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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 a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)

    Summary
    EudraCT number
    		 2018-004109-21
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 May 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    14 May 2022
    First version publication date
    05 Dec 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V114-029
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03893448
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    24 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. Non-inferiority to Prevnar 13™ for immunoglobulin g (IgG) responses rates for the 13 shared and 2 serotypes unique to V114 were assessed at 30 days following Dose 3. Non-inferiority based on IgG geometric mean concentrations (GMCs) for the 13 shared and 2 serotypes unique to V114 were assessed at 30 days following Dose 3, and 30 days following Dose 4. Both IgG response rates following Dose 3, and IgG GMCs following Dose 3 and Dose 4 were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes. The primary hypotheses are: V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes and for the 2 unique V114 serotypes based on the IgG response rates at 30 days following Dose 3 and IgG GMCs at 30 days following Dose 3 and at 30 days following Dose 4.
    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
    19 Jun 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Puerto Rico: 171
    Country: Number of subjects enrolled
    Thailand: 390
    Country: Number of subjects enrolled
    Turkey: 126
    Country: Number of subjects enrolled
    United States: 1033
    Worldwide total number of subjects
    1720
    EEA total number of subjects
    0
    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)
    1720
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study recruited healthy infants approximately 2 months (42 to 90 days, inclusive) of age, without a history of invasive pneumococcal disease or prior administration of any pneumococcal vaccine.

    Pre-assignment
    Screening details
    		 1720 participants were randomized in a 1:1 ratio to receive a 4-dose regimen of either V114 or Prevnar 13™. One participant randomized to the Prevnar 13™ arm was inadvertently treated with Prevnar 13™ and V114.

    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
    Blinding implementation details
    Study was double-blinded with in-house blinding procedures.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V114
    Arm description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V114 0.5 mL sterile suspension for intramuscular injection
    Investigational medicinal product code
    Other name
    15-valent pneumococcal conjugate vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL single-dose prefilled syringes, Single dose at Visits 1, 2, 3, and 5 (~2, 4, 6, and 12 to 15 months of age, respectively).

    Investigational medicinal product name
    RotaTeq™
    Investigational medicinal product code
    Other name
    V260
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    RotaTeq™ live, pentavalent Rotavirus Vaccine given as oral solution. Single 2 mL dose at Visits 1, 2, and 3 (~2, 4, 6 months of age respectively)

    Investigational medicinal product name
    Pentacel™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given via IM injection in the opposite limb to V114 and Prevnar13™ administration. Single 0.5 mL dose at Visits 1, 2, and 3 (~2, 4, 6 months of age respectively)

    Investigational medicinal product name
    RECOMBIVAX HB™
    Investigational medicinal product code
    Other name
    V232, HEPTAVAX™-II,HBVAXPRO
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given via IM injection in the opposite limb to V114 and Prevnar 13™ administration. Single 0.5 mL dose at Visits 1, 2, and 3 (~2, 4, 6 months of age respectively).

    Investigational medicinal product name
    VAQTA™
    Investigational medicinal product code
    Other name
    HAVRIX
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    VAQTA™ anti-hepatitis A antigen Vaccine given via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration. Single 0.5 mL dose at Visit 5 (~12 to 15 months of age, respectively).

    Investigational medicinal product name
    HIBERIX™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given via IM injection in the opposite limb to V114 and Prevnar 13™ administration. Single 0.5 mL dose at Visit 5 (~12 to 15 months of age, respectively).

    Investigational medicinal product name
    M-M-R™II
    Investigational medicinal product code
    Other name
    V205C
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given via SC injection in the opposite limb to V114 and Prevnar 13™ administration. Single 0.5 mL dose at Visit 5 (~12 to 15 months of age, respectively).

    Investigational medicinal product name
    VARIVAX™
    Investigational medicinal product code
    Other name
    V210
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    VARIVAX™ Varicella Virus Vaccine Live, given via SC injection in the opposite limb to V114 and Prevnar 13™ administration. Single 0.5 mL dose at Visit 5 (~12 to 15 months of age, respectively).

    Arm title
    		 Prevnar 13™
    Arm description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevnar 13™
    Investigational medicinal product code
    Other name
    13-valent pneumococcal conjugate vaccine (PCV13)
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL single-dose prefilled syringes, Single dose at Visits 1, 2, 3, and 5 (~2, 4, 6, and 12 to 15 months of age, respectively)

    Investigational medicinal product name
    RotaTeq™
    Investigational medicinal product code
    Other name
    V260
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    RotaTeq™ live, pentavalent Rotavirus Vaccine given via oral solution. Single 2.0 mL dose at Visits 1, 2, and 3 (~2, 4, 6 months of age respectively).

    Investigational medicinal product name
    Pentacel™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as via IM injection in the opposite limb to V114 and Prevnar 13™ administration. Single 0.5 mL dose at Visits 1, 2, and 3 (~2, 4, 6 months of age respectively).

    Investigational medicinal product name
    RECOMBIVAX HB™
    Investigational medicinal product code
    Other name
    V232, HEPTAVAX™-II,HBVAXPRO
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given via IM injection in the opposite limb to V114 and Prevnar 13™ administration. Single 0.5 mL dose at Visits 1, 2, and 3 (~2, 4, 6 months of age respectively).

    Investigational medicinal product name
    VAQTA™
    Investigational medicinal product code
    Other name
    HAVRIX
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    VAQTA™ anti-hepatitis A antigen Vaccine, given via IM injection in the opposite limb toV114 and Prevnar 13™ administration. Single 0.5 mL dose at Visit 5 (~12 to 15 months of age, respectively).

    Investigational medicinal product name
    HIBERIX™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given via IM injection in the opposite limb to V114 and Prevnar 13™ administration. Single 0.5 mL dose at Visit 5 (~12 to 15 months of age, respectively).

    Investigational medicinal product name
    M-M-R™II
    Investigational medicinal product code
    Other name
    V205C
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given via SC injection in the opposite limb to V114 and Prevnar 13™ administration. Single 0.5 mL dose at Visit 5 (~12 to 15 months of age, respectively).

    Investigational medicinal product name
    VARIVAX™
    Investigational medicinal product code
    Other name
    V210
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    VARIVAX™ Varicella Virus Vaccine Live, given via SC injection in the opposite limb to V114 and Prevnar 13™ administration. Single 0.5 mL dose at Visit 5 (~12 to 15 months of age, respectively).

    Number of subjects in period 1
    		V114 Prevnar 13™
    Started
    860
    860
    Treated
    858
    856
    Completed
    758
    734
    Not completed
    102
    126
         Physician decision
    8
    14
         Withdrawal By Parent/Guardian
    59
    85
         Death
    1
    -
         Lost to follow-up
    34
    27

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.

    Reporting group values
    		 V114 Prevnar 13™ Total
    Number of subjects
    		 860 860 1720
    Age Categorical
    Units: Participants
        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)
    		 860 860 1720
        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 ± 1.2 8.4 ± 1.3 -
    Gender Categorical
    Units: Participants
        Female
    		 397 428 825
        Male
    		 463 432 895
    Race
    Units: Subjects
        American Indian Or Alaska Native
    		 6 13 19
        Asian
    		 223 227 450
        Black Or African American
    		 52 53 105
        Multiple
    		 98 80 178
        Native Hawaiian Or Other Pacific Islander
    		 6 4 10
        White
    		 474 483 957
        Missing
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic Or Latino
    		 207 204 411
        Not Hispanic Or Latino
    		 640 645 1285
        Not Reported
    		 11 6 17
        Unknown
    		 2 5 7

    End points

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    End points reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.

    Primary: Percentage of Participants with Solicited Injection-Site Adverse Events (AEs) in V114 versus Prevnar 13™

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    End point title
    		 Percentage of Participants with Solicited Injection-Site Adverse Events (AEs) in V114 versus Prevnar 13™
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump. The analysis population for this endpoint included all randomized participants who received at least 1 dose of either V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
    End point type
    Primary
    End point timeframe
    Up to 14 days after each vaccination with either V114 or Prevnar 13™
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    855
    Units: Percentage of participants
    number (not applicable)
        Solicited injection site AEs
    69.0
    69.2
        Injection site erythema (redness)
    33.7
    38.5
        Injection site induration (hard lump)
    26.3
    26.8
        Injection site pain (pain)
    49.8
    46.9
        Injection site swelling (swelling)
    26.3
    24.0
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Injection site erythema Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1713
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.039
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.3
         upper limit
    		 -0.2
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Injection site induration Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1713
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.836
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 3.7
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Injection site pain Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1713
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.235
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 7.6
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Injection site swelling Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1713
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.26
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 6.5

    Primary: Percentage of Participants with Solicited Systemic AEs

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    End point title
    		 Percentage of Participants with Solicited Systemic AEs
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of irritability, drowsiness, appetite lost, and hives or welts. The analysis population for this endpoint included all randomized participants who received at least 1 dose either of V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
    End point type
    Primary
    End point timeframe
    Up to 14 days after each vaccination with either V114 or Prevnar 13™
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    855
    Units: Percentage of participants
    number (not applicable)
        Solicited systemic adverse events
    84.4
    84.8
        Decreased appetite
    34.3
    36.0
        Irritability
    76.5
    75.4
        Somnolence (drowsiness)
    59.0
    62.0
        Urticaria (hives)
    6.5
    6.5
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Decreased appetite Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1713
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.446
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 2.8
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Somnolence (drowsiness) Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1713
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.202
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.6
         upper limit
    		 1.6
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Urticaria (Hives) Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1713
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.985
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 2.3
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Irritability Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1713
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.622
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 5.1

    Primary: Percentage of Participants with Vaccine-Related Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants with Vaccine-Related Serious Adverse Events (SAEs)
    End point description
    An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. Any SAEs that are at least possibly related to vaccination are summarized. The analysis population for this endpoint included all randomized participants who received at least 1 dose of either V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 6 months after Vaccination 4 (up to 21 months)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    855
    Units: Percentage of participants
        number (not applicable)
    0.0
    0.0
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1713
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Point Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.4

    Primary: Percentage of Participants with Anti-Pneumococcal Polysaccharide (anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 μg/mL One Month After Vaccination 3

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    End point title
    		 Percentage of Participants with Anti-Pneumococcal Polysaccharide (anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 μg/mL One Month After Vaccination 3
    End point description
    Anti-PnP serotype-specific IgG response rates for the 15 serotypes contained in V114 were measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab ≥0.35 μg/mL are reported for each serotype. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis. IgG response rates were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
    End point type
    Primary
    End point timeframe
    One month after Vaccination 3 (Month 7)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    856
    Units: Percentage of participants
    number (not applicable)
        Serotype 1 (n=702, 665)
    95.7
    99.1
        Serotype 3 (n=699, 662)
    94.7
    79.2
        Serotype 4 (n=699, 663)
    96.4
    98.6
        Serotype 5 (n=702, 664)
    95.3
    97.4
        Serotype 6A (n=702, 663)
    93.7
    98.6
        Serotype 6B (n=699, 662)
    88.6
    92.0
        Serotype 7F (n=701, 665)
    99.0
    99.8
        Serotype 9V (n=700, 661)
    97.1
    98.2
        Serotype 14 (n=700, 661)
    97.9
    97.9
        Serotype 18C (n=700, 662)
    97.4
    98.3
        Serotype 19A (n=702, 665)
    97.9
    99.7
        Serotype 19F (n=700, 663)
    99.0
    100.0
        Serotype 23F (n=698, 661)
    91.5
    91.8
        Serotype 22F (n=701, 661)
    98.6
    91.8
        Serotype 33F (n=702, 661)
    87.3
    91.8
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 1 Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [1]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 -1.8
    Notes
    [1] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 3 Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [2]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    15.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.1
         upper limit
    		 19.2
    Notes
    [2] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 4 Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [3]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 -0.6
    Notes
    [3] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 5 Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [4]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 -0.2
    Notes
    [4] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 6A Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [5]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 -3
    Notes
    [5] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 6B Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [6]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 -0.3
    Notes
    [6] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 7F Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [7]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 -0.1
    Notes
    [7] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 9V Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [8]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 0.6
    Notes
    [8] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 14 Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [9]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 1.6
    Notes
    [9] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 18C Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [10]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 0.7
    Notes
    [10] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 19A Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [11]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 -0.8
    Notes
    [11] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 19F Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [12]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 -0.4
    Notes
    [12] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 23F Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [13]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 2.7
    Notes
    [13] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 22F This analysis represents the difference between response rate to Serotype 22F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [14]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.6
         upper limit
    		 9.2
    Notes
    [14] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Serotype 33F This analysis represents the difference between response rate to Serotype 22F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [15]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.8
         upper limit
    		 -1.3
    Notes
    [15] - p-value is 1-sided

    Primary: Geometric Mean Concentration (GMC) of anti-PnP IgG Ab One Month After Vaccination 3

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    End point title
    		 Geometric Mean Concentration (GMC) of anti-PnP IgG Ab One Month After Vaccination 3
    End point description
    The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 3 and reported for the 15 serotypes contained in V114. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
    End point type
    Primary
    End point timeframe
    One month after Vaccination 3 (Month 7)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    856
    Units: ug/mL
    geometric mean (not applicable)
        Serotype 1 (n=702, 665)
    1.21 ± 9999
    1.89 ± 9999
        Serotype 3 (n=699, 662)
    1.08 ± 9999
    0.62 ± 9999
        Serotype 4 (n=699, 663)
    1.29 ± 9999
    1.35 ± 9999
        Serotype 5 (n=702, 664)
    1.63 ± 9999
    2.25 ± 9999
        Serotype 6A (n=702, 663)
    1.55 ± 9999
    2.95 ± 9999
        Serotype 6B (n=699, 662)
    1.60 ± 9999
    1.97 ± 9999
        Serotype 7F (n=701, 665)
    2.48 ± 9999
    3.23 ± 9999
        Serotype 9V (n=700, 661)
    1.73 ± 9999
    1.89 ± 9999
        Serotype 14 (n=700, 661)
    4.78 ± 9999
    6.80 ± 9999
        Serotype 18C (n=700, 662)
    1.53 ± 9999
    2.00 ± 9999
        Serotype 19A (n=702, 665)
    1.63 ± 9999
    2.29 ± 9999
        Serotype 19F (n=700, 663)
    2.01 ± 9999
    2.72 ± 9999
        Serotype 23F (n=698, 661)
    1.31 ± 9999
    1.47 ± 9999
        Serotype 22F (n=701, 660)
    4.91 ± 9999
    1.35 ± 9999
        Serotype 33F (n=702, 664)
    1.67 ± 9999
    1.35 ± 9999
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 1 GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.69
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 3 GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.61
         upper limit
    		 1.87
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 4 GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.03
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 5 GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.8
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 6A GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.167
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 0.58
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 6B GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 0.93
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 7F GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 0.83
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 9V GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 14 GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.78
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 18C GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.83
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 19A GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.77
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 19F GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 0.79
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 23F GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 0.99
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    3.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.33
         upper limit
    		 3.98
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 33F IgG GMC for Serotype 22F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 1.39

    Primary: GMC of anti-PnP IgG Ab One Month After Vaccination 4

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    End point title
    		 GMC of anti-PnP IgG Ab One Month After Vaccination 4
    End point description
    The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 4 and reported for the 15 serotypes contained in V114. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
    End point type
    Primary
    End point timeframe
    One month after Vaccination 4 (Month 13 to Month 16)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    856
    Units: ug/mL
    geometric mean (not applicable)
        Serotype 1 (n=715, 685)
    1.35 ± 9999
    2.03 ± 9999
        Serotype 3 (n=712, 686)
    0.96 ± 9999
    0.71 ± 9999
        Serotype 4 (n=713, 682)
    1.23 ± 9999
    1.60 ± 9999
        Serotype 5 (n=713, 682)
    2.49 ± 9999
    3.95 ± 9999
        Serotype 6A (n=713, 682)
    3.70 ± 9999
    6.21 ± 9999
        Serotype 6B (n=712, 682)
    4.76 ± 9999
    6.43 ± 9999
        Serotype 7F (n=714, 686)
    3.42 ± 9999
    4.85 ± 9999
        Serotype 9V (n=716, 686)
    2.40 ± 9999
    3.29 ± 9999
        Serotype 14 (n=716, 685)
    5.61 ± 9999
    6.95 ± 9999
        Serotype 18C (n-713, 684)
    2.62 ± 9999
    3.08 ± 9999
        Serotype 19A (n=715, 685)
    4.10 ± 9999
    5.53 ± 9999
        Serotype 19F (n=715, 685)
    3.55 ± 9999
    4.47 ± 9999
        Serotype 23F (n=713, 683)
    2.04 ± 9999
    3.32 ± 9999
        Serotype 22F (n=714, 682)
    7.52 ± 9999
    1.60 ± 9999
        Serotype 33F (n=714, 677)
    4.15 ± 9999
    1.60 ± 9999
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 1 GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 0.72
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 3 GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    1.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 1.46
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 4 GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 0.84
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 5 GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.69
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 6A GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 0.65
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 6B GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 0.81
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 7F GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.77
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 9V GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 0.8
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 14 GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 0.89
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 18C GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 0.93
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 19A GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.8
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 19F GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 0.86
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 23F GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 0.68
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to to lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    4.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.3
         upper limit
    		 5.11
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 33F IgG GMC for Serotype 22F in recipients of V114 was compared to to lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    2.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.36
         upper limit
    		 2.83

    Secondary: Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (anti-Diptheria Toxoid, Tetanus Toxoid, and Pertuss Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3

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    End point title
    		 Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (anti-Diptheria Toxoid, Tetanus Toxoid, and Pertuss Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
    End point description
    Antibody responses to diphtheria toxoid, tetanus toxoid, and pertussis antigens were measured using Luminex Assay. The percentage of participants meeting specific criteria are summarized for each serotype. The serotype-specific response rate criteria are as follows: diphtheria toxoid: % ≥0.1 IU/mL; tetanus toxoid: % ≥0.1 IU/mL; pertussis toxin (PT): % ≥ 5 EU/mL; pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL; pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL; pertussis pertactin (PRN): % ≥5 EU/mL; poliovirus 1: % neutralizing antibody (NAb) ≥1:8 dilution; poliovirus 2: % NAb ≥1:8 dilution, poliovirus 3: % NAb ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 μg/mL. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 3 (Month 7)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    856
    Units: Percentage of participants
    number (not applicable)
        Diphtheria toxoid (n=703, 666)
    96.9
    97.6
        Tetanus toxoid (n=703, 666)
    100.0
    99.8
        Pertussis toxin (n=703, 666)
    99.0
    98.5
        Pertussis filamentous hemagglutinin (n=703, 666)
    99.1
    99.4
        Pertussis fimbrae types 2/3 (n=703, 666)
    63.7
    61.7
        Pertussis pertactin (n=703, 666)
    67.3
    65.5
        Poliovirus 1 (n=662, 619)
    99.8
    99.8
        Poliovirus 2 (n=648, 614)
    100.0
    100.0
        Poliovirus 3 (n=650, 607)
    100.0
    100.0
        Hib-PRP (n=648, 615)
    92.1
    93.5
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Diphtheria toxoid % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [16]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 1.1
    Notes
    [16] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Tetanus toxoid: % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [17]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.8
    Notes
    [17] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Pertussis toxin (PT): % ≥ 5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [18]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 1.9
    Notes
    [18] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [19]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.8
    Notes
    [19] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [20]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 7.1
    Notes
    [20] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Pertussis pertactin (PRN): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [21]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 6.8
    Notes
    [21] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Poliovirus 1: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [22]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.8
    Notes
    [22] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Poliovirus 2: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [23]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.6
    Notes
    [23] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Poliovirus 3: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [24]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Miettinen & Nurminen
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.6
    Notes
    [24] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 μg/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [25]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 1.5
    Notes
    [25] - p-value is 1-sided

    Secondary: Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3

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    End point title
    		 Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
    End point description
    Pertussis antibody GMCs were measured using Luminex Assay. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 3 (Month 7)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    856
    Units: ug/mL
    geometric mean (confidence interval 95%)
        Pertussis - PT (n=703, 666)
    43.73 (-9999 to 9999)
    44.35 (-9999 to 9999)
        Pertussis - FHA (n=703, 666)
    67.51 (-9999 to 9999)
    69.18 (-9999 to 9999)
        Pertussis - FIM 2/3 (n=703, 666)
    39.79 (-9999 to 9999)
    36.87 (-9999 to 9999)
        Pertussis - PRN (n=703, 666)
    13.16 (-9999 to 9999)
    13.17 (-9999 to 9999)
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Pertussis - PT GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.09
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Pertussis - FHA GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.09
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Pertussis - FIM 2/3 GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.28
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Pertussis - PRN GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.19

    Secondary: Hepatitis A Antibody Response Rate One Month After Vaccination 4

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    End point title
    		 Hepatitis A Antibody Response Rate One Month After Vaccination 4
    End point description
    Antibody response rates to hepatitis A were measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL are reported. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available HAV EIA data.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 4 (Month 13 to Month 16)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    649
    626
    Units: Percentage of participants
        number (not applicable)
    97.4
    97.1
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1275
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [26]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 2.2
    Notes
    [26] - p value is 1-sided

    Secondary: Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4

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    End point title
    		 Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4
    End point description
    Antibody responses to measles were measured with the bulk measles IgG enzyme immunoassay (EIA). Antibody responses to mumps were measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella were measured with Bulk Rubella IgG EIA. The percentage of participants with measles antigen ≥255 mIU/ML; mumps antigen ≥10 mumps Ab units/mL; and rubella antigen ≥10 IU/mL, are reported. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 4 (Month 13 to Month 16)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    856
    Units: Percentage of participants
    number (not applicable)
        Measles antigen ≥255 mIU/ML (n=670, 648)
    98.1
    98.3
        Mumps antigen ≥10 mumps Ab units/mL (n=670, 648)
    95.8
    97.5
        Rubella antigen ≥10 IU/mL (n=670, 648)
    98.1
    98.9
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Measles antigen ≥255 mIU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [27]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 1.3
    Notes
    [27] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Mumps antigen ≥10 mumps Ab units/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [28]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 0.2
    Notes
    [28] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Rubella antigen ≥10 IU/mL Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [29]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 0.5
    Notes
    [29] - p-value is 1-sided

    Secondary: Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4

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    End point title
    		 Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4
    End point description
    Antibody responses to varicella-zoster virus were measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL are reported. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available VZV gpELISA data.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 4 (Month 13 to Month 16)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    715
    685
    Units: Percentage of participants
        number (not applicable)
    96.4
    97.7
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1400
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [30]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 0.5
    Notes
    [30] - p-value is 1-sided

    Secondary: Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4

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    End point title
    		 Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4
    End point description
    Antibody responses to Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP) were measured with ELISA. The percentage of participants with anti-HiB PRP antigen ≥0.15 μg/mL are reported. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity, who had sufficient blood volume to perform the analysis, and who had available Hib PRP ELISA data.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 4 (Month 13 to Month 16)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    650
    626
    Units: Percentage of participants
        number (not applicable)
    98.9
    100.0
    Statistical analysis title
    		 Percentage Point Difference (V114 - Prevnar 13™)
    Statistical analysis description
    Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1276
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [31]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 -0.5
    Notes
    [31] - p-value is 1-sided

    Secondary: Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes

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    End point title
    		 Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes
    End point description
    Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes were measured with PnECL. The GMCs for each serotype are reported. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 3 (Month 7)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    856
    Units: ug/mL
    geometric mean (not applicable)
        22F (n=701, 660)
    4.91 ± 9999
    0.05 ± 9999
        33F (n=702, 664)
    1.67 ± 9999
    0.06 ± 9999
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 22F GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    92.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 83.47
         upper limit
    		 101.47
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 33F GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    29.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.16
         upper limit
    		 33.26

    Secondary: Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes

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    End point title
    		 Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes
    End point description
    Serotype-specific anti-PnP IgG response rates for the 2 unique V114 serotypes were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 3 (Month 7)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    856
    Units: Percentage of participants
    number (not applicable)
        Serotype 22F (n=701, 660)
    98.6
    3.5
        Serotype 33F (n=702, 664)
    87.3
    2.1
    Statistical analysis title
    		 Percentage Point Difference (V114-Prevnar 13™)
    Statistical analysis description
    Serotype 33F Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [32]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    85.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 82.3
         upper limit
    		 87.7
    Notes
    [32] - p-value is 1-sided
    Statistical analysis title
    		 Percentage Point Difference (V114-Prevnar 13™)
    Statistical analysis description
    Serotype 22F Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method.
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [33]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    95.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 93.1
         upper limit
    		 96.5
    Notes
    [33] - p-value is 1-sided

    Secondary: Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes

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    End point title
    		 Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes
    End point description
    Serotype-specific anti-PnP GMCs were measured with PnECL. The GMC for each serotype is reported. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 4 (Month 13 to Month 16)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    858
    856
    Units: ug/mL
    geometric mean (not applicable)
        22F (n=714, 682)
    7.52 ± 9999
    0.11 ± 9999
        33F (n=714, 677)
    4.15 ± 9999
    0.09 ± 9999
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 22F GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    68.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 63.1
         upper limit
    		 75.02
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    Serotype 33F GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1714
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    44.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 41.04
         upper limit
    		 49.14

    Secondary: Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3

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    End point title
    		 Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
    End point description
    Serotype-specific anti-PnP OPA GMTs were measured with multiplex opsonophagocytic assay (MOPA). The GMTs for each serotype are summarized. Due to the large serum volume required for MOPA, the analysis population for OPA testing was performed on a subset of participants, which included the first 20% of all participants with sufficient serum volume at 30 days PD3.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 3 (Month 7)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    176
    168
    Units: titers
    geometric mean (confidence interval 95%)
        Serotype 1 (n=170, 162)
    56.9 (46.1 to 70.3)
    78.3 (61.5 to 99.5)
        Serotype 3 (n=169, 158)
    284.7 (253.5 to 319.8)
    210.6 (188.2 to 235.7)
        Serotype 4 (n=169, 159)
    1304.8 (1139.6 to 1494.0)
    1566.7 (1381.8 to 1776.4)
        Serotype 5 (n=171, 162)
    387.4 (315.0 to 476.3)
    510.8 (415.9 to 627.2)
        Serotype 6A (n=171, 159)
    2072.1 (1787.5 to 2401.9)
    2743.4 (2368.1 to 3178.2)
        Serotype 6B (n=169, 160)
    1932.5 (1612.1 to 2316.6)
    1963.7 (1604.9 to 2402.8)
        Serotype 7F (n=170, 158)
    4973.2 (4277.6 to 5781.8)
    7335.1 (6181.8 to 8703.5)
        Serotype 9V (n=168, 162)
    1217.3 (1040.2 to 1424.6)
    1534.1 (1305.5 to 1802.8)
        Serotype 14 (n=167, 160)
    2400.7 (1980.8 to 2909.6)
    1853.1 (1511.2 to 2272.5)
        Serotype 18C (n=171, 162)
    1171.2 (1022.7 to 1341.4)
    1330.2 (1158.3 to 1527.5)
        Serotype 19A (n=171,162)
    841.3 (716.0 to 988.6)
    1400.7 (1205.5 to 1627.4)
        Serotype 19F (n=171, 162)
    703.9 (614.2 to 806.6)
    850.6 (744.5 to 971.9)
        Serotype 23F (n=167, 158)
    2078.9 (1779.2 to 2428.9)
    3668.8 (3069.2 to 4385.6)
        Serotype 22F (n=170, 155)
    1849.3 (1606.9 to 2128.2)
    9.1 (7.9 to 10.4)
        Serotype 33F (n=170, 155)
    8262.6 (6585.3 to 10367.1)
    119.6 (83.2 to 171.8)
    No statistical analyses for this end point

    Secondary: Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3

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    End point title
    		 Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
    End point description
    Serotype-specific anti-PnP OPA GMTs were measured with MOPA. The percentage of participants meeting assay-derived threshold values are reported for each serotype. Due to the large serum volume required for MOPA, the analysis population for OPA testing was performed on a subset of participants, which included the first 20% of all participants with sufficient serum volume at 30 days PD3.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 3 (Month 7)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    176
    168
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype 1 (n=170, 162)
    86.5 (80.4 to 91.2)
    87.7 (81.6 to 92.3)
        Serotype 3 (n=169, 158)
    100.0 (97.8 to 100.00)
    100.0 (97.7 to 100.0)
        Serotype 4 (n=169, 159)
    99.4 (96.7 to 100.0)
    100.0 (97.7 to 100.0)
        Serotype 5 (n=171, 162)
    96.5 (92.5 to 98.7)
    98.1 (94.7 to 99.6)
        Serotype 6A (n=171, 159)
    97.1 (93.3 to 99.0)
    98.1 (94.6 to 99.6)
        Serotype 6B (n=169, 160)
    98.2 (94.9 to 99.6)
    98.1 (94.6 to 99.6)
        Serotype 7F (170, 158)
    100.0 (97.9 to 100.0)
    100.0 (97.7 to 100.0)
        Serotype 9V (n=168, 162)
    98.2 (94.9 to 99.6)
    97.5 (93.8 to 99.3)
        Serotype 14 (n=167, 160)
    98.8 (95.7 to 99.9)
    98.8 (95.6 to 99.8)
        Serotype 18C (n=171, 162)
    98.8 (95.8 to 99.9)
    99.4 (96.6 to 100.00)
        Serotype 19A (n=171, 162)
    98.2 (95.0 to 99.6)
    99.4 (96.6 to 100.0)
        Serotype 19F (n=171, 162)
    95.9 (91.7 to 98.3)
    98.8 (95.6 to 99.9)
        Serotype 23F (n=167, 158)
    99.4 (96.7 to 100.0)
    100.0 (97.7 to 100.0)
        Serotype 22F (n=170, 155)
    99.4 (96.8 to 100.0)
    5.8 (2.7 to 10.7)
        Serotype 33F (n=170, 155)
    98.8 (95.8 to 99.9)
    56.8 (48.6 to 64.7)
    No statistical analyses for this end point

    Secondary: Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3

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    End point title
    		 Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3
    End point description
    Serotype 3-specific anti-PnP IgG response rates were measured with PnECL. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 3 (Month 7)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    699
    662
    Units: Percentage of participants
        number (not applicable)
    94.7
    79.2
    Statistical analysis title
    		 Percentage Point Difference (V114-Prevnar 13™)
    Statistical analysis description
    Estimated difference, CI, and p-value are based on the Miettinen & Nurminen method
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    1361
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [34]
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Percentage Point Difference
    Point estimate
    15.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.1
         upper limit
    		 19.2
    Notes
    [34] - p-value is 1-sided

    Secondary: Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3

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    End point title
    		 Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3
    End point description
    Serotype 3-specific anti-PnP GMC were measured with PnECL. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 3 (Month 7)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    699
    662
    Units: ug/mL
        geometric mean (not applicable)
    1.08 ± 9999
    0.62 ± 9999
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1361
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.61
         upper limit
    		 1.87

    Secondary: Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4

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    End point title
    		 Anti-Pneumococcal Polysaccharide (anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4
    End point description
    Serotype 3-specific anti-PnP GMC were measured with PnECL. The analysis population included all randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
    End point type
    Secondary
    End point timeframe
    One month after Vaccination 4 (Month 13 to Month 16)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    712
    686
    Units: ug/mL
        geometric mean (not applicable)
    0.96 ± 9999
    0.71 ± 9999
    Statistical analysis title
    		 GMC Ratio (V114 / Prevnar 13™)
    Statistical analysis description
    GMC ratio, 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 Prevnar 13™
    Number of subjects included in analysis
    1398
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC Ratio (V114 / Prevnar 13™)
    Point estimate
    1.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 1.46

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~21 months)
    Adverse event reporting additional description
    All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination with follow-up after V114 or Prevnar 13™.
    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
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.

    Reporting group title
    Cross-Treated Participants
    Reporting group description
    		 One participant assigned to the Prevnar 13™ arm who inadvertently received both V114 and Prevnar 13™. The participant received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and a single 0.5 mL IM injection of V114 Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). The participant concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.

    Reporting group title
    Prevnar 13[TM]
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15.

    Serious adverse events
    		 V114 Cross-Treated Participants Prevnar 13[TM]
    Total subjects affected by serious adverse events
         subjects affected / exposed
    88 / 858 (10.26%)
    1 / 1 (100.00%)
    81 / 855 (9.47%)
         number of deaths (all causes)
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Brain contusion
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    Head injury
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    2 / 855 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Road traffic accident
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Heart disease congenital
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Vascular disorders
    Kawasaki's disease
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         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
    3 / 858 (0.35%)
    0 / 1 (0.00%)
    2 / 855 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Idiopathic generalised epilepsy
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infantile spasms
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    Seizure
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    3 / 855 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    0 / 855 (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
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Flatulence
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    Inguinal hernia
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    Reproductive system and breast disorders
    Penile haemorrhage
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         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
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    0 / 855 (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
    Respiratory failure
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    11 / 858 (1.28%)
    1 / 1 (100.00%)
    6 / 855 (0.70%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    5 / 858 (0.58%)
    0 / 1 (0.00%)
    2 / 855 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    COVID-19
         subjects affected / exposed
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    Dengue fever
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    3 / 858 (0.35%)
    0 / 1 (0.00%)
    3 / 855 (0.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    7 / 858 (0.82%)
    0 / 1 (0.00%)
    11 / 855 (1.29%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         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 viral
         subjects affected / exposed
    6 / 858 (0.70%)
    0 / 1 (0.00%)
    2 / 855 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral viral infection
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    Periorbital cellulitis
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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
    Pharyngitis
         subjects affected / exposed
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    0 / 855 (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
    Pneumonia
         subjects affected / exposed
    5 / 858 (0.58%)
    0 / 1 (0.00%)
    5 / 855 (0.58%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    4 / 858 (0.47%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    2 / 855 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         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 syncytial virus bronchiolitis
         subjects affected / exposed
    7 / 858 (0.82%)
    0 / 1 (0.00%)
    12 / 855 (1.40%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    3 / 855 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scarlet fever
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    2 / 855 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 858 (0.35%)
    0 / 1 (0.00%)
    3 / 855 (0.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    4 / 858 (0.47%)
    0 / 1 (0.00%)
    2 / 855 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    2 / 855 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral rhinitis
         subjects affected / exposed
    0 / 858 (0.00%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 858 (0.23%)
    0 / 1 (0.00%)
    1 / 855 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Failure to thrive
         subjects affected / exposed
    1 / 858 (0.12%)
    0 / 1 (0.00%)
    0 / 855 (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 Cross-Treated Participants Prevnar 13[TM]
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    790 / 858 (92.07%)
    1 / 1 (100.00%)
    778 / 855 (90.99%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    506 / 858 (58.97%)
    0 / 1 (0.00%)
    530 / 855 (61.99%)
         occurrences all number
    1257
    0
    1309
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    289 / 858 (33.68%)
    1 / 1 (100.00%)
    329 / 855 (38.48%)
         occurrences all number
    488
    1
    584
    Injection site induration
         subjects affected / exposed
    226 / 858 (26.34%)
    1 / 1 (100.00%)
    229 / 855 (26.78%)
         occurrences all number
    385
    1
    404
    Injection site pain
         subjects affected / exposed
    427 / 858 (49.77%)
    1 / 1 (100.00%)
    401 / 855 (46.90%)
         occurrences all number
    903
    2
    832
    Injection site swelling
         subjects affected / exposed
    226 / 858 (26.34%)
    0 / 1 (0.00%)
    205 / 855 (23.98%)
         occurrences all number
    360
    0
    348
    Pyrexia
         subjects affected / exposed
    265 / 858 (30.89%)
    0 / 1 (0.00%)
    270 / 855 (31.58%)
         occurrences all number
    431
    0
    464
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    46 / 858 (5.36%)
    0 / 1 (0.00%)
    62 / 855 (7.25%)
         occurrences all number
    62
    0
    76
    Vomiting
         subjects affected / exposed
    42 / 858 (4.90%)
    0 / 1 (0.00%)
    46 / 855 (5.38%)
         occurrences all number
    54
    0
    52
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    35 / 858 (4.08%)
    0 / 1 (0.00%)
    45 / 855 (5.26%)
         occurrences all number
    39
    0
    48
    Nasal congestion
         subjects affected / exposed
    36 / 858 (4.20%)
    0 / 1 (0.00%)
    47 / 855 (5.50%)
         occurrences all number
    40
    0
    49
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    56 / 858 (6.53%)
    0 / 1 (0.00%)
    56 / 855 (6.55%)
         occurrences all number
    69
    0
    69
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    656 / 858 (76.46%)
    1 / 1 (100.00%)
    645 / 855 (75.44%)
         occurrences all number
    2514
    3
    2435
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    55 / 858 (6.41%)
    0 / 1 (0.00%)
    42 / 855 (4.91%)
         occurrences all number
    55
    0
    44
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    294 / 858 (34.27%)
    0 / 1 (0.00%)
    308 / 855 (36.02%)
         occurrences all number
    579
    0
    606

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Feb 2020
    Amendment 02: This primary purpose of this amendment was to incorporate changes to the statistical analyses for the evaluation of the 2 unique V114 serotypes compared with Prevnar 13™
    16 Mar 2021
    Amendment 01: The primary purpose of this amendment is to expand the visit windows for Visit 3 (Dose 3 vaccination), Visit 4 (postdose 3 blood draw) and Visit 6 (postdose 4 blood draw) to allow inclusion of more participants in the immunogenicity analysis based on the per-protocol population. This change is being made in response to the COVID-19 global pandemic, which impacted the ability of many participants to attend study visits within the prescribed visit windows due to local conditions and travel restrictions. This amendment also includes the addition of 3 secondary hypotheses relating to the demonstration of superiority for serotype 3 immune responses.

    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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