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

    Summary
    EudraCT number
    		 2018-003308-38
    Trial protocol
    		 DE   FI  
    Global end of trial date
    26 Mar 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Aug 2022
    First version publication date
    08 Oct 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V114-031
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03692871
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. The study included both full-term infants (≥37 weeks gestational age) and premature infants (<37 weeks gestational age). Premature infants were included in a Premature Infant Immunogenicity Substudy, which assessed immunogenicity and safety following administration of V114 or Prevnar 13™.
    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
    14 Dec 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 34
    Country: Number of subjects enrolled
    Canada: 309
    Country: Number of subjects enrolled
    Finland: 221
    Country: Number of subjects enrolled
    Germany: 215
    Country: Number of subjects enrolled
    Israel: 97
    Country: Number of subjects enrolled
    Malaysia: 291
    Country: Number of subjects enrolled
    Peru: 183
    Country: Number of subjects enrolled
    Taiwan: 135
    Country: Number of subjects enrolled
    Thailand: 391
    Country: Number of subjects enrolled
    United States: 533
    Worldwide total number of subjects
    2409
    EEA total number of subjects
    436
    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)
    2409
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 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 approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
    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 capsular polysaccharide with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose

    Arm title
    		 Prevnar 13™
    Arm description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevnar 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

    Number of subjects in period 1
    		V114 Prevnar 13™
    Started
    1972
    437
    Completed
    1847
    400
    Not completed
    125
    37
         Physician decision
    22
    7
         Protocol Deviation
    1
    -
         Death
    1
    1
         Withdrawal by Parent/Guardian
    77
    20
         Lost to follow-up
    24
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

    Reporting group values
    		 V114 Prevnar 13™ Total
    Number of subjects
    		 1972 437 2409
    Age Categorical
    Units: Participants
    Age Continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 8.7 ± 1.5 8.8 ± 1.5 -
    Gender Categorical
    Units: Participants
        Female
    		 948 227 1175
        Male
    		 1024 210 1234
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 64 20 84
        Asian
    		 730 152 882
        Black or African American
    		 54 19 73
        Multiple
    		 154 31 185
        Native Hawaiian or Other Pacific Islander
    		 2 1 3
        White
    		 966 214 1180
        Missing
    		 2 0 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 293 74 367
        Not Hispanic or Latino
    		 1678 362 2040
        Not Reported
    		 1 1 2

    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 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

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

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    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
    Up to Day 14 after each study vaccination
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1965
    433
    Units: Percentage of participants
    number (not applicable)
        Injection site erythema
    43.9
    36.0
        Injection site induration
    25.3
    25.6
        Injection site pain
    42.9
    36.5
        Injection site swelling
    27.9
    23.3
    Statistical analysis title
    		 Injection site erythema
    Comparison groups
    Prevnar 13™ v V114
    Number of subjects included in analysis
    2398
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in Percentage
    Point estimate
    7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 12.8
    Statistical analysis title
    		 Injection site induration
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    2398
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.882
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 4
    Statistical analysis title
    		 Injection site pain
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    2398
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.014
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in Percentage
    Point estimate
    6.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 11.3
    Statistical analysis title
    		 Injection site swelling
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    2398
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.051
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in Percentage
    Point estimate
    4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 8.9

    Primary: Percentage of Participants with a Solicited Systemic Adverse Event

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    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
    Up to Day 14 after each study vaccination
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1965
    433
    Units: Percentage of participants
    number (not applicable)
        Decreased appetite
    41.6
    36.0
        Irritability
    74.9
    69.3
        Somnolence
    55.4
    55.0
        Urticaria
    5.9
    6.7
    Statistical analysis title
    		 Decreased appetite
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    2398
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.033
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in Percentage
    Point estimate
    5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 10.5
    Statistical analysis title
    		 Irritability
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    2398
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.016
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in Percentage
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 10.5
    Statistical analysis title
    		 Somnolence
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    2398
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.878
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 5.6
    Statistical analysis title
    		 Urticaria
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    2398
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.503
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in Percentage
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 1.5

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

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    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 6 months after Vaccination 4 (up to 19 months after Vaccination 1)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    1965
    433
    Units: Percentage of participants
        number (not applicable)
    0.1
    0
    Statistical analysis title
    		 Vaccine-related Serious Adverse Events
    Comparison groups
    V114 v Prevnar 13™
    Number of subjects included in analysis
    2398
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 0.4

    Secondary: Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days after Vaccination 3 (Premature Infants only)

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    End point title
    		 Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days after Vaccination 3 (Premature Infants only)
    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 Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. The analysis population included all randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis.
    End point type
    Secondary
    End point timeframe
    30 days after Vaccination 3 (approximately 5 months after Vaccination 1)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    38
    35
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (n=38, 35)
    1.15 (0.88 to 1.52)
    1.61 (1.25 to 2.09)
        Serotype 3 (n=38, 35)
    0.86 (0.65 to 1.13)
    0.58 (0.45 to 0.76)
        Serotype 4 (n=38, 35)
    1.41 (1.01 to 1.99)
    1.27 (0.96 to 1.68)
        Serotype 5 (n=38, 35)
    1.48 (1.04 to 2.10)
    1.66 (1.09 to 2.53)
        Serotype 6A (n=38, 35)
    1.37 (0.95 to 1.96)
    3.19 (2.31 to 4.43)
        Serotype 6B (n=38, 35)
    1.69 (1.15 to 2.48)
    2.53 (1.64 to 3.89)
        Serotype 7F (n=38, 35)
    1.95 (1.46 to 2.62)
    2.92 (2.21 to 3.87)
        Serotype 9V (n=38, 35)
    1.47 (1.08 to 2.00)
    1.50 (1.07 to 2.12)
        Serotype 14 (n=38, 35)
    4.38 (3.18 to 6.03)
    6.52 (4.35 to 9.77)
        Serotype 18C (n=38, 35)
    1.46 (1.08 to 1.96)
    1.54 (1.16 to 2.04)
        Serotype 19A (n=38, 35)
    1.63 (1.25 to 2.13)
    3.00 (2.18 to 4.11)
        Serotype 19F (n=38, 35)
    2.03 (1.53 to 2.68)
    2.78 (2.17 to 3.58)
        Serotype 23F (n=38, 35)
    1.17 (0.81 to 1.70)
    1.18 (0.82 to 1.68)
        Serotype 22F (n=38, 35)
    4.33 (3.18 to 5.90)
    0.05 (0.03 to 0.07)
        Serotype 33F (n=38, 35)
    1.58 (0.93 to 2.69)
    0.05 (0.04 to 0.08)
    No statistical analyses for this end point

    Secondary: GMC of Serotype-specific IgG before Vaccination 4 (Premature Infants only)

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    End point title
    		 GMC of Serotype-specific IgG before Vaccination 4 (Premature Infants only)
    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 Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. The analysis population included all randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 4 (10-13 months after Vaccination 1)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    38
    40
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (n=38, 40)
    0.30 (0.24 to 0.38)
    0.47 (0.38 to 0.59)
        Serotype 3 (n=38, 40)
    0.22 (0.16 to 0.29)
    0.13 (0.10 to 0.17)
        Serotype 4 (n=38, 40)
    0.24 (0.19 to 0.31)
    0.31 (0.24 to 0.38)
        Serotype 5 (n=38, 40)
    0.77 (0.60 to 1.01)
    0.89 (0.65 to 1.22)
        Serotype 6A (n=38, 40)
    0.32 (0.24 to 0.43)
    0.72 (0.52 to 0.99)
        Serotype 6B (n=38, 40)
    0.59 (0.47 to 0.75)
    0.61 (0.43 to 0.87)
        Serotype 7F (n=38, 40)
    0.57 (0.44 to 0.73)
    0.95 (0.74 to 1.21)
        Serotype 9V (n=38, 40)
    0.40 (0.32 to 0.51)
    0.46 (0.35 to 0.62)
        Serotype 14 (n=38, 40)
    1.14 (0.84 to 1.54)
    2.22 (1.73 to 2.84)
        Serotype 18C (n=38, 40)
    0.35 (0.28 to 0.45)
    0.36 (0.27 to 0.49)
        Serotype 19A (n=38, 40)
    0.38 (0.29 to 0.51)
    0.81 (0.52 to 1.24)
        Serotype 19F (n=38, 40)
    0.41 (0.31 to 0.53)
    0.69 (0.52 to 0.90)
        Serotype 23F (n=38, 40)
    0.33 (0.24 to 0.45)
    0.37 (0.26 to 0.52)
        Serotype 22F (n=38, 40)
    1.24 (0.98 to 1.58)
    0.05 (0.04 to 0.07)
        Serotype 33F (n=38, 40)
    1.09 (0.82 to 1.45)
    0.05 (0.04 to 0.07)
    No statistical analyses for this end point

    Secondary: GMC of Serotype-specific IgG at 30 Days after Vaccination 4 (Premature Infants only)

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    End point title
    		 GMC of Serotype-specific IgG at 30 Days after Vaccination 4 (Premature Infants only)
    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 Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. The analysis population included all randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis.
    End point type
    Secondary
    End point timeframe
    30 days after Vaccination 4 (11-14 months after Vaccination 1)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    34
    39
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (n=34, 39)
    1.56 (1.19 to 2.06)
    1.96 (1.54 to 2.50)
        Serotype 3 (n=34, 39)
    1.04 (0.80 to 1.36)
    0.79 (0.60 to 1.06)
        Serotype 4 (n=34, 39)
    1.55 (1.11 to 2.16)
    1.61 (1.21 to 2.15)
        Serotype 5 (n=34, 39)
    3.30 (2.34 to 4.65)
    3.60 (2.53 to 5.13)
        Serotype 6A (n=34, 39)
    4.18 (3.17 to 5.49)
    6.38 (4.69 to 8.68)
        Serotype 6B (n=34, 39)
    6.62 (5.24 to 8.37)
    6.75 (4.43 to 10.28)
        Serotype 7F (n=34, 39)
    4.01 (2.98 to 5.40)
    5.10 (3.76 to 6.90)
        Serotype 9V (n=34, 39)
    3.10 (2.36 to 4.08)
    3.09 (2.31 to 4.12)
        Serotype 14 (n=34, 39)
    5.40 (3.89 to 7.49)
    7.15 (5.33 to 9.61)
        Serotype 18C (n=34, 39)
    3.21 (2.32 to 4.45)
    2.77 (1.99 to 3.85)
        Serotype 19A (n=34, 39)
    4.96 (3.85 to 6.39)
    6.47 (4.46 to 9.40)
        Serotype 19F (n=34, 39)
    4.48 (3.51 to 5.73)
    4.83 (3.66 to 6.38)
        Serotype 23F (n=34, 39)
    2.38 (1.76 to 3.20)
    3.04 (2.16 to 4.27)
        Serotype 22F (n=34, 38)
    9.83 (7.47 to 12.92)
    0.08 (0.07 to 0.11)
        Serotype 33F (n=34, 37)
    5.46 (4.29 to 6.96)
    0.10 (0.07 to 0.13)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days after Vaccination 3 (Premature Infants only)

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    End point title
    		 Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days after Vaccination 3 (Premature Infants only)
    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 Prevnar 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 will be determined using a PnECL assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. The analysis population included all randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis.
    End point type
    Secondary
    End point timeframe
    30 days after Vaccination 3 (approximately 5 months after Vaccination 1)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    38
    35
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype 1
    97.4 (86.2 to 99.9)
    97.1 (85.1 to 99.9)
        Serotype 3
    89.5 (75.2 to 97.1)
    74.3 (56.7 to 87.5)
        Serotype 4
    94.7 (82.3 to 99.4)
    97.1 (85.1 to 99.9)
        Serotype 5
    97.4 (86.2 to 99.9)
    88.6 (73.3 to 96.8)
        Serotype 6A
    97.4 (86.2 to 99.9)
    97.1 (85.1 to 99.9)
        Serotype 6B
    92.1 (78.6 to 98.3)
    94.3 (80.8 to 99.3)
        Serotype 7F
    97.4 (86.2 to 99.9)
    100 (90.0 to 100.0)
        Serotype 9V
    97.4 (86.2 to 99.9)
    94.3 (80.8 to 99.3)
        Serotype 14
    100 (90.7 to 100.0)
    97.1 (85.1 to 99.9)
        Serotype 18C
    97.4 (86.2 to 99.9)
    94.3 (80.8 to 99.3)
        Serotype 19A
    94.7 (82.3 to 99.4)
    97.1 (85.1 to 99.9)
        Serotype 19F
    97.4 (86.2 to 99.9)
    100 (90.0 to 100.0)
        Serotype 23F
    89.5 (75.2 to 97.1)
    94.3 (80.8 to 99.3)
        Serotype 22F
    97.4 (86.2 to 99.9)
    2.9 (0.1 to 14.9)
        Serotype 33F
    86.8 (71.9 to 95.6)
    2.9 (0.1 to 14.9)
    No statistical analyses for this end point

    Adverse events

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    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 6 months after Vaccination 4 (up to 19 months after Vaccination 1)
    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
    23.1
    Reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).

    Serious adverse events
    		 V114 Prevnar 13™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    192 / 1965 (9.77%)
    45 / 433 (10.39%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatoblastoma
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (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
    8 / 1965 (0.41%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal haemorrhage
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    1 / 1965 (0.05%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental exposure to product
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone contusion
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical poisoning
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 1965 (0.05%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fibula fracture
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 1965 (0.00%)
    2 / 433 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital absence of bile ducts
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiomyopathy
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    4 / 1965 (0.20%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myoclonus
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paroxysmal choreoathetosis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 1965 (0.10%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 1965 (0.10%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Chronic recurrent multifocal osteomyelitis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oligoarthritis
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (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
    27 / 1965 (1.37%)
    7 / 433 (1.62%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    8 / 1965 (0.41%)
    2 / 433 (0.46%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coxsackie viral infection
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    2 / 1965 (0.10%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    3 / 1965 (0.15%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    8 / 1965 (0.41%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    6 / 1965 (0.31%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    7 / 1965 (0.36%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    15 / 1965 (0.76%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    2 / 1965 (0.10%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    4 / 1965 (0.20%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis shigella
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    5 / 1965 (0.25%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    3 / 1965 (0.15%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    3 / 1965 (0.15%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    4 / 1965 (0.20%)
    3 / 433 (0.69%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    3 / 1965 (0.15%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pertussis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (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
    12 / 1965 (0.61%)
    4 / 433 (0.92%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    2 / 1965 (0.10%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia parainfluenzae viral
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (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
    5 / 1965 (0.25%)
    2 / 433 (0.46%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    7 / 1965 (0.36%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (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
    9 / 1965 (0.46%)
    4 / 433 (0.92%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (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 infection
         subjects affected / exposed
    2 / 1965 (0.10%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    3 / 1965 (0.15%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 1965 (0.25%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (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 bacterial
         subjects affected / exposed
    2 / 1965 (0.10%)
    1 / 433 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (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
    4 / 1965 (0.20%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral pharyngitis
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 1965 (0.05%)
    0 / 433 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 1965 (0.00%)
    1 / 433 (0.23%)
         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 Prevnar 13™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1807 / 1965 (91.96%)
    395 / 433 (91.22%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    1088 / 1965 (55.37%)
    238 / 433 (54.97%)
         occurrences all number
    2696
    590
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    863 / 1965 (43.92%)
    156 / 433 (36.03%)
         occurrences all number
    1528
    272
    Injection site induration
         subjects affected / exposed
    497 / 1965 (25.29%)
    111 / 433 (25.64%)
         occurrences all number
    885
    205
    Injection site pain
         subjects affected / exposed
    843 / 1965 (42.90%)
    158 / 433 (36.49%)
         occurrences all number
    1580
    288
    Injection site swelling
         subjects affected / exposed
    549 / 1965 (27.94%)
    101 / 433 (23.33%)
         occurrences all number
    929
    163
    Pyrexia
         subjects affected / exposed
    775 / 1965 (39.44%)
    176 / 433 (40.65%)
         occurrences all number
    1533
    329
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    188 / 1965 (9.57%)
    40 / 433 (9.24%)
         occurrences all number
    235
    49
    Vomiting
         subjects affected / exposed
    116 / 1965 (5.90%)
    19 / 433 (4.39%)
         occurrences all number
    135
    20
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    115 / 1965 (5.85%)
    29 / 433 (6.70%)
         occurrences all number
    139
    40
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    1472 / 1965 (74.91%)
    300 / 433 (69.28%)
         occurrences all number
    5402
    1053
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    158 / 1965 (8.04%)
    37 / 433 (8.55%)
         occurrences all number
    182
    41
    Upper respiratory tract infection
         subjects affected / exposed
    129 / 1965 (6.56%)
    30 / 433 (6.93%)
         occurrences all number
    139
    32
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    817 / 1965 (41.58%)
    156 / 433 (36.03%)
         occurrences all number
    1664
    302

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Mar 2019
    Amendment 1: The main purpose for this protocol amendment was to add opsonophagocytic activity (OPA) testing to the Premature Infant Immunogenicity Substudy.

    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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    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.

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