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    Clinical Trial Results:
    A Phase 1/2, Randomized, Descriptive, Safety and Immunogenicity Study to Assess Pentavalent Meningococcal ABCYW Vaccine Formulations in Adults (18 to 25 years of age) and Adolescents (10 to 17 years of age)

    Summary
    EudraCT number
    		 2023-000924-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    27 Aug 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Sep 2026
    First version publication date
    25 Sep 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VAN00010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT06128733
    WHO universal trial number (UTN)
    		 U1111-1272-6824
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur Inc
    Sponsor organisation address
    Discovery Drive, Swiftwater, Pennsylvania, United States, 18370-0187
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, 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-003379-PIP01-22
    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
    30 Mar 2026
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Aug 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the safety profile of the MenPenta vaccine formulations and the comparator vaccines in healthy adults and adolescents. To describe the immune response to the MenPenta vaccine formulations and the comparator vaccines after the second vaccination when administered to healthy adolescents as measured by serum bactericidal assay using human complement (hSBA) in the A, C, W-135, Y, and the reference MenB strains.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Participants with allergy to any of the vaccine components were not vaccinated. After vaccination, participants 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
    31 Oct 2023
    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
    Puerto Rico: 32
    Country: Number of subjects enrolled
    United States: 1183
    Worldwide total number of subjects
    1215
    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)
    381
    Adolescents (12-17 years)
    713
    Adults (18-64 years)
    121
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 42 centers in 2 countries from 31 October 2023 to 27 August 2025.

    Pre-assignment
    Screening details
    		 A total of 1215 participants were randomized in the study (participants treated in 'Adolescents - Group 7: PENBRAYA' were open-label and enrolled). Adult participants (18 to 25 years of age) were randomized in a 1:1:1:1:1:1 ratio to 6 groups and adolescent participants (10 to 17 years of age) were randomized in a 3:3:1:1:1:1:1 ratio to 7 groups.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor
    Blinding implementation details
    Completed milestone= End of active phase.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adults - Group 1: MenPenta Formulation 1
    Arm description
    		 Participants aged 18 to 25 years received MenPenta formulation 1 (pentavalent meningococcal ABCYW standard dose) vaccine via intermuscular (IM) injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.
    Arm type
    		 Experimental

    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
    Placebo IM injection on Day 1.

    Investigational medicinal product name
    MenPenta Formulation 1
    Investigational medicinal product code
    Other name
    MenPenta SD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenPenta formulation 1 vaccine via IM injection on Days 1, 31 and 181.

    Arm title
    		 Adults - Group 2: MenPenta Formulation 2
    Arm description
    		 Participants aged 18 to 25 years received MenPenta formulation 2 (pentavalent meningococcal ABCYW high dose) vaccine via IM injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.
    Arm type
    		 Experimental

    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
    Placebo IM injection on Day 1.

    Investigational medicinal product name
    MenPenta Formulation 2
    Investigational medicinal product code
    Other name
    MenPenta fHD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenPenta formulation 2 vaccine via IM injection on Days 1, 31 and 181.

    Arm title
    		 Adults - Group 3: Bexsero + Menveo
    Arm description
    		 Participants aged 18 to 25 years received Bexsero (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Bexsero vaccine via IM injection on Day 31. Additionally, participants received a placebo IM injection on Day 181.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    J07AH09
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Bexsero vaccine via IM injection on Days 1 and 31.

    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
    Placebo IM injection on Day 181.

    Investigational medicinal product name
    Menveo
    Investigational medicinal product code
    J07AH08
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menveo vaccine via IM injection on Day 1.

    Arm title
    		 Adults - Group 4: Trumenba + Menveo
    Arm description
    		 Participants aged 18 to 25 years received Trumenba (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Trumenba vaccine via IM injection on Days 31 and 181.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menveo
    Investigational medicinal product code
    J07AH08
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menveo vaccine via IM injection on Day 1.

    Investigational medicinal product name
    Trumenba
    Investigational medicinal product code
    J07AH09
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Trumenba vaccine via IM injection on Days 1, 31 and 181.

    Arm title
    		 Adults - Group 5: MenQuadfi
    Arm description
    		 Participants aged 18 to 25 years received MenQuadfi (meningococcal ACYW conjugate) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Days 1 and 31.
    Arm type
    		 Active comparator

    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
    Placebo IM injection on Days 1 and 31.

    Investigational medicinal product name
    MenQuadfi
    Investigational medicinal product code
    J07AH08
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenQuadfi vaccine via IM injection on Days 1 and 181.

    Arm title
    		 Adults - Group 6: Sanofi MenB
    Arm description
    		 Participants aged 18 to 25 years received Sanofi MenB (meningococcal B antigens standard dose) vaccine via IM injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.
    Arm type
    		 Active comparator

    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
    Placebo IM injection on Day 1.

    Investigational medicinal product name
    Sanofi MenB
    Investigational medicinal product code
    J07AH09
    Other name
    Sanofi MenB SD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Sanofi MenB vaccine via IM injection on Days 1, 31 and 181.

    Arm title
    		 Adolescents - Group 1: MenPenta Formulation 1
    Arm description
    		 Participants aged 10 to 17 years received MenPenta formulation 1 (pentavalent meningococcal ABCYW standard dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.
    Arm type
    		 Experimental

    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
    Placebo IM injection on Day 1.

    Investigational medicinal product name
    MenPenta Formulation 1
    Investigational medicinal product code
    Other name
    MenPenta SD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenPenta formulation 1 vaccine via IM injection on Days 1 and 181.

    Arm title
    		 Adolescents - Group 2: MenPenta Formulation 2
    Arm description
    		 Participants aged 10 to 17 years received MenPenta formulation 2 (pentavalent meningococcal ABCYW high dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.
    Arm type
    		 Experimental

    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
    Placebo IM injection on Day 1.

    Investigational medicinal product name
    MenPenta Formulation 2
    Investigational medicinal product code
    Other name
    MenPenta fHD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenPenta formulation 2 vaccine via IM injection on Days 1 and 181.

    Arm title
    		 Adolescents - Group 3: Bexsero + Menveo
    Arm description
    		 Participants aged 10 to 17 years received Bexsero (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Bexsero vaccine via IM injection on Day 181.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menveo
    Investigational medicinal product code
    J07AH08
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menveo vaccine via IM injection on Day 1.

    Investigational medicinal product name
    Bexsero
    Investigational medicinal product code
    J07AH09
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Bexsero vaccine via IM injection on Days 1 and 181.

    Arm title
    		 Adolescents - Group 4: Trumenba + Menveo
    Arm description
    		 Participants aged 10 to 17 years received Trumenba (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Trumenba vaccine via IM injection on Day 181.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Menveo
    Investigational medicinal product code
    J07AH08
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Menveo vaccine via IM injection on Day 1.

    Investigational medicinal product name
    Trumenba
    Investigational medicinal product code
    J07AH09
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Trumenba vaccine via IM injection on Days 1 and 181.

    Arm title
    		 Adolescents - Group 5: MenQuadfi
    Arm description
    		 Participants aged 10 to 17 years received MenQuadfi (meningococcal ACYW conjugate) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.
    Arm type
    		 Active comparator

    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
    Placebo IM injection on Day 1.

    Investigational medicinal product name
    MenQuadfi
    Investigational medicinal product code
    J07AH08
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MenQuadfi vaccine via IM injection on Days 1 and 181.

    Arm title
    		 Adolescents - Group 6: Sanofi MenB
    Arm description
    		 Participants aged 10 to 17 years received Sanofi MenB (meningococcal B antigens standard dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.
    Arm type
    		 Active comparator

    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
    Placebo IM injection on Day 1.

    Investigational medicinal product name
    Sanofi MenB
    Investigational medicinal product code
    J07AH09
    Other name
    Sanofi MenB SD
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Sanofi MenB vaccine via IM injection on Days 1 and 181.

    Arm title
    		 Adolescents - Group 7: PENBRAYA
    Arm description
    		 Participants aged 10 to 17 years received PENBRAYA (meningococcal ABCYW conjugate) vaccine via IM injection on Days 1 and 181.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PENBRAYA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    PENBRAYA vaccine via IM injection on Days 1 and 181.

    Number of subjects in period 1
    		Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Started
    20
    21
    20
    20
    20
    20
    298
    300
    100
    97
    100
    99
    100
    Completed
    17
    17
    17
    15
    19
    16
    266
    270
    91
    87
    92
    94
    95
    Not completed
    3
    4
    3
    5
    1
    4
    32
    30
    9
    10
    8
    5
    5
         Consent withdrawn by subject
    1
    1
    -
    -
    -
    -
    4
    3
    -
    2
    -
    3
    -
         Adverse event, non-fatal
    1
    -
    -
    -
    -
    -
    -
    1
    -
    1
    -
    -
    -
         Protocol deviation
    1
    2
    2
    3
    -
    2
    7
    5
    3
    3
    2
    1
    -
         Lost to follow-up
    -
    1
    1
    2
    1
    2
    12
    11
    4
    2
    1
    1
    3
         Withdrawal by parent/guardian
    -
    -
    -
    -
    -
    -
    9
    10
    2
    2
    5
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adults - Group 1: MenPenta Formulation 1
    Reporting group description
    		 Participants aged 18 to 25 years received MenPenta formulation 1 (pentavalent meningococcal ABCYW standard dose) vaccine via intermuscular (IM) injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adults - Group 2: MenPenta Formulation 2
    Reporting group description
    		 Participants aged 18 to 25 years received MenPenta formulation 2 (pentavalent meningococcal ABCYW high dose) vaccine via IM injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adults - Group 3: Bexsero + Menveo
    Reporting group description
    		 Participants aged 18 to 25 years received Bexsero (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Bexsero vaccine via IM injection on Day 31. Additionally, participants received a placebo IM injection on Day 181.

    Reporting group title
    Adults - Group 4: Trumenba + Menveo
    Reporting group description
    		 Participants aged 18 to 25 years received Trumenba (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Trumenba vaccine via IM injection on Days 31 and 181.

    Reporting group title
    Adults - Group 5: MenQuadfi
    Reporting group description
    		 Participants aged 18 to 25 years received MenQuadfi (meningococcal ACYW conjugate) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Days 1 and 31.

    Reporting group title
    Adults - Group 6: Sanofi MenB
    Reporting group description
    		 Participants aged 18 to 25 years received Sanofi MenB (meningococcal B antigens standard dose) vaccine via IM injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 1: MenPenta Formulation 1
    Reporting group description
    		 Participants aged 10 to 17 years received MenPenta formulation 1 (pentavalent meningococcal ABCYW standard dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 2: MenPenta Formulation 2
    Reporting group description
    		 Participants aged 10 to 17 years received MenPenta formulation 2 (pentavalent meningococcal ABCYW high dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 3: Bexsero + Menveo
    Reporting group description
    		 Participants aged 10 to 17 years received Bexsero (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Bexsero vaccine via IM injection on Day 181.

    Reporting group title
    Adolescents - Group 4: Trumenba + Menveo
    Reporting group description
    		 Participants aged 10 to 17 years received Trumenba (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Trumenba vaccine via IM injection on Day 181.

    Reporting group title
    Adolescents - Group 5: MenQuadfi
    Reporting group description
    		 Participants aged 10 to 17 years received MenQuadfi (meningococcal ACYW conjugate) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 6: Sanofi MenB
    Reporting group description
    		 Participants aged 10 to 17 years received Sanofi MenB (meningococcal B antigens standard dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 7: PENBRAYA
    Reporting group description
    		 Participants aged 10 to 17 years received PENBRAYA (meningococcal ABCYW conjugate) vaccine via IM injection on Days 1 and 181.

    Reporting group values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA Total
    Number of subjects
    		 20 21 20 20 20 20 298 300 100 97 100 99 100 1215
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 22.2 ( 2.41 ) 22.1 ( 2.21 ) 21.7 ( 2.36 ) 22.9 ( 1.73 ) 22.1 ( 2.00 ) 22.0 ( 2.27 ) 13.6 ( 2.59 ) 13.6 ( 2.70 ) 13.6 ( 2.60 ) 13.6 ( 2.64 ) 13.7 ( 2.72 ) 13.8 ( 2.57 ) 13.5 ( 2.54 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 11 15 9 13 9 16 150 139 44 50 39 47 44 586
        Male
    		 9 6 11 7 11 4 148 161 56 47 61 52 56 629
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 2 2 0 0 1 0 0 5
        Asian
    		 0 0 0 1 1 0 3 1 1 0 1 1 2 11
        Black or African American
    		 8 5 7 4 6 2 77 66 17 25 24 26 25 292
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 1 0 0 0 0 0 0 1
        White
    		 12 13 11 15 13 16 207 214 75 71 68 69 70 854
        Mixed Origin
    		 0 3 2 0 0 1 6 14 6 1 6 2 3 44
        Not Reported
    		 0 0 0 0 0 0 2 2 1 0 0 1 0 6
        Unknown
    		 0 0 0 0 0 1 0 1 0 0 0 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    Adults - Group 1: MenPenta Formulation 1
    Reporting group description
    		 Participants aged 18 to 25 years received MenPenta formulation 1 (pentavalent meningococcal ABCYW standard dose) vaccine via intermuscular (IM) injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adults - Group 2: MenPenta Formulation 2
    Reporting group description
    		 Participants aged 18 to 25 years received MenPenta formulation 2 (pentavalent meningococcal ABCYW high dose) vaccine via IM injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adults - Group 3: Bexsero + Menveo
    Reporting group description
    		 Participants aged 18 to 25 years received Bexsero (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Bexsero vaccine via IM injection on Day 31. Additionally, participants received a placebo IM injection on Day 181.

    Reporting group title
    Adults - Group 4: Trumenba + Menveo
    Reporting group description
    		 Participants aged 18 to 25 years received Trumenba (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Trumenba vaccine via IM injection on Days 31 and 181.

    Reporting group title
    Adults - Group 5: MenQuadfi
    Reporting group description
    		 Participants aged 18 to 25 years received MenQuadfi (meningococcal ACYW conjugate) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Days 1 and 31.

    Reporting group title
    Adults - Group 6: Sanofi MenB
    Reporting group description
    		 Participants aged 18 to 25 years received Sanofi MenB (meningococcal B antigens standard dose) vaccine via IM injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 1: MenPenta Formulation 1
    Reporting group description
    		 Participants aged 10 to 17 years received MenPenta formulation 1 (pentavalent meningococcal ABCYW standard dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 2: MenPenta Formulation 2
    Reporting group description
    		 Participants aged 10 to 17 years received MenPenta formulation 2 (pentavalent meningococcal ABCYW high dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 3: Bexsero + Menveo
    Reporting group description
    		 Participants aged 10 to 17 years received Bexsero (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Bexsero vaccine via IM injection on Day 181.

    Reporting group title
    Adolescents - Group 4: Trumenba + Menveo
    Reporting group description
    		 Participants aged 10 to 17 years received Trumenba (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Trumenba vaccine via IM injection on Day 181.

    Reporting group title
    Adolescents - Group 5: MenQuadfi
    Reporting group description
    		 Participants aged 10 to 17 years received MenQuadfi (meningococcal ACYW conjugate) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 6: Sanofi MenB
    Reporting group description
    		 Participants aged 10 to 17 years received Sanofi MenB (meningococcal B antigens standard dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 7: PENBRAYA
    Reporting group description
    		 Participants aged 10 to 17 years received PENBRAYA (meningococcal ABCYW conjugate) vaccine via IM injection on Days 1 and 181.

    Primary: Number of Participants With Unsolicited Systemic Adverse Events (AEs) After Each Vaccine Administration

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    End point title
    		 Number of Participants With Unsolicited Systemic Adverse Events (AEs) After Each Vaccine Administration [1]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination. The Safety analysis set (SafAS) included all randomized and enrolled (PENBRAYA only) participants who had received protocol-defined study vaccines at Day 1, or received 1 protocol-defined study vaccine at Day 31 or Day 181.
    End point type
    Primary
    End point timeframe
    Adults: Within 30 minutes after vaccine administration on Days 1, 31 and 181 Adolescents: Within 30 minutes after vaccine administration on Days 1 and 181
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    20
    21
    19
    20
    20
    20
    296
    300
    100
    97
    99
    97
    100
    Units: participants
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Solicited Injection Site Reactions After Each Vaccine Administration

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    End point title
    		 Number of Participants With Solicited Injection Site Reactions After Each Vaccine Administration [2]
    End point description
    An adverse reaction (AR) is any noxious and unintended response to a study vaccine related to any dose. Solicited injection site reactions are reactions at and around the injection site of the vaccine observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form. The SafAS included all randomized and enrolled (PENBRAYA only) participants who had received protocol-defined study vaccines at Day 1, or received 1 protocol-defined study vaccine at Day 31 or Day 181.
    End point type
    Primary
    End point timeframe
    Adults: Within 7 days after vaccine administration on Days 1, 31 and 181 Adolescents: Within 7 days after vaccine administration on Days 1 and 181
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    20
    21
    18
    20
    19
    20
    295
    299
    100
    96
    99
    97
    100
    Units: participants
    14
    16
    15
    14
    10
    19
    219
    219
    89
    75
    31
    73
    80
    No statistical analyses for this end point

    Primary: Number of Participants With Solicited Systemic Reactions After Each Vaccine Administration

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    End point title
    		 Number of Participants With Solicited Systemic Reactions After Each Vaccine Administration [3]
    End point description
    An AR is any noxious and unintended response to a study vaccine related to any dose. Solicited systemic reactions are systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form. The SafAS included all randomized and enrolled (PENBRAYA only) participants who had received protocol-defined study vaccines at Day 1, or received 1 protocol-defined study vaccine at Day 31 or Day 181.
    End point type
    Primary
    End point timeframe
    Adults: Within 7 days after vaccine administration on Days 1, 31 and 181 Adolescents: Within 7 days after vaccine administration on Days 1 and 181
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    20
    21
    18
    20
    19
    20
    295
    299
    100
    96
    99
    97
    100
    Units: participants
    10
    16
    11
    14
    13
    15
    192
    183
    75
    68
    51
    58
    72
    No statistical analyses for this end point

    Primary: Number of Participants With Unsolicited Adverse Events After Each Vaccine Administration

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    End point title
    		 Number of Participants With Unsolicited Adverse Events After Each Vaccine Administration [4]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. The SafAS included all randomized and enrolled (PENBRAYA only) participants who had received protocol-defined study vaccines at Day 1, or received 1 protocol-defined study vaccine at Day 31 or Day 181.
    End point type
    Primary
    End point timeframe
    Adults: Within 30 days after vaccine administration on Days 1, 31 and 181 Adolescents: Within 30 days after vaccine administration on Days 1 and 181
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    20
    21
    19
    20
    20
    20
    296
    300
    100
    97
    99
    97
    100
    Units: participants
    3
    6
    4
    6
    7
    5
    65
    58
    27
    24
    24
    32
    14
    No statistical analyses for this end point

    Primary: Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)

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    End point title
    		 Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) [5]
    End point description
    An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. An AESI (serious or non-serious) is 1 of scientific and medical concern specific to the Sponsor’s study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. The SafAS included all randomized and enrolled (PENBRAYA only) participants who had received protocol-defined study vaccines at Day 1, or received 1 protocol-defined study vaccine at Day 31 or Day 181.
    End point type
    Primary
    End point timeframe
    From the first vaccine administration (Day 1) until 180 days after last vaccine administration, approximately 361 days
    Notes
    [5] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    20
    21
    19
    20
    20
    20
    296
    300
    100
    97
    99
    97
    100
    Units: participants
        Any SAEs
    0
    0
    1
    1
    0
    0
    2
    3
    1
    1
    0
    0
    0
        Any AESIs
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Medically Attended Adverse Events (MAAEs)

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    End point title
    		 Number of Participants With Medically Attended Adverse Events (MAAEs) [6]
    End point description
    An MAAE is a new onset or a worsening of a condition that prompts the participant or participant’s parent/legally acceptable representative to seek unplanned medical advice at a physician’s office or emergency department. The SafAS included all randomized and enrolled (PENBRAYA only) participants who had received protocol-defined study vaccines at Day 1, or received 1 protocol-defined study vaccine at Day 31 or Day 181.
    End point type
    Primary
    End point timeframe
    From the first vaccine administration (Day 1) until 180 days after last vaccine administration, approximately 361 days
    Notes
    [6] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    20
    21
    19
    20
    20
    20
    296
    300
    100
    97
    99
    97
    100
    Units: participants
    1
    2
    2
    6
    3
    2
    41
    37
    20
    20
    18
    16
    13
    No statistical analyses for this end point

    Primary: Number of Participants With Abnormal Biological Test Results

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    End point title
    		 Number of Participants With Abnormal Biological Test Results [7]
    End point description
    Blood samples were collected for assessment of abnormal hematology and clinical chemistry parameters. Only participants with outside normal range hematology and clinical chemistry parameters are reported. SafAS–Day01S was a subset of SafAS-Day01 included participants from sentinel cohort. SafAS–Day31S was a subset of SafAS-Day31 included participants from sentinel cohort. SafAS–Day181S was a subset of SafAS-Day181 included participants from sentinel cohort. Hemoglobin(Hb);White Blood Cell(WBC);Lymphocytes(LYM);Neutrophils(NEU);Eosinophils(EOS);Platelets(PLT);Prothrombin time(PT);Active partial thromboplastin time(aPTT);Creatinine(Cr);C-reactive protein(CRP);Alanine aminotransferase(ALT);Aspartate transaminase(AST);Alkaline phosphatase(ALP);Bilirubin(BR);Liver function test(LFT);BR increase-LFT increase(BR-LFT inc);BR increase-LFT normal(BR-LFT normal). Here, n=Number of participants analyzed at specific timepoints; and 99999=No participants analyzed at specific timepoints.
    End point type
    Primary
    End point timeframe
    Adults: Within 8 days after vaccine administration on Days 1, 31 and 181 Adolescents: Within 8 days after vaccine administration on Days 1 and 181
    Notes
    [7] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    5
    6
    4
    5
    5
    5
    10
    11
    2
    1
    3
    3
    0 [8]
    Units: participants
        Day 9: Hb decrease (n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    1
    0
    2
    0
    1
    0
    4
    4
    0
    1
    2
    2
        Day 9: WBC increase(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
        Day 9:WBC decrease(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    1
    0
    0
    2
    2
    0
    0
    0
    0
        Day 9: LYM decrease(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    0
    0
    0
    2
    2
    0
    0
    0
    1
        Day 9:NEU decrease(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
        Day 9: EOS increase(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
        Day 9: PLT decrease(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
        Day 9: PT increase (n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    2
    1
    0
    4
    0
    1
    0
    1
    1
        Day 9:aPTT increase(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    0
    0
    1
    4
    4
    0
    1
    0
    1
        Day 9: Cr increase (n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Day 9: CRP increase(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    1
    0
    0
    0
    2
    1
    0
    1
    0
    0
    0
    0
        Day 9: ALT increase(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Day 9: AST increase(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Day 9: ALP increase(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Day 9:BR-LFT inc (n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Day9:BR-LFT normal(n=5,6,4,5,5,5,10,11,2,1,3,3,0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
        Day 39: Hb decrease (n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    1
    0
    2
    0
    0
    0
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39: WBC increase(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    0
    1
    0
    0
    0
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39:WBC decrease(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    0
    0
    0
    0
    0
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39: LYM decrease(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    0
    0
    0
    0
    0
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39:NEU decrease(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    0
    0
    0
    0
    0
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39: EOS increase(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    1
    0
    0
    1
    0
    0
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39: PLT decrease(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    0
    0
    0
    0
    0
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39: PT increase (n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    1
    0
    0
    0
    1
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39:aPTT increase(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    0
    0
    0
    0
    1
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39: Cr increase (n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    0
    0
    0
    0
    0
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39: CRP increase(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    0
    1
    0
    0
    1
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39: ALT increase(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    1
    1
    0
    0
    1
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39: AST increase(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    1
    1
    0
    0
    1
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39: ALP increase(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    0
    0
    0
    0
    1
    99999
    99999
    99999
    99999
    99999
    99999
        Day 39:BR-LFT inc (n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    0
    0
    0
    0
    0
    99999
    99999
    99999
    99999
    99999
    99999
        Day39:BR-LFT normal(n=4,4,4,4,5,4,0,0,0,0,0,0,0)
    0
    0
    0
    0
    1
    0
    99999
    99999
    99999
    99999
    99999
    99999
        Day 189:Hb decrease(n=3,4,3,4,5,3,6,9,2,0,3,2,0)
    1
    0
    2
    0
    0
    1
    2
    3
    0
    99999
    2
    0
        Day189:WBC increase(n=3,4,3,4,5,3,5,9,2,0,3,2,0)
    0
    0
    0
    0
    0
    1
    0
    1
    0
    99999
    0
    0
        Day189:WBC decrease(n=3,4,3,4,5,3,5,9,2,0,3,2,0)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    99999
    0
    0
        Day189:LYM decrease(n=3,4,3,4,5,3,5,9,2,0,3,2,0)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    99999
    0
    0
        Day189:NEU decrease(n=3,4,3,4,5,3,5,9,2,0,3,2,0)
    0
    0
    1
    0
    0
    0
    1
    1
    0
    99999
    1
    1
        Day189:EOS increase(n=3,4,3,4,5,3,5,9,2,0,3,2,0)
    1
    1
    0
    1
    0
    0
    0
    3
    0
    99999
    1
    0
        Day189:PLT decrease(n=3,4,3,4,5,3,5,9,2,0,3,2,0)
    0
    0
    0
    0
    1
    0
    0
    0
    0
    99999
    0
    0
        Day 189:PT increase(n=2,4,3,4,5,3,5,10,2,0,3,2,0)
    0
    0
    0
    0
    1
    1
    2
    2
    1
    99999
    0
    0
        Day189:aPTTincrease(n=2,4,3,4,5,3,5,10,2,0,3,2,0)
    0
    0
    0
    0
    1
    1
    1
    2
    1
    99999
    0
    0
        Day 189:Cr increase(n=3,4,3,4,5,3,6,10,2,0,3,2,0)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    99999
    0
    0
        Day189:CRP increase(n=3,4,3,4,5,3,6,10,2,0,3,2,0)
    0
    0
    1
    0
    1
    1
    0
    1
    0
    99999
    0
    0
        Day189:ALT increase(n=3,4,3,4,5,3,6,10,2,0,3,2,0)
    0
    1
    0
    0
    0
    0
    0
    0
    0
    99999
    0
    0
        Day189:AST increase(n=3,4,3,4,5,3,6,10,2,0,3,2,0)
    0
    0
    0
    0
    0
    0
    0
    1
    0
    99999
    0
    0
        Day189:ALP increase(n=3,4,3,4,5,3,5,10,2,0,3,2,0)
    0
    0
    0
    0
    0
    0
    0
    2
    0
    99999
    0
    0
        Day 189:BR-LFT inc (n=3,4,3,4,5,3,6,10,2,0,3,2,0)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    99999
    0
    0
        Day189:BR-LFTnormal(n=3,4,3,4,5,3,6,10,2,0,3,2,0)
    1
    0
    0
    0
    1
    0
    0
    0
    0
    99999
    1
    0
    Notes
    [8] - No participants analyzed; abnormal biological test results were analyzed for sentinel cohort only.
    No statistical analyses for this end point

    Primary: Adolescents Only: Percentage of Participants With Seroresponse Against Meningococcal Serogroups A, C, W and Y Strains at Days 1 and 211

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    End point title
    		 Adolescents Only: Percentage of Participants With Seroresponse Against Meningococcal Serogroups A, C, W and Y Strains at Days 1 and 211 [9] [10]
    End point description
    The seroresponse was defined as post-second vaccination titers >=1:16 for participants with pre-vaccination human complement serum bactericidal assay (hSBA) titers <1:4, or post-second vaccination titers >=4 times the pre-vaccination titer for participants with a pre-vaccination titer >= the lower limit of quantification (LLOQ). The LLOQ was a titer of 1:4, and it is the same as the limit of detection (LOD) for the meningococcal serogroups A, C, W and Y hSBA assay. The Full analysis set (FAS) 2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for specific serogroup.
    End point type
    Primary
    End point timeframe
    Pre-vaccination on Day 1 and 1 month after the second vaccination (Day 211)
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [10] - 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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    245
    254
    81
    81
    82
    84
    90
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A (n=227,240,77,78,82,78,88)
    97.8 (94.9 to 99.3)
    96.3 (93.0 to 98.3)
    98.7 (93.0 to 100)
    55.1 (43.4 to 66.4)
    86.6 (77.3 to 93.1)
    96.2 (89.2 to 99.2)
    90.9 (82.9 to 96.0)
        Serogroup C (n=237,244,81,81,78,81,88)
    97.0 (94.0 to 98.8)
    98.0 (95.3 to 99.3)
    95.1 (87.8 to 98.6)
    75.3 (64.5 to 84.2)
    97.4 (91.0 to 99.7)
    66.7 (55.3 to 76.8)
    92.0 (84.3 to 96.7)
        Serogroup W (n=245,254,81,79,82,84,90)
    96.7 (93.7 to 98.6)
    95.3 (91.9 to 97.5)
    71.6 (60.5 to 81.1)
    74.7 (63.6 to 83.8)
    98.8 (93.4 to 100)
    14.3 (7.6 to 23.6)
    96.7 (90.6 to 99.3)
        Serogroup Y (n=224,232,75,76,74,81,85)
    97.8 (94.9 to 99.3)
    97.4 (94.5 to 99.0)
    78.7 (67.7 to 87.3)
    82.9 (72.5 to 90.6)
    100 (95.1 to 100)
    11.1 (5.2 to 20.0)
    94.1 (86.8 to 98.1)
    No statistical analyses for this end point

    Primary: Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:8 Against Meningococcal Serogroups A, C, W and Y Strains at Days 1 and 211

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    End point title
    		 Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:8 Against Meningococcal Serogroups A, C, W and Y Strains at Days 1 and 211 [11] [12]
    End point description
    The percentage of participants with antibody titers >=1:8 against meningococcal serogroups A, C, W and Y was measured by hSBA. The 95% confidence interval (CI) for the single percentage was based on the Clopper-Pearson method. The FAS2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints.
    End point type
    Primary
    End point timeframe
    Pre-vaccination on Day 1 and 1 month after the second vaccination (Day 211)
    Notes
    [11] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [12] - 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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    260
    265
    88
    84
    89
    87
    93
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A: Day 1 (n=245,256,83,79,85,83,92)
    52.2 (45.8 to 58.6)
    59.8 (53.5 to 65.8)
    48.2 (37.1 to 59.4)
    57.0 (45.3 to 68.1)
    56.5 (45.3 to 67.2)
    56.6 (45.3 to 67.5)
    53.3 (42.6 to 63.7)
        Serogroup A: Day 211 (n=243,252,84,84,88,84,90)
    99.6 (97.7 to 100)
    99.2 (97.2 to 99.9)
    98.8 (93.5 to 100)
    85.7 (76.4 to 92.4)
    97.7 (92.0 to 99.7)
    100 (95.7 to 100)
    97.8 (92.2 to 99.7)
        Serogroup C: Day 1 (n=253,256,83,83,85,86,89)
    32.8 (27.1 to 39.0)
    39.8 (33.8 to 46.1)
    34.9 (24.8 to 46.2)
    30.1 (20.5 to 41.2)
    30.6 (21.0 to 41.5)
    31.4 (21.8 to 42.3)
    37.1 (27.1 to 48.0)
        Serogroup C: Day 211 (n=247,256,88,83,84,84,93)
    100 (98.5 to 100)
    99.6 (97.8 to 100)
    98.9 (93.8 to 100)
    94.0 (86.5 to 98.0)
    100 (95.7 to 100)
    85.7 (76.4 to 92.4)
    98.9 (94.2 to 100)
        Serogroup W: Day 1 (n=248,256,85,80,84,87,92)
    41.9 (35.7 to 48.3)
    46.5 (40.3 to 52.8)
    34.1 (24.2 to 45.2)
    45.0 (33.8 to 56.5)
    47.6 (36.6 to 58.8)
    50.6 (39.6 to 61.5)
    38.0 (28.1 to 48.8)
        Serogroup W: Day 211 (n=260,265,86,84,89,86,92)
    100 (98.6 to 100)
    99.2 (97.3 to 99.9)
    90.7 (82.5 to 95.9)
    95.2 (88.3 to 98.7)
    100 (95.9 to 100)
    57.0 (45.8 to 67.6)
    100 (96.1 to 100)
        Serogroup Y: Day 1 (n=234,239,80,78,79,83,90)
    29.5 (23.7 to 35.8)
    22.2 (17.1 to 28.0)
    21.3 (12.9 to 31.8)
    21.8 (13.2 to 32.6)
    27.8 (18.3 to 39.1)
    28.9 (19.5 to 39.9)
    20.0 (12.3 to 29.8)
        Serogroup Y: Day 211 (n=249,261,84,82,85,86,89)
    100 (98.5 to 100)
    99.6 (97.9 to 100)
    86.9 (77.8 to 93.3)
    90.2 (81.7 to 95.7)
    100 (95.8 to 100)
    33.7 (23.9 to 44.7)
    100 (95.9 to 100)
    No statistical analyses for this end point

    Primary: Adolescents Only: Geometric Mean Titers (GMT) of Antibodies Against Meningococcal Serogroups A, C, W and Y Strains at Days 1 and 211

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    End point title
    		 Adolescents Only: Geometric Mean Titers (GMT) of Antibodies Against Meningococcal Serogroups A, C, W and Y Strains at Days 1 and 211 [13] [14]
    End point description
    The antibodies titer against meningococcal serogroups A, C, W and Y was measured by hSBA and the results were expressed as GMT. The 95% CI for the single percentage was based on the Clopper-Pearson method. The FAS2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. Here, n= Number of participants analyzed for each serogroup at specific timepoints.
    End point type
    Primary
    End point timeframe
    Pre-vaccination on Day 1 and 1 month after the second vaccination (Day 211)
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    260
    265
    88
    84
    89
    87
    93
    Units: titer
    geometric mean (confidence interval 95%)
        Serogroup A: Day 1 (n=245,256,83,79,85,83,92)
    7.00 (6.13 to 8.00)
    8.58 (7.41 to 9.94)
    6.33 (5.31 to 7.55)
    8.89 (6.52 to 12.1)
    8.27 (6.54 to 10.4)
    8.00 (6.10 to 10.5)
    7.42 (5.78 to 9.53)
        Serogroup A: Day 211 (n=243,252,84,84,88,84,90)
    638 (531 to 767)
    640 (536 to 763)
    967 (720 to 1298)
    43.8 (29.5 to 65.0)
    217 (157 to 299)
    678 (485 to 947)
    272 (202 to 366)
        Serogroup C: Day 1 (n=253,256,83,83,85,86,89)
    5.15 (4.32 to 6.13)
    6.64 (5.45 to 8.08)
    5.54 (4.11 to 7.47)
    5.36 (3.97 to 7.23)
    4.99 (3.76 to 6.61)
    5.84 (4.18 to 8.17)
    5.81 (4.20 to 8.05)
        Serogroup C: Day 211 (n=247,256,88,83,84,84,93)
    823 (716 to 945)
    970 (833 to 1130)
    250 (188 to 332)
    69.0 (46.7 to 102)
    604 (456 to 799)
    53.4 (35.6 to 80.1)
    297 (226 to 390)
        Serogroup W: Day 1 (n=248,256,85,80,84,87,92)
    6.15 (5.18 to 7.31)
    6.86 (5.80 to 8.10)
    5.45 (4.17 to 7.13)
    7.40 (5.33 to 10.3)
    5.94 (4.60 to 7.68)
    8.06 (5.82 to 11.2)
    5.53 (4.20 to 7.28)
        Serogroup W: Day 211 (n=260,265,86,84,89,86,92)
    402 (349 to 462)
    410 (350 to 481)
    71.1 (48.2 to 105)
    89.8 (63.0 to 128)
    456 (342 to 607)
    10.3 (7.12 to 14.8)
    291 (243 to 348)
        Serogroup Y: Day 1 (n=234,239,80,78,79,83,90)
    4.40 (3.73 to 5.18)
    3.89 (3.31 to 4.56)
    3.48 (2.73 to 4.44)
    3.63 (2.82 to 4.66)
    3.70 (2.95 to 4.64)
    4.50 (3.32 to 6.09)
    3.97 (2.98 to 5.30)
        Serogroup Y: Day 211 (n=249,261,84,82,85,86,89)
    466 (405 to 536)
    482 (417 to 556)
    60.9 (41.0 to 90.6)
    81.1 (54.6 to 120)
    435 (340 to 556)
    6.08 (4.18 to 8.84)
    283 (232 to 346)
    No statistical analyses for this end point

    Primary: Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Meningococcal Serogroups A, C, W and Y Strains at Days 1 and 211

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    End point title
    		 Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Meningococcal Serogroups A, C, W and Y Strains at Days 1 and 211 [15] [16]
    End point description
    The percentage of participants with antibody titers >=LLOQ against meningococcal serogroups A, C, W and Y was measured by hSBA. The LLOQ was a titer of 1:4, and it is the same as the LOD for the meningococcal serogroups A, C, W and Y hSBA assay. The 95% CI for the single percentage was based on the Clopper-Pearson method. The FAS2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints.
    End point type
    Primary
    End point timeframe
    Pre-vaccination on Day 1 and 1 month after the second vaccination (Day 211)
    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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [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: As specified in the endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    260
    265
    88
    84
    89
    87
    93
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A: Day 1 (n=245,256,83,79,85,83,92)
    82.0 (76.7 to 86.6)
    84.0 (78.9 to 88.3)
    85.5 (76.1 to 92.3)
    79.7 (69.2 to 88.0)
    81.2 (71.2 to 88.8)
    79.5 (69.2 to 87.6)
    77.2 (67.2 to 85.3)
        Serogroup A: Day 211 (n=243,252,84,84,88,84,90)
    100 (98.5 to 100)
    100 (98.5 to 100)
    100 (95.7 to 100)
    92.9 (85.1 to 97.3)
    100 (95.9 to 100)
    100 (95.7 to 100)
    97.8 (92.2 to 99.7)
        Serogroup C: Day 1 (n=253,256,83,83,85,86,89)
    50.2 (43.9 to 56.5)
    56.3 (49.9 to 62.4)
    56.6 (45.3 to 67.5)
    54.2 (42.9 to 65.2)
    54.1 (43.0 to 65.0)
    53.5 (42.4 to 64.3)
    55.1 (44.1 to 65.6)
        Serogroup C: Day 211 (n=247,256,88,83,84,84,93)
    100 (98.5 to 100)
    99.6 (97.8 to 100)
    98.9 (93.8 to 100)
    96.4 (89.8 to 99.2)
    100 (95.7 to 100)
    91.7 (83.6 to 96.6)
    100 (96.1 to 100)
        Serogroup W: Day 1 (n=248,256,85,80,84,87,92)
    53.6 (47.2 to 60.0)
    63.3 (57.1 to 69.2)
    57.6 (46.4 to 68.3)
    61.3 (49.7 to 71.9)
    54.8 (43.5 to 65.7)
    65.5 (54.6 to 75.4)
    51.1 (40.4 to 61.7)
        Serogroup W: Day 211 (n=260,265,86,84,89,86,92)
    100 (98.6 to 100)
    99.6 (97.9 to 100)
    96.5 (90.1 to 99.3)
    97.6 (91.7 to 99.7)
    100 (95.9 to 100)
    67.4 (56.5 to 77.2)
    100 (96.1 to 100)
        Serogroup Y: Day 1 (n=234,239,80,78,79,83,90)
    36.3 (30.2 to 42.8)
    31.8 (25.9 to 38.1)
    30.0 (20.3 to 41.3)
    30.8 (20.8 to 42.2)
    32.9 (22.7 to 44.4)
    34.9 (24.8 to 46.2)
    31.1 (21.8 to 41.7)
        Serogroup Y: Day 211 (n=249,261,84,82,85,86,89)
    100 (98.5 to 100)
    99.6 (97.9 to 100)
    91.7 (83.6 to 96.6)
    93.9 (86.3 to 98.0)
    100 (95.8 to 100)
    41.9 (31.3 to 53.0)
    100 (95.9 to 100)
    No statistical analyses for this end point

    Primary: Adolescents Only: Percentage of Participants With Seroresponse Against Reference Strains of Meningococcal Serogroup B at Days 1 and 211

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    End point title
    		 Adolescents Only: Percentage of Participants With Seroresponse Against Reference Strains of Meningococcal Serogroup B at Days 1 and 211 [17] [18]
    End point description
    The seroresponse was defined as a 4-fold increase in hSBA titers from pre-vaccination to post-second vaccination. The FAS2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for specific serogroup.
    End point type
    Primary
    End point timeframe
    Pre-vaccination on Day 1 and 1 month after the second vaccination (Day 211)
    Notes
    [17] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [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: As specified in the endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    256
    263
    87
    84
    90
    88
    94
    Units: percentage of participants
    number (confidence interval 95%)
        Strain (A56) (n=256,263,86,83,90,87,94)
    33.2 (27.5 to 39.3)
    45.2 (39.1 to 51.5)
    10.5 (4.9 to 18.9)
    85.5 (76.1 to 92.3)
    1.1 (0 to 6.0)
    35.6 (25.6 to 46.6)
    85.1 (76.3 to 91.6)
        Strain (B44) (n=255,262,86,82,88,86,91)
    55.3 (49.0 to 61.5)
    65.6 (59.6 to 71.4)
    62.8 (51.7 to 73.0)
    80.5 (70.3 to 88.4)
    5.7 (1.9 to 12.8)
    65.1 (54.1 to 75.1)
    72.5 (62.2 to 81.4)
        Strain (A10) (n=255,260,83,84,89,85,91)
    40.4 (34.3 to 46.7)
    43.1 (37.0 to 49.3)
    12.0 (5.9 to 21.0)
    0 (0 to 4.3)
    1.1 (0 to 6.1)
    55.3 (44.1 to 66.1)
    0 (0 to 4.0)
        Strain (B79) (n=255,259,87,75,88,88,82)
    86.3 (81.4 to 90.2)
    89.2 (84.8 to 92.7)
    96.6 (90.3 to 99.3)
    14.7 (7.6 to 24.7)
    2.3 (0.3 to 8.0)
    96.6 (90.4 to 99.3)
    15.9 (8.7 to 25.6)
    No statistical analyses for this end point

    Primary: Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:4 and >=1:8 Against Reference Strains of Meningococcal Serogroup B at Days 1 and 211

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    End point title
    		 Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:4 and >=1:8 Against Reference Strains of Meningococcal Serogroup B at Days 1 and 211 [19] [20]
    End point description
    The percentage of participants with antibody titers >=1:4 and >=1:8 against the reference strains of the meningococcal serogroup B was measured by hSBA. The 95% CI for the single percentage was based on the Clopper-Pearson method. The FAS2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. S-A56= Strain (A56); S-B44= Strain (B44); S-A10= Strain (A10); S-B79= Strain (B79). Here, n= Number of participants analyzed for each serogroup at specific timepoints.
    End point type
    Primary
    End point timeframe
    Pre-vaccination on Day 1 and 1 month after the second vaccination (Day 211)
    Notes
    [19] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    263
    267
    89
    85
    91
    89
    94
    Units: percentage of participants
    number (confidence interval 95%)
        S-A56:Day1,>=1:4(n=258,266,89,83,90,89,94)
    100 (98.6 to 100)
    100 (98.6 to 100)
    100 (95.9 to 100)
    100 (95.7 to 100)
    100 (96.0 to 100)
    100 (95.9 to 100)
    100 (96.2 to 100)
        S-A56:Day1,>=1:8(n=258,266,89,83,90,89,94)
    5.0 (2.7 to 8.5)
    6.0 (3.5 to 9.6)
    3.4 (0.7 to 9.5)
    4.8 (1.3 to 11.9)
    6.7 (2.5 to 13.9)
    6.7 (2.5 to 14.1)
    3.2 (0.7 to 9.0)
        S-A56:Day211,>=1:4(n=262,266,87,85,91,87,94)
    100 (98.6 to 100)
    100 (98.6 to 100)
    100 (95.8 to 100)
    100 (95.8 to 100)
    100 (96.0 to 100)
    100 (95.8 to 100)
    100 (96.2 to 100)
        S-A56:Day211,>=1:8(n=262,266,87,85,91,87,94)
    57.6 (51.4 to 63.7)
    66.2 (60.1 to 71.8)
    41.4 (30.9 to 52.4)
    96.5 (90.0 to 99.3)
    7.7 (3.1 to 15.2)
    54.0 (43.0 to 64.8)
    98.9 (94.2 to 100)
        S-B44:Day1,>=1:4(n=259,264,89,83,90,87,91)
    73.7 (67.9 to 79.0)
    73.1 (67.3 to 78.4)
    68.5 (57.8 to 78.0)
    73.5 (62.7 to 82.6)
    73.3 (63.0 to 82.1)
    75.9 (65.5 to 84.4)
    71.4 (61.0 to 80.4)
        S-B44:Day1,>=1:8(n=259,264,89,83,90,87,91)
    53.3 (47.0 to 59.5)
    48.1 (41.9 to 54.3)
    48.3 (37.6 to 59.2)
    49.4 (38.2 to 60.6)
    52.2 (41.4 to 62.9)
    49.4 (38.5 to 60.4)
    60.4 (49.6 to 70.5)
        S-B44:Day211,>=1:4(n=260,267,87,84,89,88,94)
    97.3 (94.5 to 98.9)
    99.6 (97.9 to 100)
    100 (95.8 to 100)
    100 (95.7 to 100)
    73.0 (62.6 to 81.9)
    98.9 (93.8 to 100)
    100 (96.2 to 100)
        S-B44:Day211,>=1:8(n=260,267,87,84,89,88,94)
    92.3 (88.4 to 95.2)
    97.4 (94.7 to 98.9)
    98.9 (93.8 to 100)
    98.8 (93.5 to 100)
    55.1 (44.1 to 65.6)
    96.6 (90.4 to 99.3)
    100 (96.2 to 100)
        S-A10:Day1,>=1:4(n=257,266,88,84,90,88,92)
    1.9 (0.6 to 4.5)
    4.5 (2.4 to 7.7)
    3.4 (0.7 to 9.6)
    2.4 (0.3 to 8.3)
    5.6 (1.8 to 12.5)
    4.5 (1.3 to 11.2)
    4.3 (1.2 to 10.8)
        S-A10:Day1,>=1:8(n=257,266,88,84,90,88,92)
    1.6 (0.4 to 3.9)
    3.4 (1.6 to 6.3)
    2.3 (0.3 to 8.0)
    2.4 (0.3 to 8.3)
    3.3 (0.7 to 9.4)
    3.4 (0.7 to 9.6)
    3.3 (0.7 to 9.2)
        S-A10:Day211,>=1:4(n=262,263,85,85,90,86,93)
    72.5 (66.7 to 77.8)
    80.6 (75.3 to 85.2)
    24.7 (16.0 to 35.3)
    4.7 (1.3 to 11.6)
    5.6 (1.8 to 12.5)
    86.0 (76.9 to 92.6)
    2.2 (0.3 to 7.6)
        S-A10:Day211,>=1:8(n=262,263,85,85,90,86,93)
    63.0 (56.8 to 68.8)
    69.6 (63.6 to 75.1)
    22.4 (14.0 to 32.7)
    2.4 (0.3 to 8.2)
    4.4 (1.2 to 11.0)
    79.1 (69.0 to 87.1)
    1.1 (0 to 5.8)
        S-B79:Day1,>=1:4(n=256,261,89,83,88,89,91)
    4.3 (2.2 to 7.6)
    5.7 (3.3 to 9.3)
    4.5 (1.2 to 11.1)
    7.2 (2.7 to 15.1)
    6.8 (2.5 to 14.3)
    6.7 (2.5 to 14.1)
    8.8 (3.9 to 16.6)
        S-B79:Day1,>=1:8(n=256,261,89,83,88,89,91)
    4.3 (2.2 to 7.6)
    5.4 (3.0 to 8.8)
    4.5 (1.2 to 11.1)
    7.2 (2.7 to 15.1)
    6.8 (2.5 to 14.3)
    5.6 (1.8 to 12.6)
    8.8 (3.9 to 16.6)
        S-B79:Day211,>=1:4(n=263,267,88,76,90,88,84)
    93.5 (89.9 to 96.2)
    97.8 (95.2 to 99.2)
    97.7 (92.0 to 99.7)
    34.2 (23.7 to 46.0)
    10.0 (4.7 to 18.1)
    98.9 (93.8 to 100)
    29.8 (20.3 to 40.7)
        S-B79:Day211,>=1:8(n=263,267,88,76,90,88,84)
    93.2 (89.4 to 95.9)
    97.8 (95.2 to 99.2)
    97.7 (92.0 to 99.7)
    34.2 (23.7 to 46.0)
    10.0 (4.7 to 18.1)
    98.9 (93.8 to 100)
    27.4 (18.2 to 38.2)
    No statistical analyses for this end point

    Primary: Adolescents Only: Geometric Mean Titers of Antibodies Against Reference Strains of Meningococcal Serogroup B at Days 1 and 211

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    End point title
    		 Adolescents Only: Geometric Mean Titers of Antibodies Against Reference Strains of Meningococcal Serogroup B at Days 1 and 211 [21] [22]
    End point description
    The antibodies titer against the reference strains of the meningococcal serogroup B was measured by hSBA and the results were expressed as GMT. The 95% CI for the single percentage was based on the Clopper-Pearson method. The FAS2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. Here, n= Number of participants analyzed for each serogroup at specific timepoints.
    End point type
    Primary
    End point timeframe
    Pre-vaccination on Day 1 and 1 month after the second vaccination (Day 211)
    Notes
    [21] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    263
    267
    89
    85
    91
    89
    94
    Units: titer
    geometric mean (confidence interval 95%)
        Strain (A56): Day 1 (n=258,266,89,83,90,89,94)
    4.98 (4.70 to 5.27)
    5.01 (4.73 to 5.31)
    4.76 (4.45 to 5.10)
    4.82 (4.49 to 5.18)
    4.95 (4.57 to 5.36)
    4.99 (4.54 to 5.48)
    4.67 (4.46 to 4.89)
        Strain (A56):Day211(n=262,266,87,85,91,87,94)
    21.2 (17.3 to 25.9)
    33.1 (26.6 to 41.0)
    9.00 (7.35 to 11.0)
    107 (84.2 to 137)
    5.18 (4.64 to 5.78)
    19.6 (13.9 to 27.6)
    119 (94.8 to 149)
        Strain (B44): Day 1 (n=259,264,89,83,90,87,91)
    9.24 (7.86 to 10.9)
    8.80 (7.53 to 10.3)
    8.20 (6.26 to 10.7)
    7.61 (6.01 to 9.64)
    9.50 (7.20 to 12.6)
    8.54 (6.69 to 10.9)
    10.7 (8.03 to 14.2)
        Strain (B44): Day 211 (n=260,267,87,84,89,88,94)
    57.1 (48.0 to 67.9)
    79.4 (67.9 to 93.0)
    52.8 (43.4 to 64.3)
    111 (88.0 to 140)
    9.90 (7.44 to 13.2)
    78.0 (58.6 to 104)
    111 (93.7 to 132)
        Strain (A10): Day 1 (n=257,266,88,84,90,88,92)
    2.65 (2.50 to 2.80)
    2.73 (2.59 to 2.88)
    2.78 (2.41 to 3.20)
    2.69 (2.42 to 2.99)
    2.88 (2.49 to 3.35)
    2.77 (2.47 to 3.10)
    2.68 (2.49 to 2.89)
        Strain (A10):Day211(n=262,263,85,85,90,86,93)
    13.9 (11.6 to 16.6)
    17.5 (14.7 to 20.9)
    4.57 (3.51 to 5.94)
    2.65 (2.49 to 2.81)
    2.87 (2.51 to 3.29)
    25.5 (18.6 to 34.9)
    2.56 (2.48 to 2.64)
        Strain (B79):Day 1 (n=256,261,89,83,88,89,91)
    3.87 (3.61 to 4.14)
    3.87 (3.66 to 4.09)
    3.82 (3.49 to 4.17)
    4.16 (3.47 to 4.99)
    3.94 (3.55 to 4.38)
    3.98 (3.55 to 4.45)
    4.27 (3.67 to 4.97)
        Strain (B79):Day211(n=263,267,88,76,90,88,84)
    209 (168 to 260)
    267 (222 to 322)
    584 (444 to 769)
    7.79 (5.78 to 10.5)
    4.30 (3.73 to 4.95)
    516 (371 to 717)
    6.84 (5.29 to 8.83)
    No statistical analyses for this end point

    Primary: Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Reference Strains of Meningococcal Serogroup B at Days 1 and 211

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    End point title
    		 Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Reference Strains of Meningococcal Serogroup B at Days 1 and 211 [23] [24]
    End point description
    The percentage of participants with antibody titers >=LLOQ against the reference strains of the meningococcal serogroup B was measured by hSBA. The 95% CI for the single percentage was based on the Clopper-Pearson method. The FAS2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints.
    End point type
    Primary
    End point timeframe
    Pre-vaccination on Day 1 and 1 month after the second vaccination (Day 211)
    Notes
    [23] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
    [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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    263
    267
    89
    85
    91
    89
    94
    Units: percentage of participants
    number (confidence interval 95%)
        Strain (A56): Day 1 (n=258,266,89,83,90,89,94)
    5.0 (2.7 to 8.5)
    6.0 (3.5 to 9.6)
    3.4 (0.7 to 9.5)
    4.8 (1.3 to 11.9)
    6.7 (2.5 to 13.9)
    6.7 (2.5 to 14.1)
    3.2 (0.7 to 9.0)
        Strain (A56):Day211(n=262,266,87,85,91,87,94)
    57.6 (51.4 to 63.7)
    66.2 (60.1 to 71.8)
    41.4 (30.9 to 52.4)
    96.5 (90.0 to 99.3)
    7.7 (3.1 to 15.2)
    54.0 (43.0 to 64.8)
    98.9 (94.2 to 100)
        Strain (B44): Day 1 (n=259,264,89,83,90,87,91)
    73.7 (67.9 to 79.0)
    73.1 (67.3 to 78.4)
    68.5 (57.8 to 78.0)
    73.5 (62.7 to 82.6)
    73.3 (63.0 to 82.1)
    75.9 (65.5 to 84.4)
    71.4 (61.0 to 80.4)
        Strain (B44): Day 211 (n=260,267,87,84,89,88,94)
    97.3 (94.5 to 98.9)
    99.6 (97.9 to 100)
    100 (95.8 to 100)
    100 (95.7 to 100)
    73.0 (62.6 to 81.9)
    98.9 (93.8 to 100)
    100 (96.2 to 100)
        Strain (A10): Day 1 (n=257,266,88,84,90,88,92)
    1.9 (0.6 to 4.5)
    4.5 (2.4 to 7.7)
    3.4 (0.7 to 9.6)
    2.4 (0.3 to 8.3)
    5.6 (1.8 to 12.5)
    4.5 (1.3 to 11.2)
    4.3 (1.2 to 10.8)
        Strain (A10):Day211(n=262,263,85,85,90,86,93)
    72.5 (66.7 to 77.8)
    80.6 (75.3 to 85.2)
    24.7 (16.0 to 35.3)
    4.7 (1.3 to 11.6)
    5.6 (1.8 to 12.5)
    86.0 (76.9 to 92.6)
    2.2 (0.3 to 7.6)
        Strain (B79): Day 1 (n=256,261,89,83,88,89,91)
    4.3 (2.2 to 7.6)
    5.7 (3.3 to 9.3)
    4.5 (1.2 to 11.1)
    7.2 (2.7 to 15.1)
    6.8 (2.5 to 14.3)
    6.7 (2.5 to 14.1)
    8.8 (3.9 to 16.6)
        Strain (B79):Day211(n=263,267,88,76,90,88,84)
    93.5 (89.9 to 96.2)
    97.8 (95.2 to 99.2)
    97.7 (92.0 to 99.7)
    34.2 (23.7 to 46.0)
    10.0 (4.7 to 18.1)
    98.9 (93.8 to 100)
    29.8 (20.3 to 40.7)
    No statistical analyses for this end point

    Secondary: Adolescents Only: Percentage of Participants With Seroresponse Against Meningococcal Serogroups A, C, W and Y Strains at Days 31 and 181

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    End point title
    		 Adolescents Only: Percentage of Participants With Seroresponse Against Meningococcal Serogroups A, C, W and Y Strains at Days 31 and 181 [25]
    End point description
    The seroresponse was defined as post-vaccination titers >=1:16 for participants with pre-vaccination hSBA titers <1:4, or post-vaccination titers >=4 times the pre-vaccination titer for participants with a pre-vaccination titer >= the LLOQ. The LLOQ was a titer of 1:4, and it is the same as the LOD for the meningococcal serogroups A, C, W and Y hSBA assay. Day 31: FAS1 – adolescents included participants who were vaccinated per protocol at Day 1 and had 1 valid post-vaccination blood sample at Day 31. Day 181: FAS2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    One month after the first vaccination (Day 31) and pre-vaccination on Day 181
    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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    91
    81
    40
    32
    31
    57
    15
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A: Day 31 (n=35,47,11,6,18,13,0)
    100 (90.0 to 100)
    93.6 (82.5 to 98.7)
    72.7 (39.0 to 94.0)
    66.7 (22.3 to 95.7)
    50.0 (26.0 to 74.0)
    100 (75.3 to 100)
    99999 (-99999 to 99999)
        Serogroup A: Day 181 (n=0,0,0,0,0,1,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    100 (2.5 to 100)
    99999 (-99999 to 99999)
        Serogroup C: Day 31 (n=91,81,40,32,31,57,15)
    91.2 (83.4 to 96.1)
    95.1 (87.8 to 98.6)
    85.0 (70.2 to 94.3)
    68.8 (50.0 to 83.9)
    96.8 (83.3 to 99.9)
    50.9 (37.3 to 64.4)
    60.0 (32.3 to 83.7)
        Serogroup C: Day 181 (n=0,0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Serogroup W: Day 31 (n=34,42,13,5,13,15,0)
    91.2 (76.3 to 98.1)
    92.9 (80.5 to 98.5)
    100 (75.3 to 100)
    60.0 (14.7 to 94.7)
    92.3 (64.0 to 99.8)
    13.3 (1.7 to 40.5)
    99999 (-99999 to 99999)
        Serogroup W: Day 181 (n=0,0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Serogroup Y: Day 31 (n=43,45,21,14,12,22,0)
    93.0 (80.9 to 98.5)
    97.8 (88.2 to 99.9)
    85.7 (63.7 to 97.0)
    92.9 (66.1 to 99.8)
    91.7 (61.5 to 99.8)
    9.1 (1.1 to 29.2)
    99999 (-99999 to 99999)
        Serogroup Y: Day 181 (n=0,0,0,0,0,1,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    0 (0 to 97.5)
    99999 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:8 Against Meningococcal Serogroups A, C, W and Y Strains at Days 31 and 181

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    End point title
    		 Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:8 Against Meningococcal Serogroups A, C, W and Y Strains at Days 31 and 181 [26]
    End point description
    The percentage of participants with antibody titers >=1:8 against meningococcal serogroups A, C, W and Y was measured by hSBA. The 95% CI for the single percentage was based on the Clopper-Pearson method. Day 31: FAS1 – adolescents included participants who were vaccinated per protocol at Day 1 and had 1 valid post-vaccination blood sample at Day 31. Day 181: FAS2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    One month after the first vaccination (Day 31) and pre-vaccination on Day 181
    Notes
    [26] - 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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    93
    81
    42
    33
    33
    59
    15
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A: Day 31 (n=39,50,12,9,19,14,0)
    100 (91.0 to 100)
    100 (92.9 to 100)
    75.0 (42.8 to 94.5)
    88.9 (51.8 to 99.7)
    84.2 (60.4 to 96.6)
    100 (76.8 to 100)
    99999 (-99999 to 99999)
        Serogroup A: Day 181 (n=0,0,0,0,0,1,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    100 (2.5 to 100)
    99999 (-99999 to 99999)
        Serogroup C: Day 31 (n=93,81,42,33,33,59,15)
    97.8 (92.4 to 99.7)
    97.5 (91.4 to 99.7)
    90.5 (77.4 to 97.3)
    81.8 (64.5 to 93.0)
    100 (89.4 to 100)
    81.4 (69.1 to 90.3)
    86.7 (59.5 to 98.3)
        Serogroup C: Day 181 (n=0,0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Serogroup W: Day 31 (n=40,50,15,5,16,16,0)
    100 (91.2 to 100)
    100 (92.9 to 100)
    100 (78.2 to 100)
    100 (47.8 to 100)
    100 (79.4 to 100)
    56.3 (29.9 to 80.2)
    99999 (-99999 to 99999)
        Serogroup W: Day 181 (n=0,0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Serogroup Y: Day 31 (n=50,52,23,15,17,25,0)
    96.0 (86.3 to 99.5)
    100 (93.2 to 100)
    100 (85.2 to 100)
    100 (78.2 to 100)
    94.1 (71.3 to 99.9)
    32.0 (14.9 to 53.5)
    99999 (-99999 to 99999)
        Serogroup Y: Day 181 (n=0,0,0,0,0,1,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    0 (0 to 97.5)
    99999 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Adolescents Only: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W and Y Strains at Days 31 and 181

    		 Close Top of page
    End point title
    		 Adolescents Only: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W and Y Strains at Days 31 and 181 [27]
    End point description
    The antibodies titer against meningococcal serogroups A, C, W and Y was measured by hSBA and the results were expressed as GMT. The 95% CI for the single percentage was based on the Clopper-Pearson method. Day 31: FAS1 – adolescents included participants who were vaccinated per protocol at Day 1 and had 1 valid post-vaccination blood sample at Day 31. Day 181: FAS2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. Here, n= Number of participants analyzed for each serogroup at specific timepoints; -9999 and 9999= The 95% CI was not computed, if number analyzed was <=5 or standard deviation was 0; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    One month after the first vaccination (Day 31) and pre-vaccination on Day 181
    Notes
    [27] - 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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    93
    81
    42
    33
    33
    59
    15
    Units: titer
    geometric mean (confidence interval 95%)
        Serogroup A: Day 31 (n=39,50,12,9,19,14,0)
    189 (134 to 268)
    246 (170 to 354)
    71.8 (16.6 to 311)
    110 (18.8 to 639)
    46.1 (17.8 to 120)
    164 (93.9 to 286)
    99999 (-99999 to 99999)
        Serogroup A: Day 181 (n=0,0,0,0,0,1,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    32.0 (-9999 to 9999)
    99999 (-99999 to 99999)
        Serogroup C: Day 31 (n=93,81,42,33,33,59,15)
    231 (174 to 306)
    301 (227 to 400)
    141 (77.8 to 257)
    60.1 (29.2 to 124)
    273 (183 to 407)
    30.9 (19.4 to 49.3)
    92.6 (32.3 to 266)
        Serogroup C: Day 181 (n=0,0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Serogroup W: Day 31 (n=40,50,15,5,16,16,0)
    122 (79.0 to 187)
    143 (100 to 204)
    70.2 (34.6 to 143)
    73.5 (-9999 to 9999)
    76.1 (46.4 to 125)
    7.03 (3.67 to 13.5)
    99999 (-99999 to 99999)
        Serogroup W: Day 181 (n=0,0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Serogroup Y: Day 31 (n=50,52,23,15,17,25,0)
    95.7 (63.4 to 144)
    158 (111 to 225)
    51.8 (26.9 to 99.7)
    77.0 (30.9 to 192)
    81.7 (36.5 to 183)
    5.43 (2.83 to 10.4)
    99999 (-99999 to 99999)
        Serogroup Y: Day 181 (n=0,0,0,0,0,1,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    2.00 (-9999 to 9999)
    99999 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Meningococcal Serogroups A, C, W and Y Strains at Days 31 and 181

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    End point title
    		 Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Meningococcal Serogroups A, C, W and Y Strains at Days 31 and 181 [28]
    End point description
    The percentage of participants with antibody titers >=LLOQ against meningococcal serogroups A, C, W and Y was measured by hSBA. The LLOQ was a titer of 1:4, and it is the same as the LOD for the meningococcal serogroups A, C, W and Y hSBA assay. The 95% CI for the single percentage was based on the Clopper-Pearson method. Day 31: FAS1 – adolescents included participants who were vaccinated per protocol at Day 1 and had 1 valid post-vaccination blood sample at Day 31. Day 181: FAS2 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    One month after the first vaccination (Day 31) and pre-vaccination on Day 181
    Notes
    [28] - 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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    93
    81
    42
    33
    33
    59
    15
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A: Day 31 (n=39,50,12,9,19,14,0)
    100 (91.0 to 100)
    100 (92.9 to 100)
    83.3 (51.6 to 97.9)
    88.9 (51.8 to 99.7)
    84.2 (60.4 to 96.6)
    100 (76.8 to 100)
    99999 (-99999 to 99999)
        Serogroup A: Day 181 (n=0,0,0,0,0,1,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    100 (2.5 to 100)
    99999 (-99999 to 99999)
        Serogroup C: Day 31 (n=93,81,42,33,33,59,15)
    98.9 (94.2 to 100)
    98.8 (93.3 to 100)
    92.9 (80.5 to 98.5)
    93.9 (79.8 to 99.3)
    100 (89.4 to 100)
    89.8 (79.2 to 96.2)
    100 (78.2 to 100)
        Serogroup C: Day 181 (n=0,0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Serogroup W: Day 31 (n=40,50,15,5,16,16,0)
    100 (91.2 to 100)
    100 (92.9 to 100)
    100 (78.2 to 100)
    100 (47.8 to 100)
    100 (79.4 to 100)
    56.3 (29.9 to 80.2)
    99999 (-99999 to 99999)
        Serogroup W: Day 181 (n=0,0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Serogroup Y: Day 31 (n=50,52,23,15,17,25,0)
    96.0 (86.3 to 99.5)
    100 (93.2 to 100)
    100 (85.2 to 100)
    100 (78.2 to 100)
    100 (80.5 to 100)
    36.0 (18.0 to 57.5)
    99999 (-99999 to 99999)
        Serogroup Y: Day 181 (n=0,0,0,0,0,1,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    0 (0 to 97.5)
    99999 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Adolescents Only: Percentage of Participants With Seroresponse Against Reference Strains of Meningococcal Serogroup B at Days 31 and 181

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    End point title
    		 Adolescents Only: Percentage of Participants With Seroresponse Against Reference Strains of Meningococcal Serogroup B at Days 31 and 181 [29]
    End point description
    The seroresponse was defined as a 4-fold increase in hSBA titers from pre-vaccination to post-vaccination. The seroresponse against reference strains of meningococcal serogroup B at Days 31 and 181 was not applicable. Therefore, no data collected and analyzed.
    End point type
    Secondary
    End point timeframe
    One month after the first vaccination (Day 31) and pre-vaccination on Day 181
    Notes
    [29] - 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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    0 [34]
    0 [35]
    0 [36]
    Units: percentage of participants
    number (confidence interval 95%)
        Strain (A56): Day 31
    ( to )
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    ( to )
        Strain (A56): Day 181
    ( to )
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    ( to )
        Strain (B44): Day 31
    ( to )
    ( to )
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    ( to )
    ( to )
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    ( to )
        Strain (B44): Day 181
    ( to )
    ( to )
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    ( to )
    ( to )
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    ( to )
        Strain (A10): Day 31
    ( to )
    ( to )
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    ( to )
    ( to )
    ( to )
    ( to )
        Strain (A10): Day 181
    ( to )
    ( to )
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    ( to )
    ( to )
    ( to )
    ( to )
        Strain (B79): Day 31
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
        Strain (B79): Day 181
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [30] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    [31] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    [32] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    [33] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    [34] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    [35] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    [36] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    No statistical analyses for this end point

    Secondary: Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:4 and >=1:8 Against Reference Strains of Meningococcal Serogroup B at Days 31 and 181

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    End point title
    		 Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:4 and >=1:8 Against Reference Strains of Meningococcal Serogroup B at Days 31 and 181 [37]
    End point description
    The percentage of participants with antibody titers >=1:4 and >=1:8 against the reference strains of the meningococcal serogroup B was measured by hSBA. The 95% CI for the single percentage was based on the Clopper-Pearson method. The antibodies titer against reference strains of meningococcal serogroup B at Days 31 and 181 was not applicable. Therefore, no data collected and analyzed.
    End point type
    Secondary
    End point timeframe
    One month after the first vaccination (Day 31) and pre-vaccination on Day 181
    Notes
    [37] - 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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    0 [38]
    0 [39]
    0 [40]
    0 [41]
    0 [42]
    0 [43]
    0 [44]
    Units: percentage of participants
    number (confidence interval 95%)
        Strain (A56): Day 31, >= 1:4
    ( to )
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    ( to )
        Strain (A56): Day 31, >= 1:8
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    ( to )
    ( to )
    ( to )
    ( to )
        Strain (A56): Day 181, >= 1:4
    ( to )
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        Strain (A56): Day 181, >= 1:8
    ( to )
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    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
        Strain (B44): Day 31, >= 1:4
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
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        Strain (B44): Day 31, >= 1:8
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    ( to )
        Strain (B44): Day 181, >= 1:4
    ( to )
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        Strain (B44): Day 181, >= 1:8
    ( to )
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    ( to )
    ( to )
    ( to )
    ( to )
        Strain (A10): Day 31, >= 1:4
    ( to )
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    ( to )
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    ( to )
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        Strain (A10): Day 31, >= 1:8
    ( to )
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    ( to )
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        Strain (A10): Day 181, >= 1:4
    ( to )
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    ( to )
    ( to )
    ( to )
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        Strain (A10): Day 181, >= 1:8
    ( to )
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    ( to )
    ( to )
    ( to )
    ( to )
        Strain (B79): Day 31, >= 1:4
    ( to )
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    ( to )
    ( to )
    ( to )
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        Strain (B79): Day 31, >= 1:8
    ( to )
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        Strain (B79): Day 181, >= 1:4
    ( to )
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        Strain (B79): Day 181, >= 1:8
    ( to )
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    ( to )
    ( to )
    ( to )
    Notes
    [38] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [39] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [40] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [41] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [42] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [43] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [44] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    No statistical analyses for this end point

    Secondary: Adolescents Only: Geometric Mean Titers of Antibodies Against Reference Strains of Meningococcal Serogroup B at Days 31 and 181

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    End point title
    		 Adolescents Only: Geometric Mean Titers of Antibodies Against Reference Strains of Meningococcal Serogroup B at Days 31 and 181 [45]
    End point description
    The antibodies titer against the reference strains of the meningococcal serogroup B was measured by hSBA and the results were expressed as GMT. The 95% CI for the single percentage was based on the Clopper-Pearson method. The antibodies titer against reference strains of meningococcal serogroup B at Days 31 and 181 was not applicable. Therefore, no data collected and analyzed.
    End point type
    Secondary
    End point timeframe
    One month after the first vaccination (Day 31) and pre-vaccination on Day 181
    Notes
    [45] - 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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    0 [46]
    0 [47]
    0 [48]
    0 [49]
    0 [50]
    0 [51]
    0 [52]
    Units: titer
    geometric mean (confidence interval 95%)
        Strain (A56): Day 31
    ( to )
    ( to )
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    ( to )
    ( to )
    ( to )
    ( to )
        Strain (A56): Day 181
    ( to )
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    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
        Strain (B44): Day 31
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
        Strain (B44): Day 181
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
        Strain (A10): Day 31
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
        Strain (A10): Day 181
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
        Strain (B79): Day 31
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
        Strain (B79): Day 181
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [46] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [47] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [48] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [49] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [50] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [51] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [52] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    No statistical analyses for this end point

    Secondary: Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Reference Strains of Meningococcal Serogroup B at Days 31 and 181

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    End point title
    		 Adolescents Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Reference Strains of Meningococcal Serogroup B at Days 31 and 181 [53]
    End point description
    The percentage of participants with antibody titers >=LLOQ against the reference strains of the meningococcal serogroup B was measured by hSBA. The 95% CI for the single percentage was based on the Clopper-Pearson method. The antibodies titer against reference strains of meningococcal serogroup B at Days 31 and 181 was not applicable. Therefore, no data collected and analyzed.
    End point type
    Secondary
    End point timeframe
    One month after the first vaccination (Day 31) and pre-vaccination on Day 181
    Notes
    [53] - 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 endpoint title, only adolescent participants were included in the analysis for this endpoint.
    End point values
    		 Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    0 [54]
    0 [55]
    0 [56]
    0 [57]
    0 [58]
    0 [59]
    0 [60]
    Units: percentage of participants
    number (confidence interval 95%)
        Strain (A56): Day 31
    ( to )
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        Strain (A56): Day 181
    ( to )
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        Strain (B44): Day 31
    ( to )
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        Strain (B44): Day 181
    ( to )
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        Strain (A10): Day 31
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        Strain (A10): Day 181
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        Strain (B79): Day 31
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    ( to )
    ( to )
    ( to )
    ( to )
        Strain (B79): Day 181
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [54] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [55] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [56] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [57] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [58] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [59] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [60] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Seroresponse Against Reference and Additional Strains of Meningococcal Serogroup B at Days 61 and 211

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    End point title
    		 Percentage of Participants With Seroresponse Against Reference and Additional Strains of Meningococcal Serogroup B at Days 61 and 211
    End point description
    The seroresponse was defined as a 4-fold increase in hSBA titers from pre-vaccination to post-vaccination. FAS3 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211, producing at least 1 result for the 19 strains of serogroup B. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints for adolescent groups; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Adults: 1 month after the second and third vaccination (Day 61 and Day 211, respectively); Adolescents: 1 month after the second vaccination (Day 211)
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    0 [61]
    0 [62]
    0 [63]
    0 [64]
    0 [65]
    0 [66]
    256
    263
    87
    84
    90
    88
    94
    Units: percentage of participants
    number (confidence interval 95%)
        Strain (A56):Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56):Day211(n=256,263,86,83,90,87,94)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    33.2 (27.5 to 39.3)
    45.2 (39.1 to 51.5)
    10.5 (4.9 to 18.9)
    85.5 (76.1 to 92.3)
    1.1 (0 to 6.0)
    35.6 (25.6 to 46.6)
    85.1 (76.3 to 91.6)
        Strain (B44): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 211(n=255,262,86,82,88,86,91)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    55.3 (49.0 to 61.5)
    65.6 (59.6 to 71.4)
    62.8 (51.7 to 73.0)
    80.5 (70.3 to 88.4)
    5.7 (1.9 to 12.8)
    65.1 (54.1 to 75.1)
    72.5 (62.2 to 81.4)
        Strain (A10): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10):Day 211(n=255,260,83,84,89,85,91)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    40.4 (34.3 to 46.7)
    43.1 (37.0 to 49.3)
    12.0 (5.9 to 21.0)
    0 (0 to 4.3)
    1.1 (0 to 6.1)
    55.3 (44.1 to 66.1)
    0 (0 to 4.0)
        Strain (B79): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79):Day 211(n=255,259,87,75,88,88,82)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    86.3 (81.4 to 90.2)
    89.2 (84.8 to 92.7)
    96.6 (90.3 to 99.3)
    14.7 (7.6 to 24.7)
    2.3 (0.3 to 8.0)
    96.6 (90.4 to 99.3)
    15.9 (8.7 to 25.6)
        Strain (B24): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B24): Day 211(n=129,133,44,41,46,40,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    23.3 (16.3 to 31.5)
    25.6 (18.4 to 33.8)
    97.7 (88.0 to 99.9)
    58.5 (42.1 to 73.7)
    0 (0 to 7.7)
    22.5 (10.8 to 38.5)
    99999 (-99999 to 99999)
        Strain (A22): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A22): Day 211(n=127,128,44,39,43,39,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    28.3 (20.7 to 37.0)
    31.3 (23.4 to 40.0)
    38.6 (24.4 to 54.5)
    66.7 (49.8 to 80.9)
    2.3 (0.1 to 12.3)
    17.9 (7.5 to 33.5)
    99999 (-99999 to 99999)
        Strain (A26): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A26): Day 211(n=116,128,40,37,39,36,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    97.4 (92.6 to 99.5)
    95.3 (90.1 to 98.3)
    97.5 (86.8 to 99.9)
    8.1 (1.7 to 21.9)
    5.1 (0.6 to 17.3)
    100 (90.3 to 100)
    99999 (-99999 to 99999)
        Strain (99-A10): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (99-A10): Day 211(n=117,118,41,39,44,35,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    96.6 (91.5 to 99.1)
    95.8 (90.4 to 98.6)
    97.6 (87.1 to 99.9)
    17.9 (7.5 to 33.5)
    2.3 (0.1 to 12.0)
    100 (90.0 to 100)
    99999 (-99999 to 99999)
        Strain (A07): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A07): Day 211(n=126,130,43,40,43,40,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    15.1 (9.3 to 22.5)
    26.9 (19.5 to 35.4)
    65.1 (49.1 to 79.0)
    12.5 (4.2 to 26.8)
    2.3 (0.1 to 12.3)
    7.5 (1.6 to 20.4)
    99999 (-99999 to 99999)
        Strain (B03): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B03): Day 211(n=126,131,42,39,43,40,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    52.4 (43.3 to 61.3)
    62.6 (53.7 to 70.9)
    90.5 (77.4 to 97.3)
    46.2 (30.1 to 62.8)
    2.3 (0.1 to 12.3)
    42.5 (27.0 to 59.1)
    99999 (-99999 to 99999)
        Strain (B09): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B09): Day 211(n=77,81,27,25,28,25,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    11.7 (5.5 to 21.0)
    21.0 (12.7 to 31.5)
    14.8 (4.2 to 33.7)
    12.0 (2.5 to 31.2)
    0 (0 to 12.3)
    20.0 (6.8 to 40.7)
    99999 (-99999 to 99999)
        Strain (A05): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A05): Day 211(n=72,76,25,25,26,18,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    36.1 (25.1 to 48.3)
    42.1 (30.9 to 54.0)
    8.0 (1.0 to 26.0)
    96.0 (79.6 to 99.9)
    0 (0 to 13.2)
    50.0 (26.0 to 74.0)
    99999 (-99999 to 99999)
        Strain (A12): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A12): Day 211(n=123,129,41,40,42,40,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    13.8 (8.3 to 21.2)
    21.7 (14.9 to 29.8)
    41.5 (26.3 to 57.9)
    42.5 (27.0 to 59.1)
    4.8 (0.6 to 16.2)
    17.5 (7.3 to 32.8)
    99999 (-99999 to 99999)
        Strain (A06): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A06): Day 211(n=121,125,41,36,42,38,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    23.1 (16.0 to 31.7)
    24.8 (17.5 to 33.3)
    24.4 (12.4 to 40.3)
    66.7 (49.0 to 81.4)
    2.4 (0.1 to 12.6)
    28.9 (15.4 to 45.9)
    99999 (-99999 to 99999)
        Strain (A15): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A15): Day 211(n=75,81,26,25,27,25,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    8.0 (3.0 to 16.6)
    9.9 (4.4 to 18.5)
    7.7 (0.9 to 25.1)
    32.0 (14.9 to 53.5)
    0 (0 to 12.8)
    16.0 (4.5 to 36.1)
    99999 (-99999 to 99999)
    Notes
    [61] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    [62] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    [63] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    [64] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    [65] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    [66] - No participants analyzed; seroresponse to strains of meningococcal serogroup B was not applicable.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:4 and >=1:8 Against Reference and Additional Strains of Meningococcal Serogroup B at Days 61 and 211

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    End point title
    		 Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:4 and >=1:8 Against Reference and Additional Strains of Meningococcal Serogroup B at Days 61 and 211
    End point description
    The percentage of participants with antibody titers >=1:4 and >=1:8 against the reference and additional strains of meningococcal serogroup B was measured by hSBA. The 95% CI for single percentage was based on the Clopper-Pearson method. FAS3 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211, producing at least 1 result for 19 strains of serogroup B. The percentages are rounded off to the tenth decimal place. S-A56= Strain (A56); S-B44= Strain (B44); S-A10= Strain (A10); S-B79= Strain (B79); S-B24= Strain (B24); S-A22= Strain (A22); S-A26= Strain (A26); S-99-A10= Strain (99-A10); S-A07= Strain (A07); S-B03= Strain (B03); S-B09= Strain (B09); S-A05= Strain (A05); S-A12= Strain (A12); S-A06= Strain (A06); S-A15= Strain (A15). Here, n= Number of participants analyzed for each serogroup at specific timepoints for adolescent groups; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Adults: 1 month after the second and third vaccination (Day 61 and Day 211, respectively); Adolescents: 1 month after the second vaccination (Day 211)
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    0 [67]
    0 [68]
    0 [69]
    0 [70]
    0 [71]
    0 [72]
    263
    267
    88
    85
    91
    88
    94
    Units: percentage of participants
    number (confidence interval 95%)
        S-A56: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A56: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A56: Day 211, >= 1:4(n=262,266,87,85,91,87,94)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    100 (98.6 to 100)
    100 (98.6 to 100)
    100 (95.8 to 100)
    100 (95.8 to 100)
    100 (96.0 to 100)
    100 (95.8 to 100)
    100 (96.2 to 100)
        S-A56: Day 211, >= 1:8(n=262,266,87,85,91,87,94)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    57.6 (51.4 to 63.7)
    66.2 (60.1 to 71.8)
    41.4 (30.9 to 52.4)
    96.5 (90.0 to 99.3)
    7.7 (3.1 to 15.2)
    54.0 (43.0 to 64.8)
    98.9 (94.2 to 100)
        S-B44: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-B44: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-B44: Day 211, >= 1:4(n=260,267,87,84,89,88,94)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    97.3 (94.5 to 98.9)
    99.6 (97.9 to 100)
    100 (95.8 to 100)
    100 (95.7 to 100)
    73.0 (62.6 to 81.9)
    98.9 (93.8 to 100)
    100 (96.2 to 100)
        S-B44: Day 211, >= 1:8(n=260,267,87,84,89,88,94)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    92.3 (88.4 to 95.2)
    97.4 (94.7 to 98.9)
    98.9 (93.8 to 100)
    98.8 (93.5 to 100)
    55.1 (44.1 to 65.6)
    96.6 (90.4 to 99.3)
    100 (96.2 to 100)
        S-A10: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A10: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A10: Day 211, >= 1:4(n=262,263,85,85,90,86,93)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    72.5 (66.7 to 77.8)
    80.6 (75.3 to 85.2)
    24.7 (16.0 to 35.3)
    4.7 (1.3 to 11.6)
    5.6 (1.8 to 12.5)
    86.0 (76.9 to 92.6)
    2.2 (0.3 to 7.6)
        S-A10: Day 211, >= 1:8(n=262,263,85,85,90,86,93)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    63.0 (56.8 to 68.8)
    69.6 (63.6 to 75.1)
    22.4 (14.0 to 32.7)
    2.4 (0.3 to 8.2)
    4.4 (1.2 to 11.0)
    79.1 (69.0 to 87.1)
    1.1 (0 to 5.8)
        S-B79: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-B79: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-B79: Day 211, >= 1:4(n=263,267,88,76,90,88,84)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    93.5 (89.9 to 96.2)
    97.8 (95.2 to 99.2)
    97.7 (92.0 to 99.7)
    34.2 (23.7 to 46.0)
    10.0 (4.7 to 18.1)
    98.9 (93.8 to 100)
    29.8 (20.3 to 40.7)
        S-B79: Day 211, >= 1:8(n=263,267,88,76,90,88,84)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    93.2 (89.4 to 95.9)
    97.8 (95.2 to 99.2)
    97.7 (92.0 to 99.7)
    34.2 (23.7 to 46.0)
    10.0 (4.7 to 18.1)
    98.9 (93.8 to 100)
    27.4 (18.2 to 38.2)
        S-B24: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-B24: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-B24: Day 211, >= 1:4(n=130,133,45,41,46,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    54.6 (45.7 to 63.4)
    57.1 (48.3 to 65.7)
    100 (92.1 to 100)
    92.7 (80.1 to 98.5)
    23.9 (12.6 to 38.8)
    53.7 (37.4 to 69.3)
    99999 (-99999 to 99999)
        S-B24: Day 211, >= 1:8(n=130,133,45,41,46,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    42.3 (33.7 to 51.3)
    50.4 (41.6 to 59.2)
    100 (92.1 to 100)
    87.8 (73.8 to 95.9)
    13.0 (4.9 to 26.3)
    46.3 (30.7 to 62.6)
    99999 (-99999 to 99999)
        S-A22: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A22: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A22: Day 211, >= 1:4(n=128,130,45,40,45,40,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    73.4 (64.9 to 80.9)
    79.2 (71.2 to 85.8)
    86.7 (73.2 to 94.9)
    92.5 (79.6 to 98.4)
    48.9 (33.7 to 64.2)
    80.0 (64.4 to 90.9)
    99999 (-99999 to 99999)
        S-A22: Day 211, >= 1:8(n=128,130,45,40,45,40,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    67.2 (58.3 to 75.2)
    73.1 (64.6 to 80.5)
    84.4 (70.5 to 93.5)
    92.5 (79.6 to 98.4)
    46.7 (31.7 to 62.1)
    72.5 (56.1 to 85.4)
    99999 (-99999 to 99999)
        S-A26: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A26: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A26:Day211,>= 1:4(n=122,130,43,39,42,40,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    100 (97.0 to 100)
    100 (97.2 to 100)
    100 (91.8 to 100)
    100 (91.0 to 100)
    100 (91.6 to 100)
    100 (91.2 to 100)
    99999 (-99999 to 99999)
        S-A26:Day211,>= 1:8(n=122,130,43,39,42,40,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    100 (97.0 to 100)
    99.2 (95.8 to 100)
    97.7 (87.7 to 99.9)
    43.6 (27.8 to 60.4)
    33.3 (19.6 to 49.5)
    100 (91.2 to 100)
    99999 (-99999 to 99999)
        S-99-A10: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-99-A10: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-99-A10:Day 211,>= 1:4(n=118,118,42,39,45,36,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99.2 (95.4 to 100)
    100 (96.9 to 100)
    97.6 (87.4 to 99.9)
    64.1 (47.2 to 78.8)
    20.0 (9.6 to 34.6)
    100 (90.3 to 100)
    99999 (-99999 to 99999)
        S-99-A10:Day 211,>= 1:8(n=118,118,42,39,45,36,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99.2 (95.4 to 100)
    100 (96.9 to 100)
    97.6 (87.4 to 99.9)
    64.1 (47.2 to 78.8)
    17.8 (8.0 to 32.1)
    100 (90.3 to 100)
    99999 (-99999 to 99999)
        S-A07: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A07: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A07: Day 211, >= 1:4(n=128,130,44,40,45,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    57.0 (48.0 to 65.7)
    66.9 (58.1 to 74.9)
    97.7 (88.0 to 99.9)
    55.0 (38.5 to 70.7)
    24.4 (12.9 to 39.5)
    39.0 (24.2 to 55.5)
    99999 (-99999 to 99999)
        S-A07: Day 211, >= 1:8(n=128,130,44,40,45,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    39.8 (31.3 to 48.9)
    53.8 (44.9 to 62.6)
    97.7 (88.0 to 99.9)
    40.0 (24.9 to 56.7)
    22.2 (11.2 to 37.1)
    24.4 (12.4 to 40.3)
    99999 (-99999 to 99999)
        S-B03: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-B03: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-B03: Day 211, >= 1:4(n=129,131,43,39,44,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    65.1 (56.2 to 73.3)
    78.6 (70.6 to 85.3)
    97.7 (87.7 to 99.9)
    64.1 (47.2 to 78.8)
    6.8 (1.4 to 18.7)
    65.9 (49.4 to 79.9)
    99999 (-99999 to 99999)
        S-B03: Day 211, >= 1:8(n=129,131,43,39,44,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    57.4 (48.4 to 66.0)
    71.8 (63.2 to 79.3)
    97.7 (87.7 to 99.9)
    61.5 (44.6 to 76.6)
    4.5 (0.6 to 15.5)
    51.2 (35.1 to 67.1)
    99999 (-99999 to 99999)
        S-B09: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-B09: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-B09: Day 211, >= 1:4(n=78,81,27,25,29,26,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    100 (95.4 to 100)
    100 (95.5 to 100)
    100 (87.2 to 100)
    100 (86.3 to 100)
    100 (88.1 to 100)
    100 (86.8 to 100)
    99999 (-99999 to 99999)
        S-B09: Day 211, >= 1:8(n=78,81,27,25,29,26,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    23.1 (14.3 to 34.0)
    33.3 (23.2 to 44.7)
    44.4 (25.5 to 64.7)
    40.0 (21.1 to 61.3)
    6.9 (0.8 to 22.8)
    34.6 (17.2 to 55.7)
    99999 (-99999 to 99999)
        S-A05: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A05: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A05:Day 211,>= 1:4(n=77,78,26,26,29,24,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    100 (95.3 to 100)
    100 (95.4 to 100)
    100 (86.8 to 100)
    100 (86.8 to 100)
    100 (88.1 to 100)
    100 (85.8 to 100)
    99999 (-99999 to 99999)
        S-A05:Day 211,>= 1:8(n=77,78,26,26,29,24,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    63.6 (51.9 to 74.3)
    71.8 (60.5 to 81.4)
    50.0 (29.9 to 70.1)
    100 (86.8 to 100)
    20.7 (8.0 to 39.7)
    75.0 (53.3 to 90.2)
    99999 (-99999 to 99999)
        S-A12: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A12: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A12: Day 211, >= 1:4(n=126,129,42,40,43,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    82.5 (74.8 to 88.7)
    82.9 (75.3 to 89.0)
    95.2 (83.8 to 99.4)
    95.0 (83.1 to 99.4)
    72.1 (56.3 to 84.7)
    90.2 (76.9 to 97.3)
    99999 (-99999 to 99999)
        S-A12: Day 211, >= 1:8(n=126,129,42,40,43,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    70.6 (61.9 to 78.4)
    74.4 (66.0 to 81.7)
    90.5 (77.4 to 97.3)
    90.0 (76.3 to 97.2)
    60.5 (44.4 to 75.0)
    78.0 (62.4 to 89.4)
    99999 (-99999 to 99999)
        S-A06: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A06: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A06: Day 211, >= 1:4(n=124,125,42,36,44,39,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    100 (97.1 to 100)
    100 (97.1 to 100)
    100 (91.6 to 100)
    100 (90.3 to 100)
    100 (92.0 to 100)
    100 (91.0 to 100)
    99999 (-99999 to 99999)
        S-A06: Day 211, >= 1:8(n=124,125,42,36,44,39,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    36.3 (27.8 to 45.4)
    43.2 (34.4 to 52.4)
    47.6 (32.0 to 63.6)
    83.3 (67.2 to 93.6)
    15.9 (6.6 to 30.1)
    43.6 (27.8 to 60.4)
    99999 (-99999 to 99999)
        S-A15: Day 61, >= 1:4(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A15: Day 61, >= 1:8(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        S-A15: Day 211, >= 1:4(n=78,81,27,25,29,26,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    100 (95.4 to 100)
    100 (95.5 to 100)
    100 (87.2 to 100)
    100 (86.3 to 100)
    100 (88.1 to 100)
    100 (86.8 to 100)
    99999 (-99999 to 99999)
        S-A15: Day 211, >= 1:8(n=78,81,27,25,29,26,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    30.8 (20.8 to 42.2)
    34.6 (24.3 to 46.0)
    44.4 (25.5 to 64.7)
    80.0 (59.3 to 93.2)
    24.1 (10.3 to 43.5)
    42.3 (23.4 to 63.1)
    99999 (-99999 to 99999)
    Notes
    [67] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [68] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [69] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [70] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [71] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [72] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Antibodies Against Reference and Additional Strains of Meningococcal Serogroup B at Days 61 and 211

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    End point title
    		 Geometric Mean Titers of Antibodies Against Reference and Additional Strains of Meningococcal Serogroup B at Days 61 and 211
    End point description
    The antibodies titer against the reference and additional strains of the meningococcal serogroup B was measured by hSBA and the results were expressed as GMT. The 95% CI for the single percentage was based on the Clopper-Pearson method. FAS3 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211, producing at least 1 result for the 19 strains of serogroup B. Here, n= Number of participants analyzed for each serogroup at specific timepoints for adolescent groups; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Adults: 1 month after the second and third vaccination (Day 61 and Day 211, respectively); Adolescents: 1 month after the second vaccination (Day 211)
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    0 [73]
    0 [74]
    0 [75]
    0 [76]
    0 [77]
    0 [78]
    263
    267
    88
    85
    91
    88
    94
    Units: titer
    geometric mean (confidence interval 95%)
        Strain (A56):Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56):Day211(n=262,266,87,85,91,87,94)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    21.2 (17.3 to 25.9)
    33.1 (26.6 to 41.0)
    9.00 (7.35 to 11.0)
    107 (84.2 to 137)
    5.18 (4.64 to 5.78)
    19.6 (13.9 to 27.6)
    119 (94.8 to 149)
        Strain (B44): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 211(n=260,267,87,84,89,88,94)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    57.1 (48.0 to 67.9)
    79.4 (67.9 to 93.0)
    52.8 (43.4 to 64.3)
    111 (88.0 to 140)
    9.90 (7.44 to 13.2)
    78.0 (58.6 to 104)
    111 (93.7 to 132)
        Strain (A10): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10):Day 211(n=262,263,85,85,90,86,93)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    13.9 (11.6 to 16.6)
    17.5 (14.7 to 20.9)
    4.57 (3.51 to 5.94)
    2.65 (2.49 to 2.81)
    2.87 (2.51 to 3.29)
    25.5 (18.6 to 34.9)
    2.56 (2.48 to 2.64)
        Strain (B79): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79):Day 211(n=263,267,88,76,90,88,84)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    209 (168 to 260)
    267 (222 to 322)
    584 (444 to 769)
    7.79 (5.78 to 10.5)
    4.30 (3.73 to 4.95)
    516 (371 to 717)
    6.84 (5.29 to 8.83)
        Strain (B24): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B24): Day 211(n=130,133,45,41,46,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    9.24 (7.29 to 11.7)
    10.5 (8.15 to 13.5)
    347 (250 to 480)
    36.0 (23.5 to 55.0)
    4.27 (3.39 to 5.40)
    10.7 (6.59 to 17.4)
    99999 (-99999 to 99999)
        Strain (A22): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A22): Day 211(n=128,130,45,40,45,40,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    18.1 (13.8 to 23.7)
    24.0 (18.3 to 31.4)
    30.9 (20.6 to 46.4)
    46.7 (31.8 to 68.5)
    9.75 (6.18 to 15.4)
    19.2 (12.7 to 29.2)
    99999 (-99999 to 99999)
        Strain (A26): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A26): Day 211(n=122,130,43,39,42,40,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    2670 (2003 to 3561)
    2650 (2024 to 3469)
    4926 (2944 to 8241)
    16.9 (10.1 to 28.3)
    10.9 (7.12 to 16.7)
    3934 (2586 to 5986)
    99999 (-99999 to 99999)
        Strain (99-A10): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (99-A10): Day 211(n=118,118,42,39,45,36,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    529 (408 to 685)
    552 (448 to 680)
    917 (647 to 1301)
    14.7 (9.60 to 22.6)
    5.55 (4.00 to 7.70)
    813 (538 to 1230)
    99999 (-99999 to 99999)
        Strain (A07): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A07): Day 211(n=128,130,44,40,45,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    6.99 (5.68 to 8.60)
    10.1 (8.05 to 12.6)
    34.8 (25.2 to 48.1)
    7.26 (4.88 to 10.8)
    4.03 (2.98 to 5.46)
    5.05 (3.56 to 7.16)
    99999 (-99999 to 99999)
        Strain (B03): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B03): Day 211(n=129,131,43,39,44,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    15.1 (11.0 to 20.7)
    25.1 (18.5 to 34.0)
    51.5 (37.2 to 71.3)
    11.0 (6.65 to 18.3)
    2.23 (1.96 to 2.54)
    13.9 (7.58 to 25.5)
    99999 (-99999 to 99999)
        Strain (B09): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B09): Day 211(n=78,81,27,25,29,26,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    8.27 (6.60 to 10.4)
    12.0 (8.82 to 16.3)
    11.4 (7.17 to 18.2)
    10.0 (6.56 to 15.3)
    6.00 (4.46 to 8.09)
    12.1 (6.81 to 21.5)
    99999 (-99999 to 99999)
        Strain (A05): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A05): Day 211(n=77,78,26,26,29,24,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    22.0 (14.8 to 32.8)
    33.9 (21.9 to 52.4)
    9.72 (6.40 to 14.8)
    149 (105 to 210)
    6.04 (4.05 to 9.00)
    37.4 (18.1 to 77.3)
    99999 (-99999 to 99999)
        Strain (A12): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A12): Day 211(n=126,129,42,40,43,41,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    17.1 (13.6 to 21.4)
    20.2 (15.7 to 26.0)
    37.7 (26.4 to 53.9)
    39.2 (26.3 to 58.5)
    13.3 (8.42 to 21.1)
    19.5 (13.7 to 27.9)
    99999 (-99999 to 99999)
        Strain (A06): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A06): Day 211(n=124,125,42,36,44,39,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    13.5 (10.6 to 17.2)
    17.4 (13.2 to 22.8)
    14.7 (10.2 to 21.3)
    67.3 (41.2 to 110)
    7.52 (5.81 to 9.74)
    16.5 (10.3 to 26.5)
    99999 (-99999 to 99999)
        Strain (A15): Day 61(n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A15): Day 211(n=78,81,27,25,29,26,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    7.90 (6.30 to 9.90)
    8.85 (6.90 to 11.3)
    8.72 (6.16 to 12.3)
    23.1 (14.2 to 37.5)
    6.17 (4.83 to 7.88)
    9.27 (6.12 to 14.0)
    99999 (-99999 to 99999)
    Notes
    [73] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [74] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [75] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [76] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [77] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [78] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Human Complement Serum Bactericidal Assay Composite >=Lower Limit of Quantification Against Reference and Additional Strains of Meningococcal Serogroup B at Days 61 and 211

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    End point title
    		 Percentage of Participants With Human Complement Serum Bactericidal Assay Composite >=Lower Limit of Quantification Against Reference and Additional Strains of Meningococcal Serogroup B at Days 61 and 211
    End point description
    The percentage of participants with antibody titers >=LLOQ against the reference and additional strains of the meningococcal serogroup B was measured by hSBA. The 95% CI for the single percentage was based on the Clopper-Pearson method. FAS3 – adolescents included participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211, producing at least 1 result for the 19 strains of serogroup B. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints for adolescent groups; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Adults: 1 month after the second and third vaccination (Day 61 and Day 211, respectively); Adolescents: 1 month after the second vaccination (Day 211)
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 5: MenQuadfi Adolescents - Group 6: Sanofi MenB Adolescents - Group 7: PENBRAYA
    Number of subjects analysed
    0 [79]
    0 [80]
    0 [81]
    0 [82]
    0 [83]
    0 [84]
    68
    64
    24
    17
    23
    20
    0 [85]
    Units: percentage of participants
    number (confidence interval 95%)
        Day 61 (n=0,0,0,0,0,0,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    ( to )
        Day 211 (n=68,64,24,17,23,20,0)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    8.8 (3.3 to 18.2)
    15.6 (7.8 to 26.9)
    16.7 (4.7 to 37.4)
    0 (0 to 19.5)
    0 (0 to 14.8)
    15.0 (3.2 to 37.9)
    ( to )
    Notes
    [79] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [80] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [81] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [82] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [83] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [84] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    [85] - No participants analyzed;antibodies titer to strains of meningococcal serogroupB was not applicable.
    No statistical analyses for this end point

    Secondary: Adults Only: Percentage of Participants With Seroresponse Against Meningococcal Serogroups A, C, W and Y Strains at Days 1, 31, 61, 181 and 211

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    End point title
    		 Adults Only: Percentage of Participants With Seroresponse Against Meningococcal Serogroups A, C, W and Y Strains at Days 1, 31, 61, 181 and 211 [86]
    End point description
    The seroresponse was defined as post-vaccination titers >=1:16 for participants with pre-vaccination hSBA titers <1:4, or post-vaccination titers >=4 times the pre-vaccination titer for participants with a pre-vaccination titer >= the LLOQ. The LLOQ was a titer of 1:4, and it is the same as the LOD for the meningococcal serogroups A, C, W and Y hSBA assay. Day 31 (FAS1–adults): Participants who were vaccinated per protocol at Day 1 and had 1 valid post-vaccination blood sample at Day 31. Day 61 (FAS2–adults): Participants who were vaccinated per protocol at Days 1 and 31, and had 1 valid post-vaccination blood sample at Day 61. Days 181 and 211 (FAS3–adults): Participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Days 1, 31 and 181 and 1 month after second and third vaccination (Day 61 and Day 211, respectively)
    Notes
    [86] - 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 endpoint title, only adult participants were included in the analysis for this endpoint.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB
    Number of subjects analysed
    13
    13
    16
    12
    16
    16
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A: Day 31 (n=2,3,4,2,1,4)
    50.0 (1.3 to 98.7)
    66.7 (9.4 to 99.2)
    100 (39.8 to 100)
    100 (15.8 to 100)
    100 (2.5 to 100)
    100 (39.8 to 100)
        Serogroup A: Day 61 (n=3,1,0,3,0,3)
    100 (29.2 to 100)
    100 (2.5 to 100)
    99999 (-99999 to 99999)
    66.7 (9.4 to 99.2)
    99999 (-99999 to 99999)
    100 (29.2 to 100)
        Serogroup A: Day 181 (n=10,11,9,8,11,8)
    60.0 (26.2 to 87.8)
    63.6 (30.8 to 89.1)
    66.7 (29.9 to 92.5)
    75.0 (34.9 to 96.8)
    72.7 (39.0 to 94.0)
    75.0 (34.9 to 96.8)
        Serogroup A: Day 211 (n=11,11,16,12,15,13)
    100 (71.5 to 100)
    100 (71.5 to 100)
    68.8 (41.3 to 89.0)
    50.0 (21.1 to 78.9)
    86.7 (59.5 to 98.3)
    100 (75.3 to 100)
        Serogroup C: Day 31 (n=1,3,5,5,4,10)
    100 (2.5 to 100)
    66.7 (9.4 to 99.2)
    100 (47.8 to 100)
    100 (47.8 to 100)
    100 (39.8 to 100)
    40.0 (12.2 to 73.8)
        Serogroup C: Day 61 (n=5,2,5,4,5,6)
    100 (47.8 to 100)
    100 (15.8 to 100)
    100 (47.8 to 100)
    100 (39.8 to 100)
    100 (47.8 to 100)
    83.3 (35.9 to 99.6)
        Serogroup C: Day 181 (n=9,13,13,8,13,9)
    100 (66.4 to 100)
    92.3 (64.0 to 99.8)
    92.3 (64.0 to 99.8)
    87.5 (47.3 to 99.7)
    69.2 (38.6 to 90.9)
    33.3 (7.5 to 70.1)
        Serogroup C: Day 211 (n=11,12,15,11,16,15)
    100 (71.5 to 100)
    91.7 (61.5 to 99.8)
    60.0 (32.3 to 83.7)
    81.8 (48.2 to 97.7)
    93.8 (69.8 to 99.8)
    73.3 (44.9 to 92.2)
        Serogroup W: Day 31 (n=1,2,3,2,1,3)
    100 (2.5 to 100)
    100 (15.8 to 100)
    100 (29.2 to 100)
    50.0 (1.3 to 98.7)
    100 (2.5 to 100)
    0 (0 to 70.8)
        Serogroup W: Day 61 (n=2,1,0,1,0,3)
    100 (15.8 to 100)
    100 (2.5 to 100)
    99999 (-99999 to 99999)
    100 (2.5 to 100)
    99999 (-99999 to 99999)
    0 (0 to 70.8)
        Serogroup W: Day 181 (n=10,11,11,11,14,16)
    90.0 (55.5 to 99.7)
    72.7 (39.0 to 94.0)
    36.4 (10.9 to 69.2)
    72.7 (39.0 to 94.0)
    85.7 (57.2 to 98.2)
    6.3 (0.2 to 30.2)
        Serogroup W: Day 211 (n=12,12,15,12,16,15)
    91.7 (61.5 to 99.8)
    91.7 (61.5 to 99.8)
    53.3 (26.6 to 78.7)
    83.3 (51.6 to 97.9)
    93.8 (69.8 to 99.8)
    26.7 (7.8 to 55.1)
        Serogroup Y: Day 31 (n=2,1,4,3,4,10)
    100 (15.8 to 100)
    100 (2.5 to 100)
    100 (39.8 to 100)
    100 (29.2 to 100)
    75.0 (19.4 to 99.4)
    0 (0 to 30.8)
        Serogroup Y: Day 61 (n=1,0,0,2,0,3)
    100 (2.5 to 100)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    50.0 (1.3 to 98.7)
    99999 (-99999 to 99999)
    0 (0 to 70.8)
        Serogroup Y: Day 181 (n=3,3,5,2,5,7)
    100 (29.2 to 100)
    66.7 (9.4 to 99.2)
    40.0 (5.3 to 85.3)
    50.0 (1.3 to 98.7)
    80.0 (28.4 to 99.5)
    0 (0 to 41.0)
        Serogroup Y: Day 211 (n=13,12,14,11,15,16)
    92.3 (64.0 to 99.8)
    100 (73.5 to 100)
    50.0 (23.0 to 77.0)
    90.9 (58.7 to 99.8)
    93.3 (68.1 to 99.8)
    6.3 (0.2 to 30.2)
    No statistical analyses for this end point

    Secondary: Adults Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:8 Against Meningococcal Serogroups A, C, W and Y Strains at Days 1, 31, 61, 181 and 211

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    End point title
    		 Adults Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:8 Against Meningococcal Serogroups A, C, W and Y Strains at Days 1, 31, 61, 181 and 211 [87]
    End point description
    The percentage of participants with antibody titers >=1:8 against meningococcal serogroups A, C, W and Y was measured by hSBA. The 95% CI for the single percentage was based on the Clopper-Pearson method. Day 31 (FAS1–adults): Participants who were vaccinated per protocol at Day 1 and had 1 valid post-vaccination blood sample at Day 31. Day 61 (FAS2–adults): Participants who were vaccinated per protocol at Days 1 and 31, and had 1 valid post-vaccination blood sample at Day 61. Days 181 and 211 (FAS3–adults): Participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Days 1, 31 and 181 and 1 month after second and third vaccination (Day 61 and Day 211, respectively)
    Notes
    [87] - 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 endpoint title, only adult participants were included in the analysis for this endpoint.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB
    Number of subjects analysed
    16
    15
    17
    14
    18
    16
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A: Day 1 (n=5,8,8,8,7,12)
    100 (47.8 to 100)
    87.5 (47.3 to 99.7)
    62.5 (24.5 to 91.5)
    75.0 (34.9 to 96.8)
    71.4 (29.0 to 96.3)
    58.3 (27.7 to 84.8)
        Serogroup A: Day 31 (n=2,3,4,2,1,4)
    50.0 (1.3 to 98.7)
    100 (29.2 to 100)
    100 (39.8 to 100)
    100 (15.8 to 100)
    100 (2.5 to 100)
    100 (39.8 to 100)
        Serogroup A: Day 61 (n=3,1,0,3,0,3)
    100 (29.2 to 100)
    100 (2.5 to 100)
    99999 (-99999 to 99999)
    100 (29.2 to 100)
    99999 (-99999 to 99999)
    100 (29.2 to 100)
        Serogroup A: Day 181 (n=11,12,10,8,12,8)
    90.9 (58.7 to 99.8)
    100 (73.5 to 100)
    100 (69.2 to 100)
    100 (63.1 to 100)
    100 (73.5 to 100)
    100 (63.1 to 100)
        Serogroup A: Day 211 (n=12,12,17,12,15,14)
    100 (73.5 to 100)
    100 (73.5 to 100)
    100 (80.5 to 100)
    91.7 (61.5 to 99.8)
    100 (78.2 to 100)
    100 (76.8 to 100)
        Serogroup C: Day 1 (n=2,6,7,7,8,13)
    0 (0 to 84.2)
    50.0 (11.8 to 88.2)
    71.4 (29.0 to 96.3)
    57.1 (18.4 to 90.1)
    50.0 (15.7 to 84.3)
    15.4 (1.9 to 45.4)
        Serogroup C: Day 31 (n=2,4,6,5,4,10)
    100 (15.8 to 100)
    100 (39.8 to 100)
    100 (54.1 to 100)
    100 (47.8 to 100)
    100 (39.8 to 100)
    70.0 (34.8 to 93.3)
        Serogroup C: Day 61 (n=5,3,6,5,5,6)
    100 (47.8 to 100)
    100 (29.2 to 100)
    100 (54.1 to 100)
    100 (47.8 to 100)
    100 (47.8 to 100)
    83.3 (35.9 to 99.6)
        Serogroup C: Day 181 (n=9,14,14,9,13,9)
    100 (66.4 to 100)
    100 (76.8 to 100)
    100 (76.8 to 100)
    88.9 (51.8 to 99.7)
    100 (75.3 to 100)
    66.7 (29.9 to 92.5)
        Serogroup C: Day 211 (n=12,12,16,12,16,15)
    100 (73.5 to 100)
    100 (73.5 to 100)
    93.8 (69.8 to 99.8)
    91.7 (61.5 to 99.8)
    100 (79.4 to 100)
    93.3 (68.1 to 99.8)
        Serogroup W: Day 1 (n=5,7,8,7,7,13)
    20.0 (0.5 to 71.6)
    57.1 (18.4 to 90.1)
    75.0 (34.9 to 96.8)
    57.1 (18.4 to 90.1)
    57.1 (18.4 to 90.1)
    23.1 (5.0 to 53.8)
        Serogroup W: Day 31 (n=1,2,3,2,2,3)
    100 (2.5 to 100)
    100 (15.8 to 100)
    100 (29.2 to 100)
    100 (15.8 to 100)
    100 (15.8 to 100)
    0 (0 to 70.8)
        Serogroup W: Day 61 (n=3,2,0,1,1,3)
    100 (29.2 to 100)
    100 (15.8 to 100)
    99999 (-99999 to 99999)
    100 (2.5 to 100)
    100 (2.5 to 100)
    66.7 (9.4 to 99.2)
        Serogroup W: Day 181 (n=12,12,13,12,16,16)
    100 (73.5 to 100)
    91.7 (61.5 to 99.8)
    100 (75.3 to 100)
    91.7 (61.5 to 99.8)
    100 (79.4 to 100)
    50.0 (24.7 to 75.3)
        Serogroup W: Day 211 (n=13,12,17,12,16,15)
    100 (75.3 to 100)
    100 (73.5 to 100)
    100 (80.5 to 100)
    100 (73.5 to 100)
    100 (79.4 to 100)
    60.0 (32.3 to 83.7)
        Serogroup Y: Day 1 (n=3,5,7,6,7,13)
    33.3 (0.8 to 90.6)
    40.0 (5.3 to 85.3)
    71.4 (29.0 to 96.3)
    50.0 (11.8 to 88.2)
    28.6 (3.7 to 71.0)
    15.4 (1.9 to 45.4)
        Serogroup Y: Day 31 (n=3,2,5,5,4,10)
    100 (29.2 to 100)
    100 (15.8 to 100)
    100 (47.8 to 100)
    100 (47.8 to 100)
    100 (39.8 to 100)
    10.0 (0.3 to 44.5)
        Serogroup Y: Day 61 (n=1,1,0,2,1,3)
    100 (2.5 to 100)
    100 (2.5 to 100)
    99999 (-99999 to 99999)
    100 (15.8 to 100)
    100 (2.5 to 100)
    33.3 (0.8 to 90.6)
        Serogroup Y: Day 181 (n=6,5,6,4,6,7)
    100 (54.1 to 100)
    100 (47.8 to 100)
    100 (54.1 to 100)
    100 (39.8 to 100)
    100 (54.1 to 100)
    28.6 (3.7 to 71.0)
        Serogroup Y: Day 211 (n=16,15,17,14,18,16)
    100 (79.4 to 100)
    100 (78.2 to 100)
    94.1 (71.3 to 99.9)
    100 (76.8 to 100)
    100 (81.5 to 100)
    25.0 (7.3 to 52.4)
    No statistical analyses for this end point

    Secondary: Adults Only: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W and Y Strains at Days 1, 31, 61, 181 and 211

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    End point title
    		 Adults Only: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W and Y Strains at Days 1, 31, 61, 181 and 211 [88]
    End point description
    The antibodies titer against meningococcal serogroups A, C, W and Y was measured by hSBA and the results were expressed as GMT. The 95% CI for the single percentage was based on the Clopper-Pearson method. Day 31 (FAS1–adults): Participants who were vaccinated per protocol at Day 1 and had 1 valid post-vaccination blood sample at Day 31. Day 61 (FAS2–adults): Participants who were vaccinated per protocol at Days 1 and 31, and had 1 valid post-vaccination blood sample at Day 61. Days 181 and 211 (FAS3–adults): Participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. Here, n= Number of participants analyzed for each serogroup at specific timepoints; -9999 and 9999= The 95% CI was not computed, if number analyzed was <=5 or standard deviation was 0; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Days 1, 31 and 181 and 1 month after second and third vaccination (Day 61 and Day 211, respectively)
    Notes
    [88] - 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 endpoint title, only adult participants were included in the analysis for this endpoint.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB
    Number of subjects analysed
    16
    15
    17
    14
    18
    16
    Units: titer
    geometric mean (confidence interval 95%)
        Serogroup A: Day 1 (n=5,8,8,8,7,12)
    10.6 (-9999 to 9999)
    24.7 (8.86 to 68.7)
    14.7 (4.02 to 53.5)
    22.6 (5.29 to 96.7)
    14.5 (4.15 to 50.6)
    8.48 (4.05 to 17.7)
        Serogroup A: Day 31 (n=2,3,4,2,1,4)
    8.00 (-9999 to 9999)
    256 (-9999 to 9999)
    256 (-9999 to 9999)
    45.3 (-9999 to 9999)
    256 (-9999 to 9999)
    45.3 (-9999 to 9999)
        Serogroup A: Day 61 (n=3,1,0,3,0,3)
    323 (-9999 to 9999)
    512 (-9999 to 9999)
    99999 (-99999 to 99999)
    64.0 (-9999 to 9999)
    99999 (-99999 to 99999)
    102 (-9999 to 9999)
        Serogroup A: Day 181 (n=11,12,10,8,12,8)
    77.3 (22.5 to 265)
    95.9 (44.8 to 205)
    59.7 (31.5 to 113)
    140 (30.2 to 645)
    60.4 (25.8 to 141)
    58.7 (33.0 to 104)
        Serogroup A: Day 211 (n=12,12,17,12,15,14)
    1722 (685 to 4332)
    1085 (474 to 2484)
    157 (67.6 to 365)
    53.8 (19.5 to 148)
    140 (66.2 to 298)
    2048 (879 to 4769)
        Serogroup C: Day 1 (n=2,6,7,7,8,13)
    2.00 (-9999 to 9999)
    8.98 (1.90 to 42.5)
    14.5 (3.55 to 59.1)
    6.56 (2.20 to 19.6)
    10.4 (3.41 to 31.6)
    4.45 (2.30 to 8.60)
        Serogroup C: Day 31 (n=2,4,6,5,4,10)
    45.3 (-9999 to 9999)
    215 (-9999 to 9999)
    724 (486 to 1078)
    512 (-9999 to 9999)
    256 (-9999 to 9999)
    14.9 (4.93 to 45.2)
        Serogroup C: Day 61 (n=5,3,6,5,5,6)
    676 (-9999 to 9999)
    203 (-9999 to 9999)
    203 (56.8 to 726)
    388 (-9999 to 9999)
    588 (-9999 to 9999)
    35.9 (6.66 to 194)
        Serogroup C: Day 181 (n=9,14,14,9,13,9)
    219 (99.7 to 483)
    312 (165 to 590)
    122 (52.7 to 281)
    87.1 (22.9 to 331)
    207 (88.9 to 481)
    13.7 (4.32 to 43.5)
        Serogroup C: Day 211 (n=12,12,16,12,16,15)
    912 (558 to 1490)
    724 (266 to 1973)
    76.1 (30.6 to 189)
    85.4 (28.8 to 253)
    450 (214 to 944)
    80.6 (32.7 to 199)
        Serogroup W: Day 1 (n=5,7,8,7,7,13)
    2.64 (-9999 to 9999)
    16.0 (2.18 to 117)
    17.4 (4.02 to 75.7)
    10.8 (2.86 to 40.6)
    11.9 (2.85 to 49.5)
    4.22 (2.02 to 8.80)
        Serogroup W: Day 31 (n=1,2,3,2,2,3)
    1024 (-9999 to 9999)
    512 (-9999 to 9999)
    512 (-9999 to 9999)
    181 (-9999 to 9999)
    362 (-9999 to 9999)
    2.52 (-9999 to 9999)
        Serogroup W: Day 61 (n=3,2,0,1,1,3)
    203 (-9999 to 9999)
    724 (-9999 to 9999)
    99999 (-99999 to 99999)
    64.0 (-9999 to 9999)
    128 (-9999 to 9999)
    6.35 (-9999 to 9999)
        Serogroup W: Day 181 (n=12,12,13,12,16,16)
    228 (96.8 to 537)
    108 (35.9 to 322)
    93.0 (46.3 to 187)
    102 (39.5 to 261)
    123 (58.2 to 258)
    5.91 (3.05 to 11.4)
        Serogroup W: Day 211 (n=13,12,17,12,16,15)
    436 (195 to 976)
    384 (127 to 1155)
    163 (70.2 to 380)
    136 (68.1 to 270)
    378 (195 to 732)
    8.77 (4.08 to 18.9)
        Serogroup Y: Day 1 (n=3,5,7,6,7,13)
    3.17 (-9999 to 9999)
    6.06 (-9999 to 9999)
    23.8 (3.62 to 156)
    10.1 (1.13 to 90.1)
    6.56 (1.45 to 29.8)
    3.06 (1.63 to 5.75)
        Serogroup Y: Day 31 (n=3,2,5,5,4,10)
    203 (-9999 to 9999)
    181 (-9999 to 9999)
    588 (-9999 to 9999)
    294 (-9999 to 9999)
    304 (-9999 to 9999)
    3.25 (1.75 to 6.04)
        Serogroup Y: Day 61 (n=1,1,0,2,1,3)
    128 (-9999 to 9999)
    1024 (-9999 to 9999)
    99999 (-99999 to 99999)
    362 (-9999 to 9999)
    256 (-9999 to 9999)
    4.00 (-9999 to 9999)
        Serogroup Y: Day 181 (n=6,5,6,4,6,7)
    181 (23.4 to 1398)
    294 (-9999 to 9999)
    128 (26.0 to 630)
    215 (-9999 to 9999)
    181 (35.0 to 936)
    3.62 (1.42 to 9.26)
        Serogroup Y: Day 211 (n=16,15,17,14,18,16)
    724 (409 to 1283)
    371 (185 to 741)
    128 (52.5 to 312)
    256 (99.8 to 657)
    310 (165 to 585)
    4.97 (1.98 to 12.5)
    No statistical analyses for this end point

    Secondary: Adults Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Meningococcal Serogroups A, C, W and Y Strains at Days 1, 31, 61, 181 and 211

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    End point title
    		 Adults Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Meningococcal Serogroups A, C, W and Y Strains at Days 1, 31, 61, 181 and 211 [89]
    End point description
    The percentage of participants with antibody titers >=LLOQ against meningococcal serogroups A, C, W and Y was measured by hSBA. The LLOQ was a titer of 1:4, and it is the same as the LOD for the meningococcal serogroups A, C, W and Y hSBA assay. The 95% CI for the single percentage was based on the Clopper-Pearson method. Day 31 (FAS1–adults): Participants who were vaccinated per protocol at Day 1 and had 1 valid post-vaccination blood sample at Day 31. Day 61 (FAS2–adults): Participants who were vaccinated per protocol at Days 1 and 31, and had 1 valid post-vaccination blood sample at Day 61. Days 181 and 211 (FAS3–adults): Participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Days 1, 31 and 181 and 1 month after second and third vaccination (Day 61 and Day 211, respectively)
    Notes
    [89] - 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 endpoint title, only adult participants were included in the analysis for this endpoint.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB
    Number of subjects analysed
    16
    15
    17
    14
    18
    16
    Units: percentage of participants
    number (confidence interval 95%)
        Serogroup A: Day 1 (n=5,8,8,8,7,12)
    100 (47.8 to 100)
    87.5 (47.3 to 99.7)
    75.0 (34.9 to 96.8)
    100 (63.1 to 100)
    85.7 (42.1 to 99.6)
    83.3 (51.6 to 97.9)
        Serogroup A: Day 31 (n=2,3,4,2,1,4)
    50.0 (1.3 to 98.7)
    100 (29.2 to 100)
    100 (39.8 to 100)
    100 (15.8 to 100)
    100 (2.5 to 100)
    100 (39.8 to 100)
        Serogroup A: Day 61 (n=3,1,0,3,0,3)
    100 (29.2 to 100)
    100 (2.5 to 100)
    99999 (-99999 to 99999)
    100 (29.2 to 100)
    99999 (-99999 to 99999)
    100 (29.2 to 100)
        Serogroup A: Day 181 (n=11,12,10,8,12,8)
    90.9 (58.7 to 99.8)
    100 (73.5 to 100)
    100 (69.2 to 100)
    100 (63.1 to 100)
    100 (73.5 to 100)
    100 (63.1 to 100)
        Serogroup A: Day 211 (n=12,12,17,12,15,14)
    100 (73.5 to 100)
    100 (73.5 to 100)
    100 (80.5 to 100)
    91.7 (61.5 to 99.8)
    100 (78.2 to 100)
    100 (76.8 to 100)
        Serogroup C: Day 1 (n=2,6,7,7,8,13)
    0 (0 to 84.2)
    66.7 (22.3 to 95.7)
    71.4 (29.0 to 96.3)
    71.4 (29.0 to 96.3)
    87.5 (47.3 to 99.7)
    69.2 (38.6 to 90.9)
        Serogroup C: Day 31 (n=2,4,6,5,4,10)
    100 (15.8 to 100)
    100 (39.8 to 100)
    100 (54.1 to 100)
    100 (47.8 to 100)
    100 (39.8 to 100)
    90.0 (55.5 to 99.7)
        Serogroup C: Day 61 (n=5,3,6,5,5,6)
    100 (47.8 to 100)
    100 (29.2 to 100)
    100 (54.1 to 100)
    100 (47.8 to 100)
    100 (47.8 to 100)
    100 (54.1 to 100)
        Serogroup C: Day 181 (n=9,14,14,9,13,9)
    100 (66.4 to 100)
    100 (76.8 to 100)
    100 (76.8 to 100)
    88.9 (51.8 to 99.7)
    100 (75.3 to 100)
    77.8 (40.0 to 97.2)
        Serogroup C: Day 211 (n=12,12,16,12,16,15)
    100 (73.5 to 100)
    100 (73.5 to 100)
    100 (79.4 to 100)
    91.7 (61.5 to 99.8)
    100 (79.4 to 100)
    100 (78.2 to 100)
        Serogroup W: Day 1 (n=5,7,8,7,7,13)
    20.0 (0.5 to 71.6)
    57.1 (18.4 to 90.1)
    87.5 (47.3 to 99.7)
    71.4 (29.0 to 96.3)
    85.7 (42.1 to 99.6)
    46.2 (19.2 to 74.9)
        Serogroup W: Day 31 (n=1,2,3,2,2,3)
    100 (2.5 to 100)
    100 (15.8 to 100)
    100 (29.2 to 100)
    100 (15.8 to 100)
    100 (15.8 to 100)
    33.3 (0.8 to 90.6)
        Serogroup W: Day 61 (n=3,2,0,1,1,3)
    100 (29.2 to 100)
    100 (15.8 to 100)
    99999 (-99999 to 99999)
    100 (2.5 to 100)
    100 (2.5 to 100)
    66.7 (9.4 to 99.2)
        Serogroup W: Day 181 (n=12,12,13,12,16,16)
    100 (73.5 to 100)
    91.7 (61.5 to 99.8)
    100 (75.3 to 100)
    100 (73.5 to 100)
    100 (79.4 to 100)
    50.0 (24.7 to 75.3)
        Serogroup W: Day 211 (n=13,12,17,12,16,15)
    100 (75.3 to 100)
    100 (73.5 to 100)
    100 (80.5 to 100)
    100 (73.5 to 100)
    100 (79.4 to 100)
    60.0 (32.3 to 83.7)
        Serogroup Y: Day 1 (n=3,5,7,6,7,13)
    33.3 (0.8 to 90.6)
    60.0 (14.7 to 94.7)
    71.4 (29.0 to 96.3)
    50.0 (11.8 to 88.2)
    57.1 (18.4 to 90.1)
    15.4 (1.9 to 45.4)
        Serogroup Y: Day 31 (n=3,2,5,5,4,10)
    100 (29.2 to 100)
    100 (15.8 to 100)
    100 (47.8 to 100)
    100 (47.8 to 100)
    100 (39.8 to 100)
    40.0 (12.2 to 73.8)
        Serogroup Y: Day 61 (n=1,1,0,2,1,3)
    100 (2.5 to 100)
    100 (2.5 to 100)
    99999 (-99999 to 99999)
    100 (15.8 to 100)
    100 (2.5 to 100)
    33.3 (0.8 to 90.6)
        Serogroup Y: Day 181 (n=6,5,6,4,6,7)
    100 (54.1 to 100)
    100 (47.8 to 100)
    100 (54.1 to 100)
    100 (39.8 to 100)
    100 (54.1 to 100)
    28.6 (3.7 to 71.0)
        Serogroup Y: Day 211 (n=16,15,17,14,18,16)
    100 (79.4 to 100)
    100 (78.2 to 100)
    94.1 (71.3 to 99.9)
    100 (76.8 to 100)
    100 (81.5 to 100)
    37.5 (15.2 to 64.6)
    No statistical analyses for this end point

    Secondary: Adults Only: Percentage of Participants With Seroresponse Against Reference Strains of Meningococcal Serogroup B at Days 1, 31, 61, 181 and 211

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    End point title
    		 Adults Only: Percentage of Participants With Seroresponse Against Reference Strains of Meningococcal Serogroup B at Days 1, 31, 61, 181 and 211 [90]
    End point description
    The seroresponse was defined as a 4-fold increase in hSBA titers from pre-vaccination to post-vaccination. The seroresponse against reference strains of meningococcal serogroup B at Days 31, 61 and 181 was not applicable. Therefore, no data collected and analyzed. Day 31 (FAS1–adults): Participants who were vaccinated per protocol at Day 1 and had 1 valid post-vaccination blood sample at Day 31. Day 61 (FAS2–adults): Participants who were vaccinated per protocol at Days 1 and 31, and had 1 valid post-vaccination blood sample at Day 61. Days 181 and 211 (FAS3–adults): Participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. The percentages are rounded off to the tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Days 1, 31 and 181 and 1 month after second and third vaccination (Day 61 and Day 211, respectively)
    Notes
    [90] - 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 endpoint title, only adult participants were included in the analysis for this endpoint.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB
    Number of subjects analysed
    16
    17
    17
    14
    18
    16
    Units: percentage of participants
    number (confidence interval 95%)
        Strain (A56): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 211 (n=16,17,17,14,18,16)
    75.0 (47.6 to 92.7)
    64.7 (38.3 to 85.8)
    0 (0 to 19.5)
    85.7 (57.2 to 98.2)
    0 (0 to 18.5)
    75.0 (47.6 to 92.7)
        Strain (B44): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 211 (n=16,16,17,13,18,16)
    50.0 (24.7 to 75.3)
    56.3 (29.9 to 80.2)
    29.4 (10.3 to 56.0)
    76.9 (46.2 to 95.0)
    0 (0 to 18.5)
    62.5 (35.4 to 84.8)
        Strain (A10): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 211 (n=16,15,17,14,18,16)
    37.5 (15.2 to 64.6)
    40.0 (16.3 to 67.7)
    0 (0 to 19.5)
    7.1 (0.2 to 33.9)
    5.6 (0.1 to 27.3)
    62.5 (35.4 to 84.8)
        Strain (B79): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 211 (n=16,16,15,14,18,16)
    81.3 (54.4 to 96.0)
    81.3 (54.4 to 96.0)
    60.0 (32.3 to 83.7)
    28.6 (8.4 to 58.1)
    0 (0 to 18.5)
    100 (79.4 to 100)
    No statistical analyses for this end point

    Secondary: Adults Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:4 and >=1:8 Against Reference Strains of Meningococcal Serogroup B at Days 1, 31, 61, 181 and 211

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    End point title
    		 Adults Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=1:4 and >=1:8 Against Reference Strains of Meningococcal Serogroup B at Days 1, 31, 61, 181 and 211 [91]
    End point description
    Percentage of participants with antibody titers >=1:4 and >=1:8 against reference strains of meningococcal serogroup B was measured by hSBA. 95% CI for single percentage was based on Clopper-Pearson method. Antibodies titer against reference strains of meningococcal serogroup B at Days 31, 61 and 181 was not applicable. Therefore, no data collected and analyzed. Day 31 (FAS1–adults): Participants who were vaccinated per protocol at Day 1 and had 1 valid post-vaccination blood sample at Day 31. Day 61 (FAS2–adults): Participants who were vaccinated per protocol at Days 1 and 31, and had 1 valid post-vaccination blood sample at Day 61. Days 181 and 211 (FAS3–adults): Participants who were vaccinated per protocol at Day 181 and had 1 valid post-vaccination blood sample at Day 211. Percentages are rounded off to tenth decimal place. Here, n=Number of participants analyzed for each serogroup at specific timepoints; and -99999 and 99999=No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Days 1, 31 and 181 and 1 month after second and third vaccination (Day 61 and Day 211, respectively)
    Notes
    [91] - 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 endpoint title, only adult participants were included in the analysis for this endpoint.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB
    Number of subjects analysed
    16
    17
    17
    14
    18
    16
    Units: percentage of participants
    number (confidence interval 95%)
        Strain (A56): Day 1, >= 1:4 (n=5,8,8,8,8,13)
    100 (47.8 to 100)
    100 (63.1 to 100)
    100 (63.1 to 100)
    100 (63.1 to 100)
    100 (63.1 to 100)
    100 (75.3 to 100)
        Strain (A56): Day 1, >= 1:8 (n=5,8,8,8,8,13)
    0 (0 to 52.2)
    25.0 (3.2 to 65.1)
    37.5 (8.5 to 75.5)
    25.0 (3.2 to 65.1)
    25.0 (3.2 to 65.1)
    7.7 (0.2 to 36.0)
        Strain (A56): Day 31, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain(A56): Day 31, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 61, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 61, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 181, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 181, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56):Day211,>=1:4(n=16,17,17,14,18,16)
    100 (79.4 to 100)
    100 (80.5 to 100)
    100 (80.5 to 100)
    100 (76.8 to 100)
    100 (81.5 to 100)
    100 (79.4 to 100)
        Strain (A56):Day211,>=1:8(n=16,17,17,14,18,16)
    87.5 (61.7 to 98.4)
    82.4 (56.6 to 96.2)
    35.3 (14.2 to 61.7)
    100 (76.8 to 100)
    16.7 (3.6 to 41.4)
    93.8 (69.8 to 99.8)
        Strain (B44): Day 1, >= 1:4 (n=5,8,8,7,8,13)
    20.0 (0.5 to 71.6)
    75.0 (34.9 to 96.8)
    100 (63.1 to 100)
    100 (59.0 to 100)
    62.5 (24.5 to 91.5)
    76.9 (46.2 to 95.0)
        Strain (B44): Day 1, >= 1:8 (n=5,8,8,7,8,13)
    0 (0 to 52.2)
    62.5 (24.5 to 91.5)
    87.5 (47.3 to 99.7)
    85.7 (42.1 to 99.6)
    62.5 (24.5 to 91.5)
    69.2 (38.6 to 90.9)
        Strain (B44): Day 31, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 31, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 61, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 61, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 181, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 181, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44):Day 211, >= 1:4 (n=16,17,17,14,18,16)
    100 (79.4 to 100)
    94.1 (71.3 to 99.9)
    100 (80.5 to 100)
    100 (76.8 to 100)
    72.2 (46.5 to 90.3)
    100 (79.4 to 100)
        Strain (B44):Day 211, >= 1:8 (n=16,17,17,14,18,16)
    100 (79.4 to 100)
    94.1 (71.3 to 99.9)
    100 (80.5 to 100)
    100 (76.8 to 100)
    66.7 (41.0 to 86.7)
    100 (79.4 to 100)
        Strain (A10): Day 1, >= 1:4 (n=5,8,8,8,8,13)
    0 (0 to 52.2)
    25.0 (3.2 to 65.1)
    25.0 (3.2 to 65.1)
    12.5 (0.3 to 52.7)
    25.0 (3.2 to 65.1)
    0 (0 to 24.7)
        Strain (A10): Day 1, >= 1:8 (n=5,8,8,8,8,13)
    0 (0 to 52.2)
    25.0 (3.2 to 65.1)
    25.0 (3.2 to 65.1)
    12.5 (0.3 to 52.7)
    12.5 (0.3 to 52.7)
    0 (0 to 24.7)
        Strain (A10): Day 31, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 31, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 61, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 61, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 181, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 181, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10):Day211,>=1:4(n=16,16,17,14,18,16)
    75.0 (47.6 to 92.7)
    87.5 (61.7 to 98.4)
    29.4 (10.3 to 56.0)
    28.6 (8.4 to 58.1)
    22.2 (6.4 to 47.6)
    87.5 (61.7 to 98.4)
        Strain (A10):Day211,>=1:8(n=16,16,17,14,18,16)
    68.8 (41.3 to 89.0)
    81.3 (54.4 to 96.0)
    23.5 (6.8 to 49.9)
    21.4 (4.7 to 50.8)
    16.7 (3.6 to 41.4)
    87.5 (61.7 to 98.4)
        Strain (B79): Day 1, >= 1:4 (n=5,8,7,8,8,13)
    0 (0 to 52.2)
    12.5 (0.3 to 52.7)
    0 (0 to 41.0)
    25.0 (3.2 to 65.1)
    37.5 (8.5 to 75.5)
    0 (0 to 24.7)
        Strain (B79): Day 1, >= 1:8 (n=5,8,7,8,8,13)
    0 (0 to 52.2)
    12.5 (0.3 to 52.7)
    0 (0 to 41.0)
    25.0 (3.2 to 65.1)
    37.5 (8.5 to 75.5)
    0 (0 to 24.7)
        Strain (B79): Day 31, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 31, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 61, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 61, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 181, >= 1:4 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 181, >= 1:8 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79):Day211,>=1:4(n=16,17,16,14,18,16)
    81.3 (54.4 to 96.0)
    94.1 (71.3 to 99.9)
    87.5 (61.7 to 98.4)
    50.0 (23.0 to 77.0)
    33.3 (13.3 to 59.0)
    100 (79.4 to 100)
        Strain (B79):Day211,>=1:8(n=16,17,16,14,18,16)
    81.3 (54.4 to 96.0)
    94.1 (71.3 to 99.9)
    87.5 (61.7 to 98.4)
    50.0 (23.0 to 77.0)
    33.3 (13.3 to 59.0)
    100 (79.4 to 100)
    No statistical analyses for this end point

    Secondary: Adults Only: Geometric Mean Titers of Antibodies Against Reference Strains of Meningococcal Serogroup B at Days 1, 31, 61, 181 and 211

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    End point title
    		 Adults Only: Geometric Mean Titers of Antibodies Against Reference Strains of Meningococcal Serogroup B at Days 1, 31, 61, 181 and 211 [92]
    End point description
    The antibodies titer against the reference strains of the meningococcal serogroup B was measured by hSBA and the results were expressed as GMT. The 95% CI for the single percentage was based on the Clopper-Pearson method. The antibodies titer against reference strains of meningococcal serogroup B at Days 31, 61 and 181 was not applicable. Therefore, no data collected and analyzed. Day 31 (FAS1–adults), Day 61 (FAS2–adults), and Days 181 and 211 (FAS3–adults) analysis set. Here, n= Number of participants analyzed for each serogroup at specific timepoints; -9999 and 9999= The 95% CI was not computed, if number analyzed was <=5 or standard deviation was 0; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Days 1, 31 and 181 and 1 month after second and third vaccination (Day 61 and Day 211, respectively)
    Notes
    [92] - 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 endpoint title, only adult participants were included in the analysis for this endpoint.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB
    Number of subjects analysed
    16
    17
    17
    14
    18
    16
    Units: titer
    geometric mean (confidence interval 95%)
        Strain (A56): Day 1 (n=5,8,8,8,8,13)
    4.50 (-9999 to 9999)
    7.77 (3.10 to 19.5)
    7.78 (3.99 to 15.2)
    6.10 (3.73 to 9.98)
    5.55 (3.99 to 7.72)
    4.75 (4.23 to 5.33)
        Strain (A56): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 211 (n=16,17,17,14,18,16)
    82.3 (32.4 to 209)
    53.4 (25.3 to 113)
    6.78 (4.77 to 9.63)
    159 (81.5 to 312)
    5.38 (4.26 to 6.79)
    98.3 (45.8 to 211)
        Strain (B44): Day 1 (n=5,8,8,7,8,13)
    2.49 (-9999 to 9999)
    15.0 (3.97 to 56.7)
    19.8 (6.96 to 56.4)
    31.0 (8.86 to 108)
    9.83 (2.67 to 36.2)
    12.4 (5.05 to 30.7)
        Strain (B44): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 211 (n=16,17,17,14,18,16)
    84.9 (45.2 to 159)
    77.0 (38.7 to 153)
    29.4 (17.2 to 50.3)
    215 (116 to 396)
    12.2 (6.15 to 24.3)
    126 (67.5 to 235)
        Strain (A10): Day 1 (n=5,8,8,8,8,13)
    2.50 (-9999 to 9999)
    4.57 (1.67 to 12.5)
    3.83 (1.93 to 7.60)
    3.15 (1.82 to 5.46)
    4.35 (1.53 to 12.3)
    2.50 (-9999 to 9999)
        Strain (A10): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 211 (n=16,16,17,14,18,16)
    14.0 (7.25 to 27.0)
    22.2 (11.3 to 43.4)
    3.87 (2.64 to 5.69)
    4.45 (2.33 to 8.50)
    4.09 (2.35 to 7.12)
    32.4 (15.6 to 67.4)
        Strain (B79): Day 1 (n=5,8,7,8,8,13)
    3.50 (-9999 to 9999)
    6.63 (1.46 to 30.1)
    3.50 (-9999 to 9999)
    6.50 (2.45 to 17.3)
    7.16 (3.07 to 16.7)
    3.50 (-9999 to 9999)
        Strain (B79): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 211 (n=16,17,16,14,18,16)
    271 (75.5 to 972)
    299 (121 to 738)
    53.0 (18.2 to 154)
    15.3 (5.31 to 44.3)
    6.43 (3.98 to 10.4)
    1222 (640 to 2332)
    No statistical analyses for this end point

    Secondary: Adults Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Reference Strains of Meningococcal Serogroup B at Days 1, 31, 61, 181 and 211

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    End point title
    		 Adults Only: Percentage of Participants With Human Complement Serum Bactericidal Assay Titer >=Lower Limit of Quantification Against Reference Strains of Meningococcal Serogroup B at Days 1, 31, 61, 181 and 211 [93]
    End point description
    Percentage of participants with antibody titers >=LLOQ against reference strains of meningococcal serogroup B was measured by hSBA. The 95% CI for single percentage was based on Clopper-Pearson method. Antibodies titer against reference strains of meningococcal serogroup B at Days 31, 61 and 181 was not applicable. Therefore, no data collected and analyzed. Day 31 (FAS1–adults), Day 61 (FAS2–adults), and Days 181 and 211 (FAS3–adults) analysis set. The percentages are rounded off to tenth decimal place. Here, n= Number of participants analyzed for each serogroup at specific timepoints; and -99999 and 99999= No participants analyzed at specific timepoints.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination on Days 1, 31 and 181 and 1 month after second and third vaccination (Day 61 and Day 211, respectively)
    Notes
    [93] - 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 endpoint title, only adult participants were included in the analysis for this endpoint.
    End point values
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB
    Number of subjects analysed
    16
    17
    17
    14
    18
    16
    Units: percentage of participants
    number (confidence interval 95%)
        Strain (A56): Day 1 (n=5,8,8,8,8,13)
    0 (0 to 52.2)
    25.0 (3.2 to 65.1)
    37.5 (8.5 to 75.5)
    25.0 (3.2 to 65.1)
    25.0 (3.2 to 65.1)
    7.7 (0.2 to 36.0)
        Strain (A56): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A56): Day 211 (n=16,17,17,14,18,16)
    87.5 (61.7 to 98.4)
    82.4 (56.6 to 96.2)
    35.3 (14.2 to 61.7)
    100 (76.8 to 100)
    16.7 (3.6 to 41.4)
    93.8 (69.8 to 99.8)
        Strain (B44): Day 1 (n=5,8,8,7,8,13)
    20.0 (0.5 to 71.6)
    75.0 (34.9 to 96.8)
    100 (63.1 to 100)
    100 (59.0 to 100)
    62.5 (24.5 to 91.5)
    76.9 (46.2 to 95.0)
        Strain (B44): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B44): Day 211 (n=16,17,17,14,18,16)
    100 (79.4 to 100)
    94.1 (71.3 to 99.9)
    100 (80.5 to 100)
    100 (76.8 to 100)
    72.2 (46.5 to 90.3)
    100 (79.4 to 100)
        Strain (A10): Day 1 (n=5,8,8,8,8,13)
    0 (0 to 52.2)
    25.0 (3.2 to 65.1)
    25.0 (3.2 to 65.1)
    12.5 (0.3 to 52.7)
    25.0 (3.2 to 65.1)
    0 (0 to 24.7)
        Strain (A10): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (A10): Day 211 (n=16,16,17,14,18,16)
    75.0 (47.6 to 92.7)
    87.5 (61.7 to 98.4)
    29.4 (10.3 to 56.0)
    28.6 (8.4 to 58.1)
    22.2 (6.4 to 47.6)
    87.5 (61.7 to 98.4)
        Strain (B79): Day 1 (n=5,8,7,8,8,13)
    0 (0 to 52.2)
    12.5 (0.3 to 52.7)
    0 (0 to 41.0)
    25.0 (3.2 to 65.1)
    37.5 (8.5 to 75.5)
    0 (0 to 24.7)
        Strain (B79): Day 31 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 61 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 181 (n=0,0,0,0,0,0)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
        Strain (B79): Day 211 (n=16,17,16,14,18,16)
    81.3 (54.4 to 96.0)
    94.1 (71.3 to 99.9)
    87.5 (61.7 to 98.4)
    50.0 (23.0 to 77.0)
    33.3 (13.3 to 59.0)
    100 (79.4 to 100)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs, other AEs and all-cause mortality were collected from the first vaccine administration (Day 1) until 180 days after last vaccine administration (Day 181), approximately 361 days
    Adverse event reporting additional description
    Analysis was performed on the SafAS.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Reporting groups
    Reporting group title
    Adults - Group 1: MenPenta Formulation 1
    Reporting group description
    		 Participants aged 18 to 25 years received MenPenta formulation 1 (pentavalent meningococcal ABCYW standard dose) vaccine via IM injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adults - Group 2: MenPenta Formulation 2
    Reporting group description
    		 Participants aged 18 to 25 years received MenPenta formulation 2 (pentavalent meningococcal ABCYW high dose) vaccine via IM injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adults - Group 3: Bexsero + Menveo
    Reporting group description
    		 Participants aged 18 to 25 years received Bexsero (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Bexsero vaccine via IM injection on Day 31. Additionally, participants received a placebo IM injection on Day 181.

    Reporting group title
    Adults - Group 4: Trumenba + Menveo
    Reporting group description
    		 Participants aged 18 to 25 years received Trumenba (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Trumenba vaccine via IM injection on Days 31 and 181.

    Reporting group title
    Adults - Group 5: MenQuadfi
    Reporting group description
    		 Participants aged 18 to 25 years received MenQuadfi (meningococcal ACYW conjugate) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Days 1 and 31.

    Reporting group title
    Adults - Group 6: Sanofi MenB
    Reporting group description
    		 Participants aged 18 to 25 years received Sanofi MenB (meningococcal B antigens standard dose) vaccine via IM injection on Days 1, 31 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 1: MenPenta Formulation 1
    Reporting group description
    		 Participants aged 10 to 17 years received MenPenta formulation 1 (pentavalent meningococcal ABCYW standard dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 3: Bexsero + Menveo
    Reporting group description
    		 Participants aged 10 to 17 years received Bexsero (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Bexsero vaccine via IM injection on Day 181.

    Reporting group title
    Adolescents - Group 2: MenPenta Formulation 2
    Reporting group description
    		 Participants aged 10 to 17 years received MenPenta formulation 2 (pentavalent meningococcal ABCYW high dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 4: Trumenba + Menveo
    Reporting group description
    		 Participants aged 10 to 17 years received Trumenba (meningococcal group B) + Menveo (meningococcal ACYW conjugate) vaccine via IM injection on Day 1 and only Trumenba vaccine via IM injection on Day 181.

    Reporting group title
    Adolescents - Group 6: Sanofi MenB
    Reporting group description
    		 Participants aged 10 to 17 years received Sanofi MenB (meningococcal B antigens standard dose) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 5: MenQuadfi
    Reporting group description
    		 Participants aged 10 to 17 years received MenQuadfi (meningococcal ACYW conjugate) vaccine via IM injection on Days 1 and 181. Additionally, participants received a placebo IM injection on Day 1.

    Reporting group title
    Adolescents - Group 7: PENBRAYA
    Reporting group description
    		 Participants aged 10 to 17 years received PENBRAYA (meningococcal ABCYW conjugate) vaccine via IM injection on Days 1 and 181.

    Serious adverse events
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 6: Sanofi MenB Adolescents - Group 5: MenQuadfi Adolescents - Group 7: PENBRAYA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 296 (0.68%)
    1 / 100 (1.00%)
    3 / 300 (1.00%)
    1 / 97 (1.03%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Gun Shot Wound
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull Fractured Base
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Irritable Bowel Syndrome
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 296 (0.34%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal Hypertrophy
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillar Hypertrophy
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    0 / 100 (0.00%)
    1 / 300 (0.33%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Vitiligo
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
    1 / 97 (1.03%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 296 (0.34%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    1 / 100 (1.00%)
    0 / 300 (0.00%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adults - Group 1: MenPenta Formulation 1 Adults - Group 2: MenPenta Formulation 2 Adults - Group 3: Bexsero + Menveo Adults - Group 4: Trumenba + Menveo Adults - Group 5: MenQuadfi Adults - Group 6: Sanofi MenB Adolescents - Group 1: MenPenta Formulation 1 Adolescents - Group 3: Bexsero + Menveo Adolescents - Group 2: MenPenta Formulation 2 Adolescents - Group 4: Trumenba + Menveo Adolescents - Group 6: Sanofi MenB Adolescents - Group 5: MenQuadfi Adolescents - Group 7: PENBRAYA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 20 (85.00%)
    17 / 21 (80.95%)
    16 / 19 (84.21%)
    19 / 20 (95.00%)
    15 / 20 (75.00%)
    19 / 20 (95.00%)
    243 / 296 (82.09%)
    90 / 100 (90.00%)
    237 / 300 (79.00%)
    83 / 97 (85.57%)
    80 / 97 (82.47%)
    58 / 99 (58.59%)
    87 / 100 (87.00%)
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 20 (15.00%)
    10 / 21 (47.62%)
    7 / 19 (36.84%)
    10 / 20 (50.00%)
    9 / 20 (45.00%)
    8 / 20 (40.00%)
    107 / 296 (36.15%)
    37 / 100 (37.00%)
    96 / 300 (32.00%)
    36 / 97 (37.11%)
    29 / 97 (29.90%)
    33 / 99 (33.33%)
    43 / 100 (43.00%)
         occurrences all number
    5
    17
    9
    15
    12
    16
    131
    45
    119
    50
    36
    40
    56
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    7 / 20 (35.00%)
    11 / 21 (52.38%)
    6 / 19 (31.58%)
    11 / 20 (55.00%)
    9 / 20 (45.00%)
    15 / 20 (75.00%)
    116 / 296 (39.19%)
    46 / 100 (46.00%)
    114 / 300 (38.00%)
    48 / 97 (49.48%)
    35 / 97 (36.08%)
    34 / 99 (34.34%)
    52 / 100 (52.00%)
         occurrences all number
    9
    20
    8
    17
    15
    23
    154
    61
    148
    60
    48
    43
    78
    Injection Site Erythema
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    5 / 20 (25.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    21 / 296 (7.09%)
    17 / 100 (17.00%)
    37 / 300 (12.33%)
    8 / 97 (8.25%)
    6 / 97 (6.19%)
    3 / 99 (3.03%)
    20 / 100 (20.00%)
         occurrences all number
    1
    2
    0
    7
    0
    3
    26
    25
    41
    12
    8
    4
    29
    Pyrexia
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    1 / 19 (5.26%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    19 / 296 (6.42%)
    6 / 100 (6.00%)
    15 / 300 (5.00%)
    10 / 97 (10.31%)
    2 / 97 (2.06%)
    4 / 99 (4.04%)
    6 / 100 (6.00%)
         occurrences all number
    1
    1
    1
    1
    1
    1
    21
    6
    15
    10
    2
    4
    8
    Injection Site Swelling
         subjects affected / exposed
    3 / 20 (15.00%)
    2 / 21 (9.52%)
    0 / 19 (0.00%)
    3 / 20 (15.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    30 / 296 (10.14%)
    16 / 100 (16.00%)
    35 / 300 (11.67%)
    7 / 97 (7.22%)
    7 / 97 (7.22%)
    6 / 99 (6.06%)
    13 / 100 (13.00%)
         occurrences all number
    3
    2
    0
    4
    0
    1
    37
    23
    45
    11
    9
    9
    18
    Injection Site Pain
         subjects affected / exposed
    14 / 20 (70.00%)
    16 / 21 (76.19%)
    15 / 19 (78.95%)
    14 / 20 (70.00%)
    10 / 20 (50.00%)
    19 / 20 (95.00%)
    217 / 296 (73.31%)
    89 / 100 (89.00%)
    218 / 300 (72.67%)
    75 / 97 (77.32%)
    72 / 97 (74.23%)
    30 / 99 (30.30%)
    79 / 100 (79.00%)
         occurrences all number
    25
    37
    30
    38
    19
    46
    388
    169
    397
    134
    128
    47
    130
    Injection Site Pruritus
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    1 / 296 (0.34%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
    0 / 97 (0.00%)
    1 / 97 (1.03%)
    2 / 99 (2.02%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    1
    0
    0
    0
    1
    2
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    4 / 296 (1.35%)
    0 / 100 (0.00%)
    5 / 300 (1.67%)
    2 / 97 (2.06%)
    6 / 97 (6.19%)
    2 / 99 (2.02%)
    2 / 100 (2.00%)
         occurrences all number
    1
    0
    0
    1
    0
    3
    4
    0
    6
    2
    7
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 296 (0.34%)
    1 / 100 (1.00%)
    5 / 300 (1.67%)
    3 / 97 (3.09%)
    2 / 97 (2.06%)
    5 / 99 (5.05%)
    2 / 100 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    1
    5
    3
    2
    5
    2
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    5 / 296 (1.69%)
    2 / 100 (2.00%)
    5 / 300 (1.67%)
    1 / 97 (1.03%)
    2 / 97 (2.06%)
    2 / 99 (2.02%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    5
    2
    5
    1
    2
    2
    0
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 296 (0.00%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Anxiety
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 19 (5.26%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 296 (0.34%)
    0 / 100 (0.00%)
    2 / 300 (0.67%)
    0 / 97 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    2
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    8 / 20 (40.00%)
    13 / 21 (61.90%)
    9 / 19 (47.37%)
    12 / 20 (60.00%)
    8 / 20 (40.00%)
    11 / 20 (55.00%)
    144 / 296 (48.65%)
    66 / 100 (66.00%)
    146 / 300 (48.67%)
    57 / 97 (58.76%)
    52 / 97 (53.61%)
    30 / 99 (30.30%)
    62 / 100 (62.00%)
         occurrences all number
    10
    21
    11
    15
    10
    23
    195
    92
    202
    76
    70
    39
    92
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    6 / 296 (2.03%)
    0 / 100 (0.00%)
    4 / 300 (1.33%)
    1 / 97 (1.03%)
    1 / 97 (1.03%)
    3 / 99 (3.03%)
    2 / 100 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    6
    0
    4
    1
    1
    3
    2
    Urinary Tract Infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 19 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    1 / 296 (0.34%)
    0 / 100 (0.00%)
    0 / 300 (0.00%)
    0 / 97 (0.00%)
    1 / 97 (1.03%)
    0 / 99 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Oct 2023
    Clarified the definition of sentinel cohort participant and the number of adolescent participants included in the sentinel cohort.
    10 Jan 2024
    Added an additional study group in the adolescent cohort to receive the PENBRAYA vaccine. Clarified some elements of the study design based on Center for Biologics Evaluation and Research's feedback.
    08 Apr 2024
    Added interim analysis for business purpose. Clarified some elements and align with the statistical analysis plan.
    04 Jul 2024
    Updated the safety information and potential and identified risks with MenQuadfi. Updated interim analysis strategy.
    18 Oct 2024
    Updated the objectives and endpoints wording for clarification. Clarified the unblinding strategy for the interim analyses.
    13 Mar 2025
    Updated the strategy for the interim analysis.

    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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