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    Clinical Trial Results:
    A phase IIIB, randomized, controlled, observer-blind study to evaluate safety and immunogenicity of GSK’s meningococcal ABCWY vaccine when administered in healthy adolescents and adults, previously primed with meningococcal ACWY vaccine

    Summary
    EudraCT number
    		 2019-004982-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 May 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Aug 2024
    First version publication date
    13 Apr 2024
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    213171
    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, 1330
    Public contact
    GSK Response Center, GSK Response Center, 044 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 044 8664357343, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    -To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4 fold rise1 in hSBA titers against N. meningitidis serogroups A, C, W, and Y, at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose). -To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4 fold rise1 in hSBA titers against N. meningitidis serogroups A, C, W, and Y, at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose). -To evaluate the safety and reactogenicity of the MenABCWY and MenACWY vaccines.
    Protection of trial subjects
    The participants were observed closely for at least 30 minutes after the administration of the vaccine(s)/product. Appropriate medical treatment was readily available during the observation period in case of anaphylaxis and/or syncope.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 May 2021
    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
    Argentina: 232
    Country: Number of subjects enrolled
    Australia: 237
    Country: Number of subjects enrolled
    Canada: 49
    Country: Number of subjects enrolled
    United States: 729
    Worldwide total number of subjects
    1247
    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)
    0
    Adolescents (12-17 years)
    891
    Adults (18-64 years)
    356
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of 1250 participants enrolled,3 participants did not receive vaccination as they did not meet the eligibility criteria, therefore only 1247 participants were included in the Exposed Set and started the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Assessor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ABCWY Group
    Arm description
    		 Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Combined Meningococcal Groups A, B, C, W and Y vaccine
    Investigational medicinal product code
    MenABCWY
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule).

    Investigational medicinal product name
    Meningococcal Group B Vaccine
    Investigational medicinal product code
    rMenB+OMV NZ
    Other name
    Bexsero
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 doses of MenB vaccine on Day 181 and Day 211.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of placebo on Day 211.

    Arm title
    		 ACWY Group
    Arm description
    		 Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meningococcal Groups A, C, W and Y Conjugate Vaccine
    Investigational medicinal product code
    MenACWY
    Other name
    Menveo
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of MenACWY vaccine administered intramuscularly on Day 1.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: This was an Observer-blind study. Recipients & study evaluators were unaware of vaccine administered.
    Number of subjects in period 1
    		ABCWY Group ACWY Group
    Started
    626
    621
    Completed
    541
    542
    Not completed
    85
    79
         Consent withdrawn by subject
    27
    25
         Adverse event, non-fatal
    5
    8
         MIGRATED / MOVED FROM THE STUDY AREA
    8
    8
         Lost to follow-up
    44
    31
         UNSPECIFIED
    -
    2
         Protocol deviation
    1
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABCWY Group
    Reporting group description
    		 Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.

    Reporting group title
    ACWY Group
    Reporting group description
    		 Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.

    Reporting group values
    		 ABCWY Group ACWY Group Total
    Number of subjects
    		 626 621 1247
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 450 441 891
        Adults (18-64 years)
    		 176 180 356
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 17.2 ( 2.53 ) 17.2 ( 2.63 ) -
    Sex: Female, Male
    Units: Participants
        Male
    		 283 297 580
        Female
    		 343 324 667
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    		 94 86 180
        American Indian or Alaska Native
    		 1 1 2
        Asian
    		 22 33 55
        Native Hawaiian or Other Pacific Islander
    		 2 6 8
        White
    		 474 464 938
        Other UNSPECIFIED
    		 33 31 64

    End points

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    End points reporting groups
    Reporting group title
    ABCWY Group
    Reporting group description
    		 Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.

    Reporting group title
    ACWY Group
    Reporting group description
    		 Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.

    Primary: Percentages of Participants with a 4-fold Rise in human serum bactericidal assay (hSBA) Titers against N. Meningitidis Serogroups A, C, W, and Y at 1 month after the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline

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    End point title
    		 Percentages of Participants with a 4-fold Rise in human serum bactericidal assay (hSBA) Titers against N. Meningitidis Serogroups A, C, W, and Y at 1 month after the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline
    End point description
    Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (>=) 16 for participants with a pre-vaccination hSBA titer <4; - a post-vaccination hSBA titer >= 4 times the LLOQ for participants with a pre vaccination hSBA titer >= limit of detection (LOD) but < LLOQ; and - a post-vaccination hSBA titer >= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer >= LLOQ.
    End point type
    Primary
    End point timeframe
    At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) compared to Day 1 (Baseline)
    End point values
    		 ABCWY Group ACWY Group
    Number of subjects analysed
    181
    546
    Units: Percentage of Participants
    number (confidence interval 95%)
        Meningitis A (N=169,505)
    95.3 (90.89 to 97.93)
    95.0 (92.78 to 96.77)
        Meningitis C (N=181,546)
    94.5 (90.07 to 97.32)
    94.0 (91.62 to 95.80)
        Meningitis W (N=181,544)
    95.6 (91.48 to 98.07)
    93.9 (91.59 to 95.79)
        Meningitis Y (N=180,537)
    95.0 (90.72 to 97.69)
    94.4 (92.12 to 96.20)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).
    Comparison groups
    ABCWY Group v ACWY Group
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    0.2
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 -4.38
         upper limit
    		 3.5
    Notes
    [1] - Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup A.
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups W at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).
    Comparison groups
    ABCWY Group v ACWY Group
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    1.6
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 -2.73
         upper limit
    		 4.89
    Notes
    [2] - Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup W.
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).
    Comparison groups
    ABCWY Group v ACWY Group
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    0.6
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 -3.93
         upper limit
    		 3.91
    Notes
    [3] - Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup Y.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).
    Comparison groups
    ABCWY Group v ACWY Group
    Number of subjects included in analysis
    727
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    0.5
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 -4.14
         upper limit
    		 3.98
    Notes
    [4] - Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup C.

    Primary: Percentages of Participants with a 4-fold Rise in hSBA Titers against N. Meningitidis Serogroups A, C, W, and Y at 1 month after the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline

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    End point title
    		 Percentages of Participants with a 4-fold Rise in hSBA Titers against N. Meningitidis Serogroups A, C, W, and Y at 1 month after the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline
    End point description
    Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (>=) 16 for participants with a pre-vaccination hSBA titer <4; - a post-vaccination hSBA titer >= 4 times the LLOQ for participants with a pre vaccination hSBA titer >= limit of detection (LOD) but < LLOQ; and - a post-vaccination hSBA titer >= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer >= LLOQ.
    End point type
    Primary
    End point timeframe
    At 1 month after the first vaccination (i.e., Day 31) compared to Day 1 (Baseline)
    End point values
    		 ABCWY Group ACWY Group
    Number of subjects analysed
    570
    546
    Units: Percentage of Participants
    number (confidence interval 95%)
        Meningitis A (N=509, 505)
    92.5 (89.90 to 94.66)
    95.0 (92.78 to 96.77)
        Meningitis C (N=570, 546)
    94.0 (91.76 to 95.83)
    94.0 (91.62 to 95.80)
        Meningitis W (N=565,544)
    94.3 (92.10 to 96.09)
    93.9 (91.59 to 95.79)
        Meningitis Y (N=567,537)
    93.7 (91.32 to 95.51)
    94.4 (92.12 to 96.20)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).
    Comparison groups
    ABCWY Group v ACWY Group
    Number of subjects included in analysis
    1116
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    -2.5
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 -5.59
         upper limit
    		 0.47
    Notes
    [5] - Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in the 4-fold rise in hSBA titers (p_MenABCWY– p_MenACWY) is above −10% for serogroup A.
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).
    Comparison groups
    ABCWY Group v ACWY Group
    Number of subjects included in analysis
    1116
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    -0.8
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 -3.62
         upper limit
    		 2.09
    Notes
    [6] - Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p_MenABCWY– p_MenACWY) is above −10% for serogroup Y.
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroupsW at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).
    Comparison groups
    ABCWY Group v ACWY Group
    Number of subjects included in analysis
    1116
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    0.4
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 -2.41
         upper limit
    		 3.25
    Notes
    [7] - Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p_MenABCWY– p_MenACWY) is above −10% for serogroup W.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).
    Comparison groups
    ABCWY Group v ACWY Group
    Number of subjects included in analysis
    1116
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    Method
    Parameter type
    		 Difference in percentage of participants
    Point estimate
    0.1
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 -2.76
         upper limit
    		 2.94
    Notes
    [8] - Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p_MenABCWY– p_MenACWY) is above −10% for serogroup C.

    Primary: Number of Participants with solicited administration site events following vaccination at day 1 for ABCWY group and ACWY group

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    End point title
    		 Number of Participants with solicited administration site events following vaccination at day 1 for ABCWY group and ACWY group [9]
    End point description
    Assessed solicited administration site events include injection site pain, erythema, swelling, induration. Any pain = occurrence of the symptom regardless of intensity grade and any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters.
    End point type
    Primary
    End point timeframe
    During the 7 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 ABCWY Group ACWY Group
    Number of subjects analysed
    608
    601
    Units: Participants
        Injection site pain (N=608,601)
    486
    191
        Erythema (N=608,600)
    29
    9
        Swelling (N=608,600)
    26
    13
        Induration (N=608,600)
    24
    14
    No statistical analyses for this end point

    Primary: Number of Participants with solicited administration site events following vaccination at Day 181 for ABCWY group

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    End point title
    		 Number of Participants with solicited administration site events following vaccination at Day 181 for ABCWY group [10] [11]
    End point description
    Assessed solicited administration site events include injection site pain, erythema, swelling, induration. Any pain = occurrence of the symptom regardless of intensity grade and any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters.
    End point type
    Primary
    End point timeframe
    During the 7 days (including day of vaccination) following vaccination at Day 181 for ABCWY group
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As specified in the Protocol, the analysis assesses the safety and reactogenicity of the MenABCWY vaccines.
    End point values
    		 ABCWY Group
    Number of subjects analysed
    507
    Units: Participants
        Injection site pain (N=507)
    377
        Erythema (N=505)
    31
        Swelling (N=505)
    30
        Induration (N=505)
    22
    No statistical analyses for this end point

    Primary: Number of Participants with solicited systemic events following vaccination at day 1 for the ABCWY group and ACWY group

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    End point title
    		 Number of Participants with solicited systemic events following vaccination at day 1 for the ABCWY group and ACWY group [12]
    End point description
    Assessed solicited systemic events include fever [body temperature >= 38.0°C (celsius) /100.4°F (Fahrenheit)], nausea, fatigue, myalgia, arthralgia, headache.
    End point type
    Primary
    End point timeframe
    During the 7 days (including day of vaccination) following vaccination at day 1 for the ABCWY group and ACWY group
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 ABCWY Group ACWY Group
    Number of subjects analysed
    608
    601
    Units: Participants
        Fever (N=608,600)
    12
    7
        Nausea (N=608,600)
    88
    75
        Fatigue (N=608,600)
    244
    222
        Myalgia (N=608,600)
    90
    66
        Arthralgia (N=608,600)
    45
    49
        Headache (N=608,600)
    249
    208
    No statistical analyses for this end point

    Primary: Number of Participants with solicited systemic events following vaccination at day 181 for the ABCWY group

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    End point title
    		 Number of Participants with solicited systemic events following vaccination at day 181 for the ABCWY group [13] [14]
    End point description
    Assessed solicited systemic events include fever [body temperature >= 38.0°C/100.4°F], nausea, fatigue, myalgia, arthralgia, headache.
    End point type
    Primary
    End point timeframe
    During the 7 days (including day of vaccination) following vaccination at day 181 for the ABCWY group
    Notes
    [13] - 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: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As specified in the Protocol, the analysis assesses the safety and reactogenicity of the MenABCWY vaccines.
    End point values
    		 ABCWY Group
    Number of subjects analysed
    505
    Units: Participants
        Fever (N=505)
    9
        Nausea (N=505)
    58
        Fatigue (N=505)
    167
        Myalgia (N=505)
    67
        Arthralgia (N=505)
    30
        Headache (N=505)
    167
    No statistical analyses for this end point

    Primary: Number of Participants with any unsolicited adverse events (AEs) (including all serious adverse events [SAEs], AEs leading to withdrawal, AEs of special interest [AESIs] and medically attended AEs)

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    End point title
    		 Number of Participants with any unsolicited adverse events (AEs) (including all serious adverse events [SAEs], AEs leading to withdrawal, AEs of special interest [AESIs] and medically attended AEs) [15]
    End point description
    Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. An MAE is defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
    End point type
    Primary
    End point timeframe
    During the 30 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
    Notes
    [15] - 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: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 ABCWY Group ACWY Group
    Number of subjects analysed
    626
    621
    Units: Participants
    96
    93
    No statistical analyses for this end point

    Primary: Number of Participants with any unsolicited adverse events (AEs) (including all serious adverse events [SAEs], AEs leading to withdrawal, AEs of special interest [AESIs] and medically attended AEs) following vaccination at day 181 for ABCWY group

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    End point title
    		 Number of Participants with any unsolicited adverse events (AEs) (including all serious adverse events [SAEs], AEs leading to withdrawal, AEs of special interest [AESIs] and medically attended AEs) following vaccination at day 181 for ABCWY group [16] [17]
    End point description
    Any AE-untoward medical occurrence in a patient/clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
    End point type
    Primary
    End point timeframe
    During the 30 days (including day of vaccination) following vaccination at day 181 for ABCWY group
    Notes
    [16] - 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: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As specified in the Protocol, the analysis assesses the safety and reactogenicity of the MenABCWY vaccines.
    End point values
    		 ABCWY Group
    Number of subjects analysed
    626
    Units: Participants
    72
    No statistical analyses for this end point

    Primary: Number of Participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs

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    End point title
    		 Number of Participants with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs [18]
    End point description
    SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were assessed throughout the study period are reported in this outcome measure.
    End point type
    Primary
    End point timeframe
    From Day 1 to Day 361 (throughout the study period)
    Notes
    [18] - 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: The analysis of this primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 ABCWY Group ACWY Group
    Number of subjects analysed
    626
    621
    Units: Participants
        SAEs
    18
    7
        AEs leading to withdrawal
    4
    6
        AESIs
    0
    4
        Medically Attended AEs
    223
    206
    No statistical analyses for this end point

    Secondary: Percentages of Participants with hSBA titers >= Lower Limit of Quantitation (LLOQ) against serogroups A, C, W, and Y at day 1, 1 month after the first MenABCWY vaccination and after the single MenACWY vaccination

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    End point title
    		 Percentages of Participants with hSBA titers >= Lower Limit of Quantitation (LLOQ) against serogroups A, C, W, and Y at day 1, 1 month after the first MenABCWY vaccination and after the single MenACWY vaccination
    End point description
    The immune response to MenABCWY vaccine after the first and second dose and single dose of MenACWY vaccine was evaluated by measuring the percentage of participants with hSBA titers >= LLOQ against each of the serogroups A, C, W and Y.
    End point type
    Secondary
    End point timeframe
    At Day 1 (pre-vaccination) and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)
    End point values
    		 ABCWY Group ACWY Group
    Number of subjects analysed
    609
    593
    Units: Percentage of Participants
    number (confidence interval 95%)
        Meningitis A, Day 1 (N=546, 549)
    27.7 (23.94 to 31.61)
    28.8 (25.02 to 32.77)
        Meningitis A, Day 31 (N=605,585)
    98.3 (96.98 to 99.20)
    98.1 (96.66 to 99.06)
        Meningitis C, Day 1 (N=601,584)
    57.7 (53.67 to 61.72)
    56.2 (52.03 to 60.23)
        Meningitis C, Day 31 (N=609,593)
    98.9 (97.65 to 99.54)
    99.0 (97.81 to 99.63)
        Meningitis W, Day 1 (N=597,583)
    36.3 (32.48 to 40.35)
    33.4 (29.62 to 37.44)
        Meningitis W, Day 31 (N=607,592)
    98.4 (96.99 to 99.21)
    96.8 (95.03 to 98.06)
        Meningitis Y, Day 1 (N=600,576)
    37.5 (33.61 to 41.51)
    34.9 (31.00 to 38.94)
        Meningitis Y, Day 31 (N=606,591)
    97.9 (96.36 to 98.85)
    97.6 (96.06 to 98.70)
    No statistical analyses for this end point

    Secondary: hSBA Geometric Mean Titers (GMTs) against serogroups A, C, W, and Y at day 1, 1 month after the first MenABCWY vaccination and after the single MenACWY vaccination

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    End point title
    		 hSBA Geometric Mean Titers (GMTs) against serogroups A, C, W, and Y at day 1, 1 month after the first MenABCWY vaccination and after the single MenACWY vaccination
    End point description
    The immune response to MenABCWY after first dose and single dose of MenACWY vaccine was evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their associated 2-sided 95% confidence intervals were calculated.
    End point type
    Secondary
    End point timeframe
    At Day 1 and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)
    End point values
    		 ABCWY Group ACWY Group
    Number of subjects analysed
    609
    593
    Units: Titers
    geometric mean (confidence interval 95%)
        Meningitis A, Day 1 (N=546,549)
    15.30 (13.07 to 17.92)
    16.34 (13.96 to 19.14)
        Meningitis A, Day 31 (N=605,585)
    670.78 (594.71 to 756.58)
    1282.56 (1135.84 to 1448.23)
        Meningitis C, Day 1 (N=601,584)
    31.90 (26.63 to 38.23)
    29.76 (24.81 to 35.71)
        Meningitis C, Day 31 (N=609,593)
    2945.68 (2471.13 to 3511.36)
    2552.27 (2138.66 to 3045.87)
        Meningitis W, Day 1 (N=592,583)
    12.08 (10.31 to 14.15)
    11.08 (9.45 to 12.99)
        Meningitis W, Day 31 (N=607, 592)
    1899.60 (1638.73 to 2202.00)
    1665.64 (1435.57 to 1932.58)
        Meningitis Y, Day 1 (N=600,576)
    12.84 (11.16 to 14.76)
    11.86 (10.29 to 13.66)
        Meningitis Y, Day 31 (N=606,591)
    1590.71 (1380.78 to 1832.55)
    1578.42 (1369.00 to 1819.88)
    No statistical analyses for this end point

    Secondary: Geometric mean ratios (GMRs) against serogroups A, C, W, and Y at 1 month after the first and second MenABCWY vaccination and after the single MenACWY vaccination

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    End point title
    		 Geometric mean ratios (GMRs) against serogroups A, C, W, and Y at 1 month after the first and second MenABCWY vaccination and after the single MenACWY vaccination
    End point description
    The immune response to MenABCWY vaccine after first and single dose of MenACWY vaccine are evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.
    End point type
    Secondary
    End point timeframe
    At 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) compared to baseline (Day 1)
    End point values
    		 ABCWY Group ACWY Group
    Number of subjects analysed
    597
    583
    Units: Ratio
    geometric mean (confidence interval 95%)
        Meningitis A, Day 31/Baseline(N=539,539)
    43.98 (36.92 to 52.40)
    76.91 (64.53 to 91.66)
        Meningitis C, Day 31/Baseline(N=597,583)
    92.87 (77.13 to 111.83)
    86.36 (71.63 to 104.12)
        Meningitis W, Day 1/Baseline(N=591,581)
    154.09 (125.80 to 188.73)
    150.83 (123.00 to 184.96)
        Meningitis Y, Day 1/Baseline(N=593.573)
    124.11 (103.23 to 149.23)
    134.66 (111.75 to 162.26)
    No statistical analyses for this end point

    Secondary: Percentages of Participants with hSBA Titers >= LLOQ for Each and all Serogroup B indicator Strains at Day 1 and at 1 month after the second dose of MenABCWY vaccination

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    End point title
    		 Percentages of Participants with hSBA Titers >= LLOQ for Each and all Serogroup B indicator Strains at Day 1 and at 1 month after the second dose of MenABCWY vaccination [19]
    End point description
    The immune response to MenABCWY vaccine after second dose was evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively).
    End point type
    Secondary
    End point timeframe
    At Day 1 and at Day 211
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As specified in the Protocol, the analysis assesses the immune response to the MenABCWY vaccine against N. meningitidis serogroup B indicator strains.
    End point values
    		 ABCWY Group
    Number of subjects analysed
    184
    Units: Percentage of Participants
    number (confidence interval 95%)
        fHbp (M14459) Ab, Day 1 (N=184)
    8.7 (5.05 to 13.74)
        fHbp (M14459) Ab, Day 211 (N=165)
    88.5 (82.60 to 92.92)
        NadA (96217) Ab, Day 1 (N=183)
    7.7 (4.25 to 12.50)
        NadA (96217) Ab, Day 211 (N=165)
    95.8 (91.45 to 98.28)
        NHBA (M13520) Ab, Day 1 (N=183)
    20.2 (14.65 to 26.77)
        NHBA (M13520) Ab, Day 211 (N=164)
    96.3 (92.21 to 98.65)
        PorAP1.4 (NZ98/254) Ab, Day 1 (N=184)
    2.7 (0.89 to 6.23)
        PorAP1.4 (NZ98/254) Ab, Day 211 (N=164)
    75.6 (68.30 to 81.97)
        Composite Response, Day 1 (N=181)
    1.1 (0.13 to 3.93)
        Composite Response, Day 211 (N=164)
    72.0 (64.41 to 78.68)
    No statistical analyses for this end point

    Secondary: Percentages of participants with 4-fold rise in hSBA titers against each N. meningitidis serogroup B indicator strains at 1 month after the second MenABCWY vaccination

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    End point title
    		 Percentages of participants with 4-fold rise in hSBA titers against each N. meningitidis serogroup B indicator strains at 1 month after the second MenABCWY vaccination [20]
    End point description
    The immune response to MenABCWY after second dose is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). compared to baseline (day 1) in terms of 4-fold rise in hSBA titers. For each of the serogroup B indicator strains, the 4-fold rise is defined as: a post-vaccination hSBA titer >=16 for participants with a pre-vaccination hSBA titer <4; . a post-vaccination hSBA titer >= 4 times the LLOQ for participants with a prevaccination hSBA titer >= limit of detection (LOD) but < LLOQ; and, a post-vaccination hSBA titer >= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer >= LLOQ.
    End point type
    Secondary
    End point timeframe
    At Day 211 compared to baseline (Day 1)
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As specified in the Protocol, the analysis assesses the immune response to the MenABCWY vaccine against N. meningitidis serogroup B indicator strains.
    End point values
    		 ABCWY Group
    Number of subjects analysed
    163
    Units: Percentage of Participants
    number (confidence interval 95%)
        fHbp (M14459) Ab (N=163)
    68.1 (60.35 to 75.17)
        NadA (96217) Ab (N=162)
    90.1 (84.46 to 94.25)
        NHBA (M13520) Ab (N=161)
    64.6 (56.68 to 71.96)
        PorAP1.4 (NZ98/254) Ab (N=162)
    45.7 (37.84 to 53.68)
    No statistical analyses for this end point

    Secondary: GMTs against each serogroup B indicator strains at day 1 and at 1 month after second MenABCWY vaccination

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    End point title
    		 GMTs against each serogroup B indicator strains at day 1 and at 1 month after second MenABCWY vaccination [21]
    End point description
    The immune response to MenABCWY vaccine after the second dose is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) in terms of GMTs at baseline (Day 1) and 1 month after second MenABCWY vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 1 and at Day 211
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As specified in the Protocol, the analysis assesses the immune response to the MenABCWY vaccine against N. meningitidis serogroup B indicator strains.
    End point values
    		 ABCWY Group
    Number of subjects analysed
    184
    Units: Titers
    geometric mean (confidence interval 95%)
        fHbp (M14459) Ab, Day 1 (N=184)
    2.84 (2.53 to 3.19)
        fHbp (M14459) Ab, Day 211 (N=165)
    17.56 (13.52 to 22.80)
        NadA (96217) Ab, Day 1 (N=183)
    8.62 (7.39 to 10.06)
        NadA (96217) Ab, Day 211 (N=165)
    143.61 (106.71 to 193.26)
        NHBA (M13520) Ab, Day 1 (N=183)
    3.28 (2.59 to 4.15)
        NHBA (M13520) Ab, Day 211 (N=164)
    24.82 (19.19 to 32.11)
        PorAP1.4 (NZ98/254) Ab, Day 1 (N=184)
    3.13 (2.86 to 3.43)
        PorAP1.4 (NZ98/254) Ab, Day 211 (N=164)
    11.44 (8.61 to 15.19)
    No statistical analyses for this end point

    Secondary: GMRs against each serogroup B indicator strains at 1 month after second dose of MenABCWY vaccination

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    End point title
    		 GMRs against each serogroup B indicator strains at 1 month after second dose of MenABCWY vaccination [22]
    End point description
    The immune response to MenABCWY vaccine after second dose is evaluated by measuring the human serum bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.
    End point type
    Secondary
    End point timeframe
    At Day 211 compared to baseline (Day 1)
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As specified in the Protocol, the analysis assesses the immune response to the MenABCWY vaccine against N. meningitidis serogroup B indicator strains.
    End point values
    		 ABCWY Group
    Number of subjects analysed
    163
    Units: Ratio
    geometric mean (confidence interval 95%)
        fHbp (M14459) Ab, Day 211/Baseline (N=163)
    6.29 (4.84 to 8.18)
        NadA (96217) Ab, Day 211/Baseline (N=162)
    16.67 (12.25 to 22.70)
        NHBA (M13520) Ab, Day 211/Baseline (N=161)
    7.69 (6.08 to 9.72)
        PorAP1.4 (NZ98/254) Ab, Day 211/Baseline (N=162)
    3.65 (2.76 to 4.83)
    No statistical analyses for this end point

    Secondary: Percentages of Participants with hSBA titers >= Lower Limit of Quantitation (LLOQ) against serogroups A, C, W, and Y at 1 month after the second MenABCWY vaccination

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    End point title
    		 Percentages of Participants with hSBA titers >= Lower Limit of Quantitation (LLOQ) against serogroups A, C, W, and Y at 1 month after the second MenABCWY vaccination [23]
    End point description
    The immune response to MenABCWY vaccine after the second dose was evaluated by measuring the percentage of participants with hSBA titers >= LLOQ against each of the serogroups A, C, W and Y.
    End point type
    Secondary
    End point timeframe
    1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As specified in the Protocol, the analysis assesses the immune response to the MenABCWY vaccine against N. meningitidis serogroup B indicator strains.
    End point values
    		 ABCWY Group
    Number of subjects analysed
    609
    Units: Percentage of Participants
    number (confidence interval 95%)
        Meningitis A, Day 211 (N=213)
    99.5 (97.41 to 99.99)
        Meningitis C, Day 211 (N=211)
    100.0 (98.27 to 100.0)
        Meningitis W, Day 211 (N=212)
    100.0 (98.28 to 100.0)
        Meningitis Y, Day 211 (N=210)
    100.0 (98.26 to 100.0)
    No statistical analyses for this end point

    Secondary: hSBA Geometric Mean Titers (GMTs) against serogroups A, C, W, and Y at 1 month after the second MenABCWY vaccination

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    End point title
    		 hSBA Geometric Mean Titers (GMTs) against serogroups A, C, W, and Y at 1 month after the second MenABCWY vaccination [24]
    End point description
    The immune response to MenABCWY after second dose was evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their associated 2-sided 95% confidence intervals were calculated.
    End point type
    Secondary
    End point timeframe
    1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As specified in the Protocol, the analysis assesses the immune response to the MenABCWY vaccine against N. meningitidis serogroup B indicator strains.
    End point values
    		 ABCWY Group
    Number of subjects analysed
    609
    Units: Titers
    geometric mean (confidence interval 95%)
        Meningitis A, Day 211 (N=213)
    645.24 (544.11 to 765.16)
        Meningitis C, Day 211 (N=211)
    2350.14 (1809.69 to 3052.00)
        Meningitis W, Day 211 (N=212)
    1173.61 (940.25 to 1464.89)
        Meningitis Y, Day 211 (N=210)
    1130.54 (916.85 to 1394.04)
    No statistical analyses for this end point

    Secondary: Geometric mean ratios (GMRs) against serogroups A, C, W, and Y at 1 month after second MenABCWY vaccination

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    End point title
    		 Geometric mean ratios (GMRs) against serogroups A, C, W, and Y at 1 month after second MenABCWY vaccination [25]
    End point description
    The immune response to MenABCWY vaccine after second dose are evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.
    End point type
    Secondary
    End point timeframe
    At 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) compared to baseline (Day 1)
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As specified in the Protocol, the analysis assesses the immune response to the MenABCWY vaccine against N. meningitidis serogroup B indicator strains.
    End point values
    		 ABCWY Group
    Number of subjects analysed
    597
    Units: Ratio
    geometric mean (confidence interval 95%)
        Meningitis A, Day 211 (N=196)
    44.74 (34.67 to 57.74)
        Meningitis C, Day 211 (N=205)
    68.33 (52.19 to 89.46)
        Meningitis W, Day 211 (N=207)
    97.66 (72.52 to 131.52)
        Meningitis Y, Day 211 (N=202)
    82.45 (62.80 to 108.24)
    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 during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected from Day 1 up to study end [Day 361]
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 v26.0
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    ACWY Group
    Reporting group description
    		 Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.

    Reporting group title
    ABCWY Group
    Reporting group description
    		 Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.

    Serious adverse events
    		 ACWY Group ABCWY Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 621 (1.13%)
    18 / 626 (2.88%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Gastroschisis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wolff-Parkinson-White syndrome congenital
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Impaired gastric emptying
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Major depression
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional self-injury
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Parotitis
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Norovirus infection
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pilonidal disease
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ACWY Group ABCWY Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    552 / 621 (88.89%)
    583 / 626 (93.13%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Infected naevus
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences all number
    2
    1
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous complete
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Facial pain
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Administration site swelling
         subjects affected / exposed
    37 / 621 (5.96%)
    49 / 626 (7.83%)
         occurrences all number
    93
    136
    Administration site pain
         subjects affected / exposed
    455 / 621 (73.27%)
    524 / 626 (83.71%)
         occurrences all number
    1949
    2656
    Administration site induration
         subjects affected / exposed
    40 / 621 (6.44%)
    54 / 626 (8.63%)
         occurrences all number
    143
    136
    Administration site erythema
         subjects affected / exposed
    30 / 621 (4.83%)
    53 / 626 (8.47%)
         occurrences all number
    63
    139
    Chills
         subjects affected / exposed
    1 / 621 (0.16%)
    2 / 626 (0.32%)
         occurrences all number
    1
    2
    Pain
         subjects affected / exposed
    3 / 621 (0.48%)
    2 / 626 (0.32%)
         occurrences all number
    3
    2
    Pyrexia
         subjects affected / exposed
    16 / 621 (2.58%)
    24 / 626 (3.83%)
         occurrences all number
    33
    39
    Swelling face
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Vaccination site pain
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences all number
    2
    1
    Vaccination site reaction
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Vessel puncture site pain
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    293 / 621 (47.18%)
    318 / 626 (50.80%)
         occurrences all number
    1006
    974
    Influenza like illness
         subjects affected / exposed
    6 / 621 (0.97%)
    2 / 626 (0.32%)
         occurrences all number
    6
    2
    Injection site bruising
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Injection site induration
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences all number
    2
    1
    Injection site mass
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Injection site nodule
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Injection site pain
         subjects affected / exposed
    5 / 621 (0.81%)
    2 / 626 (0.32%)
         occurrences all number
    5
    2
    Injection site pruritus
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences all number
    2
    1
    Injection site rash
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Injection site reaction
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Food allergy
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Hypocomplementaemia
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Mite allergy
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 621 (0.00%)
    6 / 626 (0.96%)
         occurrences all number
    0
    6
    Social circumstances
    Physical assault
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Varicocele
         subjects affected / exposed
    1 / 621 (0.16%)
    2 / 626 (0.32%)
         occurrences all number
    1
    3
    Menstruation irregular
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Menstrual disorder
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Dysmenorrhoea
         subjects affected / exposed
    3 / 621 (0.48%)
    4 / 626 (0.64%)
         occurrences all number
    3
    4
    Cervical dysplasia
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Breast pain
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Bartholin's cyst
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    5 / 621 (0.81%)
    5 / 626 (0.80%)
         occurrences all number
    6
    6
    Asthma exercise induced
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Asthmatic crisis
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Bronchial obstruction
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Bronchospasm
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Cough
         subjects affected / exposed
    4 / 621 (0.64%)
    4 / 626 (0.64%)
         occurrences all number
    6
    4
    Dyspnoea
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Epistaxis
         subjects affected / exposed
    2 / 621 (0.32%)
    3 / 626 (0.48%)
         occurrences all number
    2
    3
    Nasal congestion
         subjects affected / exposed
    5 / 621 (0.81%)
    6 / 626 (0.96%)
         occurrences all number
    5
    7
    Nasal polyps
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Nasal septum deviation
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    15 / 621 (2.42%)
    10 / 626 (1.60%)
         occurrences all number
    15
    10
    Pneumonitis
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences all number
    2
    1
    Rhinorrhoea
         subjects affected / exposed
    3 / 621 (0.48%)
    2 / 626 (0.32%)
         occurrences all number
    3
    2
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Tonsillolith
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    4 / 621 (0.64%)
    5 / 626 (0.80%)
         occurrences all number
    4
    5
    Affective disorder
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Anxiety
         subjects affected / exposed
    8 / 621 (1.29%)
    13 / 626 (2.08%)
         occurrences all number
    8
    13
    Anxiety disorder
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Autism spectrum disorder
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Bipolar disorder
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Borderline personality disorder
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Depression
         subjects affected / exposed
    8 / 621 (1.29%)
    7 / 626 (1.12%)
         occurrences all number
    8
    8
    Depressive symptom
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Generalised anxiety disorder
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences all number
    2
    1
    Intentional self-injury
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Major depression
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Mixed anxiety and depressive disorder
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Obsessive-compulsive disorder
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Panic attack
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Psychotic disorder
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Social anxiety disorder
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Stress
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Trichotillomania
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Behavioural insomnia of childhood
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Investigations
    Antinuclear antibody positive
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    SARS-CoV-2 test positive
         subjects affected / exposed
    4 / 621 (0.64%)
    0 / 626 (0.00%)
         occurrences all number
    4
    0
    Weight decreased
         subjects affected / exposed
    1 / 621 (0.16%)
    2 / 626 (0.32%)
         occurrences all number
    1
    2
    Weight increased
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Ankle fracture
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Arthropod bite
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Bone contusion
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Concussion
         subjects affected / exposed
    3 / 621 (0.48%)
    5 / 626 (0.80%)
         occurrences all number
    3
    5
    Contusion
         subjects affected / exposed
    3 / 621 (0.48%)
    2 / 626 (0.32%)
         occurrences all number
    3
    2
    Skin laceration
         subjects affected / exposed
    1 / 621 (0.16%)
    8 / 626 (1.28%)
         occurrences all number
    1
    8
    Road traffic accident
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Radial nerve injury
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Radial head dislocation
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Procedural pain
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Nasal injury
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Nail injury
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Nail avulsion
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Muscle strain
         subjects affected / exposed
    1 / 621 (0.16%)
    2 / 626 (0.32%)
         occurrences all number
    1
    2
    Muscle rupture
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Muscle injury
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Face injury
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Fall
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Fibula fracture
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Foot fracture
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Fractured coccyx
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Gun shot wound
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Hand fracture
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences all number
    2
    1
    Immunisation reaction
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Joint dislocation
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    2
    Joint injury
         subjects affected / exposed
    1 / 621 (0.16%)
    4 / 626 (0.64%)
         occurrences all number
    1
    4
    Ligament injury
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Ligament rupture
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    7 / 621 (1.13%)
    8 / 626 (1.28%)
         occurrences all number
    7
    8
    Limb injury
         subjects affected / exposed
    2 / 621 (0.32%)
    3 / 626 (0.48%)
         occurrences all number
    2
    3
    Tooth injury
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Tooth fracture
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Tibia fracture
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Thermal burn
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences all number
    2
    1
    Tendon injury
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Splinter
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Soft tissue injury
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Underdose
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Traumatic haematoma
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Torus fracture
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Stab wound
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Phimosis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Hypermobility syndrome
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Nervous system disorders
    Migraine without aura
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    7 / 621 (1.13%)
    9 / 626 (1.44%)
         occurrences all number
    7
    10
    Headache
         subjects affected / exposed
    291 / 621 (46.86%)
    323 / 626 (51.60%)
         occurrences all number
    828
    878
    Idiopathic intracranial hypertension
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Loss of consciousness
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    3 / 621 (0.48%)
    1 / 626 (0.16%)
         occurrences all number
    3
    1
    Migraine with aura
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Ophthalmic migraine
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Presyncope
         subjects affected / exposed
    0 / 621 (0.00%)
    3 / 626 (0.48%)
         occurrences all number
    0
    4
    Sensory disturbance
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    3 / 621 (0.48%)
    2 / 626 (0.32%)
         occurrences all number
    3
    3
    Tension headache
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Lymphadenitis
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Lymphadenopathy
         subjects affected / exposed
    4 / 621 (0.64%)
    0 / 626 (0.00%)
         occurrences all number
    5
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences all number
    2
    1
    Deafness neurosensory
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Ear congestion
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Ear pain
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Ear swelling
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Eustachian tube dysfunction
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Eye irritation
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Keratitis
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Retinal detachment
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Retinal tear
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Abdominal hernia
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    5 / 621 (0.81%)
    3 / 626 (0.48%)
         occurrences all number
    5
    6
    Abdominal pain lower
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    4 / 621 (0.64%)
    8 / 626 (1.28%)
         occurrences all number
    4
    8
    Aphthous ulcer
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Coeliac disease
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    6 / 621 (0.97%)
    2 / 626 (0.32%)
         occurrences all number
    6
    2
    Diarrhoea
         subjects affected / exposed
    5 / 621 (0.81%)
    10 / 626 (1.60%)
         occurrences all number
    5
    11
    Food poisoning
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Gastritis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    4 / 621 (0.64%)
    1 / 626 (0.16%)
         occurrences all number
    4
    2
    Haematochezia
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Malpositioned teeth
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Mouth ulceration
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    124 / 621 (19.97%)
    132 / 626 (21.09%)
         occurrences all number
    256
    260
    Odynophagia
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Reflux gastritis
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Tooth impacted
         subjects affected / exposed
    2 / 621 (0.32%)
    4 / 626 (0.64%)
         occurrences all number
    2
    4
    Toothache
         subjects affected / exposed
    3 / 621 (0.48%)
    1 / 626 (0.16%)
         occurrences all number
    3
    1
    Ulcerative Colitis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Uvulitis
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    6 / 621 (0.97%)
    4 / 626 (0.64%)
         occurrences all number
    7
    4
    Crohn's disease
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    2 / 621 (0.32%)
    5 / 626 (0.80%)
         occurrences all number
    2
    5
    Acne
         subjects affected / exposed
    6 / 621 (0.97%)
    8 / 626 (1.28%)
         occurrences all number
    7
    8
    Alopecia
         subjects affected / exposed
    1 / 621 (0.16%)
    2 / 626 (0.32%)
         occurrences all number
    1
    2
    Angioedema
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Dermatitis atopic
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Skin mass
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    2
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Skin fissures
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Rosacea
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Pityriasis rosea
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    2
    Night sweats
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Ingrowing nail
         subjects affected / exposed
    1 / 621 (0.16%)
    2 / 626 (0.32%)
         occurrences all number
    1
    3
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Haematuria
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Glycosuria
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Dysuria
         subjects affected / exposed
    3 / 621 (0.48%)
    1 / 626 (0.16%)
         occurrences all number
    3
    1
    Chromaturia
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Synovial cyst
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Scoliosis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Plantar fasciitis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Pain in jaw
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    2 / 621 (0.32%)
    5 / 626 (0.80%)
         occurrences all number
    2
    5
    Neck pain
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences all number
    2
    1
    Myalgia
         subjects affected / exposed
    113 / 621 (18.20%)
    139 / 626 (22.20%)
         occurrences all number
    247
    265
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Muscle spasms
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Ligament laxity
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Joint stiffness
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    5 / 621 (0.81%)
    5 / 626 (0.80%)
         occurrences all number
    5
    5
    Arthritis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Arthralgia
         subjects affected / exposed
    78 / 621 (12.56%)
    71 / 626 (11.34%)
         occurrences all number
    148
    131
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Tenosynovitis stenosans
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Tendonitis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Atypical pneumonia
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Acute sinusitis
         subjects affected / exposed
    6 / 621 (0.97%)
    3 / 626 (0.48%)
         occurrences all number
    6
    3
    Bacterial vaginosis
         subjects affected / exposed
    0 / 621 (0.00%)
    3 / 626 (0.48%)
         occurrences all number
    0
    3
    Bronchitis
         subjects affected / exposed
    2 / 621 (0.32%)
    1 / 626 (0.16%)
         occurrences all number
    3
    1
    Cervicitis human papilloma virus
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Campylobacter infection
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Chlamydial infection
         subjects affected / exposed
    2 / 621 (0.32%)
    5 / 626 (0.80%)
         occurrences all number
    3
    5
    Conjunctivitis
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 621 (0.16%)
    3 / 626 (0.48%)
         occurrences all number
    1
    3
    Epididymitis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    3
    Ear infection
         subjects affected / exposed
    2 / 621 (0.32%)
    2 / 626 (0.32%)
         occurrences all number
    2
    2
    COVID-19
         subjects affected / exposed
    97 / 621 (15.62%)
    92 / 626 (14.70%)
         occurrences all number
    99
    97
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    2 / 621 (0.32%)
    3 / 626 (0.48%)
         occurrences all number
    2
    3
    Gastroenteritis
         subjects affected / exposed
    3 / 621 (0.48%)
    3 / 626 (0.48%)
         occurrences all number
    3
    3
    Fungal foot infection
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    7 / 621 (1.13%)
    5 / 626 (0.80%)
         occurrences all number
    8
    5
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Helicobacter infection
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Herpeszoster
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Hordeolum
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Impetigo
         subjects affected / exposed
    1 / 621 (0.16%)
    3 / 626 (0.48%)
         occurrences all number
    1
    3
    Infectious mononucleosis
         subjects affected / exposed
    2 / 621 (0.32%)
    2 / 626 (0.32%)
         occurrences all number
    2
    2
    Influenza
         subjects affected / exposed
    7 / 621 (1.13%)
    11 / 626 (1.76%)
         occurrences all number
    7
    11
    Laryngitis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Laryngitis viral
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Localised infection
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 621 (0.48%)
    0 / 626 (0.00%)
         occurrences all number
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    6 / 621 (0.97%)
    10 / 626 (1.60%)
         occurrences all number
    6
    11
    Omphalitis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Orchitis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Otitis externa
         subjects affected / exposed
    3 / 621 (0.48%)
    2 / 626 (0.32%)
         occurrences all number
    3
    2
    Otitis media
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2
    Otitis media acute
         subjects affected / exposed
    3 / 621 (0.48%)
    2 / 626 (0.32%)
         occurrences all number
    3
    2
    Paronychia
         subjects affected / exposed
    1 / 621 (0.16%)
    2 / 626 (0.32%)
         occurrences all number
    1
    2
    Pelvic inflammatory disease
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Pericoronitis
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    3
    0
    Gonorrhoea
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    3
    Pharyngitis bacterial
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    7 / 621 (1.13%)
    10 / 626 (1.60%)
         occurrences all number
    7
    10
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Pilonidal disease
         subjects affected / exposed
    1 / 621 (0.16%)
    2 / 626 (0.32%)
         occurrences all number
    1
    3
    Post procedural infection
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Pyuria
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Rash pustular
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 621 (0.16%)
    3 / 626 (0.48%)
         occurrences all number
    1
    3
    Rhinovirus infection
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Scrotal abscess
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    10 / 621 (1.61%)
    5 / 626 (0.80%)
         occurrences all number
    10
    5
    Sinusitis bacterial
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Subcutaneous abscess
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Suspected COVID-19
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Tinea infection
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Tinea versicolour
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    2 / 621 (0.32%)
    2 / 626 (0.32%)
         occurrences all number
    2
    2
    Tooth abscess
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Tooth infection
         subjects affected / exposed
    2 / 621 (0.32%)
    0 / 626 (0.00%)
         occurrences all number
    2
    0
    Trichomoniasis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 621 (1.29%)
    17 / 626 (2.72%)
         occurrences all number
    8
    17
    Pharyngitis streptococcal
         subjects affected / exposed
    6 / 621 (0.97%)
    7 / 626 (1.12%)
         occurrences all number
    6
    7
    Viral infection
         subjects affected / exposed
    4 / 621 (0.64%)
    1 / 626 (0.16%)
         occurrences all number
    4
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    9 / 621 (1.45%)
    7 / 626 (1.12%)
         occurrences all number
    9
    8
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 621 (0.00%)
    1 / 626 (0.16%)
         occurrences all number
    0
    1
    Viral pharyngitis
         subjects affected / exposed
    1 / 621 (0.16%)
    2 / 626 (0.32%)
         occurrences all number
    1
    2
    Metabolism and nutrition disorders
    Abnormal loss of weight
         subjects affected / exposed
    1 / 621 (0.16%)
    0 / 626 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    1 / 621 (0.16%)
    1 / 626 (0.16%)
         occurrences all number
    1
    1
    Iron deficiency
         subjects affected / exposed
    0 / 621 (0.00%)
    4 / 626 (0.64%)
         occurrences all number
    0
    4
    Vitamin D deficiency
         subjects affected / exposed
    0 / 621 (0.00%)
    2 / 626 (0.32%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Feb 2021
    The primary goal of this amendment was to promote one of the secondary endpoints to co-primary, which allowed to evaluate vaccine immunogenicity at 1 month after both the first and the second MenABCWY vaccinations (0,6-months). Also, considering that some of the study interventions are combination products constituted of a device and biologic product (pre-filled syringes), the amended protocol provides instructions for collection of safety information related to the use of medical devices.
    01 Nov 2021
    1. To extend the window for the priming MenACWY vaccination prior to enrollment from 4 to 6 years to at least 4 years. This was to increase the pool of potential participants who may benefit from the intervention. 2. To allow for interim analyses of immunological objectives after all participants have completed Visit 4, and of safety objectives after at least 50% of participants have completed Visit 4. 3. Other minor changes included the timing for reporting pregnancies and the change of the reference N MenB NHBA strain.

    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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    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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