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    Clinical Trial Results:
    A Phase 3, Randomized, Active-controlled, Observer-blinded Study To Assess The Immunogenicity, Safety, And Tolerability Of Bivalent rLP2086 When Administered As A 2-Dose Regimen And A First-in-human Study To Describe The Immunogenicity, Safety, And Tolerability Of A Bivalent rLP2086–Containing Pentavalent Vaccine (MenABCWY) In Healthy Subjects >=10 to <26 Years Of Age

    Summary
    EudraCT number
    		 2016-004421-17
    Trial protocol
    		 CZ   FI   PL  
    Global end of trial date
    25 Oct 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 May 2023
    First version publication date
    10 May 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B1971057
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03135834
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 10017 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 10017 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000299-PIP01-08
    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
    07 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess immune response induced by bivalent rLP2086 as measured by hSBA performed with 4 primary MnB test strains, 2 expressing an LP2086 subfamily A protein and 2 expressing an LP2086 subfamily B protein, measured 1 month after second vaccination, in bivalent rLP2086 arms (Group 2 and 4 subjects) combined. To describe safety profile of bivalent rLP2086, as measured by local reactions, systemic events, adverse events (AEs), serious adverse events (SAEs), newly diagnosed chronic medical conditions (NDCMCs), medically attended AEs, and immediate AEs, following Vaccinations 1 and 2 in bivalent rLP2086 arms combined. To describe safety profile of MenABCWY, as measured by local reactions, systemic events, AEs, SAEs, NDCMCs, medically attended AEs, and immediate AEs, after booster vaccination. To describe safety profile of bivalent rLP2086, as measured by local reactions, systemic events, AEs, SAEs, NDCMCs, medically attended AEs, and immediate AEs, after booster vaccination.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Apr 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czechia: 131
    Country: Number of subjects enrolled
    Finland: 128
    Country: Number of subjects enrolled
    Poland: 30
    Country: Number of subjects enrolled
    United States: 1311
    Worldwide total number of subjects
    1600
    EEA total number of subjects
    289
    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)
    337
    Adolescents (12-17 years)
    560
    Adults (18-64 years)
    703
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study had 2 stages: 1 and 2. Study was conducted at 68 sites in Stage 1, with 39 of those sites participating in Stage 2. Subjects were randomized as ACWY-naive and ACWY-experienced (received 1 prior dose of a vaccine containing 1 or more ACWY groups greater than or equal to [>=] 4 years prior to randomization).

    Pre-assignment
    Screening details
    		 A total of 1610 subjects were randomized in this study, out of which 10 withdrew before vaccination.

    Period 1
    Period 1 title
    Stage 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: MenABCWY + Saline (ACWY-Naive)
    Arm description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Normal saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of saline solution at Month 0 during Stage 1.

    Investigational medicinal product name
    Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of MenABCWY vaccine each at Month 0 and 6 during Stage 1.

    Arm title
    		 Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
    Arm description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM)
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection at Month 0 during Stage 1.

    Investigational medicinal product name
    Bivalent recombinant lipoprotein 2086 vaccine (Bivalent rLP2086)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of bivalent rLP2086 each at Month 0 and 6 during Stage 1.

    Arm title
    		 Group 3: MenABCWY + Saline (ACWY-Experienced)
    Arm description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Normal saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of saline solution at Month 0 during Stage 1.

    Investigational medicinal product name
    Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of MenABCWY vaccine each at Month 0 and 6 during Stage 1.

    Arm title
    		 Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Arm description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM)
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection at Month 0 during Stage 1.

    Investigational medicinal product name
    Bivalent recombinant lipoprotein 2086 vaccine (Bivalent rLP2086)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of bivalent rLP2086 each at Month 0 and 6 during Stage 1.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Not all the subjects who completed Stage 1 entered Stage 2.
    Number of subjects in period 1
    		Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Started
    272
    534
    271
    523
    Vaccination 1 at Month 0
    272
    534
    271
    523
    Vaccination 2 at Month 6
    242
    469
    244
    477
    Completed
    233
    462
    232
    463
    Not completed
    39
    72
    39
    60
         Adverse event, serious fatal
    1
    -
    -
    -
         Consent withdrawn by subject
    16
    22
    7
    10
         Physician decision
    -
    1
    -
    -
         Adverse event, non-fatal
    1
    2
    2
    1
         No longer met eligibility criteria
    1
    6
    2
    5
         Pregnancy
    -
    4
    2
    4
         Unspecified
    -
    2
    1
    -
         Lost to follow-up
    17
    24
    21
    38
         Withdrawal by parent/guardian
    2
    10
    2
    1
         Protocol deviation
    1
    1
    2
    1
    Period 2
    Period 2 title
    Stage 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: MenABCWY + Saline (ACWY-Naive)
    Arm description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of MenABCWY vaccine each at Month 0 and 6 during Stage 1.

    Investigational medicinal product name
    Normal saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of saline solution at Month 0 during Stage 1.

    Arm title
    		 Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
    Arm description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM)
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection at Month 0 during Stage 1.

    Investigational medicinal product name
    Bivalent recombinant lipoprotein 2086 vaccine (Bivalent rLP2086)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of bivalent rLP2086 each at Month 0 and 6 during Stage 1.

    Arm title
    		 Group 3: MenABCWY + Saline (ACWY-Experienced)
    Arm description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Normal saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of saline solution at Month 0 during Stage 1.

    Investigational medicinal product name
    Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of MenABCWY vaccine each at Month 0 and 6 during Stage 1.

    Arm title
    		 Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Arm description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM)
    Investigational medicinal product code
    Other name
    Menveo
    Pharmaceutical forms
    Concentrate and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection at Month 0 during Stage 1.

    Investigational medicinal product name
    Bivalent recombinant lipoprotein 2086 vaccine (Bivalent rLP2086)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered 0.5 mL intramuscular injection of bivalent rLP2086 each at Month 0 and 6 during Stage 1.

    Number of subjects in period 2 [2]
    		Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Started
    114
    65
    101
    73
    Antibody Persistence:Blood draw Month18
    114
    63
    53 [3]
    23 [4]
    Antibody Persistence:Blood draw Month24
    104
    61
    96
    71
    Antibody Persistence:Blood draw Month42
    97
    55
    97
    68
    Completed Persistence Phase
    97
    55
    97
    68
    Booster Vaccination at Month 54
    67
    40
    77
    58
    Completed
    67
    38
    77
    58
    Not completed
    47
    27
    24
    15
         Consent withdrawn by subject
    -
    1
    -
    -
         Did not receive Booster Vaccination
    1
    1
    -
    -
         Lost to follow-up
    -
    1
    -
    -
         Withdrawn Before Booster Vaccination
    46
    24
    24
    15
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all the subjects who completed Stage 1 entered Stage 2.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: These are the number of subjects with blood drawn at Month 18 for evaluation of antibody persistence.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: These are the number of subjects with blood drawn at Month 18 for evaluation of antibody persistence.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: MenABCWY + Saline (ACWY-Naive)
    Reporting group description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.

    Reporting group title
    Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
    Reporting group description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.

    Reporting group title
    Group 3: MenABCWY + Saline (ACWY-Experienced)
    Reporting group description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.

    Reporting group title
    Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Reporting group description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.

    Reporting group values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Total
    Number of subjects
    		 272 534 271 523 1600
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 108 194 13 22 337
        Adolescents (12-17 years)
    		 46 101 137 276 560
        Adults (18-64 years)
    		 118 239 121 225 703
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 16.0 ( 5.67 ) 16.5 ( 5.81 ) 17.7 ( 3.57 ) 17.8 ( 3.66 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 144 333 152 289 918
        Male
    		 128 201 119 234 682
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 10 13 6 20 49
        Asian
    		 1 4 3 8 16
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 27 53 25 60 165
        White
    		 234 464 237 435 1370
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 35 73 24 61 193
        Not Hispanic or Latino
    		 236 461 246 461 1404
        Unknown or Not Reported
    		 1 0 1 1 3

    End points

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    End points reporting groups
    Reporting group title
    Group 1: MenABCWY + Saline (ACWY-Naive)
    Reporting group description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.

    Reporting group title
    Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
    Reporting group description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.

    Reporting group title
    Group 3: MenABCWY + Saline (ACWY-Experienced)
    Reporting group description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.

    Reporting group title
    Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Reporting group description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
    Reporting group title
    Group 1: MenABCWY + Saline (ACWY-Naive)
    Reporting group description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.

    Reporting group title
    Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
    Reporting group description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.

    Reporting group title
    Group 3: MenABCWY + Saline (ACWY-Experienced)
    Reporting group description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.

    Reporting group title
    Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Reporting group description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.

    Subject analysis set title
    Stage 1: Groups 2+4 Combined
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Stage 1: ACWY-naive and experienced subjects received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0 and 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 evaluable immunogenicity population (EIP), included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor.

    Subject analysis set title
    Stage 1: Groups 2+4 Combined
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Stage 1: ACWY-naive and experienced subjects received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0and 0.5 mL of bivalent rLP2086 vaccine at Month 6. The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available.

    Subject analysis set title
    Stage 1: Group 1+3 Combined
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Stage 1: ACWY-naive and experienced subjects who received an intramuscular injection of 0.5 mL of MenABCWY vaccine and 0.5 mL of saline at Month 0 and 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 evaluable immunogenicity population (EIP), included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor.

    Subject analysis set title
    Stage 2: Group 1+3 Combined
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. Stage 2 modified intent to treat (mITT) population included all subjects who signed the ICD at Month 18 and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available in Stage 2.

    Subject analysis set title
    Stage 2: Groups 2+4 Combined
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Stage 2: Subjects received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54. Stage 2 modified intent to treat (mITT) population included all subjects who signed the ICD at Month 18 and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available in Stage 2.

    Subject analysis set title
    Stage 2: Group 1+3 Combined
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. The booster evaluable immunogenicity population (EIP) included subjects who were eligible for the study (ie, met all Stage 1 eligibility criteria as well as continually met Stage 2 eligibility criteria), received a booster dose as intended (the same vaccine as they received in Stage 1), had blood drawn for assay testing within the required time frame at Month 55 (Visit 11), and had a valid and determinate MenB or MenA/C/W/Y assay result after the booster dose, as well as no major protocol violations as determined by the sponsor’s global medical monitor.

    Subject analysis set title
    Stage 2: Groups 2+4 Combined
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Stage 2: Subjects received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54. The booster evaluable immunogenicity population (EIP) included subjects who were eligible for the study (ie, met all Stage 1 eligibility criteria as well as continually met Stage 2 eligibility criteria), received a booster dose as intended (the same vaccine as they received in Stage 1), had blood drawn for assay testing within the required time frame at Month 55 (Visit 11), and had a valid and determinate MenB or MenA/C/W/Y assay result after the booster dose, as well as no major protocol violations as determined by the sponsor’s global medical monitor.

    Primary: Stage1: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= Lower Limit of Quantitation (LLOQ) for all 4 Primary Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= Lower Limit of Quantitation (LLOQ) for all 4 Primary Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined) [1]
    End point description
    Percentage of subjects who achieved an hSBA titer >= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this endpoint. Stage 1 evaluable immunogenicity population (EIP), included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘Number of subjects Analysed’ signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    1 month after Vaccination 2
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    814
    Units: Percentage of subjects
        number (confidence interval 95%)
    74.3 (71.2 to 77.3)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With Fold Rise >= 4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With Fold Rise >= 4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined) [2]
    End point description
    The 4-fold increase: a) subjects with baseline hSBA titer below limit of detection (LOD or an hSBA titer <1:4), response was defined as hSBA titer >=1:16 or LLOQ (whichever titer is higher); b) subjects with baseline hSBA titer >= LOD and < LLOQ, response was defined as hSBA titer >= 4 times the LLOQ; c) subjects with baseline hSBA titer >= LLOQ, response was defined as hSBA titer >=4 times baseline titer. Stage 1 EIP: all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. “n”: subjects with valid and determinate hSBA titers for the given strain at both the specified time point and baseline. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    From Baseline (blood draw prior to Vaccination 1) to 1 month after Vaccination 2
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    864
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22) (n =827)
    73.8 (70.6 to 76.7)
        PMB2001 (A56) (n =823)
    95.0 (93.3 to 96.4)
        PMB2948 (B24) (n =835)
    67.4 (64.1 to 70.6)
        PMB2707 (B44) (n =850)
    86.4 (83.9 to 88.6)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) [3]
    End point description
    Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Here, ‘Number of subjects Analyzed’ signifies number of subjects with known values. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 1
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1044
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Mild
    6.8 (5.3 to 8.5)
        Redness: Moderate
    8.0 (6.5 to 9.9)
        Redness: Severe
    2.0 (1.2 to 3.1)
        Swelling: Mild
    9.8 (8.0 to 11.7)
        Swelling: Moderate
    6.9 (5.4 to 8.6)
        Swelling: Severe
    0.3 (0.1 to 0.8)
        Pain at injection site: Mild
    41.2 (38.2 to 44.2)
        Pain at injection site: Moderate
    39.1 (36.1 to 42.1)
        Pain at injection site: Severe
    4.7 (3.5 to 6.2)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) [4]
    End point description
    Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Here, ‘Number of subjects Analyzed’ signifies number of subjects with known values. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 2
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    903
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Mild
    5.2 (3.8 to 6.9)
        Redness: Moderate
    8.4 (6.7 to 10.4)
        Redness: Severe
    1.1 (0.5 to 2.0)
        Swelling: Mild
    6.4 (4.9 to 8.2)
        Swelling: Moderate
    7.5 (5.9 to 9.4)
        Swelling: Severe
    0.3 (0.1 to 1.0)
        Pain at injection site: Mild
    38.9 (35.7 to 42.1)
        Pain at injection site: Moderate
    37.9 (34.7 to 41.1)
        Pain at injection site: Severe
    5.4 (4.0 to 7.1)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) [5]
    End point description
    Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as >=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours). Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: number of subjects with known values.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 1
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1044
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: 38.0 to 38.4 degree C
    4.0 (2.9 to 5.4)
        Fever: 38.5 to 38.9 degree C
    2.1 (1.3 to 3.2)
        Fever: 39.0 to 40.0 degree C
    0.6 (0.2 to 1.2)
        Fever: > 40.0 degree C
    0.0 (0.0 to 0.4)
        Fatigue: Mild
    25.4 (22.8 to 28.1)
        Fatigue: Moderate
    23.7 (21.1 to 26.4)
        Fatigue: Severe
    2.9 (1.9 to 4.1)
        Headache: Mild
    25.1 (22.5 to 27.8)
        Headache: Moderate
    19.0 (16.6 to 21.5)
        Headache: Severe
    2.4 (1.6 to 3.5)
        Chills: Mild
    11.5 (9.6 to 13.6)
        Chills: Moderate
    5.7 (4.4 to 7.3)
        Chills: Severe
    1.2 (0.7 to 2.1)
        Vomiting: Mild
    2.9 (1.9 to 4.1)
        Vomiting: Moderate
    0.9 (0.4 to 1.6)
        Vomiting: severe
    0.0 (0.0 to 0.4)
        Diarrhea: Mild
    10.7 (8.9 to 12.8)
        Diarrhea: Moderate
    3.3 (2.3 to 4.5)
        Diarrhea: Severe
    0.1 (0.0 to 0.5)
        Muscle pain: Mild
    15.8 (13.6 to 18.2)
        Muscle pain: Moderate
    11.6 (9.7 to 13.7)
        Muscle pain: Severe
    1.1 (0.5 to 1.9)
        Joint pain: Mild
    10.2 (8.5 to 12.3)
        Joint pain: Moderate
    8.6 (7.0 to 10.5)
        Joint pain: Severe
    0.8 (0.3 to 1.5)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) [6]
    End point description
    Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as >=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours). Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: number of subjects with known values.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 2
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    903
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: 38.0 to 38.4 degree C
    1.9 (1.1 to 3.0)
        Fever: 38.5 to 38.9 degree C
    0.7 (0.2 to 1.4)
        Fever: 39.0 to 40.0 degree C
    0.7 (0.2 to 1.4)
        Fever: > 40.0 degree C
    0.0 (0.0 to 0.4)
        Fatigue: Mild
    23.0 (20.3 to 25.9)
        Fatigue: Moderate
    19.2 (16.6 to 21.9)
        Fatigue: Severe
    3.0 (2.0 to 4.3)
        Headache: Mild
    23.1 (20.4 to 26.0)
        Headache: Moderate
    16.5 (14.1 to 19.1)
        Headache: Severe
    2.0 (1.2 to 3.1)
        Chills: Mild
    11.6 (9.6 to 13.9)
        Chills: Moderate
    6.2 (4.7 to 8.0)
        Chills: Severe
    0.7 (0.2 to 1.4)
        Vomiting: Mild
    2.0 (1.2 to 3.1)
        Vomiting: Moderate
    0.8 (0.3 to 1.6)
        Vomiting: Severe
    0.0 (0.0 to 0.4)
        Diarrhea: Mild
    7.6 (6.0 to 9.6)
        Diarrhea: Moderate
    2.5 (1.6 to 3.8)
        Diarrhea: Severe
    0.4 (0.1 to 1.1)
        Muscle pain: Mild
    11.5 (9.5 to 13.8)
        Muscle pain: Moderate
    7.8 (6.1 to 9.7)
        Muscle pain: Severe
    2.1 (1.3 to 3.3)
        Joint pain: Mild
    11.2 (9.2 to 13.4)
        Joint pain: Moderate
    6.5 (5.0 to 8.3)
        Joint pain: Severe
    1.0 (0.5 to 1.9)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With Antipyretic Medication use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With Antipyretic Medication use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) [7]
    End point description
    Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: number of subjects with known values. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 1
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1044
    Units: Percentage of subjects
        number (confidence interval 95%)
    18.6 (16.3 to 21.1)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With Antipyretic Medication use Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With Antipyretic Medication use Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) [8]
    End point description
    Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: number of subjects with known values. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 2
    Notes
    [8] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    903
    Units: Percentage of subjects
        number (confidence interval 95%)
    14.4 (12.2 to 16.9)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined) [9]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after Vaccination 1
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.0 (0.0 to 0.3)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined) [10]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: evaluable subjects. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after Vaccination 2
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    946
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.0 (0.0 to 0.4)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 SAE Within 30 Days After any Vaccination (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 SAE Within 30 Days After any Vaccination (Group 2 and 4 Combined) [11]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after any vaccination
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.0 (0.0 to 0.3)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 SAE During the Vaccination Phase (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 SAE During the Vaccination Phase (Group 2 and 4 Combined) [12]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.8 (0.3 to 1.5)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 SAE Throughout the Stage 1 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 SAE Throughout the Stage 1 (Group 2 and 4 Combined) [13]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    1.3 (0.7 to 2.2)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 SAE During the Follow-up Phase (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 SAE During the Follow-up Phase (Group 2 and 4 Combined) [14]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: evaluable subjects. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
    Notes
    [14] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    950
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.5 (0.2 to 1.2)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined) [15]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after Vaccination 1
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    6.3 (4.9 to 8.0)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Medically Attended AE During the Vaccination Phase (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Medically Attended AE During the Vaccination Phase (Group 2 and 4 Combined) [16]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    26.7 (24.0 to 29.5)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Within 30 Days After any Vaccination (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Within 30 Days After any Vaccination (Group 2 and 4 Combined) [17]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after any vaccination
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    13.3 (11.3 to 15.5)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined) [18]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: evaluable subjects. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after Vaccination 2
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    946
    Units: Percentage of subjects
        number (confidence interval 95%)
    8.8 (7.0 to 10.8)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined) [19]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: evaluable subjects. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after Vaccination 2
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    946
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.2 (0.0 to 0.8)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After any Vaccination (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After any Vaccination (Group 2 and 4 Combined) [20]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after any Vaccination
    Notes
    [20] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.5 (0.2 to 1.1)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined) [21]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after Vaccination 1
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.3 (0.1 to 0.8)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Throughout the Stage 1 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Throughout the Stage 1 (Group 2 and 4 Combined) [22]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
    Notes
    [22] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    33.7 (30.8 to 36.6)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase (Group 2 and 4 Combined) [23]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
    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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.8 (0.3 to 1.5)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Medically Attended AE During the Follow-up Phase (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Medically Attended AE During the Follow-up Phase (Group 2 and 4 Combined) [24]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: evaluable subjects. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
    Notes
    [24] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    950
    Units: Percentage of subjects
        number (confidence interval 95%)
    16.6 (14.3 to 19.2)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow-up Phase (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow-up Phase (Group 2 and 4 Combined) [25]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: evaluable subjects. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
    Notes
    [25] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    950
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.3 (0.1 to 0.9)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Throughout the Stage 1 (Group 2 and 4)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Throughout the Stage 1 (Group 2 and 4) [26]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
    Notes
    [26] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.9 (0.5 to 1.7)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined) [27]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after Vaccination 1
    Notes
    [27] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    13.8 (11.8 to 16.0)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined) [28]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: evaluable subjects. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after Vaccination 2
    Notes
    [28] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    946
    Units: Percentage of subjects
        number (confidence interval 95%)
    14.7 (12.5 to 17.1)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 AE Within 30 Days After any Vaccination (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 AE Within 30 Days After any Vaccination (Group 2 and 4 Combined) [29]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 days after any vaccination
    Notes
    [29] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    24.1 (21.6 to 26.8)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 AE During Vaccination Phase (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 AE During Vaccination Phase (Group 2 and 4 Combined) [30]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
    Notes
    [30] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    40.7 (37.7 to 43.7)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Immediate AE After Vaccination 1 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Immediate AE After Vaccination 1 (Group 2 and 4 Combined) [31]
    End point description
    Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration. The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 minutes after Vaccination 1
    Notes
    [31] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.9 (0.4 to 1.6)
    No statistical analyses for this end point

    Primary: Stage1: Percentage of Subjects With at Least 1 Immediate AE After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Immediate AE After Vaccination 2 (Group 2 and 4 Combined) [32]
    End point description
    Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration. The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. “Number of subjects Analysed”: evaluable subjects. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    30 minutes after Vaccination 2
    Notes
    [32] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    946
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.3 (0.1 to 0.9)
    No statistical analyses for this end point

    Primary: Stage1: Number of Subjects who Missed School/Work due to AE During the Vaccination Phase (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Number of Subjects who Missed School/Work due to AE During the Vaccination Phase (Group 2 and 4 Combined) [33]
    End point description
    Stage 1 Safety population: subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.
    End point type
    Primary
    End point timeframe
    Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
    Notes
    [33] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    1057
    Units: Subjects
    171
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 [34]
    End point description
    Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies number of subjects with known values. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    7 days after booster vaccination
    Notes
    [34] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    59
    35
    74
    55
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Mild
    5.1 (1.1 to 14.1)
    11.4 (3.2 to 26.7)
    9.5 (3.9 to 18.5)
    14.5 (6.5 to 26.7)
        Redness: Moderate
    3.4 (0.4 to 11.7)
    11.4 (3.2 to 26.7)
    8.1 (3.0 to 16.8)
    9.1 (3.0 to 20.0)
        Redness: Severe
    5.1 (1.1 to 14.1)
    5.7 (0.7 to 19.2)
    4.1 (0.8 to 11.4)
    1.8 (0.0 to 9.7)
        Swelling: Mild
    10.2 (3.8 to 20.8)
    11.4 (3.2 to 26.7)
    6.8 (2.2 to 15.1)
    9.1 (3.0 to 20.0)
        Swelling: Moderate
    8.5 (2.8 to 18.7)
    11.4 (3.2 to 26.7)
    12.2 (5.7 to 21.8)
    7.3 (2.0 to 17.6)
        Swelling: Severe
    0.0 (0.0 to 6.1)
    2.9 (0.1 to 14.9)
    0.0 (0.0 to 4.9)
    1.8 (0.0 to 9.7)
        Pain at injection site: Mild
    41.4 (28.6 to 55.1)
    25.7 (12.5 to 43.3)
    36.5 (25.6 to 48.5)
    47.3 (33.7 to 61.2)
        Pain at injection site: Moderate
    36.2 (24.0 to 49.9)
    45.7 (28.8 to 63.4)
    47.3 (35.6 to 59.3)
    38.2 (25.4 to 52.3)
        Pain at injection site: Severe
    1.7 (0.0 to 9.2)
    14.3 (4.8 to 30.3)
    1.4 (0.0 to 7.3)
    0.0 (0.0 to 6.5)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 [35]
    End point description
    Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as >=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours). Stage 2 safety population: subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies number of subjects with known values. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    7 days after booster vaccination
    Notes
    [35] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    60
    39
    76
    56
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: 38.0 to 38.4 degree C
    1.7 (0.0 to 8.9)
    0.0 (0.0 to 9.0)
    0.0 (0.0 to 4.7)
    1.8 (0.0 to 9.6)
        Fever: 38.4 to 38.9 degree C
    0.0 (0.0 to 6.0)
    2.6 (0.1 to 13.5)
    0.0 (0.0 to 4.7)
    0.0 (0.0 to 6.4)
        Fever: 38.9 to 40.0 degree C
    3.3 (0.4 to 11.5)
    0.0 (0.0 to 9.0)
    0.0 (0.0 to 4.7)
    0.0 (0.0 to 6.4)
        Fever: > 40.0 degree C
    0.0 (0.0 to 6.0)
    0.0 (0.0 to 9.0)
    0.0 (0.0 to 4.7)
    0.0 (0.0 to 6.4)
        Fatigue: Mild
    25.0 (14.7 to 37.9)
    25.6 (13.0 to 42.1)
    50.0 (38.3 to 61.7)
    37.5 (24.9 to 51.5)
        Fatigue: Moderate
    21.7 (12.1 to 34.2)
    30.8 (17.0 to 47.6)
    10.5 (4.7 to 19.7)
    23.2 (13.0 to 36.4)
        Fatigue: Severe
    0.0 (0.0 to 6.0)
    5.1 (0.6 to 17.3)
    1.3 (0.0 to 7.1)
    5.4 (1.1 to 14.9)
        Headache: Mild
    25.0 (14.7 to 37.9)
    20.5 (9.3 to 36.5)
    34.2 (23.7 to 46.0)
    39.3 (26.5 to 53.2)
        Headache: Moderate
    8.3 (2.8 to 18.4)
    28.2 (15.0 to 44.9)
    10.5 (4.7 to 19.7)
    14.3 (6.4 to 26.2)
        Headache: Severe
    3.3 (0.4 to 11.5)
    5.1 (0.6 to 17.3)
    1.3 (0.0 to 7.1)
    1.8 (0.0 to 9.6)
        Chills: Mild
    10.0 (3.8 to 20.5)
    12.8 (4.3 to 27.4)
    15.8 (8.4 to 26.0)
    12.5 (5.2 to 24.1)
        Chills: Moderate
    0.0 (0.0 to 6.0)
    5.1 (0.6 to 17.3)
    2.6 (0.3 to 9.2)
    0.0 (0.0 to 6.4)
        Chills: Severe
    0.0 (0.0 to 6.0)
    0.0 (0.0 to 9.0)
    0.0 (0.0 to 4.7)
    1.8 (0.0 to 9.6)
        Vomiting: Mild
    1.7 (0.0 to 8.9)
    0.0 (0.0 to 9.0)
    1.3 (0.0 to 7.1)
    1.8 (0.0 to 9.6)
        Vomiting: Moderate
    1.7 (0.0 to 8.9)
    0.0 (0.0 to 9.0)
    1.3 (0.0 to 7.1)
    0.0 (0.0 to 6.4)
        Vomiting: severe
    0.0 (0.0 to 6.0)
    0.0 (0.0 to 9.0)
    0.0 (0.0 to 4.7)
    0.0 (0.0 to 6.4)
        Diarrhea: Mild
    5.0 (1.0 to 13.9)
    7.7 (1.6 to 20.9)
    7.9 (3.0 to 16.4)
    7.1 (2.0 to 17.3)
        Diarrhea: Moderate
    0.0 (0.0 to 6.0)
    2.6 (0.1 to 13.5)
    1.3 (0.0 to 7.1)
    5.4 (1.1 to 14.9)
        Diarrhea: Severe
    0.0 (0.0 to 6.0)
    0.0 (0.0 to 9.0)
    0.0 (0.0 to 4.7)
    0.0 (0.0 to 6.4)
        Muscle pain: Mild
    13.3 (5.9 to 24.6)
    10.3 (2.9 to 24.2)
    22.4 (13.6 to 33.4)
    19.6 (10.2 to 32.4)
        Muscle pain: Moderate
    5.0 (1.0 to 13.9)
    12.8 (4.3 to 27.4)
    7.9 (3.0 to 16.4)
    3.6 (0.4 to 12.3)
        Muscle pain: Severe
    0.0 (0.0 to 6.0)
    7.7 (1.6 to 20.9)
    1.3 (0.0 to 7.1)
    0.0 (0.0 to 6.4)
        Joint pain: Mild
    15.0 (7.1 to 26.6)
    12.8 (4.3 to 27.4)
    11.8 (5.6 to 21.3)
    12.5 (5.2 to 24.1)
        Joint pain: Moderate
    3.3 (0.4 to 11.5)
    10.3 (2.9 to 24.2)
    9.2 (3.8 to 18.1)
    3.6 (0.4 to 12.3)
        Joint pain: Severe
    0.0 (0.0 to 6.0)
    2.6 (0.1 to 13.5)
    0.0 (0.0 to 4.7)
    0.0 (0.0 to 6.4)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With Antipyretic Medication use Within 7 Days After Booster Vaccination: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With Antipyretic Medication use Within 7 Days After Booster Vaccination: Group 1 Through Group 4 [36]
    End point description
    The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies number of subjects with known values. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    7 days after booster vaccination
    Notes
    [36] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    60
    39
    76
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    16.7 (8.3 to 28.5)
    20.5 (9.3 to 36.5)
    13.2 (6.5 to 22.9)
    10.7 (4.0 to 21.9)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With at Least 1 SAE During Booster Phase: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With at Least 1 SAE During Booster Phase: Group 1 Through Group 4 [37]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    Booster vaccination phase: From booster vaccination through 1 month after booster vaccination
    Notes
    [37] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    40
    77
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.0 (0.0 to 5.4)
    0.0 (0.0 to 8.8)
    0.0 (0.0 to 4.7)
    1.8 (0.0 to 9.6)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With at Least 1 SAE During the Booster Follow-up Phase: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With at Least 1 SAE During the Booster Follow-up Phase: Group 1 Through Group 4 [38]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    Booster follow-up phase: From 1 month after booster vaccination through 6 months after booster vaccination
    Notes
    [38] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    38
    77
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.0 (0.0 to 5.4)
    0.0 (0.0 to 9.3)
    2.6 (0.3 to 9.1)
    0.0 (0.0 to 6.4)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With at Least 1 SAE Throughout Booster Phase: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With at Least 1 SAE Throughout Booster Phase: Group 1 Through Group 4 [39]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    Booster vaccination phase: From booster vaccination through 6 months after booster vaccination
    Notes
    [39] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    40
    77
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.0 (0.0 to 5.4)
    0.0 (0.0 to 8.8)
    2.6 (0.3 to 9.1)
    0.0 (0.0 to 6.4)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With at Least 1 Medically Attended AE During Booster Phase: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With at Least 1 Medically Attended AE During Booster Phase: Group 1 Through Group 4 [40]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    Booster vaccination phase: From booster vaccination through 1 month after booster vaccination
    Notes
    [40] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    40
    77
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    9.0 (3.4 to 18.5)
    5.0 (0.6 to 16.9)
    2.6 (0.3 to 9.1)
    7.1 (2.0 to 17.3)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With at Least 1 Medically Attended AE During the Booster Follow-up Phase: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With at Least 1 Medically Attended AE During the Booster Follow-up Phase: Group 1 Through Group 4 [41]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination
    Notes
    [41] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    38
    77
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    3.0 (0.4 to 10.4)
    13.2 (4.4 to 28.1)
    6.5 (2.1 to 14.5)
    7.1 (2.0 to 17.3)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With at Least 1 Medically Attended AE Throughout Booster Phase: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With at Least 1 Medically Attended AE Throughout Booster Phase: Group 1 Through Group 4 [42]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    Booster Vaccination Phase: From booster vaccination through 6 months after booster vaccination
    Notes
    [42] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    40
    77
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    10.4 (4.3 to 20.3)
    15.0 (5.7 to 29.8)
    7.8 (2.9 to 16.2)
    14.3 (6.4 to 26.2)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With at Least 1 NDCMC During Booster Phase: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With at Least 1 NDCMC During Booster Phase: Group 1 Through Group 4 [43]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination
    Notes
    [43] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    40
    77
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.0 (0.0 to 5.4)
    0.0 (0.0 to 8.8)
    0.0 (0.0 to 4.7)
    0.0 (0.0 to 6.4)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With at Least 1 NDCMC During the Booster Follow-up Phase: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With at Least 1 NDCMC During the Booster Follow-up Phase: Group 1 Through Group 4 [44]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination
    Notes
    [44] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    38
    77
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.0 (0.0 to 5.4)
    0.0 (0.0 to 9.3)
    2.6 (0.3 to 9.1)
    0.0 (0.0 to 6.4)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With at Least 1 NDCMC Throughout Booster Phase: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With at Least 1 NDCMC Throughout Booster Phase: Group 1 Through Group 4 [45]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    Booster Vaccination Phase: From booster vaccination through 6 months after booster vaccination
    Notes
    [45] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    40
    77
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.0 (0.0 to 5.4)
    0.0 (0.0 to 8.8)
    2.6 (0.3 to 9.1)
    0.0 (0.0 to 6.4)
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With at Least 1 AE During Booster Phase: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With at Least 1 AE During Booster Phase: Group 1 Through Group 4 [46]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination
    Notes
    [46] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    40
    77
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    13.4 (6.3 to 24.0)
    10.0 (2.8 to 23.7)
    10.4 (4.6 to 19.4)
    17.9 (8.9 to 30.4)
    No statistical analyses for this end point

    Primary: Stage2: Number of Subjects who Missed School/Work due to AE After Booster Vaccination: Group 1 Through Group 4

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    End point title
    		 Stage2: Number of Subjects who Missed School/Work due to AE After Booster Vaccination: Group 1 Through Group 4 [47]
    End point description
    The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies subjects evaluable for this endpoint. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination
    Notes
    [47] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    40
    77
    56
    Units: Subjects
    3
    0
    3
    2
    No statistical analyses for this end point

    Primary: Stage2: Percentage of Subjects With at Least 1 Immediate AE After Booster Vaccination: Group 1 Through Group 4

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    End point title
    		 Stage2: Percentage of Subjects With at Least 1 Immediate AE After Booster Vaccination: Group 1 Through Group 4 [48]
    End point description
    Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration. The safety population for Stage 2 included subjects who received the booster vaccination and for whom safety data were available. Analysis was planned for Group 1 through Group 4.
    End point type
    Primary
    End point timeframe
    30 minutes after booster vaccination
    Notes
    [48] - 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: Only descriptive analysis was planned for this endpoint.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    67
    40
    77
    56
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA Titer Level >= LLOQ for all 4 Primary MenB Test Strains Combined Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With hSBA Titer Level >= LLOQ for all 4 Primary MenB Test Strains Combined Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)
    End point description
    Percentage of subjects who achieved an hSBA titer >= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this endpoint. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1, 1 month after Vaccination 2
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    864
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22) Before Vaccination 1, (n=839)
    25.1 (22.2 to 28.2)
        PMB80 (A22) 1 month after Vaccination 2, (n=852)
    91.0 (88.8 to 92.8)
        PMB2001 (A56) Before Vaccination 1, (n=833)
    12.8 (10.6 to 15.3)
        PMB2001 (A56) 1 month after Vaccination 2, (n=854)
    99.4 (98.6 to 99.8)
        PMB2948 (B24) Before Vaccination 1, (n=855)
    11.9 (9.8 to 14.3)
        PMB2948 (B24) 1 month after Vaccination 2,(n=842)
    79.3 (76.4 to 82.0)
        PMB2707 (B44) Before Vaccination 1, (n=861)
    4.5 (3.2 to 6.1)
        PMB2707 (B44) 1 month after Vaccination 2,(n=853)
    94.5 (92.7 to 95.9)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for all 4 Primary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for all 4 Primary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)
    End point description
    Percentage of subjects who achieved an hSBA titer >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for all 4 primary MenB test strains was reported in this endpoint. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, 'n’ signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 month after Vaccination 2 (Vacc 2)
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    864
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22) Before Vacc 1 >=1:4,(n=839)
    36.6 (33.3 to 40.0)
        PMB80 (A22) Before Vacc 1 >=1:8,(n=839)
    31.8 (28.7 to 35.1)
        PMB80 (A22) Before Vacc 1 >=1:16,(n=839)
    25.1 (22.2 to 28.2)
        PMB80 (A22) Before Vacc 1 >=1:32,(n=839)
    11.4 (9.4 to 13.8)
        PMB80 (A22) Before Vacc 1 >=1:64, (n=839)
    4.4 (3.1 to 6.0)
        PMB80 (A22) Before Vacc 1 >=1:128,(n=839)
    0.8 (0.3 to 1.7)
        PMB80 (A22) 1 Month after Vacc 2 >=1:4,(n=852)
    91.7 (89.6 to 93.4)
        PMB80 (A22) 1 Month after Vacc 2 >=1:8,n=852)
    91.5 (89.5 to 93.3)
        PMB80 (A22) 1 Month after Vacc 2 >=1:16,(n=852)
    91.0 (88.8 to 92.8)
        PMB80 (A22) 1 Month after Vacc 2 >=1:32,(n=852)
    80.2 (77.3 to 82.8)
        PMB80 (A22) 1 Month after Vacc 2 >=1:64,(n=852)
    54.9 (51.5 to 58.3)
        PMB80 (A22) 1 Month after Vacc 2 >=1:128,(n=852)
    27.3 (24.4 to 30.5)
        PMB2001 (A56) Before Vacc 1 >=1:4,(n=833)
    17.5 (15.0 to 20.3)
        PMB2001 (A56) Before Vacc 1 >=1:8,(n=833)
    12.8 (10.6 to 15.3)
        PMB2001 (A56) Before Vacc 1 >=1:16,(n=833)
    11.0 (9.0 to 13.4)
        PMB2001 (A56) Before Vacc 1 >=1:32,(n=833)
    7.6 (5.9 to 9.6)
        PMB2001 (A56) Before Vacc 1 >=1:64,(n=833)
    4.3 (3.0 to 5.9)
        PMB2001 (A56) Before Vacc 1 >=1:128,(n=833)
    2.4 (1.5 to 3.7)
        PMB2001 (A56) 1 Month after Vacc 2 >=1:4,(n=854)
    99.5 (98.8 to 99.9)
        PMB2001 (A56) 1 Month after Vacc 2 >=1:8,(n=854)
    99.4 (98.6 to 99.8)
        PMB2001 (A56) 1 Month after Vacc 2 >=1:16,(n=854)
    99.1 (98.2 to 99.6)
        PMB2001 (A56) 1 Month after Vacc 2 >=1:32,(n=854)
    97.0 (95.6 to 98.0)
        PMB2001 (A56) 1 Month after Vacc 2 >=1:64,(n=854)
    87.7 (85.3 to 89.8)
        PMB2001 (A56) 1 Month after Vacc 2 >=1:128,(n=854)
    69.2 (66.0 to 72.3)
        PMB2948 (B24) Before Vacc 1 >=1:4,(n=855)
    14.6 (12.3 to 17.2)
        PMB2948 (B24) Before Vacc 1 >=1:8,(n=855)
    11.9 (9.8 to 14.3)
        PMB2948 (B24) Before Vacc 1 >=1:16,(n=855)
    8.2 (6.4 to 10.2)
        PMB2948 (B24) Before Vacc 1 >=1:32,(n=855)
    4.2 (3.0 to 5.8)
        PMB2948 (B24) Before Vacc 1 >=1:64,(n=855)
    2.3 (1.4 to 3.6)
        PMB2948 (B24) Before Vacc 1 >=1:128,(n=855)
    1.1 (0.5 to 2.0)
        PMB2948 (B24) 1 Month after Vacc 2 >=1:4,(n=842)
    81.2 (78.4 to 83.8)
        PMB2948 (B24) 1 Month after Vacc 2 >=1:8,(n=842)
    79.3 (76.4 to 82.0)
        PMB2948 (B24) 1 Month after Vacc 2 >=1:16,(n=842)
    74.0 (70.9 to 76.9)
        PMB2948 (B24) 1 Month after Vacc 2 >=1:32,(n=842)
    47.9 (44.4 to 51.3)
        PMB2948 (B24) 1 Month after Vacc 2 >=1:64,(n=842)
    24.9 (22.1 to 28.0)
        PMB2948 (B24) 1 Month after Vacc 2 >=1:128,(n=842)
    9.6 (7.7 to 11.8)
        PMB2707 (B44) Before Vacc 1 >=1:4,(n=861)
    7.2 (5.6 to 9.1)
        PMB2707 (B44) Before Vacc 1 >=1:8,(n=861)
    4.5 (3.2 to 6.1)
        PMB2707 (B44) Before Vacc 1 >=1:16,(n=861)
    3.3 (2.2 to 4.7)
        PMB2707 (B44) Before Vacc 1 >=1:32,(n=861)
    2.1 (1.2 to 3.3)
        PMB2707 (B44) Before Vacc 1 >=1:64,(n=861)
    1.2 (0.6 to 2.1)
        PMB2707 (B44) Before Vacc 1 >=1:128,(n=861)
    0.3 (0.1 to 1.0)
        PMB2707 (B44) 1 Month after Vacc 2 >=1:4,(n=853)
    96.2 (94.7 to 97.4)
        PMB2707 (B44) 1 Month after Vacc 2 >=1:8,(n=853)
    94.5 (92.7 to 95.9)
        PMB2707 (B44) 1 Month after Vacc 2 >=1:16,(n=853)
    89.0 (86.7 to 91.0)
        PMB2707 (B44) 1 Month after Vacc 2 >=1:32,(n=853)
    68.6 (65.3 to 71.7)
        PMB2707 (B44) 1 Month after Vacc 2 >=1:64,(n=853)
    41.0 (37.7 to 44.4)
        PMB2707 (B44) 1 Month after Vacc 2 >=1:128,(n=853)
    19.2 (16.6 to 22.0)
    No statistical analyses for this end point

    Secondary: Stage1: hSBA Geometric Mean Titers (GMTs) for all 4 Primary MenB Test Strains Combined Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: hSBA Geometric Mean Titers (GMTs) for all 4 Primary MenB Test Strains Combined Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)
    End point description
    GMTs were calculated using all subjects with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5 * LLOQ for analysis. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n' signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 month after Vaccination 2 (Vacc 2)
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    864
    Units: Titers
    geometric mean (confidence interval 95%)
        PMB80 (A22) Before Vacc 1,(n=839)
    10.7 (10.3 to 11.1)
        PMB80 (A22) 1 month after Vacc 2,(n=852)
    49.3 (46.2 to 52.6)
        PMB2001 (A56) Before Vacc 1,(n=833)
    5.3 (5.0 to 5.6)
        PMB2001 (A56) 1 month after Vacc 2,(n=854)
    139.5 (130.6 to 149.1)
        PMB2948 (B24) Before Vacc 1,(n=855)
    4.9 (4.7 to 5.1)
        PMB2948 (B24) 1 month after Vacc 2,(n=842)
    21.2 (19.6 to 22.9)
        PMB2707 (B44) Before Vacc 1,(n=861)
    4.3 (4.2 to 4.5)
        PMB2707 (B44) 1 month after Vacc 2,(n=853)
    37.8 (35.1 to 40.8)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)
    End point description
    Percentage of subjects who achieved an hSBA titer greater than or equal to LLOQ for for 10 Secondary MenB test strains combined (LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16) was reported in this endpoint. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on all 10 strains at the given time point. Analysis was planned for combined Group 2 and 4.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 month after Vaccination 2 (Vacc 2)
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    864
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB3175 (A29) Before Vacc 1,(n=166)
    4.8 (2.1 to 9.3)
        PMB3175 (A29) 1 month after Vacc 2,(n=166)
    95.2 (90.7 to 97.9)
        PMB3010 (A06) Before Vacc 1,(n=157)
    5.7 (2.7 to 10.6)
        PMB3010 (A06) 1 month after Vacc 2,(n=159)
    89.3 (83.4 to 93.6)
        PMB824 (A12) Before Vacc 1,(n=154)
    5.2 (2.3 to 10.0)
        PMB824 (A12) 1 month after Vacc 2,(n=157)
    83.4 (76.7 to 88.9)
        PMB3040 (A07) Before Vacc 1,(n=150)
    32.0 (24.6 to 40.1)
        PMB3040 (A07) 1 month after Vacc 2,(n=157)
    96.8 (92.7 to 99.0)
        PMB1672 (A15) Before Vacc 1,(n=166)
    22.9 (16.7 to 30.0)
        PMB1672 (A15) 1 month after Vacc 2,(n=165)
    89.1 (83.3 to 93.4)
        PMB1989 (A19) Before Vacc 1,(n=167)
    5.4 (2.5 to 10.0)
        PMB1989 (A19) 1 month after Vacc 2,(n=167)
    90.4 (84.9 to 94.4)
        PMB648 (B16) Before Vacc 1,(n=172)
    8.1 (4.5 to 13.3)
        PMB648 (B16) 1 month after Vacc 2,(n=164)
    77.4 (70.3 to 83.6)
        PMB866 (B09) Before Vacc 1,(n=171)
    9.9 (5.9 to 15.4)
        PMB866 (B09) 1 month after Vacc 2,(n=166)
    71.1 (63.6 to 77.8)
        PMB1256 (B03) Before Vacc 1,(n=172)
    3.5 (1.3 to 7.4)
        PMB1256 (B03) 1 month after Vacc 2,(n=164)
    74.4 (67.0 to 80.9)
        PMB431 (B15) Before Vacc 1,(n=172)
    6.4 (3.2 to 11.2)
        PMB431 (B15) 1 month after Vacc 2,(n=167)
    85.0 (78.7 to 90.1)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)
    End point description
    Percentage of subjects who achieved an hSBA titer >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for each of the 10 secondary MenB test strains was reported in this endpoint. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on each of the 10 Secondary strains at the given time point. Analysis was planned for combined Group 2 and 4.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 month after Vaccination 2 (Vacc 2)
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    864
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB3175 (A29) Before Vacc 1 >=1:4,(n=166)
    6.6 (3.4 to 11.5)
        PMB3175 (A29) Before Vacc 1 >=1:8,(n=166)
    4.8 (2.1 to 9.3)
        PMB3175 (A29) Before Vacc 1 >=1:16,(n=166)
    3.6 (1.3 to 7.7)
        PMB3175 (A29) Before Vacc 1 >=1:32,(n=166)
    1.2 (0.1 to 4.3)
        PMB3175 (A29) Before Vacc 1 >=1:64,(n=166)
    0.0 (0.0 to 2.2)
        PMB3175 (A29) Before Vacc 1 >=1:128,(n=166)
    0.0 (0.0 to 2.2)
        PMB3175 (A29) 1 Month after Vacc 2 >=1:4,(n=166)
    95.8 (91.5 to 98.3)
        PMB3175 (A29) 1 Month after Vacc 2 >=1:8,(n=166)
    95.2 (90.7 to 97.9)
        PMB3175 (A29) 1 Month after Vacc 2 >=1:16,(n=166)
    92.2 (87.0 to 95.8)
        PMB3175 (A29) 1 Month after Vacc 2 >=1:32,(n=166)
    71.7 (64.2 to 78.4)
        PMB3175 (A29) 1 Month after Vacc 2 >=1:64,(n=166)
    38.0 (30.5 to 45.8)
        PMB3175 (A29) 1 Month after Vacc 2 >=1:128,(n=166)
    13.9 (9.0 to 20.1)
        PMB3010 (A06) Before Vacc 1 >=1:4,(n=157)
    7.0 (3.5 to 12.2)
        PMB3010 (A06) Before Vacc 1 >=1:8,(n=157)
    6.4 (3.1 to 11.4)
        PMB3010 (A06) Before Vacc 1 >=1:16,(n=157)
    5.7 (2.7 to 10.6)
        PMB3010 (A06) Before Vacc 1 >=1:32,(n=157)
    3.8 (1.4 to 8.1)
        PMB3010 (A06) Before Vacc 1 >=1:64,(n=157)
    3.2 (1.0 to 7.3)
        PMB3010 (A06) Before Vacc 1 >=1:128,(n=157)
    1.9 (0.4 to 5.5)
        PMB3010 (A06) 1 Month after Vacc 2 >=1:4,(n=159)
    89.9 (84.2 to 94.1)
        PMB3010 (A06) 1 Month after Vacc 2 >=1:8,(n=159)
    89.3 (83.4 to 93.6)
        PMB3010 (A06) 1 Month after Vacc 2 >=1:16,(n=159)
    89.3 (83.4 to 93.6)
        PMB3010 (A06) 1 Month after Vacc 2 >=1:32,(n=159)
    79.9 (72.8 to 85.8)
        PMB3010 (A06) 1 Month after Vacc 2 >=1:64,(n=159)
    54.7 (46.6 to 62.6)
        PMB3010 (A06) 1 Month after Vacc 2 >=1:128,(n=159)
    22.0 (15.8 to 29.3)
        PMB824 (A12) Before Vacc 1 >=1:4,(n=154)
    9.7 (5.6 to 15.6)
        PMB824 (A12) Before Vacc 1 >=1:8,(n=154)
    9.1 (5.1 to 14.8)
        PMB824 (A12) Before Vacc 1 >=1:16,(n=154)
    5.2 (2.3 to 10.0)
        PMB824 (A12) Before Vacc 1 >=1:32,(n=154)
    2.6 (0.7 to 6.5)
        PMB824 (A12) Before Vacc 1 >=1:64,(n=154)
    0.0 (0.0 to 2.4)
        PMB824 (A12) Before Vacc 1 >=1:128,(n=154)
    0.0 (0.0 to 2.4)
        PMB824 (A12) 1 Month after Vacc 2 >=1:4,(n=157)
    89.2 (83.2 to 93.6)
        PMB824 (A12) 1 Month after Vacc 2 >=1:8,(n=157)
    87.9 (81.7 to 92.6)
        PMB824 (A12) 1 Month after Vacc 2 >=1:16,(n=157)
    83.4 (76.7 to 88.9)
        PMB824 (A12) 1 Month after Vacc 2 >=1:32,(n=157)
    52.9 (44.8 to 60.9)
        PMB824 (A12) 1 Month after Vacc 2 >=1:64,(n=157)
    18.5 (12.7 to 25.4)
        PMB824 (A12) 1 Month after Vacc 2 >=1:128,(n=157)
    1.3 (0.2 to 4.5)
        PMB3040 (A07) Before Vacc 1 >=1:4,(n=150)
    32.7 (25.2 to 40.8)
        PMB3040 (A07) Before Vacc 1 >=1:8,(n=150)
    32.0 (24.6 to 40.1)
        PMB3040 (A07) Before Vacc 1 >=1:16,(n=150)
    31.3 (24.0 to 39.4)
        PMB3040 (A07) Before Vacc 1 >=1:32,(n=150)
    28.7 (21.6 to 36.6)
        PMB3040 (A07) Before Vacc 1 >=1:64,(n=150)
    17.3 (11.6 to 24.4)
        PMB3040 (A07) Before Vacc 1 >=1:128,(n=150)
    2.7 (0.7 to 6.7)
        PMB3040 (A07) 1 Month after Vacc 2 >=1:4,(n=157)
    96.8 (92.7 to 99.0)
        PMB3040 (A07) 1 Month after Vacc 2 >=1:8,(n=157)
    96.8 (92.7 to 99.0)
        PMB3040 (A07) 1 Month after Vacc 2 >=1:16,(n=157)
    96.8 (92.7 to 99.0)
        PMB3040 (A07) 1 Month after Vacc 2 >=1:32,(n=157)
    94.3 (89.4 to 97.3)
        PMB3040 (A07) 1 Month after Vacc 2 >=1:64,(n=157)
    68.8 (60.9 to 75.9)
        PMB3040 (A07) 1 Month after Vacc 2 >=1:128,(n=157)
    31.2 (24.1 to 39.1)
        PMB1672 (A15) Before Vacc 1 >=1:4,(n=166)
    24.7 (18.3 to 32.0)
        PMB1672 (A15) Before Vacc 1 >=1:8,(n=166)
    22.9 (16.7 to 30.0)
        PMB1672 (A15) Before Vacc 1 >=1:16,(n=166)
    21.7 (15.7 to 28.7)
        PMB1672 (A15) Before Vacc 1 >=1:32,(n=166)
    13.9 (9.0 to 20.1)
        PMB1672 (A15) Before Vacc 1 >=1:64,(n=166)
    5.4 (2.5 to 10.0)
        PMB1672 (A15) Before Vacc 1 >=1:128,(n=166)
    0.6 (0.0 to 3.3)
        PMB1672 (A15) 1 Month after Vacc 2 >=1:4,(n=165)
    89.1 (83.3 to 93.4)
        PMB1672 (A15) 1 Month after Vacc 2 >=1:8,(n=165)
    89.1 (83.3 to 93.4)
        PMB1672 (A15) 1 Month after Vacc 2 >=1:16,(n=165)
    87.3 (81.2 to 91.9)
        PMB1672 (A15) 1 Month after Vacc 2 >=1:32,(n=165)
    69.7 (62.1 to 76.6)
        PMB1672 (A15) 1 Month after Vacc 2 >=1:64,(n=165)
    30.3 (23.4 to 37.9)
        PMB1672 (A15) 1 Month after Vacc 2 >=1:128,(n=165)
    5.5 (2.5 to 10.1)
        PMB1989 (A19) Before Vacc 1 >=1:4,(n=167)
    11.4 (7.0 to 17.2)
        PMB1989 (A19) Before Vacc 1 >=1:8,(n=167)
    8.4 (4.7 to 13.7)
        PMB1989 (A19) Before Vacc 1 >=1:16,(n=167)
    5.4 (2.5 to 10.0)
        PMB1989 (A19) Before Vacc 1 >=1:32,(n=167)
    3.6 (1.3 to 7.7)
        PMB1989 (A19) Before Vacc 1 >=1:64,(n=167)
    1.2 (0.1 to 4.3)
        PMB1989 (A19) Before Vacc 1 >=1:128,(n=167)
    0.6 (0.0 to 3.3)
        PMB1989 (A19) 1 Month after Vacc 2 >=1:4,(n=167)
    92.2 (87.1 to 95.8)
        PMB1989 (A19) 1 Month after Vacc 2 >=1:8,(n=167)
    92.2 (87.1 to 95.8)
        PMB1989 (A19) 1 Month after Vacc 2 >=1:16,(n=167)
    90.4 (84.9 to 94.4)
        PMB1989 (A19) 1 Month after Vacc 2 >=1:32,(n=167)
    84.4 (78.0 to 89.6)
        PMB1989 (A19) 1 Month after Vacc 2 >=1:64,(n=167)
    61.1 (53.2 to 68.5)
        PMB1989 (A19) 1 Month after Vacc 2 >=1:128,(n=167)
    28.7 (22.0 to 36.2)
        PMB648 (B16) Before Vacc 1 >=1:4,(n=172)
    9.9 (5.9 to 15.4)
        PMB648 (B16) Before Vacc 1 >=1:8,(n=172)
    8.1 (4.5 to 13.3)
        PMB648 (B16) Before Vacc 1 >=1:16,(n=172)
    8.1 (4.5 to 13.3)
        PMB648 (B16) Before Vacc 1 >=1:32,(n=172)
    7.6 (4.1 to 12.6)
        PMB648 (B16) Before Vacc 1 >=1:64,(n=172)
    2.3 (0.6 to 5.8)
        PMB648 (B16) Before Vacc 1 >=1:128,(n=172)
    0.6 (0.0 to 3.2)
        PMB648 (B16) 1 Month after Vacc 2 >=1:4,(n=164)
    79.3 (72.3 to 85.2)
        PMB648 (B16) 1 Month after Vacc 2 >=1:8,(n=164)
    77.4 (70.3 to 83.6)
        PMB648 (B16) 1 Month after Vacc 2 >=1:16,(n=164)
    73.8 (66.4 to 80.3)
        PMB648 (B16) 1 Month after Vacc 2 >=1:32,(n=164)
    51.2 (43.3 to 59.1)
        PMB648 (B16) 1 Month after Vacc 2 >=1:64,(n=164)
    28.7 (21.9 to 36.2)
        PMB648 (B16) 1 Month after Vacc 2 >=1:128,(n=164)
    6.1 (3.0 to 10.9)
        PMB866 (B09) Before Vacc 1 >=1:4,(n=171)
    10.5 (6.4 to 16.1)
        PMB866 (B09) Before Vacc 1 >=1:8,(n=171)
    9.9 (5.9 to 15.4)
        PMB866 (B09) Before Vacc 1 >=1:16,(n=171)
    9.4 (5.4 to 14.7)
        PMB866 (B09) Before Vacc 1 >=1:32,(n=171)
    4.7 (2.0 to 9.0)
        PMB866 (B09) Before Vacc 1 >=1:64,(n=171)
    1.2 (0.1 to 4.2)
        PMB866 (B09) Before Vacc 1 >=1:128,(n=171)
    0.0 (0.0 to 2.1)
        PMB866 (B09) 1 Month after Vacc 2 >=1:4,(n=166)
    74.7 (67.4 to 81.1)
        PMB866 (B09) 1 Month after Vacc 2 >=1:8,(n=166)
    71.1 (63.6 to 77.8)
        PMB866 (B09) 1 Month after Vacc 2 >=1:16,(n=166)
    63.3 (55.4 to 70.6)
        PMB866 (B09) 1 Month after Vacc 2 >=1:32,(n=166)
    34.3 (27.2 to 42.1)
        PMB866 (B09) 1 Month after Vacc 2 >=1:64,(n=166)
    8.4 (4.7 to 13.7)
        PMB866 (B09) 1 Month after Vacc 2 >=1:128,(n=166)
    2.4 (0.7 to 6.1)
        PMB1256 (B03) Before Vacc 1 >=1:4,(n=172)
    3.5 (1.3 to 7.4)
        PMB1256 (B03) Before Vacc 1 >=1:8,(n=172)
    3.5 (1.3 to 7.4)
        PMB1256 (B03) Before Vacc 1 >=1:16,(n=172)
    3.5 (1.3 to 7.4)
        PMB1256 (B03) Before Vacc 1 >=1:32,(n=172)
    1.7 (0.4 to 5.0)
        PMB1256 (B03) Before Vacc 1 >=1:64,(n=172)
    0.6 (0.0 to 3.2)
        PMB1256 (B03) Before Vacc 1 >=1:128,(n=172)
    0.6 (0.0 to 3.2)
        PMB1256 (B03) 1 Month after Vacc 2 >=1:4,(n=164)
    77.4 (70.3 to 83.6)
        PMB1256 (B03) 1 Month after Vacc 2 >=1:8,(n=164)
    74.4 (67.0 to 80.9)
        PMB1256 (B03) 1 Month after Vacc 2 >=1:16,(n=164)
    64.0 (56.2 to 71.4)
        PMB1256 (B03) 1 Month after Vacc 2 >=1:32,(n=164)
    42.1 (34.4 to 50.0)
        PMB1256 (B03) 1 Month after Vacc 2 >=1:64,(n=164)
    23.2 (16.9 to 30.4)
        PMB1256 (B03) 1 Month after Vacc 2 >=1:128,(n=164)
    7.3 (3.8 to 12.4)
        PMB431 (B15) Before Vacc 1 >=1:4,(n=172)
    8.1 (4.5 to 13.3)
        PMB431 (B15) Before Vacc 1 >=1:8,(n=172)
    6.4 (3.2 to 11.2)
        PMB431 (B15) Before Vacc 1 >=1:16,(n=172)
    5.8 (2.8 to 10.4)
        PMB431 (B15) Before Vacc 1 >=1:32,(n=172)
    4.1 (1.7 to 8.2)
        PMB431 (B15) Before Vacc 1 >=1:64,(n=172)
    2.3 (0.6 to 5.8)
        PMB431 (B15) Before Vacc 1 >=1:128,(n=172)
    0.0 (0.0 to 2.1)
        PMB431 (B15) 1 Month after Vacc 2 >=1:4,(n=167)
    87.4 (81.4 to 92.0)
        PMB431 (B15) 1 Month after Vacc 2 >=1:8,(n=167)
    85.0 (78.7 to 90.1)
        PMB431 (B15) 1 Month after Vacc 2 >=1:16,(n=167)
    72.5 (65.0 to 79.1)
        PMB431 (B15) 1 Month after Vacc 2 >=1:32,(n=167)
    36.5 (29.2 to 44.3)
        PMB431 (B15) 1 Month after Vacc 2 >=1:64,(n=167)
    15.0 (9.9 to 21.3)
        PMB431 (B15) 1 Month after Vacc 2 >=1:128,(n=167)
    2.4 (0.7 to 6.0)
    No statistical analyses for this end point

    Secondary: Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)

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    End point title
    		 Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 2 and 4 Combined)
    End point description
    GMTs were calculated using all subjects with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16. Titers below the LLOQ were set to 0.5*LLOQ for analysis. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on each of the 10 secondary MenB strains at the given time point. Analysis was planned for combined Group 2 and 4.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 month after Vaccination 2 (Vacc 2)
    End point values
    		 Stage 1: Groups 2+4 Combined
    Number of subjects analysed
    864
    Units: Titers
    geometric mean (confidence interval 95%)
        PMB3175 (A29) Before Vacc 1, (n=166)
    4.3 (4.1 to 4.5)
        PMB3175 (A29) 1 month after Vacc 2, (n=166)
    35.7 (30.9 to 41.2)
        PMB3010 (A06) Before Vacc 1, (n=157)
    8.9 (8.2 to 9.6)
        PMB3010 (A06) 1 month after Vacc 2, (n=159)
    46.0 (39.7 to 53.1)
        PMB824 (A12) Before Vacc 1, (n=154)
    8.4 (8.1 to 8.8)
        PMB824 (A12) 1 month after Vacc 2, (n=157)
    23.7 (21.2 to 26.5)
        PMB3040 (A07) Before Vacc 1, (n=150)
    8.7 (7.2 to 10.6)
        PMB3040 (A07) 1 month after Vacc 2, (n=157)
    60.7 (53.6 to 68.8)
        PMB1672 (A15) Before Vacc 1, (n=166)
    6.3 (5.5 to 7.3)
        PMB1672 (A15) 1 month after Vacc 2, (n=165)
    28.4 (24.7 to 32.7)
        PMB1989 (A19) Before Vacc 1, (n=167)
    8.6 (8.2 to 9.1)
        PMB1989 (A19) 1 month after Vacc 2, (n=167)
    53.5 (46.3 to 61.9)
        PMB648 (B16) Before Vacc 1, (n=172)
    4.8 (4.4 to 5.3)
        PMB648 (B16) 1 month after Vacc 2, (n=164)
    20.8 (17.5 to 24.6)
        PMB866 (B09) Before Vacc 1, (n=171)
    4.8 (4.4 to 5.2)
        PMB866 (B09) 1 month after Vacc 2, (n=166)
    13.9 (12.0 to 16.2)
        PMB1256 (B03) Before Vacc 1, (n=172)
    4.3 (4.0 to 4.5)
        PMB1256 (B03) 1 month after Vacc 2, (n=164)
    17.7 (14.8 to 21.3)
        PMB431 (B15) Before Vacc 1, (n=172)
    4.6 (4.2 to 4.9)
        PMB431 (B15) 1 month after Vacc 2, (n=167)
    17.3 (15.1 to 19.8)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4

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    End point title
    		 Stage1: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4
    End point description
    Percentage of subjects who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this endpoint. Stage 1 modified intent-to-treat (mITT) population included all randomised subjects who have received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from Month 0 to 7. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 1
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    272
    534
    271
    523
    Units: Percentage of subjects
    number (confidence interval 95%)
        MenA (n=264,510,218,411)
    99.2 (97.3 to 99.9)
    98.4 (96.9 to 99.3)
    100.0 (98.3 to 100.0)
    99.3 (97.9 to 99.8)
        MenC (n=262,509,264,506)
    92.4 (88.5 to 95.3)
    88.6 (85.5 to 91.2)
    100.0 (98.6 to 100.0)
    99.4 (98.3 to 99.9)
        MenW (n=264,512,219,414)
    98.5 (96.2 to 99.6)
    95.5 (93.3 to 97.1)
    99.5 (97.5 to 100.0)
    99.5 (98.3 to 99.9)
        MenY (n=263,510,218,413)
    99.6 (97.9 to 100.0)
    96.9 (95.0 to 98.2)
    99.5 (97.5 to 100.0)
    99.8 (98.7 to 100.0)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4

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    End point title
    		 Stage1: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4
    End point description
    Percentage of subjects who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this endpoint. Stage 1 mITT population included all randomised subjects who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point. Analysis was planned for combined Group 1 through Group 4.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 1
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    272
    534
    271
    523
    Units: Percentage of subjects
    number (confidence interval 95%)
        MenA >=1:4, (n=264,510,218,411)
    99.6 (97.9 to 100.0)
    98.4 (96.9 to 99.3)
    100.0 (98.3 to 100.0)
    99.3 (97.9 to 99.8)
        MenA >=1:8, (n=264,510,218,411)
    99.2 (97.3 to 99.9)
    98.4 (96.9 to 99.3)
    100.0 (98.3 to 100.0)
    99.3 (97.9 to 99.8)
        MenA >=1:16, (n=264,510,218,411)
    98.5 (96.2 to 99.6)
    98.0 (96.4 to 99.1)
    100.0 (98.3 to 100.0)
    99.3 (97.9 to 99.8)
        MenA >=31:2, (n=264,510,218,411)
    97.7 (95.1 to 99.2)
    93.9 (91.5 to 95.8)
    99.5 (97.5 to 100.0)
    99.0 (97.5 to 99.7)
        MenA >=1:64, (n=264,510,218,411)
    90.9 (86.8 to 94.1)
    86.3 (83.0 to 89.1)
    99.1 (96.7 to 99.9)
    98.3 (96.5 to 99.3)
        MenA >= 1:128, (n=264,510,218,411)
    75.0 (69.3 to 80.1)
    71.2 (67.0 to 75.1)
    95.4 (91.7 to 97.8)
    96.4 (94.1 to 97.9)
        MenC >=1:4 (n=262,509,264,506)
    95.4 (92.1 to 97.6)
    93.3 (90.8 to 95.3)
    100.0 (98.6 to 100.0)
    99.4 (98.3 to 99.9)
        MenC >=1:8, (n=262,509,264,506)
    92.4 (88.5 to 95.3)
    88.6 (85.5 to 91.2)
    100.0 (98.6 to 100.0)
    99.4 (98.3 to 99.9)
        MenC >=1:16, (n=262,509,264,506)
    88.2 (83.6 to 91.8)
    80.9 (77.3 to 84.3)
    100.0 (98.6 to 100.0)
    99.2 (98.0 to 99.8)
        MenC >=1:32, (262,509,264,506)
    76.3 (70.7 to 81.3)
    67.8 (63.5 to 71.8)
    98.9 (96.7 to 99.8)
    98.2 (96.7 to 99.2)
        MenC >=1:64, (n=262,509,264,506)
    61.8 (55.7 to 67.7)
    55.0 (50.6 to 59.4)
    97.3 (94.6 to 98.9)
    97.2 (95.4 to 98.5)
        MenC >=1:128, (n=262,509,264,506)
    50.8 (44.5 to 57.0)
    45.6 (41.2 to 50.0)
    95.5 (92.2 to 97.6)
    94.1 (91.6 to 96.0)
        MenW >=1:4, (n=264,512,219,414)
    99.6 (97.9 to 100.0)
    97.7 (95.9 to 98.8)
    100.0 (98.3 to 100.0)
    99.5 (98.3 to 99.9)
        MenW >=1:8, (n=264,512,219,414)
    98.5 (96.2 to 99.6)
    95.5 (93.3 to 97.1)
    99.5 (97.5 to 100.0)
    99.5 (98.3 to 99.9)
        MenW >=1:16, (n=264,512,219,414)
    96.2 (93.1 to 98.2)
    89.3 (86.2 to 91.8)
    99.5 (97.5 to 100.0)
    99.3 (97.9 to 99.9)
        MenW >=1:32, (n=264,512,219,414)
    82.2 (77.0 to 86.6)
    75.0 (71.0 to 78.7)
    99.5 (97.5 to 100.0)
    98.1 (96.2 to 99.2)
        MenW >=1:64, (n=264,512,219,414)
    65.9 (59.8 to 71.6)
    56.1 (51.6 to 60.4)
    99.1 (96.7 to 99.9)
    96.6 (94.4 to 98.1)
        MenW >=1:128, (n=264,512,219,414)
    43.9 (37.9 to 50.2)
    38.1 (33.9 to 42.4)
    98.6 (96.0 to 99.7)
    94.0 (91.2 to 96.1)
        MenY >=1:4, (n=263,510,218,413)
    100.0 (98.6 to 100.0)
    99.2 (98.0 to 99.8)
    99.5 (97.5 to 100.0)
    100.0 (99.1 to 100.0)
        MenY >=1:8, (n=263,510,218,413)
    99.6 (97.9 to 100.0)
    96.9 (95.0 to 98.2)
    99.5 (97.5 to 100.0)
    99.8 (98.7 to 100.0)
        MenY >=1:16, (n=263,510,218,413)
    98.9 (96.7 to 99.8)
    92.9 (90.4 to 95.0)
    99.5 (97.5 to 100.0)
    99.3 (97.9 to 99.8)
        MenY >=1:32, (n=263,510,218,413)
    92.4 (88.5 to 95.3)
    82.4 (78.8 to 85.6)
    99.1 (96.7 to 99.9)
    99.0 (97.5 to 99.7)
        MenY >=1:64, (n=263,510,218,413)
    78.3 (72.9 to 83.2)
    66.9 (62.6 to 70.9)
    99.1 (96.7 to 99.9)
    97.1 (95.0 to 98.5)
        MenY >=1:128, (n=263,510,218,413)
    62.0 (55.8 to 67.9)
    48.6 (44.2 to 53.1)
    98.6 (96.0 to 99.7)
    94.9 (92.3 to 96.8)
    No statistical analyses for this end point

    Secondary: Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4

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    End point title
    		 Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4
    End point description
    GMTs were calculated using all subjects with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5*LLOQ for analysis. Stage 1 mITT population included all randomized subjects who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from Visit 1 to Visit 4. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point. Analysis was planned for combined Group 1 through Group 4.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 1
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    272
    534
    271
    523
    Units: Titers
    geometric mean (confidence interval 95%)
        MenA (n=264,510,218,411)
    215.8 (184.6 to 252.4)
    203.2 (178.7 to 231.0)
    568.6 (492.9 to 656.0)
    916.1 (809.1 to 1037.3)
        MenC, (n=262,509,264,506)
    111.5 (87.2 to 142.6)
    81.4 (68.1 to 97.4)
    814.9 (689.4 to 963.2)
    827.0 (722.5 to 946.6)
        MenW, (n=264,512,219,414)
    98.4 (80.7 to 120.0)
    71.2 (61.5 to 82.4)
    1214.9 (1032.0 to 1430.1)
    1176.7 (1017.9 to 1360.2)
        MenY, (n=263,510,218,413)
    141.9 (118.8 to 169.4)
    96.6 (83.9 to 111.2)
    1174.0 (990.3 to 1391.9)
    1000.2 (872.1 to 1147.1)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3

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    End point title
    		 Stage1: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3
    End point description
    Percentage of subjects who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer greater than or equal to LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this endpoint. Stage 1 mITT population included all randomised subjects who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point.
    End point type
    Secondary
    End point timeframe
    For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    272
    534
    271
    523
    Units: Percentage of subjects
    number (confidence interval 95%)
        MenA, (n=510,411,232,191)
    100.0 (98.4 to 100.0)
    98.4 (96.9 to 99.3)
    99.5 (97.1 to 100.0)
    99.3 (97.9 to 99.8)
        MenC, (n=509,506,231,237)
    100.0 (98.4 to 100.0)
    88.6 (85.5 to 91.2)
    99.6 (97.7 to 100.0)
    99.4 (98.3 to 99.9)
        MenW, (n=512,414,233,191)
    100.0 (98.4 to 100.0)
    95.5 (93.3 to 97.1)
    99.5 (97.1 to 100.0)
    99.5 (98.3 to 99.9)
        MenY, (n=510,413,233,191)
    100.0 (98.4 to 100.0)
    96.9 (95.0 to 98.2)
    99.5 (97.1 to 100.0)
    99.8 (98.7 to 100.0)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3

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    End point title
    		 Stage1: Percentage of Subjects With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3
    End point description
    Percentage of subjects who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this endpoint. Stage 1 mITT population included all randomised subjects who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point.
    End point type
    Secondary
    End point timeframe
    For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    272
    534
    271
    523
    Units: Percentage of subjects
    number (confidence interval 95%)
        MenA >=1:4, (n=510,411,232,191)
    100.0 (98.4 to 100.0)
    98.4 (96.9 to 99.3)
    99.5 (97.1 to 100.0)
    99.3 (97.9 to 99.8)
        MenA >=1:8, (n=510,411,232,191)
    100.0 (98.4 to 100.0)
    98.4 (96.9 to 99.3)
    99.5 (97.1 to 100.0)
    99.3 (97.9 to 99.8)
        MenA >=1:16, (n=510,411,232,191)
    100.0 (98.4 to 100.0)
    98.0 (96.4 to 99.1)
    99.5 (97.1 to 100.0)
    99.3 (97.9 to 99.8)
        MenA >=1:32, (n=510,411,232,191)
    97.8 (95.0 to 99.3)
    93.9 (91.5 to 95.8)
    99.5 (97.1 to 100.0)
    99.0 (97.5 to 99.7)
        MenA >=1:64, (n=510,411,232,191)
    92.2 (88.0 to 95.3)
    86.3 (83.0 to 89.1)
    97.4 (94.0 to 99.1)
    98.3 (96.5 to 99.3)
        MenA >=1:128, (n=510,411,232,191)
    69.4 (63.0 to 75.3)
    71.2 (67.0 to 75.1)
    92.7 (88.0 to 95.9)
    96.4 (94.1 to 97.9)
        MenC >=1:4, (n=509,506,231,237)
    100.0 (98.4 to 100.0)
    93.3 (90.8 to 95.3)
    99.6 (97.7 to 100.0)
    99.4 (98.3 to 99.9)
        MenC >=1:8, (509,506,231,237)
    100.0 (98.4 to 100.0)
    88.6 (85.5 to 91.2)
    99.6 (97.7 to 100.0)
    99.4 (98.3 to 99.9)
        MenC >=1:16, (509,506,231,237)
    99.6 (97.6 to 100.0)
    80.9 (77.3 to 84.3)
    99.6 (97.7 to 100.0)
    99.2 (98.0 to 99.8)
        MenC >=1:32, (n=509,506,231,237)
    97.4 (94.4 to 99.0)
    67.8 (63.5 to 71.8)
    99.6 (97.7 to 100.0)
    98.2 (96.7 to 99.2)
        MenC >=1:64, (n=509,506,231,237)
    90.9 (86.4 to 94.3)
    55.0 (50.6 to 59.4)
    98.3 (95.7 to 99.5)
    97.2 (95.4 to 98.5)
        MenC >=1:128, (n=509,506,231,237)
    78.8 (72.9 to 83.9)
    45.6 (41.2 to 50.0)
    92.8 (88.8 to 95.8)
    94.1 (91.6 to 96.0)
        MenW >=1:4, (n=512,414,233,191)
    100.0 (98.4 to 100.0)
    97.7 (95.9 to 98.8)
    100.0 (98.1 to 100.0)
    99.5 (98.3 to 99.9)
        MenW >=1:8, (n=512,414,233,191)
    100.0 (98.4 to 100.0)
    95.5 (93.3 to 97.1)
    99.5 (97.1 to 100.0)
    99.5 (98.3 to 99.9)
        MenW >=1:16, (n=512,414,233,191)
    100.0 (98.4 to 100.0)
    89.3 (86.2 to 91.8)
    99.5 (97.1 to 100.0)
    99.3 (97.9 to 99.9)
        MenW >=1:32, (512,414,233,191)
    99.6 (97.6 to 100.0)
    75.0 (71.0 to 78.7)
    99.5 (97.1 to 100.0)
    98.1 (96.2 to 99.2)
        MenW >=1:64, (n=512,414,233,191)
    97.0 (93.9 to 98.8)
    56.1 (51.6 to 60.4)
    99.0 (96.3 to 99.9)
    96.6 (94.4 to 98.1)
        MenW >=1:128, (n=512,414,233,191)
    89.7 (85.1 to 93.3)
    38.1 (33.9 to 42.4)
    97.9 (94.7 to 99.4)
    94.0 (91.2 to 96.1)
        MenY >=1:4, (n=510,413,233,191)
    100.0 (98.4 to 100.0)
    99.2 (98.0 to 99.8)
    99.5 (97.1 to 100.0)
    100.0 (99.1 to 100.0)
        MenY >=1:8, (n=510,413,233,191)
    100.0 (98.4 to 100.0)
    96.9 (95.0 to 98.2)
    99.5 (97.1 to 100.0)
    99.8 (98.7 to 100.0)
        MenY >=1:16, (n=510,413,233,191)
    100.0 (98.4 to 100.0)
    92.9 (90.4 to 95.0)
    99.5 (97.1 to 100.0)
    99.3 (97.9 to 99.8)
        MenY >=1:32, (n=510,413,233,191)
    100.0 (98.4 to 100.0)
    82.4 (78.8 to 85.6)
    99.5 (97.1 to 100.0)
    99.0 (97.5 to 99.7)
        MenY >=1:64, (n=510,413,233,191)
    97.4 (94.5 to 99.0)
    66.9 (62.6 to 70.9)
    99.5 (97.1 to 100.0)
    97.1 (95.0 to 98.5)
        MenY >=1:128, (n=510,413,233,191)
    89.7 (85.1 to 93.3)
    48.6 (44.2 to 53.1)
    95.3 (91.2 to 97.8)
    94.9 (92.3 to 96.8)
    No statistical analyses for this end point

    Secondary: Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3

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    End point title
    		 Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3
    End point description
    GMTs were calculated using all subjects with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5*LLOQ for analysis. Stage 1 mITT population included all randomised subjects who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point.
    End point type
    Secondary
    End point timeframe
    For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    272
    534
    271
    523
    Units: Titers
    geometric mean (confidence interval 95%)
        MenA, (n=510,411,232,191)
    151.3 (134.1 to 170.7)
    203.2 (178.7 to 231.0)
    337.3 (291.7 to 390.0)
    916.1 (809.1 to 1037.3)
        MenC, (n=509,506,231,237)
    229.1 (194.7 to 269.5)
    81.4 (68.1 to 97.4)
    498.7 (429.1 to 579.6)
    827.0 (722.5 to 946.6)
        MenW, (n=512,414,233,191)
    274.1 (242.7 to 309.7)
    71.2 (61.5 to 82.4)
    570.9 (484.3 to 673.0)
    1176.7 (1017.9 to 1360.2)
        MenY, (n=510,413,233,191)
    301.5 (266.6 to 341.0)
    96.6 (83.9 to 111.2)
    558.6 (470.0 to 663.9)
    1000.2 (872.1 to 1147.1)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
    End point description
    Percentage of subjects who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this endpoint. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4 and combined Group 1 and 3.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 month after Vaccination 2 (Vacc 2)
    End point values
    		 Stage 1: Groups 2+4 Combined Stage 1: Group 1+3 Combined
    Number of subjects analysed
    864
    438
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22) Before Vacc 1, (n=427,839)
    25.1 (22.2 to 28.2)
    25.3 (21.2 to 29.7)
        PMB80 (A22) 1 month after Vacc 2, (n=433,852)
    91.0 (88.8 to 92.8)
    91.0 (87.9 to 93.5)
        PMB2001 (A56) Before Vacc 1, (n=421,833)
    12.8 (10.6 to 15.3)
    13.8 (10.6 to 17.4)
        PMB2001 (A56) 1 month after Vacc 2, (n=435,854)
    99.4 (98.6 to 99.8)
    98.6 (97.0 to 99.5)
        PMB2948 (B24) Before Vacc 1, (434,855)
    11.9 (9.8 to 14.3)
    10.4 (7.7 to 13.6)
        PMB2948 (B24) 1 month after Vacc 2, (n=426,842)
    79.3 (76.4 to 82.0)
    84.3 (80.5 to 87.6)
        PMB2707 (B44) Before Vacc 1, (434,861)
    4.5 (3.2 to 6.1)
    3.7 (2.1 to 5.9)
        PMB2707 (B44) 1 month after Vacc 2, (n=436,853)
    94.5 (92.7 to 95.9)
    95.4 (93.0 to 97.2)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for all 4 Primary MenB Strains Combined) From Baseline to 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for all 4 Primary MenB Strains Combined) From Baseline to 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
    End point description
    Percentage of subjects who achieved an hSBA titer greater than or equal to LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this endpoint. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4 and combined Group 1 and 3.
    End point type
    Secondary
    End point timeframe
    Baseline to 1 month after Vaccination 2
    End point values
    		 Stage 1: Groups 2+4 Combined Stage 1: Group 1+3 Combined
    Number of subjects analysed
    864
    438
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22), (n=422,827)
    73.8 (70.6 to 76.7)
    75.8 (71.5 to 79.8)
        PMB2001 (A56), (n=418,823)
    95.0 (93.3 to 96.4)
    94.7 (92.1 to 96.7)
        PMB2948 (B24), (n=422,835)
    67.4 (64.1 to 70.6)
    76.1 (71.7 to 80.1)
        PMB2707 (B44), (n=432,850)
    86.4 (83.9 to 88.6)
    91.7 (88.6 to 94.1)
        Composite hSBA response, (n=418,814)
    74.3 (71.2 to 77.3)
    79.9 (75.7 to 83.6)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
    End point description
    Percentage of subjects who achieved an hSBA titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for all 4 primary MenB test strains was reported in this endpoint. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4 and combined Group 1 and 3.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 2
    End point values
    		 Stage 1: Groups 2+4 Combined Stage 1: Group 1+3 Combined
    Number of subjects analysed
    864
    438
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22) >=1:4,(n=433,852)
    91.7 (89.6 to 93.4)
    91.9 (88.9 to 94.3)
        PMB80 (A22) >=1:8,(n=433,852)
    91.5 (89.5 to 93.3)
    91.7 (88.7 to 94.1)
        PMB80 (A22) >=1:16,(n=433,852)
    91.0 (88.8 to 92.8)
    91.0 (87.9 to 93.5)
        PMB80 (A22) >=1:32,(n=433,852)
    80.2 (77.3 to 82.8)
    82.4 (78.5 to 85.9)
        PMB80 (A22) >=1:64,(n=433,852)
    54.9 (51.5 to 58.3)
    58.0 (53.2 to 62.7)
        PMB80 (A22) >=1:128,(n=433,852)
    27.3 (24.4 to 30.5)
    27.9 (23.8 to 32.4)
        PMB2001 (A56) >=1:4,(n=435,854)
    99.5 (98.8 to 99.9)
    98.9 (97.3 to 99.6)
        PMB2001 (A56) >=1:8,(n=435,854)
    99.4 (98.6 to 99.8)
    98.6 (97.0 to 99.5)
        PMB2001 (A56) >=1:16,(n=435,854)
    99.1 (98.2 to 99.6)
    98.6 (97.0 to 99.5)
        PMB2001 (A56) >=1:32,(n=435,854)
    97.0 (95.6 to 98.0)
    96.8 (94.7 to 98.2)
        PMB2001 (A56) >=1:64,(n=435,854)
    87.7 (85.3 to 89.8)
    90.1 (86.9 to 92.8)
        PMB2001 (A56) >=1:128,(n=435,854)
    69.2 (66.0 to 72.3)
    74.0 (69.6 to 78.1)
        PMB2948 (B24) >=1:4,(n=426,842)
    81.2 (78.4 to 83.8)
    86.9 (83.3 to 89.9)
        PMB2948 (B24) >=1:8,(n=426,842)
    79.3 (76.4 to 82.0)
    84.3 (80.5 to 87.6)
        PMB2948 (B24) >=1:16,(n=426,842)
    74.0 (70.9 to 76.9)
    80.8 (76.7 to 84.4)
        PMB2948 (B24) >=1:32,(n=426,842)
    47.9 (44.4 to 51.3)
    58.5 (53.6 to 63.2)
        PMB2948 (B24) >=1:64,(n=426,842)
    24.9 (22.1 to 28.0)
    31.0 (26.6 to 35.6)
        PMB2948 (B24) >=1:128,(n=426,842)
    9.6 (7.7 to 11.8)
    13.4 (10.3 to 17.0)
        PMB2707 (B44) >=1:4,(n=436,853)
    96.2 (94.7 to 97.4)
    97.2 (95.2 to 98.6)
        PMB2707 (B44) >=1:8,(n=436,853)
    94.5 (92.7 to 95.9)
    95.4 (93.0 to 97.2)
        PMB2707 (B44) >=1:16,(n=436,853)
    89.0 (86.7 to 91.0)
    92.4 (89.5 to 94.7)
        PMB2707 (B44) >=1:32,(n=436,853)
    68.6 (65.3 to 71.7)
    72.9 (68.5 to 77.1)
        PMB2707 (B44) >=1:64,(n=436,853)
    41.0 (37.7 to 44.4)
    48.9 (44.1 to 53.7)
        PMB2707 (B44) >=1:128,(n=436,853)
    19.2 (16.6 to 22.0)
    22.0 (18.2 to 26.2)
    No statistical analyses for this end point

    Secondary: Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)

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    End point title
    		 Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
    End point description
    GMTs were calculated using all subjects with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5 × LLOQ for analysis. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4 and combined Group 1 and 3.
    End point type
    Secondary
    End point timeframe
    1 month after Vaccination 2
    End point values
    		 Stage 1: Groups 2+4 Combined Stage 1: Group 1+3 Combined
    Number of subjects analysed
    864
    438
    Units: Titers
    geometric mean (confidence interval 95%)
        PMB80 (A22), (n=433,852)
    49.3 (46.2 to 52.6)
    51.0 (46.7 to 55.7)
        PMB2001 (A56), (n=435,854)
    139.5 (130.6 to 149.1)
    152.3 (138.5 to 167.5)
        PMB2948 (B24), (n=426,842)
    21.2 (19.6 to 22.9)
    26.6 (23.9 to 29.7)
        PMB2707 (B44), (n=436,853)
    37.8 (35.1 to 40.8)
    43.3 (39.1 to 47.9)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and 1 Month After Vaccination 2: Groups 1, 2, 3 and 4

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    End point title
    		 Stage1: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and 1 Month After Vaccination 2: Groups 1, 2, 3 and 4
    End point description
    Percentage of subjects who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this endpoint. Stage 1 mITT population included all randomised subjects who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point. Analysis was planned for Group 1 through Group 4.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 month after Vaccination 2 (Vacc 2)
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    272
    534
    271
    523
    Units: Percentage of subjects
    number (confidence interval 95%)
        MenA Before Vacc 1, (n=270,528,219,418)
    15.9 (11.8 to 20.8)
    22.9 (19.4 to 26.7)
    53.9 (47.0 to 60.6)
    52.6 (47.7 to 57.5)
        MenA 1 Month after Vacc 2, (n=232,463,191,376)
    100.0 (98.4 to 100.0)
    95.7 (93.4 to 97.3)
    99.5 (97.1 to 100.0)
    99.5 (98.1 to 99.9)
        MenC Before Vacc 1, (n=267,526,264,511)
    38.6 (32.7 to 44.7)
    39.0 (34.8 to 43.3)
    59.5 (53.3 to 65.4)
    61.1 (56.7 to 65.3)
        MenC 1 Month after Vacc 2, (n=231,454,237,466)
    100.0 (98.4 to 100.0)
    94.1 (91.5 to 96.0)
    99.6 (97.7 to 100.0)
    99.8 (98.8 to 100.0)
        MenW Before Vacc 1, (268,527,218,418)
    32.1 (26.5 to 38.0)
    34.5 (30.5 to 38.8)
    61.9 (55.1 to 68.4)
    60.8 (55.9 to 65.5)
        MenW 1 Month after Vacc 2, (n=233,464,191,376)
    100.0 (98.4 to 100.0)
    99.1 (97.8 to 99.8)
    99.5 (97.1 to 100.0)
    100.0 (99.0 to 100.0)
        MenY Before Vacc 1, (n=265,528,219,421)
    54.0 (47.8 to 60.1)
    58.1 (53.8 to 62.4)
    79.9 (74.0 to 85.0)
    77.9 (73.6 to 81.8)
        MenY 1 Month after Vacc 2, (n=233,461,191,374)
    100.0 (98.4 to 100.0)
    97.8 (96.0 to 99.0)
    99.5 (97.1 to 100.0)
    100.0 (99.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and 1 Month After Vaccination 2: Groups 1, 2, 3 and 4

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    End point title
    		 Stage1: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and 1 Month After Vaccination 2: Groups 1, 2, 3 and 4
    End point description
    Percentage of subjects who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >= :8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this endpoint. Stage 1 mITT population included all randomised subjects who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point. Analysis was planned for combined Group 1 through Group 4.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 month after Vaccination 2 (Vacc 2)
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    272
    534
    271
    523
    Units: Percentage of subjects
    number (confidence interval 95%)
        MenA Before Vacc 1 >=1:4(n=270,528,219,418)
    26.3 (21.1 to 32.0)
    33.3 (29.3 to 37.5)
    64.4 (57.7 to 70.7)
    65.8 (61.0 to 70.3)
        MenA Before Vacc 1 >=1:8(270,528,219,418)
    15.9 (11.8 to 20.8)
    22.9 (19.4 to 26.7)
    53.9 (47.0 to 60.6)
    52.6 (47.7 to 57.5)
        MenA Before Vacc 1 >=1:16(n=270,528,219,418)
    14.4 (10.5 to 19.2)
    18.0 (14.8 to 21.5)
    40.2 (33.6 to 47.0)
    41.6 (36.9 to 46.5)
        MenA Before Vacc 1 >=1:32(n=270,528,219,418)
    8.5 (5.5 to 12.5)
    10.6 (8.1 to 13.6)
    24.2 (18.7 to 30.4)
    22.0 (18.1 to 26.3)
        MenA Before Vacc 1 >=1:64(n=270,528,219,418)
    5.2 (2.9 to 8.5)
    5.5 (3.7 to 7.8)
    12.8 (8.7 to 17.9)
    15.1 (11.8 to 18.9)
        MenA Before Vacc 1 >=1:128(n=270,528,219,418)
    3.0 (1.3 to 5.8)
    4.0 (2.5 to 6.0)
    7.8 (4.6 to 12.1)
    6.2 (4.1 to 9.0)
        MenA 1Month post Vacc 2 >=1:4(n=232,463,191,376)
    100.0 (98.4 to 100.0)
    97.0 (95.0 to 98.3)
    99.5 (97.1 to 100.0)
    99.7 (98.5 to 100.0)
        MenA 1Month post Vacc 2 >=1:8(n=232,463,191,376)
    100.0 (98.4 to 100.0)
    95.7 (93.4 to 97.3)
    99.5 (97.1 to 100.0)
    99.5 (98.1 to 99.9)
        MenA 1Month post Vacc 2 >=1:16(n=232,463,191,376)
    100.0 (98.4 to 100.0)
    90.7 (87.7 to 93.2)
    99.5 (97.1 to 100.0)
    99.5 (98.1 to 99.9)
        MenA 1Month post Vacc 2 >=1:32(232,463,191,376)
    97.8 (95.0 to 99.3)
    74.3 (70.1 to 78.2)
    99.5 (97.1 to 100.0)
    98.2 (96.7 to 99.2)
        MenA 1Month post Vacc 2 >=1:64(n=232,463,191,376)
    92.2 (88.0 to 95.3)
    51.4 (46.7 to 56.0)
    97.4 (94.0 to 99.1)
    92.8 (89.7 to 95.2)
        MenA 1Month post Vacc 2 >=1:128(n=232,463,191,376)
    69.4 (63.0 to 75.3)
    33.9 (29.6 to 38.4)
    92.7 (88.0 to 95.9)
    75.5 (70.9 to 79.8)
        MenC Before Vacc 1 >=1:4(n=267,526,264,511)
    63.7 (57.6 to 69.4)
    59.7 (55.4 to 63.9)
    76.1 (70.5 to 81.1)
    78.3 (74.4 to 81.8)
        MenC Before Vacc 1 >=1:8(n=267,526,264,511)
    38.6 (32.7 to 44.7)
    39.0 (34.8 to 43.3)
    59.5 (53.3 to 65.4)
    61.1 (56.7 to 65.3)
        MenC Before Vacc 1 >=1:16(n=267,526,264,511)
    24.3 (19.3 to 29.9)
    24.5 (20.9 to 28.4)
    42.0 (36.0 to 48.3)
    44.4 (40.1 to 48.9)
        MenC Before Vacc 1 >=1:32(n=267,526,264,511)
    12.0 (8.3 to 16.5)
    12.5 (9.8 to 15.7)
    26.9 (21.6 to 32.7)
    29.7 (25.8 to 33.9)
        MenC Before Vacc 1 >=1:64(n=267,526,264,511)
    5.2 (2.9 to 8.6)
    6.8 (4.8 to 9.3)
    15.9 (11.7 to 20.9)
    18.2 (14.9 to 21.8)
        MenC Before Vacc 1 >=1:128(n=267,526,264,511)
    4.5 (2.3 to 7.7)
    4.0 (2.5 to 6.0)
    6.8 (4.1 to 10.6)
    9.2 (6.8 to 12.0)
        MenC 1Month post Vacc 2 >=1:4(n=231,454,237,466)
    100.0 (98.4 to 100.0)
    95.8 (93.5 to 97.5)
    99.6 (97.7 to 100.0)
    99.8 (98.8 to 100.0)
        MenC 1Month post Vacc 2 >=1:8(n=231,454,237,466)
    100.0 (98.4 to 100.0)
    94.1 (91.5 to 96.0)
    99.6 (97.7 to 100.0)
    99.8 (98.8 to 100.0)
        MenC 1Month post Vacc 2 >=1:16(n=231,454,237,466)
    99.6 (97.6 to 100.0)
    90.5 (87.5 to 93.1)
    99.6 (97.7 to 100.0)
    98.9 (97.5 to 99.7)
        MenC 1Month post Vacc 2 >=1:32(n=231,454,237,466)
    97.4 (94.4 to 99.0)
    74.7 (70.4 to 78.6)
    99.6 (97.7 to 100.0)
    95.5 (93.2 to 97.2)
        MenC 1Month post Vacc 2 >=1:64(n=231,454,237,466)
    90.9 (86.4 to 94.3)
    50.4 (45.7 to 55.1)
    98.3 (95.7 to 99.5)
    86.9 (83.5 to 89.8)
        MenC 1Month post Vacc 2 >=1:128(n=231,454,237,466)
    78.8 (72.9 to 83.9)
    35.0 (30.6 to 39.6)
    92.8 (88.8 to 95.8)
    71.7 (67.3 to 75.7)
        MenW Before Vacc 1 >=1:4(n=268,527,218,418)
    47.8 (41.6 to 53.9)
    50.5 (46.1 to 54.8)
    83.0 (77.4 to 87.8)
    76.3 (71.9 to 80.3)
        MenW Before Vacc 1 >=1:8(n=268,527,218,418)
    32.1 (26.5 to 38.0)
    34.5 (30.5 to 38.8)
    61.9 (55.1 to 68.4)
    60.8 (55.9 to 65.5)
        MenW Before Vacc 1 >=1:16(n=268,527,218,418)
    23.9 (18.9 to 29.4)
    22.8 (19.3 to 26.6)
    37.6 (31.2 to 44.4)
    39.7 (35.0 to 44.6)
        MenW Before Vacc 1 >=1:32(n=268,527,218,418)
    10.8 (7.4 to 15.2)
    13.7 (10.8 to 16.9)
    20.2 (15.1 to 26.1)
    21.8 (17.9 to 26.0)
        MenW Before Vacc 1 >=1:64(n=268,527,218,418)
    7.5 (4.6 to 11.3)
    6.3 (4.3 to 8.7)
    9.2 (5.7 to 13.8)
    11.2 (8.4 to 14.7)
        MenW Before Vacc 1 >=1:128(n=268,527,218,418)
    4.5 (2.3 to 7.7)
    1.5 (0.7 to 3.0)
    5.5 (2.9 to 9.4)
    6.2 (4.1 to 9.0)
        MenW 1Month post Vacc 2 >=1:4(n=233,464,191,376)
    100.0 (98.4 to 100.0)
    99.4 (98.1 to 99.9)
    100.0 (98.1 to 100.0)
    100.0 (99.0 to 100.0)
        MenW 1Month post Vacc 2 >=1:8(n=233,464,191,376)
    100.0 (98.4 to 100.0)
    99.1 (97.8 to 99.8)
    99.5 (97.1 to 100.0)
    100.0 (99.0 to 100.0)
        MenW 1Month post Vacc 2 >=1:16(n=233,464,191,376)
    100.0 (98.4 to 100.0)
    98.3 (96.6 to 99.3)
    99.5 (97.1 to 100.0)
    99.7 (98.5 to 100.0)
        MenW 1Month post Vacc 2 >=1:32(n=233,464,191,376)
    99.6 (97.6 to 100.0)
    89.9 (86.8 to 92.5)
    99.5 (97.1 to 100.0)
    98.4 (96.6 to 99.4)
        MenW 1Month post Vacc 2 >=1:64(n=233,464,191,376)
    97.0 (93.9 to 98.8)
    72.2 (67.9 to 76.2)
    99.0 (96.3 to 99.9)
    95.7 (93.2 to 97.5)
        MenW 1Month post Vacc 2 >=1:128(n=233,464,191,376)
    89.7 (85.1 to 93.3)
    42.9 (38.3 to 47.5)
    97.9 (94.7 to 99.4)
    83.5 (79.4 to 87.1)
        MenY Before Vacc 1 >=1:4(n=265,528,219,421)
    67.2 (61.2 to 72.8)
    70.3 (66.2 to 74.1)
    87.7 (82.6 to 91.7)
    89.5 (86.2 to 92.3)
        MenY Before Vacc 1 >=1:8(n=265,528,219,421)
    54.0 (47.8 to 60.1)
    58.1 (53.8 to 62.4)
    79.9 (74.0 to 85.0)
    77.9 (73.6 to 81.8)
        MenY Before Vacc 1 >=1:16(n=265,528,219,421)
    44.2 (38.1 to 50.4)
    46.6 (42.3 to 50.9)
    67.1 (60.5 to 73.3)
    65.8 (61.0 to 70.3)
        MenY Before Vacc 1 >=1:32(n=265,528,219,421)
    21.1 (16.4 to 26.5)
    26.7 (23.0 to 30.7)
    38.4 (31.9 to 45.1)
    40.9 (36.1 to 45.7)
        MenY Before Vacc 1 >=1:64(n=265,528,219,421)
    10.9 (7.5 to 15.3)
    11.2 (8.6 to 14.2)
    21.9 (16.6 to 28.0)
    20.2 (16.5 to 24.3)
        MenY Before Vacc 1 >=1:128(n=265,528,219,421)
    4.9 (2.6 to 8.2)
    6.3 (4.3 to 8.7)
    10.0 (6.4 to 14.8)
    10.5 (7.7 to 13.8)
        MenY 1Month post Vacc 2 >=1:4(n=233,461.191,374)
    100.0 (98.4 to 100.0)
    99.8 (98.8 to 100.0)
    99.5 (97.1 to 100.0)
    100.0 (99.0 to 100.0)
        MenY 1Month post Vacc 2 >=1:8(n=233,461,191,374)
    100.0 (98.4 to 100.0)
    97.8 (96.0 to 99.0)
    99.5 (97.1 to 100.0)
    100.0 (99.0 to 100.0)
        MenY 1Month post Vacc 2 >=1:16(n=233,461,191,374)
    100.0 (98.4 to 100.0)
    97.2 (95.2 to 98.5)
    99.5 (97.1 to 100.0)
    100.0 (99.0 to 100.0)
        MenY 1Month post Vacc 2 >=1:32(n=233,461,191,374)
    100.0 (98.4 to 100.0)
    87.4 (84.0 to 90.3)
    99.5 (97.1 to 100.0)
    97.9 (95.8 to 99.1)
        MenY 1Month post Vacc 2 >=1:64(n=233,461,191,374)
    97.4 (94.5 to 99.0)
    65.1 (60.5 to 69.4)
    99.5 (97.1 to 100.0)
    92.0 (88.7 to 94.5)
        MenY 1Month post Vacc 2 >=1:128(n=233,461,191,374)
    89.7 (85.1 to 93.3)
    37.5 (33.1 to 42.1)
    95.3 (91.2 to 97.8)
    79.9 (75.5 to 83.9)
    No statistical analyses for this end point

    Secondary: Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and 1 Month After Vaccination 2: Groups 1, 2, 3 and 4

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    End point title
    		 Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and 1 Month After Vaccination 2: Groups 1, 2, 3 and 4
    End point description
    GMTs were calculated using all subjects with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains. Titers below the LLOQ were set to 0.5*LLOQ for analysis. Stage 1 mITT population included all randomised subjects who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point. Analysis was planned for Group 1 through Group 4.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 month after Vaccination 2 (Vacc 2)
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    272
    534
    271
    523
    Units: Titers
    geometric mean (confidence interval 95%)
        MenA Before Vacc 1, (n=270,528,219,418)
    5.7 (5.1 to 6.3)
    6.3 (5.7 to 6.8)
    11.0 (9.3 to 13.0)
    10.7 (9.6 to 12.0)
        MenA 1 Month after Vacc 2, (n=232,463,191,376)
    151.3 (134.1 to 170.7)
    54.9 (48.5 to 62.0)
    337.3 (291.7 to 390.0)
    224.2 (197.9 to 253.9)
        MenC Before Vacc 1, (n=267,526,264,511)
    7.5 (6.6 to 8.5)
    7.5 (6.8 to 8.2)
    11.9 (10.2 to 13.8)
    13.4 (11.9 to 15.1)
        MenC 1 Month after Vacc 2, (n=231,454,237,466)
    229.1 (194.7 to 269.5)
    58.0 (50.7 to 66.5)
    498.7 (429.1 to 579.6)
    222.6 (195.3 to 253.8)
        MenW Before Vacc 1, (268,527,218,418)
    7.0 (6.2 to 7.9)
    7.0 (6.4 to 7.5)
    10.5 (9.1 to 12.2)
    11.0 (9.8 to 12.3)
        MenW 1 Month after Vacc 2, (n=233,464,191,376)
    274.1 (242.7 to 309.7)
    80.9 (73.5 to 89.1)
    570.9 (484.3 to 673.0)
    291.3 (256.8 to 330.4)
        MenY Before Vacc 1, (n=265,528,219,421)
    10.5 (9.1 to 12.1)
    11.5 (10.4 to 12.7)
    19.2 (16.3 to 22.5)
    19.0 (16.8 to 21.4)
        MenY 1 Month after Vacc 2, (n=233,461,191,374)
    301.5 (266.6 to 341.0)
    69.8 (63.1 to 77.3)
    558.6 (470.0 to 663.9)
    268.6 (235.0 to 307.1)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
    End point description
    Percentage of subjects who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this endpoint. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4 and combined Group 1 and 3.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 Month After Vaccination 2 (Vacc 2)
    End point values
    		 Stage 1: Groups 2+4 Combined Stage 1: Group 1+3 Combined
    Number of subjects analysed
    864
    438
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22) Before Vacc 1, (n=427,839)
    25.1 (22.2 to 28.2)
    25.3 (21.2 to 29.7)
        PMB80 (A22) 1 month after Vacc 2, (n=433,852)
    91.0 (88.8 to 92.8)
    91.0 (87.9 to 93.5)
        PMB2001 (A56) Before Vacc 1, (n=421,833)
    12.8 (10.6 to 15.3)
    13.8 (10.6 to 17.4)
        PMB2001 (A56) 1 month after Vacc 2, (n=435,854)
    99.4 (98.6 to 99.8)
    98.6 (97.0 to 99.5)
        PMB2948 (B24) Before Vacc 1, (434,855)
    11.9 (9.8 to 14.3)
    10.4 (7.7 to 13.6)
        PMB2948 (B24) 1 month after Vacc 2, (n=426,842)
    79.3 (76.4 to 82.0)
    84.3 (80.5 to 87.6)
        PMB2707 (B44) Before Vacc 1, (434,861)
    4.5 (3.2 to 6.1)
    3.7 (2.1 to 5.9)
        PMB2707 (B44) 1 month after Vacc 2, (n=436,853)
    94.5 (92.7 to 95.9)
    95.4 (93.0 to 97.2)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)

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    End point title
    		 Stage1: Percentage of Subjects With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
    End point description
    Percentage of subjects who achieved an hSBA titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for all 4 primary MenB test strains was reported in this endpoint. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4 and combined Group 1 and 3.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 Month After Vaccination 2 (Vacc 2)
    End point values
    		 Stage 1: Groups 2+4 Combined Stage 1: Group 1+3 Combined
    Number of subjects analysed
    864
    438
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22) Before Vacc 1 >=1:4(n=427,839)
    36.6 (33.3 to 40.0)
    34.7 (30.1 to 39.4)
        PMB80 (A22) Before Vacc 1 >=1:8(n=427,839)
    31.8 (28.7 to 35.1)
    31.9 (27.5 to 36.5)
        PMB80 (A22) Before Vacc 1 >=1:16(n=427,839)
    25.1 (22.2 to 28.2)
    25.3 (21.2 to 29.7)
        PMB80 (A22) Before Vacc 1 >=1:32(n=427,839)
    11.4 (9.4 to 13.8)
    11.0 (8.2 to 14.4)
        PMB80 (A22) Before Vacc 1 >=1:64(n=427,839)
    4.4 (3.1 to 6.0)
    4.7 (2.9 to 7.1)
        PMB80 (A22) Before Vacc 1 >=1:128(n=427,839)
    0.8 (0.3 to 1.7)
    1.4 (0.5 to 3.0)
        PMB80 (A22) 1 month post Vacc 2>=1:4(n=433,852)
    91.7 (89.6 to 93.4)
    91.9 (88.9 to 94.3)
        PMB80 (A22) 1 month post Vacc 2>=1:8(n=433,852)
    91.5 (89.5 to 93.3)
    91.7 (88.7 to 94.1)
        PMB80 (A22) 1 month post Vacc 2>=1:16(n=433,852)
    91.0 (88.8 to 92.8)
    91.0 (87.9 to 93.5)
        PMB80 (A22) 1 month post Vacc 2>=1:32(n=433,852)
    80.2 (77.3 to 82.8)
    82.4 (78.5 to 85.9)
        PMB80 (A22) 1 month post Vacc 2>=1:64(n=433,852)
    54.9 (51.5 to 58.3)
    58.0 (53.2 to 62.7)
        PMB80 (A22) 1 month postVacc 2>=1:128(n=433,852)
    27.3 (24.4 to 30.5)
    27.9 (23.8 to 32.4)
        PMB2001 (A56) Before Vacc 1 >=1:4(n=421,833)
    17.5 (15.0 to 20.3)
    19.5 (15.8 to 23.6)
        PMB2001 (A56) Before Vacc 1 >=1:8(n=421,833)
    12.8 (10.6 to 15.3)
    13.8 (10.6 to 17.4)
        PMB2001 (A56) Before Vacc 1 >=1:16(n=421,833)
    11.0 (9.0 to 13.4)
    10.7 (7.9 to 14.0)
        PMB2001 (A56) Before Vacc 1 >=1:32(n=421,833)
    7.6 (5.9 to 9.6)
    6.7 (4.5 to 9.5)
        PMB2001 (A56) Before Vacc 1 >=1:64(n=421,833)
    4.3 (3.0 to 5.9)
    3.8 (2.2 to 6.1)
        PMB2001 (A56) Before Vacc 1 >=1:128(n=421,833)
    2.4 (1.5 to 3.7)
    2.9 (1.5 to 4.9)
        PMB2001 (A56) 1 month post Vacc 2>=1:4(n=435,854)
    99.5 (98.8 to 99.9)
    98.9 (97.3 to 99.6)
        PMB2001 (A56) 1 month post Vacc 2>=1:8(n=435,854)
    99.4 (98.6 to 99.8)
    98.6 (97.0 to 99.5)
        PMB2001 (A56) 1 month post Vacc 2>=1:16(n=435,854)
    99.1 (98.2 to 99.6)
    98.6 (97.0 to 99.5)
        PMB2001 (A56) 1 month post Vacc 2>=1:32(n=435,854)
    97.0 (95.6 to 98.0)
    96.8 (94.7 to 98.2)
        PMB2001 (A56) 1 month post Vacc 2>=1:64(n=435,854)
    87.7 (85.3 to 89.8)
    90.1 (86.9 to 92.8)
        PMB2001 (A56) 1 month postVacc 2>=1:128(n=435,854)
    69.2 (66.0 to 72.3)
    74.0 (69.6 to 78.1)
        PMB2948 (B24) Before Vacc 1 >=1:4(n=434,855)
    14.6 (12.3 to 17.2)
    14.1 (10.9 to 17.7)
        PMB2948 (B24) Before Vacc 1 >=1:8(n=434,855)
    11.9 (9.8 to 14.3)
    10.4 (7.7 to 13.6)
        PMB2948 (B24) Before Vacc 1 >=1:16(n=434,855)
    8.2 (6.4 to 10.2)
    6.2 (4.1 to 8.9)
        PMB2948 (B24) Before Vacc 1 >=1:32(n=434,855)
    4.2 (3.0 to 5.8)
    3.7 (2.1 to 5.9)
        PMB2948 (B24) Before Vacc 1 >=1:64(n=434,855)
    2.3 (1.4 to 3.6)
    0.9 (0.3 to 2.3)
        PMB2948 (B24) Before Vacc 1 >=1:128(n=434,855)
    1.1 (0.5 to 2.0)
    0.2 (0.0 to 1.3)
        PMB2948 (B24) 1 month post Vacc 2>=1:4(n=426,842)
    81.2 (78.4 to 83.8)
    86.9 (83.3 to 89.9)
        PMB2948 (B24) 1 month post Vacc 2>=1:8(n=426,842)
    79.3 (76.4 to 82.0)
    84.3 (80.5 to 87.6)
        PMB2948 (B24) 1 month post Vacc 2>=1:16(n=426,842)
    74.0 (70.9 to 76.9)
    80.8 (76.7 to 84.4)
        PMB2948 (B24) 1 month post Vacc 2>=1:32(n=426,842)
    47.9 (44.4 to 51.3)
    58.5 (53.6 to 63.2)
        PMB2948 (B24) 1 month post Vacc 2>=1:64(n=426,842)
    24.9 (22.1 to 28.0)
    31.0 (26.6 to 35.6)
        PMB2948 (B24) 1 month postVacc 2>=1:128(n=426,842)
    9.6 (7.7 to 11.8)
    13.4 (10.3 to 17.0)
        PMB2707 (B44) Before Vacc 1 >=1:4(n=434,861)
    7.2 (5.6 to 9.1)
    7.1 (4.9 to 10.0)
        PMB2707 (B44) Before Vacc 1 >=1:8(n=434,861)
    4.5 (3.2 to 6.1)
    3.7 (2.1 to 5.9)
        PMB2707 (B44) Before Vacc 1 >=1:16(n=434,861)
    3.3 (2.2 to 4.7)
    2.1 (1.0 to 3.9)
        PMB2707 (B44) Before Vacc 1 >=1:32(n=434,861)
    2.1 (1.2 to 3.3)
    0.9 (0.3 to 2.3)
        PMB2707 (B44) Before Vacc 1 >=1:64(n=434,861)
    1.2 (0.6 to 2.1)
    0.7 (0.1 to 2.0)
        PMB2707 (B44) Before Vacc 1 >=1:128(n=434,861)
    0.3 (0.1 to 1.0)
    0.5 (0.1 to 1.7)
        PMB2707 (B44) 1 month post Vacc 2>=1:4(n=436,853)
    96.2 (94.7 to 97.4)
    97.2 (95.2 to 98.6)
        PMB2707 (B44) 1 month post Vacc 2>=1:8(n=436,853)
    94.5 (92.7 to 95.9)
    95.4 (93.0 to 97.2)
        PMB2707 (B44) 1 month post Vacc 2>=1:16(n=436,853)
    89.0 (86.7 to 91.0)
    92.4 (89.5 to 94.7)
        PMB2707 (B44) 1 month post Vacc 2>=1:32(n=436,853)
    68.6 (65.3 to 71.7)
    72.9 (68.5 to 77.1)
        PMB2707 (B44) 1 month post Vacc 2>=1:64(n=436,853)
    41.0 (37.7 to 44.4)
    48.9 (44.1 to 53.7)
        PMB2707 (B44) 1 month postVacc 2>=1:128(n=436,853)
    19.2 (16.6 to 22.0)
    22.0 (18.2 to 26.2)
    No statistical analyses for this end point

    Secondary: Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)

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    End point title
    		 Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)
    End point description
    GMTs were calculated using all subjects with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5*LLOQ for analysis. Stage 1 EIP, included all eligible subjects who were randomised to the study group of interest, received all investigational products as randomised, had blood drawn for assay testing within the required time frames at Months 0 and 7, had valid and determinate assay results, had received no prohibited vaccines or treatment, and had no other major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4 and combined Group 1 and 3.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 1 (Vacc 1), 1 Month After Vaccination 2 (Vacc 2)
    End point values
    		 Stage 1: Groups 2+4 Combined Stage 1: Group 1+3 Combined
    Number of subjects analysed
    864
    438
    Units: Titers
    geometric mean (confidence interval 95%)
        PMB80 (A22), Before vacc 1, (n=427,839)
    10.7 (10.3 to 11.1)
    10.8 (10.2 to 11.5)
        PMB80 (A22), 1 month after vacc 2, (n=433,852)
    49.3 (46.2 to 52.6)
    51.0 (46.7 to 55.7)
        PMB2001 (A56), Before vacc 1, (n=421,833)
    5.3 (5.0 to 5.6)
    5.2 (4.9 to 5.7)
        PMB2001 (A56), 1 month after vacc 2, (n=435,854)
    139.5 (130.6 to 149.1)
    152.3 (138.5 to 167.5)
        PMB2948 (B24), Before vacc 1, (n=434,855)
    4.9 (4.7 to 5.1)
    4.6 (4.4 to 4.9)
        PMB2948 (B24), 1 month after vacc 2, (n=426,842)
    21.2 (19.6 to 22.9)
    26.6 (23.9 to 29.7)
        PMB2707 (B44), Before vacc 1, (n=434,861)
    4.3 (4.2 to 4.5)
    4.2 (4.1 to 4.4)
        PMB2707 (B44), 1 month after vacc 2, (n=436,853)
    37.8 (35.1 to 40.8)
    43.3 (39.1 to 47.9)
    No statistical analyses for this end point

    Secondary: Stage2: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4

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    End point title
    		 Stage2: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4
    End point description
    Percentage of subjects who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY Test Strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this endpoint. Stage 2 mITT population included all subjects who signed the ICD at Month 18 and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available in Stage 2. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point. Analysis was planned for Group 1 through Group 4.
    End point type
    Secondary
    End point timeframe
    Persistence Phase: 12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced) Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
    Number of subjects analysed
    112
    64
    101
    73
    Units: Percentage of subjects
    number (confidence interval 95%)
        MenA 12 Months after Vacc 2, (n=112,59,48,22)
    91.1 (84.2 to 95.6)
    71.2 (57.9 to 82.2)
    97.9 (88.9 to 99.9)
    100.0 (84.6 to 100.0)
        MenA 24 Months after Vacc 2, (n=101,60,61,37)
    88.1 (80.2 to 93.7)
    70.0 (56.8 to 81.2)
    100.0 (94.1 to 100.0)
    100.0 (90.5 to 100.0)
        MenA 36 Months after Vacc 2, (n=95,54,57,33)
    88.4 (80.2 to 94.1)
    72.2 (58.4 to 83.5)
    100.0 (93.7 to 100.0)
    97.0 (84.2 to 99.9)
        MenA 48 Months after Vacc 2, (n=71,41,40,23)
    81.7 (70.7 to 89.9)
    63.4 (46.9 to 77.9)
    100.0 (91.2 to 100.0)
    100.0 (85.2 to 100.0)
        MenC 12 Months after Vacc 2, (n=112,62,54,23)
    76.8 (67.9 to 84.2)
    51.6 (38.6 to 64.5)
    96.3 (87.3 to 99.5)
    91.3 (72.0 to 98.9)
        MenC 24 Months after Vacc 2, (n=101,61,97,71)
    75.2 (65.7 to 83.3)
    47.5 (34.6 to 60.7)
    96.9 (91.2 to 99.4)
    94.4 (86.2 to 98.4)
        MenC 36 Months after Vacc 2, (n=95,54,96,67)
    67.4 (57.0 to 76.6)
    44.4 (30.9 to 58.6)
    96.9 (91.1 to 99.4)
    95.5 (87.5 to 99.1)
        MenC 48 Months after Vacc 2, (n=71,42,76,58)
    62.0 (49.7 to 73.2)
    38.1 (23.6 to 54.4)
    98.7 (92.9 to 100.0)
    89.7 (78.8 to 96.1)
        MenW 12 Months after Vacc 2, (n=112,62,48,22)
    99.1 (95.1 to 100.0)
    83.9 (72.3 to 92.0)
    100.0 (92.6 to 100.0)
    95.5 (77.2 to 99.9)
        MenW 24 Months after Vacc 2, (n=103,61,61,37)
    99.0 (94.7 to 100.0)
    78.7 (66.3 to 88.1)
    100.0 (94.1 to 100.0)
    94.6 (81.8 to 99.3)
        MenW 36 Months after Vacc 2, (n=97,54,57,33)
    94.8 (88.4 to 98.3)
    77.8 (64.4 to 88.0)
    100.0 (93.7 to 100.0)
    97.0 (84.2 to 99.9)
        MenW 48 Months after Vacc 2, (n=70,41,40,23)
    91.4 (82.3 to 96.8)
    70.7 (54.5 to 83.9)
    100.0 (91.2 to 100.0)
    91.3 (72.0 to 98.9)
        MenY 12 Months after Vacc 2, (n=112,62,48,22)
    100.0 (96.8 to 100.0)
    98.4 (91.3 to 100.0)
    100.0 (92.6 to 100.0)
    100.0 (84.6 to 100.0)
        MenY 24 Months after Vacc 2, (n=102,61,61,37)
    100.0 (96.4 to 100.0)
    93.4 (84.1 to 98.2)
    100.0 (94.1 to 100.0)
    100.0 (90.5 to 100.0)
        MenY 36 Months after Vacc 2, (n=97,54,57,33)
    100.0 (96.3 to 100.0)
    90.7 (79.7 to 96.9)
    100.0 (93.7 to 100.0)
    100.0 (84.2 to 100.0)
        MenY 48 Months after Vacc 2, (n=71,42,40,22)
    100.0 (94.9 to 100.0)
    95.2 (83.8 to 99.4)
    100.0 (91.2 to 100.0)
    100.0 (84.6 to 100.0)
    No statistical analyses for this end point

    Secondary: Stage2: Percentage of Subjects With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined)

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    End point title
    		 Stage2: Percentage of Subjects With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined)
    End point description
    Percentage of subjects who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this endpoint. Stage 2 mITT population included all subjects who signed the ICD at Month 18 and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available in Stage 2. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results on all 4 strains at the given time point. Analysis was planned for combined Group 2 and 4 and combined Group 1 and 3.
    End point type
    Secondary
    End point timeframe
    Persistence Phase: 12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)
    End point values
    		 Stage 2: Group 1+3 Combined Stage 2: Groups 2+4 Combined
    Number of subjects analysed
    213
    137
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22) 12 months after Vacc 2,(n=162,83)
    32.7 (25.6 to 40.5)
    26.5 (17.4 to 37.3)
        PMB80 (A22) 24 months after Vacc 2,(n=196,128)
    36.7 (30.0 to 43.9)
    28.9 (21.2 to 37.6)
        PMB80 (A22) 36 months after Vacc 2,(n=185,116)
    29.2 (22.8 to 36.3)
    25.9 (18.2 to 34.8)
        PMB80 (A22) 48 months after Vacc 2,(n=139,94)
    28.1 (20.8 to 36.3)
    31.9 (22.7 to 42.3)
        PMB2001 (A56) 12 months after Vacc 2,(n=162,84)
    33.3 (26.1 to 41.2)
    32.1 (22.4 to 43.2)
        PMB2001 (A56) 24 months after Vacc 2,(n=196,131)
    34.7 (28.1 to 41.8)
    33.6 (25.6 to 42.4)
        PMB2001 (A56) 36 months after Vacc 2,(n=186,118)
    29.0 (22.6 to 36.1)
    33.9 (25.4 to 43.2)
        PMB2001 (A56) 48 months after Vacc 2,(n=145,98)
    34.5 (26.8 to 42.8)
    29.6 (20.8 to 39.7)
        PMB2948 (B24) 12 months after Vacc 2,(n=165,85)
    30.9 (24.0 to 38.6)
    28.2 (19.0 to 39.0)
        PMB2948 (B24) 24 months after Vacc 2,(n=196,131)
    33.2 (26.6 to 40.2)
    27.5 (20.0 to 36.0)
        PMB2948 (B24) 36 months after Vacc 2,(n=192,120)
    35.4 (28.7 to 42.6)
    28.3 (20.5 to 37.3)
        PMB2948 (B24) 48 months after Vacc 2,(n=145,98)
    36.6 (28.7 to 44.9)
    26.5 (18.1 to 36.4)
        PMB2707 (B44) 12 months after Vacc 2,(n=166,85)
    18.7 (13.1 to 25.4)
    15.3 (8.4 to 24.7)
        PMB2707 (B44) 24 months after Vacc 2,(n=200,132)
    18.0 (12.9 to 24.0)
    18.2 (12.0 to 25.8)
        PMB2707 (B44) 36 months after Vacc 2,(n=193,121)
    20.2 (14.8 to 26.6)
    19.8 (13.1 to 28.1)
        PMB2707 (B44) 48 months after Vacc 2,(n=148,99)
    18.2 (12.4 to 25.4)
    16.2 (9.5 to 24.9)
    No statistical analyses for this end point

    Secondary: Stage2: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately)

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    End point title
    		 Stage2: Percentage of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately)
    End point description
    Percentage of subjects who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this endpoint. The booster EIP included subjects who were eligible for the study (ie, met all Stage 1 eligibility criteria as well as continually met Stage 2 eligibility criteria), received a booster dose as intended (the same vaccine as they received in Stage 1), had blood drawn for assay testing within the required time frame at Month 55 (Visit 11), and had a valid and determinate MenB or MenA/C/W/Y assay result after the booster dose, as well as no major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point. Analysis was planned for Group 1 and Group 3 separately.
    End point type
    Secondary
    End point timeframe
    1 month after booster vaccination
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    60
    70
    Units: Percentage of subjects
    number (confidence interval 95%)
        MenA (n=60,33)
    100.0 (94.0 to 100.0)
    100.0 (89.4 to 100.0)
        MenC (n=60,70)
    100.0 (94.0 to 100.0)
    100.0 (94.9 to 100.0)
        MenW (n=60,33)
    100.0 (94.0 to 100.0)
    100.0 (89.4 to 100.0)
        MenY (n=60,33)
    100.0 (94.0 to 100.0)
    100.0 (89.4 to 100.0)
    No statistical analyses for this end point

    Secondary: Stage2: Percentage of Subjects With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined)

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    End point title
    		 Stage2: Percentage of Subjects With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined)
    End point description
    Percentage of subjects who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this endpoint. The booster EIP included subjects who were eligible for the study (ie, met all Stage 1 eligibility criteria as well as continually met Stage 2 eligibility criteria), received a booster dose as intended (the same vaccine as they received in Stage 1), had blood drawn for assay testing within the required time frame at Month 55 (Visit 11), and had a valid and determinate MenB or MenA/C/W/Y assay result after the booster dose, as well as no major protocol violations as determined by the sponsor’s global medical monitor. Here, ‘n’ signifies number of subjects with valid and determinate hSBA results for ACWY test strains at the given time point. Analysis was planned for combined Group 1 and Group 3 and Combined Group 2 and 4.
    End point type
    Secondary
    End point timeframe
    1 month after booster vaccination
    End point values
    		 Stage 2: Group 1+3 Combined Stage 2: Groups 2+4 Combined
    Number of subjects analysed
    130
    88
    Units: Percentage of subjects
    number (confidence interval 95%)
        PMB80 (A22) (n=122,81)
    95.1 (89.6 to 98.2)
    93.8 (86.2 to 98.0)
        PMB2001 (A56) (n=124,86)
    100.0 (97.1 to 100.0)
    98.8 (93.7 to 100.0)
        PMB2948 (B24) (n=123,84)
    95.1 (89.7 to 98.2)
    95.2 (88.3 to 98.7)
        PMB2707 (B44) (n=128,86)
    99.2 (95.7 to 100.0)
    98.8 (93.7 to 100.0)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 and 2: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With Local Reactions Within 7 Days After Vaccination 1 and 2: Group 1 and Group 3 [49]
    End point description
    Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies number of subjects with known values. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    7 days after Vaccination 1 (Vacc 1) and Vaccination 2 (Vacc 2)
    Notes
    [49] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    270
    Units: Percentage of subjects
    number (confidence interval 95%)
        Vacc 1: Redness: Mild
    7.4 (4.6 to 11.2)
    5.6 (3.2 to 9.0)
        Vacc 1: Redness: Moderate
    10.0 (6.7 to 14.3)
    7.4 (4.6 to 11.2)
        Vacc 1: Redness: Severe
    2.2 (0.8 to 4.8)
    1.9 (0.6 to 4.3)
        Vacc 1: Swelling: Mild
    9.3 (6.1 to 13.4)
    8.6 (5.5 to 12.6)
        Vacc 1: Swelling: Moderate
    10.4 (7.0 to 14.7)
    8.6 (5.5 to 12.6)
        Vacc 1: Swelling: Severe
    1.1 (0.2 to 3.2)
    0.4 (0.0 to 2.1)
        Vacc 1: Pain at injection site: Mild
    37.2 (31.4 to 43.3)
    45.4 (39.3 to 51.5)
        Vacc 1: Pain at injection site: Moderate
    45.7 (39.7 to 51.9)
    40.1 (34.2 to 46.3)
        Vacc 1: Pain at injection site: Severe
    6.3 (3.7 to 9.9)
    4.8 (2.6 to 8.1)
        Vacc 2: Redness: Mild
    7.0 (4.0 to 11.1)
    6.9 (4.0 to 10.9)
        Vacc 2: Redness: Moderate
    11.7 (7.9 to 16.6)
    9.0 (5.7 to 13.4)
        Vacc 2: Redness: Severe
    4.3 (2.1 to 7.9)
    3.4 (1.5 to 6.7)
        Vacc 2: Swelling: Mild
    8.7 (5.4 to 13.1)
    5.6 (3.0 to 9.4)
        Vacc 2: Swelling: Moderate
    10.0 (6.4 to 14.6)
    11.2 (7.4 to 15.9)
        Vacc 2: Swelling: Severe
    0.4 (0.0 to 2.4)
    1.3 (0.3 to 3.7)
        Vacc 2: Pain at injection site: Mild
    34.3 (28.2 to 40.9)
    37.8 (31.5 to 44.3)
        Vacc 2: Pain at injection site: Moderate
    47.0 (40.4 to 53.6)
    38.2 (31.9 to 44.8)
        Vacc 2: Pain at injection site: Severe
    3.9 (1.8 to 7.3)
    7.7 (4.6 to 11.9)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 and 2: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With Systemic Events Within 7 Days After Vaccination 1 and 2: Group 1 and Group 3 [50]
    End point description
    Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as >=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours). Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies number of subjects with known values. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    7 days after Vaccination 1 (Vacc 1) and Vaccination 2 (Vacc 2)
    Notes
    [50] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    270
    Units: Percentage of subjects
    number (confidence interval 95%)
        Vacc 1: Fever: 38.0 to 38.4 degree C
    4.1 (2.1 to 7.2)
    4.1 (2.1 to 7.2)
        Vacc 1: Fever: 38.4 to 38.9 degree C
    2.2 (0.8 to 4.8)
    0.7 (0.1 to 2.7)
        Vacc 1: Fever: 38.9 to 40.0 degree C
    1.1 (0.2 to 3.2)
    0.4 (0.0 to 2.1)
        Vacc 1: Fever: > 40.0 degree C
    0.0 (0.0 to 1.4)
    0.0 (0.0 to 1.4)
        Vacc 1: Fatigue: Mild
    26.8 (21.6 to 32.5)
    27.9 (22.6 to 33.6)
        Vacc 1: Fatigue: Moderate
    25.3 (20.2 to 30.9)
    17.5 (13.1 to 22.5)
        Vacc 1: Fatigue: Severe
    4.5 (2.3 to 7.7)
    3.7 (1.8 to 6.7)
        Vacc 1: Headache: Mild
    27.1 (21.9 to 32.9)
    29.4 (24.0 to 35.2)
        Vacc 1: Headache: Moderate
    19.3 (14.8 to 24.6)
    14.1 (10.2 to 18.9)
        Vacc 1: Headache: Severe
    1.9 (0.6 to 4.3)
    1.5 (0.4 to 3.8)
        Vacc 1: Chills: Mild
    14.5 (10.5 to 19.3)
    9.3 (6.1 to 13.4)
        Vacc 1: Chills: Moderate
    4.5 (2.3 to 7.7)
    4.8 (2.6 to 8.1)
        Vacc 1: Chills: Severe
    1.1 (0.2 to 3.2)
    0.7 (0.1 to 2.7)
        Vacc 1: Vomiting: Mild
    2.2 (0.8 to 4.8)
    1.9 (0.6 to 4.3)
        Vacc 1: Vomiting: Moderate
    0.4 (0.0 to 2.1)
    0.0 (0.0 to 1.4)
        Vacc 1: Vomiting: severe
    0.0 (0.0 to 1.4)
    0.0 (0.0 to 1.4)
        Vacc 1: Diarrhea: Mild
    10.0 (6.7 to 14.3)
    10.8 (7.3 to 15.1)
        Vacc 1: Diarrhea: Moderate
    2.2 (0.8 to 4.8)
    4.5 (2.3 to 7.7)
        Vacc 1: Diarrhea: Severe
    0.0 (0.0 to 1.4)
    0.0 (0.0 to 1.4)
        Vacc 1: Muscle pain: Mild
    17.1 (12.8 to 22.1)
    14.5 (10.5 to 19.3)
        Vacc 1: Muscle pain: Moderate
    10.4 (7.0 to 14.7)
    7.1 (4.3 to 10.8)
        Vacc 1: Muscle pain: Severe
    1.5 (0.4 to 3.8)
    1.1 (0.2 to 3.2)
        Vacc 1: Joint pain: Mild
    13.0 (9.2 to 17.6)
    10.8 (7.3 to 15.1)
        Vacc 1: Joint pain: Moderate
    7.8 (4.9 to 11.7)
    6.7 (4.0 to 10.4)
        Vacc 1: Joint pain: Severe
    0.0 (0.0 to 1.4)
    0.7 (0.1 to 2.7)
        Vacc 2: Fever: 38.0 to 38.4°C
    2.2 (0.7 to 5.0)
    0.9 (0.1 to 3.1)
        Vacc 2: Fever: 38.5 to 38.9°C
    1.3 (0.3 to 3.8)
    0.9 (0.1 to 3.1)
        Vacc 2: Fever: 39.0 to 40.0°C
    0.0 (0.0 to 1.6)
    0.0 (0.0 to 1.6)
        Vacc 2: Fever: > 40.0°C
    0.0 (0.0 to 1.6)
    0.0 (0.0 to 1.6)
        Vacc 2: Fatigue: Mild
    20.9 (15.8 to 26.7)
    26.2 (20.7 to 32.3)
        Vacc 2: Fatigue: Moderate
    26.1 (20.5 to 32.3)
    18.9 (14.1 to 24.5)
        Vacc 2: Fatigue: Severe
    2.6 (1.0 to 5.6)
    2.6 (1.0 to 5.5)
        Vacc 2: Headache: Mild
    22.6 (17.4 to 28.6)
    26.6 (21.1 to 32.8)
        Vacc 2: Headache: Moderate
    17.8 (13.1 to 23.4)
    13.3 (9.2 to 18.4)
        Vacc 2: Headache: Severe
    1.3 (0.3 to 3.8)
    3.9 (1.8 to 7.2)
        Vacc 2: Chills: Mild
    16.1 (11.6 to 21.5)
    11.6 (7.8 to 16.4)
        Vacc 2: Chills: Moderate
    3.9 (1.8 to 7.3)
    5.2 (2.7 to 8.8)
        Vacc 2: Chills: Severe
    0.9 (0.1 to 3.1)
    2.6 (1.0 to 5.5)
        Vacc 2: Vomiting: Mild
    1.7 (0.5 to 4.4)
    3.4 (1.5 to 6.7)
        Vacc 2: Vomiting: Moderate
    0.0 (0.0 to 1.6)
    0.4 (0.0 to 2.4)
        Vacc 2: Vomiting: Severe
    0.0 (0.0 to 1.6)
    0.0 (0.0 to 1.6)
        Vacc 2: Diarrhea: Mild
    9.6 (6.1 to 14.1)
    5.2 (2.7 to 8.8)
        Vacc 2: Diarrhea: Moderate
    3.9 (1.8 to 7.3)
    2.6 (1.0 to 5.5)
        Vacc 2: Diarrhea: Severe
    0.0 (0.0 to 1.6)
    0.4 (0.0 to 2.4)
        Vacc 2: Muscle pain: Mild
    13.0 (9.0 to 18.1)
    8.6 (5.3 to 12.9)
        Vacc 2: Muscle pain: Moderate
    10.9 (7.2 to 15.6)
    9.9 (6.4 to 14.4)
        Vacc 2: Muscle pain: Severe
    0.9 (0.1 to 3.1)
    0.9 (0.1 to 3.1)
        Vacc 2: Joint pain: Mild
    9.1 (5.7 to 13.6)
    10.7 (7.1 to 15.4)
        Vacc 2: Joint pain: Moderate
    9.1 (5.7 to 13.6)
    6.4 (3.6 to 10.4)
        Vacc 2: Joint pain: Severe
    0.4 (0.0 to 2.4)
    0.9 (0.1 to 3.1)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With Antipyretic Medication use 30 Days After Vaccination 1 and 2: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With Antipyretic Medication use 30 Days After Vaccination 1 and 2: Group 1 and Group 3 [51]
    End point description
    Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies number of subjects with known values. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    30 days after Vaccination 1 and Vaccination 2
    Notes
    [51] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
    number (confidence interval 95%)
        Vaccination 1
    20.8 (16.1 to 26.2)
    13.8 (9.9 to 18.5)
        Vaccination 2
    17.8 (13.1 to 23.4)
    13.3 (9.2 to 18.4)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 SAE Within 30 Days After Vaccination 1, 2, and any Vaccination: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 SAE Within 30 Days After Vaccination 1, 2, and any Vaccination: Group 1 and Group 3 [52]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    30 days after Vaccination 1, Vaccination 2 and any Vaccination
    Notes
    [52] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
    number (confidence interval 95%)
        Vaccination 1
    0.0 (0.0 to 1.3)
    0.7 (0.1 to 2.6)
        Vaccination 2
    0.4 (0.0 to 2.3)
    0.0 (0.0 to 1.5)
        Any vaccination
    0.4 (0.0 to 2.0)
    0.7 (0.1 to 2.6)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 SAE During the Vaccination Phase: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 SAE During the Vaccination Phase: Group 1 and Group 3 [53]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
    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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.4 (0.0 to 2.0)
    1.8 (0.6 to 4.3)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1, 2, and any Vaccination: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1, 2, and any Vaccination: Group 1 and Group 3 [54]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    30 days after vaccination 1, 2, and any vaccination
    Notes
    [54] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
    number (confidence interval 95%)
        Vaccination 1
    4.8 (2.6 to 8.0)
    5.9 (3.4 to 9.4)
        Vaccination 2
    5.8 (3.2 to 9.5)
    9.0 (5.7 to 13.3)
        Any vaccination
    9.6 (6.3 to 13.7)
    13.3 (9.5 to 17.9)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 SAE Throughout the Stage 1: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 SAE Throughout the Stage 1: Group 1 and Group 3 [55]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
    Notes
    [55] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
        number (confidence interval 95%)
    1.5 (0.4 to 3.7)
    2.2 (0.8 to 4.8)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 SAE During the Follow-up Phase: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 SAE During the Follow-up Phase: Group 1 and Group 3 [56]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies number of subjects with known values. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
    Notes
    [56] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    239
    239
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.8 (0.1 to 3.0)
    0.4 (0.0 to 2.3)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Throughout the Stage 1: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Medically Attended AE Throughout the Stage 1: Group 1 and Group 3 [57]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
    Notes
    [57] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
        number (confidence interval 95%)
    30.9 (25.4 to 36.7)
    35.1 (29.4 to 41.1)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 Medically Attended AE During the Follow-up Phase: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Medically Attended AE During the Follow-up Phase: Group 1 and Group 3 [58]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies number of subjects with known values. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
    Notes
    [58] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    239
    239
    Units: Percentage of subjects
        number (confidence interval 95%)
    13.8 (9.7 to 18.8)
    18.8 (14.1 to 24.4)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 Medically Attended AE During the Vaccination Phase: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Medically Attended AE During the Vaccination Phase: Group 1 and Group 3 [59]
    End point description
    Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
    Notes
    [59] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
        number (confidence interval 95%)
    23.9 (19.0 to 29.4)
    28.4 (23.1 to 34.2)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 NDCMC Within 30 Days After Vaccination 1, 2, and any Vaccination: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 NDCMC Within 30 Days After Vaccination 1, 2, and any Vaccination: Group 1 and Group 3 [60]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    30 days after Vaccination 1, 2, and any Vaccination
    Notes
    [60] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
    number (confidence interval 95%)
        Vaccination 1
    0.0 (0.0 to 1.3)
    0.0 (0.0 to 1.4)
        Vaccination 2
    0.0 (0.0 to 1.5)
    0.0 (0.0 to 1.5)
        Any vaccination
    0.0 (0.0 to 1.3)
    0.0 (0.0 to 1.4)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 NDCMC During the Vaccination Phase: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 NDCMC During the Vaccination Phase: Group 1 and Group 3 [61]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
    Notes
    [61] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.7 (0.1 to 2.6)
    0.0 (0.0 to 1.4)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 NDCMC During the Follow-up Phase: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 NDCMC During the Follow-up Phase: Group 1 and Group 3 [62]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies number of subjects with known values. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)
    Notes
    [62] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    239
    239
    Units: Percentage of subjects
        number (confidence interval 95%)
    0.4 (0.0 to 2.3)
    0.0 (0.0 to 1.5)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 NDCMC Throughout the Stage 1: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 NDCMC Throughout the Stage 1: Group 1 and Group 3 [63]
    End point description
    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)
    Notes
    [63] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
        number (confidence interval 95%)
    1.1 (0.2 to 3.2)
    0.0 (0.0 to 1.4)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 AE Within 30 Days After Vaccination 1, 2, and any Vaccination: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 AE Within 30 Days After Vaccination 1, 2, and any Vaccination: Group 1 and Group 3 [64]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Here, ‘Number of subjects Analysed’ signifies number of subjects with known values. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    30 days after Vaccination 1, 2, and any Vaccination
    Notes
    [64] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
    number (confidence interval 95%)
        Vaccination 1
    15.1 (11.0 to 19.9)
    11.1 (7.6 to 15.4)
        Vaccination 2
    16.1 (11.7 to 21.4)
    12.3 (8.5 to 17.1)
        Any vaccination
    25.7 (20.6 to 31.4)
    19.9 (15.3 to 25.2)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 AE During the Vaccination Phase: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 AE During the Vaccination Phase: Group 1 and Group 3 [65]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Stage 1 safety population: subjects who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
    Notes
    [65] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
        number (confidence interval 95%)
    41.5 (35.6 to 47.6)
    36.9 (31.1 to 42.9)
    No statistical analyses for this end point

    Secondary: Stage1: Percentage of Subjects With at Least 1 Immediate AE After Vaccination 1 and 2: Group 1 and Group 3

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    End point title
    		 Stage1: Percentage of Subjects With at Least 1 Immediate AE After Vaccination 1 and 2: Group 1 and Group 3 [66]
    End point description
    Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration. The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    30 minutes after Vaccination 1 and Vaccination 2
    Notes
    [66] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Percentage of subjects
    number (confidence interval 95%)
        Vaccination 1
    0.0 (0.0 to 1.3)
    0.0 (0.0 to 1.4)
        Vaccination 2
    0.0 (0.0 to 1.5)
    0.0 (0.0 to 1.5)
    No statistical analyses for this end point

    Secondary: Stage1: Number of Subjects who Missed School/Work due to AE During the Vaccination Phase: Group 1 and Group 3

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    End point title
    		 Stage1: Number of Subjects who Missed School/Work due to AE During the Vaccination Phase: Group 1 and Group 3 [67]
    End point description
    The safety population for Stage 1 included subjects who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3.
    End point type
    Secondary
    End point timeframe
    Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)
    Notes
    [67] - 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: This endpoint reports data only for Group 1 and 3 not for Group 1 and 4.
    End point values
    		 Group 1: MenABCWY + Saline (ACWY-Naive) Group 3: MenABCWY + Saline (ACWY-Experienced)
    Number of subjects analysed
    272
    271
    Units: Subjects
    38
    46
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Local reactions, systemic events within 7 days of each vacc; SAEs from Month 0 to 6 months post Vacc 2, 6 months post Booster Vacc; Non-SAEs from Month 0 to 1 month post Vacc 2; within 48 hours of blood draw at Month 18, 30, 42; 1 month post Booster Vacc.
    Adverse event reporting additional description
    Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Stage 1: Group 1: MenABCWY + Saline (ACWY-Naive)
    Reporting group description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.

    Reporting group title
    Stage 1:Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
    Reporting group description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.

    Reporting group title
    Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced)
    Reporting group description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.

    Reporting group title
    Stage1:Group4: Bivalent rLP2086+MenACWY-CRM (ACWY-Experienced)
    Reporting group description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.

    Reporting group title
    Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive)
    Reporting group description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.

    Reporting group title
    Stage 2:Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
    Reporting group description
    		 Stage 1: ACWY-naive subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.

    Reporting group title
    Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced)
    Reporting group description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Subjects received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.

    Reporting group title
    Stage2:Group4: Bivalent rLP2086+MenACWY-CRM (ACWY-Experienced)
    Reporting group description
    		 Stage 1: ACWY-experienced subjects were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Subjects received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Subjects received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.

    Serious adverse events
    		 Stage 1: Group 1: MenABCWY + Saline (ACWY-Naive) Stage 1:Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced) Stage1:Group4: Bivalent rLP2086+MenACWY-CRM (ACWY-Experienced) Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive) Stage 2:Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced) Stage2:Group4: Bivalent rLP2086+MenACWY-CRM (ACWY-Experienced)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 272 (1.84%)
    6 / 534 (1.12%)
    6 / 271 (2.21%)
    9 / 523 (1.72%)
    1 / 114 (0.88%)
    1 / 65 (1.54%)
    3 / 101 (2.97%)
    2 / 73 (2.74%)
         number of deaths (all causes)
    1
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Glioma
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    1 / 114 (0.88%)
    0 / 65 (0.00%)
    1 / 101 (0.99%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Cyst
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 534 (0.19%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    1 / 101 (0.99%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    1 / 271 (0.37%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Conversion disorder
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    1 / 271 (0.37%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Depression
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 534 (0.19%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Depression suicidal
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Major depression
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    1 / 65 (1.54%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    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
    Oppositional defiant disorder
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 534 (0.19%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Suicidal ideation
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    2 / 271 (0.74%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    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
    Suicide attempt
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    1 / 271 (0.37%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Psychotic disorder
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    1 / 271 (0.37%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Road traffic accident
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    1 / 271 (0.37%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Femur fracture
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    2 / 101 (1.98%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure chronic
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 534 (0.19%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Myocarditis
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Nervous system disorders
    Migraine with aura
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    1 / 271 (0.37%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Epilepsy
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Dyskinesia
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    1 / 271 (0.37%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 534 (0.19%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Faecaloma
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 534 (0.19%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Meningitis viral
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 534 (0.19%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Pharyngitis
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Metabolism and nutrition disorders
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 534 (0.19%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Stage 1: Group 1: MenABCWY + Saline (ACWY-Naive) Stage 1:Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced) Stage1:Group4: Bivalent rLP2086+MenACWY-CRM (ACWY-Experienced) Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive) Stage 2:Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced) Stage2:Group4: Bivalent rLP2086+MenACWY-CRM (ACWY-Experienced)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    267 / 272 (98.16%)
    508 / 534 (95.13%)
    259 / 271 (95.57%)
    502 / 523 (95.98%)
    54 / 114 (47.37%)
    37 / 65 (56.92%)
    72 / 101 (71.29%)
    57 / 73 (78.08%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 272 (0.00%)
    2 / 534 (0.37%)
    4 / 271 (1.48%)
    11 / 523 (2.10%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    2
    4
    11
    0
    0
    0
    0
    Injection site pain (PAIN AT INJECTION SITE)
    alternative assessment type: Systematic
         subjects affected / exposed
    256 / 272 (94.12%)
    479 / 534 (89.70%)
    251 / 271 (92.62%)
    480 / 523 (91.78%)
    48 / 114 (42.11%)
    34 / 65 (52.31%)
    65 / 101 (64.36%)
    50 / 73 (68.49%)
         occurrences all number
    445
    814
    438
    828
    48
    34
    65
    50
    Pyrexia (FEVER)
    alternative assessment type: Systematic
         subjects affected / exposed
    29 / 272 (10.66%)
    56 / 534 (10.49%)
    17 / 271 (6.27%)
    37 / 523 (7.07%)
    3 / 114 (2.63%)
    1 / 65 (1.54%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    30
    61
    18
    39
    3
    1
    0
    1
    Fatigue (FATIGUE)
    alternative assessment type: Systematic
         subjects affected / exposed
    180 / 272 (66.18%)
    315 / 534 (58.99%)
    163 / 271 (60.15%)
    344 / 523 (65.77%)
    28 / 114 (24.56%)
    24 / 65 (36.92%)
    47 / 101 (46.53%)
    37 / 73 (50.68%)
         occurrences all number
    270
    454
    243
    501
    28
    24
    47
    37
    Swelling (SWELLING)
    alternative assessment type: Systematic
         subjects affected / exposed
    77 / 272 (28.31%)
    123 / 534 (23.03%)
    67 / 271 (24.72%)
    114 / 523 (21.80%)
    11 / 114 (9.65%)
    9 / 65 (13.85%)
    14 / 101 (13.86%)
    10 / 73 (13.70%)
         occurrences all number
    154
    242
    136
    230
    16
    12
    22
    14
    Chills (CHILLS)
    alternative assessment type: Systematic
         subjects affected / exposed
    82 / 272 (30.15%)
    152 / 534 (28.46%)
    67 / 271 (24.72%)
    141 / 523 (26.96%)
    6 / 114 (5.26%)
    7 / 65 (10.77%)
    14 / 101 (13.86%)
    8 / 73 (10.96%)
         occurrences all number
    103
    190
    86
    176
    6
    7
    14
    8
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 272 (0.00%)
    3 / 534 (0.56%)
    3 / 271 (1.11%)
    2 / 523 (0.38%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    3
    3
    2
    0
    0
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    2 / 272 (0.74%)
    2 / 534 (0.37%)
    2 / 271 (0.74%)
    2 / 523 (0.38%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    3
    2
    2
    2
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    2 / 272 (0.74%)
    1 / 534 (0.19%)
    4 / 271 (1.48%)
    3 / 523 (0.57%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    2
    1
    4
    3
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    3 / 272 (1.10%)
    3 / 534 (0.56%)
    1 / 271 (0.37%)
    4 / 523 (0.76%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    3
    3
    1
    4
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    1 / 272 (0.37%)
    2 / 534 (0.37%)
    1 / 271 (0.37%)
    6 / 523 (1.15%)
    0 / 114 (0.00%)
    3 / 65 (4.62%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    2
    1
    6
    0
    3
    0
    0
    Sinus congestion
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    1 / 65 (1.54%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    Psychophysiologic insomnia
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Anxiety
         subjects affected / exposed
    3 / 272 (1.10%)
    6 / 534 (1.12%)
    0 / 271 (0.00%)
    5 / 523 (0.96%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    1 / 101 (0.99%)
    0 / 73 (0.00%)
         occurrences all number
    3
    7
    0
    5
    0
    0
    1
    0
    Depression
         subjects affected / exposed
    4 / 272 (1.47%)
    4 / 534 (0.75%)
    1 / 271 (0.37%)
    4 / 523 (0.76%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    4
    4
    1
    4
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    1 / 271 (0.37%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    1 / 65 (1.54%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    0
    0
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    1 / 114 (0.88%)
    0 / 65 (0.00%)
    2 / 101 (1.98%)
    3 / 73 (4.11%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 534 (0.19%)
    5 / 271 (1.85%)
    6 / 523 (1.15%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    1
    5
    6
    0
    0
    0
    0
    Eye injury
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    5 / 272 (1.84%)
    7 / 534 (1.31%)
    8 / 271 (2.95%)
    7 / 523 (1.34%)
    1 / 114 (0.88%)
    0 / 65 (0.00%)
    1 / 101 (0.99%)
    0 / 73 (0.00%)
         occurrences all number
    5
    8
    8
    8
    1
    0
    1
    0
    Muscle strain
         subjects affected / exposed
    1 / 272 (0.37%)
    2 / 534 (0.37%)
    2 / 271 (0.74%)
    7 / 523 (1.34%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    2
    2
    9
    0
    0
    0
    0
    Skin laceration
         subjects affected / exposed
    4 / 272 (1.47%)
    3 / 534 (0.56%)
    1 / 271 (0.37%)
    6 / 523 (1.15%)
    1 / 114 (0.88%)
    1 / 65 (1.54%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    4
    3
    1
    6
    1
    1
    0
    1
    Congenital, familial and genetic disorders
    Pectus excavatum
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    1 / 65 (1.54%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    0 / 114 (0.00%)
    1 / 65 (1.54%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 272 (0.37%)
    7 / 534 (1.31%)
    2 / 271 (0.74%)
    2 / 523 (0.38%)
    1 / 114 (0.88%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    7
    2
    2
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    6 / 272 (2.21%)
    11 / 534 (2.06%)
    4 / 271 (1.48%)
    13 / 523 (2.49%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    1 / 101 (0.99%)
    1 / 73 (1.37%)
         occurrences all number
    7
    16
    5
    17
    0
    0
    1
    1
    Syncope
         subjects affected / exposed
    2 / 272 (0.74%)
    7 / 534 (1.31%)
    3 / 271 (1.11%)
    2 / 523 (0.38%)
    1 / 114 (0.88%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    3
    7
    3
    2
    1
    0
    0
    0
    Migraine
         subjects affected / exposed
    0 / 272 (0.00%)
    5 / 534 (0.94%)
    3 / 271 (1.11%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    1 / 101 (0.99%)
    0 / 73 (0.00%)
         occurrences all number
    0
    5
    3
    2
    0
    0
    1
    0
    Headache (HEADACHE)
    alternative assessment type: Systematic
         subjects affected / exposed
    163 / 272 (59.93%)
    312 / 534 (58.43%)
    159 / 271 (58.67%)
    312 / 523 (59.66%)
    23 / 114 (20.18%)
    21 / 65 (32.31%)
    35 / 101 (34.65%)
    31 / 73 (42.47%)
         occurrences all number
    230
    432
    226
    445
    23
    22
    35
    31
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 272 (1.47%)
    9 / 534 (1.69%)
    1 / 271 (0.37%)
    5 / 523 (0.96%)
    1 / 114 (0.88%)
    0 / 65 (0.00%)
    2 / 101 (1.98%)
    0 / 73 (0.00%)
         occurrences all number
    4
    9
    1
    5
    1
    0
    2
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 272 (0.37%)
    1 / 534 (0.19%)
    0 / 271 (0.00%)
    7 / 523 (1.34%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    1
    0
    7
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 272 (0.37%)
    1 / 534 (0.19%)
    3 / 271 (1.11%)
    4 / 523 (0.76%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    1
    3
    4
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    4 / 272 (1.47%)
    2 / 534 (0.37%)
    0 / 271 (0.00%)
    2 / 523 (0.38%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    4
    2
    0
    2
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    5 / 272 (1.84%)
    1 / 534 (0.19%)
    1 / 271 (0.37%)
    2 / 523 (0.38%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    5
    1
    1
    2
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    3 / 272 (1.10%)
    4 / 534 (0.75%)
    1 / 271 (0.37%)
    6 / 523 (1.15%)
    2 / 114 (1.75%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    3
    4
    1
    6
    2
    0
    0
    0
    Diarrhoea (DIARRHEA)
    alternative assessment type: Systematic
         subjects affected / exposed
    55 / 272 (20.22%)
    104 / 534 (19.48%)
    54 / 271 (19.93%)
    105 / 523 (20.08%)
    3 / 114 (2.63%)
    4 / 65 (6.15%)
    7 / 101 (6.93%)
    7 / 73 (9.59%)
         occurrences all number
    66
    122
    61
    121
    3
    4
    7
    7
    Vomiting (VOMITING)
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 272 (4.78%)
    31 / 534 (5.81%)
    13 / 271 (4.80%)
    33 / 523 (6.31%)
    2 / 114 (1.75%)
    0 / 65 (0.00%)
    2 / 101 (1.98%)
    1 / 73 (1.37%)
         occurrences all number
    13
    32
    14
    35
    2
    0
    2
    1
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    3 / 272 (1.10%)
    1 / 534 (0.19%)
    1 / 271 (0.37%)
    6 / 523 (1.15%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    3
    1
    1
    6
    0
    0
    0
    0
    Eczema
         subjects affected / exposed
    3 / 272 (1.10%)
    0 / 534 (0.00%)
    2 / 271 (0.74%)
    3 / 523 (0.57%)
    1 / 114 (0.88%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    3
    0
    2
    3
    1
    0
    0
    0
    Dermatitis contact
         subjects affected / exposed
    4 / 272 (1.47%)
    0 / 534 (0.00%)
    4 / 271 (1.48%)
    4 / 523 (0.76%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    4
    0
    4
    4
    0
    0
    0
    0
    Erythema (REDNESS)
    alternative assessment type: Systematic
         subjects affected / exposed
    73 / 272 (26.84%)
    130 / 534 (24.34%)
    61 / 271 (22.51%)
    95 / 523 (18.16%)
    8 / 114 (7.02%)
    11 / 65 (16.92%)
    16 / 101 (15.84%)
    14 / 73 (19.18%)
         occurrences all number
    158
    269
    130
    209
    12
    14
    19
    18
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 272 (1.10%)
    3 / 534 (0.56%)
    3 / 271 (1.11%)
    4 / 523 (0.76%)
    0 / 114 (0.00%)
    1 / 65 (1.54%)
    1 / 101 (0.99%)
    0 / 73 (0.00%)
         occurrences all number
    3
    4
    3
    4
    0
    1
    1
    0
    Scoliosis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 272 (0.37%)
    3 / 534 (0.56%)
    3 / 271 (1.11%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    3
    3
    1
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    1 / 272 (0.37%)
    5 / 534 (0.94%)
    3 / 271 (1.11%)
    5 / 523 (0.96%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    5
    3
    5
    0
    0
    0
    0
    Arthralgia (JOINT PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    79 / 272 (29.04%)
    153 / 534 (28.65%)
    78 / 271 (28.78%)
    148 / 523 (28.30%)
    12 / 114 (10.53%)
    10 / 65 (15.38%)
    16 / 101 (15.84%)
    9 / 73 (12.33%)
         occurrences all number
    99
    188
    91
    187
    12
    10
    16
    9
    Myalgia (MUSCLE PAIN)
    alternative assessment type: Systematic
         subjects affected / exposed
    104 / 272 (38.24%)
    204 / 534 (38.20%)
    87 / 271 (32.10%)
    186 / 523 (35.56%)
    11 / 114 (9.65%)
    12 / 65 (18.46%)
    24 / 101 (23.76%)
    13 / 73 (17.81%)
         occurrences all number
    135
    264
    107
    230
    11
    12
    24
    13
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 272 (1.10%)
    6 / 534 (1.12%)
    2 / 271 (0.74%)
    13 / 523 (2.49%)
    2 / 114 (1.75%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    3
    6
    2
    14
    2
    0
    0
    0
    Bacterial vaginosis
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    3 / 271 (1.11%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    3
    1
    0
    0
    0
    0
    Acute sinusitis
         subjects affected / exposed
    6 / 272 (2.21%)
    5 / 534 (0.94%)
    2 / 271 (0.74%)
    13 / 523 (2.49%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    6
    5
    2
    14
    0
    0
    0
    0
    COVID-19
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    0 / 271 (0.00%)
    0 / 523 (0.00%)
    3 / 114 (2.63%)
    4 / 65 (6.15%)
    4 / 101 (3.96%)
    2 / 73 (2.74%)
         occurrences all number
    0
    0
    0
    0
    3
    4
    4
    2
    Gastroenteritis viral
         subjects affected / exposed
    8 / 272 (2.94%)
    12 / 534 (2.25%)
    4 / 271 (1.48%)
    6 / 523 (1.15%)
    1 / 114 (0.88%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    11
    12
    4
    6
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    6 / 272 (2.21%)
    14 / 534 (2.62%)
    4 / 271 (1.48%)
    9 / 523 (1.72%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    6
    14
    4
    10
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    3 / 272 (1.10%)
    6 / 534 (1.12%)
    0 / 271 (0.00%)
    1 / 523 (0.19%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    4
    6
    0
    1
    0
    0
    0
    0
    Impetigo
         subjects affected / exposed
    1 / 272 (0.37%)
    1 / 534 (0.19%)
    3 / 271 (1.11%)
    1 / 523 (0.19%)
    1 / 114 (0.88%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    1
    1
    3
    1
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    9 / 272 (3.31%)
    14 / 534 (2.62%)
    4 / 271 (1.48%)
    18 / 523 (3.44%)
    2 / 114 (1.75%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    9
    14
    4
    19
    2
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    11 / 272 (4.04%)
    19 / 534 (3.56%)
    16 / 271 (5.90%)
    21 / 523 (4.02%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    1 / 101 (0.99%)
    0 / 73 (0.00%)
         occurrences all number
    12
    19
    20
    22
    0
    0
    1
    0
    Otitis externa
         subjects affected / exposed
    3 / 272 (1.10%)
    2 / 534 (0.37%)
    2 / 271 (0.74%)
    5 / 523 (0.96%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    3
    2
    2
    6
    0
    0
    0
    0
    Otitis media
         subjects affected / exposed
    1 / 272 (0.37%)
    11 / 534 (2.06%)
    6 / 271 (2.21%)
    4 / 523 (0.76%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    2
    11
    6
    4
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 272 (5.15%)
    32 / 534 (5.99%)
    11 / 271 (4.06%)
    28 / 523 (5.35%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    15
    36
    12
    35
    0
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    3 / 272 (1.10%)
    9 / 534 (1.69%)
    8 / 271 (2.95%)
    15 / 523 (2.87%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    5
    11
    8
    15
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    2 / 272 (0.74%)
    2 / 534 (0.37%)
    7 / 271 (2.58%)
    6 / 523 (1.15%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    2
    2
    8
    9
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    5 / 272 (1.84%)
    9 / 534 (1.69%)
    9 / 271 (3.32%)
    14 / 523 (2.68%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    5
    11
    10
    15
    0
    0
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    6 / 272 (2.21%)
    9 / 534 (1.69%)
    9 / 271 (3.32%)
    13 / 523 (2.49%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    7
    11
    9
    15
    0
    0
    0
    0
    Otitis media acute
         subjects affected / exposed
    3 / 272 (1.10%)
    5 / 534 (0.94%)
    1 / 271 (0.37%)
    2 / 523 (0.38%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    3
    5
    1
    2
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    5 / 272 (1.84%)
    11 / 534 (2.06%)
    5 / 271 (1.85%)
    10 / 523 (1.91%)
    1 / 114 (0.88%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    6
    13
    5
    12
    1
    0
    0
    1
    Viral pharyngitis
         subjects affected / exposed
    3 / 272 (1.10%)
    3 / 534 (0.56%)
    1 / 271 (0.37%)
    9 / 523 (1.72%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    5
    3
    1
    9
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 272 (1.10%)
    11 / 534 (2.06%)
    1 / 271 (0.37%)
    8 / 523 (1.53%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    3
    11
    1
    11
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 272 (0.00%)
    0 / 534 (0.00%)
    3 / 271 (1.11%)
    3 / 523 (0.57%)
    0 / 114 (0.00%)
    0 / 65 (0.00%)
    0 / 101 (0.00%)
    0 / 73 (0.00%)
         occurrences all number
    0
    0
    3
    3
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2019
    1. Opened enrollment in Stage 2 to ACWY-experienced subjects in addition to ACWY-naïve subjects. This was based on the recommendation from the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) to obtain data on the persistence of the immune response after 2 doses of MenABCWY as well as on the safety and immunogenicity of the booster response in individuals who had previously received an ACWY-containing vaccine.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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