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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-TRUE)

    Summary
    EudraCT number
    		 2018-004266-33
    Trial protocol
    		 GB   FI   DK  
    Global end of trial date
    03 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Apr 2021
    First version publication date
    02 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V114-020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03950856
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, 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
    03 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives were to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days post-vaccination.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable countryand/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
    12 Jun 2019
    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: 109
    Country: Number of subjects enrolled
    Chile: 190
    Country: Number of subjects enrolled
    Denmark: 466
    Country: Number of subjects enrolled
    Finland: 473
    Country: Number of subjects enrolled
    United Kingdom: 46
    Country: Number of subjects enrolled
    United States: 1056
    Worldwide total number of subjects
    2340
    EEA total number of subjects
    939
    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)
    1039
    From 65 to 84 years
    1288
    85 years and over
    13

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Healthy males or females ≥50 years of age without a history of invasive pneumococcal disease or prior administration of any pneumococcal vaccine were enrolled in this study.

    Period 1
    Period 1 title
    Randomized (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 Lot 1
    Arm description
    		 Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)
    Arm type
    		 Experimental

    Investigational medicinal product name
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single intramuscular (IM) dose at 0.5 mL of V114 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Arm title
    		 V114 Lot 2
    Arm description
    		 Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)
    Arm type
    		 Experimental

    Investigational medicinal product name
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single intramuscular (IM) dose at 0.5 mL of V114 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Arm title
    		 V114 Lot 3
    Arm description
    		 Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)
    Arm type
    		 Experimental

    Investigational medicinal product name
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single intramuscular (IM) dose at 0.5 mL of V114 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Arm title
    		 Prevnar 13™
    Arm description
    		 Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in each 0.5. mL dose.
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single IM dose at Visit 1 (Day 1)

    Number of subjects in period 1
    		V114 Lot 1 V114 Lot 2 V114 Lot 3 Prevnar 13™
    Started
    702
    704
    701
    233
    Vaccinated
    698
    704
    700
    231
    Completed
    683
    689
    683
    227
    Not completed
    19
    15
    18
    6
         Adverse event, serious fatal
    1
    2
    -
    -
         Consent withdrawn by subject
    4
    1
    3
    1
         Unable to phone
    7
    6
    7
    2
         Lost to follow-up
    5
    6
    8
    2
         Protocol deviation
    2
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V114 Lot 1
    Reporting group description
    		 Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Reporting group title
    V114 Lot 2
    Reporting group description
    		 Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Reporting group title
    V114 Lot 3
    Reporting group description
    		 Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)

    Reporting group values
    		 V114 Lot 1 V114 Lot 2 V114 Lot 3 Prevnar 13™ Total
    Number of subjects
    		 702 704 701 233 2340
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 313 312 311 103 1039
        From 65-84 years
    		 385 388 387 128 1288
        85 years and over
    		 4 4 3 2 13
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.4 ± 7.5 64.4 ± 7.8 64.3 ± 7.4 64.2 ± 8.0 -
    Gender Categorical
    Units: Subjects
        Female
    		 387 422 404 133 1346
        Male
    		 315 282 297 100 994
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 4 0 0 5
        Asian
    		 18 34 36 10 98
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 0 1
        Black or African American
    		 35 41 34 20 130
        White
    		 644 621 628 203 2096
        More than one race
    		 3 4 3 0 10
        Unknown or Not Reported
    		 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 131 154 138 41 464
        Not Hispanic or Latino
    		 560 540 558 190 1848
        Unknown or Not Reported
    		 11 10 5 2 28

    End points

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    End points reporting groups
    Reporting group title
    V114 Lot 1
    Reporting group description
    		 Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Reporting group title
    V114 Lot 2
    Reporting group description
    		 Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Reporting group title
    V114 Lot 3
    Reporting group description
    		 Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)

    Subject analysis set title
    V114 Combined Lots 1,2 and 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Single IM dose at 0.5 mL of either V114 Lots 1,2 or 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Subject analysis set title
    Prevnar 13™
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)

    Primary: Percentage of Participants with a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots

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    End point title
    		 Percentage of Participants with a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited injection-site AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots. The population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
    End point type
    Primary
    End point timeframe
    Up to Day 5
    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: Comparison of treatment arms was not performed for this endpoint per the statistical analysis plan.
    End point values
    		 V114 Lot 1 V114 Lot 2 V114 Lot 3 Prevnar 13™
    Number of subjects analysed
    699
    704
    700
    0 [2]
    Units: Percentage of participants
    number (confidence interval 95%)
        Injection site erythema
    10.2 (8.0 to 12.6)
    11.5 (9.2 to 14.1)
    11.0 (8.8 to 13.6)
    ( to )
        Injection site pain
    66.1 (62.5 to 69.6)
    67.0 (63.4 to 70.5)
    67.3 (63.7 to 70.8)
    ( to )
        Injection site swelling
    15.6 (13.0 to 18.5)
    15.8 (13.2 to 18.7)
    14.7 (12.2 to 17.6)
    ( to )
    Notes
    [2] - The Prevnar 13™ treatment group was not analyzed per the statistical analysis plan.
    No statistical analyses for this end point

    Primary: Percentage of Participants with a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™

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    End point title
    		 Percentage of Participants with a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. Per the statistical analysis plan, within-group CIs were not calculated. The population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
    End point type
    Primary
    End point timeframe
    Up to Day 5
    End point values
    		 V114 Combined Lots 1,2 and 3 Prevnar 13™
    Number of subjects analysed
    2103
    230
    Units: Percentage of participants
    number (not applicable)
        Injection site erythema
    10.9
    9.6
        Injection site pain
    66.8
    52.2
        Injection site swelling
    15.4
    14.3
    Statistical analysis title
    		 Injection site erythema
    Statistical analysis description
    V114 Combined Lots minus Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.538
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 4.8
    Statistical analysis title
    		 Injection site pain
    Statistical analysis description
    V114 Combined Lots minus Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    14.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.9
         upper limit
    		 21.4
    Statistical analysis title
    		 Injection site swelling
    Statistical analysis description
    V114 Combined Lots minus Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.686
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 5.3

    Primary: Percentage of Participants with a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots

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    End point title
    		 Percentage of Participants with a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots [3]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited systemic AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots. The population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
    End point type
    Primary
    End point timeframe
    Up to Day 14
    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: Comparison of treatment arms was not performed for this endpoint per the statistical analysis plan.
    End point values
    		 V114 Lot 1 V114 Lot 2 V114 Lot 3 Prevnar 13™
    Number of subjects analysed
    699
    704
    700
    0 [4]
    Units: Percentage of participants
    number (confidence interval 95%)
        Arthralgia
    7.6 (5.7 to 9.8)
    7.0 (5.2 to 9.1)
    8.4 (6.5 to 10.7)
    ( to )
        Fatigue
    22.0 (19.0 to 25.3)
    20.9 (17.9 to 24.1)
    21.6 (18.6 to 24.8)
    ( to )
        Headache
    18.2 (15.4 to 21.2)
    19.9 (17.0 to 23.0)
    18.6 (15.8 to 21.7)
    ( to )
        Myalgia
    28.0 (24.7 to 31.5)
    24.3 (21.2 to 27.6)
    28.4 (25.1 to 31.9)
    ( to )
    Notes
    [4] - The Prevnar 13™ treatment group was not analyzed per the statistical analysis plan.
    No statistical analyses for this end point

    Primary: Percentage of Participants with a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™

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    End point title
    		 Percentage of Participants with a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Per the statistical analysis plan, within-group CIs were not calculated. The population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
    End point type
    Primary
    End point timeframe
    Up to Day 14
    End point values
    		 V114 Combined Lots 1,2 and 3 Prevnar 13™
    Number of subjects analysed
    2103
    230
    Units: Percentage of participants
    number (not applicable)
        Arthralgia
    7.7
    5.7
        Fatigue
    21.5
    22.2
        Headache
    18.9
    18.7
        Myalgia
    26.9
    21.7
    Statistical analysis title
    		 Arthralgia
    Statistical analysis description
    V114 Combined Lots minus Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.272
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 4.7
    Statistical analysis title
    		 Fatigue
    Statistical analysis description
    V114 Combined Lots minus Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.812
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.7
         upper limit
    		 4.5
    Statistical analysis title
    		 Headache
    Statistical analysis description
    V114 Combined Lots minus Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    P-value
    		 = 0.947
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 5
    Notes
    [5] - Method of Miettinen & Nurminen
    Statistical analysis title
    		 Myalgia
    Statistical analysis description
    V114 Combined Lots minus Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.091
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 10.4

    Primary: Percentage of Participants with a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots

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    End point title
    		 Percentage of Participants with a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots [6]
    End point description
    A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with SAEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots. The population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
    End point type
    Primary
    End point timeframe
    Up to Month 6
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Comparison of treatment arms was not performed for this endpoint per the statistical analysis plan.
    End point values
    		 V114 Lot 1 V114 Lot 2 V114 Lot 3 Prevnar 13™
    Number of subjects analysed
    699
    704
    700
    0 [7]
    Units: Percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 0.4)
    0.0 (0.0 to 0.4)
    0.0 (0.0 to 0.4)
    ( to )
    Notes
    [7] - The Prevnar 13™ treatment group was not analyzed per the statistical analysis plan.
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants with a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
    End point description
    A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. Per the statistical analysis plan, within-group CIs were not calculated. The population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
    End point type
    Primary
    End point timeframe
    Up to Month 6
    End point values
    		 V114 Combined Lots 1,2 and 3 Prevnar 13™
    Number of subjects analysed
    2103
    230
    Units: Percentage of participants
        number (not applicable)
    0.0
    0.0
    Statistical analysis title
    		 Vaccine-related SAEs
    Statistical analysis description
    V114 Combined Lots minus Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 0.2
    Notes
    [8] - Method of Miettinen & Nurminen

    Primary: Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots

    		 Close Top of page
    End point title
    		 Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
    End point description
    Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). The brackets next to each serotype show the number of participants analyzed for Lots 1, 2 and 3. Per the statistical analysis plan, within-group CIs were not calculated, but 95% CIs were calculated for the GMT ratios between pairs of V114 lots by a constrained longitudinal data analysis (cLDA) model. The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the endpoint. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Primary
    End point timeframe
    Day 30
    End point values
    		 V114 Lot 1 V114 Lot 2 V114 Lot 3 Prevnar 13™
    Number of subjects analysed
    698
    704
    700
    0 [9]
    Units: 1/dil
    number (not applicable)
        Serotype 1 (n=693,693,688)
    248.5
    251.6
    239.4
        Serotype 3 (n=693,693,688)
    198.3
    232.2
    214.4
        Serotype 4 (n=693,692,688)
    1073.1
    1303.7
    1074.4
        Serotype 5 (n=693,693,688)
    389.8
    461.6
    391.3
        Serotype 6A (n=688,691,686)
    5845.0
    6077.6
    6123.8
        Serotype 6B (n=693,692,688)
    5160.6
    5362.7
    5109.5
        Serotype 7F (n=692,692,687)
    3757.7
    4590.5
    4202.0
        Serotype 9V (n=691,693,688)
    1708.4
    1690.6
    1749.9
        Serotype 14 (n=693,693,687)
    2364.8
    2509.6
    2050.6
        Serotype 18C (n=693,692,688)
    3880.8
    3522.4
    3381.0
        Serotype 19A (n=693,693,688)
    3384.7
    3774.8
    3498.5
        Serotype 19F (n=693,692,688)
    1866.4
    2017.8
    1993.2
        Serotype 23F (n=690,692,686)
    2222.9
    2417.8
    2133.0
        Serotype 22F (n=688,692,684)
    2617.4
    2761.6
    2676.0
        Serotype 33F (n=691,690,688)
    7758.1
    7736.9
    7365.6
    Notes
    [9] - The Prevnar 13™ treatment group was not analyzed per the statistical analysis plan.
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 2 v V114 Lot 1
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [10]
    P-value
    		 < 0.001 [11]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.18
    Notes
    [10] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [11] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [12]
    P-value
    		 < 0.001 [13]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.24
    Notes
    [12] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [13] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [14]
    P-value
    		 < 0.001 [15]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.25
    Notes
    [14] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [15] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [16]
    P-value
    		 < 0.001 [17]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.97
    Notes
    [16] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [17] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [18]
    P-value
    		 < 0.001 [19]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.05
    Notes
    [18] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [19] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [20]
    P-value
    		 < 0.001 [21]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.23
    Notes
    [20] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [21] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [22]
    P-value
    		 < 0.001 [23]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.97
    Notes
    [22] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [23] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [24]
    P-value
    		 < 0.001 [25]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.18
    Notes
    [24] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [25] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [26]
    P-value
    		 < 0.001 [27]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 1.43
    Notes
    [26] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [27] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [28]
    P-value
    		 < 0.001 [29]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.02
    Notes
    [28] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [29] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [30]
    P-value
    		 < 0.001 [31]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.2
    Notes
    [30] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [31] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [32]
    P-value
    		 < 0.001 [33]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.42
    Notes
    [32] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [33] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [34]
    P-value
    		 < 0.001 [35]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.12
    Notes
    [34] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [35] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [36]
    P-value
    		 < 0.001 [37]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.12
    Notes
    [36] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [37] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [38]
    P-value
    		 < 0.001 [39]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.16
    Notes
    [38] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [39] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [40]
    P-value
    		 < 0.001 [41]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.12
    Notes
    [40] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [41] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [42]
    P-value
    		 < 0.001 [43]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.18
    Notes
    [42] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [43] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [44]
    P-value
    		 < 0.001 [45]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.23
    Notes
    [44] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [45] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [46]
    P-value
    		 < 0.001 [47]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.93
    Notes
    [46] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [47] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [48]
    P-value
    		 < 0.001 [49]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.01
    Notes
    [48] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [49] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [50]
    P-value
    		 < 0.001 [51]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.24
    Notes
    [50] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [51] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [52]
    P-value
    		 < 0.001 [53]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.16
    Notes
    [52] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [53] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [54]
    P-value
    		 < 0.001 [55]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.12
    Notes
    [54] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [55] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [56]
    P-value
    		 < 0.001 [57]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.11
    Notes
    [56] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [57] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [58]
    P-value
    		 < 0.001 [59]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.1
    Notes
    [58] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [59] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [60]
    P-value
    		 < 0.001 [61]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.34
    Notes
    [60] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [61] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [62]
    P-value
    		 < 0.001 [63]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 1.43
    Notes
    [62] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [63] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [64]
    P-value
    		 < 0.001 [65]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.26
    Notes
    [64] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [65] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [66]
    P-value
    		 < 0.001 [67]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.31
    Notes
    [66] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [67] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [68]
    P-value
    		 < 0.001 [69]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.19
    Notes
    [68] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [69] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [70]
    P-value
    		 < 0.001 [71]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.02
    Notes
    [70] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [71] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [72]
    P-value
    		 < 0.001 [73]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.1
    Notes
    [72] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [73] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [74]
    P-value
    		 < 0.001 [75]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.22
    Notes
    [74] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [75] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [76]
    P-value
    		 < 0.001 [77]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.05
    Notes
    [76] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [77] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [78]
    P-value
    		 < 0.001 [79]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.07
    Notes
    [78] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [79] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [80]
    P-value
    		 < 0.001 [81]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.15
    Notes
    [80] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [81] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [82]
    P-value
    		 < 0.001 [83]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.1
    Notes
    [82] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [83] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [84]
    P-value
    		 < 0.001 [85]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.24
    Notes
    [84] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [85] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [86]
    P-value
    		 < 0.001 [87]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.35
    Notes
    [86] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [87] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 22F
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [88]
    P-value
    		 < 0.001 [89]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.11
    Notes
    [88] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [89] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 22F
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [90]
    P-value
    		 < 0.001 [91]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.14
    Notes
    [90] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [91] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 22F
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [92]
    P-value
    		 < 0.001 [93]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.21
    Notes
    [92] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [93] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 33F
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [94]
    P-value
    		 < 0.001 [95]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.16
    Notes
    [94] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [95] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 33F
    Statistical analysis description
    GMT Ratio V114 Lot 1 / V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [96]
    P-value
    		 < 0.001 [97]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.22
    Notes
    [96] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [97] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.
    Statistical analysis title
    		 Serotype 33F
    Statistical analysis description
    GMT Ratio V114 Lot 2 / V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [98]
    P-value
    		 < 0.001 [99]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.22
    Notes
    [98] - P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).
    [99] - Identical p-values for the lower and upper bounds. Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.

    Secondary: Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots

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    End point title
    		 Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
    End point description
    The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay. The brackets next to each serotype show the number of participants analyzed for Lots 1, 2 and 3. Per the statistical analysis plan, within-group CIs were not calculated, but 95% CIs for the GMC ratios between pairs of V114 lots were based on a cLDA model. The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the endpoint. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    		 V114 Lot 1 V114 Lot 2 V114 Lot 3 Prevnar 13™
    Number of subjects analysed
    698
    704
    700
    0 [100]
    Units: μg/mL
    number (not applicable)
        Serotype 1 (n=693,693,688)
    3.91
    4.05
    3.83
        Serotype 3 (n=693,693,688)
    0.74
    0.86
    0.73
        Serotype 4 (n=693,692,688)
    1.79
    2.18
    1.67
        Serotype 5 (n=693,693,688)
    3.81
    4.63
    3.96
        Serotype 6A (n=693,693,688)
    8.09
    8.84
    8.16
        Serotype 6B (n=693,693,688)
    10.92
    11.46
    10.44
        Serotype 7F (n=693,693,688)
    5.71
    7.11
    5.94
        Serotype 9V (n=693,693,688)
    4.20
    4.44
    4.26
        Serotype 14 (n=693,693,688)
    9.82
    11.38
    8.66
        Serotype 18C (n=693,693,688)
    14.07
    11.81
    10.66
        Serotype 19A (n=693,693,688)
    15.45
    17.34
    15.81
        Serotype 19F (n=693,693,688)
    9.78
    11.22
    10.65
        Serotype 23F (n=693,693,688)
    7.38
    7.97
    7.44
        Serotype 22F (n=693,693,688)
    4.12
    4.41
    3.80
        Serotype 33F (n=693,693,688)
    9.92
    10.88
    9.45
    Notes
    [100] - The Prevnar 13™ treatment group was not analyzed per the statistical analysis plan.
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [101]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.1
    Notes
    [101] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [102]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.17
    Notes
    [102] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [103]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.21
    Notes
    [103] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [104]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.13
    Notes
    [104] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [105]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 0.95
    Notes
    [105] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [106]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.06
         upper limit
    		 1.32
    Notes
    [106] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [107]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.94
    Notes
    [107] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [108]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.23
    Notes
    [108] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [109]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.95
    Notes
    [109] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [110]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.14
         upper limit
    		 1.5
    Notes
    [110] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [111]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.11
    Notes
    [111] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [112]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.35
    Notes
    [112] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [113]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.07
    Notes
    [113] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [114]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.16
    Notes
    [114] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [115]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.11
    Notes
    [115] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [116]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.27
    Notes
    [116] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [117]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.22
    Notes
    [117] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [118]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.28
    Notes
    [118] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [119]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.92
    Notes
    [119] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [120]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.1
    Notes
    [120] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [121]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 1.37
    Notes
    [121] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [122]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.08
    Notes
    [122] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [123]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.13
    Notes
    [123] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [124]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.19
    Notes
    [124] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [125]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1
    Notes
    [125] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [126]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.31
    Notes
    [126] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [127]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.14
         upper limit
    		 1.52
    Notes
    [127] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [128]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 1.36
    Notes
    [128] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [129]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.15
         upper limit
    		 1.51
    Notes
    [129] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [130]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.27
    Notes
    [130] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [131]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.02
    Notes
    [131] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [132]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.11
    Notes
    [132] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [133]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.25
    Notes
    [133] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [134]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.05
    Notes
    [134] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [135]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1
    Notes
    [135] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [136]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.21
    Notes
    [136] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [137]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.07
    Notes
    [137] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [138]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.15
    Notes
    [138] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [139]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.24
    Notes
    [139] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [140]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.08
    Notes
    [140] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [141]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.35
    Notes
    [141] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [142]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.26
    Notes
    [142] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 2
    Comparison groups
    V114 Lot 1 v V114 Lot 2
    Number of subjects included in analysis
    1402
    Analysis specification
    Pre-specified
    Analysis type
    		 [143]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.06
    Notes
    [143] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F
    Statistical analysis description
    GMC Ratio V114 Lot 1 divided by V114 Lot 3
    Comparison groups
    V114 Lot 1 v V114 Lot 3
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 [144]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.22
    Notes
    [144] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F
    Statistical analysis description
    GMC Ratio V114 Lot 2 divided by V114 Lot 3
    Comparison groups
    V114 Lot 2 v V114 Lot 3
    Number of subjects included in analysis
    1404
    Analysis specification
    Pre-specified
    Analysis type
    		 [145]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.34
    Notes
    [145] - GMC ratio and 95% CI were estimated from a cLDA model.

    Secondary: Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™

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    End point title
    		 Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
    End point description
    The GMC of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. The brackets next to each serotype show the number of participants analyzed for combined V114 lots and Prevnar 13™ respectively. Per the statistical analysis plan, within-group CIs were not calculated. The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the endpoint. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    		 V114 Combined Lots 1,2 and 3 Prevnar 13™
    Number of subjects analysed
    2102
    231
    Units: μg/mL
    number (not applicable)
        Serotype 1 (n=2074,225)
    3.91
    5.22
        Serotype 3 (n=2074,225)
    0.77
    0.55
        Serotype 4 (n=2073,225)
    1.87
    2.38
        Serotype 5 (n=2074,225)
    4.14
    4.66
        Serotype 6A (n=2074,225)
    8.38
    7.20
        Serotype 6B (n=2074,225)
    10.92
    7.28
        Serotype 7F (n=2074,225)
    6.19
    7.12
        Serotype 9V (n=2074,225)
    4.30
    4.97
        Serotype 14 (n=2074,225)
    9.89
    9.97
        Serotype 18C (n=2074,225)
    12.08
    9.58
        Serotype 19A (n=2074,225)
    16.18
    16.66
        Serotype 19F (n=2074,225)
    10.52
    10.25
        Serotype 23F (n=2074,225)
    7.58
    6.03
        Serotype 22F (n=2074,225)
    4.10
    0.34
        Serotype 33F (n=2074,225)
    10.03
    1.07
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [146]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 0.91
    Notes
    [146] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [147]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 1.61
    Notes
    [147] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [148]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.94
    Notes
    [148] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [149]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.07
    Notes
    [149] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [150]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.43
    Notes
    [150] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [151]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 1.86
    Notes
    [151] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [152]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.04
    Notes
    [152] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [153]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.04
    Notes
    [153] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [154]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.2
    Notes
    [154] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [155]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 1.51
    Notes
    [155] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [156]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.15
    Notes
    [156] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [157]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.23
    Notes
    [157] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [158]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 1.54
    Notes
    [158] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [159]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    12.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.11
         upper limit
    		 14.74
    Notes
    [159] - GMC ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F
    Statistical analysis description
    GMC Ratio V114 Combined Lots divided by Prevnar 13™
    Comparison groups
    V114 Combined Lots 1,2 and 3 v Prevnar 13™
    Number of subjects included in analysis
    2333
    Analysis specification
    Pre-specified
    Analysis type
    		 [160]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    9.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.96
         upper limit
    		 11.13
    Notes
    [160] - GMC ratio and 95% CI were estimated from a cLDA model.

    Secondary: Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots

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    End point title
    		 Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
    End point description
    Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA which reads the reciprocal of the highest dilution that gives ≥50% bacterial killing. The brackets next to each serotype show the number of participants analyzed for Lots 1, 2 and 3. The Geometric Mean Fold Rise (GMFR) is the geometric mean of the ratio Day 30/Day 1 OPA responses. 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 population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the endpoint. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Day 30
    End point values
    		 V114 Lot 1 V114 Lot 2 V114 Lot 3 Prevnar 13™
    Number of subjects analysed
    698
    704
    700
    0 [161]
    Units: Ratio
    number (confidence interval 95%)
        Serotype 1 (n=676,667,661)
    15.9 (13.9 to 18.2)
    16.5 (14.6 to 18.8)
    15.4 (13.6 to 17.4)
    ( to )
        Serotype 3 (n=666,665,657)
    6.5 (5.9 to 7.2)
    7.6 (6.8 to 8.4)
    6.9 (6.2 to 7.6)
    ( to )
        Serotype 4 (n=670,663,658)
    17.4 (15.4 to 19.8)
    20.7 (18.3 to 23.4)
    16.5 (14.6 to 18.7)
    ( to )
        Serotype 5 (n=676,675,665)
    11.2 (9.9 to 12.8)
    13.3 (11.8 to 15.1)
    11.1 (9.8 to 12.7)
    ( to )
        Serotype 6A (n=620,618,611)
    13.7 (12.1 to 15.5)
    14.1 (12.5 to 16.0)
    14.6 (12.8 to 16.5)
    ( to )
        Serotype 6B (n=659,658,653)
    33.4 (29.0 to 38.5)
    31.2 (27.0 to 36.1)
    34.9 (30.2 to 40.3)
    ( to )
        Serotype 7F (n=648,638,646)
    11.9 (10.4 to 13.7)
    14.3 (12.4 to 16.5)
    12.9 (11.3 to 14.8)
    ( to )
        Serotype 9V (n=652,650,641)
    4.8 (4.4 to 5.3)
    4.8 (4.3 to 5.3)
    5.0 (4.5 to 5.6)
    ( to )
        Serotype 14 (n=671,667,662)
    7.6 (6.6 to 8.6)
    7.6 (6.7 to 8.7)
    6.2 (5.4 to 7.0)
    ( to )
        Serotype 18C (n=669,662,651)
    16.7 (14.9 to 18.8)
    15.0 (13.4 to 16.8)
    14.1 (12.6 to 15.8)
    ( to )
        Serotype 19A (n=665,660,650)
    10.4 (9.2 to 11.8)
    11.0 (9.6 to 12.5)
    11.7 (10.3 to 13.4)
    ( to )
        Serotype 19F (n=663,667,659)
    6.5 (5.9 to 7.3)
    6.8 (6.1 to 7.6)
    7.3 (6.5 to 8.1)
    ( to )
        Serotype 23F (n=609,626,633)
    16.8 (14.6 to 19.4)
    17.4 (15.2 to 20.0)
    17.0 (14.8 to 19.4)
    ( to )
        Serotype 22F (n=610,597,602)
    27.2 (22.3 to 33.1)
    31.1 (25.6 to 38.0)
    28.3 (23.4 to 34.3)
    ( to )
        Serotype 33F (n=647,641,641)
    8.4 (7.2 to 9.7)
    7.7 (6.6 to 8.9)
    7.5 (6.5 to 8.7)
    ( to )
    Notes
    [161] - The Prevnar 13™ treatment group was not analyzed per the statistical analysis plan.
    No statistical analyses for this end point

    Secondary: GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots

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    End point title
    		 GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
    End point description
    The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. The brackets next to each serotype show the number of participants analyzed for Lots 1, 2 and 3. The GMFR is the geometric mean of the ratio of Day 30/Day 1 IgG concentration. 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 population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the endpoint. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Day 30
    End point values
    		 V114 Lot 1 V114 Lot 2 V114 Lot 3 Prevnar 13™
    Number of subjects analysed
    698
    704
    700
    0 [162]
    Units: Ratio
    number (confidence interval 95%)
        Serotype 1 (n=677,674,666)
    10.9 (9.8 to 12.2)
    11.2 (10.1 to 12.4)
    10.3 (9.2 to 11.5)
    ( to )
        Serotype 3 (n=677,674,666)
    5.4 (4.9 to 5.9)
    6.3 (5.7 to 6.9)
    5.2 (4.8 to 5.7)
    ( to )
        Serotype 4 (n=673,672,664)
    8.6 (7.8 to 9.5)
    10.5 (9.5 to 11.6)
    7.9 (7.1 to 8.7)
    ( to )
        Serotype 5 (n=677,674,666)
    4.5 (4.1 to 5.0)
    5.5 (4.9 to 6.0)
    4.7 (4.2 to 5.2)
    ( to )
        Serotype 6A (n=677,674,666)
    22.6 (20.1 to 25.3)
    24.1 (21.5 to 27.1)
    22.9 (20.4 to 25.8)
    ( to )
        Serotype 6B (n=676,674,666)
    23.5 (21.0 to 26.3)
    24.1 (21.5 to 27.0)
    22.1 (19.7 to 24.8)
    ( to )
        Serotype 7F (n=677,674,666)
    11.7 (10.5 to 13.1)
    14.8 (13.2 to 16.6)
    12.0 (10.7 to 13.3)
    ( to )
        Serotype 9V (n=676,673,665)
    9.5 (8.6 to 10.5)
    9.8 (8.9 to 10.9)
    9.6 (8.6 to 10.6)
    ( to )
        Serotype 14 (n=676,674,666)
    6.5 (5.8 to 7.3)
    6.8 (6.1 to 7.7)
    5.2 (4.7 to 5.8)
    ( to )
        Serotype 18C (n=676,674,666)
    20.6 (18.3 to 23.1)
    17.0 (15.1 to 19.1)
    15.9 (14.2 to 17.9)
    ( to )
        Serotype 19A (n=677,674,666)
    9.1 (8.2 to 10.0)
    10.6 (9.6 to 11.7)
    9.5 (8.6 to 10.5)
    ( to )
        Serotype 19F (n=677,673,665)
    12.3 (11.1 to 13.7)
    13.8 (12.5 to 15.4)
    13.1 (11.8 to 14.5)
    ( to )
        Serotype 23F (n=677,674,665)
    14.3 (12.7 to 16.1)
    16.2 (14.4 to 18.1)
    14.8 (13.2 to 16.6)
    ( to )
        Serotype 22F (n=677,674,666)
    12.8 (11.4 to 14.4)
    13.4 (11.8 to 15.1)
    11.1 (9.9 to 12.5)
    ( to )
        Serotype 33F (n=677,673,666)
    9.2 (8.3 to 10.3)
    9.5 (8.6 to 10.6)
    7.9 (7.1 to 8.8)
    ( to )
    Notes
    [162] - The Prevnar 13™ treatment group was not analyzed per the statistical analysis plan.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots

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    End point title
    		 Percentage of Participants with ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
    End point description
    Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, with the MOPA which reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing. The brackets next to each serotype show the number of participants analyzed for Lots 1, 2 and 3. Percentage of participants with a ≥ 4-fold change GMFR from Day 1 (baseline) to Day 30 are presented. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the endpoint. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Day 30
    End point values
    		 V114 Lot 1 V114 Lot 2 V114 Lot 3 Prevnar 13™
    Number of subjects analysed
    698
    704
    700
    0 [163]
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype 1 (n=676,667,661)
    74.4 (70.9 to 77.7)
    76.8 (73.4 to 79.9)
    77.2 (73.8 to 80.3)
    ( to )
        Serotype 3 (n=666,665,657)
    64.7 (61.0 to 68.3)
    68.9 (65.2 to 72.4)
    64.8 (61.1 to 68.5)
    ( to )
        Serotype 4 (n=670,663,658)
    79.4 (76.1 to 82.4)
    83.6 (80.5 to 86.3)
    79.5 (76.2 to 82.5)
    ( to )
        Serotype 5 (n=676,675,665)
    71.3 (67.7 to 74.7)
    76.1 (72.7 to 79.3)
    69.5 (65.8 to 73.0)
    ( to )
        Serotype 6A (n=620,618,611)
    78.5 (75.1 to 81.7)
    77.8 (74.3 to 81.0)
    76.9 (73.4 to 80.2)
    ( to )
        Serotype 6B (n=659,658,653)
    83.3 (80.2 to 86.1)
    83.6 (80.5 to 86.3)
    84.5 (81.5 to 87.2)
    ( to )
        Serotype 7F (n=648,638,646)
    69.4 (65.7 to 73.0)
    71.6 (68.0 to 75.1)
    70.4 (66.7 to 73.9)
    ( to )
        Serotype 9V (n=652,650,641)
    53.4 (49.5 to 57.3)
    51.2 (47.3 to 55.1)
    53.2 (49.3 to 57.1)
    ( to )
        Serotype 14 (n=671,667,662)
    56.8 (52.9 to 60.6)
    57.6 (53.7 to 61.4)
    52.3 (48.4 to 56.1)
    ( to )
        Serotype 18C (n=669,662,651)
    80.1 (76.9 to 83.1)
    79.0 (75.7 to 82.0)
    78.3 (75.0 to 81.4)
    ( to )
        Serotype 19A (n=665,660,650)
    67.8 (64.1 to 71.4)
    69.8 (66.2 to 73.3)
    71.2 (67.6 to 74.7)
    ( to )
        Serotype 19F (n=663,667,659)
    60.8 (57.0 to 64.5)
    61.9 (58.1 to 65.6)
    63.0 (59.2 to 66.7)
    ( to )
        Serotype 23F (n=609,626,633)
    75.4 (71.7 to 78.7)
    78.3 (74.8 to 81.4)
    78.2 (74.8 to 81.4)
    ( to )
        Serotype 22F (n=610,597,602)
    71.1 (67.4 to 74.7)
    73.4 (69.6 to 76.9)
    72.8 (69.0 to 76.3)
    ( to )
        Serotype 33F (n=647,641,641)
    59.5 (55.6 to 63.3)
    58.3 (54.4 to 62.2)
    56.8 (52.8 to 60.7)
    ( to )
    Notes
    [163] - The Prevnar 13™ treatment group was not analyzed per the statistical analysis plan.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots

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    End point title
    		 Percentage of Participants with ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
    End point description
    The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. The brackets next to each serotype show the number of participants analyzed for Lots 1, 2 and 3. Percentage of participants with a ≥ 4-fold change GMFR from Day 1 (baseline) to Day 30 are presented. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of endpoint. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Day 30
    End point values
    		 V114 Lot 1 V114 Lot 2 V114 Lot 3 Prevnar 13™
    Number of subjects analysed
    698
    704
    700
    0 [164]
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype 1 (n=677,674,666)
    73.9 (70.4 to 77.1)
    75.2 (71.8 to 78.4)
    73.0 (69.4 to 76.3)
    ( to )
        Serotype 3 (n=677,674,666)
    58.6 (54.8 to 62.4)
    61.9 (58.1 to 65.6)
    54.7 (50.8 to 58.5)
    ( to )
        Serotype 4 (n=673,672,664)
    68.8 (65.1 to 72.3)
    73.8 (70.3 to 77.1)
    65.7 (61.9 to 69.3)
    ( to )
        Serotype 5 (n=677,674,666)
    45.6 (41.8 to 49.5)
    52.5 (48.7 to 56.3)
    45.9 (42.1 to 49.8)
    ( to )
        Serotype 6A (n=677,674,666)
    86.6 (83.8 to 89.0)
    87.2 (84.5 to 89.7)
    83.8 (80.8 to 86.5)
    ( to )
        Serotype 6B (n=676,674,666)
    87.0 (84.2 to 89.4)
    85.6 (82.7 to 88.2)
    84.2 (81.2 to 86.9)
    ( to )
        Serotype 7F (n=677,674,666)
    75.3 (71.9 to 78.5)
    78.8 (75.5 to 81.8)
    74.8 (71.3 to 78.0)
    ( to )
        Serotype 9V (n=676,673,665)
    72.6 (69.1 to 76.0)
    73.0 (69.4 to 76.3)
    71.6 (68.0 to 75.0)
    ( to )
        Serotype 14 (n=676,674,666)
    54.4 (50.6 to 58.2)
    57.9 (54.0 to 61.6)
    48.3 (44.5 to 55.2)
    ( to )
        Serotype 18C (n=676,674,666)
    84.6 (81.7 to 87.3)
    78.6 (75.3 to 81.7)
    76.7 (73.3 to 79.9)
    ( to )
        Serotype 19A (n=677,674,666)
    70.6 (67.0 to 74.0)
    74.2 (70.7 to 77.5)
    71.0 (67.4 to 74.4)
    ( to )
        Serotype 19F (n=677,673,665)
    77.8 (74.5 to 80.9)
    79.0 (75.8 to 82.1)
    78.6 (75.3 to 81.7)
    ( to )
        Serotype 23F (n=677,674,665)
    76.1 (72.7 to 79.2)
    80.7 (77.5 to 83.6)
    76.7 (73.3 to 79.9)
    ( to )
        Serotype 22F (n=677,674,666)
    75.3 (71.9 to 78.5)
    75.4 (71.9 to 78.6)
    72.1 (68.5 to 75.5)
    ( to )
        Serotype 33F (n=677,673,666)
    69.4 (65.8 to 72.9)
    70.9 (67.3 to 74.3)
    66.1 (62.3 to 69.7)
    ( to )
    Notes
    [164] - The Prevnar 13™ treatment group was not analyzed per the statistical analysis plan.
    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 (AEs) were reported from Day 1 through Day 14 following vaccination. Serious AEs (SAEs) were reported from Day 1 following vaccination up to Month 6. All-Cause Mortality were reported from randomization up to Month 6.
    Adverse event reporting additional description
    For SAEs and Non-serious AEs the population analyzed was randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1. For All-Cause Mortality the population analyzed was all randomized participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    V114 Lot 1
    Reporting group description
    		 Single intramuscular (IM) dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Reporting group title
    V114 Lot 3
    Reporting group description
    		 Single intramuscular (IM) dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1)

    Reporting group title
    V114 Lot 2
    Reporting group description
    		 Single intramuscular (IM) dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1)

    Serious adverse events
    		 V114 Lot 1 V114 Lot 3 Prevnar 13™ V114 Lot 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 699 (1.72%)
    7 / 700 (1.00%)
    5 / 230 (2.17%)
    19 / 704 (2.70%)
         number of deaths (all causes)
    1
    0
    0
    2
         number of deaths resulting from adverse events
    1
    0
    0
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Breast cancer
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    0 / 704 (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
    Breast cancer female
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    0 / 704 (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 cancer
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    1 / 230 (0.43%)
    0 / 704 (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
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 699 (0.00%)
    1 / 700 (0.14%)
    0 / 230 (0.00%)
    0 / 704 (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
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    1 / 230 (0.43%)
    0 / 704 (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
    Metastases to peritoneum
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    0 / 704 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 699 (0.00%)
    1 / 700 (0.14%)
    0 / 230 (0.00%)
    0 / 704 (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
    Rectal cancer
         subjects affected / exposed
    0 / 699 (0.00%)
    1 / 700 (0.14%)
    0 / 230 (0.00%)
    0 / 704 (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
    Injury, poisoning and procedural complications
    Pelvic fracture
         subjects affected / exposed
    0 / 699 (0.00%)
    1 / 700 (0.14%)
    0 / 230 (0.00%)
    0 / 704 (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
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    1 / 230 (0.43%)
    0 / 704 (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
    Angina unstable
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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 failure congestive
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    1 / 1
    Coronary artery disease
         subjects affected / exposed
    0 / 699 (0.00%)
    1 / 700 (0.14%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    0 / 704 (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
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    0 / 704 (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
    Cerebrovascular accident
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Migraine
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Seizure
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Transient ischaemic attack
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Death
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    1 / 1
    Eye disorders
    Blindness
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 699 (0.00%)
    1 / 700 (0.14%)
    0 / 230 (0.00%)
    0 / 704 (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
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    1 / 230 (0.43%)
    0 / 704 (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
    Cholelithiasis
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    2 / 704 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    2 / 704 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    1 / 1
    Pulmonary embolism
         subjects affected / exposed
    0 / 699 (0.00%)
    1 / 700 (0.14%)
    0 / 230 (0.00%)
    0 / 704 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    0 / 704 (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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 699 (0.00%)
    1 / 700 (0.14%)
    0 / 230 (0.00%)
    0 / 704 (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
    Bronchitis
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    0 / 704 (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
    Cellulitis
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Cystitis
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    1 / 230 (0.43%)
    0 / 704 (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
    Diverticulitis
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    0 / 704 (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
    Peritonitis
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Pneumonia
         subjects affected / exposed
    1 / 699 (0.14%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Sepsis
         subjects affected / exposed
    0 / 699 (0.00%)
    0 / 700 (0.00%)
    0 / 230 (0.00%)
    1 / 704 (0.14%)
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V114 Lot 1 V114 Lot 3 Prevnar 13™ V114 Lot 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    548 / 699 (78.40%)
    535 / 700 (76.43%)
    151 / 230 (65.65%)
    534 / 704 (75.85%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    127 / 699 (18.17%)
    130 / 700 (18.57%)
    43 / 230 (18.70%)
    140 / 704 (19.89%)
         occurrences all number
    166
    171
    53
    170
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    154 / 699 (22.03%)
    151 / 700 (21.57%)
    51 / 230 (22.17%)
    147 / 704 (20.88%)
         occurrences all number
    202
    189
    74
    182
    Injection site erythema
         subjects affected / exposed
    77 / 699 (11.02%)
    89 / 700 (12.71%)
    22 / 230 (9.57%)
    86 / 704 (12.22%)
         occurrences all number
    82
    91
    24
    91
    Injection site pain
         subjects affected / exposed
    464 / 699 (66.38%)
    471 / 700 (67.29%)
    122 / 230 (53.04%)
    475 / 704 (67.47%)
         occurrences all number
    518
    514
    134
    520
    Injection site swelling
         subjects affected / exposed
    111 / 699 (15.88%)
    106 / 700 (15.14%)
    34 / 230 (14.78%)
    115 / 704 (16.34%)
         occurrences all number
    115
    109
    34
    117
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    53 / 699 (7.58%)
    59 / 700 (8.43%)
    13 / 230 (5.65%)
    49 / 704 (6.96%)
         occurrences all number
    68
    75
    14
    54
    Myalgia
         subjects affected / exposed
    196 / 699 (28.04%)
    199 / 700 (28.43%)
    50 / 230 (21.74%)
    171 / 704 (24.29%)
         occurrences all number
    226
    226
    54
    196

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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