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    Clinical Trial Results:
    A phase 2b, randomized, controlled, observer-blind, multi-center, non-inferiority immunogenicity and safety study of two formulations of GSK Biologicals’ Meningococcal ACWY conjugate vaccine (GSK3536820A and Menveo) administered to healthy adults 18 to 40 years of age.

    Summary
    EudraCT number
    		 2017-003692-61
    Trial protocol
    		 DE   EE   BE   IT  
    Global end of trial date
    22 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Feb 2021
    First version publication date
    25 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    205343
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 044 2089-904466, GSKClinicalSupportHD@gsk.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate non-inferiority of the MenACWY liquid vaccine with approximately 30% Men A Free Saccharide (FS) to that of currently licensed MenACWY vaccine, as measured by the human serum bactericidal assay (hSBA) Geometric Mean Titers (GMTs) directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination. Criterion to demonstrate non-inferiority: Non-inferiority will be concluded if the lower limit of the two-sided 95% confidence interval (CI) for the ratio of hSBA GMTs against serogroup A between the liquid formulation and the licensed formulation is greater than 0.5.
    Protection of trial subjects
    All subjects were observed closely for at least 30 minutes following the administration of the vaccine, with appropriate medical treatment readily available in case of anaphylaxis. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccine. Safety was monitored for 6 months after vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Sep 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
    Australia: 184
    Country: Number of subjects enrolled
    Canada: 285
    Country: Number of subjects enrolled
    Belgium: 175
    Country: Number of subjects enrolled
    Germany: 200
    Country: Number of subjects enrolled
    Italy: 152
    Worldwide total number of subjects
    996
    EEA total number of subjects
    527
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    996
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrolment from 8 centers in Australia,2 in Belgium,10 in Canada,6 in Germany,4 in Italy.Planned age range in this study was 18-40 years.But 1 subject aged 44 years not meeting inclusion criteria was enrolled & vaccinated in GSK3536820A ACWY_Liq Group & therefore was considered for all analyses except per protocol set for immunogenicity analyses

    Pre-assignment
    Screening details
    		 Among 996 enrolled subjects,16 subjects did not receive any treatment and ICF documentation was not retrievable for 1 subject.

    Pre-assignment period milestones
    Number of subjects started
    		 996
    Number of subjects completed
    		 979

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Did not receive any study treatment: 16
    Reason: Number of subjects
    		 ICF documentation not retrievable: 1
    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, Monitor, Carer, Data analyst, Assessor
    Blinding implementation details
    This was an observer blind study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK3536820A ACWY_Liq Group
    Arm description
    		 Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MenACWY liquid vaccine with approximately 30% MenA FS (GSK3536820A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm

    Arm title
    		 ACWY Group
    Arm description
    		 Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Licensed GSK MenACWY vaccine
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm

    Number of subjects in period 1 [1]
    		GSK3536820A ACWY_Liq Group ACWY Group
    Started
    490
    489
    Completed
    486
    484
    Not completed
    4
    5
         Consent withdrawn by subject
    3
    5
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported in the baseline period are the number vaccinated and therefore differ from the worldwide enrolled number.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK3536820A ACWY_Liq Group
    Reporting group description
    		 Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.

    Reporting group title
    ACWY Group
    Reporting group description
    		 Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).

    Reporting group values
    		 GSK3536820A ACWY_Liq Group ACWY Group Total
    Number of subjects
    		 490 489 979
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 490 489 979
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.7 ( 5.8 ) 31.9 ( 5.8 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 309 305 614
        Male
    		 181 184 365
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian Or Alaska Native
    		 4 0 4
        Asian
    		 40 27 67
        Black Or African American
    		 4 8 12
        Native Hawaiian Or Other Pacific Islander
    		 2 2 4
        Other
    		 13 13 26
        White
    		 427 439 866

    End points

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    End points reporting groups
    Reporting group title
    GSK3536820A ACWY_Liq Group
    Reporting group description
    		 Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.

    Reporting group title
    ACWY Group
    Reporting group description
    		 Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).

    Primary: Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroup A for each vaccine group, and between-group ratios

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    End point title
    		 Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) against N. meningitidis serogroup A for each vaccine group, and between-group ratios
    End point description
    hSBA titers against N.meningitidis serogroup A were calculated in terms of GMTs adjusted for pre-vaccination titer. Analysis was performed on the per protocol set for immunogenicity that includes subjects who received the vaccine, did not have any protocol deviation leading to exclusion, who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.
    End point type
    Primary
    End point timeframe
    At Day 29
    End point values
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Number of subjects analysed
    386
    404
    Units: Titers
        geometric mean (confidence interval 95%)
    185.16 (147.90 to 231.81)
    211.33 (169.61 to 263.32)
    Statistical analysis title
    		 hSBA GMT ratio for serogroup A at day 29
    Statistical analysis description
    To demonstrate non-inferiority of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY_Liq Group) to that of currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted human serum bactericidal assay (hSBA) Geometric Mean Titers (GMTs) directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    790
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.2
    Notes
    [1] - Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratio for serogroup A is > 0.5

    Secondary: hSBA GMTs against each of the N.meningitidis serogroups A, C, W and Y for each vaccine group, and between-group ratios

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    End point title
    		 hSBA GMTs against each of the N.meningitidis serogroups A, C, W and Y for each vaccine group, and between-group ratios
    End point description
    hSBA titers were calculated in terms of GMTs, at Day 1 and Day 29, against each of the N. meningitidis serogroups A, C, W and Y. Analysis was performed on the per protocol set for immunogenicity that includes subjects who received the vaccine, did not have any protocol deviation leading to exclusion, who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 29
    End point values
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Number of subjects analysed
    459
    467
    Units: Titers
    geometric mean (confidence interval 95%)
        Meningitis A, Day 1(N=446,446)
    2.79 (2.52 to 3.10)
    2.97 (2.68 to 3.29)
        Meningitis A, Day 29(N=386,404)
    182.96 (145.11 to 230.68)
    213.42 (170.11 to 267.77)
        Meningitis C, Day 1(N=459,467)
    11.41 (9.81 to 13.27)
    12.05 (10.38 to 14.00)
        Meningitis C, Day 29(N=437,441)
    153.95 (115.03 to 206.04)
    139.63 (104.56 to 186.47)
        Meningitis W, Day 1(N=455,457)
    9.6 (8.05 to 11.45)
    10.92 (9.16 to 13.02)
        Meningitis W, Day 29(N=445,443)
    59.74 (47.67 to 74.86)
    54.12 (43.17 to 67.86)
        Meningitis Y, Day 1(N=458,463)
    4.14 (3.63 to 4.71)
    4.75 (4.17 to 5.40)
        Meningitis Y, Day 29(N=452,455)
    60.29 (48.67 to 74.68)
    54.99 (44.44 to 68.06)
    Statistical analysis title
    		 hSBA GMT ratio for serogroup C
    Statistical analysis description
    To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup C at Day 29
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    926
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.68
    Statistical analysis title
    		 hSBA GMT ratio for serogroup W
    Statistical analysis description
    To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup W at Day 29
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    926
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.58
    Statistical analysis title
    		 hSBA GMT ratio for serogroup Y
    Statistical analysis description
    To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup Y at Day 29
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    926
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 ANCOVA
    Parameter type
    		 GMT ratio
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.58

    Secondary: Within-group Geometric Mean Ratios (GMRs) against each of the N.meningitidis serogroups A, C, W and Y

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    End point title
    		 Within-group Geometric Mean Ratios (GMRs) against each of the N.meningitidis serogroups A, C, W and Y
    End point description
    Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroups A, C, W and Y at Day 29 compared to Day 1. Analysis was performed on the per protocol set for immunogenicity that includes subjects who received the vaccine, did not have any protocol deviation leading to exclusion, who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.
    End point type
    Secondary
    End point timeframe
    At Day 29
    End point values
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Number of subjects analysed
    452
    455
    Units: Ratio
    geometric mean (confidence interval 95%)
        Meningitis A(N=386,404)
    65.24 (51.81 to 82.16)
    73.01 (58.26 to 91.49)
        Meningitis C(N=437,441)
    13.17 (10.30 to 16.84)
    11.07 (8.68 to 14.13)
        Meningitis W(N=445,443)
    6.1 (5.07 to 7.33)
    4.8 (3.99 to 5.77)
        Meningitis Y(N=452,455)
    14.64 (11.88 to 18.04)
    11.48 (9.33 to 14.13)
    No statistical analyses for this end point

    Secondary: Percentages of subjects with a ≥4 fold rise in hSBA antibody titers for each of the N.meningitidis serogroups A, C,W and Y for each vaccine group, and between-group differences

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    End point title
    		 Percentages of subjects with a ≥4 fold rise in hSBA antibody titers for each of the N.meningitidis serogroups A, C,W and Y for each vaccine group, and between-group differences
    End point description
    The percentages of subjects with a ≥ 4-fold rise in post-vaccination hSBA (at Day 29 compared to Day 1) and associated 2-sided 95% Clopper-Pearson CIs were computed by group and for each N. meningitidis serogroups A, C, W and Y. A 4-fold rise in the hSBA titers is defined as: for individuals, whose pre-vaccination titers are < the LOD (limit of detection), the post-vaccination titers must be ≥ 4-fold the LOD or ≥ the LLOQ (lower of limit of quantitation) whichever is greater; for individuals, whose pre-vaccination titers are ≥ the LOD and ≤ the LLOQ, the post-vaccination titers must be at least four times the LLOQ; for individuals whose pre-vaccination titers are > the LLOQ, the post-vaccination titers must be at least four times the pre-vaccination
    End point type
    Secondary
    End point timeframe
    At Day 29
    End point values
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Number of subjects analysed
    452
    455
    Units: Percentages of subjects
    number (confidence interval 95%)
        Meningitis A(N=386,404)
    79.8 (75.4 to 83.7)
    83.7 (79.7 to 87.1)
        Meningitis C(N=437,441)
    56.3 (51.5 to 61.0)
    54.4 (49.6 to 59.1)
        Meningitis W(N=445,443)
    44.7 (40.0 to 49.5)
    40.2 (35.6 to 44.9)
        Meningitis Y(N=452,455)
    63.3 (58.6 to 67.7)
    58 (53.3 to 62.6)
    Statistical analysis title
    		 Between-groups differences- Serogroup A
    Statistical analysis description
    Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    907
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -3.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.3
         upper limit
    		 1.52
    Statistical analysis title
    		 Between-group differences- serogroup C
    Statistical analysis description
    Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    907
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    1.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 8.43
    Statistical analysis title
    		 Between-group differences- serogroup W
    Statistical analysis description
    Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    907
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    4.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.97
         upper limit
    		 11.01
    Statistical analysis title
    		 Between-group differences- serogroup Y
    Statistical analysis description
    Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    907
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    5.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.11
         upper limit
    		 11.57

    Secondary: Percentages of subjects with hSBA titers ≥8 against each of the N. meningitidis serogroups A, C, W and Y for each vaccine group, and between-group differences

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    End point title
    		 Percentages of subjects with hSBA titers ≥8 against each of the N. meningitidis serogroups A, C, W and Y for each vaccine group, and between-group differences
    End point description
    For each vaccine group the percentage of subjects with hSBA titer ≥8, and its associated two-sided 95% Clopper-Pearson CIs were computed for each of the N. meningitidis serogroups A, C, W and Y. Analysis was performed on the per protocol set for immunogenicity that includes subjects who received the vaccine, did not have any protocol deviation leading to exclusion, who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 29
    End point values
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Number of subjects analysed
    460
    467
    Units: Percentages of subjects
    number (confidence interval 95%)
        Meningitis A, Day 1(N=446,446)
    8.7 (6.3 to 11.8)
    11.2 (8.4 to 14.5)
        Meningitis A, Day 29(N=406, 428)
    82.8 (78.7 to 86.3)
    86.4 (82.8 to 89.5)
        Meningitis C, Day 1(N=459,467)
    53.8 (49.1 to 58.4)
    54.4 (49.7 to 59.0)
        Meningitis C, Day 29(N=443,446)
    74.5 (70.2 to 78.5)
    74.9 (70.6 to 78.8)
        Meningitis W, Day 1(N=455,457)
    39.8 (35.3 to 44.4)
    45.7 (41.1 to 50.4)
        Meningitis W, Day 29(N=454,457)
    73.3 (69.0 to 77.4)
    73.1 (68.8 to 77.1)
        Meningitis Y, Day 1(N=458,463)
    22.7 (18.9 to 26.8)
    25.5 (21.6 to 29.7)
        Meningitis Y, Day 29(N=460,463)
    77.2 (73.1 to 80.9)
    76 (71.9 to 79.8)
    Statistical analysis title
    		 Between-group differences- Serogroup A, Day 1
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 1
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -2.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.47
         upper limit
    		 1.49
    Statistical analysis title
    		 Between-group differences-Serogroup C, day 1
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 1
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.99
         upper limit
    		 5.83
    Statistical analysis title
    		 Between-group differences-Serogroup W, day 1
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 1
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -5.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.33
         upper limit
    		 0.47
    Statistical analysis title
    		 Between-group differences-Serogroup Y, day 1
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 1
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -2.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.3
         upper limit
    		 2.76
    Statistical analysis title
    		 Between-group differences-Serogroup A, day 29
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 29
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -3.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.65
         upper limit
    		 1.21
    Statistical analysis title
    		 Between-group differences-Serogroup C, day 29
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 29
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.12
         upper limit
    		 5.33
    Statistical analysis title
    		 Between-group differences-Serogroup W, day 29
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 29
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.49
         upper limit
    		 6.02
    Statistical analysis title
    		 Between-group differences-Serogroup Y, day 29
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 29
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.33
         upper limit
    		 6.62

    Secondary: Percentages of subjects with hSBA titers ≥LLOQ against each of the N. meningitidis serogroups A, C, W and Y for each vaccine group, and between-group differences

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    End point title
    		 Percentages of subjects with hSBA titers ≥LLOQ against each of the N. meningitidis serogroups A, C, W and Y for each vaccine group, and between-group differences
    End point description
    For each vaccine group the percentage of subjects with hSBA titer ≥LLOQ, and its associated two-sided 95% Clopper-Pearson CIs were computed for each of the N. meningitidis serogroups A, C, W and Y. Analysis was performed on the per protocol set for immunogenicity that includes subjects who received the vaccine, did not have any protocol deviation leading to exclusion, who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.
    End point type
    Secondary
    End point timeframe
    At Day 1 and Day 29
    End point values
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Number of subjects analysed
    460
    467
    Units: Percentages of subjects
    number (confidence interval 95%)
        Meningitis A, Day 1(N=446,446)
    10.5 (7.8 to 13.8)
    13.5 (10.4 to 17.0)
        Meningitis A, Day 29(N=406,428)
    82.8 (78.7 to 86.3)
    86.7 (83.1 to 89.8)
        Meningitis C, Day 1(N=459,467)
    61.2 (56.6 to 65.7)
    62.3 (57.7 to 66.7)
        Meningitis C, Day 29(N=443,446)
    76.5 (72.3 to 80.4)
    76.5 (72.2 to 80.3)
        Meningitis W, Day 1(N=455,457)
    41.3 (36.8 to 46.0)
    47.3 (42.6 to 52.0)
        Meningitis W, Day 29(N=454,457)
    73.3 (69.0 to 77.4)
    73.5 (69.2 to 77.5)
        Meningitis Y, Day 1(N=458,463)
    23.8 (20.0 to 28.0)
    26.3 (22.4 to 30.6)
        Meningitis Y, Day 29(N=460, 463)
    77.8 (73.7 to 81.5)
    77.3 (73.2 to 81.1)
    Statistical analysis title
    		 Between-group differences-Serogroup A, day 1
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -2.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.24
         upper limit
    		 1.37
    Statistical analysis title
    		 Between-group differences-Serogroup C, day 1
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.34
         upper limit
    		 5.16
    Statistical analysis title
    		 Between-group differences-Serogroup W, day 1
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -5.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.35
         upper limit
    		 0.5
    Statistical analysis title
    		 Between-group differences-Serogroup Y, day 1
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -2.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.15
         upper limit
    		 3.06
    Statistical analysis title
    		 Between-group differences-Serogroup A, day 29
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -3.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.87
         upper limit
    		 0.96
    Statistical analysis title
    		 Between-group differences-Serogroup C, day 29
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.52
         upper limit
    		 5.65
    Statistical analysis title
    		 Between-group differences-Serogroup W, day 29
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.92
         upper limit
    		 5.57
    Statistical analysis title
    		 Between-group differences-Serogroup Y, day 29
    Statistical analysis description
    Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29
    Comparison groups
    GSK3536820A ACWY_Liq Group v ACWY Group
    Number of subjects included in analysis
    927
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 Miettinen and Nurminen score method
    Parameter type
    		 Difference in percentage of subjects
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.89
         upper limit
    		 5.9

    Secondary: Number of subjects reported with solicited local and systemic AEs

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    End point title
    		 Number of subjects reported with solicited local and systemic AEs
    End point description
    Number of subjects with solicited local and systemic AEs during the 7-days period (including the day of vaccination) after the vaccination. Analysis was performed on the solicited safety set that includes all enrolled subjects who received a study vaccination and reported any solicited adverse events data for the defined period.
    End point type
    Secondary
    End point timeframe
    From Day 1 (6 hours) to Day 7 after vaccination
    End point values
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Number of subjects analysed
    489
    487
    Units: Participants
        Erythema
    28
    28
        Induration
    25
    24
        Pain
    200
    182
        Arthralgia
    43
    46
        Chills
    42
    40
        Fatigue
    159
    159
        Fever (Temperature >= 38 C)
    7
    10
        Headache
    158
    165
        Loss of Appetite
    31
    40
        Myalgia
    58
    58
        Nausea
    49
    50
    No statistical analyses for this end point

    Secondary: Number of subjects reported with other indicators of reactogenicity

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    End point title
    		 Number of subjects reported with other indicators of reactogenicity
    End point description
    Number of subjects reporting other indicators of reactogenicity such as use of analgesics/antipyretics within 7 days after vaccination. Analysis was performed on the solicited safety set that includes all enrolled subjects who received a study vaccination and reported any indicators of reactogenicity data for the defined period.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 7 after vaccination
    End point values
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Number of subjects analysed
    489
    487
    Units: Participants
        Analgesic/Antipyretic Prevention, Yes
    36
    40
        Analgesic/Antipyretic Prevention, No
    453
    447
        Analgesic/Antipyretic Treatment, Yes
    80
    79
        Analgesic/Antipyretic Treatment, No
    409
    408
    No statistical analyses for this end point

    Secondary: Number of subjects reported with any unsolicited AEs within 29 days after vaccination

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    End point title
    		 Number of subjects reported with any unsolicited AEs within 29 days after vaccination
    End point description
    An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Analysis was performed on the unsolicited safety set that includes all enrolled subjects who received a study vaccination and reported unsolicited adverse events data for the defined period.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 29 after vaccination
    End point values
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Number of subjects analysed
    489
    489
    Units: Participants
    117
    111
    No statistical analyses for this end point

    Secondary: Number of subjects reported with AEs leading to withdrawal, medically attended AEs and serious adverse events (SAEs)

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    End point title
    		 Number of subjects reported with AEs leading to withdrawal, medically attended AEs and serious adverse events (SAEs)
    End point description
    Medically attended AEs are defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) is occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination. Serious adverse event is any congenital anomaly/birth defect in the offspring of a study subject or any untoward medical occurrence that results in death or life threatening or requires hospitalization or results in disability or incapacity. Analysis was performed on the unsolicited safety set that includes all enrolled subjects who received a study vaccination and reported any adverse events data in the defined period.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 181 (during the entire study period)
    End point values
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Number of subjects analysed
    489
    489
    Units: Participants
        Aes leading to withdrawal
    0
    0
        MAEs
    79
    84
        SAEs
    6
    9
    No statistical analyses for this end point

    Secondary: Number of subjects reported with any unsolicited adverse events (AEs) within 30 minutes after vaccination

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    End point title
    		 Number of subjects reported with any unsolicited adverse events (AEs) within 30 minutes after vaccination
    End point description
    An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Analysis was performed on the unsolicited safety set that includes all enrolled subjects who received a study vaccination and reported unsolicited adverse events data for the defined period.
    End point type
    Secondary
    End point timeframe
    Within 30 minutes after vaccination at Day 1
    End point values
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Number of subjects analysed
    489
    489
    Units: Participants
    5
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs were collected from Day 1 to Day 7 after vaccination and Unsolicited AEs from Day 1 to Day 29 after vaccination. SAEs were collected from Day 1 to Day 181 (during the entire study period)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    GSK3536820A ACWY_Liq Group
    Reporting group description
    		 Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.

    Reporting group title
    ACWY Group
    Reporting group description
    		 Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).

    Serious adverse events
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 490 (1.22%)
    9 / 489 (1.84%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine cancer
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Jaw fracture
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hemiplegic migraine
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abortion spontaneous incomplete
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hernia
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst ruptured
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Dengue fever
         subjects affected / exposed
    1 / 490 (0.20%)
    1 / 489 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GSK3536820A ACWY_Liq Group ACWY Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    336 / 490 (68.57%)
    335 / 489 (68.51%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign breast neoplasm
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Administration site joint pain
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Chills
         subjects affected / exposed
    43 / 490 (8.78%)
    40 / 489 (8.18%)
         occurrences all number
    44
    40
    Fatigue
         subjects affected / exposed
    160 / 490 (32.65%)
    162 / 489 (33.13%)
         occurrences all number
    163
    163
    Feeling abnormal
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Feeling hot
         subjects affected / exposed
    1 / 490 (0.20%)
    1 / 489 (0.20%)
         occurrences all number
    1
    1
    Influenza like illness
         subjects affected / exposed
    5 / 490 (1.02%)
    2 / 489 (0.41%)
         occurrences all number
    5
    2
    Injection site bruising
         subjects affected / exposed
    1 / 490 (0.20%)
    1 / 489 (0.20%)
         occurrences all number
    1
    1
    Injection site erythema
         subjects affected / exposed
    30 / 490 (6.12%)
    31 / 489 (6.34%)
         occurrences all number
    31
    32
    Injection site haemorrhage
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Injection site induration
         subjects affected / exposed
    26 / 490 (5.31%)
    25 / 489 (5.11%)
         occurrences all number
    27
    25
    Injection site joint pain
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    2
    0
    Injection site oedema
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Injection site pain
         subjects affected / exposed
    200 / 490 (40.82%)
    184 / 489 (37.63%)
         occurrences all number
    204
    184
    Injection site pruritus
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Injection site rash
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Injection site swelling
         subjects affected / exposed
    1 / 490 (0.20%)
    1 / 489 (0.20%)
         occurrences all number
    1
    1
    Injection site warmth
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    2 / 490 (0.41%)
    0 / 489 (0.00%)
         occurrences all number
    2
    0
    Mass
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    10 / 490 (2.04%)
    10 / 489 (2.04%)
         occurrences all number
    11
    10
    Vaccination site induration
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Vaccination site paraesthesia
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 490 (0.20%)
    1 / 489 (0.20%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    2 / 490 (0.41%)
    1 / 489 (0.20%)
         occurrences all number
    2
    1
    Menorrhagia
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Ovarian cyst
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Allergic sinusitis
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Bronchospasm
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    3 / 490 (0.61%)
    1 / 489 (0.20%)
         occurrences all number
    3
    1
    Dyspnoea
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    7 / 490 (1.43%)
    2 / 489 (0.41%)
         occurrences all number
    7
    2
    Rhinorrhoea
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Disorientation
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    3 / 490 (0.61%)
    0 / 489 (0.00%)
         occurrences all number
    4
    0
    Panic attack
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Cartilage injury
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Contusion
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    2 / 490 (0.41%)
    1 / 489 (0.20%)
         occurrences all number
    2
    1
    Post-traumatic pain
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Procedural pain
         subjects affected / exposed
    1 / 490 (0.20%)
    2 / 489 (0.41%)
         occurrences all number
    1
    2
    Skin laceration
         subjects affected / exposed
    2 / 490 (0.41%)
    0 / 489 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    0 / 490 (0.00%)
    2 / 489 (0.41%)
         occurrences all number
    0
    2
    Dizziness
         subjects affected / exposed
    4 / 490 (0.82%)
    1 / 489 (0.20%)
         occurrences all number
    4
    1
    Dysgeusia
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    162 / 490 (33.06%)
    171 / 489 (34.97%)
         occurrences all number
    167
    183
    Loss of consciousness
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Migraine with aura
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Presyncope
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 490 (0.20%)
    3 / 489 (0.61%)
         occurrences all number
    1
    4
    Ear and labyrinth disorders
    Meniere's disease
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye pain
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
         subjects affected / exposed
    2 / 490 (0.41%)
    1 / 489 (0.20%)
         occurrences all number
    2
    1
    Abdominal pain lower
         subjects affected / exposed
    0 / 490 (0.00%)
    2 / 489 (0.41%)
         occurrences all number
    0
    2
    Constipation
         subjects affected / exposed
    2 / 490 (0.41%)
    0 / 489 (0.00%)
         occurrences all number
    2
    0
    Dental caries
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 490 (0.41%)
    2 / 489 (0.41%)
         occurrences all number
    2
    2
    Dyspepsia
         subjects affected / exposed
    2 / 490 (0.41%)
    0 / 489 (0.00%)
         occurrences all number
    2
    0
    Food poisoning
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Inguinal hernia
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    51 / 490 (10.41%)
    51 / 489 (10.43%)
         occurrences all number
    52
    52
    Stomatitis
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 490 (0.20%)
    2 / 489 (0.41%)
         occurrences all number
    1
    2
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Dermal cyst
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Rash pruritic
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Sensitive skin
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    43 / 490 (8.78%)
    49 / 489 (10.02%)
         occurrences all number
    44
    49
    Back pain
         subjects affected / exposed
    1 / 490 (0.20%)
    1 / 489 (0.20%)
         occurrences all number
    1
    1
    Bursitis
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Flank pain
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Joint stiffness
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    59 / 490 (12.04%)
    58 / 489 (11.86%)
         occurrences all number
    59
    58
    Myosclerosis
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    2 / 490 (0.41%)
    0 / 489 (0.00%)
         occurrences all number
    2
    0
    Pain in extremity
         subjects affected / exposed
    1 / 490 (0.20%)
    1 / 489 (0.20%)
         occurrences all number
    1
    1
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Synovitis
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 490 (0.20%)
    2 / 489 (0.41%)
         occurrences all number
    1
    2
    Candida infection
         subjects affected / exposed
    1 / 490 (0.20%)
    1 / 489 (0.20%)
         occurrences all number
    1
    1
    Cellulitis
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Cellulitis orbital
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    2 / 490 (0.41%)
    0 / 489 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Erysipelas
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    3 / 490 (0.61%)
    0 / 489 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 490 (0.00%)
    2 / 489 (0.41%)
         occurrences all number
    0
    2
    Gastrointestinal infection
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Infected cyst
         subjects affected / exposed
    2 / 490 (0.41%)
    0 / 489 (0.00%)
         occurrences all number
    2
    0
    Influenza
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    2 / 490 (0.41%)
    1 / 489 (0.20%)
         occurrences all number
    2
    1
    Localised infection
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    11 / 490 (2.24%)
    10 / 489 (2.04%)
         occurrences all number
    11
    10
    Onychomycosis
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    2 / 490 (0.41%)
    2 / 489 (0.41%)
         occurrences all number
    2
    2
    Pneumonia
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Post procedural infection
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 490 (0.20%)
    0 / 489 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 490 (0.20%)
    6 / 489 (1.23%)
         occurrences all number
    1
    6
    Sinusitis
         subjects affected / exposed
    0 / 490 (0.00%)
    4 / 489 (0.82%)
         occurrences all number
    0
    4
    Streptococcal infection
         subjects affected / exposed
    1 / 490 (0.20%)
    1 / 489 (0.20%)
         occurrences all number
    1
    1
    Tonsillitis
         subjects affected / exposed
    2 / 490 (0.41%)
    1 / 489 (0.20%)
         occurrences all number
    2
    1
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 490 (2.04%)
    6 / 489 (1.23%)
         occurrences all number
    10
    6
    Urinary tract infection
         subjects affected / exposed
    0 / 490 (0.00%)
    1 / 489 (0.20%)
         occurrences all number
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 490 (0.00%)
    2 / 489 (0.41%)
         occurrences all number
    0
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 490 (0.41%)
    2 / 489 (0.41%)
         occurrences all number
    2
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    31 / 490 (6.33%)
    41 / 489 (8.38%)
         occurrences all number
    31
    42

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Jan 2018
    -Two similar exclusion criteria combined into a single criterion -Clarification of immunogenicity endpoints that will be included in a sub group analysis -Editorial changes to the protocol
    15 Mar 2018
    Intensity scales for solicited AEs were updated to correct the intensity scores of some of the AEs solicited. Redness/ swelling changed to erythema/induration, in line with local AEs solicited.

    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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