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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 Six Months Later in Immunocompetent Adults Between 18 and 49 Years of Age at Increased Risk for Pneumococcal Disease (PNEU–DAY).

    Summary
    EudraCT number
    		 2017-004915-38
    Trial protocol
    		 PL  
    Global end of trial date
    20 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jan 2021
    First version publication date
    23 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V114-017
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    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
    20 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.
    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
    16 Jul 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
    Australia: 55
    Country: Number of subjects enrolled
    Canada: 113
    Country: Number of subjects enrolled
    Chile: 96
    Country: Number of subjects enrolled
    New Zealand: 176
    Country: Number of subjects enrolled
    Poland: 279
    Country: Number of subjects enrolled
    Russian Federation: 15
    Country: Number of subjects enrolled
    United States: 781
    Worldwide total number of subjects
    1515
    EEA total number of subjects
    279
    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)
    1515
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 1515 participants were randomized across 77 study sites. Eligible participants were to be randomly assigned in a 3:1 ratio to receive a single dose of either V114 or Prevnar 13™ on Day 1. Participants also received a single dose of PNEUMOVAX™23 at Month 6.

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

    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 were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (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
    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

    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

    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 were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2)
    Arm type
    		 Experimental

    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

    Number of subjects in period 1
    		V114 Prevnar 13™
    Started
    1135
    380
    Vaccination 1-V114 or Prevnar 13™, Day 1
    1133
    379
    Vaccination 2-PNEUMOVAX™23, Month 6
    1035 [1]
    346 [2]
    Completed
    1038
    350
    Not completed
    97
    30
         Adverse event, serious fatal
    4
    2
         Consent withdrawn by subject
    34
    12
         Screen Failure
    -
    1
         Lost to follow-up
    59
    15
    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 were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (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 were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (Vaccination 2)

    Reporting group values
    		 V114 Prevnar 13™ Total
    Number of subjects
    		 1135 380 1515
    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)
    		 1135 380 1515
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.9 ± 8.9 35.8 ± 8.9 -
    Sex: Female, Male
    Units:
        Female
    		 581 201 782
        Male
    		 554 179 733
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 445 148 593
        Asian
    		 15 8 23
        Native Hawaiian or Other Pacific Islander
    		 33 11 44
        Black or African American
    		 43 18 61
        White
    		 582 192 774
        More than one race
    		 17 3 20
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 135 39 174
        Not Hispanic or Latino
    		 984 338 1322
        Unknown or Not Reported
    		 16 3 19

    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 were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (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 were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (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™ [1]
    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 intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™ (PCV13), the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson. The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
    End point type
    Primary
    End point timeframe
    Up to 5 days after Vaccination 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1134
    378
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site redness/erythema
    15.1 (13.0 to 17.3)
    14.0 (10.7 to 17.9)
        Injection site tenderness/pain
    75.8 (73.2 to 78.3)
    68.8 (63.8 to 73.4)
        Injection site swelling
    21.7 (19.3 to 24.2)
    22.2 (18.1 to 26.8)
    No statistical analyses for this end point

    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™ [2]
    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 intervention, whether or not considered related to the study intervention. 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. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
    End point type
    Primary
    End point timeframe
    Up to 14 days after Vaccination 1
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1134
    378
    Units: Percentage of Participants
    number (confidence interval 95%)
        Joint pain/arthralgia
    12.7 (10.8 to 14.8)
    11.6 (8.6 to 15.3)
        Tiredness/fatigue
    34.3 (31.5 to 37.1)
    36.8 (31.9 to 41.9)
        Headache
    26.5 (23.9 to 29.1)
    24.9 (20.6 to 29.5)
        Muscle pain/myalgia
    28.8 (26.2 to 31.6)
    25.5 (22.1 to 31.2)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants with a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™ [3]
    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 serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
    End point type
    Primary
    End point timeframe
    Up to Month 6 (before Vaccination 2)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1134
    378
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.0 (0.0 to 0.3)
    0.0 (0.0 to 0.8)
    No statistical analyses for this end point

    Primary: Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™

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    End point title
    		 Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ [4]
    End point description
    The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (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 multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The analysis population included 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
    Day 30
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1133
    379
    Units: Titers
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=1019, 341)
    268.6 (243.7 to 296.0)
    267.2 (220.4 to 323.9)
        Serotype 3 (Shared) (n=1004, 340)
    199.3 (184.6 to 215.2)
    150.6 (130.6 to 173.8)
        Serotype 4 (Shared)(n=1016, 342)
    1416.0 (1308.9 to 1531.8)
    2576.1 (2278.0 to 2913.2)
        Serotype 5 (Shared) (n=1018, 343)
    564.8 (512.7 to 622.2)
    731.1 (613.6 to 871.0)
        Serotype 6A (Shared) (n=1006, 335)
    12928.8 (11923.4 to 14019.0)
    11282.4 (9718.8 to 13097.5)
        Serotype 6B (Shared) (n=1014, 342)
    10336.9 (9649.4 to 11073.4)
    6995.7 (6024.7 to 8123.2)
        Serotype 7F (Shared) (n=1019, 342)
    5756.4 (5410.4 to 6124.6)
    7588.9 (6775.3 to 8500.2)
        Serotype 9V (Shared) (n=1015, 343)
    3355.1 (3135.4 to 3590.1)
    3983.7 (3557.8 to 4460.7)
        Serotype 14 (Shared) (n=1016, 343)
    5228.9 (4847.6 to 5640.2)
    5889.8 (5218.2 to 6647.8)
        Serotype 18C (Shared) (n=1014, 343)
    5709.0 (5331.1 to 6113.6)
    3063.2 (2699.8 to 3475.5)
        Serotype 19A (Shared) (n=1015, 343)
    5369.9 (5017.7 to 5746.8)
    5888.0 (5228.2 to 6631.0)
        Serotype 19F (Shared) (n=1018, 343)
    3266.3 (3064.4 to 3481.4)
    3272.7 (2948.2 to 3632.9)
        Serotype 23F (Shared) (n=1016, 340)
    4853.5 (4469.8 to 5270.2)
    3887.3 (3335.8 to 4530.0)
        Serotype 22F (Unique to V114) (n=1005, 320)
    3926.5 (3645.9 to 4228.7)
    291.6 (221.8 to 383.6)
        Serotype 33F (Unique to V114) (n=1014, 338)
    11627.8 (10824.6 to 12490.7)
    2180.6 (1828.7 to 2600.2)
    No statistical analyses for this end point

    Secondary: 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 2 with PNEUMOVAX® 23 (PPV23), the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. All randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Up to 5 days after Vaccination 2 (Month 6)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1036
    345
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site redness/erythema
    22.6 (20.1 to 25.3)
    25.5 (21.0 to 30.5)
        Injection site tenderness/pain
    68.8 (65.9 to 71.6)
    67.0 (61.7 to 71.9)
        Injection site swelling
    29.4 (26.7 to 32.3)
    32.2 (27.3 to 37.4)
    No statistical analyses for this end point

    Secondary: 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 adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 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. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Up to 14 days after Vaccination 2 (Month 6)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1036
    345
    Units: Percentage of Participants
    number (confidence interval 95%)
        Joint pain/arthralgia
    12.0 (10.1 to 14.1)
    11.0 (7.9 to 14.8)
        Tiredness/fatigue
    30.1 (27.3 to 33.0)
    30.7 (25.9 to 35.9)
        Headache
    21.2 (18.8 to 23.9)
    21.2 (17.0 to 25.9)
        Muscle pain/myalgia
    24.1 (21.6 to 26.9)
    25.5 (21.0 to 30.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23

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    End point title
    		 Percentage of Participants with a Vaccine-related Serious Adverse Event 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 serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
    End point type
    Secondary
    End point timeframe
    From Month 6 (before Vaccination 2) to Month 7
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1036
    345
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.0 (0.0 to 0.3)
    0.3 (0.0 to 1.6)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30

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    End point title
    		 Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
    End point description
    The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (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 within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The analysis population included 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
    1133
    379
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=1020, 343)
    3.56 (3.29 to 3.85)
    4.59 (4.00 to 5.26)
        Serotype 3 (Shared) (n=1017, 343)
    0.77 (0.72 to 0.83)
    0.63 (0.57 to 0.71)
        Serotype 4 (Shared) (n=1015, 343)
    1.53 (1.40 to 1.66)
    2.71 (2.34 to 3.13)
        Serotype 5 (Shared) (n=1020, 342)
    3.43 (3.14 to 3.75)
    4.48 (3.77 to 5.32)
        Serotype 6A (Shared) (n=1020, 343)
    11.84 (10.71 to 13.10)
    10.87 (9.06 to 13.05)
        Serotype 6B (Shared) (n=1020, 342)
    17.90 (16.21 to 19.76)
    11.36 (9.45 to 13.66)
        Serotype 7F (Shared) (n=1020, 343)
    5.18 (4.77 to 5.62)
    6.88 (5.95 to 7.95)
        Serotype 9V (Shared) (n=1019, 343)
    4.44 (4.11 to 4.80)
    5.31 (4.62 to 6.10)
        Serotype 14 (Shared) (n=1020, 343)
    15.91 (14.46 to 17.51)
    17.35 (14.93 to 20.16)
        Serotype 18C (Shared) (n=1020, 343)
    14.57 (13.42 to 15.81)
    9.32 (8.06 to 10.79)
        Serotype 19A (Shared) (n=1020, 343)
    19.41 (18.00 to 20.93)
    21.79 (18.85 to 25.19)
        Serotype 19F (Shared) (n=1018, 343)
    13.98 (12.90 to 15.14)
    13.35 (11.52 to 15.47)
        Serotype 23F (Shared) (n=1019, 343)
    13.57 (12.44 to 14.80)
    10.98 (9.34 to 12.91)
        Serotype 22F (Unique to V114) (n=1020, 342)
    6.22 (5.74 to 6.74)
    0.52 (0.45 to 0.60)
        Serotype 33F (Unique to V114) (n=1020, 342)
    7.79 (7.16 to 8.48)
    0.88 (0.78 to 1.00)
    No statistical analyses for this end point

    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 Multiplex Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. The analysis population included 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
    1133
    379
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=1001, 334)
    22.8 (20.6 to 25.1)
    21.9 (18.4 to 26.2)
        Serotype 3 (Shared) (n=982, 329)
    5.8 (5.4 to 6.3)
    4.8 (4.3 to 5.5)
        Serotype 4 (Shared) (n=988, 329)
    17.9 (16.2 to 19.8)
    33.4 (28.1 to 39.7)
        Serotype 5 (Shared) (n=1003, 337)
    17.3 (15.7 to 18.9)
    21.1 (18.0 to 24.7)
        Serotype 6A (Shared) (n=910, 298)
    21.7 (19.6 to 23.9)
    21.4 (18.0 to 25.5)
        Serotype 6B (Shared) (n=969, 328)
    32.2 (28.6 to 36.3)
    25.0 (20.6 to 30.5)
        Serotype 7F (Shared) (n=945, 318)
    7.3 (6.6 to 8.2)
    10.0 (8.3 to 12.0)
        Serotype 9V (Shared) (n=977, 332)
    4.9 (4.5 to 5.3)
    5.7 (5.0 to 6.6)
        Serotype 14 (Shared) (n=973, 331)
    8.2 (7.4 to 9.2)
    8.7 (7.2 to 10.6)
        Serotype 18C (Shared) (n=973, 331)
    20.4 (18.6 to 22.4)
    11.7 (10.1 to 13.6)
        Serotype 19A (Shared) (n=975, 326)
    12.5 (11.3 to 13.9)
    13.6 (11.4 to 16.2)
        Serotype 19F (Shared) (n=985, 329)
    7.5 (6.9 to 8.2)
    7.4 (6.4 to 8.6)
        Serotype 23F (Shared) (n=945, 310)
    22.5 (20.0 to 25.4)
    17.8 (14.6 to 21.7)
        Serotype 22F (Unique to V114)(n=885, 290)
    13.9 (11.8 to 16.3)
    1.3 (1.1 to 1.6)
        Serotype 33F (Unique to V114) (n=979, 326)
    5.4 (4.9 to 5.9)
    1.0 (0.8 to 1.1)
    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
    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. GMFR is the geometric mean of fold rise from baseline to postvaccination. The analysis population included 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
    1133
    379
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=1007, 338)
    12.2 (11.3 to 13.2)
    15.7 (13.9 to 17.8)
        Serotype 3 (Shared) (n=1004, 338)
    4.1 (3.8 to 4.3)
    3.6 (3.2 to 4.0)
        Serotype 4 (Shared) (n=1001, 338)
    8.0 (7.4 to 8.6)
    16.2 (14.3 to 18.4)
        Serotype 5 (Shared) (n=1007, 337)
    4.3 (4.0 to 4.7)
    5.2 (4.5 to 6.0)
        Serotype 6A (Shared) (n=1007, 338)
    35.5 (32.5 to 38.8)
    31.3 (26.7 to 36.6)
        Serotype 6B (Shared) (n=1006, 338)
    40.5 (37.1 to 44.2)
    28.0 (24.2 to 32.4)
        Serotype 7F (Shared) (n=1007, 338)
    12.2 (11.3 to 13.2)
    16.9 (14.8 to 19.3)
        Serotype 9V (Shared) (n=1006, 338)
    10.6 (9.8 to 11.4)
    12.8 (11.3 to 14.5)
        Serotype 14 (Shared) (n=1007, 338)
    11.3 (10.3 to 12.5)
    11.5 (9.7 to 13.7)
        Serotype 18C (Shared) (n=1007, 338)
    30.5 (28.0 to 33.1)
    20.0 (17.2 to 23.2)
        Serotype 19A (Shared) (n=1007, 338)
    11.1 (10.2 to 12.0)
    14.0 (12.2 to 16.0)
        Serotype 19F (Shared) (n=1005, 338)
    14.4 (13.2 to 15.7)
    15.3 (13.1 to 17.7)
        Serotype 23F (Shared) (n=1006, 338)
    26.5 (24.2 to 29.0)
    22.0 (19.0 to 25.5)
        Serotype 22F (Unique to V114) (n=1007, 337)
    11.4 (10.4 to 12.6)
    1.0 (1.0 to 1.1)
        Serotype 33F (Unique to V114) (n=1007, 337)
    8.3 (7.7 to 8.9)
    1.0 (1.0 to 1.0)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants with ≥4-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. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. The analysis population included 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
    1133
    379
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=1001, 334)
    83.9 (81.5 to 86.1)
    81.4 (76.8 to 85.5)
        Serotype 3 (Shared) (n=982, 329)
    62.2 (59.1 to 65.3)
    56.8 (51.3 to 62.3)
        Serotype 4 (Shared) (n=988, 329)
    79.0 (76.4 to 81.5)
    87.8 (83.8 to 91.2)
        Serotype 5 (Shared) (n=1003, 337)
    83.4 (81.0 to 85.7)
    84.9 (80.6 to 88.5)
        Serotype 6A (Shared) (n=910, 298)
    87.5 (85.1 to 89.6)
    85.2 (80.7 to 89.1)
        Serotype 6B (Shared) (n=969, 328)
    84.7 (82.3 to 86.9)
    83.8 (79.4 to 87.7)
        Serotype 7F (Shared) (n=945, 318)
    56.8 (53.6 to 60.0)
    64.5 (58.9 to 69.7)
        Serotype 9V (Shared) (n=977, 332)
    51.5 (48.3 to 54.7)
    55.4 (49.0 to 60.8)
        Serotype 14 (Shared) (n=973, 331)
    59.8 (56.7 to 62.9)
    60.4 (54.9 to 65.7)
        Serotype 18C (Shared) (n=973, 331)
    84.5 (82.1 to 86.7)
    75.8 (70.8 to 80.3)
        Serotype 19A (Shared) (n=975, 326)
    72.1 (69.2 to 74.9)
    75.2 (70.1 to 79.8)
        Serotype 19F (Shared) (n=985, 329)
    64.3 (61.2 to 67.3)
    65.7 (60.2 to 70.8)
        Serotype 23F (Shared) (n=945, 310)
    78.7 (76.0 to 81.3)
    77.7 (72.7 to 82.2)
        Serotype 22F (Unique to V114) (n=885, 290)
    58.9 (55.5 to 62.1)
    15.5 (11.5 to 20.2)
        Serotype 33F (Unique to V114) (n=979, 326)
    52.9 (49.7 to 56.1)
    3.1 (1.5 to 5.6)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
    End point description
    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 percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. The analysis population included 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
    1133
    379
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=1007, 338)
    81.2 (78.7 to 83.6)
    86.4 (82.3 to 89.9)
        Serotype 3 (Shared) (n=1004, 338)
    44.8 (41.7 to 48.0)
    41.1 (35.8 to 46.6)
        Serotype 4 (Shared) (n=1001, 338)
    70.1 (67.2 to 73.0)
    86.1 (81.9 to 89.6)
        Serotype 5 (Shared) (n=1007, 337)
    44.1 (41.0 to 47.2)
    50.4 (45.0 to 55.9)
        Serotype 6A (Shared) (n=1007, 338)
    93.3 (91.6 to 94.8)
    88.2 (84.2 to 91.4)
        Serotype 6B (Shared) (n=1006, 337)
    93.4 (91.7 to 94.9)
    90.5 (86.9 to 93.4)
        Serotype 7F (Shared) (n=1007, 338)
    79.3 (76.7 to 81.8)
    86.4 (82.3 to 89.9)
        Serotype 9V (Shared) (n=1006, 338)
    76.5 (73.8 to 79.1)
    84.0 (79.7 to 87.8)
        Serotype 14 (Shared) (n=1007, 338)
    70.8 (67.9 to 73.6)
    68.6 (63.4 to 73.6)
        Serotype 18C (Shared) (n=1007, 338)
    91.1 (89.1 to 92.8)
    87.3 (83.2 to 90.6)
        Serotype 19A (Shared) (n=1007, 338)
    75.3 (72.5 to 77.9)
    82.0 (77.4 to 85.9)
        Serotype 19F (Shared) (n=1005, 338)
    80.0 (77.4 to 82.4)
    80.8 (76.2 to 84.8)
        Serotype 23F (Shared) (n=1006, 338)
    89.2 (87.1 to 91.0)
    87.6 (83.6 to 90.9)
        Serotype 22F (Unique to V114) (n=1007, 337)
    73.1 (70.2 to 75.8)
    1.5 (0.5 to 3.4)
        Serotype 33F (Unique to V114) (n=1007, 337)
    70.0 (67.1 to 72.8)
    0.3 (0.0 to 1.6)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer of Serotype-specific OPA at Month 7

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    End point title
    		 Geometric Mean Titer of Serotype-specific OPA at Month 7
    End point description
    The geometric mean titer (GMT) of serotype-specific 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 multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The analysis population included 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 7
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1133
    379
    Units: Titers
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=841, 281)
    266.6 (243.6 to 291.8)
    214.4 (180.7 to 254.5)
        Serotype 3 (Shared) (n=837, 279)
    211.0 (195.2 to 228.1)
    208.0 (179.7 to 240.7)
        Serotype 4 (Shared) (n=840, 283)
    1734.5 (1620.7 to 1856.4)
    1980.6 (1771.3 to 2214.6)
        Serotype 5 (Shared) (n=844, 283)
    595.1 (544.5 to 650.5)
    626.7 (531.7 to 738.7)
        Serotype 6A (Shared) (n=830, 276)
    5810.3 (5366.9 to 6290.3)
    5739.9 (4974.4 to 6623.1)
        Serotype 6B (Shared) (n=843, 283)
    5215.2 (4863.6 to 5592.2)
    4412.4 (3892.8 to 5001.5)
        Serotype 7F (Shared) (n=843, 283)
    6070.5 (5699.7 to 6465.6)
    6223.9 (5595.3 to 6923.0)
        Serotype 9V (Shared) (n=842, 282)
    3133.1 (2918.4 to 3363.7)
    3364.1 (2972.2 to 3807.6)
        Serotype 14 (Shared) (n=843, 283)
    5644.9 (5262.5 to 6055.2)
    5317.6 (4686.1 to 6034.1)
        Serotype 18C (Shared) (n=842, 281)
    3260.6 (3057.3 to 3477.5)
    2294.4 (2052.5 to 2564.8)
        Serotype 19A (Shared) (n=836, 283)
    4336.2 (4038.6 to 4655.6)
    4286.4 (3838.6 to 4786.4)
        Serotype 19F (Shared) (n=844, 282)
    3198.6 (3011.0 to 3397.8)
    3085.4 (2770.7 to 3435.9)
        Serotype 23F (Shared) (n=839, 283)
    3057.3 (2823.0 to 3311.0)
    2896.0 (2494.1 to 3362.7)
        Serotype 22F (Unique to V114) (n=837, 280)
    3624.0 (3384.5 to 3880.3)
    4060.2 (3358.6 to 4908.4)
        Serotype 33F (Unique to V114) (n=837, 282)
    11356.6 (10492.4 to 12291.9)
    16053.2 (13688.1 to 18827.1)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration of Serotype-specific IgG at Month 7

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    End point title
    		 Geometric Mean Concentration of Serotype-specific IgG at Month 7
    End point description
    The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (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 included 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 7
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1133
    379
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=844, 283)
    2.91 (2.71 to 3.12)
    3.42 (3.02 to 3.87)
        Serotype 3 (Shared) (n=844, 283)
    0.66 (0.62 to 0.71)
    0.68 (0.61 to 0.76)
        Serotype 4 (Shared) (n=843, 281)
    1.33 (1.23 to 1.44)
    1.77 (1.55 to 2.02)
        Serotype 5 (Shared) (n=844, 283)
    3.45 (3.17 to 3.75)
    3.92 (3.37 to 4.56)
        Serotype 6A (Shared) (n=843, 283)
    4.25 (3.84 to 4.69)
    4.88 (4.08 to 5.85)
        Serotype 6B (Shared) (n=844, 283)
    6.79 (6.15 to 7.49)
    6.04 (5.08 to 7.19)
        Serotype 7F (Shared) (n=844, 283)
    3.46 (3.36 to 3.94)
    4.07 (3.54 to 4.68)
        Serotype 9V (Shared) (n=844, 283)
    3.18 (2.96 to 3.43)
    3.61 (3.17 to 4.12)
        Serotype 14 (Shared) (n=844, 283)
    14.28 (13.13 to 15.53)
    14.59 (12.64 to 16.85)
        Serotype 18C (Shared) (n=844, 283)
    5.50 (5.07 to 5.98)
    4.24 (3.71 to 4.84)
        Serotype 19A (Shared) (n=844, 283)
    11.26 (10.47 to 12.11)
    12.04 (10.57 to 13.72)
        Serotype 19F (Shared) (n=844, 283)
    9.07 (8.45 to 9.74)
    8.81 (7.74 to 10.02)
        Serotype 23F (Shared) (n=844, 282)
    5.42 (4.98 to 5.89)
    4.96 (4.25 to 5.81)
        Serotype 22F (Unique to V114) (n=844, 283)
    4.85 (4.50 to 5.23)
    4.76 (4.01 to 5.65)
        Serotype 33F (Unique to V114) (n=844, 283)
    5.98 (5.50 to 6.50)
    8.66 (7.31 to 10.26)
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific OPA Day 1 to Month 7

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    End point title
    		 GMFR in Serotype-specific OPA Day 1 to Month 7
    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 included 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 7
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1133
    379
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=826, 276)
    22.6 (20.6 to 24.8)
    17.4 (14.8 to 20.5)
        Serotype 3 (Shared) (n=820, 270)
    6.1 (5.6 to 6.6)
    6.4 (5.6 to 7.3)
        Serotype 4 (Shared) (n=820, 273)
    21.6 (19.5 to 23.9)
    25.6 (21.7 to 30.3)
        Serotype 5 (Shared) (n=831, 279)
    17.8 (16.3 to 19.3)
    18.3 (15.8 to 21.1)
        Serotype 6A (Shared) (n=754, 247)
    9.6 (8.7 to 10.5)
    11.0 (9.3 to 13.0)
        Serotype 6B (Shared) (n=802, 273)
    16.6 (14.7 to 18.7)
    15.7 (12.8 to 19.2)
        Serotype 7F (Shared) (n=777, 264)
    7.7 (6.9 to 8.6)
    8.2 (6.7 to 9.9)
        Serotype 9V (Shared) (n=810, 273)
    4.5 (4.2 to 4.9)
    4.9 (4.2 to 5.7)
        Serotype 14 (Shared) (n=809, 275)
    9.2 (8.2 to 10.3)
    8.0 (6.6 to 9.7)
        Serotype 18C (Shared) (n=805, 273)
    11.1 (10.2 to 12.2)
    9.1 (7.9 to 10.5)
        Serotype 19A (Shared) (n=806, 271)
    9.6 (8.6 to 10.6)
    9.7 (8.1 to 11.6)
        Serotype 19F (Shared) (n=818, 272)
    6.9 (6.3 to 7.6)
    7.1 (6.1 to 8.3)
        Serotype 23F (Shared) (n=780, 260)
    14.0 (12.4 to 15.7)
    12.6 (10.3 to 15.4)
        Serotype 22F (Unique to V114) (n=742, 254)
    12.1 (10.4 to 14.3)
    16.6 (12.2 to 22.6)
        Serotype 33F (Unique to V114) (n=810, 273)
    5.1 (4.6 to 5.7)
    6.6 (5.5 to 8.0)
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific IgG Day 1 to Month 7

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    End point title
    		 GMFR in Serotype-specific IgG Day 1 to Month 7
    End point description
    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. GMFR is the geometric mean of fold rise from baseline to postvaccination. The analysis population included 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 7
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1133
    379
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=833, 280)
    10.1 (9.4 to 10.8)
    11.4 (10.1 to 12.8)
        Serotype 3 (Shared) (n=833, 280)
    3.5 (3.3 to 3.7)
    3.8 (3.4 to 4.2)
        Serotype 4 (Shared) (n=830, 278)
    7.1 (6.7 to 7.6)
    10.7 (9.5 to 12.0)
        Serotype 5 (Shared) (n=833, 280)
    4.3 (4.0 to 4.8)
    4.6 (4.1 to 5.2)
        Serotype 6A (Shared) (n=832, 280)
    12.3 (11.3 to 13.4)
    13.9 (12.0 to 16.1)
        Serotype 6B (Shared) (n=832, 280)
    15.3 (14.1 to 16.6)
    14.9 (13.0 to 17.0)
        Serotype 7F (Shared) (n=833, 280)
    8.7 (8.1 to 9.3)
    10.1 (9.0 to 11.3)
        Serotype 9V (Shared) (n=833, 280)
    7.6 (7.1 to 8.1)
    8.5 (7.6 to 9.5)
        Serotype 14 (Shared) (n=833, 280)
    10.3 (9.4 to 11.3)
    10.0 (8.5 to 11.8)
        Serotype 18C (Shared) (n=833, 280)
    11.5 (10.7 to 12.4)
    9.3 (8.2 to 10.4)
        Serotype 19A (Shared) (n=833, 280)
    6.4 (6.0 to 6.9)
    7.5 (6.7 to 8.5)
        Serotype 19F (Shared) (n=833, 280)
    9.0 (8.3 to 9.7)
    9.8 (8.6 to 11.2)
        Serotype 23F (Shared) (n=833, 279)
    10.8 (9.9 to 11.7)
    10.3 (9.0 to 11.7)
        Serotype 22F (Unique to V114) (n=833, 280)
    8.9 (8.1 to 9.7)
    8.9 (7.5 to 10.7)
        Serotype 33F (Unique to V114) (n=833, 280)
    6.4 (6.0 to 6.9)
    9.6 (8.4 to 11.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
    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 included 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 7
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1133
    379
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=826, 276)
    87.7 (85.2 to 89.8)
    83.7 (78.8 to 87.9)
        Serotype 3 (Shared) (n=820, 270)
    66.5 (63.1 to 69.7)
    66.7 (60.7 to 72.3)
        Serotype 4 (Shared) (n=820, 273)
    84.3 (81.6 to 86.7)
    86.4 (81.8 to 90.3)
        Serotype 5 (Shared) (n=831, 279)
    86.8 (84.3 to 89.0)
    87.1 (82.6 to 90.8)
        Serotype 6A (Shared) (n=754, 247)
    73.5 (70.2 to 76.6)
    80.2 (74.6 to 84.9)
        Serotype 6B (Shared) (n=802, 273)
    75.8 (72.7 to 78.7)
    74.4 (68.7 to 79.4)
        Serotype 7F (Shared) (n=777, 264)
    59.8 (56.3 to 63.3)
    60.2 (54.0 to 66.2)
        Serotype 9V (Shared) (n=810, 273)
    50.5 (47.0 to 54.0)
    52.4 (46.3 to 58.4)
        Serotype 14 (Shared) (n=809, 275)
    64.9 (61.5 to 68.2)
    58.9 (52.8 to 64.8)
        Serotype 18C (Shared) (n=805, 273)
    77.5 (74.5 to 80.4)
    76.2 (70.7 to 81.1)
        Serotype 19A (Shared) (n=806, 271)
    68.2 (64.9 to 71.4)
    70.5 (64.7 to 75.8)
        Serotype 19F (Shared) (n=818, 272)
    61.0 (57.6 to 64.4)
    62.9 (56.8 to 68.6)
        Serotype 23F (Shared) (n=780, 260)
    73.5 (70.2 to 76.5)
    71.9 (66.0 to 77.3)
        Serotype 22F (Unique to V114) (n=742, 254)
    59.0 (55.4 to 62.6)
    65.4 (59.2 to 71.2)
        Serotype 33F (Unique to V114) (n=810, 273)
    53.3 (49.8 to 56.8)
    60.8 (54.7 to 66.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
    End point description
    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 percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. The analysis population included 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 7
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1133
    379
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=833, 280)
    81.4 (78.6 to 84.0)
    83.6 (78.7 to 87.7)
        Serotype 3 (Shared) (n=833, 280)
    40.7 (37.3 to 44.1)
    46.1 (40.1 to 52.1)
        Serotype 4 (Shared) (n=830, 278)
    71.2 (68.0 to 74.3)
    82.0 (77.0 to 86.3)
        Serotype 5 (Shared) (n=833, 280)
    48.7 (45.3 to 52.2)
    51.8 (45.8 to 57.8)
        Serotype 6A (Shared) (n=832, 280)
    81.6 (78.8 to 84.2)
    81.8 (76.8 to 86.1)
        Serotype 6B (Shared) (n=832, 280)
    86.4 (83.9 to 88.7)
    85.4 (80.7 to 89.3)
        Serotype 7F (Shared) (n=833, 280)
    77.4 (74.4 to 80.2)
    84.3 (79.5 to 88.3)
        Serotype 9V (Shared) (n=833, 280)
    71.8 (68.6 to 74.8)
    77.1 (71.8 to 81.9)
        Serotype 14 (Shared) (n=833, 280)
    76.7 (73.7 to 79.5)
    70.7 (65.0 to 76.0)
        Serotype 18C (Shared) (n=833, 280)
    82.7 (80.0 to 85.2)
    80.4 (75.2 to 84.8)
        Serotype 19A (Shared) (n=833, 280)
    65.8 (62.5 to 69.0)
    74.6 (69.1 to 79.6)
        Serotype 19F (Shared) (n=833, 280)
    74.5 (71.4 to 77.5)
    78.9 (73.7 to 83.6)
        Serotype 23F (Shared) (n=833, 279)
    77.8 (74.8 to 80.6)
    78.1 (72.8 to 82.8)
        Serotype 22F (Unique to V114) (n=833, 280)
    68.8 (65.5 to 71.9)
    65.7 (59.8 to 71.3)
        Serotype 33F (Unique to V114) (n=833, 280)
    68.2 (64.9 to 71.3)
    75.7 (70.3 to 80.6)
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific OPA Month 6 to Month 7

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    End point title
    		 GMFR in Serotype-specific OPA Month 6 to Month 7
    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 the Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. The analysis population included 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 6 (Baseline before Vaccination 2) and Month 7
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1133
    379
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=839, 280)
    3.2 (2.9 to 3.5)
    2.0 (1.7 to 2.2)
        Serotype 3 (Shared) (n=826, 274)
    2.0 (1.9 to 2.1)
    2.4 (2.2 to 2.7)
        Serotype 4 (Shared) (n=837, 281)
    2.7 (2.5 to 2.9)
    1.7 (1.5 to 1.9)
        Serotype 5 (Shared) (n=840, 282)
    2.7 (2.5 to 2.9)
    2.1 (1.9 to 2.4)
        Serotype 6A (Shared) (n=818, 270)
    1.0 (1.0 to 1.1)
    1.1 (1.0 to 1.2)
        Serotype 6B (Shared) (n=842, 280)
    1.1 (1.1 to 1.2)
    1.2 (1.1 to 1.4)
        Serotype 7F (Shared) (n=837, 281)
    1.9 (1.8 to 2.0)
    1.4 (1.3 to 1.6)
        Serotype 9V (Shared) (n=835, 278)
    1.6 (1.5 to 1.7)
    1.5 (1.4 to 1.7)
        Serotype 14 (Shared) (n=841, 280)
    2.0 (1.8 to 2.1)
    1.5 (1.3 to 1.6)
        Serotype 18C (Shared) (n=839, 279)
    1.3 (1.3 to 1.4)
    1.6 (1.4 to 1.7)
        Serotype 19A (Shared) (n=830, 282)
    1.7 (1.6 to 1.8)
    1.5 (1.4 to 1.7)
        Serotype 19F (Shared) (n=843, 280)
    1.9 (1.8 to 2.0)
    1.6 (1.5 to 1.8)
        Serotype 23F (Shared) (n=837, 280)
    1.3 (1.2 to 1.4)
    1.4 (1.2 to 1.6)
        Serotype 22F (Unique to V114) (n=822, 253)
    1.8 (1.7 to 1.9)
    9.6 (7.1 to 13.0)
        Serotype 33F (Unique to V114) (n=834, 278)
    1.6 (1.5 to 1.8)
    6.5 (5.5 to 7.6)
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific IgG Month 6 to Month 7

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    End point title
    		 GMFR in Serotype-specific IgG Month 6 to Month 7
    End point description
    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. GMFR is the geometric mean of fold rise from baseline to postvaccination. The analysis population included 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 6 (Baseline before Vaccination 2) and Month 7
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1133
    379
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=843, 282)
    2.1 (2.0 to 2.2)
    1.5 (1.4 to 1.7)
        Serotype 3 (Shared) (n=842, 282)
    1.7 (1.6 to 1.7)
    2.0 (1.8 to 2.1)
        Serotype 4 (Shared) (n=840, 280)
    2.0 (1.9 to 2.1)
    1.6 (1.5 to 1.7)
        Serotype 5 (Shared) (n=843, 282)
    1.9 (1.8 to 1.9)
    1.5 (1.4 to 1.6)
        Serotype 6A (Shared) (n=842, 282)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.1)
        Serotype 6B (Shared) (n=843, 282)
    1.1 (1.0 to 1.1)
    1.2 (1.2 to 1.3)
        Serotype 7F (Shared) (n=843, 282)
    1.7 (1.6 to 1.8)
    1.4 (1.3 to 1.5)
        Serotype 9V (Shared) (n=841, 282)
    1.5 (1.5 to 1.6)
    1.4 (1.3 to 1.5)
        Serotype 14 (Shared) (n=843, 282)
    1.7 (1.6 to 1.8)
    1.4 (1.3 to 1.5)
        Serotype 18C (Shared) (n=843, 282)
    1.1 (1.0 to 1.1)
    1.1 (1.1 to 1.2)
        Serotype 19A (Shared) (n=842, 282)
    1.4 (1.3 to 1.4)
    1.4 (1.3 to 1.4)
        Serotype 19F (Shared) (n=843, 282)
    1.6 (1.6 to 1.7)
    1.6 (1.5 to 1.7)
        Serotype 23F (Shared) (n=842, 281)
    1.1 (1.1 to 1.2)
    1.2 (1.1 to 1.2)
        Serotype 22F (Unique to V114) (n=843, 282)
    1.8 (1.7 to 1.9)
    8.8 (7.4 to 10.4)
        Serotype 33F (Unique to V114) (n=843, 282)
    1.6 (1.6 to 1.7)
    9.9 (8.6 to 11.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
    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 included 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 6 (Baseline before Vaccination 2) and Month 7
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1133
    379
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=839, 280)
    40.2 (36.8 to 43.6)
    21.4 (16.8 to 26.7)
        Serotype 3 (Shared) (n=826, 274)
    19.2 (16.6 to 22.1)
    25.5 (20.5 to 31.1)
        Serotype 4 (Shared) (n=837, 281)
    30.8 (27.7 to 34.1)
    14.9 (11.0 to 19.7)
        Serotype 5 (Shared) (n=840, 282)
    32.5 (29.3 to 35.8)
    23.0 (18.3 to 28.4)
        Serotype 6A (Shared) (n=818, 270)
    3.9 (2.7 to 5.5)
    5.9 (3.4 to 9.4)
        Serotype 6B (Shared) (n=842, 280)
    4.6 (3.3 to 6.3)
    6.4 (3.9 to 10.0)
        Serotype 7F (Shared) (n=837, 281)
    14.6 (12.3 to 17.2)
    7.5 (4.7 to 11.2)
        Serotype 9V (Shared) (n=835, 278)
    11.9 (9.7 to 14.2)
    10.4 (7.1 to 14.6)
        Serotype 14 (Shared) (n=841, 280)
    17.8 (15.3 to 20.6)
    8.6 (5.6 to 12.5)
        Serotype 18C (Shared) (n=839, 279)
    5.4 (3.9 to 7.1)
    14.3 (10.4 to 19.0)
        Serotype 19A (Shared) (n=830, 282)
    15.9 (13.5 to 18.6)
    12.1 (8.5 to 16.4)
        Serotype 19F (Shared) (n=843, 280)
    17.7 (15.2 to 20.4)
    12.9 (9.2 to 17.4)
        Serotype 23F (Shared) (n=837, 280)
    9.2 (7.3 to 11.4)
    11.4 (7.9 to 15.7)
        Serotype 22F (Unique to V114) (n=822, 253)
    16.7 (14.2 to 19.4)
    52.6 (46.2 to 58.9)
        Serotype 33F (Unique to V114) (n=834, 278)
    15.8 (13.4 to 18.5)
    62.6 (56.6 to 68.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7

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    End point title
    		 Percentage of Participants with ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
    End point description
    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 percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. The analysis population included 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 6 (Baseline before Vaccination 2) and Month 7
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1133
    379
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=843, 282)
    16.4 (13.9 to 19.0)
    8.2 (5.2 to 12.0)
        Serotype 3 (Shared) (n=842, 282)
    6.3 (4.8 to 8.2)
    13.8 (10.0 to 18.4)
        Serotype 4 (Shared) (n=840, 280)
    15.2 (12.9 to 17.8)
    7.5 (4.7 to 11.2)
        Serotype 5 (Shared) (n=843, 282)
    12.1 (10.0 to 14.5)
    5.7 (3.3 to 9.1)
        Serotype 6A (Shared) (n=842, 282)
    0.6 (0.2 to 1.4)
    1.1 (0.2 to 3.1)
        Serotype 6B (Shared) (n=843, 282)
    0.7 (0.3 to 1.5)
    2.8 (1.2 to 5.5)
        Serotype 7F (Shared) (n=843, 282)
    8.4 (6.6 to 10.5)
    4.3 (2.2 to 7.3)
        Serotype 9V (Shared) (n=841, 282)
    6.3 (4.8 to 8.2)
    3.9 (2.0 to 6.9)
        Serotype 14 (Shared) (n=843, 282)
    9.8 (7.9 to 12.1)
    3.9 (2.0 to 6.9)
        Serotype 18C (Shared) (n=843, 282)
    0.6 (0.2 to 1.4)
    0.7 (0.1 to 2.5)
        Serotype 19A (Shared) (n=842, 282)
    3.4 (2.3 to 4.9)
    4.3 (2.2 to 7.3)
        Serotype 19F (Shared) (n=843, 282)
    8.1 (6.3 to 10.1)
    6.4 (3.8 to 9.9)
        Serotype 23F (Shared) (n=842, 281)
    0.5 (0.1 to 1.2)
    1.1 (0.2 to 3.1)
        Serotype 22F (Unique to V114) (n=843, 282)
    10.2 (8.2 to 12.4)
    64.9 (59.0 to 70.5)
        Serotype 33F (Unique to V114) (n=843, 282)
    7.5 (5.8 to 9.5)
    75.9 (70.5 to 80.8)
    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 7 (Up to 44 days after vaccination 2).
    Adverse event reporting additional description
    The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
    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 6 (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 6 (Vaccination 2).

    Reporting group title
    V114 (Post-PNEUMOVAX™23)
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 6 (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 6 (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
    49 / 1134 (4.32%)
    12 / 378 (3.17%)
    3 / 1036 (0.29%)
    3 / 345 (0.87%)
         number of deaths (all causes)
    4
    2
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Endometrial cancer
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Gastrointestinal neoplasm
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Uterine leiomyoma
         subjects affected / exposed
    2 / 1134 (0.18%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Vascular disorders
    Hypertensive urgency
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Hypotension
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    1 / 345 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Social circumstances
    Physical assault
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Pelvic pain
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 1134 (0.18%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Pleuritic pain
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Pneumonia aspiration
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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 embolism
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    1 / 1036 (0.10%)
    0 / 345 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Drug dependence
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Suicidal ideation
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Suicide attempt
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Clavicle fracture
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Eyelid injury
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Facial bones fracture
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Hand fracture
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Multiple injuries
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Tibia fracture
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Craniocerebral injury
         subjects affected / exposed
    0 / 1134 (0.00%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    1 / 345 (0.29%)
         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
    Cardiac disorders
    Angina unstable
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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 failure
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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 / 1
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Pulseless electrical activity
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Acute left ventricular failure
         subjects affected / exposed
    0 / 1134 (0.00%)
    0 / 378 (0.00%)
    1 / 1036 (0.10%)
    0 / 345 (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
    Cardiac arrest
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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 / 1
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    IIIrd nerve paralysis
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Migraine
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    3 / 1134 (0.26%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 1134 (0.00%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    1 / 345 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 1134 (0.00%)
    0 / 378 (0.00%)
    1 / 1036 (0.10%)
    0 / 345 (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
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Gastric ulcer perforation
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Inguinal hernia
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Large intestine perforation
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Pancreatitis acute
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 1134 (0.09%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Cholecystitis
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Cholecystitis acute
         subjects affected / exposed
    2 / 1134 (0.18%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Cholelithiasis
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Acute kidney injury
         subjects affected / exposed
    2 / 1134 (0.18%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Nephrolithiasis
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Nephrotic syndrome
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Endocrine disorders
    Diabetes insipidus
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Goitre
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Gastroenteritis
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Groin abscess
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Haematoma infection
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Influenza
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Localised infection
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Meningitis
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Periorbital cellulitis
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Perirectal abscess
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Peritonsillitis
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Pneumonia
         subjects affected / exposed
    1 / 1134 (0.09%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Postoperative wound infection
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Pyelonephritis
         subjects affected / exposed
    2 / 1134 (0.18%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Sepsis
         subjects affected / exposed
    0 / 1134 (0.00%)
    1 / 378 (0.26%)
    0 / 1036 (0.00%)
    0 / 345 (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
    Hypoglycaemia
         subjects affected / exposed
    1 / 1134 (0.09%)
    0 / 378 (0.00%)
    0 / 1036 (0.00%)
    0 / 345 (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
    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
    934 / 1134 (82.36%)
    298 / 378 (78.84%)
    771 / 1036 (74.42%)
    258 / 345 (74.78%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    300 / 1134 (26.46%)
    94 / 378 (24.87%)
    220 / 1036 (21.24%)
    73 / 345 (21.16%)
         occurrences all number
    425
    122
    274
    93
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    389 / 1134 (34.30%)
    139 / 378 (36.77%)
    312 / 1036 (30.12%)
    106 / 345 (30.72%)
         occurrences all number
    510
    186
    366
    139
    Injection site erythema
         subjects affected / exposed
    174 / 1134 (15.34%)
    56 / 378 (14.81%)
    235 / 1036 (22.68%)
    88 / 345 (25.51%)
         occurrences all number
    180
    57
    237
    91
    Injection site pain
         subjects affected / exposed
    865 / 1134 (76.28%)
    260 / 378 (68.78%)
    714 / 1036 (68.92%)
    231 / 345 (66.96%)
         occurrences all number
    931
    292
    762
    252
    Injection site swelling
         subjects affected / exposed
    251 / 1134 (22.13%)
    84 / 378 (22.22%)
    305 / 1036 (29.44%)
    113 / 345 (32.75%)
         occurrences all number
    257
    84
    307
    113
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    144 / 1134 (12.70%)
    44 / 378 (11.64%)
    124 / 1036 (11.97%)
    38 / 345 (11.01%)
         occurrences all number
    180
    63
    130
    47
    Myalgia
         subjects affected / exposed
    327 / 1134 (28.84%)
    100 / 378 (26.46%)
    250 / 1036 (24.13%)
    88 / 345 (25.51%)
         occurrences all number
    377
    113
    260
    99

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jun 2018
    Amendment 01: The primary purpose of this amendment is to remove the collection of medical device incidents from the protocol.
    18 Sep 2018
    Amendment 02: The primary purpose of this amendment is to include a spirometry assessment at Visit 1 for those who have a clinical history of asthma or chronic obstructive pulmonary disease (COPD) and who do not have spirometry results from within the previous 5 years.
    07 May 2019
    Amendment 03: The primary purpose of this amendment is to include country-specific requirements for the Ministry of Healthcare (MoH) of the Russian Federation.

    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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