Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2)

    Summary
    EudraCT number
    		 2018-003788-70
    Trial protocol
    		 FI   NO   DK   SE   IT  
    Global end of trial date
    02 Nov 2021

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V114-026
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04016714
    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
    29 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the safety, tolerability, and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries. The primary hypotheses were: V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) 30 days after Dose 3; V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates and on anti-PnPs serotype-specific IgG GMCs 30 days after Dose 3; and Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™ administered concomitantly with Prevenar 13™ 30 days after Dose 3 for each antigen included in Vaxelis™.
    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
    28 Aug 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
    Denmark: 379
    Country: Number of subjects enrolled
    Finland: 612
    Country: Number of subjects enrolled
    Italy: 105
    Country: Number of subjects enrolled
    Norway: 95
    Worldwide total number of subjects
    1191
    EEA total number of subjects
    1191
    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)
    1191
    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
    		 -

    Pre-assignment
    Screening details
    		 This study enrolled healthy infants. Other inclusion criteria applied.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V114
    Arm description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
    Arm type
    		 Experimental

    Investigational medicinal product name
    V114
    Investigational medicinal product code
    Other name
    VAXNEUVANCE™ Pneumococcal 15-Valent Conjugate Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, serotype 6B and aluminum phosphate adjuvant in each 0.5 mL dose.

    Investigational medicinal product name
    Vaxelis™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL single dose

    Investigational medicinal product name
    M-M-R™II
    Investigational medicinal product code
    Other name
    Measles, Mumps, and Rubella Virus Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL single dose

    Investigational medicinal product name
    Varivax™
    Investigational medicinal product code
    Other name
    Varicella Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL single dose

    Arm title
    		 Prevenar 13™
    Arm description
    		 Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar 13™
    Investigational medicinal product code
    Other name
    Pneumococcal 13-valent Conjugate Vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13-valent pneumococcal capsular polysaccharide with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

    Investigational medicinal product name
    Varivax™
    Investigational medicinal product code
    Other name
    Varicella Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL single dose

    Investigational medicinal product name
    M-M-R™II
    Investigational medicinal product code
    Other name
    Measles, Mumps, and Rubella Virus Vaccine Live
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 mL single dose

    Investigational medicinal product name
    Vaxelis™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL single dose

    Number of subjects in period 1
    		V114 Prevenar 13™
    Started
    595
    596
    Vaccination 1 (V114 or Prevenar 13™)
    595
    596
    Vaccination 2 (V114 or Prevenar 13™)
    585
    588
    Vaccination 3 (V114 or Prevenar 13™)
    573
    581
    Completed
    572
    580
    Not completed
    23
    16
         Physician decision
    3
    3
         Death
    1
    -
         Withdrawal by Parent/Guardian
    16
    12
         Lost to follow-up
    3
    1

    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 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

    Reporting group title
    Prevenar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

    Reporting group values
    		 V114 Prevenar 13™ Total
    Number of subjects
    		 595 596 1191
    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)
    		 595 596 1191
        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)
    		 12.4 ± 1.4 12.5 ± 1.4 -
    Gender Categorical
    Units: Participants
        Female
    		 272 289 561
        Male
    		 323 307 630
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 1 2
        Asian
    		 2 4 6
        Multiple
    		 13 12 25
        White
    		 579 579 1158
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 26 22 48
        Not Hispanic or Latino
    		 564 570 1134
        Not Reported
    		 3 3 6
        Unknown
    		 2 1 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

    Reporting group title
    Prevenar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

    Primary: Percentage of Participants with a Solicited Injection-site Adverse Event

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Solicited Injection-site Adverse Event
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling. The analysis population for this endpoint included all randomized participants who received at least 1 dose of study vaccination.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 14 after each vaccination
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    595
    594
    Units: Percentage of participants
    number (not applicable)
        Injection-site erythema
    60.0
    65.5
        Injection-site induration
    57.0
    59.1
        Injection-site pain
    63.0
    59.6
        Injection-site swelling
    46.4
    44.1
    Statistical analysis title
    		 Injection-site erythema
    Comparison groups
    Prevenar 13™ v V114
    Number of subjects included in analysis
    1189
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.05
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentage vs Prevenar 13™
    Point estimate
    -5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 0
    Statistical analysis title
    		 Injection-site pain
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1189
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.225
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentage vs Prevenar 13™
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 8.9
    Statistical analysis title
    		 Injection-site swelling
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1189
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.43
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentage vs Prevenar 13™
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 7.9
    Statistical analysis title
    		 Injection-site induration
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1189
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.46
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentage vs Prevenar 13™
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.7
         upper limit
    		 3.5

    Primary: Percentage of Participants with a Solicited Systemic Adverse Event

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Solicited Systemic Adverse Event
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts). The analysis population for this endpoint included all randomized participants who received at least 1 dose of study vaccination.
    End point type
    Primary
    End point timeframe
    Day 1 to Day 14 after each vaccination
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    595
    594
    Units: Percentage of participants
    number (not applicable)
        Decreased appetite
    54.8
    58.2
        Irritability
    96.3
    94.1
        Somnolence
    77.3
    77.9
        Urticaria
    16.8
    21.4
    Statistical analysis title
    		 Decreased appetite
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1189
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.229
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentage vs Prevenar 13™
    Point estimate
    -3.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.1
         upper limit
    		 2.2
    Statistical analysis title
    		 Irritability
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1189
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.077
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentage vs Prevenar 13™
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 4.7
    Statistical analysis title
    		 Somnolence
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1189
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.793
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentage vs Prevenar 13™
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 4.1
    Statistical analysis title
    		 Urticaria
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1189
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.045
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentage vs Prevenar 13™
    Point estimate
    -4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.1
         upper limit
    		 -0.1

    Primary: Percentage of Participants with a Vaccine-related Serious Adverse Event

    		 Close Top of page
    End point title
    		 Percentage of Participants with a Vaccine-related Serious Adverse Event
    End point description
    A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized. The analysis population for this endpoint included all randomized participants who received at least 1 dose of study vaccination.
    End point type
    Primary
    End point timeframe
    Up to approximately 6 months after Dose 3 (up to approximately 16 months)
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    595
    594
    Units: Percentage of participants
        number (not applicable)
    0.3
    0.3
    Statistical analysis title
    		 Vaccine-related SAEs
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1189
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentage vs Prevenar 13™
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.9

    Primary: Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days after Dose 3

    		 Close Top of page
    End point title
    		 Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days after Dose 3
    End point description
    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. The analysis population for this endpoint included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype.
    End point type
    Primary
    End point timeframe
    30 days after Dose 3
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    500
    525
    Units: Percentage of participants
    number (not applicable)
        Serotype 1 (n=500, 525)
    96.8
    99.0
        Serotype 3 (n=500, 525)
    92.8
    82.3
        Serotype 4 (n=500, 523)
    96.6
    98.5
        Serotype 5 (n=500, 524)
    99.4
    99.6
        Serotype 6A (n=500, 523)
    99.2
    99.4
        Serotype 6B (n=500, 523)
    99.2
    99.0
        Serotype 7F (n=500, 525)
    100.0
    99.6
        Serotype 9V (n=499, 525)
    99.8
    99.6
        Serotype 14 (n=500, 523)
    99.2
    99.6
        Serotype 18C (n=500, 525)
    99.8
    99.4
        Serotype 19A (n=500, 523)
    99.6
    99.8
        Serotype 19F (n=500, 524)
    99.8
    99.6
        Serotype 23F (n=497, 521)
    97.8
    96.9
        Serotype 22F (n=500, 520)
    99.4
    5.4
        Serotype 33F (n=500, 510)
    99.2
    2.0
    Statistical analysis title
    		 Serotype 1
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 -0.6
    Statistical analysis title
    		 Serotype 3
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.6
         upper limit
    		 14.6
    Statistical analysis title
    		 Serotype 4
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 0
    Statistical analysis title
    		 Serotype 5
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 0.8
    Statistical analysis title
    		 Serotype 6A
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 1
    Statistical analysis title
    		 Serotype 6B
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 1.5
    Statistical analysis title
    		 Serotype 7F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 1.4
    Statistical analysis title
    		 Serotype 9V
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 1.2
    Statistical analysis title
    		 Serotype 14
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 0.7
    Statistical analysis title
    		 Serotype 18C
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 1.5
    Statistical analysis title
    		 Serotype 19A
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0.7
    Statistical analysis title
    		 Serotype 19F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 1.2
    Statistical analysis title
    		 Serotype 23F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 3
    Statistical analysis title
    		 Serotype 22F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 91.6
         upper limit
    		 95.8
    Statistical analysis title
    		 Serotype 33F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    97.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 95.4
         upper limit
    		 98.4

    Primary: Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days after Dose 3

    		 Close Top of page
    End point title
    		 Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days after Dose 3
    End point description
    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. The analysis population for this endpoint included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype.
    End point type
    Primary
    End point timeframe
    30 days after Dose 3
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    500
    525
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (n=500, 525)
    1.28 (1.21 to 1.36)
    2.20 (2.08 to 2.34)
        Serotype 3 (n=500, 525)
    0.85 (0.79 to 0.90)
    0.65 (0.61 to 0.69)
        Serotype 4 (n=500, 523)
    1.41 (1.31 to 1.51)
    2.00 (1.86 to 2.16)
        Serotype 5 (n=500, 524)
    2.08 (1.95 to 2.21)
    3.35 (3.11 to 3.60)
        Serotype 6A (n=500, 523)
    3.21 (2.97 to 3.47)
    5.36 (4.98 to 5.78)
        Serotype 6B (n=500, 523)
    4.56 (4.20 to 4.94)
    5.12 (4.71 to 5.57)
        Serotype 7F (n=500, 525)
    2.78 (2.64 to 2.94)
    3.74 (3.53 to 3.97)
        Serotype 9V (n=499, 525)
    2.14 (2.02 to 2.27)
    3.07 (2.89 to 3.26)
        Serotype 14 (n=500, 523)
    5.35 (4.93 to 5.80)
    6.83 (6.33 to 7.37)
        Serotype 18C (n=500, 525)
    2.10 (1.98 to 2.23)
    2.48 (2.33 to 2.65)
        Serotype 19A (n=500, 523)
    4.74 (4.43 to 5.08)
    6.38 (5.96 to 6.83)
        Serotype 19F (n=500, 524)
    4.08 (3.82 to 4.36)
    5.18 (4.85 to 5.53)
        Serotype 23F (n=497, 521)
    1.58 (1.47 to 1.70)
    1.77 (1.64 to 1.91)
        Serotype 22F (n=500, 520)
    6.06 (5.68 to 6.46)
    0.09 (0.08 to 0.10)
        Serotype 33F (n=500, 510)
    3.28 (3.06 to 3.51)
    0.07 (0.06 to 0.07)
    Statistical analysis title
    		 Serotype 3
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 1.43
    Statistical analysis title
    		 Serotype 1
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 0.63
    Statistical analysis title
    		 Serotype 4
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.78
    Statistical analysis title
    		 Serotype 5
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 0.68
    Statistical analysis title
    		 Serotype 6A
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 0.67
    Statistical analysis title
    		 Serotype 7F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 0.81
    Statistical analysis title
    		 Serotype 6B
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1
    Statistical analysis title
    		 Serotype 9V
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 0.76
    Statistical analysis title
    		 Serotype 14
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.87
    Statistical analysis title
    		 Serotype 18C
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 0.92
    Statistical analysis title
    		 Serotype 19A
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.82
    Statistical analysis title
    		 Serotype 19F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.87
    Statistical analysis title
    		 Serotype 23F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1
    Statistical analysis title
    		 Serotype 22F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    68.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 61.73
         upper limit
    		 75.65
    Statistical analysis title
    		 Serotype 33F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 1-sided
    Parameter type
    		 GMC ratio
    Point estimate
    48.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 44.45
         upper limit
    		 54.01

    Secondary: Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days after Dose 3

    		 Close Top of page
    End point title
    		 Percentage of Participants Meeting Specified Vaxelis™ Antigen Reponses 30 Days after Dose 3
    End point description
    Antigen-specific response rates in participants administered V114 concomitantly with Vaxelis™ were compared with response rates in participants administered Prevenar 13™ concomitantly with Vaxelis™, and the percentages of participants meeting specified Vaxelis™ antigen responses recorded. Antigens in Vaxelis™ include: diphtheria toxoid, tetanus toxoid, pertussis toxin (PT), pertussis filamentous hemagglutinin (FHA), pertussis fimbriae 2/3 (FIM 2/3), pertussis pertactin (PRN), Haemophilus influenzae type b polyribosylribitol phosphate (Hib-PRP), hepatitis B surface antigen (HBsAg), and poliovirus serotypes 1, 2, and 3. The analysis population for this endpoint included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype.
    End point type
    Secondary
    End point timeframe
    30 days after Dose 3
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    500
    525
    Units: Percentage of participants
    number (not applicable)
        Diphtheria toxoid: % ≥0.1 IU/mL (n=514, 543)
    100.0
    99.8
        Tetanus toxoid: % ≥0.1 IU/mL (n=514, 543)
    100.0
    99.8
        Pertussis - PT: % ≥5 EU/mL (n=514, 543)
    100.0
    99.8
        Pertussis - FHA: % ≥5 EU/mL (n=514, 543)
    100.0
    99.8
        Pertussis - FIM 2/3: % ≥20 EU/m L (n=514, 543)
    99.8
    99.6
        Pertussis - PRN: % ≥5 EU/mL (n=514, 543)
    99.8
    99.6
        Hib-PRP: % ≥0.15 μg/mL (n=495, 523)
    96.8
    97.9
        HBsAg: % ≥10 mIU/m L (n=495, 523)
    99.0
    99.6
        Poliovirus 1: % w/ Nab ≥1:8 dilution (n=502, 529)
    99.8
    99.8
        Poliovirus 2: % w/ Nab ≥1:8 dilution (n=499, 518)
    100.0
    99.8
        Poliovirus 3: % w/ Nab ≥1:8 dilution (n=503, 529)
    100.0
    100.0
    Statistical analysis title
    		 Tetanus toxoid
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 1
    Statistical analysis title
    		 Diphtheria toxoid
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 1
    Statistical analysis title
    		 Pertussis - PT
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 1
    Statistical analysis title
    		 Pertussis - FIM 2/3
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 1.2
    Statistical analysis title
    		 Pertussis - FHA
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 1
    Statistical analysis title
    		 Pertussis - PRN
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 1.2
    Statistical analysis title
    		 Hib-PRP
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 0.9
    Statistical analysis title
    		 HBsAg
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 0.5
    Statistical analysis title
    		 Poliovirus 1
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.9
    Statistical analysis title
    		 Poliovirus 2
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 1.1
    Statistical analysis title
    		 Poliovirus 3
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1025
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Percentage point difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.7

    Secondary: Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days after Dose 2

    		 Close Top of page
    End point title
    		 Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL 30 Days after Dose 2
    End point description
    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex ECL assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a PnECL assay. The analysis population for this endpoint included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype.
    End point type
    Secondary
    End point timeframe
    30 days after Dose 2
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    505
    499
    Units: Percentage of participants
    number (not applicable)
        Serotype 1 (n=505, 499)
    97.2
    98.2
        Serotype 3 (n=505, 499)
    96.8
    78.0
        Serotype 4 (n=505, 498)
    97.6
    98.2
        Serotype 5 (n=505, 498)
    92.1
    91.2
        Serotype 6A (n=505, 498)
    77.2
    91.4
        Serotype 6B (n=505, 499)
    59.0
    40.3
        Serotype 7F (n=505, 499)
    98.6
    99.8
        Serotype 9V (n=504, 498)
    94.0
    94.8
        Serotype 14 (n=504, 498)
    96.6
    96.0
        Serotype 18C (n=505, 499)
    93.1
    94.4
        Serotype 19A (n=505, 499)
    94.1
    96.6
        Serotype 19F (n=505, 499)
    98.0
    99.4
        Serotype 23F (n=505, 498)
    75.4
    66.7
        Serotype 22F (n=505, 499)
    97.8
    2.0
        Serotype 33F (n=505, 499)
    49.5
    1.6
    No statistical analyses for this end point

    Secondary: GMC of Serotype-specific IgG 30 Days after Dose 2

    		 Close Top of page
    End point title
    		 GMC of Serotype-specific IgG 30 Days after Dose 2
    End point description
    The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex ECL assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a PnECL assay. The analysis population for this endpoint included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype.
    End point type
    Secondary
    End point timeframe
    30 days after Dose 2
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    505
    499
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (n=505, 499)
    1.39 (1.30 to 1.48)
    1.70 (1.60 to 1.81)
        Serotype 3 (n=505, 499)
    1.10 (1.04 to 1.17)
    0.61 (0.57 to 0.65)
        Serotype 4 (n=505, 498)
    1.74 (1.62 to 1.86)
    1.59 (1.48 to 1.70)
        Serotype 5 (n=505, 498)
    1.14 (1.05 to 1.23)
    1.26 (1.16 to 1.37)
        Serotype 6A (n=505, 498)
    0.67 (0.61 to 0.73)
    1.53 (1.40 to 1.68)
        Serotype 6B (n=505, 499)
    0.42 (0.37 to 0.48)
    0.24 (0.22 to 0.27)
        Serotype 7F (n=505, 499)
    1.69 (1.59 to 1.80)
    2.18 (2.06 to 2.31)
        Serotype 9V (n=504, 498)
    1.55 (1.43 to 1.68)
    1.55 (1.43 to 1.67)
        Serotype 14 (n=504, 498)
    5.59 (5.09 to 6.13)
    5.48 (4.92 to 6.10)
        Serotype 18C (n=505,499)
    1.18 (1.11 to 1.26)
    1.58 (1.46 to 1.70)
        Serotype 19A (n=505, 499)
    1.70 (1.56 to 1.84)
    2.35 (2.15 to 2.56)
        Serotype 19F (n=505, 499)
    2.79 (2.59 to 3.01)
    4.04 (3.76 to 4.34)
        Serotype 23F (n=505, 498)
    0.71 (0.65 to 0.78)
    0.54 (0.49 to 0.59)
        Serotype 22F (n=505, 499)
    3.16 (2.92 to 3.42)
    0.04 (0.04 to 0.04)
        Serotype 33F (n=505, 499)
    0.30 (0.27 to 0.34)
    0.04 (0.04 to 0.04)
    Statistical analysis title
    		 Serotype 3
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    1.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.66
         upper limit
    		 1.98
    Statistical analysis title
    		 Serotype 1
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.89
    Statistical analysis title
    		 Serotype 5
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.01
    Statistical analysis title
    		 Serotype 4
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.21
    Statistical analysis title
    		 Serotype 7F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 0.84
    Statistical analysis title
    		 Serotype 6A
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 0.5
    Statistical analysis title
    		 Serotype 6B
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 2.05
    Statistical analysis title
    		 Serotype 9V
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.12
    Statistical analysis title
    		 Serotype 14
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.18
    Statistical analysis title
    		 Serotype 18C
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.82
    Statistical analysis title
    		 Serotype 19A
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 0.81
    Statistical analysis title
    		 Serotype 19F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 0.77
    Statistical analysis title
    		 Serotype 23F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.16
         upper limit
    		 1.51
    Statistical analysis title
    		 Serotype 22F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    81.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 73.12
         upper limit
    		 89.75
    Statistical analysis title
    		 Serotype 33F
    Comparison groups
    V114 v Prevenar 13™
    Number of subjects included in analysis
    1004
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    7.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.82
         upper limit
    		 8.94

    Secondary: Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days after Dose 3

    		 Close Top of page
    End point title
    		 Percentage of Participants Meeting Specified Opsonophagocytic Activity (OPA) Responses 30 Days after Dose 3
    End point description
    OPA for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was measured using a multiplex opsonophagocytic assay (MOPA). The analysis population for this endpoint included all randomized participants in the OPA Subset without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype.
    End point type
    Secondary
    End point timeframe
    30 days after Dose 3
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    108
    95
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype 1: % ≥1:9 dilution (n=108, 94)
    98.1 (93.5 to 99.8)
    97.9 (92.5 to 99.7)
        Serotype 3: % ≥1:19 dilution (n=102, 92)
    99.0 (94.7 to 100.0)
    97.8 (92.4 to 99.7)
        Serotype 4: % ≥1:34 dilution (n=105, 92)
    100.0 (96.5 to 100.0)
    100.0 (96.1 to 100.0)
        Serotype 5: % ≥1:27 dilution (n=108, 95)
    100.0 (96.6 to 100.0)
    100.0 (96.2 to 100.0)
        Serotype 6A: % ≥1:232 dilution (n=100, 93)
    100.0 (96.4 to 100.0)
    100.0 (96.1 to 100.0)
        Serotype 6B: % ≥1:40 dilution (n=106, 93)
    100.0 (96.6 to 100.0)
    100.0 (96.1 to 100.0)
        Serotype 7F: % ≥1:61 dilution (n=106, 94)
    100.0 (96.6 to 100.0)
    100.0 (96.2 to 100.0)
        Serotype 9V: % ≥1:151 dilution (n=102, 91)
    99.0 (94.7 to 100.0)
    100.0 (96.0 to 100.0)
        Serotype 14: % ≥1:62 dilution (n=105, 93)
    100.0 (96.5 to 100.0)
    100.0 (96.1 to 100.0)
        Serotype 18C: % ≥1:115 dilution (n=104, 93)
    99.0 (94.8 to 100.0)
    100.0 (96.1 to 100.0)
        Serotype 19A : % ≥1:31 dilution (n=108, 93)
    100.0 (96.6 to 100.0)
    100.0 (96.1 to 100.0)
        Serotype 19F: % ≥1:113 dilution (n=104, 92)
    100.0 (96.5 to 100.0)
    100.0 (96.1 to 100.0)
        Serotype 23F: % ≥1:55 dilution (n=104, 91)
    100.0 (96.5 to 100.0)
    100.0 (96.0 to 100.0)
        Serotype 22F: % ≥1:15 dilution (n=104, 91)
    100.0 (96.5 to 100.0)
    26.4 (17.7 to 36.7)
        Serotype 33F: % ≥1:20 dilution (n=105, 95)
    100.0 (96.5 to 100.0)
    98.9 (94.3 to 100.0)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days after Dose 3

    		 Close Top of page
    End point title
    		 Geometric Mean Titers (GMTs) of Serotype-specific OPA 30 Days after Dose 3
    End point description
    Sera from participants was used to measure GMT of the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevenar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA. The analysis population for this endpoint included all randomized participants in the OPA Subset without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and who had sufficient data to perform the analysis for each serotype.
    End point type
    Secondary
    End point timeframe
    30 days after Dose 3
    End point values
    		 V114 Prevenar 13™
    Number of subjects analysed
    108
    95
    Units: Titer
    geometric mean (confidence interval 95%)
        Serotype 1 (n=108, 94)
    152.2 (122.6 to 189.0)
    184.0 (147.2 to 230.0)
        Serotype 3 (n=102, 92)
    320.4 (266.9 to 384.8)
    296.2 (245.5 to 357.3)
        Serotype 4 (n=105, 92)
    2290.8 (1856.9 to 2826.1)
    2842.0 (2404.6 to 3359.0)
        Serotype 5 (n=108, 95)
    855.5 (699.9 to 1045.7)
    1024.5 (850.5 to 1234.0)
        Serotype 6A (n=100, 93)
    3316.8 (2828.4 to 3889.5)
    4649.1 (3951.6 to 5469.7)
        Serotype 6B (n=106, 93)
    2691.6 (2244.4 to 3227.8)
    2658.7 (2234.2 to 3163.8)
        Serotype 7F (n=106, 94)
    5819.2 (4985.3 to 6792.7)
    7839.0 (6786.9 to 9054.2)
        Serotype 9V (n=102, 91)
    2192.1 (1807.8 to 2658.1)
    2745.1 (2284.2 to 3298.9)
        Serotype 14 (n=105, 93)
    3449.4 (2803.1 to 4244.7)
    2360.2 (1972.4 to 2824.3)
        Serotype 18C (n=104, 93)
    2203.1 (1872.6 to 2592.1)
    2003.4 (1725.7 to 2325.7)
        Serotype 19A (n=108, 93)
    2839.1 (2455.2 to 3282.9)
    3843.6 (3366.9 to 4387.8)
        Serotype 19F (n=104, 92)
    1748.4 (1469.8 to 2079.7)
    2067.0 (1800.1 to 2373.4)
        Serotype 23F (n= 104, 91)
    3650.2 (3041.3 to 4381.0)
    6776.2 (5344.0 to 8592.3)
        Serotype 22F (n=104, 91)
    2927.9 (2547.0 to 3365.7)
    29.3 (17.8 to 48.4)
        Serotype 33F (n=105, 95)
    13334.7 (11334.6 to 15687.7)
    1557.9 (1227.3 to 1977.5)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Non-serious AEs: up to 14 days after each vaccination dose; serious AEs and deaths (all causes): up to approximately 6 months after Dose 3 (up to approximately 16 months)
    Adverse event reporting additional description
    The safety analysis population included all randomized participants who received at least 1 dose of study vaccination. The analysis population for number of deaths (all causes) included all randomized participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

    Reporting group title
    Prevenar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevenar 13™ at Visit 1, 2 and 4 (approximately 3, 5, and 12 months of age). As part of the study design, participants also received other pediatric vaccines, including Vaxelis™ (0.5 mL single dose at Visits 1, 2, and 4); M-M-R™II (0.5 mL single dose at Visit 4); and VARIVAX™ (0.5 mL single dose at Visit 4, except participants in Norway and Denmark, who received a second dose of VARIVAX™ at Visit 5, according to local vaccination requirements).

    Serious adverse events
    		 V114 Prevenar 13™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 595 (5.04%)
    28 / 594 (4.71%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain neoplasm
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Laryngomalacia
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infantile spasms
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Petit mal epilepsy
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 595 (0.67%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis infective
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 595 (0.34%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 595 (0.17%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 595 (0.17%)
    3 / 594 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pertussis
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 595 (0.17%)
    3 / 594 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 595 (0.34%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 595 (0.17%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 595 (0.00%)
    2 / 594 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 595 (0.17%)
    0 / 594 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 595 (0.00%)
    1 / 594 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V114 Prevenar 13™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    590 / 595 (99.16%)
    592 / 594 (99.66%)
    Investigations
    Body temperature increased
         subjects affected / exposed
    51 / 595 (8.57%)
    61 / 594 (10.27%)
         occurrences all number
    74
    91
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    460 / 595 (77.31%)
    463 / 594 (77.95%)
         occurrences all number
    1118
    1085
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    357 / 595 (60.00%)
    389 / 594 (65.49%)
         occurrences all number
    613
    658
    Injection site pain
         subjects affected / exposed
    375 / 595 (63.03%)
    354 / 594 (59.60%)
         occurrences all number
    646
    595
    Injection site induration
         subjects affected / exposed
    339 / 595 (56.97%)
    351 / 594 (59.09%)
         occurrences all number
    658
    679
    Injection site swelling
         subjects affected / exposed
    276 / 595 (46.39%)
    262 / 594 (44.11%)
         occurrences all number
    444
    417
    Pyrexia
         subjects affected / exposed
    318 / 595 (53.45%)
    330 / 594 (55.56%)
         occurrences all number
    728
    762
    Gastrointestinal disorders
    Teething
         subjects affected / exposed
    47 / 595 (7.90%)
    50 / 594 (8.42%)
         occurrences all number
    60
    67
    Diarrhoea
         subjects affected / exposed
    69 / 595 (11.60%)
    70 / 594 (11.78%)
         occurrences all number
    82
    89
    Vomiting
         subjects affected / exposed
    31 / 595 (5.21%)
    38 / 594 (6.40%)
         occurrences all number
    38
    41
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    100 / 595 (16.81%)
    127 / 594 (21.38%)
         occurrences all number
    130
    173
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    573 / 595 (96.30%)
    559 / 594 (94.11%)
         occurrences all number
    2266
    2304
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    70 / 595 (11.76%)
    84 / 594 (14.14%)
         occurrences all number
    80
    101
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    326 / 595 (54.79%)
    346 / 594 (58.25%)
         occurrences all number
    632
    686

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2021
    Amendment 03: The primary purpose of this amendment was to expand the visit windows for Visit 2 (Dose 2 vaccination), Visit 3 (post-dose 2 blood draw), Visit 4 (Dose 3 vaccination), and Visit 5 (post-dose 3 blood draw) to allow inclusion of more participants in the immunogenicity analysis based on the per-protocol population.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 12:55:31 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA