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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   39192   clinical trials with a EudraCT protocol, of which   6421   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).
     
    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, Open-label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine in Recipients of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years and Older

    Summary
    EudraCT number
    2009-012087-13
    Trial protocol
    BE   DE   SE   FR   NL   ES   CZ   Outside EU/EEA  
    Global end of trial date
    16 May 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Jun 2016
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    B1851022 (6115A1-3003-WW)
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00980655
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 1 8007181021, 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
    15 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immune responses 1 month after 3 doses of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) as measured by fold rises of serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in subjects aged 2 Years and older.
    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 Conference on Harmonization (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
    18 Jan 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Belgium: 81
    Country: Number of subjects enrolled
    France: 46
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    Sweden: 35
    Country: Number of subjects enrolled
    Czech Republic: 7
    Country: Number of subjects enrolled
    Poland: 13
    Country: Number of subjects enrolled
    United States: 15
    Country: Number of subjects enrolled
    Canada: 6
    Worldwide total number of subjects
    247
    EEA total number of subjects
    226
    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)
    34
    Adolescents (12-17 years)
    25
    Adults (18-64 years)
    168
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Total 61 and 190 subjects were enrolled in 13vPnC, 23vPS (Pediatric Subjects) and 13vPnC, 23vPS (Adult Subjects) respectively. Of these, 59 subjects in 13vPnC, 23vPS (Pediatric Subjects) and 188 subjects in 13vPnC, 23vPS (Adult Subjects) were treated.

    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, 23vPS (Pediatric Subjects)
    Arm description
    Pediatric subjects aged 2 to 17 years received 4 single doses of 13vPnC followed by a single dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
    Arm type
    Experimental

    Investigational medicinal product name
    23vPS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5 milliliter (mL) dose of 23vPS intramuscular injection administered 1 month after 13vPnC Dose 4.

    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 4 single 0.5 mL doses of 13vPnC intramuscular injections. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3

    Arm title
    13vPnC, 23vPS (Adult Subjects)
    Arm description
    Adult subjects aged 18 years and above received 4 single doses of 13vPnC followed by single dose of 23vPS. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
    Arm type
    Experimental

    Investigational medicinal product name
    23vPS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5 mL dose of 23vPS intramuscular injection administered 1 month after 13vPnC Dose 4.

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4 single 0.5 mL doses of 13vPnC intramuscular injections. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3.

    Number of subjects in period 1
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects)
    Started
    59
    188
    Vaccinated 13vPnC Dose 1
    59
    188
    Vaccinated 23vPS Dose
    45
    140
    Vaccinated 13vPnC Dose 4
    46
    146
    Vaccinated 13vPnC Dose 2
    55
    176
    Vaccinated 13vPnC Dose 3
    54
    167
    Completed
    45
    139
    Not completed
    14
    49
         Death
    -
    7
         Withdrawal by Subject
    -
    3
         Protocol Violation
    1
    6
         Unspecified
    -
    1
         Adverse Event
    13
    31
         Lost to follow-up
    -
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    13vPnC, 23vPS (Pediatric Subjects)
    Reporting group description
    Pediatric subjects aged 2 to 17 years received 4 single doses of 13vPnC followed by a single dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.

    Reporting group title
    13vPnC, 23vPS (Adult Subjects)
    Reporting group description
    Adult subjects aged 18 years and above received 4 single doses of 13vPnC followed by single dose of 23vPS. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.

    Reporting group values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) Total
    Number of subjects
    59 188 247
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    10.3 ± 4.41 47.3 ± 12.39 -
    Gender categorical
    Units: Subjects
        Female
    26 74 100
        Male
    33 114 147

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    13vPnC, 23vPS (Pediatric Subjects)
    Reporting group description
    Pediatric subjects aged 2 to 17 years received 4 single doses of 13vPnC followed by a single dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.

    Reporting group title
    13vPnC, 23vPS (Adult Subjects)
    Reporting group description
    Adult subjects aged 18 years and above received 4 single doses of 13vPnC followed by single dose of 23vPS. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.

    Subject analysis set title
    13vPnC, 23vPS (All Subjects)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All subjects aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.

    Primary: Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Subjects

    Close Top of page
    End point title
    Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Subjects [1]
    End point description
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all subjects with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws. Evaluable immunogenicity population: eligible subjects who received vaccination as assigned; had blood drawn within pre-specified time-frames; had at least 1 valid, determinate assay result; had no major protocol violation, n = subjects evaluable for specified serotype.
    End point type
    Primary
    End point timeframe
    Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3
    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: Only descriptive data was planned to be reported for this end point.
    End point values
    13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    247 [2]
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 1 (n=191)
    17.96 (13.63 to 23.66)
        Serotype 3 (n=192)
    5.07 (3.98 to 6.46)
        Serotype 4 (n=193)
    23.85 (17.61 to 32.3)
        Serotype 5 (n=194)
    2.99 (2.46 to 3.63)
        Serotype 6A (n=195)
    5.35 (4.18 to 6.85)
        Serotype 6B (n=192)
    5.18 (3.99 to 6.74)
        Serotype 7F (n=195)
    10.28 (8.15 to 12.96)
        Serotype 9V (n=196)
    5.76 (4.63 to 7.17)
        Serotype 14 (n=197)
    4.95 (3.72 to 6.58)
        Serotype 18C (n=196)
    8.22 (6.36 to 10.62)
        Serotype 19A (n=196)
    3.9 (3.1 to 4.89)
        Serotype 19F (n=195)
    6.73 (5.15 to 8.78)
        Serotype 23F (n=197)
    8.01 (6.11 to 10.51)
    Notes
    [2] - N (number of subjects analyzed)=subjects evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Subjects

    Close Top of page
    End point title
    Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Subjects
    End point description
    Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all subjects are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all subjects with available data for 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable immunogenicity population. Here, 'n' signifies all subjects who were evaluable for specified serotype for each treatment arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 month after 13vPnC Dose 3
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    49 [3]
    149 [4]
    198 [5]
    Units: microgram per milliliter (mcg/mL)
    geometric mean (confidence interval 95%)
        Serotype 1 (n=49, 147, 196)
    3.52 (2.38 to 5.19)
    2.05 (1.53 to 2.76)
    2.35 (1.84 to 2.99)
        Serotype 3 (n=49, 147, 196)
    1.6 (1.13 to 2.26)
    0.62 (0.49 to 0.79)
    0.79 (0.64 to 0.97)
        Serotype 4 (n=49, 147, 196)
    4.13 (2.68 to 6.36)
    1.78 (1.35 to 2.34)
    2.2 (1.73 to 2.78)
        Serotype 5 (n=48, 149, 197)
    4.18 (2.95 to 5.91)
    2 (1.6 to 2.51)
    2.39 (1.97 to 2.91)
        Serotype 6A (n=49, 148, 197)
    7.61 (5.16 to 11.23)
    3.31 (2.53 to 4.33)
    4.07 (3.25 to 5.11)
        Serotype 6B (n=48, 147, 195)
    6.29 (3.88 to 10.19)
    3 (2.25 to 3.98)
    3.6 (2.81 to 4.61)
        Serotype 7F (n=48, 149, 197)
    7.34 (5.12 to 10.53)
    3.92 (3.08 to 5)
    4.57 (3.72 to 5.61)
        Serotype 9V (n=49, 149, 198)
    4.17 (3.01 to 5.98)
    2.44 (1.93 to 3.1)
    2.79 (2.29 to 3.4)
        Serotype 14 (n=49, 149, 198)
    6.22 (4.03 to 9.61)
    5.99 (4.35 to 8.26)
    6.05 (4.65 to 7.86)
        Serotype 18C (n=49, 148, 197)
    4.17 (2.9 to 5.98)
    3.04 (2.37 to 3.91)
    3.29 (2.67 to 4.05)
        Serotype 19A (n=49, 148, 197)
    8.26 (5.86 to 11.65)
    4.77 (3.77 to 6.04)
    5.47 (4.49 to 6.67)
        Serotype 19F (n=49, 148, 197)
    5.8 (3.8 to 8.84)
    3.48 (2.69 to 4.5)
    3.95 (3.17 to 4.93)
        Serotype 23F (n=49, 149, 198)
    6.74 (4.12 to 11.05)
    3.87 (2.85 to 5.26)
    4.44 (3.42 to 5.77)
    Notes
    [3] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [4] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [5] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects

    Close Top of page
    End point title
    Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects
    End point description
    Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all subjects are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all subjects with available data for 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable immunogenicity population. Here , 'n' signifies all subjects who were evaluable for specified serotype for each treatment arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 month after 13vPnC Dose 4
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    38 [6]
    124 [7]
    162 [8]
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (n=38, 123, 161)
    8.75 (5.64 to 13.59)
    4.67 (0.71 to 1.17)
    5.41 (0.7 to 1.2)
        Serotype 3 (n=38, 123, 161)
    1.23 (0.89 to 1.7)
    0.91 (3.31 to 6.27)
    0.97 (3.99 to 6.86)
        Serotype 4 (n=36, 124, 160)
    8.41 (5.15 to 13.72)
    4.56 (4.28 to 7.26)
    5.23 (4.95 to 7.64)
        Serotype 5 (n=38, 122, 160)
    8.43 (6.07 to 11.7)
    5.57 (8.63 to 17)
    6.15 (9.99 to 17.13)
        Serotype 6A (n=37, 122, 159)
    16.33 (10.59 to 25.16)
    12.23 (8.81 to 16.98)
    13.08 (10.04 to 17.7)
        Serotype 6B (n=38, 124, 162)
    18.13 (11.15 to 29.47)
    12.13 (3.37 to 6.47)
    13.33 (7 to 10.83)
        Serotype 7F (n=38, 124, 162)
    10.37 (7.36 to 14.61)
    8.26 (6.33 to 10.78)
    8.71 (4.13 to 7.1)
        Serotype 9V (n=37, 124, 161)
    7.78 (5.21 to 11.61)
    5.09 (3.93 to 6.59)
    5.61 (4.5 to 6.98)
        Serotype 14 (n=37, 124, 161)
    16.04 (10.04 to 25.63)
    12.24 (9.09 to 16.47)
    13.02 (10.13 to 16.74)
        Serotype 18C (n=38, 122, 160)
    6.54 (4.04 to 10.59)
    6.69 (5.01 to 8.93)
    6.65 (5.2 to 8.51)
        Serotype 19A (n=37, 124, 161)
    16.94 (11.05 to 25.98)
    12.99 (9.78 to 17.26)
    13.81 (10.88 to 17.52)
        Serotype 19F (n=38, 123, 161)
    19.96 (12.19 to 32.68)
    13.69 (9.93 to 18.88)
    14.96 (11.42 to 19.61)
        Serotype 23F (n=38, 123, 161)
    16.65 (10.73 to 25.82)
    12.68 (8.82 to 18.22)
    13.52 (10.07 to 18.15)
    Notes
    [6] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [7] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [8] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Subjects

    Close Top of page
    End point title
    Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Subjects
    End point description
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all students with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws. Evaluable immunogenicity population. Here , 'n' signifies all subjects who were evaluable for specified serotype for each treatment arm, respectively.
    End point type
    Secondary
    End point timeframe
    Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects)
    Number of subjects analysed
    49 [9]
    148 [10]
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 1 (n=48, 143)
    27.64 (16.75 to 45.62)
    15.54 (11.2 to 21.56)
        Serotype 3 (n=48, 144)
    7.58 (4.74 to 12.13)
    4.43 (3.35 to 5.88)
        Serotype 4 (n=49, 144)
    40.83 (23.84 to 69.95)
    19.86 (13.83 to 28.52)
        Serotype 5 (n=47, 147)
    4.11 (2.86 to 5.9)
    2.7 (2.15 to 3.39)
        Serotype 6A (n=48, 147)
    7.49 (4.79 to 11.72)
    4.79 (3.57 to 6.44)
        Serotype 6B (n=47, 145)
    6.02 (3.79 to 9.55)
    4.94 (3.6 to 6.77)
        Serotype 7F (n=48, 147)
    14.65 (9.63 to 22.28)
    9.15 (6.95 to 12.05)
        Serotype 9V (n=48, 148)
    7.64 (5.4 to 10.82)
    5.26 (4.02 to 6.87)
        Serotype 14 (n=49, 148)
    5.01 (2.83 to 8.86)
    4.92 (3.53 to 6.87)
        Serotype 18C (n=49, 147)
    12.59 (7.84 to 20.21)
    7.13 (5.27 to 9.65)
        Serotype 19A (n=49, 147)
    5.04 (3.38 to 7.51)
    3.58 (2.72 to 4.7)
        Serotype 19F (n=49, 146)
    7.66 (4.67 to 12.57)
    6.44 (4.69 to 8.85)
        Serotype 23F (n=49, 148)
    9.73 (5.79 to 16.34)
    7.52 (5.46 to 10.35)
    Notes
    [9] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [10] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects

    Close Top of page
    End point title
    Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects
    End point description
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all subjects with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 4 blood draws. Evaluable immunogenicity population. Here, 'n' signifies all subjects who were evaluable for specified serotype for each treatment arm, respectively.
    End point type
    Secondary
    End point timeframe
    Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    38 [11]
    123 [12]
    161 [13]
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 1 (n=37, 120, 157)
    70.66 (39.2 to 127.36)
    35.81 (25.06 to 51.18)
    42.03 (30.94 to 57.11)
        Serotype 3 (n=37, 120, 157)
    5.88 (3.25 to 10.61)
    6.41 (4.74 to 8.66)
    6.28 (4.81 to 8.19)
        Serotype 4 (n=36, 121, 157)
    90.31 (48.05 to 169.77)
    47.47 (32.09 to 70.22)
    55.02 (39.39 to 76.85)
        Serotype 5 (n=37, 119, 156)
    7.76 (4.81 to 12.51)
    7.29 (5.32 to 9.99)
    7.4 (5.69 to 9.63)
        Serotype 6A (n=36, 121, 157)
    15.62 (9.63 to 25.34)
    17.02 (11.95 to 24.23)
    16.7 (12.47 to 22.34)
        Serotype 6B (n=37, 122, 159)
    16.9 (9.76 to 29.25)
    20.09 (13.94 to 28.94)
    19.29 (14.22 to 26.18)
        Serotype 7F (n=38, 123, 161)
    19.18 (11.75 to 31.33)
    18.69 (13.7 to 25.5)
    18.81 (14.48 to 24.43)
        Serotype 9V (n=36, 122, 158)
    14.9 (9.55 to 23.25)
    11.13 (8.27 to 14.99)
    11.9 (9.27 to 15.27)
        Serotype 14 (n=37, 123, 160)
    12.61 (6.47 to 24.56)
    9.69 (6.8 to 13.8)
    10.3 (7.55 to 14.03)
        Serotype 18C (n=38, 121, 159)
    21.22 (12.05 to 37.36)
    14.4 (10.17 to 20.41)
    15.8 (11.76 to 21.24)
        Serotype 19A (n=37, 123, 160)
    11.46 (7.22 to 18.2)
    9.52 (6.9 to 13.12)
    9.94 (7.61 to 12.98)
        Serotype 19F (n=38, 120, 158)
    29.31 (16.63 to 51.64)
    25.63 (17.56 to 37.43)
    26.47 (19.31 to 36.29)
        Serotype 23F (n=38, 122, 160)
    25.37 (14.69 to 43.83)
    23.02 (15.63 to 33.92)
    23.56 (17.11 to 32.45)
    Notes
    [11] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [12] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [13] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects

    Close Top of page
    End point title
    Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects
    End point description
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all subjects with available data from both after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws. Evaluable immunogenicity population. Here, 'n' signifies all subjects who were evaluable for specified serotype for each treatment arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    37 [14]
    121 [15]
    157 [16]
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 1 (n=37, 119, 156)
    2.8 (1.99 to 3.95)
    2.16 (1.65 to 2.82)
    2.3 (1.85 to 2.86)
        Serotype 3 (n=37, 119, 156)
    0.88 (0.64 to 1.22)
    1.32 (1.07 to 1.62)
    1.2 (1.01 to 1.43)
        Serotype 4 (n=35, 121, 156)
    2.19 (1.51 to 3.19)
    2.32 (1.88 to 2.86)
    2.29 (1.91 to 2.74)
        Serotype 5 (n=37, 119, 156)
    2.25 (1.74 to 2.93)
    2.43 (1.94 to 3.06)
    2.39 (1.99 to 2.87)
        Serotype 6A (n=36, 119, 155)
    2.36 (1.87 to 2.99)
    3.06 (2.35 to 3.98)
    2.88 (2.34 to 3.55)
        Serotype 6B (n=37, 120, 157)
    2.96 (2.09 to 4.19)
    3.1 (2.44 to 3.95)
    3.07 (2.51 to 3.75)
        Serotype 7F (n=36, 121, 157)
    1.51 (1.08 to 2.11)
    1.83 (1.47 to 2.29)
    1.75 (1.46 to 2.11)
        Serotype 9V (n=36, 121, 157)
    2.08 (1.43 to 3.03)
    1.82 (1.48 to 2.23)
    1.88 (1.57 to 2.24)
        Serotype 14 (n=36, 121, 157)
    2.5 (1.65 to 3.8)
    1.68 (1.32 to 2.13)
    1.84 (1.5 to 2.26)
        Serotype 18C (n=37, 118, 155)
    1.64 (1.24 to 2.16)
    1.87 (1.54 to 2.28)
    1.81 (1.54 to 2.13)
        Serotype 19A (n=36, 121, 157)
    2.25 (1.6 to 3.17)
    2.33 (1.91 to 2.85)
    2.31 (1.95 to 2.74)
        Serotype 19F (n=37, 120, 157)
    3.5 (2.15 to 5.68)
    3.65 (2.9 to 4.59)
    3.61 (2.94 to 4.44)
        Serotype 23F (n=37, 120, 157)
    2.49 (1.72 to 3.61)
    2.59 (2.04 to 3.3)
    2.57 (2.1 to 3.14)
    Notes
    [14] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [15] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [16] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 1

    Close Top of page
    End point title
    Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 1
    End point description
    Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for subjects aged 2 to less than [<]12 years and 2.5 to 5.0 cm for subjects aged greater than or equal to [ >=] 12 years); Moderate (2.5 to 7.0 cm for subjects aged 2 to <12 years and 5.5 to 10.0 cm for subjects aged >=12 years); Severe (greater than [>] 7.0 cm for subjects aged 2 to <12 years and >10.0 cm for subjects aged >=12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Population analysed was the safety population. Here, 'n' signifies subjects with known values for specified local reaction. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 1
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    52 [17]
    171 [18]
    223 [19]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: any (n = 38, 130, 168)
    21.1 (9.6 to 37.3)
    11.5 (6.6 to 18.3)
    13.7 (8.9 to 19.8)
        Redness: mild (n = 38, 130, 168)
    15.8 (0 to 9.5)
    10.8 (6 to 17.4)
    11.9 (7.4 to 17.8)
        Redness: moderate (n = 37, 128, 165)
    10.8 (12.7 to 41.2)
    1.6 (0.2 to 5.5)
    3.6 (1.3 to 7.7)
        Redness: severe (n = 37, 128, 165)
    0 (2.9 to 24.2)
    0 (0 to 2.8)
    0 (0 to 2.2)
        Swelling: any (n = 40, 130, 170)
    25 (9.3 to 36.5)
    11.5 (6.6 to 18.3)
    14.7 (9.7 to 20.9)
        Swelling: mild (n = 39, 130, 169)
    10.3 (0 to 9.5)
    10.8 (6 to 17.4)
    10.7 (6.4 to 16.3)
        Swelling: moderate (n = 39, 128, 167)
    20.5 (64.7 to 88.7)
    0.8 (0 to 4.3)
    5.4 (2.5 to 10)
        Swelling: severe (n = 37, 128, 165)
    0 (53.7 to 81.3)
    0.8 (0 to 4.3)
    0.6 (0 to 3.3)
        Pain: any (n = 51, 171, 222)
    78.4 (29.8 to 61.3)
    73.1 (65.8 to 79.6)
    74.3 (68.1 to 79.9)
        Pain: mild (n = 48, 169, 217)
    68.8 (0.7 to 18.2)
    69.8 (62.3 to 76.6)
    69.6 (63 to 75.6)
        Pain: moderate (n = 42, 138, 180)
    45.2 (9.6 to 37.3)
    22.5 (15.8 to 30.3)
    27.8 (21.4 to 34.9)
        Pain: severe (n = 37, 129, 166)
    5.4 (0.7 to 18.2)
    2.3 (0.5 to 6.6)
    3 (1 to 6.9)
    Notes
    [17] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [18] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [19] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 2

    Close Top of page
    End point title
    Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 2
    End point description
    Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for subjects aged 2 to <12 years and 2.5 to 5.0 cm for subjects aged >=12 years); Moderate (2.5 to 7.0 cm for subjects aged 2 to <12 years and 5.5 to 10.0 cm for subjects aged >=12 years); Severe >7.0 cm for subjects aged 2 to <12 years and >10.0 cm for subjects aged >=12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Population analysed was the safety population. Here, 'n' signifies subjects with known values for specified local reaction. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 2
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    41 [20]
    157 [21]
    198 [22]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: any (n = 28, 109, 137)
    42.9 (24.5 to 62.8)
    16.5 (10.1 to 24.8)
    21.9 (15.3 to 29.8)
        Redness: mild (n = 26, 108, 134)
    34.6 (17.2 to 55.7)
    15.7 (9.4 to 24)
    19.4 (13.1 to 27.1)
        Redness: moderate (n = 26, 103, 129)
    26.9 (11.6 to 47.8)
    1.9 (0.2 to 6.8)
    7 (3.2 to 12.8)
        Redness: severe (n = 24, 103, 127)
    4.2 (0.1 to 21.1)
    1 (0 to 5.3)
    1.6 (0.2 to 5.6)
        Swelling: any (n = 28, 105, 133)
    35.7 (18.6 to 55.9)
    14.3 (8.2 to 22.5)
    18.8 (12.5 to 26.5)
        Swelling: mild (n = 26, 105, 131)
    15.4 (4.4 to 34.9)
    14.3 (8.2 to 22.5)
    14.5 (9 to 21.7)
        Swelling: moderate (n = 26, 102, 128)
    26.9 (11.6 to 47.8)
    0 (0 to 3.6)
    5.5 (2.2 to 10.9)
        Swelling: severe (n = 24, 102, 126)
    0 (0 to 14.2)
    0 (0 to 3.6)
    0 (0 to 2.9)
        Pain: any (n = 40, 154, 194)
    77.5 (61.5 to 89.2)
    74.7 (67 to 81.3)
    75.3 (68.6 to 81.2)
        Pain: mild (n = 36, 148, 184)
    66.7 (49 to 81.4)
    70.9 (62.9 to 78.1)
    70.1 (62.9 to 76.6)
        Pain: moderate (n = 32, 116, 148)
    53.1 (34.7 to 70.9)
    27.6 (19.7 to 36.7)
    33.1 (25.6 to 41.3)
        Pain: severe (n = 27, 104, 131)
    14.8 (4.2 to 33.7)
    1.9 (0.2 to 6.8)
    4.6 (1.7 to 9.7)
    Notes
    [20] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [21] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [22] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 3

    Close Top of page
    End point title
    Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 3
    End point description
    Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for subjects aged 2 to <12 years and 2.5 to 5.0 cm for subjects aged >=12 years); Moderate (2.5 to 7.0 cm for subjects aged 2 to <12 years and 5.5 to 10.0 cm for subjects aged >=12 years); Severe >7.0 cm for subjects aged 2 to <12 years and >10.0 cm for subjects aged >=12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Population analysed was the safety population. Here, 'n' signifies subjects with known values for specified local reaction. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 3
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    37 [23]
    138 [24]
    175 [25]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: any (n = 25, 95, 120)
    32 (45.25 to 80.8)
    9.5 (4.4 to 17.2)
    14.2 (8.5 to 21.7)
        Redness: mild (n = 24, 94, 118)
    20.8 (22.2 to 56.4)
    8.5 (3.7 to 16.1)
    11 (6 to 18.1)
        Redness: moderate (n = 24, 93, 117)
    20.8 (14.9 to 53.5)
    1.1 (0 to 5.8)
    5.1 (1.9 to 10.8)
        Redness: severe (n = 23, 93, 116)
    4.3 (7.1 to 42.2)
    1.1 (0 to 5.8)
    1.7 (0.2 to 6.1)
        Swelling: any (n = 28, 93, 121)
    35.7 (7.1 to 42.2)
    8.6 (3.8 to 16.2)
    14.9 (9.1 to 22.5)
        Swelling: mild (n = 27, 93, 120)
    25.9 (0.1 to 21.9)
    8.6 (3.8 to 16.2)
    12.5 (7.2 to 19.8)
        Swelling: moderate (n = 25, 92, 117)
    20 (18.6 to 55.9)
    0 (0 to 3.9)
    4.3 (1.4 to 9.7)
        Swelling: severe (n = 23, 92, 115)
    4.3 (11.1 to 46.3)
    0 (0 to 3.9)
    0.9 (0 to 4.7)
        Pain: any (n = 37, 138, 175)
    70.3 (6.8 to 40.7)
    73.2 (65 to 80.4)
    72.6 (65.3 to 79)
        Pain: mild (n = 31, 132, 163)
    64.5 (0.1 to 21.9)
    67.4 (58.7 to 75.3)
    66.9 (59.1 to 74)
        Pain: moderate (n = 34, 107, 141)
    38.2 (53 to 84.1)
    27.1 (19 to 36.6)
    29.8 (22.4 to 38.1)
        Pain: severe (n = 24, 93, 117)
    8.3 (1 to 27)
    3.2 (0.7 to 9.1)
    4.3 (1.4 to 9.7)
    Notes
    [23] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [24] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [25] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 4

    Close Top of page
    End point title
    Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 4
    End point description
    Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for subjects aged 2 to <12 years and 2.5 to 5.0 cm for subjects aged >=12 years); Moderate (2.5 to 7.0 cm for subjects aged 2 to <12 years and 5.5 to 10.0 cm for subjects aged >=12 years); Severe >7.0 cm for subjects aged 2 to <12 years and >10.0 cm for subjects aged >=12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Population analysed was the safety population. Here, 'n' signifies subjects with known values for specified local reaction. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 4
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    35 [26]
    116 [27]
    151 [28]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: any (n = 21, 79, 100)
    71.4 (47.8 to 88.7)
    22.8 (14.1 to 33.6)
    33 (23.9 to 43.1)
        Redness: mild (n = 20, 77, 97)
    50 (27.2 to 72.8)
    15.6 (8.3 to 25.6)
    22.7 (14.8 to 32.3)
        Redness: moderate (n = 18, 72, 90)
    50 (26 to 74)
    9.7 (4 to 19)
    17.8 (10.5 to 27.3)
        Redness: severe (n = 16, 73, 89)
    12.5 (1.6 to 38.3)
    4.1 (0.9 to 11.5)
    5.6 (1.8 to 12.6)
        Swelling: any (n = 27, 81, 108)
    66.7 (46 to 83.5)
    28.4 (18.9 to 39.5)
    38 (28.8 to 47.8)
        Swelling: mild (n = 21, 79, 100)
    38.1 (18.1 to 61.6)
    21.5 (13.1 to 32.2)
    25 (16.9 to 34.7)
        Swelling: moderate (n = 23, 72, 95)
    52.2 (30.6 to 73.2)
    6.9 (2.3 to 15.5)
    17.9 (10.8 to 27.1)
        Swelling: severe (n = 15, 73, 88)
    6.7 (0.2 to 31.9)
    4.1 (0.9 to 11.5)
    4.5 (1.3 to 11.2)
        Pain: any (n = 30, 113, 143)
    86.7 (69.3 to 96.2)
    77 (68.1 to 84.4)
    79 (71.4 to 85.4)
        Pain: mild (n = 25, 105, 130)
    76 (54.9 to 90.6)
    71.4 (61.8 to 79.8)
    72.3 (63.8 to 79.8)
        Pain: moderate (n = 24, 85, 109)
    62.5 (40.6 to 81.2)
    31.8 (22.1 to 42.8)
    38.5 (29.4 to 48.3)
        Pain: severe (n = 16, 74, 90)
    12.5 (1.6 to 38.3)
    5.4 (1.5 to 13.3)
    6.7 (2.5 to 13.9)
    Notes
    [26] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [27] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [28] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 1

    Close Top of page
    End point title
    Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 1
    End point description
    Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an e-diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). Safety population. Here, 'n' signifies subjects with known values for specified systemic event. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 1
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    51 [29]
    172 [30]
    223 [31]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38 degrees C (n = 39, 130, 169)
    12.8 (4.3 to 27.4)
    6.2 (2.7 to 11.8)
    7.7 (4.2 to 12.8)
        Fever: >=38, <38.5 degrees C (n = 37, 130, 167)
    5.4 (0.7 to 18.2)
    6.2 (2.7 to 11.8)
    6 (2.9 to 10.7)
        Fever: >=38.5, <39 degrees C (n = 37, 128, 165)
    5.4 (0.7 to 18.2)
    0 (0 to 2.8)
    1.2 (0.1 to 4.3)
        Fever: >=39, =<40 degrees C (n = 39, 128, 167)
    7.7 (1.6 to 20.9)
    0 (0 to 2.8)
    1.8 (0.4 to 5.2)
        Fever: >40 degrees C (n = 37, 128, 165)
    0 (0 to 9.5)
    0 (0 to 2.8)
    0 (0 to 2.2)
        Fatigue: Any (n = 45, 159, 204)
    53.3 (37.9 to 68.3)
    59.7 (51.7 to 67.4)
    58.3 (51.2 to 65.2)
        Fatigue: Mild (n = 41, 149, 190)
    36.6 (22.1 to 53.1)
    49 (40.7 to 57.3)
    46.3 (39.1 to 53.7)
        Fatigue: Moderate (n = 44, 148, 192)
    36.4 (22.4 to 52.2)
    35.8 (28.1 to 44.1)
    35.9 (29.2 to 43.2)
        Fatigue: Severe (n = 37, 136, 173)
    10.8 (3 to 25.4)
    11.8 (6.9 to 18.4)
    11.6 (7.2 to 17.3)
        Headache: Any (n = 42, 147, 189)
    45.2 (29.8 to 61.3)
    44.2 (36 to 52.6)
    44.4 (37.2 to 51.8)
        Headache: Mild (n = 41, 145, 186)
    39 (24.2 to 55.5)
    37.9 (30 to 46.4)
    38.2 (31.2 to 45.6)
        Headache: Moderate (n = 40, 134, 174)
    20 (9.1 to 35.6)
    17.2 (11.2 to 24.6)
    17.8 (12.4 to 24.3)
        Headache: Severe (n = 37, 130, 167)
    2.7 (0.1 to 14.2)
    2.3 (0.5 to 6.6)
    2.4 (0.7 to 6)
        Vomiting: Any (n = 39, 134, 173)
    20.5 (9.3 to 36.5)
    20.9 (14.4 to 28.8)
    20.8 (15 to 27.6)
        Vomiting: Mild (n = 38, 134, 172)
    18.4 (7.7 to 34.3)
    17.9 (11.8 to 25.5)
    18 (12.6 to 24.6)
        Vomiting: Moderate (n = 38, 128, 166)
    2.6 (0.1 to 13.8)
    3.9 (1.3 to 8.9)
    3.6 (1.3 to 7.7)
        Vomiting: Severe (n = 37, 128, 165)
    5.4 (0.7 to 18.2)
    0 (0 to 2.8)
    1.2 (0.1 to 4.3)
        Diarrhea: Any (n = 44, 145, 189)
    31.8 (18.6 to 47.6)
    35.9 (28.1 to 44.2)
    34.9 (28.1 to 42.2)
        Diarrhea: Mild (n = 44, 142, 186)
    31.8 (18.6 to 47.6)
    33.8 (26.1 to 42.2)
    33.3 (26.6 to 40.6)
        Diarrhea: Moderate (n = 38, 133, 171)
    5.3 (0.6 to 17.7)
    9 (4.7 to 15.2)
    8.2 (4.5 to 13.4)
        Diarrhea: Severe (n = 37, 131, 168)
    0 (0 to 9.5)
    3.8 (1.3 to 8.7)
    3 (1 to 6.8)
        Muscle Pain: Any (n = 47, 154, 201)
    55.3 (40.1 to 69.8)
    50 (41.8 to 58.2)
    51.2 (44.1 to 58.3)
        Muscle Pain: Mild (n = 43, 148, 191)
    46.5 (31.2 to 62.3)
    42.6 (34.5 to 51)
    43.5 (36.3 to 50.8)
        Muscle Pain: Moderate (n = 44, 139, 183)
    36.4 (22.4 to 52.2)
    21.6 (15.1 to 29.4)
    25.1 (19 to 32.1)
        Muscle Pain: Severe (n = 37, 131, 168)
    5.4 (0.7 to 18.2)
    5.3 (2.2 to 10.7)
    5.4 (2.5 to 9.9)
        Joint Pain: Any (n = 38, 143, 181)
    26.3 (13.4 to 43.1)
    26.6 (19.5 to 34.6)
    26.5 (20.2 to 33.6)
        Joint Pain: Mild (n = 37, 139, 176)
    18.9 (8 to 35.2)
    19.4 (13.2 to 27)
    19.3 (13.8 to 25.9)
        Joint Pain: Moderate (n = 38, 137, 175)
    15.8 (6 to 31.3)
    14.6 (9.2 to 21.6)
    14.9 (9.9 to 21)
        Joint Pain: Severe (n = 37, 130, 167)
    2.7 (0.1 to 14.2)
    3.1 (0.8 to 7.7)
    3 (1 to 6.8)
        Use of Medication to Treat Pain (n= 40, 136, 176)
    25 (12.7 to 41.2)
    13.2 (8 to 20.1)
    15.9 (10.8 to 22.2)
        Use of Medication to Treat Fever (n= 41, 133, 174)
    24.4 (12.4 to 40.3)
    14.3 (8.8 to 21.4)
    16.7 (11.5 to 23.1)
    Notes
    [29] - N signifies subjects with known values for any systemic event.
    [30] - N signifies subjects with known values for any systemic event.
    [31] - N signifies subjects with known values for any systemic event.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 2

    Close Top of page
    End point title
    Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 2
    End point description
    Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an e-diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). Safety population. Here, 'n' signifies subjects with known values for specified systemic event. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 2
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    45 [32]
    146 [33]
    191
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38 degrees C (n = 26, 105, 131)
    23.1 (9 to 43.6)
    6.7 (2.7 to 13.3)
    27.5 (5.4 to 16.4)
        Fever: >=38, <38.5 degrees C (n = 26, 105, 131)
    19.2 (6.6 to 39.4)
    5.7 (2.1 to 12)
    9.7 (4.3 to 14.5)
        Fever: >=38.5, <39 degrees C (n = 24, 102, 126)
    8.3 (1 to 27)
    1 (0 to 5.3)
    1.6 (0.5 to 6.8)
        Fever: >=39, =<40 degrees C (n = 24, 102, 126)
    8.3 (1 to 27)
    1 (0 to 5.3)
    45 (0.5 to 6.8)
        Fever: >40 degrees C (n = 24, 102, 126)
    0 (0 to 14.2)
    0 (0 to 3.6)
    36 (0 to 2.9)
        Fatigue: Any (n = 38, 133, 171)
    60.5 (43.4 to 76)
    56.4 (47.5 to 65)
    28 (49.5 to 64.8)
        Fatigue: Mild (n = 31, 125, 156)
    45.2 (27.3 to 64)
    39.2 (30.6 to 48.3)
    6.1 (32.6 to 48.5)
        Fatigue: Moderate (n = 33, 122, 155)
    45.5 (28.1 to 63.6)
    37.7 (29.1 to 46.9)
    25.2 (31.6 to 47.5)
        Fatigue: Severe (n = 24, 107, 131)
    12.5 (2.7 to 32.4)
    9.3 (4.6 to 16.5)
    21.1 (5.4 to 16.4)
        Headache: Any (n = 31, 121,152)
    32.3 (16.7 to 51.4)
    35.5 (27 to 44.8)
    14.7 (27.3 to 43)
        Headache: Mild (n = 30, 117, 147)
    30 (14.7 to 49.4)
    29.9 (21.8 to 39.1)
    2.3 (22.7 to 38)
        Headache: Moderate (n = 26, 110, 136)
    7.7 (0.9 to 25.1)
    16.4 (10 to 24.6)
    11.3 (9.2 to 21.8)
        Headache: Severe (n = 24, 104, 128)
    0 (0 to 14.2)
    1.9 (0.2 to 6.8)
    14.9 (0.2 to 5.5)
        Vomiting: Any (n = 28, 107, 135)
    21.4 (8.3 to 41)
    13.1 (7.3 to 21)
    9.9 (9.3 to 21.9)
        Vomiting: Mild (n = 27, 107, 134)
    18.5 (6.3 to 38.1)
    10.3 (5.2 to 17.7)
    8.4 (7 to 18.7)
        Vomiting: Moderate (n = 28, 103, 131)
    14.3 (4 to 32.7)
    4.9 (1.6 to 11)
    2.4 (3.2 to 12.6)
        Vomiting: Severe (n = 24, 102, 126)
    0 (0 to 14.2)
    1 (0 to 5.3)
    2.4 (0 to 4.3)
        Diarrhea: Any (n = 29, 121, 150)
    31 (15.3 to 50.8)
    28.9 (21 to 37.9)
    0 (22.2 to 37.3)
        Diarrhea: Mild (n = 29, 120, 149)
    31 (15.3 to 50.8)
    26.7 (19 to 35.5)
    57.3 (20.5 to 35.4)
        Diarrhea: Moderate (n = 25, 109, 134)
    8 (1 to 26)
    10.1 (5.1 to 17.3)
    40.4 (5.3 to 16)
        Diarrhea: Severe (n = 24, 103, 127)
    0 (0 to 14.2)
    1.9 (0.2 to 6.8)
    39.4 (0.2 to 5.6)
        Muscle Pain: Any (n = 36, 124, 160)
    44.4 (27.9 to 61.9)
    45.2 (36.2 to 54.3)
    9.9 (37.1 to 53.1)
        Muscle Pain: Mild (n = 32, 118, 150)
    31.3 (16.1 to 50)
    37.3 (28.6 to 46.7)
    34.9 (28.3 to 44.2)
        Muscle Pain: Moderate (n = 32, 111, 143)
    37.5 (21.1 to 56.3)
    25.2 (17.5 to 34.4)
    29.9 (20.8 to 36.1)
        Muscle Pain: Severe (n = 25, 106, 131)
    8 (1 to 26)
    5.7 (2.1 to 11.9)
    14.7 (2.7 to 11.7)
        Joint Pain: Any (n = 31, 116, 147)
    32.3 (16.7 to 51.4)
    23.3 (15.9 to 32)
    1.6 (18.4 to 33)
        Joint Pain: Mild (n = 27, 115, 142)
    18.5 (6.3 to 38.1)
    21.7 (14.6 to 30.4)
    14.8 (14.7 to 28.8)
        Joint Pain: Moderate (n = 30, 106, 136)
    30 (14.7 to 49.4)
    10.4 (5.3 to 17.8)
    11.9 (9.2 to 21.8)
        Joint Pain: Severe (n = 25, 104, 129)
    4 (0.1 to 20.4)
    1.9 (0.2 to 6.8)
    6.9 (0.5 to 6.6)
        Use of Medication to Treat Pain (n= 28, 105, 133)
    25 (10.7 to 44.9)
    7.6 (3.3 to 14.5)
    0.8 (6.5 to 17.9)
        Use of Medication to Treat Fever (n= 27, 107, 134)
    33.3 (16.5 to 54)
    10.3 (5.2 to 17.7)
    29.3 (9.4 to 22.1)
    Notes
    [32] - N signifies subjects with known values for any systemic event.
    [33] - N signifies subjects with known values for any systemic event.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 3

    Close Top of page
    End point title
    Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 3
    End point description
    Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an e-diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). Safety population. Here, 'n' signifies subjects with known values for specified systemic event. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 3
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    42 [34]
    136 [35]
    178 [36]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38 degrees C (n = 27, 93, 120)
    14.8 (0.1 to 21.1)
    4.3 (1.2 to 10.6)
    6.7 (2.9 to 12.7)
        Fever: >=38, <38.5 degrees C (n = 26, 93, 119)
    11.5 (0.1 to 21.1)
    3.2 (0.7 to 9.1)
    5 (1.9 to 10.7)
        Fever: >=38.5, <39 degrees C (n = 24, 93, 117)
    4.2 (0 to 14.8)
    3.2 (0.7 to 9.1)
    3.4 (0.9 to 8.5)
        Fever: >=39, =<40 degrees C (n = 24, 92, 116)
    4.2 (31.4 to 66)
    1.1 (0 to 5.9)
    1.7 (0.2 to 6.1)
        Fever: >40 degrees C (n = 23, 92, 115)
    0 (23.7 to 59.4)
    0 (0 to 3.9)
    0 (0 to 3.2)
        Fatigue: Any (n = 35, 122, 157)
    48.6 (17.3 to 52.8)
    49.2 (40 to 58.4)
    49 (41 to 57.1)
        Fatigue: Mild (n = 32, 116, 148)
    40.6 (0.1 to 21.1)
    38.8 (29.9 to 48.3)
    39.2 (31.3 to 47.5)
        Fatigue: Moderate (n = 30, 107, 137)
    33.3 (4.2 to 33.7)
    29.9 (21.4 to 39.5)
    30.7 (23.1 to 39.1)
        Fatigue: Severe (n = 24, 96, 120)
    4.2 (2.4 to 30.2)
    7.3 (3 to 14.4)
    6.7 (2.9 to 12.7)
        Headache: Any (n = 32, 110,142)
    37.5 (21.1 to 56.3)
    37.3 (28.2 to 47)
    37.3 (29.4 to 45.8)
        Headache: Mild (n = 30, 108, 138)
    30 (14.7 to 49.4)
    32.4 (23.7 to 42.1)
    31.9 (24.2 to 40.4)
        Headache: Moderate (n = 27, 95, 122)
    22.2 (8.6 to 42.3)
    15.8 (9.1 to 24.7)
    17.2 (11 to 25.1)
        Headache: Severe (n = 25, 94, 119)
    8 (1 to 26)
    2.1 (0.3 to 7.5)
    3.4 (0.9 to 8.4)
        Vomiting: Any (n = 25, 95, 120)
    8 (1 to 26)
    11.6 (5.9 to 19.8)
    10.8 (5.9 to 17.8)
        Vomiting: Mild (n = 24, 95, 119)
    4.2 (0.1 to 21.1)
    5.3 (1.7 to 11.9)
    5 (1.9 to 10.7)
        Vomiting: Moderate (n = 24, 93, 117)
    4.2 (0.1 to 21.1)
    7.5 (3.1 to 14.9)
    6.8 (3 to 13)
        Vomiting: Severe (n = 23, 92, 115)
    0 (0 to 14.8)
    0 (0 to 3.9)
    0 (0 to 3.2)
        Diarrhea: Any (n = 26, 104, 130)
    15.4 (4.4 to 34.9)
    25 (17 to 34.4)
    23.1 (16.1 to 31.3)
        Diarrhea: Mild (n = 26, 102, 128)
    15.4 (4.4 to 34.9)
    21.6 (14 to 30.8)
    20.3 (13.7 to 28.3)
        Diarrhea: Moderate (n = 24, 95, 119)
    4.2 (0.1 to 21.1)
    5.3 (1.7 to 11.9)
    5 (1.9 to 10.7)
        Diarrhea: Severe (n = 23, 94, 117)
    0 (0 to 14.8)
    2.1 (0.3 to 7.5)
    1.7 (0.2 to 6)
        Muscle Pain: Any (n = 35, 117, 152)
    45.7 (28.8 to 63.4)
    38.5 (29.6 to 47.9)
    40.1 (32.3 to 48.4)
        Muscle Pain: Mild (n = 30, 112, 142)
    33.3 (17.3 to 52.8)
    33 (24.4 to 42.6)
    33.1 (25.4 to 41.5)
        Muscle Pain: Moderate (n = 31, 101, 132)
    32.3 (16.7 to 51.4)
    16.8 (10.1 to 25.6)
    20.5 (13.9 to 28.3)
        Muscle Pain: Severe (n = 24, 94, 118)
    4.2 (0.1 to 21.1)
    3.2 (0.7 to 9)
    3.4 (0.9 to 8.5)
        Joint Pain: Any (n = 28, 104, 132)
    25 (10.7 to 44.9)
    20.2 (13 to 29.2)
    21.2 (14.6 to 29.2)
        Joint Pain: Mild (n = 26, 102, 128)
    19.2 (6.6 to 39.4)
    17.6 (10.8 to 26.4)
    18 (11.7 to 25.7)
        Joint Pain: Moderate (n = 27, 95, 122)
    18.5 (6.3 to 38.1)
    8.4 (3.7 to 15.9)
    10.7 (5.8 to 17.5)
        Joint Pain: Severe (n = 25, 94, 119)
    8 (1 to 26)
    2.1 (0.3 to 7.5)
    3.4 (0.9 to 8.4)
        Use of Medication to Treat Pain (n= 28, 97, 125)
    21.4 (8.3 to 41)
    12.4 (6.6 to 20.6)
    14.4 (8.8 to 21.8)
        Use of Medication to Treat Fever (n= 30, 101, 131)
    26.7 (12.3 to 45.9)
    15.8 (9.3 to 24.4)
    18.3 (12.1 to 26)
    Notes
    [34] - N signifies subjects with known values for any systemic event.
    [35] - N signifies subjects with known values for any systemic event.
    [36] - N signifies subjects with known values for any systemic event.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 4

    Close Top of page
    End point title
    Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 4
    End point description
    Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an e-diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). Safety population. Here, 'n' signifies subjects with known values for specified systemic event. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 4
    End point values
    13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    32 [37]
    116 [38]
    148 [39]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38 degrees C (n= 18, 78, 96)
    27.8 (9.7 to 53.5)
    15.4 (8.2 to 25.3)
    17.7 (10.7 to 26.8)
        Fever: >=38, <38.5 degrees C (n = 16, 76, 92)
    12.5 (1.6 to 38.3)
    13.2 (6.5 to 22.9)
    13 (6.9 to 21.7)
        Fever: >=38.5, <39 degrees C (n = 17, 73, 90)
    17.6 (3.8 to 43.4)
    2.7 (0.3 to 9.5)
    5.6 (1.8 to 12.5)
        Fever: >=39, =<40 degrees C (n = 15, 72, 87)
    0 (0 to 21.8)
    2.8 (0.3 to 9.7)
    2.3 (0.3 to 8.1)
        Fever: >40 degrees C (n = 15, 71, 86)
    0 (0 to 21.8)
    0 (0 to 5.1)
    0 (0 to 4.2)
        Fatigue: Any (n = 28, 100, 128)
    67.9 (47.6 to 84.1)
    67 (56.9 to 76.1)
    67.2 (58.3 to 75.2)
        Fatigue: Mild (n = 26, 95, 121)
    61.5 (40.6 to 79.8)
    54.7 (44.2 to 65)
    56.2 (46.9 to 65.2)
        Fatigue: Moderate (n = 20, 86, 106)
    45 (23.1 to 68.5)
    45.3 (34.6 to 56.5)
    45.3 (35.6 to 55.2)
        Fatigue: Severe (n = 16, 77, 93)
    12.5 (1.6 to 38.3)
    13 (6.4 to 22.6)
    12.9 (6.8 to 21.5)
        Headache: Any (n = 21, 93, 114)
    52.4 (29.8 to 74.3)
    45.2 (34.8 to 55.8)
    46.5 (37.1 to 56.1)
        Headache: Mild (n = 21, 88, 109)
    47.6 (25.7 to 70.2)
    38.6 (28.4 to 49.6)
    40.4 (31.1 to 50.2)
        Headache: Moderate (n = 16, 82, 98)
    18.8 (4 to 45.6)
    28 (18.7 to 39.1)
    26.5 (18.1 to 36.4)
        Headache: Severe (n = 16, 74, 90)
    12.5 (1.6 to 38.3)
    5.4 (1.5 to 13.3)
    6.7 (2.5 to 13.9)
        Vomiting: Any (n = 16, 73, 89)
    6.3 (0.2 to 30.2)
    5.5 (1.5 to 13.4)
    5.6 (1.8 to 12.6)
        Vomiting: Mild (n = 16, 73, 89)
    6.3 (0.2 to 30.2)
    5.5 (1.5 to 13.4)
    5.6 (1.8 to 12.6)
        Vomiting: Moderate (n = 15, 71, 86)
    0 (0 to 21.8)
    0 (0 to 5.1)
    0 (0 to 4.2)
        Vomiting: Severe (n = 15, 71, 86)
    0 (0 to 21.8)
    0 (0 to 5.1)
    0 (0 to 4.2)
        Diarrhea: Any (n = 18, 83, 101)
    22.2 (6.4 to 47.6)
    30.1 (20.5 to 41.2)
    28.7 (20.1 to 38.6)
        Diarrhea: Mild (n = 18, 82, 100)
    22.2 (6.4 to 47.6)
    29.3 (19.7 to 40.4)
    28 (19.5 to 37.9)
        Diarrhea: Moderate (n = 15, 72, 87)
    0 (0 to 21.8)
    4.2 (0.9 to 11.7)
    3.4 (0.7 to 9.7)
        Diarrhea: Severe (n = 15, 72, 87)
    0 (0 to 21.8)
    1.4 (0 to 7.5)
    1.1 (0 to 6.2)
        Muscle Pain: Any (n = 24, 99, 123)
    58.3 (36.6 to 77.9)
    60.6 (50.3 to 70.3)
    60.2 (50.9 to 68.9)
        Muscle Pain: Mild (n = 22, 92, 114)
    50 (28.2 to 71.8)
    50 (39.4 to 60.6)
    50 (40.5 to 59.5)
        Muscle Pain: Moderate (n = 19, 80, 99)
    36.8 (16.3 to 61.6)
    30 (20.3 to 41.3)
    31.3 (22.4 to 41.4)
        Muscle Pain: Severe (n = 16, 75, 91)
    12.5 (1.6 to 38.3)
    6.7 (2.2 to 14.9)
    7.7 (3.1 to 15.2)
        Joint Pain: Any (n = 16, 83, 99)
    25 (7.3 to 52.4)
    32.5 (22.6 to 43.7)
    31.3 (22.4 to 41.4)
        Joint Pain: Mild (n = 15, 78, 93)
    13.3 (1.7 to 40.5)
    24.4 (15.3 to 35.4)
    22.6 (14.6 to 32.4)
        Joint Pain: Moderate (n = 16, 75, 91)
    12.5 (1.6 to 38.3)
    17.3 (9.6 to 27.8)
    16.5 (9.5 to 25.7)
        Joint Pain: Severe (n = 16, 74, 90)
    6.3 (0.2 to 30.2)
    4.1 (0.8 to 11.4)
    4.4 (1.2 to 11)
        Use of Medication to Treat Pain (n= 16, 77, 93)
    18.8 (4 to 45.6)
    16.9 (9.3 to 27.1)
    17.2 (10.2 to 26.4)
        Use of Medication to Treat Fever (n= 17, 77, 94)
    23.5 (6.8 to 49.9)
    15.6 (8.3 to 25.6)
    17 (10.1 to 26.2)
    Notes
    [37] - N signifies subjects with known values for any systemic event.
    [38] - N signifies subjects with known values for any systemic event.
    [39] - N signifies subjects with known values for any systemic event.
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Subjects recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 14 days after 13vPnC vaccination)
    Adverse event reporting additional description
    AEs/SAEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions for dose 1, 2, 3, 4 of 13vPnC; systematic assessment), on case report form at each visit (non systematic assessment). Safety population was analysed. Version was not captured, 0.0 is mentioned for dictionary version.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    13vPnC Dose 3 Blood Draw to 13vPnC Dose 4
    Reporting group description
    All subjects aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from blood draw 1 month after 13vPnC Dose 3 to prior to administration of 13vPnC Dose 4.

    Reporting group title
    13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw
    Reporting group description
    All subjects aged 2 years and above who received 3 single 0.5 mL doses of 13vPnC intramuscular injections at 1-month intervals, were assessed from 13vPnC Dose 1 to the blood draw 1 month after 13vPnC Dose 3.

    Reporting group title
    13vPnC Dose 4
    Reporting group description
    All subjects aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from 13vPnC Dose 4 to the blood draw 1 month after 13vPnC Dose 4.

    Reporting group title
    23vPS Dose
    Reporting group description
    All subjects aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from 23vPS Dose to the blood draw 1 month after 23vPS Dose.

    Reporting group title
    Follow-up
    Reporting group description
    All subjects aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from blood draw 1 month after 23vPS Dose to 6-month follow-up.

    Serious adverse events
    13vPnC Dose 3 Blood Draw to 13vPnC Dose 4 13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw 13vPnC Dose 4 23vPS Dose Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    42 / 221 (19.00%)
    58 / 247 (23.48%)
    11 / 192 (5.73%)
    11 / 184 (5.98%)
    28 / 247 (11.34%)
         number of deaths (all causes)
    1
    11
    2
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    2 / 221 (0.90%)
    6 / 247 (2.43%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia recurrent
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Plasma cell myeloma recurrent
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Plasmacytoma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Post transplant lymphoproliferative disorder
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Acute lymphocytic leukaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Acute lymphocytic leukaemia recurrent
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Ependymoma
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Mantle cell lymphoma
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Refractory anaemia with an excess of blasts
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Juvenile chronic myelomonocytic leukaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Leukaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    4 / 221 (1.81%)
    6 / 247 (2.43%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    3 / 247 (1.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Graft versus host disease
         subjects affected / exposed
    1 / 221 (0.45%)
    5 / 247 (2.02%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    2 / 247 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in intestine
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic graft versus host disease
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in liver
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in skin
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 221 (1.81%)
    6 / 247 (2.43%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    4 / 247 (1.62%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 8
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injection site erythema
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    General physical health deterioration
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Death
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Completed suicide
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Epididymitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Injury, poisoning and procedural complications
    Spinal fracture
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Tibia fracture
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Sternal fracture
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Investigations
    Cytomegalovirus test positive
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    False positive investigation result
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Blood and lymphatic system disorders
    Haemolytic anaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia haemolytic autoimmune
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Febrile neutropenia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    2 / 247 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Lymphadenitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Warm type haemolytic anaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Uncoded
    Additional description: Term was not coded because it violated sponsor’s coding conventions.
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Dyspnoea
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Respiratory failure
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    VIIth nerve paralysis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Headache
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Hernial eventration
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Pancreatitis acute
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatocellular injury
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Musculoskeletal and connective tissue disorders
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Osteonecrosis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Diabetes mellitus
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Hyperglycaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Escherichia sepsis
         subjects affected / exposed
    2 / 221 (0.90%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    4 / 221 (1.81%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    1 / 184 (0.54%)
    2 / 247 (0.81%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 221 (0.90%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    4 / 247 (1.62%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Bacterial sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral toxoplasmosis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Enterocolitis viral
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastroenteritis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Gingivitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Molluscum contagiosum
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Sepsis
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Haemophilus sepsis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatic candidiasis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatitis B
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Herpes virus infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Herpes zoster disseminated
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Meningitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Nasopharyngitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Oral herpes
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia pseudomonas aeruginosa
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Urinary tract infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    H1N1 influenza
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Streptococcal sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Device related infection
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Thrombophlebitis septic
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Varicella
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Bronchiolitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Oral candidiasis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    13vPnC Dose 3 Blood Draw to 13vPnC Dose 4 13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw 13vPnC Dose 4 23vPS Dose Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    89 / 221 (40.27%)
    203 / 247 (82.19%)
    127 / 192 (66.15%)
    93 / 184 (50.54%)
    19 / 247 (7.69%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 221 (0.45%)
    7 / 247 (2.83%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    7
    0
    0
    0
    Hypotension
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Thrombophlebitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Flushing
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vasodilatation
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Venous insufficiency
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Venous thrombosis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hot flush
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    0
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasmacytoma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Precursor B-lymphoblastic lymphoma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Acute leukaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Kaposi's sarcoma
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Anogenital warts
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Immune system disorders
    Graft versus host disease
         subjects affected / exposed
    8 / 221 (3.62%)
    21 / 247 (8.50%)
    2 / 192 (1.04%)
    4 / 184 (2.17%)
    0 / 247 (0.00%)
         occurrences all number
    9
    24
    2
    4
    0
    Chronic graft versus host disease
         subjects affected / exposed
    3 / 221 (1.36%)
    12 / 247 (4.86%)
    0 / 192 (0.00%)
    3 / 184 (1.63%)
    0 / 247 (0.00%)
         occurrences all number
    3
    14
    0
    3
    0
    Graft versus host disease in liver
         subjects affected / exposed
    1 / 221 (0.45%)
    5 / 247 (2.02%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    1
    7
    0
    1
    0
    Graft versus host disease in skin
         subjects affected / exposed
    6 / 221 (2.71%)
    4 / 247 (1.62%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    7
    4
    0
    0
    0
    Food allergy
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Acute graft versus host disease
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Chronic graft versus host disease in liver
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Graft versus host disease in intestine
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypersensitivity
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 221 (1.36%)
    15 / 247 (6.07%)
    3 / 192 (1.56%)
    5 / 184 (2.72%)
    0 / 247 (0.00%)
         occurrences all number
    4
    17
    3
    6
    0
    Pyrexia
         subjects affected / exposed
    5 / 221 (2.26%)
    16 / 247 (6.48%)
    3 / 192 (1.56%)
    8 / 184 (4.35%)
    1 / 247 (0.40%)
         occurrences all number
    5
    17
    3
    8
    2
    Oedema peripheral
         subjects affected / exposed
    6 / 221 (2.71%)
    12 / 247 (4.86%)
    0 / 192 (0.00%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences all number
    6
    12
    0
    2
    0
    Asthenia
         subjects affected / exposed
    2 / 221 (0.90%)
    10 / 247 (4.05%)
    1 / 192 (0.52%)
    3 / 184 (1.63%)
    1 / 247 (0.40%)
         occurrences all number
    2
    10
    1
    3
    1
    Injection site swelling
         subjects affected / exposed
    0 / 221 (0.00%)
    4 / 247 (1.62%)
    3 / 192 (1.56%)
    8 / 184 (4.35%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    4
    9
    0
    Injection site erythema
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    4 / 192 (2.08%)
    5 / 184 (2.72%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    5
    5
    0
    Oedema
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    2
    1
    0
    1
    Catheter site rash
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Complication of device removal
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Feeling cold
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gait disturbance
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Injection site movement impairment
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    5 / 192 (2.60%)
    8 / 184 (4.35%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    5
    8
    0
    Medical device complication
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pain
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Vaccination site haematoma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Vaccination site pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    6 / 184 (3.26%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    6
    0
    Vaccination site reaction
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    4 / 184 (2.17%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    4
    0
    Inflammation
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Spinal pain
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vaccination site erythema
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    5 / 184 (2.72%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    5
    0
    Vaccination site swelling
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    4 / 184 (2.17%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0
    Injection site induration
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injection site inflammation
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vaccination site oedema
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vaccination site rash
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hernia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    0
    0
    0
    1
    Fever >=38 degrees C: 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    0 / 221 (0.00%)
    13 / 169 (7.69%)
    17 / 96 (17.71%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    17
    0
    0
    Fever >=38, <38.5 degrees C: 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    0 / 221 (0.00%)
    10 / 167 (5.99%)
    12 / 92 (13.04%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    10
    12
    0
    0
    Fever >=38.5, <39 degrees C: 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    0 / 221 (0.00%)
    2 / 165 (1.21%)
    5 / 90 (5.56%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    5
    0
    0
    Fever >=39, =<40 degrees C: 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    0 / 221 (0.00%)
    3 / 167 (1.80%)
    2 / 87 (2.30%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    2
    0
    0
    Fatigue (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    0 / 221 (0.00%)
    77 / 157 (49.04%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    77
    0
    0
    0
    Fatigue (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    0 / 221 (0.00%)
    42 / 137 (30.66%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    42
    0
    0
    0
    Fatigue (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    0 / 221 (0.00%)
    8 / 120 (6.67%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    8
    0
    0
    0
    Headache (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    0 / 221 (0.00%)
    53 / 142 (37.32%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    53
    0
    0
    0
    Headache (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    0 / 221 (0.00%)
    44 / 138 (31.88%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    44
    0
    0
    0
    Headache (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    0 / 221 (0.00%)
    21 / 122 (17.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    21
    0
    0
    0
    Headache (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    0 / 221 (0.00%)
    4 / 119 (3.36%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    Vomiting (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    0 / 221 (0.00%)
    13 / 120 (10.83%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    0
    0
    0
    Vomiting (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    0 / 221 (0.00%)
    6 / 119 (5.04%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Vomiting (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    0 / 221 (0.00%)
    8 / 117 (6.84%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    8
    0
    0
    0
    Diarrhea (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    0 / 221 (0.00%)
    30 / 130 (23.08%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    30
    0
    0
    0
    Diarrhea (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    0 / 221 (0.00%)
    26 / 128 (20.31%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    26
    0
    0
    0
    Diarrhea (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    0 / 221 (0.00%)
    6 / 119 (5.04%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Diarrhea (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    0 / 221 (0.00%)
    2 / 117 (1.71%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Muscle pain (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    0 / 221 (0.00%)
    61 / 152 (40.13%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    61
    0
    0
    0
    Muscle pain (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    0 / 221 (0.00%)
    47 / 142 (33.10%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    47
    0
    0
    0
    Muscle pain (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    0 / 221 (0.00%)
    27 / 132 (20.45%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    27
    0
    0
    0
    Muscle pain (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    0 / 221 (0.00%)
    4 / 118 (3.39%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    Joint pain (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [23]
    0 / 221 (0.00%)
    28 / 132 (21.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    28
    0
    0
    0
    Joint pain (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    0 / 221 (0.00%)
    23 / 128 (17.97%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    23
    0
    0
    0
    Joint pain (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    0 / 221 (0.00%)
    13 / 122 (10.66%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    0
    0
    0
    Joint pain (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    0 / 221 (0.00%)
    4 / 119 (3.36%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    Fever >=38 degrees C: 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    0 / 221 (0.00%)
    13 / 131 (9.92%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    0
    0
    0
    Fever >=38, <38.5 degrees C: 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    0 / 221 (0.00%)
    11 / 131 (8.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    11
    0
    0
    0
    Fever >=38.5, <39 degrees C: 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    0 / 221 (0.00%)
    3 / 126 (2.38%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Fever >=39, =<40 degrees C: 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    0 / 221 (0.00%)
    3 / 126 (2.38%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Fever >=38 degrees C: 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    0 / 221 (0.00%)
    8 / 120 (6.67%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    8
    0
    0
    0
    Fever >=38, <38.5 degrees C: 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    0 / 221 (0.00%)
    6 / 119 (5.04%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Fever >=38.5, <39 degrees C: 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    0 / 221 (0.00%)
    4 / 117 (3.42%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    Fever >=39, =<40 degrees C: 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    0 / 221 (0.00%)
    2 / 116 (1.72%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Fatigue (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    0 / 221 (0.00%)
    119 / 204 (58.33%)
    86 / 128 (67.19%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    119
    86
    0
    0
    Fatigue (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    0 / 221 (0.00%)
    88 / 190 (46.32%)
    68 / 121 (56.20%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    88
    68
    0
    0
    Fatigue (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    0 / 221 (0.00%)
    69 / 192 (35.94%)
    48 / 106 (45.28%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    69
    48
    0
    0
    Fatigue (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    0 / 221 (0.00%)
    20 / 173 (11.56%)
    12 / 93 (12.90%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    20
    12
    0
    0
    Fatigue (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    0 / 221 (0.00%)
    91 / 171 (53.22%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    91
    0
    0
    0
    Fatigue (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    0 / 221 (0.00%)
    63 / 156 (40.38%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    63
    0
    0
    0
    Fatigue (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    0 / 221 (0.00%)
    61 / 155 (39.35%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    61
    0
    0
    0
    Fatigue (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [42]
    0 / 221 (0.00%)
    13 / 131 (9.92%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    0
    0
    0
    Headache (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [43]
    0 / 221 (0.00%)
    84 / 189 (44.44%)
    53 / 114 (46.49%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    84
    53
    0
    0
    Headache (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [44]
    0 / 221 (0.00%)
    71 / 186 (38.17%)
    44 / 109 (40.37%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    71
    44
    0
    0
    Headache (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [45]
    0 / 221 (0.00%)
    31 / 174 (17.82%)
    26 / 98 (26.53%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    31
    26
    0
    0
    Headache (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [46]
    0 / 221 (0.00%)
    6 / 167 (3.59%)
    6 / 90 (6.67%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    6
    0
    0
    Headache (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [47]
    0 / 221 (0.00%)
    53 / 152 (34.87%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    53
    0
    0
    0
    Headache (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [48]
    0 / 221 (0.00%)
    44 / 147 (29.93%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    44
    0
    0
    0
    Headache (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [49]
    0 / 221 (0.00%)
    20 / 136 (14.71%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    Headache (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [50]
    0 / 221 (0.00%)
    2 / 128 (1.56%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Vomiting (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [51]
    0 / 221 (0.00%)
    36 / 173 (20.81%)
    5 / 89 (5.62%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    36
    5
    0
    0
    Vomiting (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [52]
    0 / 221 (0.00%)
    31 / 172 (18.02%)
    5 / 89 (5.62%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    31
    5
    0
    0
    Vomiting (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [53]
    0 / 221 (0.00%)
    6 / 166 (3.61%)
    0 / 86 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Vomiting (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [54]
    0 / 221 (0.00%)
    2 / 165 (1.21%)
    0 / 86 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Vomiting (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [55]
    0 / 221 (0.00%)
    20 / 135 (14.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    20
    0
    0
    0
    Vomiting (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [56]
    0 / 221 (0.00%)
    16 / 134 (11.94%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    16
    0
    0
    0
    Vomiting (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [57]
    0 / 221 (0.00%)
    9 / 131 (6.87%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    9
    0
    0
    0
    Vomiting (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [58]
    0 / 221 (0.00%)
    1 / 126 (0.79%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Diarrhea (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [59]
    0 / 221 (0.00%)
    66 / 189 (34.92%)
    29 / 101 (28.71%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    66
    29
    0
    0
    Diarrhea (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [60]
    0 / 221 (0.00%)
    62 / 186 (33.33%)
    28 / 100 (28.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    62
    28
    0
    0
    Diarrhea (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [61]
    0 / 221 (0.00%)
    14 / 171 (8.19%)
    3 / 87 (3.45%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    14
    3
    0
    0
    Diarrhea (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [62]
    0 / 221 (0.00%)
    5 / 168 (2.98%)
    1 / 87 (1.15%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    5
    1
    0
    0
    Diarrhea (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [63]
    0 / 221 (0.00%)
    44 / 150 (29.33%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    44
    0
    0
    0
    Diarrhea (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [64]
    0 / 221 (0.00%)
    41 / 149 (27.52%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    41
    0
    0
    0
    Diarrhea (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [65]
    0 / 221 (0.00%)
    13 / 134 (9.70%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    0
    0
    0
    Diarrhea (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [66]
    0 / 221 (0.00%)
    2 / 127 (1.57%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Muscle pain (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [67]
    0 / 221 (0.00%)
    103 / 201 (51.24%)
    74 / 123 (60.16%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    103
    74
    0
    0
    Muscle pain (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [68]
    0 / 221 (0.00%)
    83 / 191 (43.46%)
    57 / 114 (50.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    83
    57
    0
    0
    Muscle pain (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.