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    Clinical Trial Results:
    A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine In Healthy Infants Given With Routine Pediatric Vaccinations In Taiwan

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2008-004766-40
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Nov 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    01 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    reporting periods and duplicate AEs in their data

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    6096A1-3004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00688870
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Protocol ID: B1851005
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Clinical Trials.gov Call Center, Pfizer Inc., 001 8007181021, clinicaltrials.gov_inquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc., 001 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
    14 May 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the pneumococcal immune responses induced by 13 valent pneumococcal conjugate vaccine (13vPnC) relative to the pneumococcal immune responses induced by 7 valent pneumococcal conjugate vaccine (7vPnC) when measured 1 month after the infant series. To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).
    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
    05 Jun 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Taiwan: 168
    Worldwide total number of subjects
    168
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    168
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited in Taiwan from June 2008 to Nov 2009.

    Pre-assignment
    Screening details
    		 A total of 169 subjects were screened, 168 subjects were randomly assigned in a 1:1 ratio to either the 13vPnC group (n=84) or the 7vPnC group (n=84).

    Period 1
    Period 1 title
    Infant Series
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infant Series 13vPnC
    Arm description
    		 Subjects received 1 single dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and Haemophilus influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 single 0.5 millilitre (mL) dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series).

    Investigational medicinal product name
    DTaP-IPV-Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single intramuscular dose of DTaP-IPV-Hib at 2 and 4 months of age.

    Investigational medicinal product name
    DTaP-IPV-Hib-HBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single intramuscular dose of DTaP-IPV-Hib-HBV at 6 months of age.

    Arm title
    		 Infant Series 7vPnC
    Arm description
    		 Subjects received 1 single dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: DTaP; IPV; and Hib. At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series).

    Investigational medicinal product name
    DTaP-IPV-Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single intramuscular dose of DTaP-IPV-Hib at 2 and 4 months of age.

    Investigational medicinal product name
    DTaP-IPV-Hib-HBV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single intramuscular dose of DTaP-IPV-Hib-HBV at 6 months of age.

    Number of subjects in period 1
    		Infant Series 13vPnC Infant Series 7vPnC
    Started
    84
    84
    Vaccinated Dose 1
    83
    84
    Vaccinated Dose 2
    80
    84
    Vaccinated Dose 3
    80
    84
    Completed
    80
    84
    Not completed
    4
    0
         Parent or legal guardian request
    4
    -
    Period 2
    Period 2 title
    After Infant Series
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 After Infant Series 13vPnC
    Arm description
    		 Included subjects who received 1 single dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: DTaP; IPV; and Hib. At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 After Infant Series 7vPnC
    Arm description
    		 Included subjects who received 1 single dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: DTaP; IPV; and Hib. At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		After Infant Series 13vPnC After Infant Series 7vPnC
    Started
    80
    84
    Completed
    80
    84
    Period 3
    Period 3 title
    Toddler Dose
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Toddler Series 13vPnC
    Arm description
    		 Subjects received 1 single dose of 13vPnC, administered intramuscularly, at 15 months of age (toddler dose).
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 15 months of age (toddler dose).

    Arm title
    		 Toddler Series 7vPnC
    Arm description
    		 Subjects received 1 single dose of 7vPnC, administered intramuscularly, at 15 months of age (toddler dose).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 15 months of age (toddler dose).

    Number of subjects in period 3
    		Toddler Series 13vPnC Toddler Series 7vPnC
    Started
    80
    84
    Completed
    80
    84

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infant Series 13vPnC
    Reporting group description
    		 Subjects received 1 single dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and Haemophilus influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.

    Reporting group title
    Infant Series 7vPnC
    Reporting group description
    		 Subjects received 1 single dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: DTaP; IPV; and Hib. At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.

    Reporting group values
    		 Infant Series 13vPnC Infant Series 7vPnC Total
    Number of subjects
    		 84 84 168
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 2.2 ( 0.3 ) 2.3 ( 0.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 40 47 87
        Male
    		 44 37 81
    Region of Enrollment
    Units: Subjects
        Taiwan
    		 84 84 168

    End points

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    End points reporting groups
    Reporting group title
    Infant Series 13vPnC
    Reporting group description
    		 Subjects received 1 single dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and Haemophilus influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.

    Reporting group title
    Infant Series 7vPnC
    Reporting group description
    		 Subjects received 1 single dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: DTaP; IPV; and Hib. At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.
    Reporting group title
    After Infant Series 13vPnC
    Reporting group description
    		 Included subjects who received 1 single dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: DTaP; IPV; and Hib. At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.

    Reporting group title
    After Infant Series 7vPnC
    Reporting group description
    		 Included subjects who received 1 single dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: DTaP; IPV; and Hib. At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.
    Reporting group title
    Toddler Series 13vPnC
    Reporting group description
    		 Subjects received 1 single dose of 13vPnC, administered intramuscularly, at 15 months of age (toddler dose).

    Reporting group title
    Toddler Series 7vPnC
    Reporting group description
    		 Subjects received 1 single dose of 7vPnC, administered intramuscularly, at 15 months of age (toddler dose).

    Subject analysis set title
    Infant Series 13vPnc Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received 1 single dose of 13vPnC, administered intramuscularly, at 2 months of age (infant series). At 2 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine DTaP; IPV; and Hib.

    Subject analysis set title
    Infant Series 7vPnC Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received 1 single dose of 7vPnC , administered intramuscularly, at 2 months of age (infant series). At 2 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine DTaP; IPV; and Hib.

    Subject analysis set title
    Infant Series 13vPnc Dose 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received 1 single dose of 13vPnc, administered intramuscularly, at 4 months of age (infant series).At 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine DTaP; IPV; and Hib.

    Subject analysis set title
    Infant Series 7vPnC Dose 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received 1 single dose of 7vPnc, administered intramuscularly, at 4 months of age (infant series). At 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine DTaP; IPV; and Hib.

    Subject analysis set title
    Infant Series 13vPnc Dose 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received 1 single dose of 13vPnc, administered intramuscularly, at 6 months of age (infant series). At 6 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine DTaP; IPV; and Hib. At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.

    Subject analysis set title
    Infant Series 7vPnC Dose 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received 1 single dose of 7vPnc, administered intramuscularly, at 6 months of age (infant series). At 6 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine DTaP; IPV; and Hib. At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.

    Primary: Percentage of Subjects Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms

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    End point title
    		 Percentage of Subjects Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms
    End point description
    Percentage of subjects achieving a predefined antibody level of greater than or equal to (>=) 0.35 mcg/mL along with the corresponding exact 95 percentage (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
    End point type
    Primary
    End point timeframe
    1 month after the infant series (7 months of age)
    End point values
    		 Infant Series 13vPnC Infant Series 7vPnC
    Number of subjects analysed
    80
    83
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotypes - Serotype 4
    98.8 (93.2 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 6B
    100 (95.5 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 9V
    98.8 (93.2 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 14
    100 (95.5 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 18C
    100 (95.5 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 19F
    98.8 (93.2 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 23F
    95 (87.7 to 98.6)
    100 (95.7 to 100)
        Additional Serotypes - Serotype 1
    98.8 (93.2 to 100)
    2.4 (0.3 to 8.4)
        Additional Serotypes - Serotype 3
    97.5 (91.3 to 99.7)
    2.4 (0.3 to 8.4)
        Additional Serotypes - Serotype 5
    98.8 (93.2 to 100)
    61.5 (49.8 to 72.3)
        Additional Serotypes - Serotype 6A
    100 (95.5 to 100)
    77.1 (66.6 to 85.6)
        Additional Serotypes - Serotype 7F
    100 (95.5 to 100)
    2.4 (0.3 to 8.4)
        Additional Serotypes - Serotype 19A
    100 (95.5 to 100)
    100 (95.6 to 100)
    Statistical analysis title
    		 Common Serotypes - Serotype 4
    Comparison groups
    Infant Series 7vPnC v Infant Series 13vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 3.3
    Notes
    [1] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common Serotypes - Serotype 6B
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 4.3
    Notes
    [2] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common serotypes - serotype 9V
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 3.3
    Notes
    [3] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common serotypes - serotype 14
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 4.3
    Notes
    [4] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common serotypes - serotype 18C
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 4.3
    Notes
    [5] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common serotypes - serotype 19F
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 3.3
    Notes
    [6] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common serotypes - serotype 23F
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.3
         upper limit
    		 -0.3
    Notes
    [7] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 1
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    96.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 89.4
         upper limit
    		 99.2
    Notes
    [8] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 3
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    95.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 87.7
         upper limit
    		 98.6
    Notes
    [9] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 5
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    37.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 26.2
         upper limit
    		 48.9
    Notes
    [10] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 6A
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    22.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.4
         upper limit
    		 33.4
    Notes
    [11] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 7F
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    97.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 91.6
         upper limit
    		 99.7
    Notes
    [12] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 19A
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 4.5
    Notes
    [13] - The statistical analyses was descriptive. 

    Secondary: Percentage of Subjects Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose

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    End point title
    		 Percentage of Subjects Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose
    End point description
    Percentage of subjects achieving a predefined antibody level of >=0.35 mcg/mL along with the corresponding exact 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after toddler dose (16 months of age)
    End point values
    		 Toddler Series 13vPnC Toddler Series 7vPnC
    Number of subjects analysed
    79
    84
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotypes - Serotype 4
    98.7 (93.1 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 6B
    100 (95.4 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 9V
    98.7 (93.1 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 14
    100 (95.4 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 18C
    100 (95.4 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 19F
    98.7 (93.1 to 100)
    100 (95.7 to 100)
        Common Serotypes - Serotype 23F
    100 (95.4 to 100)
    100 (95.7 to 100)
        Additional Serotypes - Serotype 1
    100 (95.4 to 100)
    5 (1.4 to 12.3)
        Additional Serotypes - Serotype 3
    96.2 (89.3 to 99.2)
    13.8 (7.1 to 23.3)
        Additional Serotypes - Serotype 5
    100 (95.4 to 100)
    90.4 (81.9 to 95.7)
        Additional Serotypes - Serotype 6A
    100 (95.4 to 100)
    100 (95.7 to 100)
        Additional Serotypes - Serotype 7F
    100 (95.4 to 100)
    6.3 (2.1 to 14)
        Additional Serotypes - Serotype 19A
    100 (95.4 to 100)
    98.8 (93.5 to 100)
    Statistical analysis title
    		 Common serotypes - serotype 4
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 3.1
    Notes
    [14] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common serotypes - serotype 6B
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 4.4
    Notes
    [15] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common serotypes - serotype 9V
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 3.1
    Notes
    [16] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common serotypes - serotype 14
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 4.4
    Notes
    [17] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common serotypes - serotype 18C
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [18]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 4.4
    Notes
    [18] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common serotypes - serotype 19F
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 3.1
    Notes
    [19] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Common serotypes - serotype 23F
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [20]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 4.4
    Notes
    [20] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 1
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 87.7
         upper limit
    		 98.6
    Notes
    [21] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 3
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [22]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    82.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 72
         upper limit
    		 90.1
    Notes
    [22] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 5
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    9.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 18.1
    Notes
    [23] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 6A
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [24]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.6
         upper limit
    		 4.4
    Notes
    [24] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 7F
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [25]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    93.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 86
         upper limit
    		 97.9
    Notes
    [25] - The statistical analyses was descriptive. 
    Statistical analysis title
    		 Additional serotypes - serotype 19A
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [26]
    Method
    		 Chan and Zhang
    Parameter type
    		 Difference
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 6.5
    Notes
    [26] - The statistical analyses was descriptive. 

    Other pre-specified: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series
    End point description
    Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
    End point type
    Other pre-specified
    End point timeframe
    1 month after the 3-dose infant series (7 months of age)
    End point values
    		 Infant Series 13vPnC Infant Series 7vPnC
    Number of subjects analysed
    80
    83
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common serotypes - serotype 4
    2.89 (2.45 to 3.42)
    4.64 (4 to 5.37)
        Common serotypes - serotype 6B
    4.37 (3.58 to 5.33)
    4.82 (4.09 to 5.67)
        Common serotypes - serotype 9V
    1.97 (1.7 to 2.27)
    2.92 (2.55 to 3.34)
        Common serotypes - serotype 14
    9.76 (8.34 to 11.43)
    11.59 (9.79 to 13.71)
        Common serotypes - serotype 18C
    2.39 (2.04 to 2.82)
    3.07 (2.64 to 3.56)
        Common serotypes - serotype 19F
    3.6 (3 to 4.32)
    4.77 (4.17 to 5.47)
        Common serotypes - serotype 23F
    1.93 (1.56 to 2.37)
    3.25 (2.78 to 3.8)
        Additional serotypes - serotype 1
    4.14 (3.45 to 4.96)
    0.02 (0.02 to 0.02)
        Additional serotypes - serotype 3
    1.2 (1 to 1.45)
    0.05 (0.04 to 0.06)
        Additional serotypes - serotype 5
    2.47 (2.09 to 2.92)
    0.43 (0.35 to 0.53)
        Additional serotypes - serotype 6A
    4.57 (3.92 to 5.34)
    0.79 (0.63 to 0.99)
        Additional serotypes - serotype 7F
    3.67 (3.14 to 4.29)
    0.04 (0.03 to 0.05)
        Additional serotypes - serotype 19A
    3.69 (3.2 to 4.24)
    2.46 (2.13 to 2.84)
    Statistical analysis title
    		 Common serotypes - serotype 4
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [27]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 0.78
    Notes
    [27] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 6B
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [28]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.17
    Notes
    [28] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 9V
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [29]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 0.82
    Notes
    [29] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 14
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [30]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.06
    Notes
    [30] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 18C
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.97
    Notes
    [31] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 19F
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [32]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 0.94
    Notes
    [32] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 23F
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [33]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 0.77
    Notes
    [33] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 1
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [34]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    202.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 157.04
         upper limit
    		 261.32
    Notes
    [34] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 3
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [35]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    24.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.46
         upper limit
    		 31.49
    Notes
    [35] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 5
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [36]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    5.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.37
         upper limit
    		 7.41
    Notes
    [36] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 6A
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [37]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    5.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.42
         upper limit
    		 7.67
    Notes
    [37] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 7F
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [38]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    96.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 75.6
         upper limit
    		 122.17
    Notes
    [38] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 19A
    Statistical analysis description
    Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
    Comparison groups
    Infant Series 13vPnC v Infant Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [39]
    Method
    Parameter type
    		 ratio of GMCs
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.23
         upper limit
    		 1.83
    Notes
    [39] - The statistical analyses was descriptive.

    Other pre-specified: GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose

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    End point title
    		 GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose
    End point description
    Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
    End point type
    Other pre-specified
    End point timeframe
    1 month after the toddler dose (16 months of age)
    End point values
    		 Toddler Series 13vPnC Toddler Series 7vPnC
    Number of subjects analysed
    79
    84
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common serotypes - serotype 4
    4.06 (3.34 to 4.93)
    6.34 (5.26 to 7.65)
        Common serotypes - serotype 6B
    13.62 (11.08 to 16.73)
    13.28 (10.87 to 16.21)
        Common serotypes - serotype 9V
    3.18 (2.66 to 3.8)
    3.88 (3.27 to 4.6)
        Common serotypes - serotype 14
    8.17 (6.53 to 10.22)
    12.04 (9.9 to 14.63)
        Common serotypes - serotype 18C
    3.67 (3 to 4.49)
    4.87 (4.01 to 5.9)
        Common serotypes - serotype 19F
    8.07 (6.58 to 9.9)
    7.41 (6.16 to 8.92)
        Common serotypes - serotype 23F
    5.51 (4.46 to 6.81)
    7.97 (6.55 to 9.68)
        Additional serotypes - serotype 1
    7.62 (6.3 to 9.21)
    0.03 (0.02 to 0.03)
        Additional serotypes - serotype 3
    1.29 (1.09 to 1.53)
    0.12 (0.09 to 0.16)
        Additional serotypes - serotype 5
    4.57 (3.87 to 5.39)
    0.95 (0.8 to 1.13)
        Additional serotypes - serotype 6A
    11.55 (9.66 to 13.81)
    3.79 (3.01 to 4.76)
        Additional serotypes - serotype 7F
    5.91 (4.95 to 7.06)
    0.06 (0.04 to 0.07)
        Additional serotypes - serotype 19A
    8.82 (7.45 to 10.43)
    1.98 (1.69 to 2.32)
    Statistical analysis title
    		 Common serotypes - serotype 4
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [40]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 0.84
    Notes
    [40] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 6B
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [41]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.36
    Notes
    [41] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 9V
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [42]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.05
    Notes
    [42] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 14
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [43]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 0.91
    Notes
    [43] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 18C
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [44]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.99
    Notes
    [44] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 19F
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [45]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.43
    Notes
    [45] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Common serotypes - serotype 23F
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [46]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 0.92
    Notes
    [46] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 1
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [47]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    303.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 213.63
         upper limit
    		 431.83
    Notes
    [47] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 3
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [48]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    10.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.77
         upper limit
    		 14.62
    Notes
    [48] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 5
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [49]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    4.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.78
         upper limit
    		 6.08
    Notes
    [49] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 6A
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [50]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    3.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.28
         upper limit
    		 4.08
    Notes
    [50] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 7F
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [51]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    105
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 75.6
         upper limit
    		 145.84
    Notes
    [51] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Additional serotypes - serotype 19A
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 other [52]
    Method
    Parameter type
    		 ratio of GMC
    Point estimate
    4.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.54
         upper limit
    		 5.6
    Notes
    [52] - The statistical analyses was descriptive.

    Other pre-specified: Percentage of Subjects With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population: all subjects who received dose 1 of the infant series vaccination (2 months of age). (n)= number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after Dose 1 of the infant series (2 Months of Age)
    End point values
    		 Infant Series 13vPnc Dose 1 Infant Series 7vPnC Dose 1
    Number of subjects analysed
    83
    84
    Units: percentage of subjects
    number (not applicable)
        Tenderness - Any
    31.3
    34.2
        Tenderness - Significant
    5.3
    9.3
        Swelling - Any
    25.6
    11.8
        Swelling - Mild
    24.4
    11.8
        Swelling - Moderate (n=74,74)
    1.4
    0
        Swelling - Severe (n=74,74)
    0
    0
        Redness - Any
    29.9
    28.9
        Redness - Mild
    26
    26.3
        Redness - Moderate (n=74,74)
    8.1
    2.7
        Redness - Severe (n=74,74)
    0
    0
    Statistical analysis title
    		 Tenderness - Any
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [53]
    P-value
    		 = 0.735
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [53] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Tenderness - Significant
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [54]
    P-value
    		 = 0.533
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [54] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Any
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [55]
    P-value
    		 = 0.039
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [55] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Mild
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [56]
    P-value
    		 = 0.059
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [56] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Moderate
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [57]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [57] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Severe
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [58]
    P-value
    		 = 99999 [59]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [58] - The statistical analyses was descriptive.
    [59] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with severe swelling in either treatment group, p-value could not be estimated.
    Statistical analysis title
    		 Redness - Any
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [60]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [60] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Mild
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [61]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [61] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Moderate
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [62]
    P-value
    		 = 0.275
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [62] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Severe
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [63]
    P-value
    		 = 99999 [64]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [63] - The statistical analyses was descriptive.
    [64] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with severe redness in either treatment group, p-value could not be estimated.

    Other pre-specified: Percentage of Subjects With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)

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    End point title
    		 Percentage of Subjects With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population: all subjects who received the first 2 doses of the infant series vaccination (4 months of age). n= number of subjects reporting yes for at least 1 day or no for all days for each treatment group respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 Days after Dose 2 of the infant series (4 months of age)
    End point values
    		 Infant Series 13vPnc Dose 2 Infant Series 7vPnC Dose 2
    Number of subjects analysed
    80
    84
    Units: percentage of subjects
    number (not applicable)
        Tenderness - Any
    23.6
    22.4
        Tenderness - Significant (n=69,71)
    2.9
    1.4
        Swelling - Any (n=70,72)
    12.9
    15.3
        Swelling - Mild (n=70,72)
    12.9
    15.3
        Swelling - Moderate (n=69,71)
    0
    0
        Swelling - Severe (n=69,71)
    0
    0
        Redness - Any (n=70,74)
    17.1
    20.3
        Redness - Mild (n=70,74)
    17.1
    17.6
        Redness - Moderate (n=69,71)
    0
    2.8
        Redness - Severe (n=69,71)
    0
    0
    Statistical analysis title
    		 Tenderness - Any
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [65]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [65] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Tenderness - Significant
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [66]
    P-value
    		 = 0.617
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [66] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Any
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [67]
    P-value
    		 = 0.81
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [67] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Mild
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [68]
    P-value
    		 = 0.81
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [68] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Moderate
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [69]
    P-value
    		 = 99999 [70]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [69] - The statistical analyses was descriptive.
    [70] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with moderate swelling in either treatment group, p-value could not be estimated.
    Statistical analysis title
    		 Swelling - Severe
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [71]
    P-value
    		 = 99999 [72]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [71] - The statistical analyses was descriptive.
    [72] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with severe swelling in either treatment group, p-value could not be estimated.
    Statistical analysis title
    		 Redness - Any
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [73]
    P-value
    		 = 0.674
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [73] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Mild
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [74]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [74] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Moderate
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [75]
    P-value
    		 = 0.497
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [75] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Severe
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [76]
    P-value
    		 = 99999 [77]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [76] - The statistical analyses was descriptive.
    [77] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with severe redness in either treatment group, p-value could not be estimated.

    Other pre-specified: Percentage of Subjects With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)

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    End point title
    		 Percentage of Subjects With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population: all subjects who received all 3 doses of the infant series vaccination (6 months of age). n=number of subjects reporting yes for at least 1 day or no for all days for each treatment group respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after Dose 3 of the infant series (6 months of age)
    End point values
    		 Infant Series 13vPnc Dose 3 Infant Series 7vPnC Dose 3
    Number of subjects analysed
    80
    84
    Units: percentage of subjects
    number (not applicable)
        Tenderness - Any (n=67,67)
    19.4
    17.9
        Tenderness - Significant (n=65,65)
    0
    1.5
        Swelling - Any (n=65,65)
    16.9
    4.6
        Swelling - Mild (n=65,65)
    15.4
    4.6
        Swelling - Moderate (n=65,64)
    3.1
    0
        Swelling - Severe (n=65,64)
    0
    0
        Redness - Any (n=67,65)
    20.9
    13.8
        Redness - Mild (n=66,65)
    18.2
    13.8
        Redness - Moderate (n=66,64)
    4.5
    0
        Redness - Severe (n=65,64)
    0
    0
    Statistical analysis title
    		 Tenderness - Any
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [78]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [78] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Tenderness - Significant
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [79]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [79] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Any
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [80]
    P-value
    		 = 0.044
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [80] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Mild
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [81]
    P-value
    		 = 0.076
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [81] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Moderate
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [82]
    P-value
    		 = 0.496
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [82] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Severe
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [83]
    P-value
    		 = 99999 [84]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [83] - The statistical analyses was descriptive.
    [84] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with severe swelling in either treatment group, p-value could not be estimated.
    Statistical analysis title
    		 Redness - Any
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [85]
    P-value
    		 = 0.361
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [85] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Mild
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [86]
    P-value
    		 = 0.635
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [86] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Moderate
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [87]
    P-value
    		 = 0.244
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [87] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Severe
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [88]
    P-value
    		 = 99999 [89]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [88] - The statistical analyses was descriptive.
    [89] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with severe redness in either treatment group, p-value could not be estimated.

    Other pre-specified: Percentage of Subjects With Pre-specified Local Reactions: Toddler Dose (15 Months of Age)

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    End point title
    		 Percentage of Subjects With Pre-specified Local Reactions: Toddler Dose (15 Months of Age)
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population: all subjects who received the toddler dose (15 months of age). n= number of subjects reporting yes for at least 1 day or no for all days for each treatment group respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after the toddler dose (15 months of age)
    End point values
    		 Toddler Series 13vPnC Toddler Series 7vPnC
    Number of subjects analysed
    80
    84
    Units: percentage of subjects
    number (not applicable)
        Tenderness - Any (n=64,75)
    10.9
    22.7
        Tenderness - Significant (n=63,69)
    0
    0
        Swelling - Any (n=63,70)
    7.9
    5.7
        Swelling - Mild (n=63,70)
    6.3
    5.7
        Swelling - Moderate (n=63,69)
    1.6
    0
        Swelling - Severe (n=63,69)
    0
    0
        Redness - Any (n=65,70)
    15.4
    12.9
        Redness - Mild (n=65,70)
    13.8
    12.9
        Redness - Moderate (n=63,69)
    1.6
    0
        Redness - Severe (n=63,69)
    0
    0
    Statistical analysis title
    		 Tenderness - Any
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 7vPnC v Toddler Series 13vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [90]
    P-value
    		 = 0.076
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [90] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Tenderness - Significant
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [91]
    P-value
    		 = 99999 [92]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [91] - The statistical analyses was descriptive.
    [92] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with significant tenderness in either treatment group, p-value could not be estimated.
    Statistical analysis title
    		 Swelling - Any
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [93]
    P-value
    		 = 0.735
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [93] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Mild
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [94]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [94] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Moderate
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [95]
    P-value
    		 = 0.477
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [95] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Swelling - Severe
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [96]
    P-value
    		 = 99999 [97]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [96] - The statistical analyses was descriptive.
    [97] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with severe swelling in either treatment group, p-value could not be estimated.
    Statistical analysis title
    		 Redness - Any
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [98]
    P-value
    		 = 0.805
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [98] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Mild
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [99]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [99] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Moderate
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [100]
    P-value
    		 = 0.477
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [100] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Redness - Severe
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [101]
    P-value
    		 = 99999 [102]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [101] - The statistical analyses was descriptive.
    [102] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with severe redness in either treatment group, p-value could not be estimated.

    Other pre-specified: Percentage of Subjects With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)

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    End point title
    		 Percentage of Subjects With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
    End point description
    Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received dose 1 of the infant series vaccination (2 months of age). (n)= number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after Dose 1 of the infant series (2 months of age)
    End point values
    		 Infant Series 13vPnc Dose 1 Infant Series 7vPnC Dose 1
    Number of subjects analysed
    83
    84
    Units: percentage of subjects
    number (not applicable)
        Fever >=38 but <=39 degrees C
    55
    50
        Fever >39 but <=40 degrees C (n=74,74)
    1.4
    1.4
        Fever >40 degrees C (n=74,74)
    0
    0
        Decreased appetite
    50
    55.6
        Irritability
    65
    70
        Increased sleep
    53.2
    50.6
        Decreased sleep
    44.3
    41
    Statistical analysis title
    		 Fever >=38 but <=39 degrees C
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [103]
    P-value
    		 = 0.633
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [103] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Fever >39 but <=40 degrees C
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [104]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [104] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Fever >40 degrees C
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [105]
    P-value
    		 = 99999 [106]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [105] - The statistical analyses was descriptive.
    [106] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with fever >40 degrees C either treatment group, p-value could not be estimated.
    Statistical analysis title
    		 Decreased appetite
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [107]
    P-value
    		 = 0.527
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [107] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Irritability
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [108]
    P-value
    		 = 0.613
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [108] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Increased sleep
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [109]
    P-value
    		 = 0.753
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [109] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Decreased sleep
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 1 v Infant Series 7vPnC Dose 1
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 other [110]
    P-value
    		 = 0.748
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [110] - The statistical analyses was descriptive.

    Other pre-specified: Percentage of Subjects With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)

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    End point title
    		 Percentage of Subjects With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
    End point description
    Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received the first 2 doses of the infant series vaccination (4 months of age). n= number of subjects reporting yes for at least 1 day or no for all days for each treatment group respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after Dose 2 of the infant series (4 months of age)
    End point values
    		 Infant Series 13vPnc Dose 2 Infant Series 7vPnC Dose 2
    Number of subjects analysed
    80
    84
    Units: percentage of subjects
    number (not applicable)
        Fever >=38 but <=39 degrees C
    52.1
    43.4
        Fever >39 but <=40 degrees C (n=69, 72)
    2.9
    2.8
        Fever >40 degrees C (n=69, 71)
    0
    0
        Decreased appetite
    50.7
    56.1
        Irritability
    56
    57.5
        Increased sleep
    41.1
    43.4
        Decreased sleep (n=71, 77)
    42.3
    32.5
    Statistical analysis title
    		 Fever >=38 but <=39 degrees C
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [111]
    P-value
    		 = 0.327
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [111] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Fever >39 but <=40 degrees C
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [112]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [112] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Fever >40 degrees C
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [113]
    P-value
    		 = 99999 [114]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [113] - The statistical analyses was descriptive.
    [114] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with fever >40 degrees C in either treatment group, p-value could not be estimated.
    Statistical analysis title
    		 Decreased appetite
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [115]
    P-value
    		 = 0.522
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [115] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Irritability
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [116]
    P-value
    		 = 0.872
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [116] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Increased sleep
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [117]
    P-value
    		 = 0.868
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [117] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Decreased sleep
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 2 v Infant Series 7vPnC Dose 2
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [118]
    P-value
    		 = 0.237
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [118] - The statistical analyses was descriptive.

    Other pre-specified: Percentage of Subjects With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)

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    End point title
    		 Percentage of Subjects With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
    End point description
    Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received all 3 doses of the infant series vaccination (6 months of age). n=number of subjects reporting yes for at least 1 day or no for all days for each treatment group respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 3 of the infant series (6 months of age)
    End point values
    		 Infant Series 13vPnc Dose 3 Infant Series 7vPnC Dose 3
    Number of subjects analysed
    80
    84
    Units: percentage of subjects
    number (not applicable)
        Fever >=38 but <=39 degrees C (n=66,66)
    31.8
    22.7
        Fever >39 but <=40 degrees C (n=65,66)
    4.6
    9.1
        Fever >40 degrees C (n=65,64)
    0
    1.6
        Decreased appetite (n=69,75)
    43.5
    52
        Irritability (n=68,71)
    42.6
    47.9
        Increased sleep (n=66,70)
    40.9
    37.1
        Decreased sleep (n=68,69)
    30.9
    33.3
    Statistical analysis title
    		 Fever >=38 but <=39 degrees C
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [119]
    P-value
    		 = 0.329
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [119] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Fever >39 but <=40 degrees C
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [120]
    P-value
    		 = 0.492
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [120] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Fever >40 degrees C
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [121]
    P-value
    		 = 0.496
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [121] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Decreased appetite
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [122]
    P-value
    		 = 0.322
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [122] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Irritability
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [123]
    P-value
    		 = 0.61
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [123] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Increased sleep
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [124]
    P-value
    		 = 0.726
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [124] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Decreased sleep
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Infant Series 13vPnc Dose 3 v Infant Series 7vPnC Dose 3
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [125]
    P-value
    		 = 0.855
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [125] - The statistical analyses was descriptive.

    Post-hoc: Percentage of Subjects With Pre-specified Systemic Events: Toddler Dose (15 Months of Age)

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    End point title
    		 Percentage of Subjects With Pre-specified Systemic Events: Toddler Dose (15 Months of Age)
    End point description
    Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received the toddler dose (15 months of age). n= number of subjects reporting yes for at least 1 day or no for all days for each treatment group respectively.
    End point type
    Post-hoc
    End point timeframe
    Within 4 days after the toddler dose (15 months of age)
    End point values
    		 Toddler Series 13vPnC Toddler Series 7vPnC
    Number of subjects analysed
    80
    84
    Units: Percentage of Subjects
    number (not applicable)
        Fever >=38 but <=39 degrees C (n=65,70)
    29.2
    21.4
        Fever >39 but <=40 degrees C (n=63,69)
    3.2
    4.3
        Fever >40 degrees C (n=63,69)
    0
    0
        Decreased appetite (n=65,75)
    27.7
    30.7
        Irritability (n=65,74)
    27.7
    27
        Increased sleep (n=66,72)
    16.7
    16.7
        Decreased sleep (n=64,74)
    17.2
    23
    Statistical analysis title
    		 Fever >=38 but <=39 degrees C
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [126]
    P-value
    		 = 0.326
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [126] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Fever >39 but <=40 degrees C
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [127]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [127] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Fever >40 degrees C
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [128]
    P-value
    		 = 99999 [129]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [128] - The statistical analyses was descriptive.
    [129] - Here, 99999 in the p-value signifies "Not estimable". Since there were no subject with fever >40 degrees C in either treatment group, p-value could not be estimated.
    Statistical analysis title
    		 Decreased appetite
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [130]
    P-value
    		 = 0.714
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [130] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Irritability
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [131]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [131] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Increased sleep
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [132]
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [132] - The statistical analyses was descriptive.
    Statistical analysis title
    		 Decreased sleep
    Statistical analysis description
    Fisher exact test was used to calculate p-value.
    Comparison groups
    Toddler Series 13vPnC v Toddler Series 7vPnC
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 other [133]
    P-value
    		 = 0.525
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [133] - The statistical analyses was descriptive.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through 1 month after last study vaccination (16 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=15 months of age
    Adverse event reporting additional description
    An AE term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event. LRs and SEs were to be assessed only for infant series and toddler dose groups.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Infant Series 13vPnC
    Reporting group description
    		 Subjects received 1 single dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and Haemophilus influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.

    Reporting group title
    Infant Series 7vPnC
    Reporting group description
    		 Subjects received 1 single dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: DTaP; IPV; and Hib. At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.

    Reporting group title
    After Infant Series 13vPnC
    Reporting group description
    		 Included subjects who received 1 single dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: DTaP; IPV; and Hib. At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.

    Reporting group title
    After Infant Series 7vPnC
    Reporting group description
    		 Included subjects who received 1 single dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: DTaP; IPV; and Hib. At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and HBV vaccine.

    Reporting group title
    Toddler Series 13vPnC
    Reporting group description
    		 Subjects received 1 single dose of 13vPnC, administered intramuscularly, at 15 months of age (toddler dose).

    Reporting group title
    Toddler Series 7vPnC
    Reporting group description
    		 Subjects received 1 single dose of 7vPnC, administered intramuscularly, at 15 months of age (toddler dose).

    Serious adverse events
    		 Infant Series 13vPnC Infant Series 7vPnC After Infant Series 13vPnC After Infant Series 7vPnC Toddler Series 13vPnC Toddler Series 7vPnC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 83 (4.82%)
    4 / 84 (4.76%)
    12 / 83 (14.46%)
    9 / 84 (10.71%)
    0 / 80 (0.00%)
    3 / 84 (3.57%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    2 / 84 (2.38%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal functional disorder
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tongue disorder
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular retraction
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 83 (0.00%)
    3 / 84 (3.57%)
    2 / 83 (2.41%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 84 (1.19%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    2 / 83 (2.41%)
    2 / 84 (2.38%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia primary atypical
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    1 / 83 (1.20%)
    3 / 84 (3.57%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    2 / 83 (2.41%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Roseola
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Infant Series 13vPnC Infant Series 7vPnC After Infant Series 13vPnC After Infant Series 7vPnC Toddler Series 13vPnC Toddler Series 7vPnC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    81 / 83 (97.59%)
    77 / 84 (91.67%)
    11 / 83 (13.25%)
    16 / 84 (19.05%)
    39 / 80 (48.75%)
    47 / 84 (55.95%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 83 (6.02%)
    2 / 84 (2.38%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    2 / 80 (2.50%)
    2 / 84 (2.38%)
         occurrences all number
    6
    2
    0
    0
    2
    2
    Fever >= 38 degrees C but <= 39 degrees C Infant Series Dose 1 and Toddler Dose
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    44 / 80 (55.00%)
    39 / 78 (50.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    19 / 65 (29.23%)
    15 / 70 (21.43%)
         occurrences all number
    44
    39
    0
    0
    19
    15
    Fever > 39 degrees C but <= 40 degrees C Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    1 / 74 (1.35%)
    1 / 74 (1.35%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    2 / 63 (3.17%)
    3 / 69 (4.35%)
         occurrences all number
    1
    1
    0
    0
    2
    3
    Irritability Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    52 / 80 (65.00%)
    56 / 80 (70.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    18 / 65 (27.69%)
    20 / 74 (27.03%)
         occurrences all number
    52
    56
    0
    0
    18
    20
    Increased sleep Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    41 / 77 (53.25%)
    41 / 81 (50.62%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    11 / 66 (16.67%)
    12 / 72 (16.67%)
         occurrences all number
    41
    41
    0
    0
    11
    12
    Decreased sleep Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    35 / 79 (44.30%)
    32 / 78 (41.03%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    11 / 64 (17.19%)
    17 / 74 (22.97%)
         occurrences all number
    35
    32
    0
    0
    11
    17
    Fever >= 38 degrees C but <= 39 degrees C Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    38 / 73 (52.05%)
    33 / 76 (43.42%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    38
    33
    0
    0
    0
    0
    Fever > 39 degrees C but <= 40 degrees C Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    2 / 69 (2.90%)
    2 / 72 (2.78%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Fever >= 38 degrees C but <= 39 degrees C nfant Series Dose 3
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    21 / 66 (31.82%)
    15 / 66 (22.73%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    21
    15
    0
    0
    0
    0
    Fever > 39 degrees C but <= 40 degrees C Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    3 / 65 (4.62%)
    6 / 66 (9.09%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    3
    6
    0
    0
    0
    0
    Decreased appetite Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    37 / 73 (50.68%)
    46 / 82 (56.10%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    37
    46
    0
    0
    0
    0
    Irritability Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    42 / 75 (56.00%)
    46 / 80 (57.50%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    42
    46
    0
    0
    0
    0
    Increased sleep Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    30 / 73 (41.10%)
    33 / 76 (43.42%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    30
    33
    0
    0
    0
    0
    Decreased sleep Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    30 / 71 (42.25%)
    25 / 77 (32.47%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    30
    25
    0
    0
    0
    0
    Fever > 40 degrees C Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    0 / 65 (0.00%)
    1 / 64 (1.56%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Decreased appetite Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    30 / 69 (43.48%)
    39 / 75 (52.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    30
    39
    0
    0
    0
    0
    Irritability Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    29 / 68 (42.65%)
    34 / 71 (47.89%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    29
    34
    0
    0
    0
    0
    Increased sleep Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    27 / 66 (40.91%)
    26 / 70 (37.14%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    27
    26
    0
    0
    0
    0
    Decreased sleep Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    21 / 68 (30.88%)
    23 / 69 (33.33%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    21
    23
    0
    0
    0
    0
    Immune system disorders
    Milk allergy
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 84 (1.19%)
    1 / 83 (1.20%)
    1 / 84 (1.19%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    2
    1
    1
    2
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    5 / 83 (6.02%)
    4 / 84 (4.76%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    2 / 80 (2.50%)
    0 / 84 (0.00%)
         occurrences all number
    5
    5
    1
    0
    2
    0
    Rhinorrhoea
         subjects affected / exposed
    4 / 83 (4.82%)
    2 / 84 (2.38%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    1 / 84 (1.19%)
         occurrences all number
    5
    2
    1
    0
    1
    1
    Cough
         subjects affected / exposed
    1 / 83 (1.20%)
    2 / 84 (2.38%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    1
    2
    0
    0
    1
    0
    Allergic respiratory disease
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Tonsillar inflammation
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Joint dislocation
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Congenital, familial and genetic disorders
    Dacryostenosis congenital
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Nervous system disorder
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Eye disorders
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 83 (1.20%)
    2 / 84 (2.38%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    2
    1
    0
    0
    0
    1
    Enteritis
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Gastric disorder
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Intestinal functional disorder
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Oesophagitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Peptic ulcer
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Eructation
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    Irritable bowel syndrome
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 83 (0.00%)
    2 / 84 (2.38%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    10 / 83 (12.05%)
    11 / 84 (13.10%)
    5 / 83 (6.02%)
    11 / 84 (13.10%)
    0 / 80 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    10
    12
    6
    12
    0
    1
    Dermatitis diaper
         subjects affected / exposed
    5 / 83 (6.02%)
    6 / 84 (7.14%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    1 / 84 (1.19%)
         occurrences all number
    7
    6
    0
    0
    1
    1
    Dermatitis contact
         subjects affected / exposed
    3 / 83 (3.61%)
    5 / 84 (5.95%)
    3 / 83 (3.61%)
    7 / 84 (8.33%)
    0 / 80 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    3
    5
    3
    8
    0
    1
    Dermatitis
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    2
    1
    0
    1
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    1 / 83 (1.20%)
    3 / 84 (3.57%)
    1 / 83 (1.20%)
    3 / 84 (3.57%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    3
    1
    3
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    2 / 84 (2.38%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    1
    2
    0
    0
    Rash
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Rash papular
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Alopecia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Heat rash
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Tenderness (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    25 / 80 (31.25%)
    26 / 76 (34.21%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    7 / 64 (10.94%)
    17 / 75 (22.67%)
         occurrences all number
    25
    26
    0
    0
    7
    17
    Tenderness (Significant) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    4 / 75 (5.33%)
    7 / 75 (9.33%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 63 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    4
    7
    0
    0
    0
    0
    Swelling (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    20 / 78 (25.64%)
    9 / 76 (11.84%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    5 / 63 (7.94%)
    4 / 70 (5.71%)
         occurrences all number
    20
    9
    0
    0
    5
    4
    Swelling (Mild) = 0.5 to 2.0 cm Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    19 / 78 (24.36%)
    9 / 76 (11.84%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    4 / 63 (6.35%)
    4 / 70 (5.71%)
         occurrences all number
    19
    9
    0
    0
    4
    4
    Swelling (Moderate) = 2.5 to 7.0 cm Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [23]
    1 / 74 (1.35%)
    0 / 74 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 63 (1.59%)
    0 / 69 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Redness (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    23 / 77 (29.87%)
    22 / 76 (28.95%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    10 / 65 (15.38%)
    9 / 70 (12.86%)
         occurrences all number
    23
    22
    0
    0
    10
    9
    Redness (Mild) = 0.5 to 2.0 cm Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    20 / 77 (25.97%)
    20 / 76 (26.32%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    9 / 65 (13.85%)
    9 / 70 (12.86%)
         occurrences all number
    20
    20
    0
    0
    9
    9
    Redness (Moderate) = 2.5 to 7.0 cm Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    6 / 74 (8.11%)
    2 / 74 (2.70%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 63 (1.59%)
    0 / 69 (0.00%)
         occurrences all number
    6
    2
    0
    0
    1
    0
    Tenderness (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    17 / 72 (23.61%)
    17 / 76 (22.37%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    17
    17
    0
    0
    0
    0
    Tenderness (Significant) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    2 / 69 (2.90%)
    1 / 71 (1.41%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Swelling (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    9 / 70 (12.86%)
    11 / 72 (15.28%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    9
    11
    0
    0
    0
    0
    Swelling (Mild) = 0.5 to 2.0 cm Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    9 / 70 (12.86%)
    11 / 72 (15.28%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    9
    11
    0
    0
    0
    0
    Redness (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    12 / 70 (17.14%)
    15 / 74 (20.27%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    12
    15
    0
    0
    0
    0
    Redness (Mild) = 0.5 to 2.0 cm Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    12 / 70 (17.14%)
    13 / 74 (17.57%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    12
    13
    0
    0
    0
    0
    Redness (Moderate) = 2.5 to 7.0 cm Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    0 / 69 (0.00%)
    2 / 71 (2.82%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Tenderness (Any) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    13 / 67 (19.40%)
    12 / 67 (17.91%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    13
    12
    0
    0
    0
    0
    Tenderness (Significant) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    0 / 65 (0.00%)
    1 / 65 (1.54%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Swelling (Any) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    11 / 65 (16.92%)
    3 / 65 (4.62%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    11
    3
    0
    0
    0
    0
    Swelling (Mild) = 0.5 to 2.0 cm Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    10 / 65 (15.38%)
    3 / 65 (4.62%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    10
    3
    0
    0
    0
    0
    Swelling (Moderate) = 2.5 to 7.0 cm Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    2 / 65 (3.08%)
    0 / 64 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Redness (Any) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    14 / 67 (20.90%)
    9 / 65 (13.85%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    14
    9
    0
    0
    0
    0
    Redness (Mild) = 0.5 to 2.0 cm Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    12 / 66 (18.18%)
    9 / 65 (13.85%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    12
    9
    0
    0
    0
    0
    Redness (Moderate) = 2.5 to 7.0 cm Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    3 / 66 (4.55%)
    0 / 64 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    Decreased appetite Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Event 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [42]
    39 / 78 (50.00%)
    45 / 81 (55.56%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    18 / 65 (27.69%)
    23 / 75 (30.67%)
         occurrences all number
    39
    45
    0
    0
    18
    23
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Scleroderma
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Torticollis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    31 / 83 (37.35%)
    53 / 84 (63.10%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    9 / 80 (11.25%)
    8 / 84 (9.52%)
         occurrences all number
    45
    90
    0
    0
    10
    8
    Bronchiolitis
         subjects affected / exposed
    4 / 83 (4.82%)
    4 / 84 (4.76%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    4
    5
    0
    1
    1
    0
    Bronchitis
         subjects affected / exposed
    7 / 83 (8.43%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    8
    2
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 83 (2.41%)
    5 / 84 (5.95%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    5
    0
    1
    0
    0
    Diarrhoea infectious
         subjects affected / exposed
    2 / 83 (2.41%)
    4 / 84 (4.76%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    1 / 84 (1.19%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Otitis externa
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Otitis media acute
         subjects affected / exposed
    0 / 83 (0.00%)
    2 / 84 (2.38%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    2 / 84 (2.38%)
         occurrences all number
    0
    2
    0
    0
    1
    2
    Acute tonsillitis
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    2 / 80 (2.50%)
    0 / 84 (0.00%)
         occurrences all number
    1
    1
    0
    0
    2
    0
    Acute sinusitis`
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 83 (0.00%)
    2 / 84 (2.38%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    0
    3
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 83 (1.20%)
    3 / 84 (3.57%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    1
    3
    0
    0
    1
    0
    Roseola
         subjects affected / exposed
    3 / 83 (3.61%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    1 / 80 (1.25%)
    0 / 84 (0.00%)
         occurrences all number
    3
    1
    0
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 83 (1.20%)
    2 / 84 (2.38%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    1 / 84 (1.19%)
         occurrences all number
    1
    3
    0
    0
    0
    1
    Abscess limb
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Bacteriuria
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Bronchopneumonia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Croup infectious
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Exanthema subitum
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 84 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Viral rash
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    2 / 83 (2.41%)
    2 / 84 (2.38%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 84 (1.19%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
    0 / 80 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Feb 2008
    1. The investigators and parents/legal guardians was allowed to take tympanic temperatures instead of axillary temperatures, as this reflected standard practice in Taiwan. 2. At visit 3, for concomitant vaccination, a combination vaccine DTaP-IPV-Hib-HBV was given instead of 2 single injections of DTaP-IPV-Hib and HBV.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Geometric Mean Concentration Outcome Measures were identified as secondary analysis in the study protocol, but are included to maintain consistency with other postings for this program.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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