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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 One Year Later in Healthy Adults 50 Years of Age or Older (PNEU-PATH)

    Summary
    EudraCT number
    		 2017-004024-30
    Trial protocol
    		 ES  
    Global end of trial date
    23 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Dec 2020
    First version publication date
    26 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V114-016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Number: V114-016
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either V114 or Prevnar 13™ in healthy adults 50 years of age or older. There was no formal hypothesis testing.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jun 2018
    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
    Korea, Republic of: 100
    Country: Number of subjects enrolled
    Spain: 120
    Country: Number of subjects enrolled
    Taiwan: 101
    Country: Number of subjects enrolled
    United States: 331
    Worldwide total number of subjects
    652
    EEA total number of subjects
    120
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    325
    From 65 to 84 years
    321
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 600 participants were planned to be randomized in a 1:1 ratio to receive either V114 or Prevnar 13™ on Day 1 and PNEUMOVAX™23 at Month 12. Randomization was stratified by age (50 to 64 years, 65 to 74 years, and 75 years or older; at least 50% of the participants were to be 65 years of age or older).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V114
    Arm description
    		 Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2)
    Arm type
    		 Experimental

    Investigational medicinal product name
    V114
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose

    Investigational medicinal product name
    PNEUMOVAX™23
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose

    Arm title
    		 Prevnar 13™
    Arm description
    		 Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevnar 13™
    Investigational medicinal product code
    Other name
    PCV13
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose

    Investigational medicinal product name
    PNEUMOVAX™23
    Investigational medicinal product code
    Other name
    PPV23
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose

    Number of subjects in period 1
    		V114 Prevnar 13™
    Started
    327
    325
    Vaccination 1-V114 or Prevnar 13™, Day 1
    326
    325
    Vaccination 2-PNEUMOVAX™23, Month 12
    298 [1]
    302 [2]
    Completed
    303
    306
    Not completed
    24
    19
         Consent withdrawn by subject
    18
    10
         Non-study pneumococcal vaccine
    1
    -
         Lost to follow-up
    4
    7
         Pain with vaccination
    1
    -
         Oncological treatment
    -
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Participants could have been considered to complete the study without receipt of PNEUMOVAX™23.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Participants could have been considered to complete the study without receipt of PNEUMOVAX™23.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2)

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2)

    Reporting group values
    		 V114 Prevnar 13™ Total
    Number of subjects
    		 327 325 652
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 163 162 325
        From 65-84 years
    		 163 158 321
        85 years and over
    		 1 5 6
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.0 ( 8.0 ) 64.1 ( 8.4 ) -
    Sex: Female, Male
    Units:
        Female
    		 190 181 371
        Male
    		 137 144 281
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 103 103 206
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 18 22 40
        White
    		 203 198 401
        More than one race
    		 2 2 4
        Unknown or Not Reported
    		 1 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 42 37 79
        Not Hispanic or Latino
    		 283 287 570
        Unknown or Not Reported
    		 2 1 3

    End points

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    End points reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2)

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2)

    Primary: Percentage of Participants with Solicited Injection-site Adverse Events Following V114 or Prevnar 13™

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    End point title
    		 Percentage of Participants with Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
    End point description
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest. (In the Prevnar 13™ group, 324 were vaccinated with Prevnar 13™; 1 was incorrectly vaccinated with V114.)
    End point type
    Primary
    End point timeframe
    Up to 5 days after Vaccination 1
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    327
    324
    Units: Percentage of Participants
    number (not applicable)
        Injection site redness/erythema
    9.8
    5.6
        Injection site tenderness/pain
    55.0
    41.4
        Injection site swelling
    16.2
    11.4
    Statistical analysis title
    		 Injection site redness/erythema
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.043
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 8.5
    Notes
    [1] - Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.
    Statistical analysis title
    		 Injection site tenderness/pain
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    13.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6
         upper limit
    		 21.2
    Notes
    [2] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.
    Statistical analysis title
    		 Injection site swelling
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    P-value
    		 = 0.077
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 10.2
    Notes
    [3] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.

    Primary: Percentage of Participants with Solicited Injection-site Adverse Events Following PNEUMOVAX™23

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    End point title
    		 Percentage of Participants with Solicited Injection-site Adverse Events Following PNEUMOVAX™23
    End point description
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited injection-site adverse events was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest.
    End point type
    Primary
    End point timeframe
    Up to 5 days after Vaccination 2
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    298
    302
    Units: Percentage of Participants
    number (not applicable)
        Injection site redness/erythema
    17.4
    16.9
        Injection site tenderness/pain
    62.1
    58.6
        Injection site swelling
    28.2
    26.2
    Statistical analysis title
    		 Injection site redness/erythema
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    600
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    P-value
    		 = 0.855
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.5
         upper limit
    		 6.6
    Notes
    [4] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.
    Statistical analysis title
    		 Injection site tenderness/pain
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    600
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    P-value
    		 = 0.385
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 11.3
    Notes
    [5] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.
    Statistical analysis title
    		 Injection site swelling
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    600
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    P-value
    		 = 0.577
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 9.2
    Notes
    [6] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.

    Primary: Percentage of Participants with Solicited Systemic Adverse Events Following V114 or Prevnar 13™

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    End point title
    		 Percentage of Participants with Solicited Systemic Adverse Events Following V114 or Prevnar 13™
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest. (In the Prevnar 13™ group, 324 were vaccinated with Prevnar 13™; 1 was incorrectly vaccinated with V114.)
    End point type
    Primary
    End point timeframe
    Up to 14 days after Vaccination 1
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    327
    324
    Units: Percentage of Participants
    number (not applicable)
        Joint pain/arthralgia
    6.4
    5.2
        Tiredness/fatigue
    23.5
    13.9
        Headache
    14.1
    12.7
        Muscle pain/myalgia
    17.7
    11.1
    Statistical analysis title
    		 Joint pain/arthralgia
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    P-value
    		 = 0.523
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 4.9
    Notes
    [7] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.
    Statistical analysis title
    		 Tiredness/fatigue
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    P-value
    		 = 0.002
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    9.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.7
         upper limit
    		 15.6
    Notes
    [8] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.
    Statistical analysis title
    		 Headache
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    P-value
    		 = 0.597
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.9
         upper limit
    		 6.7
    Notes
    [9] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.
    Statistical analysis title
    		 Muscle pain/myalgia
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    P-value
    		 = 0.016
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 12.1
    Notes
    [10] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.

    Primary: Percentage of Participants with Solicited Systemic Adverse Events Following PNEUMOVAX™23

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    End point title
    		 Percentage of Participants with Solicited Systemic Adverse Events Following PNEUMOVAX™23
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest.
    End point type
    Primary
    End point timeframe
    Up to 14 days after Vaccination 2
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    298
    302
    Units: Percentage of Participants
    number (not applicable)
        Joint pain/arthralgia
    8.4
    8.3
        Tiredness/fatigue
    25.8
    21.9
        Headache
    12.1
    12.6
        Muscle pain/myalgia
    21.5
    16.6
    Statistical analysis title
    		 Joint pain/arthralgia
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    600
    Analysis specification
    Pre-specified
    Analysis type
    		 [11]
    P-value
    		 = 0.961
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 4.7
    Notes
    [11] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.
    Statistical analysis title
    		 Tiredness/fatigue
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    600
    Analysis specification
    Pre-specified
    Analysis type
    		 [12]
    P-value
    		 = 0.252
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 10.8
    Notes
    [12] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.
    Statistical analysis title
    		 Headache
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    600
    Analysis specification
    Pre-specified
    Analysis type
    		 [13]
    P-value
    		 = 0.852
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 4.8
    Notes
    [13] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.
    Statistical analysis title
    		 Muscle pain/myalgia
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    600
    Analysis specification
    Pre-specified
    Analysis type
    		 [14]
    P-value
    		 = 0.125
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percent
    Point estimate
    4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 11.2
    Notes
    [14] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.

    Primary: Percentage of Participants with Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™

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    End point title
    		 Percentage of Participants with Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™
    End point description
    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of participants with vaccine-related serious adverse events was assessed. The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest. (In the Prevnar 13™ group, 324 were vaccinated with Prevnar 13™; 1 was incorrectly vaccinated with V114.)
    End point type
    Primary
    End point timeframe
    Up to 12 Months after Vaccination 1
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    327
    324
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.0
    Statistical analysis title
    		 SAEs following V114 or Prevnar 13™
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [15]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 1.2
    Notes
    [15] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.

    Primary: Percentage of Participants with Vaccine-related Serious Adverse Events Following PNEUMOVAX™23

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    End point title
    		 Percentage of Participants with Vaccine-related Serious Adverse Events Following PNEUMOVAX™23
    End point description
    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of participants with vaccine-related serious adverse events was assessed. The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest.
    End point type
    Primary
    End point timeframe
    Up to 44 days after Vaccination 2 (Month 12 to Month 13)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    298
    302
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.0
    Statistical analysis title
    		 SAEs following PNEUMOVAX™23
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    600
    Analysis specification
    Pre-specified
    Analysis type
    		 [16]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.3
    Notes
    [16] - Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan.

    Primary: Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23

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    End point title
    		 Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
    End point description
    Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Primary
    End point timeframe
    Month 13 (30 days after Vaccination 2)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Titers
    number (not applicable)
        Serotype 1 (Shared) (n=321, 323)
    392.2
    283.2
        Serotype 3 (Shared) (n=321, 322)
    282.6
    262.8
        Serotype 4 (Shared) (n=321, 323)
    1671.9
    1580.4
        Serotype 5 (Shared) (n=321, 323)
    705.5
    583.9
        Serotype 6A (Shared) (n=321, 323)
    3261.5
    2806.8
        Serotype 6B (Shared) (n=321, 323)
    3223.9
    2872.0
        Serotype 7F (Shared) (n=321, 322)
    5125.6
    4848.0
        Serotype 9V (Shared) (n=321, 323)
    2059.5
    1872.0
        Serotype 14 (Shared) (n=321, 323)
    3370.9
    2660.5
        Serotype 18C (Shared) (n=321, 323)
    2379.6
    2103.9
        Serotype 19A (Shared) (n=321, 323)
    3657.1
    3170.8
        Serotype 19F (Shared) (n=321, 323)
    2229.7
    2156.2
        Serotype 23F (Shared) (n=320, 323)
    1894.2
    1485.1
        Serotype 22F (Unique to V114) (n=321, 323)
    3124.4
    1921.6
        Serotype 33F (Unique to V114) (n=321, 323)
    7881.6
    8269.9
    Statistical analysis title
    		 Serotype 1 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [17]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 1.74
    Notes
    [17] - Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.
    Statistical analysis title
    		 Serotype 3 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [18]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.29
    Notes
    [18] - GMT ratio and 95% CI are estimated from a cLDA model
    Statistical analysis title
    		 Serotype 4 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [19]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.32
    Notes
    [19] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 5 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [20]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.56
    Notes
    [20] - GMT ratio and 95% CI are estimated from a cLDA model
    Statistical analysis title
    		 Serotype 6A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [21]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.43
    Notes
    [21] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6B (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [22]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.35
    Notes
    [22] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [23]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.25
    Notes
    [23] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9V (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [24]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.33
    Notes
    [24] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 14 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [25]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 1.53
    Notes
    [25] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 18C (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [26]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.34
    Notes
    [26] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [27]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.38
    Notes
    [27] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [28]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.2
    Notes
    [28] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [29]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.61
    Notes
    [29] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [30]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 2.06
    Notes
    [30] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [31]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.17
    Notes
    [31] - GMT ratio and 95% CI are estimated from a cLDA model.

    Secondary: Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23

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    End point title
    		 Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
    End point description
    Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Month 13 (30 days after Vaccination 2)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: µg/mL
    number (not applicable)
        Serotype 1 (Shared) (n=321, 323)
    5.21
    5.68
        Serotype 3 (Shared) (n=321, 323)
    1.05
    1.05
        Serotype 4 (Shared) (n=321, 323)
    1.99
    2.29
        Serotype 5 (Shared) (n=321, 323)
    5.77
    5.82
        Serotype 6A (Shared) (n=321, 323)
    4.97
    4.28
        Serotype 6B (Shared) (n=321, 323)
    6.71
    5.77
        Serotype 7F (Shared) (n=321, 323)
    5.99
    6.06
        Serotype 9V (Shared) (n=321, 323)
    4.96
    4.75
        Serotype 14 (Shared) (n=321, 323)
    14.82
    12.72
        Serotype 18C (Shared) (n=321, 323)
    7.31
    6.29
        Serotype 19A (Shared) (n=321, 323)
    13.10
    11.88
        Serotype 19F (Shared) (n=321, 323)
    9.38
    8.62
        Serotype 23F (Shared) (n=321, 323)
    4.83
    4.24
        Serotype 22F (Unique to V114) (n=321, 323)
    4.85
    3.39
        Serotype 33F (Unique to V114) (n=321, 323)
    10.60
    13.30
    Statistical analysis title
    		 Serotype 1 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [32]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.07
    Notes
    [32] - Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.
    Statistical analysis title
    		 Serotype 3 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [33]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.16
    Notes
    [33] - GMC ratio and 95% CI are estimated from a cLDA model
    Statistical analysis title
    		 Serotype 4 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [34]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.02
    Notes
    [34] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 5 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [35]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.18
    Notes
    [35] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [36]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.41
    Notes
    [36] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6B (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [37]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.4
    Notes
    [37] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [38]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.16
    Notes
    [38] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9V (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [39]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.22
    Notes
    [39] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 14 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [40]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.39
    Notes
    [40] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 18C (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [41]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.36
    Notes
    [41] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [42]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.29
    Notes
    [42] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [43]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.27
    Notes
    [43] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [44]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.35
    Notes
    [44] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [45]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.16
         upper limit
    		 1.77
    Notes
    [45] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [46]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 0.95
    Notes
    [46] - GMC ratio and 95% CI are estimated from a cLDA model.

    Secondary: GMT of Serotype-specific OPA at Day 30

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    End point title
    		 GMT of Serotype-specific OPA at Day 30
    End point description
    Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Titer
    number (not applicable)
        Serotype 1 (Shared) (n=321, 323)
    361.6
    296.2
        Serotype 3 (Shared) (n=321, 322)
    245.4
    129.4
        Serotype 4 (Shared) (n=321, 323)
    1280.4
    1685.9
        Serotype 5 (Shared) (n=321, 323)
    699.0
    655.9
        Serotype 6A (Shared) (n=321, 323)
    7352.8
    6184.2
        Serotype 6B (Shared) (n=321, 323)
    5958.1
    3631.2
        Serotype 7F (Shared) (n=321, 322)
    4966.9
    5207.6
        Serotype 9V (Shared) (n=321, 323)
    2329.9
    2293.0
        Serotype 14 (Shared) (n=321, 323)
    2677.3
    2458.1
        Serotype 18C (Shared) (n=321, 323)
    4298.2
    2896.3
        Serotype 19A (Shared) (n=321, 323)
    4856.1
    3783.0
        Serotype 19F (Shared) (n=321, 323)
    2418.8
    2203.5
        Serotype 23F (Shared) (n=320, 323)
    2648.7
    1726.9
        Serotype 22F (Unique to V114) (n=321, 323)
    3471.1
    99.6
        Serotype 33F (Unique to V114) (n=321, 323)
    11392.4
    1244.7
    Statistical analysis title
    		 Serotype 1 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [47]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.58
    Notes
    [47] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [48]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.56
         upper limit
    		 2.3
    Notes
    [48] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 4 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [49]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 0.97
    Notes
    [49] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 5 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [50]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.4
    Notes
    [50] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [51]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.53
    Notes
    [51] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6B (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [52]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.31
         upper limit
    		 2.06
    Notes
    [52] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [53]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.14
    Notes
    [53] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9V (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [54]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.24
    Notes
    [54] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 14 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [55]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.37
    Notes
    [55] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 18C (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [56]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 1.84
    Notes
    [56] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [57]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.06
         upper limit
    		 1.55
    Notes
    [57] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [58]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.32
    Notes
    [58] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [59]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.18
         upper limit
    		 2
    Notes
    [59] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [60]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    34.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.13
         upper limit
    		 46.5
    Notes
    [60] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [61]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    9.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.48
         upper limit
    		 11.2
    Notes
    [61] - GMT ratio and 95% CI are estimated from a cLDA model.

    Secondary: GMC of Serotype-specific IgG at Day 30

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    End point title
    		 GMC of Serotype-specific IgG at Day 30
    End point description
    Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: µg/mL
    number (not applicable)
        Serotype 1 (Shared) (n=321, 323)
    6.97
    7.86
        Serotype 3 (Shared) (n=321, 323)
    1.02
    0.59
        Serotype 4 (Shared) (n=321, 323)
    2.36
    2.98
        Serotype 5 (Shared) (n=321, 323)
    5.43
    5.21
        Serotype 6A (Shared) (n=321, 323)
    11.48
    8.22
        Serotype 6B (Shared) (n=321, 323)
    13.69
    8.35
        Serotype 7F (Shared) (n=321, 323)
    7.14
    7.82
        Serotype 9V (Shared) (n=321, 323)
    6.10
    5.39
        Serotype 14 (Shared) (n=321, 323)
    12.68
    11.59
        Serotype 18C (Shared) (n=321, 323)
    16.67
    10.66
        Serotype 19A (Shared) (n=321, 323)
    18.59
    16.48
        Serotype 19F (Shared) (n=321, 323)
    12.00
    10.53
        Serotype 23F (Shared) (n=321, 323)
    9.76
    6.07
        Serotype 22F (Unique to V114) (n=321, 323)
    5.07
    0.31
        Serotype 33F (Unique to V114) (n=321, 323)
    14.31
    1.12
    Statistical analysis title
    		 Serotype 1 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [62]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.09
    Notes
    [62] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [63]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 2.07
    Notes
    [63] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 4 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [64]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 0.99
    Notes
    [64] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 5 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [65]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.3
    Notes
    [65] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [66]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 1.77
    Notes
    [66] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6B (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [67]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.28
         upper limit
    		 2.1
    Notes
    [67] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [68]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.13
    Notes
    [68] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9V (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [69]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.41
    Notes
    [69] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 14 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [70]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.38
    Notes
    [70] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 18C (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [71]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 1.92
    Notes
    [71] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [72]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.39
    Notes
    [72] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [73]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.41
    Notes
    [73] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [74]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 2.04
    Notes
    [74] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [75]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    16.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.78
         upper limit
    		 19.86
    Notes
    [75] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [76]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    12.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.82
         upper limit
    		 15.19
    Notes
    [76] - GMC ratio and 95% CI are estimated from a cLDA model.

    Secondary: Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30

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    End point title
    		 Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Day 30
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=307, 314)
    22.3 (18.5 to 26.9)
    16.7 (13.8 to 20.2)
        Serotype 3 (Shared) (n=305, 313)
    8.0 (6.9 to 9.2)
    4.4 (3.8 to 5.1)
        Serotype 4 (Shared) (n=305, 312)
    18.3 (15.0 to 22.4)
    23.3 (19.3 to 28.3)
        Serotype 5 (Shared) (n=310, 315)
    17.2 (14.2 to 20.9)
    16.2 (13.3 to 19.7)
        Serotype 6A (Shared) (n=279, 283)
    17.4 (14.2 to 21.2)
    13.9 (11.5 to 16.8)
        Serotype 6B (Shared) (n=302, 306)
    28.5 (23.1 to 35.2)
    18.4 (14.9 to 22.7)
        Serotype 7F (Shared) (n=296, 296)
    10.7 (8.7 to 13.0)
    10.5 (8.5 to 13.1)
        Serotype 9V (Shared) (n=299, 310)
    6.1 (5.2 to 7.1)
    5.6 (4.7 to 6.5)
        Serotype 14 (Shared) (n=304, 308)
    6.6 (5.4 to 8.0)
    6.0 (4.9 to 7.4)
        Serotype 18C (Shared) (n=301, 310)
    18.1 (15.1 to 21.7)
    12.2 (10.2 to 14.5)
        Serotype 19A (Shared) (n=301, 309)
    13.4 (11.1 to 16.3)
    10.0 (8.4 to 12.0)
        Serotype 19F (Shared) (n=298, 308)
    7.8 (6.7 to 9.2)
    6.4 (5.5 to 7.5)
        Serotype 23F (Shared) (n=284, 288)
    18.8 (15.2 to 23.1)
    12.2 (9.8 to 15.2)
        Serotype 22F (Unique to V114) (n=250, 249)
    32.5 (24.2 to 43.6)
    1.1 (0.8 to 1.4)
        Serotype 33F (Unique to V114) (n=305, 298)
    8.3 (6.7 to 10.1)
    0.9 (0.8 to 1.0)
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific IgG Day 1 to Day 30

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    End point title
    		 GMFR in Serotype-specific IgG Day 1 to Day 30
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Day 30
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=311, 318)
    13.0 (11.0 to 15.3)
    14.4 (12.3 to 16.8)
        Serotype 3 (Shared) (n=311, 318)
    6.7 (5.8 to 7.8)
    3.9 (3.4 to 4.3)
        Serotype 4 (Shared) (n=311, 318)
    10.1 (8.6 to 11.9)
    12.4 (10.6 to 14.5)
        Serotype 5 (Shared) (n=311, 318)
    5.6 (4.8 to 6.5)
    5.2 (4.4 to 6.2)
        Serotype 6A (Shared) (n=311, 318)
    30.2 (25.3 to 36.1)
    20.8 (17.5 to 24.6)
        Serotype 6B (Shared) (n=311, 318)
    28.2 (23.4 to 34.1)
    17.1 (14.4 to 20.4)
        Serotype 7F (Shared) (n=311, 318)
    13.6 (11.5 to 16.1)
    14.3 (12.1 to 17.0)
        Serotype 9V (Shared) (n=311, 318)
    11.7 (9.9 to 13.9)
    10.3 (8.8 to 12.0)
        Serotype 14 (Shared) (n=311, 318)
    6.6 (5.4 to 7.9)
    6.3 (5.3 to 7.5)
        Serotype 18C (Shared) (n=311, 318)
    22.4 (18.7 to 26.7)
    13.7 (11.6 to 16.2)
        Serotype 19A (Shared) (n=311, 318)
    11.3 (9.5 to 13.5)
    9.5 (8.1 to 11.1)
        Serotype 19F (Shared) (n=311, 317)
    14.2 (12.0 to 16.9)
    11.9 (10.2 to 14.0)
        Serotype 23F (Shared) (n=311, 318)
    17.7 (14.7 to 21.3)
    11.0 (9.3 to 13.1)
        Serotype 22F (Unique to V114) (n=311, 318)
    14.9 (12.4 to 18.0)
    0.9 (0.9 to 1.0)
        Serotype 33F (Unique to V114) (n=311, 318)
    11.1 (9.3 to 13.1)
    0.8 (0.8 to 0.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Day 30
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=307, 314)
    83.4 (78.7 to 87.4)
    76.1 (71.0 to 80.7)
        Serotype 3 (Shared) (n=305, 313)
    72.1 (66.7 to 77.1)
    51.1 (45.4 to 56.8)
        Serotype 4 (Shared) (n=305, 312)
    79.3 (74.4 to 83.7)
    84.6 (80.1 to 88.4)
        Serotype 5 (Shared) (n=310, 315)
    76.8 (71.7 to 81.4)
    79.0 (74.1 to 83.4)
        Serotype 6A (Shared) (n=279, 283)
    79.2 (74.0 to 83.8)
    78.1 (72.8 to 82.8)
        Serotype 6B (Shared) (n=302, 306)
    83.4 (78.8 to 87.5)
    76.1 (71.0 to 80.8)
        Serotype 7F (Shared) (n=296, 296)
    67.2 (61.6 to 72.5)
    65.9 (60.2 to 71.3)
        Serotype 9V (Shared) (n=299, 310)
    61.2 (55.4 to 66.8)
    56.8 (51.1 to 62.4)
        Serotype 14 (Shared) (n=304, 308)
    53.0 (47.2 to 58.7)
    53.2 (47.5 to 58.9)
        Serotype 18C (Shared) (n=301, 310)
    83.4 (78.7 to 87.4)
    74.2 (68.9 to 79.0)
        Serotype 19A (Shared) (n=301, 309)
    70.4 (64.9 to 75.5)
    69.6 (64.1 to 74.7)
        Serotype 19F (Shared) (n=298, 308)
    63.4 (57.7 to 68.9)
    56.2 (50.4 to 61.8)
        Serotype 23F (Shared) (n=284, 288)
    79.2 (74.0 to 83.8)
    70.8 (65.2 to 76.0)
        Serotype 22F (Unique to V114) (n=250, 249)
    72.8 (66.8 to 78.2)
    16.5 (12.1 to 21.7)
        Serotype 33F (Unique to V114) (n=305, 298)
    61.3 (55.6 to 66.8)
    3.0 (1.4 to 5.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Day 30
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=311, 318)
    74.9 (69.7 to 79.6)
    80.8 (76.1 to 85.0)
        Serotype 3 (Shared) (n=311, 318)
    62.4 (56.7 to 67.8)
    42.8 (37.3 to 48.4)
        Serotype 4 (Shared) (n=311, 318)
    71.4 (66.0 to 76.3)
    74.2 (69.0 to 78.9)
        Serotype 5 (Shared) (n=311, 318)
    52.4 (46.7 to 58.1)
    49.4 (43.7 to 55.0)
        Serotype 6A (Shared) (n=311, 318)
    88.4 (84.3 to 91.8)
    84.3 (79.8 to 88.1)
        Serotype 6B (Shared) (n=311, 318)
    85.5 (81.1 to 89.2)
    77.4 (72.4 to 81.8)
        Serotype 7F (Shared) (n=311, 318)
    76.8 (71.8 to 81.4)
    75.5 (70.4 to 80.1)
        Serotype 9V (Shared) (n=311, 318)
    73.0 (67.7 to 77.8)
    70.4 (65.1 to 75.4)
        Serotype 14 (Shared) (n=311, 318)
    54.0 (48.3 to 59.7)
    56.0 (50.3 to 61.5)
        Serotype 18C (Shared) (n=311, 318)
    83.9 (79.4 to 87.8)
    75.5 (70.4 to 80.1)
        Serotype 19A (Shared) (n=311, 318)
    71.4 (66.0 to 76.3)
    69.2 (63.8 to 74.2)
        Serotype 19F (Shared) (n=311, 317)
    77.5 (72.4 to 82.0)
    76.3 (71.3 to 80.9)
        Serotype 23F (Shared) (n=311, 318)
    79.7 (74.8 to 84.1)
    70.1 (64.8 to 75.1)
        Serotype 22F (Unique to V114) (n=311, 318)
    76.8 (71.8 to 81.4)
    0.9 (0.2 to 2.7)
        Serotype 33F (Unique to V114) (n=311, 318)
    71.1 (65.7 to 76.0)
    0.6 (0.1 to 2.3)
    No statistical analyses for this end point

    Secondary: GMT of Serotype-specific OPA at Month 12

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    End point title
    		 GMT of Serotype-specific OPA at Month 12
    End point description
    Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Titer
    number (not applicable)
        Serotype 1 (Shared) (n=321, 323)
    138.2
    116.2
        Serotype 3 (Shared) (n=321, 322)
    88.3
    56.3
        Serotype 4 (Shared) (n=321, 323)
    477.2
    666.5
        Serotype 5 (Shared) (n=321, 323)
    213.4
    209.6
        Serotype 6A (Shared) (n=321, 323)
    2421.7
    2111.3
        Serotype 6B (Shared) (n=321, 323)
    2079.7
    1453.7
        Serotype 7F (Shared) (n=321, 322)
    2161.8
    2291.1
        Serotype 9V (Shared) (n=321, 323)
    1006.8
    1030.5
        Serotype 14 (Shared) (n=321, 323)
    1543.8
    1395.1
        Serotype 18C (Shared) (n=321, 323)
    1520.4
    1191.8
        Serotype 19A (Shared) (n=321, 323)
    1724.3
    1575.3
        Serotype 19F (Shared) (n=321, 323)
    948.4
    876.0
        Serotype 23F (Shared) (n=320, 323)
    984.7
    720.3
        Serotype 22F (Unique to V114) (n=321, 323)
    1267.4
    99.1
        Serotype 33F (Unique to V114) (n=321, 323)
    4099.0
    1266.6
    Statistical analysis title
    		 Serotype 1 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [77]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.53
    Notes
    [77] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [78]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 1.9
    Notes
    [78] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 4 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [79]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.9
    Notes
    [79] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 5 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [80]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.33
    Notes
    [80] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [81]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.41
    Notes
    [81] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6B (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [82]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.16
         upper limit
    		 1.77
    Notes
    [82] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [83]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.11
    Notes
    [83] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9V (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [84]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.18
    Notes
    [84] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 14 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [85]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.36
    Notes
    [85] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 18C (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [86]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 1.55
    Notes
    [86] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [87]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.31
    Notes
    [87] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [88]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.29
    Notes
    [88] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [89]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.06
         upper limit
    		 1.76
    Notes
    [89] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [90]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    12.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.44
         upper limit
    		 17.34
    Notes
    [90] - GMT ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [91]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    3.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.73
         upper limit
    		 3.84
    Notes
    [91] - GMT ratio and 95% CI are estimated from a cLDA model.

    Secondary: GMC of Serotype-specific IgG at Month 12

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    End point title
    		 GMC of Serotype-specific IgG at Month 12
    End point description
    Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Month 12
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: µg/mL
    number (not applicable)
        Serotype 1 (Shared) (n=321, 323)
    2.73
    3.52
        Serotype 3 (Shared) (n=321, 323)
    0.39
    0.28
        Serotype 4 (Shared) (n=321, 323)
    1.00
    1.31
        Serotype 5 (Shared) (n=321, 323)
    2.59
    2.91
        Serotype 6A (Shared) (n=321, 323)
    4.27
    3.13
        Serotype 6B (Shared) (n=321, 323)
    5.13
    3.46
        Serotype 7F (Shared) (n=321, 323)
    2.95
    3.45
        Serotype 9V (Shared) (n=321, 323)
    2.85
    2.75
        Serotype 14 (Shared) (n=321, 323)
    7.91
    7.50
        Serotype 18C (Shared) (n=321, 323)
    5.99
    4.32
        Serotype 19A (Shared) (n=321, 323)
    8.19
    7.22
        Serotype 19F (Shared) (n=321, 323)
    4.67
    4.14
        Serotype 23F (Shared) (n=321, 323)
    3.57
    2.66
        Serotype 22F (Unique to V114) (n=321, 323)
    2.07
    0.33
        Serotype 33F (Unique to V114) (n=321, 323)
    6.24
    1.24
    Statistical analysis title
    		 Serotype 1 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [92]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.92
    Notes
    [92] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [93]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.24
         upper limit
    		 1.63
    Notes
    [93] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 4 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [94]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 0.91
    Notes
    [94] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 5 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [95]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.05
    Notes
    [95] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [96]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 1.67
    Notes
    [96] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6B (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [97]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 1.81
    Notes
    [97] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [98]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.02
    Notes
    [98] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9V (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [99]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.23
    Notes
    [99] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 14 (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [100]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.26
    Notes
    [100] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 18C (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [101]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.17
         upper limit
    		 1.64
    Notes
    [101] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [102]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.33
    Notes
    [102] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [103]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.32
    Notes
    [103] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23F (Shared)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [104]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 1.62
    Notes
    [104] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [105]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    6.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.33
         upper limit
    		 7.21
    Notes
    [105] - GMC ratio and 95% CI are estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F (Unique to V114)
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 [106]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    5.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.38
         upper limit
    		 5.73
    Notes
    [106] - GMC ratio and 95% CI are estimated from a cLDA model.

    Secondary: GMFR in Serotype-specific OPA Day 1 to Month 12

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    End point title
    		 GMFR in Serotype-specific OPA Day 1 to Month 12
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Month 12
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=281, 277)
    9.2 (7.7 to 11.1)
    7.3 (6.1 to 8.7)
        Serotype 3 (Shared) (n=274, 276)
    3.0 (2.6 to 3.5)
    2.1 (1.9 to 2.4)
        Serotype 4 (Shared) (n=276, 277)
    7.0 (5.8 to 8.3)
    9.4 (7.7 to 11.3)
        Serotype 5 (Shared) (n=281, 280)
    5.5 (4.6 to 6.7)
    5.7 (4.7 to 6.9)
        Serotype 6A (Shared) (n=255, 254)
    5.7 (4.9 to 6.8)
    4.9 (4.2 to 5.7)
        Serotype 6B (Shared) (n=272, 273)
    10.4 (8.4 to 12.7)
    7.3 (6.1 to 8.8)
        Serotype 7F (Shared) (n=270, 262)
    4.6 (3.8 to 5.5)
    4.9 (4.1 to 6.0)
        Serotype 9V (Shared) (n=272, 275)
    2.7 (2.3 to 3.1)
    2.7 (2.3 to 3.1)
        Serotype 14 (Shared) (n=274, 270)
    3.9 (3.3 to 4.7)
    3.5 (2.9 to 4.2)
        Serotype 18C (Shared) (n=275, 274)
    6.5 (5.6 to 7.6)
    5.2 (4.5 to 6.1)
        Serotype 19A (Shared) (n=269, 276)
    4.9 (4.1 to 5.9)
    4.3 (3.6 to 5.0)
        Serotype 19F (Shared) (n=267, 272)
    3.0 (2.6 to 3.5)
    2.8 (2.5 to 3.3)
        Serotype 23F (Shared) (n=255, 256)
    7.1 (5.8 to 8.7)
    5.1 (4.2 to 6.3)
        Serotype 22F (Unique to V114)(n=225, 213)
    12.3 (9.3 to 16.3)
    1.3 (1.0 to 1.6)
        Serotype 33F (Unique to V114) (n=278, 269)
    3.0 (2.5 to 3.6)
    0.9 (0.8 to 1.0)
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific IgG Day 1 to Month 12

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    End point title
    		 GMFR in Serotype-specific IgG Day 1 to Month 12
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had data available for this endpoint and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Month 12
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=282, 282)
    5.2 (4.5 to 6.0)
    6.6 (5.7 to 7.7)
        Serotype 3 (Shared) (n=282, 282)
    2.6 (2.3 to 2.9)
    1.8 (1.7 to 2.0)
        Serotype 4 (Shared) (n=282, 281)
    4.3 (3.8 to 4.9)
    5.5 (4.8 to 6.3)
        Serotype 5 (Shared) (n=282, 282)
    2.7 (2.4 to 3.0)
    3.0 (2.6 to 3.4)
        Serotype 6A (Shared) (n=282, 282)
    11.1 (9.5 to 13.0)
    8.1 (6.9 to 9.3)
        Serotype 6B (Shared) (n=282, 282)
    10.3 (8.7 to 12.2)
    7.2 (6.2 to 8.4)
        Serotype 7F (Shared) (n=282, 282)
    5.5 (4.8 to 6.2)
    6.4 (5.5 to 7.5)
        Serotype 9V (Shared) (n=282, 282)
    5.6 (4.9 to 6.4)
    5.4 (4.7 to 6.1)
        Serotype 14 (Shared) (n=282, 282)
    3.9 (3.4 to 4.6)
    4.1 (3.5 to 4.7)
        Serotype 18C (Shared) (n=282, 282)
    8.0 (6.9 to 9.3)
    5.6 (4.9 to 6.5)
        Serotype 19A (Shared) (n=282, 282)
    4.9 (4.3 to 5.6)
    4.3 (3.8 to 4.9)
        Serotype 19F (Shared) (n=281, 281)
    5.2 (4.6 to 6.0)
    4.9 (4.3 to 5.6)
        Serotype 23F (Shared) (n=282, 282)
    6.6 (5.7 to 7.6)
    4.9 (4.3 to 5.7)
        Serotype 22F (Unique to V114) (n=282, 282)
    6.0 (5.1 to 7.0)
    1.0 (0.9 to 1.1)
        Serotype 33F (Unique to V114) (n=282, 282)
    4.7 (4.1 to 5.4)
    0.9 (0.9 to 1.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Month 12
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=281, 277)
    69.4 (63.6 to 74.7)
    61.4 (55.4 to 67.1)
        Serotype 3 (Shared) (n=274, 276)
    39.4 (33.6 to 45.5)
    25.7 (20.7 to 31.3)
        Serotype 4 (Shared) (n=276, 277)
    63.0 (57.1 to 68.8)
    67.1 (61.3 to 72.6)
        Serotype 5 (Shared) (n=281, 280)
    58.4 (52.4 to 64.2)
    57.5 (51.5 to 63.4)
        Serotype 6A (Shared) (n=255, 254)
    61.2 (54.9 to 67.2)
    54.3 (48.0 to 60.6)
        Serotype 6B (Shared) (n=272, 273)
    68.8 (62.9 to 74.2)
    60.4 (54.4 to 66.3)
        Serotype 7F (Shared) (n=270, 262)
    50.4 (44.2 to 56.5)
    48.9 (42.7 to 55.1)
        Serotype 9V (Shared) (n=272, 275)
    34.6 (28.9 to 40.5)
    32.0 (26.5 to 37.9)
        Serotype 14 (Shared) (n=274, 270)
    41.6 (35.7 to 47.7)
    42.2 (36.3 to 48.4)
        Serotype 18C (Shared) (n=275, 274)
    63.3 (57.3 to 69.0)
    54.4 (48.3 to 60.4)
        Serotype 19A (Shared) (n=269, 276)
    53.2 (47.0 to 59.2)
    47.5 (41.4 to 53.5)
        Serotype 19F (Shared) (n=267, 272)
    41.2 (35.2 to 47.4)
    35.3 (29.6 to 41.3)
        Serotype 23F (Shared) (n=255, 256)
    62.4 (56.1 to 68.3)
    53.5 (47.2 to 59.7)
        Serotype 22F (Unique to V114) (n=225, 213)
    64.0 (57.4 to 70.3)
    14.1 (9.7 to 19.5)
        Serotype 33F (Unique to V114) (n=278, 269)
    34.5 (29.0 to 40.4)
    4.8 (2.6 to 8.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥4-fold rise in IgG concentration are calculated from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Month 12
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=282, 282)
    56.0 (50.0 to 61.9)
    65.6 (59.7 to 71.1)
        Serotype 3 (Shared) (n=282, 282)
    27.0 (21.9 to 32.5)
    12.4 (8.8 to 16.8)
        Serotype 4 (Shared) (n=282, 281)
    47.2 (41.2 to 53.2)
    57.7 (51.6 to 63.5)
        Serotype 5 (Shared) (n=282, 282)
    30.9 (25.5 to 36.6)
    34.4 (28.9 to 40.3)
        Serotype 6A (Shared) (n=282, 282)
    75.5 (70.1 to 80.4)
    66.7 (60.8 to 72.1)
        Serotype 6B (Shared) (n=282, 282)
    73.0 (67.5 to 78.1)
    62.1 (56.1 to 67.7)
        Serotype 7F (Shared) (n=282, 282)
    59.9 (54.0 to 65.7)
    64.9 (59.0 to 70.5)
        Serotype 9V (Shared) (n=282, 282)
    60.6 (54.7 to 66.4)
    55.3 (49.3 to 61.2)
        Serotype 14 (Shared) (n=282, 282)
    42.6 (36.7 to 48.6)
    46.8 (40.9 to 52.8)
        Serotype 18C (Shared) (n=282, 282)
    70.2 (64.5 to 75.5)
    58.5 (52.5 to 64.3)
        Serotype 19A (Shared) (n=282, 282)
    53.9 (47.9 to 59.8)
    50.0 (44.0 to 56.0)
        Serotype 19F (Shared) (n=281, 281)
    56.9 (50.9 to 62.8)
    52.3 (46.3 to 58.3)
        Serotype 23F (Shared) (n=282, 282)
    59.6 (53.6 to 65.4)
    51.4 (45.4 to 57.4)
        Serotype 22F (Unique to V114) (n=282, 282)
    58.9 (52.9 to 64.7)
    1.8 (0.6 to 4.1)
        Serotype 33F (Unique to V114) (n=282, 282)
    52.5 (46.5 to 58.4)
    1.1 (0.2 to 3.1)
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific OPA Day 1 to Month 13

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    End point title
    		 GMFR in Serotype-specific OPA Day 1 to Month 13
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Month 13
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=272, 269)
    24.7 (20.7 to 29.4)
    15.5 (12.9 to 18.5)
        Serotype 3 (Shared) (n=268, 267)
    9.1 (7.9 to 10.5)
    8.7 (7.5 to 10.0)
        Serotype 4 (Shared) (n=270, 268)
    23.8 (19.5 to 29.2)
    21.5 (17.5 to 26.3)
        Serotype 5 (Shared) (n=273, 272)
    17.2 (14.1 to 21.1)
    14.5 (12.0 to 17.5)
        Serotype 6A (Shared) (n=243, 245)
    7.7 (6.5 to 9.2)
    6.3 (5.4 to 7.3)
        Serotype 6B (Shared) (n=264, 266)
    16.2 (13.3 to 19.8)
    14.3 (11.7 to 17.4)
        Serotype 7F (Shared) (n=262, 254)
    11.0 (9.0 to 13.4)
    10.2 (8.2 to 12.5)
        Serotype 9V (Shared) (n=265, 266)
    5.2 (4.5 to 6.1)
    4.6 (3.9 to 5.3)
        Serotype 14 (Shared) (n=268, 264)
    8.2 (6.8 to 9.8)
    6.7 (5.6 to 8.0)
        Serotype 18C (Shared) (n=267, 266)
    10.1 (8.6 to 11.7)
    9.0 (7.7 to 10.4)
        Serotype 19A (Shared) (n=262, 267)
    10.4 (8.5 to 12.6)
    8.5 (7.2 to 10.2)
        Serotype 19F (Shared) (n=263, 264)
    7.0 (6.0 to 8.1)
    6.3 (5.5 to 7.2)
        Serotype 23F (Shared) (n=250, 249)
    12.6 (10.3 to 15.5)
    9.7 (7.8 to 12.0)
        Serotype 22F (Unique to V114) (n=224, 230)
    30.2 (22.7 to 40.1)
    16.2 (11.8 to 22.2)
        Serotype 33F (Unique to V114) (n=269, 258)
    5.8 (4.8 to 7.0)
    5.5 (4.5 to 6.7)
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific IgG Day 1 to Month 13

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    End point title
    		 GMFR in Serotype-specific IgG Day 1 to Month 13
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Month 13
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=273, 274)
    9.9 (8.7 to 11.4)
    10.5 (9.1 to 12.2)
        Serotype 3 (Shared) (n=273, 274)
    6.9 (6.0 to 7.8)
    6.7 (6.0 to 7.6)
        Serotype 4 (Shared) (n=273, 273)
    8.6 (7.6 to 9.8)
    9.5 (8.3 to 11.0)
        Serotype 5 (Shared) (n=273, 274)
    5.9 (5.2 to 6.8)
    5.9 (5.2 to 6.8)
        Serotype 6A (Shared) (n=273, 274)
    13.1 (11.2 to 15.3)
    10.8 (9.3 to 12.5)
        Serotype 6B (Shared) (n=273, 274)
    13.7 (11.7 to 16.1)
    11.9 (10.2 to 13.9)
        Serotype 7F (Shared) (n=273, 274)
    11.1 (9.8 to 12.7)
    11.2 (9.7 to 12.9)
        Serotype 9V (Shared) (n=273, 274)
    9.8 (8.5 to 11.3)
    9.2 (8.0 to 10.5)
        Serotype 14 (Shared) (n=273, 274)
    7.4 (6.3 to 8.7)
    6.9 (5.9 to 8.1)
        Serotype 18C (Shared) (n=273, 274)
    9.8 (8.5 to 11.3)
    8.2 (7.1 to 9.4)
        Serotype 19A (Shared) (n=273, 274)
    7.9 (6.9 to 9.0)
    7.0 (6.1 to 8.0)
        Serotype 19F (Shared) (n=273, 273)
    10.7 (9.3 to 12.4)
    10.0 (8.6 to 11.5)
        Serotype 23F (Shared) (n=273, 274)
    9.1 (7.9 to 10.5)
    7.6 (6.6 to 8.7)
        Serotype 22F (Unique to V114) (n=273, 274)
    14.2 (12.0 to 16.7)
    10.0 (8.4 to 12.0)
        Serotype 33F (Unique to V114) (n=273, 274)
    8.1 (7.1 to 9.2)
    10.1 (8.6 to 11.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Month 13
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=272, 269)
    87.9 (83.4 to 91.5)
    78.8 (73.4 to 83.5)
        Serotype 3 (Shared) (n=268, 267)
    78.7 (73.3 to 83.5)
    76.0 (70.4 to 81.0)
        Serotype 4 (Shared) (n=270, 268)
    83.7 (78.7 to 87.9)
    84.3 (79.4 to 88.5)
        Serotype 5 (Shared) (n=273, 272)
    79.9 (74.6 to 84.4)
    80.9 (75.7 to 85.4)
        Serotype 6A (Shared) (n=243, 245)
    68.3 (62.1 to 74.1)
    64.5 (58.1 to 70.5)
        Serotype 6B (Shared) (n=264, 266)
    78.0 (72.5 to 82.9)
    77.1 (71.5 to 82.0)
        Serotype 7F (Shared) (n=262, 254)
    72.1 (66.3 to 77.5)
    64.6 (58.3 to 70.4)
        Serotype 9V (Shared) (n=265, 266)
    55.8 (49.6 to 61.9)
    50.8 (44.6 to 56.9)
        Serotype 14 (Shared) (n=268, 264)
    63.8 (57.7 to 69.6)
    58.7 (52.5 to 64.7)
        Serotype 18C (Shared) (n=267, 266)
    75.7 (70.1 to 80.7)
    73.7 (68.0 to 78.9)
        Serotype 19A (Shared) (n=262, 267)
    70.2 (64.3 to 75.7)
    66.3 (60.3 to 71.9)
        Serotype 19F (Shared) (n=263, 264)
    68.4 (62.4 to 74.0)
    62.1 (56.0 to 68.0)
        Serotype 23F (Shared) (n=250, 249)
    74.4 (68.5 to 79.7)
    66.3 (60.0 to 72.1)
        Serotype 22F (Unique to V114) (n=224, 230)
    79.5 (73.6 to 84.6)
    62.6 (56.0 to 68.9)
        Serotype 33F (Unique to V114) (n=269, 258)
    55.8 (49.6 to 61.8)
    51.6 (45.3 to 57.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥4-fold rise in IgG concentration are calculated from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Month 13
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=273, 274)
    79.5 (74.2 to 84.1)
    78.5 (73.1 to 83.2)
        Serotype 3 (Shared) (n=273, 274)
    72.5 (66.8 to 77.7)
    68.6 (62.8 to 74.1)
        Serotype 4 (Shared) (n=273, 273)
    76.6 (71.1 to 81.5)
    75.5 (69.9 to 80.4)
        Serotype 5 (Shared) (n=273, 274)
    59.7 (53.6 to 65.6)
    59.9 (53.8 to 65.7)
        Serotype 6A (Shared) (n=273, 274)
    81.0 (75.8 to 85.4)
    77.0 (71.6 to 81.9)
        Serotype 6B (Shared) (n=273, 274)
    81.0 (75.8 to 85.4)
    77.0 (71.6 to 81.9)
        Serotype 7F (Shared) (n=273, 274)
    81.7 (76.6 to 86.1)
    81.4 (76.3 to 85.8)
        Serotype 9V (Shared) (n=273, 274)
    76.2 (70.7 to 81.1)
    73.4 (67.7 to 78.5)
        Serotype 14 (Shared) (n=273, 274)
    68.5 (62.6 to 74.0)
    63.9 (57.9 to 69.6)
        Serotype 18C (Shared) (n=273, 274)
    78.0 (72.6 to 82.8)
    70.8 (65.0 to 76.1)
        Serotype 19A (Shared) (n=273, 274)
    70.0 (64.1 to 75.3)
    66.4 (60.5 to 72.0)
        Serotype 19F (Shared) (n=273, 273)
    77.3 (71.9 to 82.1)
    74.0 (68.4 to 79.1)
        Serotype 23F (Shared) (n=273, 274)
    72.2 (66.4 to 77.4)
    69.7 (63.9 to 75.1)
        Serotype 22F (Unique to V114) (n=273, 274)
    80.6 (75.4 to 85.1)
    71.9 (66.2 to 77.1)
        Serotype 33F (Unique to V114) (n=273, 274)
    75.5 (69.9 to 80.4)
    76.6 (71.2 to 81.5)
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific OPA Month 12 to Month 13

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    End point title
    		 GMFR in Serotype-specific OPA Month 12 to Month 13
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Month 12 (Baseline) and Month 13
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=273, 270)
    2.7 (2.4 to 3.0)
    2.3 (2.0 to 2.6)
        Serotype 3 (Shared) (n=267, 270)
    3.0 (2.7 to 3.4)
    4.1 (3.6 to 4.6)
        Serotype 4 (Shared) (n=273, 273)
    3.3 (2.9 to 3.9)
    2.3 (2.0 to 2.6)
        Serotype 5 (Shared) (n=275, 274)
    3.1 (2.7 to 3.5)
    2.6 (2.3 to 2.9)
        Serotype 6A (Shared) (n=264, 268)
    1.3 (1.2 to 1.5)
    1.3 (1.2 to 1.5)
        Serotype 6B (Shared) (n=273, 274)
    1.5 (1.4 to 1.7)
    1.9 (1.8 to 2.2)
        Serotype 7F (Shared) (n=275, 274)
    2.3 (2.1 to 2.6)
    2.1 (1.9 to 2.3)
        Serotype 9V (Shared) (n=274, 273)
    2.0 (1.8 to 2.2)
    1.7 (1.6 to 2.0)
        Serotype 14 (Shared) (n=272, 272)
    2.1 (1.9 to 2.4)
    1.9 (1.7 to 2.1)
        Serotype 18C (Shared) (n=272, 274)
    1.5 (1.4 to 1.7)
    1.7 (1.5 to 1.9)
        Serotype 19A (Shared) (n=270, 273)
    2.1 (1.9 to 2.4)
    2.0 (1.8 to 2.3)
        Serotype 19F (Shared) (n=273, 274)
    2.3 (2.0 to 2.6)
    2.3 (2.1 to 2.6)
        Serotype 23F (Shared) (n=268, 270)
    1.9 (1.6 to 2.1)
    1.9 (1.7 to 2.2)
        Serotype 22F (Unique to V114) (n=265, 245)
    2.5 (2.1 to 2.9)
    14.2 (10.6 to 19.0)
        Serotype 33F (Unique to V114) (n=271, 263)
    2.0 (1.8 to 2.2)
    6.2 (5.2 to 7.5)
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific IgG Month 12 to Month 13

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    End point title
    		 GMFR in Serotype-specific IgG Month 12 to Month 13
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Month 12 (Baseline) and Month 13
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=274, 274)
    1.9 (1.8 to 2.1)
    1.6 (1.5 to 1.7)
        Serotype 3 (Shared) (n=274, 274)
    2.6 (2.4 to 2.9)
    3.7 (3.3 to 4.1)
        Serotype 4 (Shared) (n=274, 272)
    2.0 (1.8 to 2.2)
    1.7 (1.6 to 1.9)
        Serotype 5 (Shared) (n=274, 274)
    2.3 (2.1 to 2.5)
    2.0 (1.8 to 2.1)
        Serotype 6A (Shared) (n=274, 274)
    1.2 (1.1 to 1.2)
    1.3 (1.3 to 1.4)
        Serotype 6B (Shared) (n=274, 274)
    1.3 (1.2 to 1.4)
    1.6 (1.5 to 1.8)
        Serotype 7F (Shared) (n=274, 274)
    2.1 (1.9 to 2.2)
    1.8 (1.6 to 1.9)
        Serotype 9V (Shared) (n=274, 274)
    1.8 (1.6 to 1.9)
    1.7 (1.6 to 1.9)
        Serotype 14 (Shared) (n=274, 274)
    1.9 (1.7 to 2.1)
    1.7 (1.6 to 1.8)
        Serotype 18C (Shared) (n=274, 274)
    1.2 (1.2 to 1.3)
    1.5 (1.4 to 1.6)
        Serotype 19A (Shared) (n=274, 274)
    1.6 (1.5 to 1.7)
    1.6 (1.5 to 1.7)
        Serotype 19F (Shared) (n=273, 274)
    2.0 (1.9 to 2.2)
    2.1 (1.9 to 2.3)
        Serotype 23F (Shared) (n=274, 274)
    1.4 (1.3 to 1.5)
    1.6 (1.5 to 1.7)
        Serotype 22F (Unique to V114) (n=274, 274)
    2.4 (2.2 to 2.6)
    10.0 (8.4 to 11.9)
        Serotype 33F (Unique to V114) (n=274, 274)
    1.7 (1.6 to 1.9)
    10.7 (9.1 to 12.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Month 12 (Baseline) and Month 13
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=273, 270)
    29.7 (24.3 to 35.5)
    25.6 (20.5 to 31.2)
        Serotype 3 (Shared) (n=267, 270)
    39.0 (33.1 to 45.1)
    49.6 (43.5 to 55.8)
        Serotype 4 (Shared) (n=273, 273)
    36.3 (30.6 to 42.3)
    22.3 (17.5 to 27.8)
        Serotype 5 (Shared) (n=275, 274)
    34.9 (29.3 to 40.9)
    29.2 (23.9 to 35.0)
        Serotype 6A (Shared) (n=264, 268)
    9.1 (5.9 to 13.2)
    10.4 (7.1 to 14.7)
        Serotype 6B (Shared) (n=273, 274)
    8.8 (5.7 to 12.8)
    16.1 (11.9 to 21.0)
        Serotype 7F (Shared) (n=275, 274)
    24.7 (19.7 to 30.3)
    21.2 (16.5 to 26.5)
        Serotype 9V (Shared) (n=274, 273)
    20.1 (15.5 to 25.3)
    16.5 (12.3 to 21.4)
        Serotype 14 (Shared) (n=272, 272)
    21.3 (16.6 to 26.7)
    12.9 (9.1 to 17.4)
        Serotype 18C (Shared) (n=272, 274)
    10.7 (7.3 to 15.0)
    15.7 (11.6 to 20.6)
        Serotype 19A (Shared) (n=270, 273)
    20.4 (15.7 to 25.7)
    17.9 (13.6 to 23.0)
        Serotype 19F (Shared) (n=273, 274)
    25.3 (20.2 to 30.9)
    27.4 (22.2 to 33.1)
        Serotype 23F (Shared) (n=268, 270)
    19.0 (14.5 to 24.2)
    17.8 (13.4 to 22.9)
        Serotype 22F (Unique to V114) (n=265, 245)
    26.8 (21.6 to 32.6)
    62.0 (55.6 to 68.1)
        Serotype 33F (Unique to V114) (n=271, 263)
    22.1 (17.3 to 27.6)
    54.4 (48.1 to 60.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
    End point description
    Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. The percentage of participants who had ≥4-fold rise in IgG concentration are calculated from baseline to postvaccination. The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
    End point type
    Secondary
    End point timeframe
    Month 12 (Baseline) and Month 13
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    326
    325
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=274, 274)
    15.0 (11.0 to 19.7)
    8.8 (5.7 to 12.8)
        Serotype 3 (Shared) (n=274, 274)
    31.4 (25.9 to 37.2)
    43.8 (37.8 to 49.9)
        Serotype 4 (Shared) (n=274, 272)
    14.2 (10.3 to 18.9)
    8.8 (5.7 to 12.8)
        Serotype 5 (Shared) (n=274, 274)
    20.1 (15.5 to 25.3)
    15.0 (11.0 to 19.7)
        Serotype 6A (Shared) (n=274, 274)
    1.1 (0.2 to 3.2)
    4.4 (2.3 to 7.5)
        Serotype 6B (Shared) (n=274, 274)
    4.7 (2.6 to 8.0)
    11.3 (7.8 to 15.7)
        Serotype 7F (Shared) (n=274, 274)
    17.2 (12.9 to 22.1)
    10.2 (6.9 to 14.4)
        Serotype 9V (Shared) (n=274, 274)
    10.6 (7.2 to 14.8)
    9.1 (6.0 to 13.2)
        Serotype 14 (Shared) (n=274, 274)
    14.2 (10.3 to 18.9)
    9.5 (6.3 to 13.6)
        Serotype 18C (Shared) (n=274, 274)
    0.4 (0.0 to 2.0)
    6.9 (4.2 to 10.6)
        Serotype 19A (Shared) (n=274, 274)
    8.0 (5.1 to 11.9)
    7.7 (4.8 to 11.5)
        Serotype 19F (Shared) (n=273, 274)
    13.9 (10.0 to 18.6)
    17.9 (13.5 to 22.9)
        Serotype 23F (Shared) (n=274, 274)
    3.6 (1.8 to 6.6)
    10.2 (6.9 to 14.4)
        Serotype 22F (Unique to V114) (n=274, 274)
    21.5 (16.8 to 26.9)
    71.2 (65.4 to 76.5)
        Serotype 33F (Unique to V114) (n=274,274)
    10.6 (7.2 to 14.8)
    77.0 (71.6 to 81.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2)
    Adverse event reporting additional description
    The analysis population included all randomized participants who received study intervention at the specified timepoint. Adverse events were reported (1) following administration of either V114 or Prevnar 13™ and (2) following administration of PNEUMOVAX™23.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).

    Reporting group title
    V114 (Post-PNEUMOVAX™23)
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).

    Reporting group title
    Prevnar 13™(Post-PNEUMOVAX™23)
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2).

    Serious adverse events
    		 V114 Prevnar 13™ V114 (Post-PNEUMOVAX™23) Prevnar 13™(Post-PNEUMOVAX™23)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 327 (5.20%)
    19 / 324 (5.86%)
    1 / 298 (0.34%)
    2 / 302 (0.66%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    0 / 327 (0.00%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the hypopharynx
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hangover
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 327 (0.00%)
    0 / 324 (0.00%)
    1 / 298 (0.34%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium tremens
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    0 / 327 (0.00%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 327 (0.31%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    1 / 302 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arachnoid cyst
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 327 (0.31%)
    2 / 324 (0.62%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholic pancreatitis
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    2 / 327 (0.61%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendiceal abscess
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 327 (0.61%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    2 / 327 (0.61%)
    0 / 324 (0.00%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 327 (0.31%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 324 (0.31%)
    0 / 298 (0.00%)
    0 / 302 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V114 Prevnar 13™ V114 (Post-PNEUMOVAX™23) Prevnar 13™(Post-PNEUMOVAX™23)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    221 / 327 (67.58%)
    181 / 324 (55.86%)
    217 / 298 (72.82%)
    210 / 302 (69.54%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    46 / 327 (14.07%)
    41 / 324 (12.65%)
    36 / 298 (12.08%)
    38 / 302 (12.58%)
         occurrences all number
    58
    52
    43
    46
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    77 / 327 (23.55%)
    45 / 324 (13.89%)
    77 / 298 (25.84%)
    66 / 302 (21.85%)
         occurrences all number
    89
    53
    103
    77
    Injection site erythema
         subjects affected / exposed
    39 / 327 (11.93%)
    26 / 324 (8.02%)
    53 / 298 (17.79%)
    51 / 302 (16.89%)
         occurrences all number
    41
    28
    57
    53
    Injection site pain
         subjects affected / exposed
    181 / 327 (55.35%)
    137 / 324 (42.28%)
    186 / 298 (62.42%)
    177 / 302 (58.61%)
         occurrences all number
    204
    155
    210
    210
    Injection site swelling
         subjects affected / exposed
    54 / 327 (16.51%)
    40 / 324 (12.35%)
    84 / 298 (28.19%)
    79 / 302 (26.16%)
         occurrences all number
    55
    43
    85
    82
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    21 / 327 (6.42%)
    17 / 324 (5.25%)
    25 / 298 (8.39%)
    25 / 302 (8.28%)
         occurrences all number
    26
    19
    34
    26
    Myalgia
         subjects affected / exposed
    58 / 327 (17.74%)
    36 / 324 (11.11%)
    64 / 298 (21.48%)
    50 / 302 (16.56%)
         occurrences all number
    62
    39
    71
    55

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jun 2018
    Added to the exclusion criteria and concomitant therapy a clarification on the specific steroid used as a reference. The schedule of activities clarified the process for administering the telephone contact questionnaire.

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

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

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