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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)

    Summary
    EudraCT number
    		 2018-003787-31
    Trial protocol
    		 DE   EE   BE   CZ   ES   PL   GR   Outside EU/EEA  
    Global end of trial date
    05 Aug 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jan 2022
    First version publication date
    21 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V114-025
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04031846
    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., Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002215-PIP01-17
    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
    05 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study evaluated the safety, tolerability and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV) when administered at ~ 2-months old. The primary hypotheses were: 1) V114 is non-inferior to Prevenar 13™, a 13-valent PCV, for the 13 shared serotypes between V114 and Prevenar 13™ based on response rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Sep 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: 17
    Country: Number of subjects enrolled
    Belgium: 67
    Country: Number of subjects enrolled
    Czechia: 14
    Country: Number of subjects enrolled
    Estonia: 111
    Country: Number of subjects enrolled
    Germany: 187
    Country: Number of subjects enrolled
    Greece: 84
    Country: Number of subjects enrolled
    Poland: 316
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Spain: 368
    Worldwide total number of subjects
    1184
    EEA total number of subjects
    1147
    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)
    1184
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Healthy males and females aged 42 to 90 days (inclusive) were enrolled. One participant randomized to the V114 group, who was cross-treated with both V114 and Prevenar 13™ (both PCVs), was excluded from the all participants as treated (APaT) i.e. the safety endpoints population; but was included in the AE module as a separate treatment group.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V114
    Arm description
    		 Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    V114
    Investigational medicinal product code
    Other name
    VAXNEUVANCE™
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    15-valent PCV containing 13 serotypes present in Prevenar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration.

    Investigational medicinal product name
    Rotarix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2).

    Investigational medicinal product name
    Infanrix™ hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13).

    Arm title
    		 Prevenar 13™
    Arm description
    		 Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar 13™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A,19F, and 23F) in each 0.5 mL intramuscular administration.

    Investigational medicinal product name
    Infanrix™ hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13).

    Investigational medicinal product name
    Rotarix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2).

    Number of subjects in period 1
    		V114 Prevenar 13™
    Started
    591
    593
    Vaccinated
    588
    591
    All Participants As Treated
    587
    591
    PCV dose at age 2 months
    588
    591
    PCV dose at age 3 months
    32 [1]
    35 [2]
    PCV dose at age 4 months
    582
    584
    PCV dose at age 11-14 months
    571
    574
    Completed
    569
    570
    Not completed
    22
    23
         Physician decision
    -
    1
         Withdrawal By Parent/Guardian
    17
    17
         Lost to follow-up
    4
    4
         Protocol deviation
    1
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Due to a subset of participants receiving PCV at age 3 months, this resulted in lower numbers vaccinated.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Due to a subset of participants receiving PCV at age 3 months, this resulted in lower numbers vaccinated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).

    Reporting group title
    Prevenar 13™
    Reporting group description
    		 Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).

    Reporting group values
    		 V114 Prevenar 13™ Total
    Number of subjects
    		 591 593 1184
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 591 593 1184
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 8.4 ± 1.5 8.5 ± 1.5 -
    Gender Categorical
    Units: Subjects
        Female
    		 283 286 569
        Male
    		 308 307 615
    Race Categorical
    Units: Subjects
        American Indian Or Alaska Native
    		 4 5 9
        Asian
    		 4 5 9
        Black Or African American
    		 4 3 7
        Multiple
    		 5 7 12
        White
    		 574 573 1147
    Ethnicity Categorical
    Units: Subjects
        Hispanic Or Latino
    		 66 65 131
        Not Hispanic Or Latino
    		 525 526 1051
        Not Reported
    		 0 1 1
        Unknown
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).

    Reporting group title
    Prevenar 13™
    Reporting group description
    		 Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).

    Primary: Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE)

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    End point title
    		 Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE)
    End point description
    An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) consisted of erythema (redness), induration (hard lump), pain (tenderness) and swelling. The population analyzed was All Participants as Treated (APat) which consisted of participants who received at least 1 dose of study vaccination based on the group to which they were randomized, and corresponding to the study vaccination they actually received. One participant randomized to V114, who inadvertently received both V114 and Prevenar 13™, was excluded from this analysis.
    End point type
    Primary
    End point timeframe
    Up to 14 days post any vaccination (up to approximately study month 13)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    587
    591
    Units: Percentage of Participants
    number (not applicable)
        Injection site erythema
    45.3
    44.7
        Injection site induration
    41.9
    39.1
        Injection site pain
    40.5
    29.3
        Injection site swelling
    33.6
    29.4
    Statistical analysis title
    		 P-value and Diff. in %: Inj. site erythema
    Statistical analysis description
    Difference in % (V114 minus Prevenar 13™) and 95 % confidence interval (CI) are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.824
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 6.3
    Statistical analysis title
    		 P-value and Diff. in %:: Inj. site induration
    Statistical analysis description
    Difference in % (V114 minus Prevenar 13™) and 95 % CI are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.324
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 8.4
    Statistical analysis title
    		 P-value and Diff. in %: Inj. site pain
    Statistical analysis description
    Difference in % (V114 minus Prevenar 13™) and 95 % CI are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    11.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.8
         upper limit
    		 16.6
    Statistical analysis title
    		 P-value and Diff. in %: Inj. site swelling
    Statistical analysis description
    Difference in % (V114 minus Prevenar 13™) and 95 % CI are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.128
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 9.4

    Primary: Percentage of Participants that Report at Least 1 Solicited Systemic AE

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    End point title
    		 Percentage of Participants that Report at Least 1 Solicited Systemic AE
    End point description
    An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Systemic AEs solicited on the VRC consisted of decreased appetite (loss of appetite), irritability, somnolence (drowsiness) and urticaria (hive/welts). The population analyzed was APat which consisted of participants who received at least 1 dose of study vaccination based on the group to which they were randomized, and corresponding to the study vaccination they actually received. One participant randomized to V114, who inadvertently received both V114 and Prevenar 13™, was excluded from this analysis.
    End point type
    Primary
    End point timeframe
    Up to 14 days post any vaccination (up to approximately study month 13)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    587
    591
    Units: Percentage of Participants
    number (not applicable)
        Decreased appetite
    33.9
    33.5
        Irritability
    71.7
    66.3
        Somnolence
    46.2
    41.8
        Urticaria
    3.7
    3.9
    Statistical analysis title
    		 P-value and Diff. in %: Decreased appetite
    Statistical analysis description
    Difference in % (V114 minus Prevenar 13™) and 95 % CI are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.885
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 5.8
    Statistical analysis title
    		 P-value and Diff. in %: Irritability
    Statistical analysis description
    Difference in % (V114 minus Prevenar 13™) and 95 % CI are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.045
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    5.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 10.7
    Statistical analysis title
    		 P-value and Diff. in %: Somnolence
    Statistical analysis description
    Difference in % (V114 minus Prevenar 13™) and 95 % CI are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.131
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    4.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 10
    Statistical analysis title
    		 P-value and Diff. in %: Urticaria
    Statistical analysis description
    Difference in % (V114 minus Prevenar 13™) and 95 % CI are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.898
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 2.1

    Primary: Percentage of Participants That Report at Least 1 Vaccine-related Serious Adverse Event (SAE)

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    End point title
    		 Percentage of Participants That Report at Least 1 Vaccine-related Serious Adverse Event (SAE)
    End point description
    A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The relatedness of a vaccine to a SAE is determined by an investigator who is a qualified physician. The population analyzed was APat which consisted of participants who received at least 1 dose of study vaccination based on the group to which they were randomized, and corresponding to the study vaccination they actually received. One participant randomized to V114, who inadvertently received both V114 and Prevenar 13™, was excluded from this analysis.
    End point type
    Primary
    End point timeframe
    Up to 6 months post last vaccination (up to approximately study month 20)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    587
    591
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.2
    Statistical analysis title
    		 Difference in % vs Prevenar 13™
    Statistical analysis description
    Percentage of participants from V114 minus Prevenar 13™. Difference in % and 95 % CI are calculated based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.5

    Primary: Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD)

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    End point title
    		 Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD)
    End point description
    Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using pneumococcal electrochemiluminescence (PnECL). The Geometric Mean Concentration (GMC) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. The population analyzed consisted of all randomized participants without deviations from the protocol that may substantially affect the results. Deviations that affect the number analyzed include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
    End point type
    Primary
    End point timeframe
    30 days PTD (Up to approximately study month 14)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    588
    591
    Units: μg/mL
    number (not applicable)
        Serotype 1 (n= 539, 537)
    1.29
    2.08
        Serotype 3 (n= 539, 537)
    0.84
    0.66
        Serotype 4 (n= 539, 535)
    1.29
    1.73
        Serotype 5 (n= 539, 535)
    1.97
    3.06
        Serotype 6A (n= 539, 535)
    3.10
    4.57
        Serotype 6B (n= 539, 535)
    4.17
    4.37
        Serotype 7F (n= 539, 536)
    3.09
    3.93
        Serotype 9V (n= 539, 537)
    2.14
    2.99
        Serotype 14 (n= 539, 537)
    5.26
    7.04
        Serotype 18C (n= 539, 536)
    1.94
    2.22
        Serotype 19A (n= 539, 535)
    4.68
    5.65
        Serotype 19F (n= 539, 537)
    4.09
    4.63
        Serotype 23F (n= 538, 535)
    1.52
    1.75
        Serotype 22F (n= 539, 535)
    5.98
    0.08
        Serotype 33F (n= 539, 530)
    3.41
    0.07
    Statistical analysis title
    		 GMC Ratio : Serotype 1
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.001 [2]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.68
    Notes
    [1] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [2] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 3
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.001 [4]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.17
         upper limit
    		 1.39
    Notes
    [3] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [4] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 4
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    P-value
    		 < 0.001 [6]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.82
    Notes
    [5] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [6] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 5
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    P-value
    		 < 0.001 [8]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.7
    Notes
    [7] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [8] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 6A
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    P-value
    		 < 0.001 [10]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 0.76
    Notes
    [9] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [10] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 6B
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    P-value
    		 < 0.001 [12]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.07
    Notes
    [11] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [12] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 7F
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [13]
    P-value
    		 < 0.001 [14]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.85
    Notes
    [13] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [14] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 9V
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [15]
    P-value
    		 < 0.001 [16]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.78
    Notes
    [15] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [16] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 14
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [17]
    P-value
    		 < 0.001 [18]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 0.83
    Notes
    [17] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [18] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 18C
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [19]
    P-value
    		 < 0.001 [20]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 0.95
    Notes
    [19] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [20] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 19A
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [21]
    P-value
    		 < 0.001 [22]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.91
    Notes
    [21] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [22] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 19F
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [23]
    P-value
    		 < 0.001 [24]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 0.97
    Notes
    [23] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [24] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 23F
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [25]
    P-value
    		 < 0.001 [26]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 0.97
    Notes
    [25] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [26] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 22F
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [27]
    P-value
    		 < 0.001 [28]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    71.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 65.16
         upper limit
    		 79.1
    Notes
    [27] - Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >2.0 (1-sided p-value <0.025).
    [28] - 1-sided p-value
    Statistical analysis title
    		 GMC Ratio : Serotype 33F
    Statistical analysis description
    GMC ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [29]
    P-value
    		 < 0.001 [30]
    Method
    		 t-distribution
    Parameter type
    		 GMC Ratio
    Point estimate
    46.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 42.19
         upper limit
    		 51.42
    Notes
    [29] - Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being >2.0 (1-sided p-value <0.025).
    [30] - 1-sided p-value

    Primary: Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD

    		 Close Top of page
    End point title
    		 Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD
    End point description
    Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. The population analyzed consisted of all randomized participants without deviations from the protocol that may substantially affect the results. Deviations that affect the number analyzed include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
    End point type
    Primary
    End point timeframe
    30 days PTD (Up to approximately study month 14)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    588
    591
    Units: Percentage of Participants
    number (not applicable)
        Serotype 1 (n= 539, 537)
    96.7
    99.4
        Serotype 3 (n= 539, 537)
    92.0
    83.8
        Serotype 4 (n= 539, 535)
    95.7
    97.9
        Serotype 5 (n= 539, 535)
    99.1
    100.0
        Serotype 6A (n= 539, 535)
    98.5
    98.9
        Serotype 6B (n= 539, 535)
    97.4
    99.1
        Serotype 7F (n= 539, 536)
    99.8
    99.8
        Serotype 9V (n= 539, 537)
    98.9
    100.0
        Serotype 14 (n= 539, 537)
    99.8
    100.0
        Serotype 18C (n= 539, 536)
    98.9
    99.3
        Serotype 19A (n= 539, 535)
    99.1
    100.0
        Serotype 19F (n= 539, 537)
    99.6
    100.0
        Serotype 23F (n= 538, 535)
    96.8
    97.4
        Serotype 22F (n= 539, 535)
    99.6
    5.8
        Serotype 33F (n= 539, 530)
    99.1
    4.2
    Statistical analysis title
    		 Percentage Difference : Serotype 1
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [31]
    P-value
    		 < 0.001 [32]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 -1.3
    Notes
    [31] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [32] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 3
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [33]
    P-value
    		 < 0.001 [34]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    8.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.4
         upper limit
    		 12.2
    Notes
    [33] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [34] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 4
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [35]
    P-value
    		 < 0.001 [36]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 -0.1
    Notes
    [35] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [36] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 5
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [37]
    P-value
    		 < 0.001 [38]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -0.2
    Notes
    [37] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [38] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 6A
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [39]
    P-value
    		 < 0.001 [40]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 1.1
    Notes
    [39] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [40] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 6B
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [41]
    P-value
    		 < 0.001 [42]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 -0.1
    Notes
    [41] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [42] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 7F
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [43]
    P-value
    		 < 0.001 [44]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.9
    Notes
    [43] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [44] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 9V
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [45]
    P-value
    		 < 0.001 [46]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 -0.4
    Notes
    [45] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [46] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 14
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [47]
    P-value
    		 < 0.001 [48]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.5
    Notes
    [47] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [48] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 18C
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [49]
    P-value
    		 < 0.001 [50]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 0.9
    Notes
    [49] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [50] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 19A
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [51]
    P-value
    		 < 0.001 [52]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -0.2
    Notes
    [51] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [52] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 19F
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [53]
    P-value
    		 < 0.001 [54]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.3
    Notes
    [53] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [54] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 23F
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [55]
    P-value
    		 < 0.001 [56]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 1.5
    Notes
    [55] - Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >-10 percentage points (1-sided p-value <0.025).
    [56] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 22F
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [57]
    P-value
    		 < 0.001 [58]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    93.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 91.5
         upper limit
    		 95.6
    Notes
    [57] - Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >10 percentage points (1-sided p-value <0.025).
    [58] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Serotype 33F
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [59]
    P-value
    		 < 0.001 [60]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    94.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 92.7
         upper limit
    		 96.5
    Notes
    [59] - Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being >10 percentage points (1-sided p-value <0.025).
    [60] - 1-sided p-value

    Secondary: Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD

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    End point title
    		 Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD
    End point description
    Sera from participants was used to measure vaccine-induced responses to 10 pre-specified Infanrix™ hexa antigens with the following threshold (% ≥) values: Diphtheria toxoid-0.1 international unit (IU)/mL;Tetanus toxoid-0.1 IU/mL; Pertussis pertussis toxin (PT)-5 endotoxin unit (EU)/mL; Pertussis filamentous hemagglutinin (FHA)-5 EU/mL; Pertussis pertactin (PRN)-5 EU/mL; Haemophilus influenzae type b (Hib) polyribosylribitol phosphate (PRP)-0.15 μg/mL; hepatitis B surface antigen (HBsAg)-10 mIU/mL; Poliovirus 1,2 and 3-1:8 neutralizing antibodies (NAb) dilution.The population analyzed consisted of all randomized participants without deviations from the protocol that may substantially affect the results, and had data available for each antigen.
    End point type
    Secondary
    End point timeframe
    30 days PTD (Up to approximately study month 14)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    588
    591
    Units: Percentage of Participants
    number (not applicable)
        Diphtheria toxoid (n=537,533)
    99.3
    99.8
        Tetanus toxoid (n=537,533)
    99.6
    100.0
        Pertussis PT (n=537,533)
    99.4
    99.6
        Pertussis FHA (n=537,533)
    99.8
    100.0
        Pertussis PRN (n=537,533)
    99.6
    100.0
        Hib PRP (n=524,523)
    98.5
    98.1
        HBsAg (n=522,521)
    99.2
    100.0
        Poliovirus 1 (n=526,521)
    100.0
    100.0
        Poliovirus 2 (n=525,525)
    100.0
    100.0
        Poliovirus 3 (n=531,523)
    100.0
    99.8
    Statistical analysis title
    		 Percentage Difference : Diphtheria toxoid
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [61]
    P-value
    		 < 0.001 [62]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 0.4
    Notes
    [61] - Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value <0.025).
    [62] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Tetanus toxoid
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [63]
    P-value
    		 < 0.001 [64]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.3
    Notes
    [63] - Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value <0.025).
    [64] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Pertussis - PT
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [65]
    P-value
    		 < 0.001 [66]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.9
    Notes
    [65] - Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value <0.025).
    [66] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Pertussis - FHA
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [67]
    P-value
    		 < 0.001 [68]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 0.5
    Notes
    [67] - Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value <0.025).
    [68] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Pertussis - PRN
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [69]
    P-value
    		 < 0.001 [70]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.3
    Notes
    [69] - Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value <0.025).
    [70] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Hib-PRP
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [71]
    P-value
    		 < 0.001 [72]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 2.1
    Notes
    [71] - Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value <0.025).
    [72] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : HBsAg
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [73]
    P-value
    		 < 0.001 [74]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 0
    Notes
    [73] - Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value <0.025).
    [74] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Poliovirus 1
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [75]
    P-value
    		 < 0.001 [76]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.7
    Notes
    [75] - Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value <0.025).
    [76] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Poliovirus 2
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [77]
    P-value
    		 < 0.001 [78]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.7
    Notes
    [77] - Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value <0.025).
    [78] - 1-sided p-value
    Statistical analysis title
    		 Percentage Difference : Poliovirus 3
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™), CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [79]
    P-value
    		 < 0.001 [80]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 1.1
    Notes
    [79] - Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value <0.025).
    [80] - 1-sided p-value

    Secondary: Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) of Rotarix™ at 30 Days Post Primary Series (PPS)

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    End point title
    		 Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) of Rotarix™ at 30 Days Post Primary Series (PPS)
    End point description
    Sera from participants was used to measure vaccine-induced antibodies in response to vaccination with Rotarix™ by assessing the GMT for IgA. The population analyzed consisted of all randomized participants without deviations from the protocol that may substantially affect the results. Deviations that affect the number analyzed include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
    End point type
    Secondary
    End point timeframe
    30 days PPS (Up to approximately study month 3)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    520
    503
    Units: Titer
        number (not applicable)
    45.39
    47.07
    Statistical analysis title
    		 GMT Ratio
    Statistical analysis description
    GMT ratio (V114/Prevenar 13™), CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1023
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [81]
    P-value
    		 < 0.001 [82]
    Method
    		 t-distribution
    Parameter type
    		 GMT Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.16
    Notes
    [81] - Non-inferiority of Rotarix™ administered concomitantly with V114 to Rotarix™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMT ratio (V114/Prevenar 13™) being >0.5 (1-sided p-value <0.025).
    [82] - 1-sided p-value

    Secondary: Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS

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    End point title
    		 Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS
    End point description
    Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using PnECL. The GMC for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. The population analyzed consisted of all randomized participants without deviations from the protocol that may substantially affect the results. Deviations that affect the number analyzed include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
    End point type
    Secondary
    End point timeframe
    30 days PPS (Up to approximately study month 3)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    588
    591
    Units: μg/mL
    number (not applicable)
        Serotype 1 (n=522,500)
    1.30
    1.62
        Serotype 3 (n=522,500)
    0.88
    0.48
        Serotype 4 (n=522,500)
    1.41
    1.30
        Serotype 5 (n=522,500)
    0.89
    1.06
        Serotype 6A (n=522,500)
    0.64
    1.42
        Serotype 6B (n=522,499)
    0.43
    0.36
        Serotype 7F (n=522,500)
    2.04
    2.46
        Serotype 9V (n=522,500)
    1.23
    1.43
        Serotype 14 (n=522,500)
    3.87
    5.14
        Serotype 18C (n=522,500)
    1.17
    1.37
        Serotype 19A (n=522,500)
    1.71
    2.20
        Serotype 19F (n=522,500)
    2.63
    3.40
        Serotype 23F (n=522,499)
    0.76
    0.62
        Serotype 22F (n=522,500)
    2.76
    0.05
        Serotype 33F(n=522,500)
    0.31
    0.05
    Statistical analysis title
    		 GMC Ratio : Serotype 1
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 0.88
    Statistical analysis title
    		 GMC Ratio : Serotype 3
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 2.02
    Statistical analysis title
    		 GMC Ratio : Serotype 4
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.19
    Statistical analysis title
    		 GMC Ratio : Serotype 5
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 0.94
    Statistical analysis title
    		 GMC Ratio : Serotype 6A
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 0.52
    Statistical analysis title
    		 GMC Ratio : Serotype 6B
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.41
    Statistical analysis title
    		 GMC Ratio : Serotype 7F
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 0.91
    Statistical analysis title
    		 GMC Ratio : Serotype 14
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.86
    Statistical analysis title
    		 GMC Ratio : Serotype 9V
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 0.96
    Statistical analysis title
    		 GMC Ratio : Serotype 18C
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 0.95
    Statistical analysis title
    		 GMC Ratio : Serotype 19A
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.87
    Statistical analysis title
    		 GMC Ratio : Serotype 19F
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.85
    Statistical analysis title
    		 GMC Ratio : Serotype 23F
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 1.4
    Statistical analysis title
    		 GMC Ratio : Serotype 22F
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    57.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 51.2
         upper limit
    		 65
    Statistical analysis title
    		 GMC Ratio : Serotype 33F
    Statistical analysis description
    GMC ratio (V114 / Prevenar 13™) and CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    6.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.46
         upper limit
    		 7.14

    Secondary: Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS

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    End point title
    		 Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS
    End point description
    Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. The population analyzed consisted of all randomized participants without deviations from the protocol that may substantially affect the results. Deviations that affect the number analyzed include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
    End point type
    Secondary
    End point timeframe
    30 days PPS (Up to approximately study month 3)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    588
    591
    Units: Percentage of Participants
    number (not applicable)
        Serotype 1 (n=522,500)
    95.4
    97.4
        Serotype 3 (n=522,500)
    93.5
    67.8
        Serotype 4 (n=522,500)
    93.9
    96.8
        Serotype 5 (n=522,500)
    84.5
    88.4
        Serotype 6A (n=522,500)
    73.2
    92.6
        Serotype 6B (n=522,499)
    57.3
    52.7
        Serotype 7F (n=522,500)
    97.9
    99.0
        Serotype 9V (n=522,500)
    88.7
    95.4
        Serotype 14 (n=522,500)
    96.9
    97.4
        Serotype 18C (n=522,500)
    92.3
    93.0
        Serotype 19A (n=522,500)
    96.2
    97.4
        Serotype 19F (n=522,500)
    98.9
    99.4
        Serotype 23F (n=522,499)
    78.5
    71.9
        Serotype 22F(n=522,500)
    95.6
    5.2
        Serotype 33F (n=522,500)
    48.7
    2.8
    Statistical analysis title
    		 Percentage Difference : Serotype 1
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 0.3
    Statistical analysis title
    		 Percentage Difference : Serotype 3
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    25.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.1
         upper limit
    		 30.3
    Statistical analysis title
    		 Percentage Difference : Serotype 4
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.7
         upper limit
    		 -0.3
    Statistical analysis title
    		 Percentage Difference : Serotype 5
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.1
         upper limit
    		 0.3
    Statistical analysis title
    		 Percentage Difference : Serotype 6A
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -19.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.9
         upper limit
    		 -15
    Statistical analysis title
    		 Percentage Difference : Serotype 6B
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 10.7
    Statistical analysis title
    		 Percentage Difference : Serotype 7F
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 0.5
    Statistical analysis title
    		 Percentage Difference : Serotype 9V
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 -3.5
    Statistical analysis title
    		 Percentage Difference : Serotype 14
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 1.7
    Statistical analysis title
    		 Percentage Difference : Serotype 18C
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.9
         upper limit
    		 2.6
    Statistical analysis title
    		 Percentage Difference : Serotype 19A
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 1
    Statistical analysis title
    		 Percentage Difference : Serotype 19F
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 0.7
    Statistical analysis title
    		 Percentage Difference : Serotype 23F
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 11.9
    Statistical analysis title
    		 Percentage Difference : Serotype 22F
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    90.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 87.4
         upper limit
    		 92.7
    Statistical analysis title
    		 Percentage Difference : Serotype 33F
    Statistical analysis description
    Percentage difference (V114 minus Prevenar 13™) and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    45.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 41.3
         upper limit
    		 50.3

    Secondary: Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD

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    End point title
    		 Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD
    End point description
    Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the multiplexed opsonophagocytic assay (MOPA). The GMT for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. The within-group CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The population analyzed consists of all randomized participants without deviations from the protocol that may substantially affect the results. Deviations that affect the number analyzed include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
    End point type
    Secondary
    End point timeframe
    30 days PTD (Up to approximately study month 14)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    116
    122
    Units: Titer
    geometric mean (confidence interval 95%)
        Serotype 1 (n=101,108)
    136.8 (107.2 to 174.6)
    164.6 (127.9 to 211.8)
        Serotype 3 (n=98,103)
    321.5 (277.2 to 372.9)
    303.0 (253.2 to 362.6)
        Serotype 4 (n=97,99)
    2231.7 (1770.5 to 2813.1)
    3206.4 (2626.6 to 3914.1)
        Serotype 5 (n=102,108)
    791.6 (640.9 to 977.8)
    947.9 (784.3 to 1145.7)
        Serotype 6A (n=98,99)
    3274.9 (2734.5 to 3921.9)
    5387.2 (4388.9 to 6612.5)
        Serotype 6B (n=94,95)
    2439.9 (1936.1 to 3074.7)
    3182.4 (2500.9 to 4049.7)
        Serotype 7F (n=97,100)
    6300.9 (5363.9 to 7401.7)
    10071.4 (8327.2 to 12181.0)
        Serotype 9V (n=97,103)
    1904.4 (1584.8 to 2288.4)
    2616.6 (2133.3 to 3209.4)
        Serotype 14 (n=99,100)
    2633.8 (2102.6 to 3299.2)
    2582.1 (2089.5 to 3190.9)
        Serotype 18C (n=98,103)
    1968.6 (1676.4 to 2311.7)
    2091.8 (1789.1 to 2445.7)
        Serotype 19A (n=101,104)
    2995.6 (2556.5 to 3510.0)
    4254.3 (3649.3 to 4959.5)
        Serotype 19F (n=98,103)
    1793.9 (1535.3 to 2096.1)
    2012.3 (1677.0 to 2414.6)
        Serotype 23F (n=97,99)
    4517.8 (3685.1 to 5538.8)
    7987.6 (6149.3 to 10375.5)
        Serotype 22F (n=98,96)
    2405.2 (1980.5 to 2921.0)
    24.5 (16.0 to 37.7)
        Serotype 33F (n=96,101)
    14268.4 (11680.1 to 17430.2)
    1875.6 (1477.4 to 2381.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD

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    End point title
    		 Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD
    End point description
    Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the MOPA. The threshold dilution (% ≥) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F) were as follows: 1:9, 1:19, 1:34, 1:27, 1:232, 1:40, 1:61, 1:151, 1:62, 1:115, 1:31, 1:113, 1:55. For Serotypes 22F and 33F the threshold dilution was 1:15 and 1:20 respectively. The within-group CIs were based on the exact binomial method of Clopper and Pearson. The population analyzed consisted of all randomized participants without deviations from the protocol that may substantially affect the results. Deviations that affect the number analyzed include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
    End point type
    Secondary
    End point timeframe
    30 days PTD (Up to approximately study month 14)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    116
    122
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (n=101,108)
    95.0 (88.8 to 98.4)
    98.1 (93.5 to 99.8)
        Serotype 3 (n=98,103)
    100.0 (96.3 to 100.0)
    98.1 (93.2 to 99.8)
        Serotype 4 (n=97,99)
    100.0 (96.3 to 100.0)
    100.0 (96.3 to 100.0)
        Serotype 5 (n=102,108)
    100.0 (96.4 to 100.0)
    100.0 (96.6 to 100.0)
        Serotype 6A (n=98,99)
    99.0 (94.4 to 100.0)
    100.0 (96.3 to 100.0)
        Serotype 6B (n=94,95)
    100.0 (96.2 to 100.0)
    100.0 (96.2 to 100.0)
        Serotype 7F (n=97,100)
    100.0 (96.3 to 100.0)
    100.0 (96.4 to 100.0)
        Serotype 9V (n=97,103)
    97.9 (92.7 to 99.7)
    100.0 (96.5 to 100.0)
        Serotype 14 (n=99,100)
    100.0 (96.3 to 100.0)
    99.0 (94.6 to 100.0)
        Serotype 18C (n=98,103)
    100.0 (96.3 to 100.0)
    100.0 (96.5 to 100.0)
        Serotype 19A (n=101,104)
    100.0 (96.4 to 100.0)
    100.0 (96.5 to 100.0)
        Serotype 19F (n=98,103)
    100.0 (96.3 to 100.0)
    99.0 (94.7 to 100.0)
        Serotype 23F (n=97,99)
    100.0 (96.3 to 100.0)
    100.0 (96.3 to 100.0)
        Serotype 22F (n=98,96)
    99.0 (94.4 to 100.0)
    28.1 (19.4 to 38.2)
        Serotype 33F (n=96,101)
    100.0 (96.2 to 100.0)
    98.0 (93.0 to 99.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants for Serotypes 22F and 33F randomized to V114 compared with Serotype 3 randomized to Prevenar 13™ at 30 Days PTD

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    End point title
    		 Percentage of Participants for Serotypes 22F and 33F randomized to V114 compared with Serotype 3 randomized to Prevenar 13™ at 30 Days PTD
    End point description
    Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. As a protocol-specified endpoint the percentage of participants that achieve the threshold value of ≥0.35 μg/mL for Serotype 3, the serotype shared by both V114 and Prevenar 13™ that exhibits the lowest IgG response rate for Prevenar 13™, was compared to that of the 2 serotypes unique to V114 (Serotypes 22F and 33F). The population analyzed consisted of all randomized participants without deviations from the protocol that may substantially affect the results. Deviations that affect the number analyzed include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
    End point type
    Secondary
    End point timeframe
    30 days PTD (Up to approximately study month 14)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    588 [83]
    591 [84]
    Units: Percentage of Participants
    number (not applicable)
        Serotype 22F (n=539), Serotype 3 (n=537)
    99.6
    83.8
        Serotype 33F (n=539), Serotype 3 (n=537)
    99.1
    83.8
    Notes
    [83] - V114 Serotypes 22F, 33F
    [84] - Prevenar 13™ Serotype 3
    Statistical analysis title
    		 Percentage Diff.: V114-33F minus Prevenar 13™-3
    Statistical analysis description
    Percentage difference and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    15.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.2
         upper limit
    		 18.7
    Statistical analysis title
    		 Percentage Diff.: V114-22F minus Prevenar 13™-3
    Statistical analysis description
    Percentage difference and CI are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    15.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.9
         upper limit
    		 19.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious AEs reported from Day 1 through 14 days following each vaccination. Serious AEs reported from Day 1 up to approximately study month 20. All-cause mortality (ACM) reported from randomization up to approximately study month 20.
    Adverse event reporting additional description
    The ACM population was all randomized participants. For AEs the population was APaT, which consisted of participants who received at least 1 dose of study vaccination. The ACM and AEs for participants inadvertently vaccinated with both V114 and Prevenar 13™were reported separately from other participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).

    Reporting group title
    V114 + Prevenar 13™
    Reporting group description
    		 Participants inadvertently vaccinated with both V114 and Prevenar 13™

    Reporting group title
    Prevenar 13™
    Reporting group description
    		 Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2).

    Serious adverse events
    		 V114 V114 + Prevenar 13™ Prevenar 13™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    57 / 587 (9.71%)
    0 / 1 (0.00%)
    70 / 591 (11.84%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    2 / 591 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Weight increased
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    2 / 591 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body ingestion
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth injury
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    2 / 591 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infantile spasms
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemolytic uraemic syndrome
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enterocolitis
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    9 / 587 (1.53%)
    0 / 1 (0.00%)
    10 / 591 (1.69%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    3 / 591 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    2 / 591 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    2 / 591 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    3 / 587 (0.51%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis viral
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 587 (0.51%)
    0 / 1 (0.00%)
    8 / 591 (1.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    2 / 591 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis sapovirus
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    2 / 591 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    2 / 587 (0.34%)
    0 / 1 (0.00%)
    3 / 591 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    2 / 587 (0.34%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    2 / 587 (0.34%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    2 / 591 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    8 / 587 (1.36%)
    0 / 1 (0.00%)
    5 / 591 (0.85%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    3 / 587 (0.51%)
    0 / 1 (0.00%)
    3 / 591 (0.51%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    1 / 591 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 587 (0.00%)
    0 / 1 (0.00%)
    3 / 591 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    2 / 591 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    3 / 587 (0.51%)
    0 / 1 (0.00%)
    2 / 591 (0.34%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 587 (0.17%)
    0 / 1 (0.00%)
    0 / 591 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V114 V114 + Prevenar 13™ Prevenar 13™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    548 / 587 (93.36%)
    1 / 1 (100.00%)
    540 / 591 (91.37%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    271 / 587 (46.17%)
    0 / 1 (0.00%)
    247 / 591 (41.79%)
         occurrences all number
    507
    0
    473
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    266 / 587 (45.32%)
    1 / 1 (100.00%)
    264 / 591 (44.67%)
         occurrences all number
    455
    1
    443
    Injection site induration
         subjects affected / exposed
    246 / 587 (41.91%)
    0 / 1 (0.00%)
    231 / 591 (39.09%)
         occurrences all number
    418
    0
    392
    Injection site pain
         subjects affected / exposed
    238 / 587 (40.55%)
    0 / 1 (0.00%)
    173 / 591 (29.27%)
         occurrences all number
    370
    0
    257
    Injection site swelling
         subjects affected / exposed
    197 / 587 (33.56%)
    0 / 1 (0.00%)
    174 / 591 (29.44%)
         occurrences all number
    315
    0
    263
    Pyrexia
         subjects affected / exposed
    261 / 587 (44.46%)
    1 / 1 (100.00%)
    251 / 591 (42.47%)
         occurrences all number
    447
    1
    437
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    39 / 587 (6.64%)
    0 / 1 (0.00%)
    45 / 591 (7.61%)
         occurrences all number
    48
    0
    66
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    421 / 587 (71.72%)
    1 / 1 (100.00%)
    392 / 591 (66.33%)
         occurrences all number
    1094
    1
    1038
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    29 / 587 (4.94%)
    0 / 1 (0.00%)
    44 / 591 (7.45%)
         occurrences all number
    33
    0
    51
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 587 (1.53%)
    1 / 1 (100.00%)
    8 / 591 (1.35%)
         occurrences all number
    9
    2
    8
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    199 / 587 (33.90%)
    0 / 1 (0.00%)
    198 / 591 (33.50%)
         occurrences all number
    354
    0
    334

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2021
    Amendment 2: In response to the COVID-19 global pandemic which impacted the ability of many participants to attend study visits, this amendment expanded the visit windows to allow inclusion of more participants in the immunogenicity analysis.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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