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   43845   clinical trials with a EudraCT protocol, of which   7282   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 Catch-up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (PNEU-PLAN)

    Summary
    EudraCT number
    		 2018-003706-88
    Trial protocol
    		 FI   PL   Outside EU/EEA  
    Global end of trial date
    09 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jun 2021
    First version publication date
    20 Jun 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V114-024
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03885934
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Study Acronym: PNEU-PLAN
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, 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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002215-PIP01-17
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis testing in this study.
    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
    25 Jun 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 167
    Country: Number of subjects enrolled
    Malaysia: 65
    Country: Number of subjects enrolled
    Poland: 94
    Country: Number of subjects enrolled
    Russian Federation: 19
    Country: Number of subjects enrolled
    Thailand: 261
    Worldwide total number of subjects
    606
    EEA total number of subjects
    261
    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)
    254
    Children (2-11 years)
    288
    Adolescents (12-17 years)
    64
    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
    		 A total of approximately 600 participants were planned for enrollment. Randomization was stratified by age and pneumococcal conjugate vaccine (PCV) history.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V114, Schedule A: Participants 7-11 months
    Arm description
    		 Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V114
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    V114 15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration

    Arm title
    		 Prevnar 13®, Schedule A: Participants 7-11 months
    Arm description
    		 Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevnar 13®
    Investigational medicinal product code
    Other name
    PCV13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

    Arm title
    		 V114, Schedule B: Participants 12-23 months
    Arm description
    		 Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
    Arm type
    		 Experimental

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

    Arm title
    		 Prevnar 13®, Schedule B: Participants 12-23 months
    Arm description
    		 Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevnar 13®
    Investigational medicinal product code
    Other name
    PCV13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

    Arm title
    		 V114, Schedule C: Participants 2-17 years
    Arm description
    		 Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
    Arm type
    		 Experimental

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

    Arm title
    		 Prevnar 13®, Schedule C: Participants 2-17 years
    Arm description
    		 Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevnar 13®
    Investigational medicinal product code
    Other name
    PCV13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

    Number of subjects in period 1
    		V114, Schedule A: Participants 7-11 months Prevnar 13®, Schedule A: Participants 7-11 months V114, Schedule B: Participants 12-23 months Prevnar 13®, Schedule B: Participants 12-23 months V114, Schedule C: Participants 2-17 years Prevnar 13®, Schedule C: Participants 2-17 years
    Started
    64
    64
    62
    64
    177
    175
    PCV Dose 1
    64
    64
    62
    64
    177
    175
    PCV Dose 2
    63
    64
    62
    64
    0 [1]
    0 [2]
    PCV Dose 3
    63
    64
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    Completed
    63
    64
    62
    64
    177
    175
    Not completed
    1
    0
    0
    0
    0
    0
         Withdrawn by Parent/Guardian
    1
    -
    -
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Schedule A: 7 to 11 months received 3 doses; Schedule B: 12-23 months received 2 doses; and Schedule C: 2-17 years received 1 dose.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Schedule A: 7 to 11 months received 3 doses; Schedule B: 12-23 months received 2 doses; and Schedule C: 2-17 years received 1 dose.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Schedule A: 7 to 11 months received 3 doses; Schedule B: 12-23 months received 2 doses; and Schedule C: 2-17 years received 1 dose.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Schedule A: 7 to 11 months received 3 doses; Schedule B: 12-23 months received 2 doses; and Schedule C: 2-17 years received 1 dose.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Schedule A: 7 to 11 months received 3 doses; Schedule B: 12-23 months received 2 doses; and Schedule C: 2-17 years received 1 dose.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Schedule A: 7 to 11 months received 3 doses; Schedule B: 12-23 months received 2 doses; and Schedule C: 2-17 years received 1 dose.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    V114, Schedule A: Participants 7-11 months
    Reporting group description
    		 Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.

    Reporting group title
    Prevnar 13®, Schedule A: Participants 7-11 months
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.

    Reporting group title
    V114, Schedule B: Participants 12-23 months
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.

    Reporting group title
    Prevnar 13®, Schedule B: Participants 12-23 months
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.

    Reporting group title
    V114, Schedule C: Participants 2-17 years
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.

    Reporting group title
    Prevnar 13®, Schedule C: Participants 2-17 years
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.

    Reporting group values
    		 V114, Schedule A: Participants 7-11 months Prevnar 13®, Schedule A: Participants 7-11 months V114, Schedule B: Participants 12-23 months Prevnar 13®, Schedule B: Participants 12-23 months V114, Schedule C: Participants 2-17 years Prevnar 13®, Schedule C: Participants 2-17 years Total
    Number of subjects
    		 64 64 62 64 177 175 606
    Age Categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0 ( 0 ) 0 ( 0 ) 0 ( 0 ) 0 ( 0 ) 6.5 ( 4.7 ) 6.5 ( 4.7 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 29 33 30 38 85 83 298
        Male
    		 35 31 32 26 92 92 308
    Race
    Units: Subjects
        Asian
    		 53 53 52 53 60 56 327
        Multiple
    		 0 0 0 0 0 1 1
        White
    		 11 11 10 11 117 118 278
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 1 0 0 1
        Not Hispanic or Latino
    		 64 64 62 63 176 174 603
        Not Reported
    		 0 0 0 0 1 1 2
    Age Continuous
    Units: Months
        arithmetic mean (standard deviation)
    		 8.6 ( 1.4 ) 8.8 ( 1.6 ) 17.7 ( 3.2 ) 17.8 ( 3.3 ) 0 ( 0 ) 0 ( 0 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    V114, Schedule A: Participants 7-11 months
    Reporting group description
    		 Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.

    Reporting group title
    Prevnar 13®, Schedule A: Participants 7-11 months
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.

    Reporting group title
    V114, Schedule B: Participants 12-23 months
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.

    Reporting group title
    Prevnar 13®, Schedule B: Participants 12-23 months
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.

    Reporting group title
    V114, Schedule C: Participants 2-17 years
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.

    Reporting group title
    Prevnar 13®, Schedule C: Participants 2-17 years
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.

    Primary: Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months

    		 Close Top of page
    End point title
    		 Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months [1] [2]
    End point description
    The geometric mean concentration (GMC) of immunoglobulin G (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 two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
    End point type
    Primary
    End point timeframe
    30 days post last vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule A: Participants 7-11 months Prevnar 13®, Schedule A: Participants 7-11 months
    Number of subjects analysed
    64
    64
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (n=60,59)
    2.47 (2.09 to 2.92)
    3.66 (2.98 to 4.50)
        Serotype 3 (n=60,59)
    2.65 (2.30 to 3.05)
    1.71 (1.40 to 2.08)
        Serotype 4 (n=60,59)
    2.21 (1.82 to 2.68)
    3.85 (3.12 to 4.76)
        Serotype 5 (n=60,59)
    3.82 (3.14 to 4.63)
    4.56 (3.58 to 5.80)
        Serotype 6A (n=60,59)
    2.23 (1.71 to 2.91)
    4.30 (3.28 to 5.65)
        Serotype 6B (n=60,59)
    3.03 (2.41 to 3.82)
    4.17 (3.25 to 5.36)
        Serotype 7F (n=60,59)
    5.16 (4.27 to 6.23)
    6.42 (5.25 to 7.85)
        Serotype 9V (n=60,59)
    2.61 (2.09 to 3.26)
    3.59 (2.86 to 4.51)
        Serotype 14 (n=60,59)
    9.62 (7.94 to 11.67)
    13.07 (10.40 to 16.42)
        Serotype 18C (n=60,59)
    3.45 (2.80 to 4.24)
    3.50 (2.75 to 4.45)
        Serotype 19A (n=60,59)
    4.59 (3.95 to 5.33)
    5.81 (4.92 to 6.85)
        Serotype 19F (n=60,59)
    3.49 (2.94 to 4.15)
    4.83 (4.03 to 5.79)
        Serotype 23F (n=60,59)
    2.62 (2.02 to 3.39)
    2.79 (2.10 to 3.69)
        Serotype 22F (n=60,58)
    9.04 (7.48 to 10.93)
    0.14 (0.10 to 0.19)
        Serotype 33F (n=60,59)
    3.37 (2.78 to 4.10)
    0.13 (0.10 to 0.16)
    No statistical analyses for this end point

    Primary: GMC of Serotype-specific IgG - Schedule B: 12-23 Months

    		 Close Top of page
    End point title
    		 GMC of Serotype-specific IgG - Schedule B: 12-23 Months [3] [4]
    End point description
    The geometric mean concentration 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 two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
    End point type
    Primary
    End point timeframe
    30 days post last vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule B: Participants 12-23 months Prevnar 13®, Schedule B: Participants 12-23 months
    Number of subjects analysed
    62
    64
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (n=56,60)
    3.83 (3.07 to 4.77)
    4.20 (3.30 to 5.34)
        Serotype 3 (n=56,60)
    2.96 (2.44 to 3.58)
    1.68 (1.29 to 2.20)
        Serotype 4 (n=56,60)
    3.46 (2.67 to 4.50)
    4.89 (3.76 to 6.36)
        Serotype 5 (n=56,60)
    3.39 (2.65 to 4.34)
    3.12 (2.52 to 3.88)
        Serotype 6A (n=56,60)
    2.05 (1.30 to 3.23)
    3.73 (2.64 to 5.29)
        Serotype 6B (n=56,60)
    2.69 (1.70 to 4.25)
    2.87 (1.92 to 4.30)
        Serotype 7F (n=56,60)
    4.80 (3.63 to 6.34)
    5.42 (4.30 to 6.82)
        Serotype 9V (n=56,60)
    2.48 (1.97 to 3.11)
    2.89 (2.21 to 3.78)
        Serotype 14 (n=56,60)
    8.23 (6.19 to 10.94)
    8.30 (6.56 to 10.51)
        Serotype 18C (n=56,60)
    5.09 (3.98 to 6.52)
    3.68 (2.85 to 4.75)
        Serotype 19A (n=56,60)
    6.74 (5.29 to 8.60)
    5.87 (4.85 to 7.11)
        Serotype 19F (n=56,60)
    5.90 (4.69 to 7.43)
    5.92 (4.93 to 7.11)
        Serotype 23F (n=56,60)
    2.85 (1.99 to 4.07)
    2.18 (1.54 to 3.07)
        Serotype 22F (n=56,60)
    15.90 (12.16 to 20.78)
    0.12 (0.09 to 0.16)
        Serotype 33F (n=56,60)
    5.17 (3.96 to 6.74)
    0.15 (0.12 to 0.19)
    No statistical analyses for this end point

    Primary: GMC of Serotype-specific IgG - Schedule C: 2-17 Years

    		 Close Top of page
    End point title
    		 GMC of Serotype-specific IgG - Schedule C: 2-17 Years [5] [6]
    End point description
    The geometric mean concentration 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 two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
    End point type
    Primary
    End point timeframe
    30 days post vaccination
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule C: Participants 2-17 years Prevnar 13®, Schedule C: Participants 2-17 years
    Number of subjects analysed
    177
    175
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (n=162,162)
    3.00 (2.60 to 3.46)
    3.99 (3.48 to 4.58)
        Serotype 3 (n=162,162)
    1.37 (1.19 to 1.58)
    1.03 (0.88 to 1.21)
        Serotype 4 (n=162,162)
    2.53 (2.17 to 2.96)
    5.22 (4.52 to 6.03)
        Serotype 5 (n=162,162)
    3.43 (2.89 to 4.07)
    4.24 (3.46 to 5.20)
        Serotype 6A (n=162,162)
    9.03 (7.07 to 11.53)
    8.81 (6.96 to 11.14)
        Serotype 6B (n=162,161)
    13.55 (10.52 to 17.46)
    10.51 (8.01 to 13.78)
        Serotype 7F (n=162,162)
    4.03 (3.46 to 4.70)
    4.63 (3.92 to 5.46)
        Serotype 9V (n=162,162)
    3.60 (3.06 to 4.24)
    4.35 (3.65 to 5.20)
        Serotype 14 (n=162,162)
    9.21 (7.11 to 11.92)
    8.04 (6.24 to 10.36)
        Serotype 18C (n=162,162)
    7.16 (6.03 to 8.52)
    4.46 (3.76 to 5.30)
        Serotype 19A (n=162,162)
    10.99 (9.12 to 13.26)
    14.90 (12.23 to 18.16)
        Serotype 19F (n=162,162)
    8.95 (7.45 to 10.76)
    12.28 (10.07 to 14.97)
        Serotype 23F (n=162,162)
    5.36 (4.41 to 6.50)
    5.12 (4.12 to 6.37)
        Serotype 22F (n=162,159)
    14.99 (12.73 to 17.66)
    0.31 (0.24 to 0.38)
        Serotype 33F (n=162,160)
    4.89 (4.12 to 5.80)
    0.27 (0.22 to 0.32)
    No statistical analyses for this end point

    Primary: Percentage of Participants with Solicited Injection-site Adverse Events - Schedule A: 7-11 Months

    		 Close Top of page
    End point title
    		 Percentage of Participants with Solicited Injection-site Adverse Events - Schedule A: 7-11 Months [7] [8]
    End point description
    An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized. The analysis population included all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to Day 14 post any vaccination
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule A: Participants 7-11 months Prevnar 13®, Schedule A: Participants 7-11 months
    Number of subjects analysed
    64
    64
    Units: Percentage of Participants
    number (confidence interval 95%)
        Redness/erythema
    28.1 (17.6 to 40.8)
    34.4 (22.9 to 47.3)
        Hardness/induration
    17.2 (8.9 to 28.7)
    14.1 (6.6 to 25.0)
        Pain
    18.8 (10.1 to 30.5)
    7.8 (2.6 to 17.3)
        Swelling
    18.8 (10.1 to 30.5)
    15.6 (7.8 to 26.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants with Solicited Injection-site AEs - Schedule B: 12-23 Months

    		 Close Top of page
    End point title
    		 Percentage of Participants with Solicited Injection-site AEs - Schedule B: 12-23 Months [9] [10]
    End point description
    An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized. The analysis population included all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to 14 days post any vaccination
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule B: Participants 12-23 months Prevnar 13®, Schedule B: Participants 12-23 months
    Number of subjects analysed
    62
    64
    Units: Percentage of Participants
    number (confidence interval 95%)
        Redness/erythema
    21.0 (11.7 to 33.2)
    21.9 (12.5 to 34.0)
        Hardness/induration
    8.1 (2.7 to 17.8)
    9.4 (3.5 to 19.3)
        Pain
    33.9 (22.3 to 47.0)
    23.4 (13.8 to 35.7)
        Swelling
    14.5 (6.9 to 25.8)
    12.5 (5.6 to 23.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants with Solicited Injection-site AEs - Schedule C: 2-17 Years

    		 Close Top of page
    End point title
    		 Percentage of Participants with Solicited Injection-site AEs - Schedule C: 2-17 Years [11] [12]
    End point description
    An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized. The analysis population included all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to 14 days post vaccination
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule C: Participants 2-17 years Prevnar 13®, Schedule C: Participants 2-17 years
    Number of subjects analysed
    177
    175
    Units: Percentage of Participants
    number (confidence interval 95%)
        Redness/erythema
    19.2 (13.7 to 25.8)
    21.1 (15.3 to 27.9)
        Hardness/induration
    6.8 (3.6 to 11.5)
    14.9 (9.9 to 21.0)
        Pain
    54.8 (47.2 to 62.3)
    56.6 (48.9 to 64.0)
        Swelling
    20.9 (15.2 to 27.6)
    24.0 (17.9 to 31.0)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months

    		 Close Top of page
    End point title
    		 Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months [13] [14]
    End point description
    An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized. The analysis population included all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to Day 14 post any vaccination
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule A: Participants 7-11 months Prevnar 13®, Schedule A: Participants 7-11 months
    Number of subjects analysed
    64
    64
    Units: Percentage of Participants
    number (confidence interval 95%)
        Decreased appetite
    15.6 (7.8 to 26.9)
    18.8 (10.1 to 30.5)
        Irritability
    32.8 (21.6 to 45.7)
    43.8 (31.4 to 56.7)
        Drowsiness/Somnolence
    21.9 (12.5 to 34.0)
    15.6 (7.8 to 26.9)
        Hives or Welts/Urticaria
    1.6 (0.0 to 8.4)
    4.7 (1.0 to 13.1)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months

    		 Close Top of page
    End point title
    		 Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months [15] [16]
    End point description
    An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized. The analysis population included all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to 14 days post any vaccination
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule B: Participants 12-23 months Prevnar 13®, Schedule B: Participants 12-23 months
    Number of subjects analysed
    62
    64
    Units: Percentage of Participants
    number (confidence interval 95%)
        Decreased appetite
    22.6 (12.9 to 35.0)
    18.8 (10.1 to 30.5)
        Irritability
    35.5 (23.7 to 48.7)
    21.9 (12.5 to 34.0)
        Drowsiness/Somnolence
    24.2 (14.2 to 36.7)
    17.2 (8.9 to 28.7)
    No statistical analyses for this end point

    Primary: Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years

    		 Close Top of page
    End point title
    		 Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years [17] [18]
    End point description
    An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. For participants ≥3 years to of age at enrollment, solicited systemic AEs include muscle pain/ myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized. The analysis population included all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to 14 days post vaccination
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule C: Participants 2-17 years Prevnar 13®, Schedule C: Participants 2-17 years
    Number of subjects analysed
    177
    175
    Units: Percentage of Participants
    number (confidence interval 95%)
        Joint pain/arthralgia
    0.0 (0.0 to 2.1)
    1.7 (0.4 to 4.9)
        Decreased Appetite
    2.3 (0.6 to 5.7)
    2.9 (0.9 to 6.5)
        Tiredness/Fatigue
    15.8 (10.8 to 22.0)
    17.1 (11.9 to 23.6)
        Headache
    11.9 (7.5 to 17.6)
    13.7 (9.0 to 19.7)
        Irritability
    2.8 (0.9 to 6.5)
    4.0 (1.6 to 8.1)
        Muscle pain/Myalgia
    23.7 (17.7 to 30.7)
    16.6 (11.4 to 22.9)
        Sleepiness/Somnolence
    2.8 (0.9 to 6.5)
    2.9 (0.9 to 6.5)
        Hives or Welts/Urticaria
    1.1 (0.1 to 4.0)
    1.1 (0.1 to 4.1)
    No statistical analyses for this end point

    Primary: Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months

    		 Close Top of page
    End point title
    		 Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months [19] [20]
    End point description
    A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to ~6 months post final vaccination
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule A: Participants 7-11 months Prevnar 13®, Schedule A: Participants 7-11 months
    Number of subjects analysed
    64
    64
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.0 (0.0 to 5.6)
    0.0 (0.0 to 5.6)
    No statistical analyses for this end point

    Primary: Percentage of Participants with at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months

    		 Close Top of page
    End point title
    		 Percentage of Participants with at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months [21] [22]
    End point description
    A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to ~6 months post final vaccination
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule B: Participants 12-23 months Prevnar 13®, Schedule B: Participants 12-23 months
    Number of subjects analysed
    62
    64
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.0 (0.0 to 5.8)
    0.0 (0.0 to 5.6)
    No statistical analyses for this end point

    Primary: Percentage of Participants with at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years

    		 Close Top of page
    End point title
    		 Percentage of Participants with at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years [23] [24]
    End point description
    A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. The analysis population included all randomized participants who received at least 1 dose of study intervention.
    End point type
    Primary
    End point timeframe
    Up to ~6 months post vaccination
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or conducted for this endpoint.
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule C: Participants 2-17 years Prevnar 13®, Schedule C: Participants 2-17 years
    Number of subjects analysed
    177
    175
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.0 (0.0 to 2.1)
    0.0 (0.0 to 2.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months

    		 Close Top of page
    End point title
    		 Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months [25]
    End point description
    Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL. The percentage that achieved the GMC threshold value of ≥0.35 μg/mL was summarized. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
    End point type
    Secondary
    End point timeframe
    30 days post final vaccination
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule A: Participants 7-11 months Prevnar 13®, Schedule A: Participants 7-11 months
    Number of subjects analysed
    64
    64
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (n=60,59)
    100.0 (94.0 to 100.0)
    100.0 (93.9 to 100.0)
        Serotype 3 (n=60,59)
    100.0 (94.0 to 100.0)
    96.6 (88.3 to 99.6)
        Serotype 4 (n=60,59)
    100.0 (94.0 to 100.0)
    100.0 (93.9 to 100.0)
        Serotype 5 (n=60,59)
    100.0 (94.0 to 100.0)
    100.0 (93.9 to 100.0)
        Serotype 6A (n=60,59)
    95.0 (86.1 to 99.0)
    98.3 (90.9 to 100.0)
        Serotype 6B (n=60,59)
    96.7 (88.5 to 99.6)
    100.0 (93.9 to 100.0)
        Serotype 7F (n=60,59)
    100.0 (94.0 to 100.0)
    100.0 (93.9 to 100.0)
        Serotype 9V (n=60,59)
    98.3 (91.1 to 100.0)
    100.0 (93.9 to 100.0)
        Serotype 14 (n=60,59)
    100.0 (94.0 to 100.0)
    100.0 (93.9 to 100.0)
        Serotype 18C (n=60,59)
    100.0 (94.0 to 100.0)
    100.0 (93.9 to 100.0)
        Serotype 19A (n=60,59)
    100.0 (94.0 to 100.0)
    100.0 (93.9 to 100.0)
        Serotype 19F (n=60,59)
    100.0 (94.0 to 100.0)
    100.0 (93.9 to 100.0)
        Serotype 23F (n=60,59)
    98.3 (91.1 to 100.0)
    100.0 (93.9 to 100.0)
        Serotype 22F (n=60,58)
    100.0 (94.0 to 100.0)
    13.8 (6.1 to 25.4)
        Serotype 33F (n=60,59)
    100.0 (94.0 to 100.0)
    11.9 (4.9 to 22.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months

    		 Close Top of page
    End point title
    		 Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months [26]
    End point description
    Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL. The percentage that achieved the GMC threshold value of ≥0.35 μg/mL was summarized. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
    End point type
    Secondary
    End point timeframe
    30 days post final vaccination
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule B: Participants 12-23 months Prevnar 13®, Schedule B: Participants 12-23 months
    Number of subjects analysed
    62
    64
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (n=56,60)
    100.0 (93.6 to 100.0)
    98.3 (91.1 to 100.0)
        Serotype 3 (n=56,60)
    98.2 (90.4 to 100.0)
    90.0 (79.5 to 96.2)
        Serotype 4 (n=56,60)
    100.0 (93.6 to 100.0)
    96.7 (88.5 to 99.6)
        Serotype 5 (n=56,60)
    98.2 (90.4 to 100.0)
    98.3 (91.1 to 100.0)
        Serotype 6A (n=56,60)
    83.9 (71.7 to 92.4)
    95.0 (86.1 to 99.0)
        Serotype 6B (n=56,60)
    89.3 (78.1 to 96.0)
    88.3 (77.4 to 95.2)
        Serotype 7F (n=56,60)
    98.2 (90.4 to 100.0)
    100.0 (94.0 to 100.0)
        Serotype 9V (n=56,60)
    98.2 (90.4 to 100.0)
    96.7 (88.5 to 99.6)
        Serotype 14 (n=56,60)
    98.2 (90.4 to 100.0)
    100.0 (94.0 to 100.0)
        Serotype 18C (n=56,60)
    96.4 (87.7 to 99.6)
    98.3 (91.1 to 100.0)
        Serotype 19A (n=56,60)
    98.2 (90.4 to 100.0)
    100.0 (94.0 to 100.0)
        Serotype 19F (n=56,60)
    100.0 (93.6 to 100.0)
    100.0 (94.0 to 100.0)
        Serotype 23F (n=56,60)
    94.6 (85.1 to 98.9)
    88.3 (77.4 to 95.2)
        Serotype 22F (n=56,60)
    100.0 (93.6 to 100.0)
    6.7 (1.8 to 16.2)
        Serotype 33F (n=56,60)
    94.6 (85.1 to 98.9)
    15.0 (7.1 to 26.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years

    		 Close Top of page
    End point title
    		 Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years [27]
    End point description
    Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL. The percentage that achieved the GMC threshold value of ≥0.35 μg/mL was summarized. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
    End point type
    Secondary
    End point timeframe
    30 days post vaccination
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Each arm of the overall study is identified in successive endpoints (Schedule A: 7-11 months, Schedule B: 12-23 months, and Schedule C: 2-17 years).
    End point values
    		 V114, Schedule C: Participants 2-17 years Prevnar 13®, Schedule C: Participants 2-17 years
    Number of subjects analysed
    177
    175
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (n=162,162)
    99.4 (96.6 to 100.0)
    100.0 (97.7 to 100.0)
        Serotype 3 (n=162,162)
    95.7 (91.3 to 98.2)
    87.7 (81.6 to 92.3)
        Serotype 4 (n=162,162)
    98.8 (95.6 to 99.9)
    100.0 (97.7 to 100.0)
        Serotype 5 (n=162,162)
    99.4 (96.6 to 100.0)
    99.4 (96.6 to 100.0)
        Serotype 6A (n=162,162)
    98.1 (94.7 to 99.6)
    98.1 (94.7 to 99.6)
        Serotype 6B (n=162,162)
    98.1 (94.7 to 99.6)
    96.9 (92.9 to 99.0)
        Serotype 7F (n=162,162)
    99.4 (96.6 to 100.0)
    100.0 (97.7 to 100.0)
        Serotype 9V (n=162,162)
    100.0 (97.7 to 100.0)
    98.8 (95.6 to 99.9)
        Serotype 14 (n=162,162)
    99.4 (96.6 to 100.0)
    98.1 (94.7 to 99.6)
        Serotype 18C (n=162,162)
    100.0 (97.7 to 100.0)
    100.0 (97.7 to 100.0)
        Serotype 19A (n=162,162)
    100.0 (97.7 to 100.0)
    100.0 (97.7 to 100.0)
        Serotype 19F (n=162,162)
    99.4 (96.6 to 100.0)
    100.0 (97.7 to 100.0)
        Serotype 23F (n=162,162)
    99.4 (96.6 to 100.0)
    95.7 (91.3 to 98.2)
        Serotype 22F (n=162,159)
    100.0 (97.7 to 100.0)
    37.7 (30.2 to 45.8)
        Serotype 33F (n=162,160)
    99.4 (96.6 to 100.0)
    37.5 (30.0 to 45.5)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse events: Up to 14 days after vaccination; Serious adverse events and all-cause mortality: Up to ~6 months after the last vaccination.
    Adverse event reporting additional description
    The analysis population included all randomized participants who received at least 1 dose of study intervention.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    V114 (7-11 months)
    Reporting group description
    		 Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.

    Reporting group title
    Prevnar (7-11 months)
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve). 3 doses. Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.

    Reporting group title
    V114 (12-23 months)
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.

    Reporting group title
    Prevnar (12-23 months)
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve), 2 doses: Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.

    Reporting group title
    V114 (2-17 years)
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.

    Reporting group title
    Prevnar (2-17 years)
    Reporting group description
    		 Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced): Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.

    Serious adverse events
    		 V114 (7-11 months) Prevnar (7-11 months) V114 (12-23 months) Prevnar (12-23 months) V114 (2-17 years) Prevnar (2-17 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 64 (10.94%)
    5 / 64 (7.81%)
    4 / 62 (6.45%)
    4 / 64 (6.25%)
    4 / 177 (2.26%)
    4 / 175 (2.29%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 62 (1.61%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
    0 / 62 (0.00%)
    1 / 64 (1.56%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    1 / 64 (1.56%)
    1 / 177 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    1 / 64 (1.56%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chikungunya virus infection
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 62 (1.61%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    1 / 64 (1.56%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    1 / 64 (1.56%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    1 / 177 (0.56%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    1 / 177 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound abscess
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 62 (1.61%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    1 / 62 (1.61%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    1 / 177 (0.56%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V114 (7-11 months) Prevnar (7-11 months) V114 (12-23 months) Prevnar (12-23 months) V114 (2-17 years) Prevnar (2-17 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 64 (68.75%)
    47 / 64 (73.44%)
    46 / 62 (74.19%)
    36 / 64 (56.25%)
    125 / 177 (70.62%)
    125 / 175 (71.43%)
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    14 / 64 (21.88%)
    10 / 64 (15.63%)
    15 / 62 (24.19%)
    11 / 64 (17.19%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences all number
    22
    15
    29
    11
    0
    0
    Headache
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    21 / 177 (11.86%)
    24 / 175 (13.71%)
         occurrences all number
    0
    0
    0
    0
    32
    33
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    18 / 64 (28.13%)
    22 / 64 (34.38%)
    13 / 62 (20.97%)
    14 / 64 (21.88%)
    34 / 177 (19.21%)
    37 / 175 (21.14%)
         occurrences all number
    29
    36
    14
    16
    37
    37
    Injection site induration
         subjects affected / exposed
    11 / 64 (17.19%)
    9 / 64 (14.06%)
    5 / 62 (8.06%)
    6 / 64 (9.38%)
    12 / 177 (6.78%)
    26 / 175 (14.86%)
         occurrences all number
    20
    16
    8
    9
    13
    28
    Injection site swelling
         subjects affected / exposed
    12 / 64 (18.75%)
    10 / 64 (15.63%)
    9 / 62 (14.52%)
    8 / 64 (12.50%)
    37 / 177 (20.90%)
    42 / 175 (24.00%)
         occurrences all number
    23
    17
    11
    8
    39
    43
    Pyrexia
         subjects affected / exposed
    20 / 64 (31.25%)
    14 / 64 (21.88%)
    9 / 62 (14.52%)
    7 / 64 (10.94%)
    13 / 177 (7.34%)
    13 / 175 (7.43%)
         occurrences all number
    26
    16
    11
    7
    14
    14
    Injection site pain
         subjects affected / exposed
    12 / 64 (18.75%)
    5 / 64 (7.81%)
    21 / 62 (33.87%)
    15 / 64 (23.44%)
    97 / 177 (54.80%)
    99 / 175 (56.57%)
         occurrences all number
    19
    6
    27
    17
    111
    106
    Fatigue
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    28 / 177 (15.82%)
    30 / 175 (17.14%)
         occurrences all number
    0
    0
    0
    0
    42
    38
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 64 (6.25%)
    3 / 64 (4.69%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences all number
    4
    3
    0
    0
    0
    0
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    21 / 64 (32.81%)
    28 / 64 (43.75%)
    22 / 62 (35.48%)
    14 / 64 (21.88%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences all number
    39
    41
    33
    18
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    0 / 62 (0.00%)
    0 / 64 (0.00%)
    42 / 177 (23.73%)
    30 / 175 (17.14%)
         occurrences all number
    0
    0
    0
    0
    46
    34
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 64 (3.13%)
    6 / 64 (9.38%)
    8 / 62 (12.90%)
    7 / 64 (10.94%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences all number
    2
    7
    11
    7
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
    4 / 62 (6.45%)
    1 / 64 (1.56%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences all number
    0
    0
    5
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    10 / 64 (15.63%)
    12 / 64 (18.75%)
    14 / 62 (22.58%)
    12 / 64 (18.75%)
    0 / 177 (0.00%)
    0 / 175 (0.00%)
         occurrences all number
    15
    17
    21
    19
    0
    0

    More information

    		 Close Top of page

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    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-Thu Apr 18 13:08:28 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA