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    Clinical Trial Results:
    Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults

    Summary
    EudraCT number
    		 2019-004461-41
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    14 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Aug 2021
    First version publication date
    12 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MET59
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04084769
    WHO universal trial number (UTN)
    		 U1111-1217-2137
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc.
    Sponsor organisation address
    Discovery Drive, Swiftwater, PA, United States, 18370-0187
    Public contact
    Trial Transparency Team, Sanofi Pasteur Inc, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur Inc, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001930-PIP01-16
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in subjects who were first vaccinated with 1 dose of MenACYW Conjugate vaccine or Menveo (meningococcal Group B) vaccine 3-6 years before the booster dose (Groups 1 and 2).
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Sep 2019
    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
    United States: 530
    Country: Number of subjects enrolled
    Puerto Rico: 40
    Worldwide total number of subjects
    570
    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)
    546
    Adults (18-64 years)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled from 03-September-2019 to 07-March-2020 at 30 active sites in the United States and Puerto Rico.

    Pre-assignment
    Screening details
    		 A total of 570 subjects who received MenACYW Conjugate vaccine or Menveo vaccine in Study MET50 (NCT02199691) or Study MET43 (NCT02842853), or outside of Sanofi Pasteur trials were enrolled in the present study (MET59).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Partially-randomised design: all subjects primed with MenACYW Conjugate vaccine who meet the inclusion/exclusion criteria were randomly assigned to Group 1, 3, or 4, while subjects primed with Menveo vaccine were automatically allocated to Group 2 (not randomised).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: MenACYW Conjugate Vaccine
    Arm description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, IM, single dose.

    Arm title
    		 Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Arm description
    		 Subjects who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, IM, single dose.

    Arm title
    		 Group 3: MenACYW Conjugate vaccine + Trumenba vaccine
    Arm description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, IM, single dose.

    Investigational medicinal product name
    Meningococcal Group B vaccine (Trumenba®)
    Investigational medicinal product code
    Other name
    Trumenba®
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, IM, single dose.

    Arm title
    		 Group 4: MenACYW Conjugate vaccine + Bexsero vaccine
    Arm description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, IM, single dose.

    Investigational medicinal product name
    Meningococcal Group B vaccine (Bexsero®)
    Investigational medicinal product code
    Other name
    Bexsero®
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, IM, single dose.

    Number of subjects in period 1
    		Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed) Group 3: MenACYW Conjugate vaccine + Trumenba vaccine Group 4: MenACYW Conjugate vaccine + Bexsero vaccine
    Started
    191
    190
    95
    94
    Safety Analysis Set (SAfAS)
    186 [1]
    184 [2]
    93 [3]
    92
    Full Analysis Set (FAS)
    191
    190
    95
    94
    Per-Protocol Analysis Set 1 (PPAS1)
    46 [4]
    45 [5]
    0 [6]
    0 [7]
    Per-Protocol Analysis Set 2 (PPAS2)
    174 [8]
    176 [9]
    90 [10]
    89 [11]
    Completed
    187
    186
    95
    92
    Not completed
    4
    4
    0
    2
         Withdrawal by parent/ guardian
    1
    -
    -
    1
         Withdrawal by Subject
    -
    1
    -
    -
         Protocol Violation
    1
    3
    -
    1
         Lost to follow-up
    2
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: SAfAS: Subjects who had received study vaccine in MET59 and had available safety data.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: SAfAS: Subjects who had received study vaccine in MET59 and had available safety data.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: SAfAS: Subjects who had received study vaccine in MET59 and had available safety data.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: PPAS1: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by serum bactericidal assay using human complement (hSBA) assessed at Day 06 after vaccination in Group 1 and 2.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: PPAS1: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination in Group 1 and 2.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: PPAS1: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination in Group 1 and 2.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: PPAS1: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination in Group 1 and 2.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: PPAS2: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or serum bactericidal assay using baby rabbit complement (rSBA) assessed at Day 30 after vaccination
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: PPAS2: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or rSBA assessed at Day 30 after vaccination.
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: PPAS2: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or rSBA assessed at Day 30 after vaccination.
    [11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: PPAS2: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or rSBA assessed at Day 30 after vaccination.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).

    Reporting group title
    Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Reporting group description
    		 Subjects who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).

    Reporting group title
    Group 3: MenACYW Conjugate vaccine + Trumenba vaccine
    Reporting group description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).

    Reporting group title
    Group 4: MenACYW Conjugate vaccine + Bexsero vaccine
    Reporting group description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).

    Reporting group values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed) Group 3: MenACYW Conjugate vaccine + Trumenba vaccine Group 4: MenACYW Conjugate vaccine + Bexsero vaccine Total
    Number of subjects
    		 191 190 95 94 570
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.4 ( 1.59 ) 15.8 ( 1.37 ) 15.1 ( 1.12 ) 15.3 ( 1.34 ) -
    Gender categorical
    Units: Subjects
        Female
    		 99 85 41 45 270
        Male
    		 92 105 54 49 300
    Race
    Units: Subjects
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 1 2
        Black or African American
    		 19 16 7 7 49
        White
    		 163 165 83 86 497
        More than one race
    		 8 6 5 0 19
        Unknown or Not Reported
    		 0 3 0 0 3

    End points

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    End points reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).

    Reporting group title
    Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Reporting group description
    		 Subjects who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).

    Reporting group title
    Group 3: MenACYW Conjugate vaccine + Trumenba vaccine
    Reporting group description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).

    Reporting group title
    Group 4: MenACYW Conjugate vaccine + Bexsero vaccine
    Reporting group description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).

    Subject analysis set title
    Pooled Groups 1, 3 and 4: MenACYW Conjugate Vaccine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Included all subjects of Groups 1, 3 and 4 who received MenACYW Conjugate vaccine in previous studies MET50 or MET43. Subjects of Group 1 received a single IM dose of MenACYW Conjugate vaccine and Group 3 and 4 subjects received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine and Bexsero vaccine at Day 0 in the present study (MET59).

    Subject analysis set title
    Pooled Groups 3 and 4: MenACYW Conjugate Vaccine
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Included all subjects of Groups 3 and 4 who received MenACYW Conjugate vaccine in previous studies MET50 or MET43. Subjects of Group 3 and 4 subjects received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine and Bexsero vaccine at Day 0 in the present study (MET59).

    Primary: Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1

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    End point title
    		 Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 [1] [2]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (>=) 1:16 for subjects with pre-vaccination hSBA titer less than (<) 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for subjects with pre-vaccination hSBA titer >= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%. Analysis was performed on PPAS2 population that included subjects who received 1 dose of study vaccine in MET59 and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or rSBA assessed at Day 30 after vaccination.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination) in study MET59
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was a statistical hypothesis as described in the endpoint description but could not reported due to single arm design.
    [2] - 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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine
    Number of subjects analysed
    174
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    94.8 (90.4 to 97.6)
        Serogroup C
    97.1 (93.4 to 99.1)
        Serogroup Y
    98.9 (95.9 to 99.9)
        Serogroup W
    97.7 (94.2 to 99.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2

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    End point title
    		 Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 [3] [4]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >=1:16 for subjects with pre-vaccination hSBA titer <1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for subjects with pre-vaccination hSBA titer >= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%. Analysis was performed on PPAS2 population.
    End point type
    Primary
    End point timeframe
    Day 30 (post-vaccination) in study MET59
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There was a statistical hypothesis as described in the endpoint description but could not reported due to single arm design.
    [4] - 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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol.
    End point values
    		 Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Number of subjects analysed
    176
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    93.2 (88.4 to 96.4)
        Serogroup C
    98.9 (96.0 to 99.9)
        Serogroup Y
    100 (97.9 to 100)
        Serogroup W
    98.9 (96.0 to 99.9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2

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    End point title
    		 Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [5]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >=1:16 for subjects with pre-vaccination hSBA titer <1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for subjects with pre-vaccination hSBA titer >= 1:8. Analysis was performed on PPAS1 population that included subjects who received 1 dose of study vaccine in MET59 and had valid serology result with no relevant protocol deviations; defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination in Groups 1 and 2.
    End point type
    Secondary
    End point timeframe
    Day 6 (post-vaccination) in study MET59
    Notes
    [5] - 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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Number of subjects analysed
    46
    45
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    82.6 (68.6 to 92.2)
    77.8 (62.9 to 88.8)
        Serogroup C
    89.1 (76.4 to 96.4)
    93.3 (81.7 to 98.6)
        Serogroup Y
    95.7 (85.2 to 99.5)
    91.1 (78.8 to 97.5)
        Serogroup W
    97.8 (88.5 to 99.9)
    88.9 (75.9 to 96.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2

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    End point title
    		 Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [6]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8. Analysis was performed on PPAS1 population.
    End point type
    Secondary
    End point timeframe
    Day 6 (post-vaccination) in study MET59
    Notes
    [6] - 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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Number of subjects analysed
    46
    45
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    91.3 (79.2 to 97.6)
    95.6 (84.9 to 99.5)
        Serogroup C
    100 (92.3 to 100)
    97.8 (88.2 to 99.9)
        Serogroup Y
    97.8 (88.5 to 99.9)
    100 (92.1 to 100)
        Serogroup W
    100 (92.3 to 100)
    100 (92.1 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [7]
    End point description
    GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on PPAS1 population.
    End point type
    Secondary
    End point timeframe
    Day 6 (post-vaccination) in study MET59
    Notes
    [7] - 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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Number of subjects analysed
    46
    45
    Units: titers
    geometric mean (confidence interval 95%)
        Serogroup A
    289 (133 to 625)
    161 (93.0 to 280)
        Serogroup C
    3799 (2504 to 5763)
    919 (500 to 1690)
        Serogroup Y
    1658 (973 to 2826)
    800 (467 to 1371)
        Serogroup W
    1928 (1187 to 3131)
    708 (463 to 1082)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2

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    End point title
    		 Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [8]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >=1:16 for subjects with pre-vaccination hSBA titer <1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for subjects with pre-vaccination hSBA titer >= 1:8. Analysis was performed on PPAS2 population.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination) in study MET59
    Notes
    [8] - 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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Number of subjects analysed
    174
    176
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A
    94.8 (90.4 to 97.6)
    93.2 (88.4 to 96.4)
        Serogroup C
    97.1 (93.4 to 99.1)
    98.9 (96.0 to 99.9)
        Serogroup Y
    98.9 (95.9 to 99.9)
    100 (97.9 to 100)
        Serogroup W
    97.7 (94.2 to 99.4)
    98.9 (96.0 to 99.9)
    Statistical analysis title
    		 Serogroup A
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Number of subjects included in analysis
    350
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    1.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.58
         upper limit
    		 6.95
    Notes
    [9] - 95% Confidence Interval (CI) of the difference in percentage was calculated from the Wilson Score method without continuity correction.
    Statistical analysis title
    		 Serogroup C
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Number of subjects included in analysis
    350
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.5
         upper limit
    		 1.6
    Notes
    [10] - 95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.
    Statistical analysis title
    		 Serogroup Y
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Number of subjects included in analysis
    350
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.09
         upper limit
    		 1.14
    Notes
    [11] - 95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.
    Statistical analysis title
    		 Serogroup W
    Comparison groups
    Group 1: MenACYW Conjugate Vaccine v Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Number of subjects included in analysis
    350
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.72
         upper limit
    		 2.07
    Notes
    [12] - 95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.

    Secondary: Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2

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    End point title
    		 Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [13]
    End point description
    Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. Seroprotection were defined as hSBA titer >=1:8. Analysis was performed on PPAS2 population.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
    Notes
    [13] - 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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Number of subjects analysed
    174
    176
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A: Day 0
    71.3 (63.9 to 77.9)
    71.0 (63.7 to 77.6)
        Serogroup A: Day 30
    99.4 (96.8 to 100)
    99.4 (96.9 to 100)
        Serogroup C: Day 0
    87.9 (82.1 to 92.4)
    50.6 (42.9 to 58.2)
        Serogroup C: Day 30
    100 (97.9 to 100)
    100 (97.9 to 100)
        Serogroup Y: Day 0
    79.9 (73.2 to 85.6)
    52.8 (45.2 to 60.4)
        Serogroup Y: Day 30
    100 (97.9 to 100)
    100 (97.9 to 100)
        Serogroup W: Day 0
    86.2 (80.2 to 91.0)
    77.8 (71.0 to 83.7)
        Serogroup W: Day 30
    100 (97.9 to 100)
    100 (97.9 to 100)
    No statistical analyses for this end point

    Secondary: GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2

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    End point title
    		 GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [14]
    End point description
    GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on PPAS2 population.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
    Notes
    [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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
    Number of subjects analysed
    174
    176
    Units: titers
    geometric mean (confidence interval 95%)
        Serogroup A: Day 0
    11.7 (9.89 to 13.8)
    11.5 (9.72 to 13.7)
        Serogroup A: Day 30
    502 (388 to 649)
    399 (318 to 502)
        Serogroup C: Day 0
    36.6 (28.8 to 46.7)
    10.2 (8.03 to 13.0)
        Serogroup C: Day 30
    3708 (3146 to 4369)
    2533 (2076 to 3091)
        Serogroup Y: Day 0
    20.5 (16.6 to 25.2)
    8.35 (6.70 to 10.4)
        Serogroup Y: Day 30
    2308 (1925 to 2767)
    3036 (2547 to 3620)
        Serogroup W: Day 0
    27.0 (22.0 to 33.1)
    14.8 (12.2 to 18.1)
        Serogroup W: Day 30
    2290 (1934 to 2711)
    2574 (2178 to 3041)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0

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    End point title
    		 Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8. Analysis was performed on full analysis set which included all subjects who had a valid pre-vaccination serology result. Here, ‘n’=subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) in study MET59
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed) Group 3: MenACYW Conjugate vaccine + Trumenba vaccine Group 4: MenACYW Conjugate vaccine + Bexsero vaccine
    Number of subjects analysed
    191
    190
    95
    94
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A (n=191,190,95,93)
    72.3 (65.3 to 78.5)
    71.1 (64.0 to 77.4)
    73.7 (63.6 to 82.2)
    73.1 (62.9 to 81.8)
        Serogroup C (n=191,190,95,94)
    86.9 (81.3 to 91.3)
    52.6 (45.3 to 59.9)
    86.3 (77.7 to 92.5)
    85.1 (76.3 to 91.6)
        Serogroup Y (n=191,190,94,94)
    79.1 (72.6 to 84.6)
    55.3 (47.9 to 62.5)
    88.3 (80.0 to 94.0)
    80.9 (71.4 to 88.2)
        Serogroup W (n=191,190,95,93)
    86.9 (81.3 to 91.3)
    77.9 (71.3 to 83.6)
    90.5 (82.8 to 95.6)
    91.4 (83.8 to 96.2)
    No statistical analyses for this end point

    Secondary: GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0

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    End point title
    		 GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0
    End point description
    GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on full analysis set which included all subjects who had a valid pre-vaccination serology results. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) in study MET59
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed) Group 3: MenACYW Conjugate vaccine + Trumenba vaccine Group 4: MenACYW Conjugate vaccine + Bexsero vaccine
    Number of subjects analysed
    191
    190
    95
    94
    Units: titers
    geometric mean (confidence interval 95%)
        Serogroup A (n=191,190,95,93)
    12.3 (10.5 to 14.5)
    12.2 (10.2 to 14.6)
    12.8 (10.0 to 16.3)
    12.7 (9.70 to 16.6)
        Serogroup C (n=191,190,95,94)
    34.5 (27.4 to 43.6)
    11.9 (9.17 to 15.3)
    38.4 (27.3 to 54.0)
    43.3 (29.8 to 63.0)
        Serogroup Y (n=191,190,94,94)
    19.8 (16.2 to 24.2)
    9.19 (7.39 to 11.4)
    26.0 (19.6 to 34.5)
    22.0 (16.1 to 30.0)
        Serogroup W (n=191,190,95,93)
    27.4 (22.4 to 33.4)
    15.1 (12.5 to 18.3)
    28.1 (21.8 to 36.2)
    32.7 (24.5 to 43.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43

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    End point title
    		 Percentage of Subjects Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 [15]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8. Analysis was performed on full analysis set which included all subjects who had a valid pre-vaccination serology result. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint and ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination), Day 30 (post-vaccination) in study MET50 or MET43
    Notes
    [15] - 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: For this endpoint, data were planned to be collected and analysed for pooled population of groups 1, 3 and 4 as pre-specified in the protocol.
    End point values
    		 Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed) Pooled Groups 1, 3 and 4: MenACYW Conjugate Vaccine
    Number of subjects analysed
    134
    376
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A: Day 0 of MET50 or MET43(n=134,376)
    35.8 (27.7 to 44.6)
    54.5 (49.3 to 59.6)
        Serogroup A: Day 30 of MET50 or MET43(n=133,376)
    81.2 (73.5 to 87.5)
    94.7 (91.9 to 96.7)
        Serogroup C: Day 0 of MET50 or MET43(n=134,376)
    12.7 (7.6 to 19.5)
    18.6 (14.8 to 22.9)
        Serogroup C: Day 30 of MET50 or MET43(n=132,376)
    74.2 (65.9 to 81.5)
    98.1 (96.2 to 99.2)
        Serogroup Y: Day 0 of MET50 or MET43(n=134,376)
    3.7 (1.2 to 8.5)
    4.5 (2.7 to 7.1)
        Serogroup Y: Day 30 of MET50 or MET43(n=133,376)
    88.7 (82.1 to 93.5)
    97.9 (95.9 to 99.1)
        Serogroup W: Day 0 of MET50 or MET43(n=134,376)
    40.3 (31.9 to 49.1)
    39.9 (34.9 to 45.0)
        Serogroup W: Day 30 of MET50 or MET43(n=133,376)
    93.2 (87.5 to 96.9)
    100 (99.0 to 100)
    No statistical analyses for this end point

    Secondary: GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59

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    End point title
    		 GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 [16]
    End point description
    GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on full analysis set which included all subjects who had a valid pre-vaccination serology result. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint and ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET50 or MET43; Day 0 (pre-vaccination) in study MET59
    Notes
    [16] - 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: For this endpoint, data were planned to be collected and analysed for pooled population of groups 1, 3 and 4, as pre-specified in the protocol.
    End point values
    		 Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed) Pooled Groups 1, 3 and 4: MenACYW Conjugate Vaccine
    Number of subjects analysed
    140
    380
    Units: titers
    geometric mean (confidence interval 95%)
        Serogroup A: Day 0 of MET50 or MET43(n=134,376)
    5.72 (4.75 to 6.87)
    7.28 (6.53 to 8.11)
        Serogroup A: Day 30 of MET50 or MET43(n=133,376)
    32.8 (25.0 to 43.1)
    45.2 (39.9 to 51.1)
        Serogroup A: Day 0 of MET59 (n=140,379)
    11.6 (9.41 to 14.3)
    12.5 (11.1 to 14.1)
        Serogroup C: Day 0 of MET50 or MET43(n=134,376)
    2.98 (2.69 to 3.30)
    3.48 (3.22 to 3.76)
        Serogroup C: Day 30 of MET50 or MET43(n=132,376)
    49.7 (32.4 to 76.4)
    417 (348 to 500)
        Serogroup C: Day 0 of MET59 (n=140,380)
    11.0 (8.09 to 14.9)
    37.5 (31.6 to 44.5)
        Serogroup Y: Day 0 of MET50 or MET43(n=134,376)
    2.30 (2.13 to 2.48)
    2.36 (2.22 to 2.50)
        Serogroup Y: Day 30 of MET50 or MET43(n=133,376)
    36.1 (27.2 to 47.8)
    91.0 (78.6 to 105)
        Serogroup Y: Day 0 of MET59 (n=140,379)
    8.49 (6.50 to 11.1)
    21.8 (18.8 to 25.1)
        Serogroup W: Day 0 of MET50 or MET43(n=134,376)
    5.54 (4.57 to 6.72)
    5.34 (4.76 to 6.00)
        Serogroup W: Day 30 of MET50 or MET43(n=133,376)
    45.1 (34.3 to 59.4)
    82.7 (73.6 to 92.9)
        Serogroup W: Day 0 of MET59 (n=140,379)
    14.9 (11.9 to 18.6)
    28.8 (25.1 to 33.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4

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    End point title
    		 Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 [17]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >=1:16 for subjects with pre-vaccination hSBA titer <1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for subjects with pre-vaccination hSBA titer >= 1:8. Analysis was performed on PPAS2 population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 30 (post-vaccination) in study MET59
    Notes
    [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: For this endpoint, data were planned to be collected and analysed for individual Groups 1, 3 and 4 and for pooled population of groups 3 and 4 only, as pre-specified in the protocol.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 3: MenACYW Conjugate vaccine + Trumenba vaccine Group 4: MenACYW Conjugate vaccine + Bexsero vaccine Pooled Groups 3 and 4: MenACYW Conjugate Vaccine
    Number of subjects analysed
    174
    90
    89
    179
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A (n=174,90,88,178)
    94.8 (90.4 to 97.6)
    93.3 (86.1 to 97.5)
    95.5 (88.8 to 98.7)
    94.4 (89.9 to 97.3)
        Serogroup C (n=174,90,88,178)
    97.1 (93.4 to 99.1)
    97.8 (92.2 to 99.7)
    96.6 (90.4 to 99.3)
    97.2 (93.6 to 99.1)
        Serogroup Y (n=174,89,89,178)
    98.9 (95.9 to 99.9)
    98.9 (93.9 to 100)
    97.8 (92.1 to 99.7)
    98.3 (95.2 to 99.7)
        Serogroup W (n=174,90,88,178)
    97.7 (94.2 to 99.4)
    98.9 (94.0 to 100)
    96.6 (90.4 to 99.3)
    97.8 (94.3 to 99.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4

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    End point title
    		 Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 [18]
    End point description
    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8. Analysis was performed on PPAS2 population. Here, ‘n’ = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
    Notes
    [18] - 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: For this endpoint, data were planned to be collected and analysed for individual Groups 1, 3 and 4 and for pooled population of groups 3 and 4, as pre-specified in the protocol.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 3: MenACYW Conjugate vaccine + Trumenba vaccine Group 4: MenACYW Conjugate vaccine + Bexsero vaccine Pooled Groups 3 and 4: MenACYW Conjugate Vaccine
    Number of subjects analysed
    174
    90
    89
    179
    Units: percentage of subjects
    number (confidence interval 95%)
        Serogroup A: Day 0 (n=174,90,88,178)
    71.3 (63.9 to 77.9)
    73.3 (63.0 to 82.1)
    71.6 (61.0 to 80.7)
    72.5 (65.3 to 78.9)
        Serogroup A: Day 30 (n=174,90,89,179)
    99.4 (96.8 to 100)
    98.9 (94.0 to 100)
    100 (95.9 to 100)
    99.4 (96.9 to 100)
        Serogroup C: Day 0 (n=174,90,89,179)
    87.9 (82.1 to 92.4)
    86.7 (77.9 to 92.9)
    86.5 (77.6 to 92.8)
    86.6 (80.7 to 91.2)
        Serogroup C: Day 30 (n=174,90,88,178)
    100 (97.9 to 100)
    100 (96.0 to 100)
    100 (95.9 to 100)
    100 (97.9 to 100)
        Serogroup Y: Day 0 (n=174,89,89,178)
    79.9 (73.2 to 85.6)
    89.9 (81.7 to 95.3)
    80.9 (71.2 to 88.5)
    85.4 (79.3 to 90.2)
        Serogroup Y: Day 30 (n=174,90,89,179)
    100 (97.9 to 100)
    100 (96.0 to 100)
    100 (95.9 to 100)
    100 (98.0 to 100)
        Serogroup W: Day 0 (n=174,90,88,178)
    86.2 (80.2 to 91.0)
    91.1 (83.2 to 96.1)
    90.9 (82.9 to 96.0)
    91.0 (85.8 to 94.8)
        Serogroup W: Day 30 (n=174,90,89,179)
    100 (97.9 to 100)
    100 (96.0 to 100)
    100 (95.9 to 100)
    100 (98.0 to 100)
    No statistical analyses for this end point

    Secondary: GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4

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    End point title
    		 GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 [19]
    End point description
    GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on PPAS2 population. Here, 'n' = subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
    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: For this endpoint, data were planned to be collected and analysed for individual Groups 1, 3 and 4 and for pooled population of groups 3 and 4, as pre-specified in the protocol.
    End point values
    		 Group 1: MenACYW Conjugate Vaccine Group 3: MenACYW Conjugate vaccine + Trumenba vaccine Group 4: MenACYW Conjugate vaccine + Bexsero vaccine Pooled Groups 3 and 4: MenACYW Conjugate Vaccine
    Number of subjects analysed
    174
    90
    89
    179
    Units: titers
    geometric mean (confidence interval 95%)
        Serogroup A: Day 0 (n=174,90,88,178)
    11.7 (9.89 to 13.8)
    12.5 (9.78 to 16.0)
    12.3 (9.37 to 16.2)
    12.4 (10.4 to 14.9)
        Serogroup A: Day 30 (n=174,90,89,179)
    502 (388 to 649)
    593 (426 to 825)
    667 (477 to 933)
    629 (498 to 794)
        Serogroup C: Day 0 (n=174,90,89,179)
    36.6 (28.8 to 46.7)
    37.6 (26.6 to 53.3)
    42.4 (29.4 to 61.0)
    39.9 (31.1 to 51.2)
        Serogroup C: Day 30 (n=174,90,88,178)
    3708 (3146 to 4369)
    4741 (3882 to 5791)
    3472 (2667 to 4518)
    4064 (3446 to 4793)
        Serogroup Y: Day 0 (n=174,89,89,178)
    20.5 (16.6 to 25.2)
    25.5 (19.4 to 33.6)
    21.0 (15.4 to 28.7)
    23.2 (18.9 to 28.5)
        Serogroup Y: Day 30 (n=174,90,89,179)
    2308 (1925 to 2767)
    2600 (2042 to 3311)
    2469 (1881 to 3241)
    2534 (2117 to 3034)
        Serogroup W: Day 0 (n=174,90,88,178)
    27.0 (22.0 to 33.1)
    28.3 (22.0 to 36.4)
    30.0 (22.5 to 40.1)
    29.1 (24.1 to 35.2)
        Serogroup W: Day 30 (n=174,90,89,179)
    2290 (1934 to 2711)
    2702 (2134 to 3422)
    2064 (1601 to 2662)
    2363 (1988 to 2810)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. Solicited reactions (SR): within 7 days post-vaccination in MET59. Serious AEs data: up to 30 days days post-vaccination in MET59.
    Adverse event reporting additional description
    Analysis performed on SafAS population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Group 1: MenACYW Conjugate Vaccine
    Reporting group description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).

    Reporting group title
    Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)
    Reporting group description
    		 Subjects who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).

    Reporting group title
    Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine
    Reporting group description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).

    Reporting group title
    Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine
    Reporting group description
    		 Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).

    Serious adverse events
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 186 (1.08%)
    2 / 184 (1.09%)
    2 / 93 (2.15%)
    0 / 92 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    0 / 186 (0.00%)
    0 / 184 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Major Depression
         subjects affected / exposed
    0 / 186 (0.00%)
    0 / 184 (0.00%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 184 (0.54%)
    1 / 93 (1.08%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 186 (0.54%)
    1 / 184 (0.54%)
    0 / 93 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: MenACYW Conjugate Vaccine Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    129 / 186 (69.35%)
    116 / 184 (63.04%)
    83 / 93 (89.25%)
    88 / 92 (95.65%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    68 / 186 (36.56%)
    67 / 184 (36.41%)
    41 / 93 (44.09%)
    36 / 92 (39.13%)
         occurrences all number
    69
    67
    42
    36
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    12 / 186 (6.45%)
    10 / 184 (5.43%)
    15 / 93 (16.13%)
    14 / 92 (15.22%)
         occurrences all number
    12
    10
    15
    19
    Injection Site Pain
         subjects affected / exposed
    71 / 186 (38.17%)
    63 / 184 (34.24%)
    77 / 93 (82.80%)
    85 / 92 (92.39%)
         occurrences all number
    71
    63
    114
    123
    Injection Site Swelling
         subjects affected / exposed
    10 / 186 (5.38%)
    3 / 184 (1.63%)
    12 / 93 (12.90%)
    15 / 92 (16.30%)
         occurrences all number
    10
    3
    13
    19
    Malaise
         subjects affected / exposed
    50 / 186 (26.88%)
    47 / 184 (25.54%)
    36 / 93 (38.71%)
    37 / 92 (40.22%)
         occurrences all number
    50
    47
    36
    37
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    61 / 186 (32.80%)
    64 / 184 (34.78%)
    60 / 93 (64.52%)
    58 / 92 (63.04%)
         occurrences all number
    61
    64
    61
    58
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 186 (4.84%)
    6 / 184 (3.26%)
    5 / 93 (5.38%)
    2 / 92 (2.17%)
         occurrences all number
    10
    6
    5
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    10 / 186 (5.38%)
    8 / 184 (4.35%)
    1 / 93 (1.08%)
    1 / 92 (1.09%)
         occurrences all number
    10
    8
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jan 2020
    Following changes were made: •Visit 3 was changed to Visit 2 for the main cohort (all subjects excluding the subset) following updates to the table of study procedures. •Visit 3 was replaced by Day 30 since this naming convention applies for all study subjects (main cohort and subset cohort).•FAS1 (full analysis set for Day 06) and FAS2 (full analysis set for Day 30) populations were defined (2 FAS analysis sets instead of 1). •Additional details were included to the statistical analysis: Geometric Mean Titer Ratio (GMTR) was added.
    10 Apr 2020
    Following changes were made: •Were completed to comply with changes requested by Center for Biologics Evaluation and Research (CBER)/Food and Drug Administration (FDA): - the primary objective and endpoint, and related statistical analyses, -one secondary objective; -observational objectives; calculation of sample size.

    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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