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    Clinical Trial Results:
    A Phase 3, Multicenter, Single-arm, Open- Label Study to Assess the Safety, Tolerability, and Immunogenicity of a Single Dose of 13-Valent Pneumococcal Conjugate Vaccine in Japanese Subjects Aged 6 to 64 Years Who are Considered to be at Increased Risk of Pneumococcal Disease and Who are Naive to Pneumococcal Vaccines

    Summary
    EudraCT number
    2018-003054-24
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    16 Nov 2018

    Results information
    Results version number
    v1
    This version publication date
    30 May 2019
    First version publication date
    30 May 2019
    Other versions
    v2

    Trial information

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    Trial identification
    Sponsor protocol code
    B1851172
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03571607
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC) as measured by the incidence of local reactions, systemic events, adverse events (AEs), and serious adverse events (SAEs).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Jul 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 206
    Worldwide total number of subjects
    206
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    18
    Adolescents (12-17 years)
    35
    Adults (18-64 years)
    153
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was conducted in Japan for a total of 206 subjects between 12 July 2018 and 16 November 2018.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    13vPnC: 6 to <18 Years
    Arm description
    Subjects aged between 6 to less than (<) 18 years received a single 0.5 milliliter (mL) dose of 13vPnC intramuscularly on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL 13vPnC conjugate vaccine intramuscularly on Day 1.

    Arm title
    13vPnC: 18 to <65 Years
    Arm description
    Subjects aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL 13vPnC conjugate vaccine intramuscularly on Day 1.

    Number of subjects in period 1
    13vPnC: 6 to <18 Years 13vPnC: 18 to <65 Years
    Started
    53
    153
    Vaccinated
    53
    153
    Completed
    53
    153

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC: 6 to <18 Years
    Reporting group description
    Subjects aged between 6 to less than (<) 18 years received a single 0.5 milliliter (mL) dose of 13vPnC intramuscularly on Day 1.

    Reporting group title
    13vPnC: 18 to <65 Years
    Reporting group description
    Subjects aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.

    Reporting group values
    13vPnC: 6 to <18 Years 13vPnC: 18 to <65 Years Total
    Number of subjects
    53 153 206
    Age categorical
    Units: Subjects
        6 to <18 years
    53 0 53
        18 to <65 years
    0 153 153
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    12.7 ± 2.66 49.0 ± 10.12 -
    Sex: Female, Male
    Units: Subjects
        Female
    22 77 99
        Male
    31 76 107
    Ethnicity, Customized
    Units: Subjects
        Non-Hispanic/non-Latino/not of Spanish origin|
    53 153 206
    Race, Customized
    Units: Subjects
        Asian
    53 153 206
    Subject analysis sets

    Subject analysis set title
    13vPnC: All Subjects
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    All subjects aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.

    Subject analysis sets values
    13vPnC: All Subjects
    Number of subjects
    206
    Age categorical
    Units: Subjects
        6 to <18 years
        18 to <65 years
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    39.6 ± 18.18
    Sex: Female, Male
    Units: Subjects
        Female
    99
        Male
    107
    Ethnicity, Customized
    Units: Subjects
        Non-Hispanic/non-Latino/not of Spanish origin|
    206
    Race, Customized
    Units: Subjects
        Asian
    206

    End points

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    End points reporting groups
    Reporting group title
    13vPnC: 6 to <18 Years
    Reporting group description
    Subjects aged between 6 to less than (<) 18 years received a single 0.5 milliliter (mL) dose of 13vPnC intramuscularly on Day 1.

    Reporting group title
    13vPnC: 18 to <65 Years
    Reporting group description
    Subjects aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.

    Subject analysis set title
    13vPnC: All Subjects
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    All subjects aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.

    Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Subjects Aged Between 6 to <18 Years

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    End point title
    Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Subjects Aged Between 6 to <18 Years [1] [2]
    End point description
    Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (greater than [>] 2.0 to 7.0 cm) and severe (>7.0 cm) for subjects aged 6 to <12 years, and as mild (2.5 to 5.0 cm), moderate (>5.0 to 10.0 cm) and, severe (>10.0 cm) for subjects aged 12 to <18 years. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Safety analysis set included all subjects who received 1 dose of study vaccine. Here, “n” signifies subjects evaluable for each specified category.
    End point type
    Primary
    End point timeframe
    Day 1 up to Day 7
    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 analysis was planned to be analyzed 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: This endpoint was planned to be analyzed only for reporting arm: “13vPnC: 6 to <18 Years”.
    End point values
    13vPnC: 6 to <18 Years
    Number of subjects analysed
    53
    Units: percentage of subjects
    number (confidence interval 95%)
        Redness: Any (n= 47)
    21.3 (10.7 to 35.7)
        Redness: Mild (n= 47)
    10.6 (3.5 to 23.1)
        Redness: Moderate (n= 47)
    10.6 (3.5 to 23.1)
        Redness: Severe (n= 47)
    0.0 (0.0 to 7.5)
        Swelling: Any (n= 47)
    34.0 (20.9 to 49.3)
        Swelling: Mild (n= 47)
    14.9 (6.2 to 28.3)
        Swelling: Moderate (n= 47)
    17.0 (7.6 to 30.8)
        Swelling: Severe (n= 47)
    2.1 (0.1 to 11.3)
        Pain at the injection site: Any (n= 52)
    78.8 (65.3 to 88.9)
        Pain at the injection site: Mild (n= 52)
    57.7 (43.2 to 71.3)
        Pain at the injection site: Moderate (n= 52)
    21.2 (11.1 to 34.7)
        Pain at the injection site: Severe (n= 52)
    0.0 (0.0 to 6.8)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Subjects Aged Between 18 to <65 Years

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    End point title
    Percentage of Subjects Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Subjects Aged Between 18 to <65 Years [3] [4]
    End point description
    Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (>5.0 to 10.0 cm) and, severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Safety analysis set included all subjects who received 1 dose of study vaccine. Here, “n” signifies subjects evaluable for each specified category.
    End point type
    Primary
    End point timeframe
    Day 1 up to Day 14
    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 analysis was planned to be analyzed 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: This endpoint was planned to be analyzed only for reporting arm: “13vPnC: 18 to <65 Years”.
    End point values
    13vPnC: 18 to <65 Years
    Number of subjects analysed
    153
    Units: percentage of subjects
    number (confidence interval 95%)
        Redness: Any (n= 135)
    7.4 (3.6 to 13.2)
        Redness: Mild (n= 135)
    5.2 (2.1 to 10.4)
        Redness: Moderate (n= 135)
    2.2 (0.5 to 6.4)
        Redness: Severe (n= 135)
    0.0 (0.0 to 2.7)
        Swelling: Any (n= 136)
    12.5 (7.5 to 19.3)
        Swelling: Mild (n= 136)
    5.1 (2.1 to 10.3)
        Swelling: Moderate (n= 136)
    7.4 (3.6 to 13.1)
        Swelling: Severe (n= 136)
    0.0 (0.0 to 2.7)
        Pain at the injection site: Any (n= 145)
    66.2 (57.9 to 73.8)
        Pain at the injection site: Mild (n= 145)
    53.8 (45.3 to 62.1)
        Pain at the injection site: Moderate (n= 145)
    11.0 (6.4 to 17.3)
        Pain at the injection site: Severe (n= 145)
    1.4 (0.2 to 4.9)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Systemic Events and use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Subjects Aged Between 6 to <18 Years

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    End point title
    Percentage of Subjects Reporting Systemic Events and use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Subjects Aged Between 6 to <18 Years [5] [6]
    End point description
    Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (greater than or equals to [>=] 6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). Safety analysis set included all subjects who received 1 dose of study vaccine. Here, “n” signifies subjects evaluable for each specified category.
    End point type
    Primary
    End point timeframe
    Day 1 up to Day 7
    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 analysis was planned to be analyzed 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: This endpoint was planned to be analyzed only for reporting arm: “13vPnC: 6 to <18 Years”.
    End point values
    13vPnC: 6 to <18 Years
    Number of subjects analysed
    53
    Units: percentage of subjects
    number (confidence interval 95%)
        Fever: 37.5 degree C to 38.4 degree C (n= 48)
    12.5 (4.7 to 25.2)
        Fever: 38.5 degree C to 38.9 degree C (n= 48)
    2.1 (0.1 to 11.1)
        Fever: 39.0 degree C to 40.0 degree C (n= 48)
    0.0 (0.0 to 7.4)
        Fever: >40.0 degree C (n= 48)
    0.0 (0.0 to 7.4)
        Fatigue: Any (n= 48)
    37.5 (24.0 to 52.6)
        Fatigue: Mild (n= 48)
    25.0 (13.6 to 39.6)
        Fatigue: Moderate (n= 48)
    10.4 (3.5 to 22.7)
        Fatigue: Severe (n= 48)
    2.1 (0.1 to 11.1)
        Headache: Any (n= 49)
    24.5 (13.3 to 38.9)
        Headache: Mild (n= 49)
    16.3 (7.3 to 29.7)
        Headache: Moderate (n= 49)
    6.1 (1.3 to 16.9)
        Headache: Severe (n= 49)
    2.0 (0.1 to 10.9)
        Vomiting: Any (n= 47)
    0.0 (0.0 to 7.5)
        Vomiting: Mild (n= 47)
    0.0 (0.0 to 7.5)
        Vomiting: Moderate (n= 47)
    0.0 (0.0 to 7.5)
        Vomiting: Severe (n= 47)
    0.0 (0.0 to 7.5)
        Diarrhea: Any (n= 48)
    8.3 (2.3 to 20.0)
        Diarrhea: Mild (n= 48)
    8.3 (2.3 to 20.0)
        Diarrhea: Moderate (n= 48)
    0.0 (0.0 to 7.4)
        Diarrhea: Severe (n= 48)
    0.0 (0.0 to 7.4)
        Muscle pain: Any (n= 49)
    30.6 (18.3 to 45.4)
        Muscle pain: Mild (n= 49)
    26.5 (14.9 to 41.1)
        Muscle pain: Moderate (n= 49)
    4.1 (0.5 to 14.0)
        Muscle pain: Severe (n= 49)
    0.0 (0.0 to 7.3)
        Joint pain: Any (n= 48)
    6.3 (1.3 to 17.2)
        Joint pain: Mild (n= 48)
    4.2 (0.5 to 14.3)
        Joint pain: Moderate (n= 48)
    2.1 (0.1 to 11.1)
        Joint pain: Severe (n= 48)
    0.0 (0.0 to 7.4)
        Use of antipyretic or pain medication (n= 47)
    6.4 (1.3 to 17.5)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Systemic Events and use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Subjects Aged Between 18 to <65 Years

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    End point title
    Percentage of Subjects Reporting Systemic Events and use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Subjects Aged Between 18 to <65 Years [7] [8]
    End point description
    Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). Safety analysis set included all subjects who received 1 dose of study vaccine. Here, “n” signifies subjects evaluable for each specified category.
    End point type
    Primary
    End point timeframe
    Day 1 up to Day 14
    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 analysis was planned to be analyzed 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: This endpoint was planned to be analyzed only for reporting arm: “13vPnC: 18 to <65 Years”.
    End point values
    13vPnC: 18 to <65 Years
    Number of subjects analysed
    153
    Units: percentage of subjects
    number (confidence interval 95%)
        Fever: 37.5 degree C to 38.4 degree C (n= 134)
    6.0 (2.6 to 11.4)
        Fever: 38.5 degree C to 38.9 degree C (n= 134)
    0.0 (0.0 to 2.7)
        Fever: 39.0 degree C to 40.0 degree C (n= 134)
    0.0 (0.0 to 2.7)
        Fever: >40.0 degree C (n= 134)
    0.0 (0.0 to 2.7)
        Fatigue: Any (n= 142)
    33.1 (25.4 to 41.5)
        Fatigue: Mild (n= 142)
    25.4 (18.4 to 33.3)
        Fatigue: Moderate (n= 142)
    7.7 (3.9 to 13.4)
        Fatigue: Severe (n= 142)
    0.0 (0.0 to 2.6)
        Headache: Any (n= 141)
    23.4 (16.7 to 31.3)
        Headache: Mild (n= 141)
    19.1 (13.0 to 26.6)
        Headache: Moderate (n= 141)
    4.3 (1.6 to 9.0)
        Headache: Severe (n= 141)
    0.0 (0.0 to 2.6)
        Vomiting: Any (n= 136)
    1.5 (0.2 to 5.2)
        Vomiting: Mild (n= 136)
    1.5 (0.2 to 5.2)
        Vomiting: Moderate (n= 136)
    0.0 (0.0 to 2.7)
        Vomiting: Severe (n= 136)
    0.0 (0.0 to 2.7)
        Diarrhea: Any (n= 141)
    18.4 (12.4 to 25.8)
        Diarrhea: Mild (n= 141)
    15.6 (10.0 to 22.7)
        Diarrhea: Moderate (n= 141)
    2.1 (0.4 to 6.1)
        Diarrhea: Severe (n= 141)
    0.7 (0.0 to 3.9)
        Muscle pain: Any (n= 139)
    27.3 (20.1 to 35.5)
        Muscle pain: Mild (n= 139)
    20.9 (14.4 to 28.6)
        Muscle pain: Moderate (n= 139)
    5.8 (2.5 to 11.0)
        Muscle pain: Severe (n= 139)
    0.7 (0.0 to 3.9)
        Joint pain: Any (n= 138)
    13.8 (8.5 to 20.7)
        Joint pain: Mild (n= 138)
    9.4 (5.1 to 15.6)
        Joint pain: Moderate (n= 138)
    3.6 (1.2 to 8.3)
        Joint pain: Severe (n= 138)
    0.7 (0.0 to 4.0)
        Use of antipyretic or pain medication (n= 134)
    8.2 (4.2 to 14.2)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    Percentage of Subjects Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) [9]
    End point description
    An AE was any untoward medical occurrence in a subjects who received study vaccine without regard to possibility of causal relationship. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect. Safety analysis set included all subjects who received 1 dose of study vaccine.
    End point type
    Primary
    End point timeframe
    signing of informed consent form (Day 1) up to Day 43
    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 analysis was planned to be analyzed for this endpoint.
    End point values
    13vPnC: All Subjects
    Number of subjects analysed
    206
    Units: percentage of subjects
    number (not applicable)
        AEs
    16
        SAEs
    0
    No statistical analyses for this end point

    Secondary: Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination

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    End point title
    Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination
    End point description
    Pneumococcal IgG antibody against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using direct binding Luminex assay. Results were expressed as IgG concentrations. IgG concentrations were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean concentrations (GMCs). Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. Evaluable immunogenicity population: eligible subjects who received the study vaccine and took no prohibited vaccines, had blood drawn within the specified time frame 1 month after vaccination with at least 1 valid and determinate assay result (OPA titer or IgG concentration) for at least 1 serotype 1 month after vaccination and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination and 1 month after vaccination
    End point values
    13vPnC: All Subjects
    Number of subjects analysed
    206
    Units: microgram per milliliter (mcg/mL)
    geometric mean (confidence interval 95%)
        Pre-vaccination; Serotype 1
    0.132 (0.109 to 0.161)
        1 month after vaccination; Serotype 1
    4.427 (3.423 to 5.726)
        Pre-vaccination; Serotype 3
    0.115 (0.094 to 0.141)
        1 month after vaccination; Serotype 3
    0.531 (0.437 to 0.646)
        Pre-vaccination; Serotype 4
    0.055 (0.045 to 0.068)
        1 month after vaccination; Serotype 4
    1.826 (1.387 to 2.404)
        Pre-vaccination; Serotype 5
    0.058 (0.046 to 0.075)
        1 month after vaccination; Serotype 5
    2.779 (1.972 to 3.915)
        Pre-vaccination; Serotype 6A
    0.173 (0.133 to 0.224)
        1 month after vaccination; Serotype 6A
    4.070 (2.915 to 5.684)
        Pre-vaccination; Serotype 6B
    0.105 (0.080 to 0.138)
        1 month after vaccination; Serotype 6B
    2.354 (1.631 to 3.396)
        Pre-vaccination; Serotype 7F
    0.117 (0.092 to 0.150)
        1 month after vaccination; Serotype 7F
    4.670 (3.629 to 6.010)
        Pre-vaccination; Serotype 9V
    0.067 (0.054 to 0.082)
        1 month after vaccination; Serotype 9V
    1.483 (1.131 to 1.944)
        Pre-vaccination; Serotype 14
    0.335 (0.252 to 0.447)
        1 month after vaccination; Serotype 14
    7.769 (5.844 to 10.328)
        Pre-vaccination; Serotype 18C
    0.168 (0.131 to 0.216)
        1 month after vaccination; Serotype 18C
    5.187 (4.026 to 6.682)
        Pre-vaccination; Serotype 19A
    0.496 (0.391 to 0.629)
        1 month after vaccination; Serotype 19A
    7.616 (5.786 to 10.026)
        Pre-vaccination; Serotype 19F
    0.217 (0.171 to 0.275)
        1 month after vaccination; Serotype 19F
    4.315 (3.241 to 5.744)
        Pre-vaccination; Serotype 23F
    0.181 (0.143 to 0.228)
        1 month after vaccination; Serotype 23F
    6.283 (4.524 to 8.727)
    No statistical analyses for this end point

    Secondary: GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination

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    End point title
    GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination
    End point description
    IgG GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in concentrations at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination. Evaluable immunogenicity population: eligible subjects who received the study vaccine and took no prohibited vaccines, had blood drawn within the specified time frame 1 month after vaccination with at least 1 valid and determinate assay result (OPA titer or IgG concentration) for at least 1 serotype 1 month after vaccination and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    Pre-vaccination to 1 month after vaccination
    End point values
    13vPnC: All Subjects
    Number of subjects analysed
    206
    Units: fold rise
    geometric mean (confidence interval 95%)
        Serotype 1
    33.445 (26.374 to 42.413)
        Serotype 3
    4.605 (3.839 to 5.524)
        Serotype 4
    32.960 (25.331 to 42.886)
        Serotype 5
    47.565 (36.867 to 61.368)
        Serotype 6A
    23.587 (18.010 to 30.890)
        Serotype 6B
    22.421 (17.045 to 29.493)
        Serotype 7F
    39.843 (31.473 to 50.438)
        Serotype 9V
    22.232 (17.426 to 28.362)
        Serotype 14
    23.161 (17.179 to 31.227)
        Serotype 18C
    30.833 (24.008 to 39.597)
        Serotype 19A
    15.354 (12.116 to 19.459)
        Serotype 19F
    19.892 (15.552 to 25.443)
        Serotype 23F
    34.809 (26.436 to 45.833)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    signing of informed consent form (Day 1) up to Day 43
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    13vPnC: 6 to <18 Years
    Reporting group description
    Subjects aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.

    Reporting group title
    13vPnC: 18 to <65 Years
    Reporting group description
    Subjects aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.

    Reporting group title
    13vPnC: All Subjects
    Reporting group description
    All subjects aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1.

    Serious adverse events
    13vPnC: 6 to <18 Years 13vPnC: 18 to <65 Years 13vPnC: All Subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 153 (0.00%)
    0 / 206 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    13vPnC: 6 to <18 Years 13vPnC: 18 to <65 Years 13vPnC: All Subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 53 (92.45%)
    121 / 153 (79.08%)
    170 / 206 (82.52%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Wrist fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 153 (0.00%)
    1 / 206 (0.49%)
         occurrences all number
    1
    0
    1
    Hyperventilation
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Headache
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    12 / 49 (24.49%)
    33 / 141 (23.40%)
    45 / 190 (23.68%)
         occurrences all number
    12
    33
    45
    General disorders and administration site conditions
    Fatigue
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    18 / 48 (37.50%)
    47 / 142 (33.10%)
    65 / 190 (34.21%)
         occurrences all number
    18
    47
    65
    Redness
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    10 / 47 (21.28%)
    10 / 135 (7.41%)
    20 / 182 (10.99%)
         occurrences all number
    10
    10
    20
    Injection site erythema
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 153 (0.00%)
    1 / 206 (0.49%)
         occurrences all number
    1
    0
    1
    Pain at the injection site
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    41 / 52 (78.85%)
    96 / 145 (66.21%)
    137 / 197 (69.54%)
         occurrences all number
    41
    96
    137
    Injection site pain
         subjects affected / exposed
    1 / 53 (1.89%)
    2 / 153 (1.31%)
    3 / 206 (1.46%)
         occurrences all number
    1
    2
    3
    Injection site swelling
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    16 / 47 (34.04%)
    17 / 136 (12.50%)
    33 / 183 (18.03%)
         occurrences all number
    16
    17
    33
    Pyrexia
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    7 / 48 (14.58%)
    8 / 134 (5.97%)
    15 / 182 (8.24%)
         occurrences all number
    7
    8
    15
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Psychiatric disorders
    Middle insomnia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    4 / 48 (8.33%)
    26 / 141 (18.44%)
    30 / 189 (15.87%)
         occurrences all number
    4
    26
    30
    Vomiting
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    0 / 47 (0.00%)
    2 / 136 (1.47%)
    2 / 183 (1.09%)
         occurrences all number
    0
    2
    2
    Enteritis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 153 (0.00%)
    1 / 206 (0.49%)
         occurrences all number
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Rash papular
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 153 (0.00%)
    1 / 206 (0.49%)
         occurrences all number
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    3 / 48 (6.25%)
    19 / 138 (13.77%)
    22 / 186 (11.83%)
         occurrences all number
    3
    19
    22
    Back pain
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Myalgia
    Additional description: Number of subjects exposed = number of subjects evaluable for the adverse event.
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    15 / 49 (30.61%)
    38 / 139 (27.34%)
    53 / 188 (28.19%)
         occurrences all number
    15
    38
    53
    Pain in extremity
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 153 (0.00%)
    1 / 206 (0.49%)
         occurrences all number
    1
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 53 (1.89%)
    8 / 153 (5.23%)
    9 / 206 (4.37%)
         occurrences all number
    1
    8
    9
    Herpes zoster
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Pharyngitis
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 153 (1.31%)
    5 / 206 (2.43%)
         occurrences all number
    3
    2
    5
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 153 (0.65%)
    1 / 206 (0.49%)
         occurrences all number
    0
    1
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects evaluable for this particular adverse event was 49, 141 and 190 for reporting arms “13vPnC: 6 to <18 Years”, “13vPnC: 18 to <65 Years” and ‘’13vPnC: All Subjects’’ respectively.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects evaluable for this particular adverse event was 48, 142 and 190 for reporting arms “13vPnC: 6 to <18 Years”, “13vPnC: 18 to <65 Years” and ‘’13vPnC: All Subjects’’ respectively.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects evaluable for this particular adverse event was 47, 135 and 182 for reporting arms “13vPnC: 6 to <18 Years”, “13vPnC: 18 to <65 Years” and ‘’13vPnC: All Subjects’’ respectively.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects evaluable for this particular adverse event was 52, 145 and 197 for reporting arms “13vPnC: 6 to <18 Years”, “13vPnC: 18 to <65 Years” and ‘’13vPnC: All Subjects’’ respectively.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects evaluable for this particular adverse event was 47, 136 and 183 for reporting arms “13vPnC: 6 to <18 Years”, “13vPnC: 18 to <65 Years” and ‘’13vPnC: All Subjects’’ respectively.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects evaluable for this particular adverse event was 48, 134 and 182 for reporting arms “13vPnC: 6 to <18 Years”, “13vPnC: 18 to <65 Years” and ‘’13vPnC: All Subjects’’ respectively.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects evaluable for this particular adverse event was 48, 141 and 189 for reporting arms “13vPnC: 6 to <18 Years”, “13vPnC: 18 to <65 Years” and ‘’13vPnC: All Subjects’’ respectively.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects evaluable for this particular adverse event was 47, 136 and 183 for reporting arms “13vPnC: 6 to <18 Years”, “13vPnC: 18 to <65 Years” and ‘’13vPnC: All Subjects’’ respectively.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects evaluable for this particular adverse event was 48, 138 and 186 for reporting arms “13vPnC: 6 to <18 Years”, “13vPnC: 18 to <65 Years” and ‘’13vPnC: All Subjects’’ respectively.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The number of subjects evaluable for this particular adverse event was 49, 139 and 188 for reporting arms “13vPnC: 6 to <18 Years”, “13vPnC: 18 to <65 Years” and ‘’13vPnC: All Subjects’’ respectively.

    More information

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    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.
    OPA will be reported once available.
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