295
    152
    Units: GMT
    geometric mean (confidence interval 95%)
        Men A Day 1 (N=295,152)
    2.7 (2.47 to 2.95)
    2.86 (2.53 to 3.24)
        Men A Day 29 (N=295,152)
    48 (39 to 57)
    3 (2.31 to 3.88)
        Men C Day 1 (N=293,150)
    7.82 (6.76 to 9.05)
    5.94 (4.85 to 7.27)
        Men C Day 29 (N=293,150)
    231 (198 to 269)
    6.04 (4.89 to 7.47)
        Men W Day 1 (N=293,151)
    51 (44 to 61)
    48 (38 to 60)
        Men W Day 29 (N=293,151)
    147 (125 to 171)
    47 (38 to 58)
        Men Y Day 1 (N=294,152)
    9.01 (7.64 to 11)
    8.82 (7.02 to 11)
        Men Y Day 29 (N=294,152)
    107 (89 to 128)
    8.4 (6.54 to 11)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and systemic AEs, oral temperature, all other AEs, and all concomitant medications were collected for 7 days following each vaccination. SAEs and AEs leading to withdrawal from the study were collected throughout the entire study period.
    Adverse event reporting additional description
    Analysis was done on safety population ie, the subjects in the exposed population who provided post-baseline safety data.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received the saline placebo

    Reporting group title
    MenACWY-CRM
    Reporting group description
    		 Subjects received one dose of MenACWY-CRM conjugate vaccine

    Serious adverse events
    		 Placebo MenACWY-CRM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 153 (0.00%)
    0 / 297 (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
    		 Placebo MenACWY-CRM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 153 (32.68%)
    117 / 297 (39.39%)
    Nervous system disorders
    Headache
    Additional description: For Occurences MedDRA 17.1 version was used
         subjects affected / exposed
    25 / 153 (16.34%)
    39 / 297 (13.13%)
         occurrences all number
    27
    48
    General disorders and administration site conditions
    Chills
    Additional description: For occurences MedDRA 17.1 version was used.
         subjects affected / exposed
    7 / 153 (4.58%)
    17 / 297 (5.72%)
         occurrences all number
    8
    22
    Injection site erythema
    Additional description: For occurences MedDRA 17.1 version was used
         subjects affected / exposed
    3 / 153 (1.96%)
    30 / 297 (10.10%)
         occurrences all number
    3
    30
    Injection site induration
    Additional description: For Occurences MedDRA 17.1 version was used
         subjects affected / exposed
    0 / 153 (0.00%)
    30 / 297 (10.10%)
         occurrences all number
    0
    30
    Injection site pain
    Additional description: For Occurences MedDRA 17.1 version was used
         subjects affected / exposed
    12 / 153 (7.84%)
    69 / 297 (23.23%)
         occurrences all number
    12
    72
    Malaise
    Additional description: For Occurences MedDRA 17.1 version was used
         subjects affected / exposed
    9 / 153 (5.88%)
    21 / 297 (7.07%)
         occurrences all number
    9
    23
    Gastrointestinal disorders
    Nausea
    Additional description: For Occurences MedDRA 17.1 version was used
         subjects affected / exposed
    10 / 153 (6.54%)
    22 / 297 (7.41%)
         occurrences all number
    11
    27
    Musculoskeletal and connective tissue disorders
    Myalgia
    Additional description: For Occurences MedDRA 17.1 version was used
         subjects affected / exposed
    13 / 153 (8.50%)
    46 / 297 (15.49%)
         occurrences all number
    15
    50

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Nov 2010
    This single amendment to the original protocol was implemented to clarify AE relatedness definitions and to correct the way indications of rash are captured. None of the revisions significantly altered the study conduct or would influence the interpretation of the study results

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

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