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    Clinical Trial Results:
    A Phase 4, Open-label Trial Describing The Safety, Tolerability, And Immunogenicity Of The 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) In Preterm Compared To Term Infants

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2009-017332-41
    Trial protocol
    		 ES   PL  
    Global end of trial date
    23 Jan 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    02 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
    B1851037
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01193335
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer CT.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer CT.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000036-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.
    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
    19 Oct 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 100
    Country: Number of subjects enrolled
    Spain: 100
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    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)
    200
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Study started on 19 October 2010. A total of 200 subjects were enrolled in study 100 were from Poland and 100 were from Spain. All 200 subjects completed the 3-dose infant series of vaccinations and 196 subjects received the toddler dose and continued through the study through the post–toddler dose blood draw. The study completed on 23 Jan 2014.

    Period 1
    Period 1 title
    Infant Series
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC Group 1 (Preterm Infant)
    Arm description
    		 Preterm infant subjects (gestational age [GA] less than [<] 37 weeks) received single dose of 13vPnC at 2, 3, 4 months of age (infant series). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    13vPnC Group 1 (Preterm Infant)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13vPnC was administered at a dose of 0.5 milliliter (mL) at 2, 3, 4 months of age (infant series).

    Arm title
    		 13vPnC Group 2 (Term Infant)
    Arm description
    		 Term infant subjects (GA >=37 weeks) received 13vPnC at 2, 3, 4 months of age (infant series).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    13vPnC Group 2 (Term Infant)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13vPnC was administered at a dose of 0.5 mL at 2, 3, 4 months of age (infant series).

    Number of subjects in period 1
    		13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Started
    100
    100
    Completed
    100
    100
    Period 2
    Period 2 title
    After Infant Series
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC Group 1 (Preterm Infant)
    Arm description
    		 Preterm infant subjects (GA <37 weeks) received single dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 3, 4 months of age (infant series). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 13vPnC Group 2 (Term Infant)
    Arm description
    		 Term infant subjects (GA >=37 weeks) received single dose of 13vPnC at 2, 3, 4 months of age (infant series).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Started
    100
    100
    Completed
    99
    97
    Not completed
    1
    3
         No longer met eligibility criteria
    -
    1
         Lost to follow-up
    1
    2
    Period 3
    Period 3 title
    Toddler Dose
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC Group 1 (Preterm Infant)
    Arm description
    		 Preterm infant subjects (GA <37 weeks) received dose of 13vPnC at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    13vPnC Group 1 (Preterm Infant)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13vPnC was administered at a dose of 0.5 milliliter (mL) at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).

    Arm title
    		 13vPnC Group 1 (Term Infant)
    Arm description
    		 Term infant subjects (GA >=37 weeks) received single dose of 13vPnC at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    13vPnC Group 2 (Term Infant)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13vPnC was administered at a dose of 0.5 mL at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).

    Number of subjects in period 3
    		13vPnC Group 1 (Preterm Infant) 13vPnC Group 1 (Term Infant)
    Started
    99
    97
    Completed
    99
    97
    Period 4
    Period 4 title
    1-Year Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC Group 1 (Preterm Infant)
    Arm description
    		 Preterm infant subjects (GA <37 weeks) received 13vPnC at 2, 3, 4 months of age (infant series). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 13vPnC Group 2 (Term Infant)
    Arm description
    		 Term infant subjects (GA >=37 weeks) received single dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Started
    99
    97
    Completed
    88
    88
    Not completed
    11
    9
         No longer willing to participate
    7
    9
         Lost to follow-up
    4
    -
    Period 5
    Period 5 title
    2-Year Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC Group 2 (Term Infant)
    Arm description
    		 Term infant subjects (GA >=37 weeks) received 13vPnC at 2, 3, 4 months of age (infant series).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 13vPnC Group 1 (Preterm Infant)
    Arm description
    		 Preterm infants (GA <37 weeks) received 13vPnC at 2, 3, 4 months of age (infant series). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 5
    		13vPnC Group 2 (Term Infant) 13vPnC Group 1 (Preterm Infant)
    Started
    88
    88
    Completed
    80
    81
    Not completed
    8
    7
         No longer met eligibility criteria
    2
    2
         No longer willing to participate
    6
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC Group 1 (Preterm Infant)
    Reporting group description
    		 Preterm infant subjects (gestational age [GA] less than [<] 37 weeks) received single dose of 13vPnC at 2, 3, 4 months of age (infant series). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).

    Reporting group title
    13vPnC Group 2 (Term Infant)
    Reporting group description
    		 Term infant subjects (GA >=37 weeks) received 13vPnC at 2, 3, 4 months of age (infant series).

    Reporting group values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant) Total
    Number of subjects
    		 100 100 200
    Age categorical
    Units: Subjects
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 1.8 ( 0.6 ) 1.5 ( 0.5 ) -
    Gender, Male/Female
    Units: participants
        Male
    		 52 45 97
        Female
    		 48 55 103

    End points

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    End points reporting groups
    Reporting group title
    13vPnC Group 1 (Preterm Infant)
    Reporting group description
    		 Preterm infant subjects (gestational age [GA] less than [<] 37 weeks) received single dose of 13vPnC at 2, 3, 4 months of age (infant series). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).

    Reporting group title
    13vPnC Group 2 (Term Infant)
    Reporting group description
    		 Term infant subjects (GA >=37 weeks) received 13vPnC at 2, 3, 4 months of age (infant series).
    Reporting group title
    13vPnC Group 1 (Preterm Infant)
    Reporting group description
    		 Preterm infant subjects (GA <37 weeks) received single dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 3, 4 months of age (infant series). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).

    Reporting group title
    13vPnC Group 2 (Term Infant)
    Reporting group description
    		 Term infant subjects (GA >=37 weeks) received single dose of 13vPnC at 2, 3, 4 months of age (infant series).
    Reporting group title
    13vPnC Group 1 (Preterm Infant)
    Reporting group description
    		 Preterm infant subjects (GA <37 weeks) received dose of 13vPnC at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).

    Reporting group title
    13vPnC Group 1 (Term Infant)
    Reporting group description
    		 Term infant subjects (GA >=37 weeks) received single dose of 13vPnC at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
    Reporting group title
    13vPnC Group 1 (Preterm Infant)
    Reporting group description
    		 Preterm infant subjects (GA <37 weeks) received 13vPnC at 2, 3, 4 months of age (infant series). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).

    Reporting group title
    13vPnC Group 2 (Term Infant)
    Reporting group description
    		 Term infant subjects (GA >=37 weeks) received single dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series).
    Reporting group title
    13vPnC Group 2 (Term Infant)
    Reporting group description
    		 Term infant subjects (GA >=37 weeks) received 13vPnC at 2, 3, 4 months of age (infant series).

    Reporting group title
    13vPnC Group 1 (Preterm Infant)
    Reporting group description
    		 Preterm infants (GA <37 weeks) received 13vPnC at 2, 3, 4 months of age (infant series). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).

    Subject analysis set title
    13vPnC Group 1A
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Preterm infant subjects with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).

    Subject analysis set title
    13vPnC Group 1B
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Preterm infant subjects with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).

    Subject analysis set title
    13vPnC Group 1C
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Preterm subjects with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).

    Subject analysis set title
    13vPnC Group 1 (Preterm Infant)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Preterm infant subjects (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).

    Primary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram per Milliliter (mcg/mL) 1 Month After Infant Series

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    End point title
    		 Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram per Milliliter (mcg/mL) 1 Month After Infant Series
    End point description
    Percentage of subjects achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 percent (%) 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) were presented. Exact 2-sided CI based on the observed proportion of subjects. Here 'n' signifies subjects with a determinate IgG concentration to the given serotype for each arm, respectively. Evaluable infant immunogenicity population included eligible subjects who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Primary
    End point timeframe
    1 month after the infant series
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    99
    98
    Units: percentage of subjects
    number (confidence interval 95%)
        4 (n=99, 97)
    96.97 (91.4 to 99.37)
    98.97 (94.39 to 99.97)
        6B (n=99, 97)
    72.73 (62.85 to 81.2)
    87.63 (79.39 to 93.44)
        9V (n=99, 97)
    96.97 (91.4 to 99.37)
    96.91 (91.23 to 99.36)
        14 (n=99, 97)
    100 (96.34 to 100)
    97.94 (92.75 to 99.75)
        18C (n=99, 97)
    96.97 (91.4 to 99.37)
    94.85 (88.38 to 98.31)
        19F (n=99, 97)
    98.99 (94.5 to 99.97)
    98.97 (94.39 to 99.97)
        23F (n=99, 97 )
    85.86 (77.41 to 92.05)
    92.78 (85.7 to 97.05)
        1 (n=99, 97)
    93.94 (87.27 to 97.74)
    95.88 (89.78 to 98.87)
        3 (n=99, 97)
    85.86 (77.41 to 92.05)
    90.72 (83.12 to 95.67)
        5 (n=99, 97)
    71.72 (61.78 to 80.31)
    90.72 (83.12 to 95.67)
        6A (n=98, 97)
    82.65 (73.69 to 89.56)
    94.85 (88.38 to 98.31)
        7F (n=99, 97)
    98.99 (94.5 to 99.97)
    98.97 (94.39 to 99.97)
        19A (n=99, 97)
    98.99 (94.5 to 99.97)
    98.97 (94.39 to 99.97)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.65
         upper limit
    		 2.88
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -14.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.4
         upper limit
    		 -3.21
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.84
         upper limit
    		 6.05
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    2.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.71
         upper limit
    		 7.25
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    2.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.09
         upper limit
    		 8.89
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.54
         upper limit
    		 4.68
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -6.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.19
         upper limit
    		 1.89
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -1.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.07
         upper limit
    		 4.86
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -4.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.4
         upper limit
    		 4.39
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.1
         upper limit
    		 -7.16
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -12.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.66
         upper limit
    		 -3.26
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.54
         upper limit
    		 4.68
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.54
         upper limit
    		 4.68

    Primary: 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 geometric mean concentration (GMC) 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. CIs for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable infant immunogenicity population. Here ‘n’ signifies subjects with a determinate IgG concentration to the given serotype for each arm, respectively.
    End point type
    Primary
    End point timeframe
    1 month after the infant series
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    99
    98
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        4 (n=99, 97)
    1.96 (1.67 to 2.31)
    2.46 (2.04 to 2.97)
        6B (n=99, 97)
    0.73 (0.55 to 0.97)
    1.3 (1 to 1.67)
        9V (n=99, 97)
    1.26 (1.08 to 1.47)
    1.7 (1.45 to 2)
        14 (n=99, 97)
    7.48 (6.23 to 8.99)
    6.08 (4.82 to 7.67)
        18C (n=99, 97)
    1.93 (1.66 to 2.24)
    1.93 (1.62 to 2.29)
        19F (n=99, 97)
    2.21 (1.89 to 2.58)
    3.05 (2.62 to 3.55)
        23F (n=99, 97)
    0.86 (0.69 to 1.07)
    1.36 (1.1 to 1.68)
        1 (n=99, 97)
    1.26 (1.06 to 1.48)
    1.79 (1.5 to 2.13)
        3 (n=99, 97)
    0.83 (0.7 to 0.98)
    0.86 (0.75 to 1)
        5 (n=99, 97)
    0.56 (0.44 to 0.7)
    1.03 (0.87 to 1.22)
        6A (n=98, 97)
    1.22 (0.98 to 1.53)
    2.01 (1.65 to 2.46)
        7F (n=99, 97)
    2.14 (1.81 to 2.53)
    3.02 (2.63 to 3.48)
        19A (n=99, 97)
    2.85 (2.44 to 3.33)
    3.35 (2.85 to 3.94)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.02
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 0.82
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.93
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.65
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.25
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.9
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 0.86
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 0.89
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.19
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 0.72
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 0.82
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.88
    Statistical analysis title
    		 Serotype 19 A
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.07

    Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Dose 1 Infant Series [1]
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] 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 for Dose 1 infant series: all subjects who received13vPnC Dose 1. Here 'N' (number of subjects analyzed)= subjects reporting yes for at least 1 day or no for all days for any local reaction.'n'=subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 1 of the infant series
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this outcome measure. 
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    98
    92
    Units: percentage of subjects
    number (not applicable)
        Tenderness- Any (n=94, 88)
    48.9
    42
        Tenderness- Mild (n=93, 88)
    46.2
    31.8
        Tenderness- Moderate (n=90, 85)
    17.8
    16.5
        Tenderness- Severe (n=86, 85)
    0
    0
        Swelling- Any (n=94, 89)
    39.4
    29.2
        Swelling- Mild (n=91, 89)
    37.4
    28.1
        Swelling- Moderate (n=91, 85)
    8.8
    8.2
        Swelling- Severe (n=86, 85)
    0
    0
        Redness- Any (n=92, 87)
    33.7
    29.9
        Redness- Mild (n=90, 87)
    32.2
    28.7
        Redness- Moderate (n=88, 85)
    3.4
    4.7
        Redness- Severe (n=86, 85)
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Dose 2 Infant Series [2]
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] 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 for Dose 2 infant series: all subjects who received 13vPnC Dose 2.Here 'N' (number of subjects analyzed)=subjects reporting yes for at least 1 day or no for all days for any local reaction.'n'=subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 2 of the infant series
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this outcome measure.
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    89
    89
    Units: percentage of subjects
    number (not applicable)
        Tenderness- Any (n=85, 88 )
    48.2
    38.6
        Tenderness- Mild (n=85, 84)
    43.5
    31
        Tenderness- Moderate (n=77, 83)
    14.3
    15.7
        Tenderness- Severe (n=73, 77)
    0
    1.3
        Swelling- Any (n=84, 82)
    35.7
    42.7
        Swelling- Mild (n=83, 82)
    33.7
    42.7
        Swelling- Moderate (n=75, 76)
    8
    2.6
        Swelling- Severe (n=73, 76)
    0
    0
        Redness- Any (n=82, 82)
    28
    40.2
        Redness- Mild (n=82, 82)
    28
    37.8
        Redness- Moderate (n=73, 76)
    2.7
    2.6
        Redness- Severe (n=73, 76)
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Dose 3 Infant Series [3]
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] 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 for Dose 3 infant series: all subjects who received 13vPnC Dose 3.Here 'N' (number of subjects analyzed)=subjects reporting yes for at least 1 day or no for all days for any local reaction.'n'=subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 3 of the infant series
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this outcome measure.
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    87
    90
    Units: percentage of subjects
    number (not applicable)
        Tenderness- Any (n=82, 84)
    39
    28.6
        Tenderness- Mild (n=81, 84)
    35.8
    26.2
        Tenderness- Moderate (n=75, 78)
    9.3
    5.1
        Tenderness- Severe (n=73, 77)
    0
    0
        Swelling- Any (n=83, 85)
    30.1
    41.2
        Swelling- Mild (n=82, 85)
    26.8
    41.2
        Swelling- Moderate (n=75, 79)
    5.3
    5.1
        Swelling- Severe (n=73, 77)
    0
    0
        Redness- Any (n=82, 87)
    32.9
    46
        Redness- Mild (n=82, 87)
    32.9
    46
        Redness- Moderate (n=74, 79)
    1.4
    3.8
        Redness- Severe (n=73, 77)
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Toddler Dose [4]
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurts if gently touched with no crying); Moderate (hurts if gently touched with crying); Severe (causes limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] 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 for Toddler Dose: all subjects who received 13vPnC Toddler Dose. Here 'N' (number of subjects analyzed)=subjects reporting yes for at least 1 day or no for all days for any local reaction.'n'=subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Primary
    End point timeframe
    Within 7 days after the toddler dose
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this outcome measure.
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    89
    88
    Units: percentage of subjects
    number (not applicable)
        Tenderness- Any (n=86, 85)
    69.8
    55.3
        Tenderness- Mild (n=86, 85)
    66.3
    51.8
        Tenderness- Moderate (n=77, 70)
    20.8
    11.4
        Tenderness- Severe (n=74, 69)
    2.7
    0
        Swelling- Any (n=81, 80)
    43.2
    35
        Swelling- Mild (n=80, 79)
    38.8
    32.9
        Swelling- Moderate (n=76, 74)
    13.2
    9.5
        Swelling- Severe (n=74, 69)
    1.4
    0
        Redness- Any (n=85, 83)
    51.8
    49.4
        Redness- Mild (n=85, 83)
    51.8
    48.2
        Redness- Moderate (n=75, 75)
    6.7
    10.7
        Redness- Severe (n=74, 69)
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Dose 1 Infant Series [5]
    End point description
    Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Subjects may be represented in more than 1 category. Safety population. Here N = number of subjects analyzed and n=subjects reporting yes for at least 1 day or no for all days for specified event for each group, respectively.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 1 of the infant series
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this outcome measure.
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    98
    99
    Units: percentage of subjects
    number (not applicable)
        Fever >=38 degrees C (n=86, 88)
    11.6
    13.6
        Fever >=38 degrees C, =<39 degrees C (n=86, 88)
    10.5
    13.6
        Fever >=39 degrees C, =<40 degrees C (n=86, 85)
    1.2
    0
        Fever >40 degrees C (n=86, 85)
    0
    0
        Decreased Appetite- Any (n=92, 89)
    60.9
    41.6
        Decreased Appetite- Mild (n=91, 88)
    54.9
    35.2
        Decreased Appetite- Moderate (n=88, 87)
    20.5
    17.2
        Decreased Appetite- Severe (n=86, 85)
    1.2
    0
        Increased Sleep- Any (n=96, 95)
    67.7
    69.5
        Increased Sleep- Mild (n=96, 93)
    60.4
    61.3
        Increased Sleep- Moderate (n=87, 88)
    29.9
    30.7
        Increased Sleep- Severe (n=86, 85)
    2.3
    2.4
        Irritability or Decreased Sleep- Any (n=95, 97)
    84.2
    82.5
        Irritability or Decreased Sleep- Mild (n=93, 95)
    77.4
    69.5
        Irritability or Decreased Sleep-Moderate (n=92, 91
    43.5
    47.3
        Irritability or Decreased Sleep- Severe (n=86, 85)
    8.1
    5.9
        Use of Antipyretic Medication (n=90, 90)
    24.4
    24.4
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Dose 2 Infant Series [6]
    End point description
    Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Subjects may be represented in more than 1 category. Safety population for Dose 2 infant series: all subjects who received 13vPnC Dose 2. Here 'N' (number of subjects analyzed)=subjects reporting yes for at least 1 day or no for all days for any event and 'n'=p
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 2 of the infant series
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification:  Only descriptive data was planned to be analysed for this outcome measure.
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    97
    96
    Units: percentage of subjects
    number (not applicable)
        Fever >=38 degrees C (n=79, 79)
    27.8
    31.6
        Fever >=38 degrees C, =<39 degrees C (n=79, 79)
    27.8
    30.4
        Fever >=39 degrees C, =<40 degrees C (n=73, 76)
    0
    1.3
        Fever >40 degrees C (n=73, 76)
    0
    0
        Decreased Appetite- Any (n=89, 84)
    61.8
    46.4
        Decreased Appetite- Mild (n=88, 84)
    55.7
    41.7
        Decreased Appetite- Moderate (n=79, 78)
    25.3
    19.2
        Decreased Appetite- Severe (n=73, 76)
    1.4
    0
        Increased Sleep- Any (n=85, 89 )
    74.1
    64
        Increased Sleep- Mild (n=83, 88)
    69.9
    59.1
        Increased Sleep- Moderate (n=78, 78)
    34.6
    29.5
        Increased Sleep- Severe (n=73, 76)
    2.7
    1.3
        Irritability or Decreased Sleep- Any (n=95, 95)
    89.5
    77.9
        Irritability or Decreased Sleep- Mild (n=90, 92)
    81.1
    71.7
        Irritability or Decreased Sleep-Moderate (n=85, 86
    64.7
    44.2
        Irritability or Decreased Sleep- Severe (n=74, 76)
    17.6
    2.6
        Use of Antipyretic Medication (n=84, 83)
    48.8
    45.8
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Dose 3 Infant Series [7]
    End point description
    Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Subjects may be represented in more than 1 category. Safety population. N =number of subjects analyzed and n=subjects reporting yes for at least 1 day or no for all days for specified event for each group, respectively.
    End point type
    Primary
    End point timeframe
    Within 7 days after Dose 3 of the infant series
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this outcome measure.
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    94
    95
    Units: percentage of subjects
    number (not applicable)
        Fever >=38 degrees C (n=79, 81)
    27.8
    30.9
        Fever >=38 degrees C, =<39 degrees C (n=78, 81)
    26.9
    30.9
        Fever >=39 degrees C, =<40 degrees C (n=75, 78)
    1.3
    2.6
        Fever >40 degrees C (n=74, 77)
    0
    0
        Decreased Appetite- Any (n=82, 84)
    48.8
    47.6
        Decreased Appetite- Mild (n=82, 84)
    36.6
    46.4
        Decreased Appetite- Moderate (n=74, 79)
    17.6
    16.5
        Decreased Appetite- Severe (n=74, 77)
    1.4
    1.3
        Increased Sleep- Any (n=88, 88 )
    52.3
    58
        Increased Sleep- Mild (n=88, 87)
    48.9
    51.7
        Increased Sleep- Moderate (n=77, 80)
    16.9
    20
        Increased Sleep- Severe (n=73, 77)
    1.4
    1.3
        Irritability or Decreased Sleep- Any (n=92, 95)
    79.3
    81.1
        Irritability or Decreased Sleep- Mild (n=90, 91)
    72.2
    74.7
        Irritability or Decreased Sleep-Moderate (n=80,87)
    33.8
    35.6
        Irritability or Decreased Sleep- Severe (n=74, 78)
    6.8
    6.4
        Use of Antipyretic Medication (n=84, 81)
    40.5
    38.3
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Toddler Dose [8]
    End point description
    Systemic events (fever >=38 degrees Celsius [C], decreased appetite, increased sleep, and irritability or decreased sleep) and use of antipyretic medication were reported using an electronic diary. Decreased appetite was scaled as Any; Mild (loss of appetite but no decreased oral intake); Moderate (decreased oral intake); Severe (refusal to feed). Increased sleep was scaled as Any; Mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (disabling not interested in usual daily activity). Irritability or decreased sleep was scaled as Any; Mild (easily consolable); Moderate (requiring increased attention); Severe (inconsolable; crying that cannot be comforted). Subjects may be represented in more than 1 category. Safety population for Toddler Dose: all subjects who received 13vPnC Toddler Dose. N=number of subjects analyzed, n=subjects reporting yes for at least 1 day or no for all days for specified event for each group.
    End point type
    Primary
    End point timeframe
    Within 7 days after the toddler dose
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this outcome measure.
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    93
    92
    Units: percentage of subjects
    number (not applicable)
        Fever >=38 degrees C (n= 80, 78)
    28.8
    43.6
        Fever >=38 degrees C, =<39 degrees C (n=80, 77)
    27.5
    42.9
        Fever >=39 degrees C, =<40 degrees C (n=74, 71)
    1.4
    4.2
        Fever >40 degrees C (n=74, 70)
    0
    1.4
        Decreased Appetite- Any (n=87, 86)
    57.5
    60.5
        Decreased Appetite- Mild (n=86, 84)
    50
    56
        Decreased Appetite- Moderate (n=78, 73)
    25.6
    23.3
        Decreased Appetite- Severe (n=75, 69)
    1.3
    1.4
        Increased Sleep- Any (n=83, 86 )
    57.8
    65.1
        Increased Sleep- Mild (n=82, 84)
    53.7
    59.5
        Increased Sleep- Moderate (n=76, 74)
    18.4
    24.3
        Increased Sleep- Severe (n=74, 70)
    0
    2.9
        Irritability or Decreased Sleep- Any (n=90, 91)
    84.4
    80.2
        Irritability or Decreased Sleep- Mild (n=90, 89)
    74.4
    76.4
        Irritability or Decreased Sleep-Moderate (n=78,80)
    44.9
    45
        Irritability or Decreased Sleep- Severe (n=76, 69)
    6.6
    4.3
        Use of Antipyretic Medication (n=82, 79)
    48.8
    50.6
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs): Infant Series
    End point description
    An AE was any untoward medical occurrence in a subject who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    End point type
    Primary
    End point timeframe
    Dose 1 up to 1 month after Dose 3 (infant series)
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    100
    100
    Units: percentage of subjects
    number (not applicable)
        AEs
    59
    55
        SAEs
    14
    5
    Statistical analysis title
    		 Subject with AEs
    Statistical analysis description
    AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.668
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Subject with SAEs
    Statistical analysis description
    SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.051
    Method
    		 Fisher exact
    Confidence interval

    Primary: Percentage of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs): After Infant Series
    End point description
    An AE was any untoward medical occurrence in a subject who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Safety population for infant series included all subjects who received at least 1 dose of 13vPnC during infant series.
    End point type
    Primary
    End point timeframe
    1 Month after Dose 3 of the infant series up to toddler dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    100
    100
    Units: percentage of subjects
    number (not applicable)
        AEs
    18
    15
        SAEs
    8
    9
    Statistical analysis title
    		 Subjects with AEs
    Statistical analysis description
    AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.704
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Subjects with SAEs
    Statistical analysis description
    SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval

    Primary: Percentage of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs): Toddler Dose
    End point description
    An AE was any untoward medical occurrence in a subject who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
    End point type
    Primary
    End point timeframe
    Toddler dose up to 1 Month after toddler dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    99
    97
    Units: percentage of subjects
    number (not applicable)
        AEs
    31.3
    26.8
        SAEs
    2
    1
    Statistical analysis title
    		 Subjects with AEs
    Statistical analysis description
    AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.531
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Subject with SAEs
    Statistical analysis description
    SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval

    Primary: Percentage of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs): 1-Year Follow-up After Toddler Dose
    End point description
    An AE was any untoward medical occurrence in a subject who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Safety population for infant series included all subjects who received at least 1 dose of 13vPnC during infant series.
    End point type
    Primary
    End point timeframe
    1 month after toddler dose up to 1-year follow-up
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    99
    97
    Units: percentage of subjects
    number (not applicable)
        AEs
    15.2
    8.2
        SAEs
    13.1
    8.2
    Statistical analysis title
    		 Subject with AEs
    Statistical analysis description
    AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.183
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Subject with SAEs
    Statistical analysis description
    SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    196
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.357
    Method
    		 Fisher exact
    Confidence interval

    Primary: Percentage of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs): 2-Year Follow-up After Toddler Dose
    End point description
    An AE was any untoward medical occurrence in a subject who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.Safety population for 2-year follow-up after toddler dose included all subjects who received 13vPnC toddler dose and had safety data available during specified follow-up period.
    End point type
    Primary
    End point timeframe
    1-year follow-up after toddler dose to 2-year follow-up after toddler dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    88
    88
    Units: percentage of subjects
    number (not applicable)
        AEs
    8
    10.2
        SAEs
    6.8
    9.1
    Statistical analysis title
    		 Subject with AEs
    Statistical analysis description
    AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.794
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Subject with SAEs
    Statistical analysis description
    SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.782
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose

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    End point title
    		 Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Toddler Pre-Dose to 1 Month After Toddler Dose
    End point description
    GMFR 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) from before 13vPnC toddler dose to 1 month after 13vPnC toddler dose were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the fold rises. GMFRs were calculated using all subjects with available data from both before 13vPnC toddler dose and after 13vPnC toddler dose blood draws. Safety population for 1-year follow-up after toddler dose included all subjects who received 13vPnC toddler dose and had safety data available during specified follow-up period. Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies subjects with a determinate IgG antibody concentration to the given serotype for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Before 13vPnC Toddler Dose (pre-vaccination), 1 month after 13vPnC Toddler Dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    88
    88
    Units: fold rise
    geometric mean (confidence interval 95%)
        4 (n= 83, 85)
    8.14 (6.61 to 10.04)
    9.61 (7.77 to 11.88)
        6B (n=80, 85)
    9.46 (7.81 to 11.45)
    7.61 (6.31 to 9.18)
        9V (n=83, 85)
    5.85 (5.05 to 6.78)
    4.92 (4.22 to 5.74)
        14 (n=83, 85)
    4.5 (3.76 to 5.38)
    4.65 (3.82 to 5.65)
        18C (n=83, 85)
    7.36 (6.29 to 8.61)
    9.14 (7.61 to 10.98)
        19F (n=83, 85)
    10.82 (8.88 to 13.17)
    12.31 (9.77 to 15.51)
        23F (n=79, 83)
    10.11 (8.13 to 12.57)
    10.15 (8.32 to 12.39)
        1 (n=83, 85)
    8.41 (6.94 to 10.2)
    9.98 (8.18 to 12.17)
        3 (n=81, 84)
    7.61 (5.79 to 10.01)
    5.23 (4.22 to 6.49)
        5 (n=80, 85)
    3.47 (3.04 to 3.97)
    3.46 (2.93 to 4.09)
        6A (n=83, 85)
    10.52 (8.75 to 12.64)
    7.72 (6.18 to 9.65)
        7F (n=83, 85)
    5.81 (5.12 to 6.61)
    6.07 (5.16 to 7.13)
        19A (n=83, 85)
    6.45 (5.39 to 7.72)
    5.59 (4.53 to 6.9)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.14
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.62
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.47
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.26
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.02
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.19
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.33
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.11
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    1.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 2.05
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.24
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.82
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.18
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMFR Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.52

    Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C

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    End point title
    		 Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Infant Series: Group 1A, 1B, 1C
    End point description
    Percentage of subjects achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 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) were presented. Exact 2-sided CI based on the observed proportion of subjects. Here 'n' signifies subjects with a determinate IgG concentration to the given serotype for each arm, respectively. Evaluable infant immunogenicity population included eligible subjects who received all the assigned vaccinations (Infant Dose 1, 2 and 3), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 Month After Infant Series
    End point values
    		 13vPnC Group 1A 13vPnC Group 1B 13vPnC Group 1C
    Number of subjects analysed
    24
    50
    25
    Units: percentage of subjects
    number (confidence interval 95%)
        4 (n=24, 50, 25)
    100 (85.75 to 100)
    96 (86.29 to 99.51)
    96 (79.65 to 99.9)
        6B (n=24, 50, 25)
    79.17 (57.85 to 92.87)
    72 (57.51 to 83.77)
    68 (46.5 to 85.05)
        9V (n=24, 50, 25)
    95.83 (78.88 to 99.89)
    98 (89.35 to 99.95)
    96 (79.65 to 99.9)
        14 (n=24, 50, 25)
    100 (85.75 to 100)
    100 (92.89 to 100)
    100 (86.28 to 100)
        18C (n=24, 50, 25)
    100 (85.75 to 100)
    94 (83.45 to 98.75)
    100 (86.28 to 100)
        19F (n=24, 50, 25)
    100 (85.75 to 100)
    98 (89.35 to 99.95)
    100 (86.28 to 100)
        23F (n=24, 50, 25)
    91.67 (73 to 98.97)
    80 (66.28 to 89.97)
    92 (73.97 to 99.02)
        1 (n=24, 50, 25)
    100 (85.75 to 100)
    92 (80.77 to 97.78)
    92 (73.97 to 99.02)
        3 (n=24, 50, 25)
    87.5 (67.64 to 97.34)
    86 (73.26 to 94.18)
    84 (63.92 to 95.46)
        5 (n=24, 50, 25)
    79.17 (57.85 to 92.87)
    66 (51.23 to 78.79)
    76 (54.87 to 90.64)
        6A (n=24, 49, 25)
    95.83 (78.88 to 99.89)
    81.63 (67.98 to 91.24)
    72 (50.61 to 87.93)
        7F (n=24, 50, 25)
    100 (85.75 to 100)
    98 (89.35 to 99.95)
    100 (86.28 to 100)
        19A (n=24, 50, 25)
    100 (85.75 to 100)
    98 (89.35 to 99.95)
    100 (86.28 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose

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    End point title
    		 Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Toddler Dose
    End point description
    Percentage of subjects achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 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) were presented. Exact 2-sided CI based on the observed proportion of subjects. Here ‘n’ signifies subjects with a determinate IgG antibody concentration to the given serotype for each arm, respectively. Evaluable Toddler Immunogenicity Population included eligible subjects who received all the assigned vaccinations (Infant Dose 1, 2, 3 and toddler dose), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    88
    88
    Units: percentage of subjects
    number (confidence interval 95%)
        4 (n= 86, 87)
    100 (95.8 to 100)
    100 (95.85 to 100)
        6B (n=86, 87)
    97.67 (91.85 to 99.72)
    100 (95.85 to 100)
        9V (n=86, 87)
    100 (95.8 to 100)
    100 (95.85 to 100)
        14 (n=86, 87)
    100 (95.8 to 100)
    100 (95.85 to 100)
        18C (n=86, 87)
    100 (95.8 to 100)
    98.85 (93.76 to 99.97)
        19F (n=86, 87)
    100 (95.8 to 100)
    100 (95.85 to 100)
        23F (n=86, 87)
    98.84 (93.69 to 99.97)
    100 (95.85 to 100)
        1 (n=86, 87)
    100 (95.8 to 100)
    100 (95.85 to 100)
        3 (n=85, 87)
    70.59 (59.71 to 79.98)
    79.31 (69.29 to 87.25)
        5 (n=86, 87)
    100 (95.8 to 100)
    100 (95.85 to 100)
        6A (n=86, 87)
    100 (95.8 to 100)
    100 (95.85 to 100)
        7F (n=86, 87)
    100 (95.8 to 100)
    100 (95.85 to 100)
        19A (n=86, 87)
    100 (95.8 to 100)
    100 (95.85 to 100)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.25
         upper limit
    		 4.31
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -2.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.15
         upper limit
    		 1.96
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.25
         upper limit
    		 4.31
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.25
         upper limit
    		 4.31
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.13
         upper limit
    		 6.24
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.25
         upper limit
    		 4.31
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.32
         upper limit
    		 3.1
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.25
         upper limit
    		 4.31
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -8.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.93
         upper limit
    		 4.42
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.25
         upper limit
    		 4.31
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.25
         upper limit
    		 4.31
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.25
         upper limit
    		 4.31
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.25
         upper limit
    		 4.31

    Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C

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    End point title
    		 Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level >=0.35 mcg/mL 1 Month After Toddler Dose: Group 1A, 1B, 1C
    End point description
    Percentage of subjects achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 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) were presented. Exact 2-sided CI based on the observed proportion of subjects. Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies subjects with a determinate IgG antibody concentration to the given serotype for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose
    End point values
    		 13vPnC Group 1A 13vPnC Group 1B 13vPnC Group 1C
    Number of subjects analysed
    21
    46
    21
    Units: percentage of subjects
    number (confidence interval 95%)
        4 (n=21, 45, 20)
    100 (83.89 to 100)
    100 (92.13 to 100)
    100 (83.16 to 100)
        6B (n=21, 45, 20)
    100 (83.89 to 100)
    95.56 (84.85 to 99.46)
    100 (83.16 to 100)
        9V (n=21, 45, 20)
    100 (83.89 to 100)
    100 (92.13 to 100)
    100 (83.16 to 100)
        14 (n=21, 45, 20)
    100 (83.89 to 100)
    100 (92.13 to 100)
    100 (83.16 to 100)
        18C (n=21, 45, 20)
    100 (83.89 to 100)
    100 (92.13 to 100)
    100 (83.16 to 100)
        19F (n=21, 45, 20)
    100 (83.89 to 100)
    100 (92.13 to 100)
    100 (83.16 to 100)
        23F (n=21, 45, 20)
    100 (83.89 to 100)
    97.78 (88.23 to 99.94)
    100 (83.16 to 100)
        1 (n=21, 45, 20)
    100 (83.89 to 100)
    100 (92.13 to 100)
    100 (83.16 to 100)
        3 (n=21, 44, 20)
    95.24 (76.18 to 99.88)
    68.18 (52.42 to 81.39)
    50 (27.5 to 72.8)
        5 (n=21, 45, 20)
    100 (83.89 to 100)
    100 (92.13 to 100)
    100 (83.16 to 100)
        6A (n=21, 45, 20)
    100 (83.89 to 100)
    100 (92.13 to 100)
    100 (83.16 to 100)
        7F (n=21, 45, 20)
    100 (83.89 to 100)
    100 (92.13 to 100)
    100 (83.16 to 100)
        19A (n=21, 45, 20)
    100 (83.89 to 100)
    100 (92.13 to 100)
    100 (83.16 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose
    End point description
    Geometric mean concentration (GMC) 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable Toddler Immunogenicity Population. Here 'n' signifies subjects with a determinate IgG concentration to the given serotype for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Before Toddler Dose (pre-vaccination)
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    88
    88
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        4 (n= 85, 85)
    0.31 (0.26 to 0.37)
    0.41 (0.34 to 0.49)
        6B (n= 82, 85)
    0.48 (0.39 to 0.58)
    0.94 (0.79 to 1.11)
        9V (n= 85, 85)
    0.39 (0.33 to 0.46)
    0.62 (0.53 to 0.72)
        14 (n= 85, 85)
    2.02 (1.68 to 2.43)
    2.36 (1.94 to 2.87)
        18C (n=85, 85)
    0.32 (0.28 to 0.37)
    0.3 (0.26 to 0.36)
        19F (n=85, 85)
    0.68 (0.57 to 0.8)
    0.93 (0.79 to 1.1)
        23F (n=81, 83)
    0.24 (0.18 to 0.31)
    0.4 (0.33 to 0.48)
        1 (n=85, 85)
    0.39 (0.34 to 0.46)
    0.41 (0.35 to 0.48)
        3 (n=84, 84)
    0.07 (0.05 to 0.09)
    0.11 (0.09 to 0.14)
        5 (n=82, 85)
    0.74 (0.64 to 0.87)
    1.06 (0.9 to 1.26)
        6A (n=85, 85)
    0.54 (0.45 to 0.65)
    1.01 (0.82 to 1.24)
        7F (n=85, 85)
    0.72 (0.63 to 0.82)
    0.84 (0.73 to 0.96)
        19A (n=85, 85)
    0.86 (0.72 to 1.03)
    1.57 (1.27 to 1.92)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 0.97
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 0.66
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 0.8
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.12
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.32
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.92
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 0.83
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.2
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 0.87
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 0.88
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 0.7
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.03
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 0.72

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose
    End point description
    Geometric mean concentration (GMC) 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies subjects with a determinate IgG concentration to the given serotype for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 Month After Toddler Dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    88
    88
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        4 (n= 86, 87)
    2.57 (2.18 to 3.03)
    3.97 (3.32 to 4.74)
        6B (n=86, 87)
    4.42 (3.64 to 5.37)
    7.27 (6.09 to 8.68)
        9V (n=86, 87)
    2.3 (1.99 to 2.66)
    3.06 (2.62 to 3.56)
        14 (n=86, 87)
    9.24 (7.66 to 11.14)
    11.02 (9.44 to 12.86)
        18C (n=86, 87)
    2.37 (2.02 to 2.79)
    2.81 (2.32 to 3.4)
        19F (n=86, 87)
    7.38 (6.23 to 8.76)
    11.67 (9.47 to 14.36)
        23F (n=86, 87)
    2.45 (2.01 to 2.98)
    4.03 (3.36 to 4.85)
        1 (n=86, 87)
    3.32 (2.83 to 3.89)
    4.09 (3.42 to 4.89)
        3 (n=85, 87)
    0.52 (0.44 to 0.62)
    0.57 (0.49 to 0.65)
        5 (n=86, 87)
    2.63 (2.28 to 3.02)
    3.72 (3.19 to 4.33)
        6A (n=86, 87)
    5.64 (4.86 to 6.54)
    7.84 (6.59 to 9.33)
        7F (n=86, 87)
    4.25 (3.75 to 4.82)
    5.13 (4.48 to 5.87)
        19A (n=86, 87)
    5.57 (4.66 to 6.65)
    8.84 (7.45 to 10.48)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 0.82
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 0.79
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 0.93
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.07
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.08
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 0.83
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 0.79
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.03
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.15
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.87
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.9
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 0.81

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose
    End point description
    The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) 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). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of subjects analyzed) signifies those subjects who were evaluable for this outcome measure during specified follow-up period and 'n' signifies subjects with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 Year After Toddler Dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    80
    80
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        4 (n= 80, 79)
    0.3 (0.25 to 0.36)
    0.37 (0.31 to 0.44)
        6B (n=80, 80)
    1.26 (1.02 to 1.57)
    2.01 (1.69 to 2.39)
        9V (n=80, 80)
    0.61 (0.48 to 0.78)
    0.98 (0.82 to 1.19)
        14 (n=79, 80)
    1.43 (1.15 to 1.78)
    1.73 (1.4 to 2.14)
        18C (n=80, 79)
    0.33 (0.27 to 0.41)
    0.66 (0.54 to 0.81)
        19F (n=80, 79)
    0.96 (0.8 to 1.15)
    1.78 (1.4 to 2.26)
        23F (n=79, 80)
    0.59 (0.47 to 0.74)
    1.24 (1.01 to 1.52)
        1 (n=78, 80)
    0.4 (0.35 to 0.46)
    0.53 (0.45 to 0.62)
        3 (n=78, 78)
    0.13 (0.1 to 0.17)
    0.22 (0.16 to 0.3)
        5 (n=79, 78)
    1.1 (0.91 to 1.32)
    1.63 (1.35 to 1.97)
        6A (n=80, 79)
    1.08 (0.89 to 1.32)
    1.59 (1.34 to 1.9)
        7F (n=79, 80)
    0.68 (0.59 to 0.8)
    0.83 (0.72 to 0.96)
        19A (n=80, 80)
    1.61 (1.22 to 2.12)
    3.16 (2.53 to 3.95)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.04
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 0.83
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 0.84
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.12
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 0.67
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 0.72
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 0.64
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 0.94
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 0.9
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 0.87
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 0.88
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.02
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 0.72

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose
    End point description
    The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) 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). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of subjects analyzed) signifies those subjects who were evaluable for this outcome measure during specified follow-up period and 'n' signifies subjects with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    2 Years After Toddler Dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    71
    71
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        4 (n=70, 71)
    0.19 (0.16 to 0.23)
    0.24 (0.2 to 0.29)
        6B (n=70, 70)
    1.44 (1.13 to 1.85)
    2.7 (2.1 to 3.48)
        9V (n=71, 70)
    0.74 (0.58 to 0.94)
    0.99 (0.8 to 1.23)
        14 (n=70, 71)
    1.06 (0.78 to 1.43)
    1.37 (1.03 to 1.82)
        18C (n=69, 71)
    0.32 (0.24 to 0.42)
    0.57 (0.47 to 0.69)
        19F (n=71, 70)
    1.1 (0.83 to 1.46)
    2.43 (1.71 to 3.44)
        23F (n=71, 71)
    1.03 (0.77 to 1.38)
    1.83 (1.42 to 2.37)
        1 (n=70, 69)
    0.32 (0.26 to 0.38)
    0.39 (0.32 to 0.47)
        3 (n=65, 63)
    0.17 (0.12 to 0.25)
    0.27 (0.18 to 0.4)
        5 (n=69, 69)
    1.34 (1.07 to 1.68)
    1.97 (1.6 to 2.41)
        6A (n=71, 71)
    1.41 (1.09 to 1.82)
    2.1 (1.64 to 2.7)
        7F (n=71, 70)
    0.6 (0.5 to 0.71)
    0.67 (0.57 to 0.8)
        19A (n=71, 71)
    2.33 (1.76 to 3.1)
    4.36 (3.4 to 5.61)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.03
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 0.76
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.03
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.17
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 0.78
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 0.71
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 0.83
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.07
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 1.11
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 0.92
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 0.95
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.13
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 0.78

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Infant Series: Group 1A, 1B, 1C
    End point description
    Geometric mean concentration (GMC) 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies subjects with a determinate IgG concentration to the given serotype for each arm, respectively. Evaluable Infant Immunogenicity Population.
    End point type
    Secondary
    End point timeframe
    1 Month After Infant Series
    End point values
    		 13vPnC Group 1A 13vPnC Group 1B 13vPnC Group 1C
    Number of subjects analysed
    24
    50
    25
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        4 (n=24, 50, 25)
    2.5 (1.92 to 3.24)
    1.86 (1.47 to 2.37)
    1.73 (1.2 to 2.49)
        6B (n=24, 50, 25)
    1.23 (0.74 to 2.07)
    0.61 (0.42 to 0.88)
    0.62 (0.3 to 1.31)
        9V (n=24, 50, 25)
    1.44 (1.02 to 2.03)
    1.25 (1.02 to 1.53)
    1.14 (0.78 to 1.65)
        14 (n=24, 50, 25)
    8.95 (6.44 to 12.42)
    7.13 (5.65 to 8.98)
    6.95 (4.2 to 11.5)
        18C (n=24, 50, 25)
    2.58 (1.97 to 3.37)
    1.78 (1.44 to 2.19)
    1.72 (1.22 to 2.43)
        19F (n=24, 50, 25)
    2.46 (1.77 to 3.43)
    2.06 (1.67 to 2.55)
    2.28 (1.61 to 3.24)
        23F (n=24, 50, 25)
    1.38 (0.84 to 2.27)
    0.65 (0.48 to 0.89)
    0.95 (0.66 to 1.35)
        1 (n=24, 50, 25)
    1.56 (1.12 to 2.18)
    1.21 (0.96 to 1.52)
    1.1 (0.75 to 1.6)
        3 (n=24, 50, 25)
    1.28 (0.86 to 1.9)
    0.75 (0.6 to 0.93)
    0.67 (0.49 to 0.91)
        5 (n=24, 50, 25)
    0.85 (0.57 to 1.28)
    0.5 (0.36 to 0.69)
    0.46 (0.26 to 0.82)
        6A (n=24, 49, 25)
    1.74 (1.19 to 2.55)
    1.15 (0.84 to 1.57)
    0.98 (0.59 to 1.65)
        7F (n=24, 50, 25)
    2.43 (1.56 to 3.77)
    1.99 (1.61 to 2.46)
    2.18 (1.55 to 3.06)
        19A (n=24, 50, 25)
    3.43 (2.52 to 4.67)
    2.6 (2.08 to 3.25)
    2.88 (2.06 to 4.02)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Before Toddler Dose: Group 1A, 1B, 1C
    End point description
    Geometric mean concentration (GMC) 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies subjects with a determinate IgG concentration to the given serotype for each arm, respectively. Evaluable Toddler Immunogenicity Population.
    End point type
    Secondary
    End point timeframe
    Before Toddler Dose (pre-vaccination)
    End point values
    		 13vPnC Group 1A 13vPnC Group 1B 13vPnC Group 1C
    Number of subjects analysed
    21
    46
    21
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        4 (n= 20, 44, 21)
    0.37 (0.27 to 0.5)
    0.28 (0.22 to 0.36)
    0.32 (0.22 to 0.46)
        6B (n= 20, 42, 20)
    0.59 (0.42 to 0.83)
    0.42 (0.31 to 0.56)
    0.49 (0.3 to 0.8)
        9V (n= 20, 44, 21)
    0.43 (0.3 to 0.6)
    0.36 (0.28 to 0.46)
    0.44 (0.33 to 0.6)
        14 (n=20, 44, 21)
    2.48 (1.74 to 3.54)
    1.83 (1.4 to 2.38)
    2.04 (1.33 to 3.12)
        18C (n=20, 44, 21)
    0.35 (0.25 to 0.48)
    0.3 (0.24 to 0.36)
    0.34 (0.24 to 0.49)
        19F (n=20, 44, 21)
    0.96 (0.57 to 1.61)
    0.58 (0.48 to 0.71)
    0.67 (0.52 to 0.87)
        23F (n=20, 41, 20)
    0.31 (0.19 to 0.52)
    0.21 (0.14 to 0.32)
    0.24 (0.14 to 0.41)
        1 (n=20, 44, 21)
    0.37 (0.27 to 0.52)
    0.39 (0.32 to 0.48)
    0.42 (0.3 to 0.61)
        3 (n=20, 44, 20)
    0.13 (0.07 to 0.24)
    0.06 (0.04 to 0.08)
    0.05 (0.02 to 0.09)
        5 (n=19, 43, 20)
    0.75 (0.56 to 1.01)
    0.71 (0.55 to 0.9)
    0.81 (0.62 to 1.06)
        6A (n=20, 44, 21)
    0.66 (0.46 to 0.93)
    0.49 (0.38 to 0.63)
    0.55 (0.35 to 0.85)
        7F (n=20, 44, 21)
    0.71 (0.55 to 0.92)
    0.64 (0.54 to 0.77)
    0.91 (0.69 to 1.19)
        19A (n=20, 44, 21)
    1.2 (0.76 to 1.89)
    0.72 (0.57 to 0.91)
    0.92 (0.66 to 1.3)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Toddler Dose: Group 1A, 1B, 1C
    End point description
    Geometric mean concentration (GMC) 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) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here 'n' signifies subjects with a determinate IgG concentration to the given serotype for each arm, respectively. Evaluable Toddler Immunogenicity Population.
    End point type
    Secondary
    End point timeframe
    1 Month After Toddler Dose
    End point values
    		 13vPnC Group 1A 13vPnC Group 1B 13vPnC Group 1C
    Number of subjects analysed
    21
    46
    21
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        4 (n= 21, 45, 20)
    3.58 (2.66 to 4.83)
    2.87 (2.29 to 3.59)
    1.41 (1.05 to 1.88)
        6B (n= 21, 45, 20)
    6.28 (4.6 to 8.58)
    4.28 (3.18 to 5.75)
    3.29 (2.24 to 4.84)
        9V (n= 21, 45, 20)
    2.99 (2.26 to 3.96)
    2.23 (1.81 to 2.74)
    1.88 (1.41 to 2.52)
        14 (n=21, 45, 20)
    13.2 (9.65 to 18.05)
    8.84 (6.58 to 11.9)
    7.01 (5.15 to 9.54)
        18C (n=21, 45, 20)
    3.71 (2.77 to 4.97)
    2.4 (1.95 to 2.96)
    1.45 (1.05 to 2)
        19F (n=21, 45, 20)
    10.45 (8.2 to 13.32)
    7.39 (5.62 to 9.71)
    5.12 (3.91 to 6.72)
        23F (n=21, 45, 20)
    3.57 (2.54 to 5.02)
    2.41 (1.8 to 3.21)
    1.71 (1.12 to 2.62)
        1 (n=21, 45, 20)
    4.78 (3.61 to 6.34)
    3.31 (2.62 to 4.18)
    2.28 (1.74 to 2.99)
        3 (n=21, 44, 20)
    0.88 (0.61 to 1.25)
    0.51 (0.41 to 0.64)
    0.31 (0.23 to 0.43)
        5 (n=21, 45, 20)
    3.41 (2.69 to 4.32)
    2.66 (2.14 to 3.3)
    1.95 (1.54 to 2.47)
        6A (n=21, 45, 20)
    6.95 (5.18 to 9.33)
    5.81 (4.68 to 7.22)
    4.23 (3.22 to 5.56)
        7F (n=21, 45, 20)
    5.29 (4.11 to 6.8)
    4.09 (3.41 to 4.89)
    3.69 (2.84 to 4.8)
        19A (n=21, 45, 20)
    8.63 (6.51 to 11.43)
    5.28 (3.96 to 7.04)
    3.96 (3.17 to 4.96)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 1 Year After Toddler Dose: Group 1A, 1B, 1C
    End point description
    The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) 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). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of subjects analyzed) signifies those subjects who were evaluable for this outcome measure during specified follow-up period and 'n' signifies subjects with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 Year After Toddler Dose
    End point values
    		 13vPnC Group 1A 13vPnC Group 1B 13vPnC Group 1C
    Number of subjects analysed
    18
    43
    19
    Units: mcg/mL (microgram per milliliter)
    geometric mean (confidence interval 95%)
        4 (n=18, 43, 19)
    0.3 (0.19 to 0.46)
    0.29 (0.23 to 0.37)
    0.32 (0.21 to 0.49)
        6B (n=18, 43, 19)
    1.49 (0.84 to 2.66)
    1.28 (0.96 to 1.7)
    1.06 (0.7 to 1.6)
        9V (n=18, 43, 19)
    0.59 (0.37 to 0.93)
    0.56 (0.42 to 0.75)
    0.8 (0.4 to 1.59)
        14 (n=18, 42, 19)
    1.37 (0.86 to 2.19)
    1.38 (1.09 to 1.75)
    1.62 (0.83 to 3.16)
        18C (n=18, 43, 19)
    0.39 (0.26 to 0.57)
    0.31 (0.24 to 0.41)
    0.32 (0.17 to 0.59)
        19F (n=18, 43, 19)
    1.27 (0.81 to 2)
    0.89 (0.7 to 1.14)
    0.86 (0.62 to 1.21)
        23F (n=18, 42, 19)
    0.79 (0.5 to 1.26)
    0.54 (0.4 to 0.74)
    0.53 (0.3 to 0.91)
        1 (n=18, 41, 19)
    0.39 (0.3 to 0.5)
    0.38 (0.32 to 0.47)
    0.45 (0.31 to 0.64)
        3 (n=18, 41, 19)
    0.17 (0.1 to 0.29)
    0.12 (0.09 to 0.17)
    0.11 (0.05 to 0.23)
        5 (n=18, 42, 19)
    0.87 (0.59 to 1.28)
    1.24 (0.93 to 1.64)
    1.05 (0.77 to 1.44)
        6A (n=18, 43, 19)
    1.17 (0.73 to 1.87)
    1.05 (0.8 to 1.4)
    1.07 (0.72 to 1.59)
        7F (n=18, 42, 19)
    0.65 (0.47 to 0.91)
    0.65 (0.52 to 0.81)
    0.81 (0.61 to 1.08)
        19A (n=18, 43, 19)
    2.12 (0.9 to 5.01)
    1.5 (1.05 to 2.14)
    1.45 (0.95 to 2.21)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Persistence 2 Years After Toddler Dose: Group 1A, 1B, 1C
    End point description
    The persistence of the antibody response induced by 13vPnC was described by geometric mean concentration (GMC) 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). GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. CIs were calculated as back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable Toddler Immunogenicity Population. Here 'n' signifies subjects with a determinate IgG concentration to the given serotype during specified follow-up period for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    2 Years After Toddler Dose
    End point values
    		 13vPnC Group 1A 13vPnC Group 1B 13vPnC Group 1C
    Number of subjects analysed
    17 [9]
    36 [10]
    18 [11]
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        4 (n=17, 35, 18)
    0.17 (0.11 to 0.28)
    0.19 (0.16 to 0.24)
    0.21 (0.13 to 0.33)
        6B (n=17, 35, 18)
    1.39 (0.81 to 2.4)
    1.81 (1.28 to 2.56)
    0.96 (0.58 to 1.6)
        9V (n=17, 36, 18)
    0.68 (0.39 to 1.17)
    0.83 (0.59 to 1.16)
    0.63 (0.36 to 1.12)
        14 (n=17, 35, 18)
    1.27 (0.59 to 2.76)
    1.02 (0.71 to 1.48)
    0.96 (0.47 to 1.96)
        18C (n=16, 35, 18)
    0.34 (0.18 to 0.65)
    0.35 (0.23 to 0.52)
    0.26 (0.16 to 0.44)
        19F (n=17, 36, 18)
    1.53 (0.83 to 2.81)
    0.93 (0.68 to 1.28)
    1.13 (0.5 to 2.53)
        23F (n=17, 36, 18)
    1.14 (0.6 to 2.15)
    1.41 (0.95 to 2.09)
    0.5 (0.27 to 0.9)
        1 (n=17, 35, 18)
    0.32 (0.23 to 0.44)
    0.35 (0.26 to 0.47)
    0.26 (0.18 to 0.39)
        3 (n=16, 33, 16)
    0.2 (0.1 to 0.39)
    0.19 (0.11 to 0.3)
    0.14 (0.06 to 0.34)
        5 (n=17, 35, 17)
    1.18 (0.67 to 2.11)
    1.67 (1.25 to 2.25)
    0.97 (0.62 to 1.5)
        6A (n=17, 36, 18)
    1.32 (0.87 to 1.99)
    1.58 (1.1 to 2.26)
    1.2 (0.63 to 2.3)
        7F (n=17, 36, 18)
    0.61 (0.39 to 0.96)
    0.68 (0.54 to 0.84)
    0.46 (0.32 to 0.67)
        19A (n=17, 36, 18)
    3.04 (1.64 to 5.64)
    2.46 (1.69 to 3.58)
    1.64 (0.83 to 3.23)
    Notes
    [9] - ‘N’(number of subjects analyzed)signifies those subjects who were evaluable for this outcome measure
    [10] - ‘N’(number of subjects analyzed)signifies those subjects who were evaluable for this outcome measure
    [11] - ‘N’(number of subjects analyzed)signifies those subjects who were evaluable for this outcome measure
    No statistical analyses for this end point

    Secondary: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series

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    End point title
    		 Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Infant Series [12]
    End point description
    Antibody-mediated serum OPA against 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) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Evaluable Infant Immunogenicity Population. Here n’ signifies subjects with a determinate OPA titer to the given serotype for each arm respectively.
    End point type
    Secondary
    End point timeframe
    1 Month After Infant Series
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification:  This end point was planned to be reported in subjects of 13vPnC (Group 2) and 13vPnC (Group 1) groups only.
    End point values
    		 13vPnC Group 2 (Term Infant) 13vPnC Group 1 (Preterm Infant)
    Number of subjects analysed
    98
    99
    Units: titer
    geometric mean (confidence interval 95%)
        4 (n=58, 62)
    923 (746.9 to 1139.7)
    1231 (986.5 to 1537.3)
        6B (n=51, 61)
    732 (494 to 1086)
    835 (478.6 to 1455.2)
        9V (n=54, 60)
    211 (108.2 to 413.4)
    151 (70.8 to 321.1)
        14 (n=55, 66)
    1033 (735.7 to 1451)
    1298 (968.3 to 1740.3)
        18C (n=56, 63)
    2057 (1594 to 2655.1)
    2931 (2341.2 to 3669.3)
        19F (n= 55, 58)
    335 (237.2 to 472.3)
    417 (330.7 to 525.8)
        23F (n=55, 60)
    582 (413.7 to 817.8)
    733 (539.3 to 997.3)
        1 (n=88, 87)
    13 (10 to 16.8)
    10 (8 to 13.4)
        3 (n=83, 86)
    57 (46.3 to 69.5)
    61 (51.2 to 73.2)
        5 (n=83, 85)
    64 (47.2 to 86.9)
    37 (25.9 to 53.9)
        6A (n=88, 88)
    1287 (980.1 to 1691.1)
    1566 (1312.3 to 1869)
        7F (n=93, 86)
    1539 (1297.4 to 1826.3)
    1605 (1277.9 to 2014.7)
        19A (n=92, 86)
    244 (204.1 to 290.6)
    283 (232.4 to 344.1)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.81
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 2.2
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 1.93
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.98
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 2
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.89
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.99
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.15
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.41
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.36
         upper limit
    		 0.94
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.68
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.39
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.51

    Secondary: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose

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    End point title
    		 Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before Toddler Dose
    End point description
    Antibody-mediated serum OPA against 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) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Evaluable Toddler Immunogenicity Population. Here 'n’ signifies subjects with a determinate OPA titer to the given serotype for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Before the toddler dose (pre-vaccination)
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    88
    88
    Units: titer
    geometric mean (confidence interval 95%)
        4 (n= 56, 59)
    10 (6 to 15.3)
    13 (7.9 to 21.9)
        6B (n= 59, 62)
    12 (6.8 to 20.1)
    15 (8.5 to 25.6)
        9V (n=52, 63)
    11 (6.2 to 20.9)
    7 (4.9 to 11.1)
        14 (n= 60, 55)
    242 (148.5 to 394)
    389 (260.4 to 582.2)
        18C (n= 54, 58)
    32 (16.1 to 61.7)
    51 (26.8 to 98.3)
        19F (n= 57, 60)
    6 (4.1 to 7.4)
    4 (3.8 to 4.7)
        23F (n=59, 62)
    11 (6.9 to 19)
    16 (9.6 to 26.6)
        1 (n=76, 80)
    6 (4.5 to 6.8)
    4 (3.9 to 4.8)
        3 (n=73, 77)
    8 (6.2 to 10)
    8 (6.6 to 10.4)
        5 (n=74, 79)
    5 (4.2 to 6)
    5 (4.2 to 5.6)
        6A (n=69, 76)
    45 (25.2 to 81.1)
    91 (56.6 to 146.3)
        7F (n=75, 79)
    228 (137.6 to 377.1)
    188 (109.3 to 323.1)
        19A (n=77, 79)
    9 (6.3 to 12)
    10 (7.1 to 14.8)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.44
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.71
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 3.12
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 1.17
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 1.55
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.77
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 1.46
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.6
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.33
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.31
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 1.04
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 2.53
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.37

    Secondary: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose

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    End point title
    		 Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Toddler Dose
    End point description
    Antibody-mediated serum OPA against 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) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies subjects with a determinate OPA titer to the given serotype for each arm respectively.
    End point type
    Secondary
    End point timeframe
    1 Month After Toddler Dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    88
    88
    Units: titer
    geometric mean (confidence interval 95%)
        4 (n= 67, 61)
    1154 (879.2 to 1514.5)
    1757 (1329.1 to 2322.4)
        6B (n= 64, 61)
    1229 (877.2 to 1722.1)
    1406 (1003.4 to 1970.3)
        9V (n=60, 58)
    1871 (1217.8 to 2873.6)
    2542 (1711.6 to 3775.2)
        14 (n= 62, 62)
    1294 (969 to 1728.4)
    1651 (1300.1 to 2097.1)
        18C (n= 62, 63)
    2464 (1696 to 3579.4)
    4510 (3399.7 to 5981.7)
        19F (n= 61, 62)
    376 (229.1 to 617.1)
    640 (431.5 to 948.3)
        23F (n=65, 63)
    1048 (738.6 to 1488)
    1657 (1217.7 to 2255)
        1 (n=80, 83)
    59 (43.7 to 78.6)
    107 (83 to 137)
        3 (n=78, 79)
    114 (97.1 to 132.7)
    121 (103.4 to 140.4)
        5 (n=80, 83)
    166 (127.9 to 216.3)
    260 (203.9 to 331.9)
        6A (n=78, 74)
    1978 (1571.5 to 2489.7)
    3154 (2606 to 3816)
        7F (n=81, 82)
    2915 (2453.4 to 3462.7)
    3154 (2746.2 to 3622.4)
        19A (n=81, 82)
    558 (456.3 to 682.6)
    825 (692.4 to 983.8)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 0.97
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.4
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.31
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.14
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 0.87
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 1.1
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.01
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 0.81
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.17
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 0.91
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 0.85
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.15
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 0.88

    Secondary: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose

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    End point title
    		 Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Year After Toddler Dose
    End point description
    Antibody-mediated serum OPA against 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) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Evaluable Toddler Immunogenicity Population. 'n' signifies subjects with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 Year After Toddler Dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    80 [13]
    80 [14]
    Units: titer
    geometric mean (confidence interval 95%)
        4 (n= 66, 59)
    24 (12.9 to 45.5)
    29 (15.2 to 54.5)
        6B (n= 65, 59)
    38 (19 to 74.9)
    36 (19.2 to 68.8)
        9V (n=61, 63)
    141 (67.5 to 293.1)
    244 (126.3 to 469.7)
        14 (n= 59, 54)
    276 (169 to 449.4)
    372 (236.1 to 586.5)
        18C (n= 62, 60)
    33 (16.4 to 67.4)
    121 (56.9 to 258.1)
        19F (n= 67, 57)
    11 (6.2 to 17.7)
    18 (9.6 to 35.4)
        23F (n=67, 62)
    45 (23.7 to 86.6)
    168 (92.4 to 303.9)
        1 (n=76, 74)
    5 (4.2 to 6.3)
    5 (4.3 to 5.8)
        3 (n=76, 70)
    11 (8.6 to 15.4)
    13 (9.2 to 18.7)
        5 (n=72, 70)
    8 (5.6 to 10.4)
    10 (7 to 13.3)
        6A (n=70, 70)
    98 (53 to 183)
    255 (152.9 to 424.8)
        7F (n=71, 71)
    599 (411 to 873.3)
    533 (348.3 to 814.1)
        19A (n=74, 73)
    28 (17.2 to 43.9)
    54 (34.2 to 85.5)
    Notes
    [13] - N (number of subjects analyzed) signifies those subjects who were evaluable for this outcome measure
    [14] - N (number of subjects analyzed) signifies those subjects who were evaluable for this outcome measure
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 2.05
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 2.63
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 1.53
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 1.44
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 0.76
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 1.3
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.11
         upper limit
    		 0.65
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.32
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.37
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.23
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 0.86
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.97
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 0.97

    Secondary: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose

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    End point title
    		 Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 2 Years After Toddler Dose
    End point description
    Antibody-mediated serum OPA against 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) was measured using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of subjects analyzed) signifies those subjects who were evaluable for this outcome measure during specified follow-up period and 'n' signifies subjects with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    2 Years After Toddler Dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    71
    71
    Units: titer
    geometric mean (confidence interval 95%)
        4 (n= 46, 54)
    15 (7 to 32.9)
    17 (9 to 32.6)
        6B (n= 56, 48)
    29 (13.7 to 59.9)
    27 (12.4 to 58.2)
        9V (n=50, 55)
    132 (57.5 to 301.5)
    75 (34.7 to 163.7)
        14 (n= 49, 45)
    262 (142 to 482.8)
    296 (161.6 to 543.8)
        18C (n= 56, 56)
    14 (7.1 to 25.9)
    29 (14.3 to 57.9)
        19F (n= 60, 58)
    13 (7.4 to 22.5)
    20 (10.1 to 39.9)
        23F (n=58, 59)
    60 (29.7 to 122.2)
    135 (71.2 to 255.3)
        1 (n=70, 68)
    5 (4.1 to 5.4)
    4 (3.9 to 4.6)
        3 (n=69, 66)
    11 (8.1 to 15.2)
    16 (10.7 to 24.2)
        5 (n=68, 69)
    5 (4.1 to 5.6)
    7 (5.4 to 9.4)
        6A (n=68, 62)
    42 (21.5 to 81.1)
    102 (53.7 to 193.4)
        7F (n=64, 65)
    170 (87.7 to 330.9)
    269 (155.6 to 463.7)
        19A (n=68, 67)
    22 (13.6 to 37.1)
    50 (30.1 to 82.6)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 2.37
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 3.07
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 5.36
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 2.07
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.18
         upper limit
    		 1.21
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 1.53
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.17
         upper limit
    		 1.15
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.31
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 0.92
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.14
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 1.03
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 0.91
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 1.48

    Secondary: Percentage of Subjects With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series

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    End point title
    		 Percentage of Subjects With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series [15]
    End point description
    Percentage of subjects achieving OPA titer >=LLOQ 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) determined in blood samples of all subjects was presented. Exact 2-sided CI based on observed proportion of subjects. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. Evaluable Infant Immunogenicity Population. Here ‘n’ signifies subjects with a determinate OPA antibody titer to the given serotype for each arm respectively.
    End point type
    Secondary
    End point timeframe
    1 Month After Infant Series
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This end point was planned to be reported in subjects of 13vPnC (Group 2) and 13vPnC (Group 1) groups only.
    End point values
    		 13vPnC Group 2 (Term Infant) 13vPnC Group 1 (Preterm Infant)
    Number of subjects analysed
    99
    98
    Units: percentage of subjects
    number (confidence interval 95%)
        4 (n= 58, 62)
    100 (93.84 to 100)
    100 (94.22 to 100)
        6B (n= 51, 61)
    90.2 (78.59 to 96.74)
    95.08 (86.29 to 98.97)
        9V (n= 54, 60)
    64.81 (50.62 to 77.32)
    71.67 (58.56 to 82.55)
        14 (n= 55, 66)
    100 (93.51 to 100)
    96.97 (89.48 to 99.63)
        18C (n= 56, 63)
    100 (93.62 to 100)
    100 (94.31 to 100)
        19F (n= 55, 58)
    100 (93.51 to 100)
    96.55 (88.09 to 99.58)
        23F (n= 55, 60)
    98.18 (90.28 to 99.95)
    96.67 (88.47 to 99.59)
        1 (n= 88, 87)
    40.91 (30.54 to 51.91)
    51.72 (40.75 to 62.58)
        3 (n=83, 86)
    100 (95.65 to 100)
    95.35 (88.52 to 98.72)
        5 (n= 83, 85)
    67.47 (56.3 to 77.35)
    83.53 (73.91 to 90.69)
        6A (n= 88, 88)
    100 (95.89 to 100)
    97.73 (92.03 to 99.72)
        7F (n= 93, 86)
    97.85 (92.45 to 99.74)
    100 (95.8 to 100)
        19A (n= 92, 86)
    98.91 (94.09 to 99.97)
    100 (95.8 to 100)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.33
         upper limit
    		 5.99
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    S Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -4.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.87
         upper limit
    		 5.39
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -6.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.28
         upper limit
    		 10.67
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    3.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.68
         upper limit
    		 10.57
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.57
         upper limit
    		 5.88
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    3.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.32
         upper limit
    		 11.91
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.73
         upper limit
    		 9.94
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -10.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.51
         upper limit
    		 4.34
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    4.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 11.48
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -16.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.15
         upper limit
    		 -2.6
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    2.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.96
         upper limit
    		 7.97
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -2.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.55
         upper limit
    		 2.1
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.96
         upper limit
    		 3.18

    Secondary: Percentage of Subjects With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose

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    End point title
    		 Percentage of Subjects With OPA Titer >= Lower Limit of Quantitation (LLOQ) Before Toddler Dose
    End point description
    Percentage of subjects achieving OPA titer >=LLOQ 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) determined in blood samples of all subjects was presented. Exact 2-sided CI based on observed proportion of subjects. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. Evaluable Toddler Immunogenicity Population. Here ‘n’ signifies subjects with a determinate OPA antibody titer to the given serotype for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Before Toddler Dose (pre-vaccination)
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    88
    88
    Units: percentage of subjects
    number (confidence interval 95%)
        4 (n=56, 59)
    21.43 (11.59 to 34.44)
    30.51 (19.19 to 43.87)
        6B (n=59, 62)
    22.03 (12.29 to 34.73)
    27.42 (16.85 to 40.23)
        9V (n=52, 63)
    19.23 (9.63 to 32.53)
    12.7 (5.65 to 23.5)
        14 (n=60, 55)
    86.67 (75.41 to 94.06)
    94.55 (84.88 to 98.86)
        18C (n=54, 58)
    44.44 (30.92 to 58.6)
    55.17 (41.54 to 68.26)
        19F (n=57, 60)
    8.77 (2.91 to 19.3)
    1.67 (0.04 to 8.94)
        23F (n=59, 62)
    23.73 (13.62 to 36.59)
    37.1 (25.16 to 50.31)
        1 (n=76, 80)
    11.84 (5.56 to 21.29)
    3.75 (0.78 to 10.57)
        3 (n=73, 77)
    32.88 (22.33 to 44.87)
    40.26 (29.23 to 52.06)
        5 (n=74, 79)
    8.11 (3.03 to 16.82)
    7.59 (2.84 to 15.8)
        6A (n=69, 76)
    52.17 (39.8 to 64.35)
    72.37 (60.91 to 82.01)
        7F (n=75, 79)
    78.67 (67.68 to 87.29)
    73.42 (62.28 to 82.73)
        19A (n=77, 79)
    25.97 (16.64 to 37.23)
    29.11 (19.43 to 40.42)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 1 (Preterm Infant) v 13vPnC Group 2 (Term Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -9.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.11
         upper limit
    		 7.49
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -5.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.03
         upper limit
    		 10.4
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    6.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.16
         upper limit
    		 21.16
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -7.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.28
         upper limit
    		 3.35
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -10.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.01
         upper limit
    		 8.11
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    7.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.52
         upper limit
    		 17.65
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -13.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.57
         upper limit
    		 3.31
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    8.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 17.81
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -7.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.86
         upper limit
    		 8.29
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.82
         upper limit
    		 10.08
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -20.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.45
         upper limit
    		 -3.95
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    5.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.5
         upper limit
    		 19.06
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -3.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.51
         upper limit
    		 11.13

    Secondary: Percentage of Subjects With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose

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    End point title
    		 Percentage of Subjects With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Toddler Dose
    End point description
    Percentage of subjects achieving OPA titer >=LLOQ 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) determined in blood samples of all subjects was presented. Exact 2-sided CI based on observed proportion of subjects. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. Evaluable Toddler Immunogenicity Population. Here 'n' signifies subjects with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 Month After Toddler Dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    88
    88
    Units: percentage of subjects
    number (confidence interval 95%)
        4 (n= 67, 61)
    100 (94.64 to 100)
    100 (94.13 to 100)
        6B (n= 64, 61)
    98.44 (91.6 to 99.96)
    98.36 (91.2 to 99.96)
        9V (n= 60, 58)
    95 (86.08 to 98.96)
    96.55 (88.09 to 99.58)
        14 (n= 62, 62)
    100 (94.22 to 100)
    100 (94.22 to 100)
        18C (n= 62, 63)
    98.39 (91.34 to 99.96)
    100 (94.31 to 100)
        19F (n= 61, 62)
    88.52 (77.78 to 95.26)
    95.16 (86.5 to 98.99)
        23F (n= 65, 63)
    98.46 (91.72 to 99.96)
    98.41 (91.47 to 99.96)
        1 (n= 80, 83)
    87.5 (78.21 to 93.84)
    93.98 (86.5 to 98.02)
        3 (n=78, 79)
    100 (95.38 to 100)
    98.73 (93.15 to 99.97)
        5 (n= 80, 83)
    96.25 (89.43 to 99.22)
    97.59 (91.57 to 99.71)
        6A (n=78, 74)
    100 (95.38 to 100)
    100 (95.14 to 100)
        7F (n= 81, 82)
    100 (95.55 to 100)
    100 (95.6 to 100)
        19A (n= 81, 82)
    100 (95.55 to 100)
    100 (95.6 to 100)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.59
         upper limit
    		 5.89
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.81
         upper limit
    		 7.37
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.87
         upper limit
    		 7.44
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.94
         upper limit
    		 5.94
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -1.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.66
         upper limit
    		 4.25
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -6.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.93
         upper limit
    		 3.56
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.74
         upper limit
    		 7.04
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -6.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.37
         upper limit
    		 2.75
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.37
         upper limit
    		 6.85
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -1.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.36
         upper limit
    		 5.14
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.73
         upper limit
    		 5.04
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.48
         upper limit
    		 4.55
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    176
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.48
         upper limit
    		 4.55

    Secondary: Percentage of Subjects With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose

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    End point title
    		 Percentage of Subjects With OPA Titer >= Lower Limit of Quantitation (LLOQ) 1 Year After Toddler Dose
    End point description
    Percentage of subjects achieving OPA titer >=LLOQ 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) determined in blood samples of all subjects was presented. Exact 2-sided CI based on observed proportion of subjects. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of subjects analyzed) signifies those subjects who were evaluable for this outcome measure during specified follow-up period and 'n' signifies subjects with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 Year After Toddler Dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    80
    80
    Units: percentage of subjects
    number (confidence interval 95%)
        4 (n= 66, 59)
    34.8 (23.5 to 47.6)
    42.4 (29.6 to 55.9)
        6B (n= 65, 59)
    41.5 (29.4 to 54.4)
    47.5 (34.3 to 60.9)
        9V (n= 61, 63)
    62.3 (49 to 74.4)
    73 (60.3 to 83.4)
        14 (n= 59, 54)
    86.4 (75 to 94)
    90.7 (79.7 to 96.9)
        18C (n= 62, 60)
    38.7 (26.6 to 51.9)
    61.7 (48.2 to 73.9)
        19F (n= 67, 57)
    17.9 (9.6 to 29.2)
    29.8 (18.4 to 43.4)
        23F (n= 67, 62)
    49.3 (36.8 to 61.8)
    77.4 (65 to 87.1)
        1 (n= 76, 74)
    10.5 (4.7 to 19.7)
    10.8 (4.8 to 20.2)
        3 (n=76, 70)
    47.4 (35.8 to 59.2)
    48.6 (36.4 to 60.8)
        5 (n= 72, 70)
    20.8 (12.2 to 32)
    31.4 (20.9 to 43.6)
        6A (n=70, 70)
    62.9 (50.5 to 74.1)
    81.4 (70.3 to 89.7)
        7F (n= 71, 71)
    93 (84.3 to 97.7)
    90.1 (80.7 to 95.9)
        19A (n= 74, 73)
    54.1 (42.1 to 65.7)
    72.6 (60.9 to 82.4)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -7.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.5
         upper limit
    		 9.9
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.6
         upper limit
    		 11.8
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -10.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.6
         upper limit
    		 6
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17
         upper limit
    		 8.4
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40
         upper limit
    		 -4.9
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -11.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.4
         upper limit
    		 3.4
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -28.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -43.9
         upper limit
    		 -11
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.9
         upper limit
    		 10.3
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.5
         upper limit
    		 15.1
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -10.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.3
         upper limit
    		 4.5
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -18.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.3
         upper limit
    		 -3
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 13.1
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -18.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.7
         upper limit
    		 -2.8

    Secondary: Percentage of Subjects With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose

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    End point title
    		 Percentage of Subjects With OPA Titer >= Lower Limit of Quantitation (LLOQ) 2 Years After Toddler Dose
    End point description
    Percentage of subjects achieving OPA titer >=LLOQ 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) determined in blood samples of all subjects was presented. Exact 2-sided CI based on observed proportion of subjects. LLOQ for each serotype: 1=18; 3=12; 4=21; 5=29; 6A=37; 6B=43; 7F=210; 9V=345; 14=35; 18C=31; 19A=18; 19F=48; 23F=13. Evaluable Toddler Immunogenicity Population. Here ‘N’ (number of subjects analyzed) signifies those subjects who were evaluable for this outcome measure during specified follow-up period and 'n' signifies subjects with a determinate OPA titer to the given serotype during specified follow-up period for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    2 Years After Toddler Dose
    End point values
    		 13vPnC Group 1 (Preterm Infant) 13vPnC Group 2 (Term Infant)
    Number of subjects analysed
    71
    71
    Units: percentage of subjects
    number (confidence interval 95%)
        4 (n= 46, 54)
    21.7 (10.9 to 36.4)
    29.6 (18 to 43.6)
        6B (n= 56, 48)
    35.7 (23.4 to 49.6)
    35.4 (22.2 to 50.5)
        9V (n= 50, 55)
    60 (45.2 to 73.6)
    52.7 (38.8 to 66.3)
        14 (n= 49, 45)
    81.6 (68 to 91.2)
    84.4 (70.5 to 93.5)
        18C (n= 56, 56)
    21.4 (11.6 to 34.4)
    39.3 (26.5 to 53.2)
        19F (n= 60, 58)
    25 (14.7 to 37.9)
    29.3 (18.1 to 42.7)
        23F (n= 58, 59)
    53.4 (39.9 to 66.7)
    74.6 (61.6 to 85)
        1 (n= 70, 68)
    8.6 (3.2 to 17.7)
    2.9 (0.4 to 10.2)
        3 (n=69, 66)
    46.4 (34.3 to 58.8)
    51.5 (38.9 to 64)
        5 (n= 68, 69)
    7.4 (2.4 to 16.3)
    21.7 (12.7 to 33.3)
        6A (n=68, 62)
    44.1 (32.1 to 56.7)
    64.5 (51.3 to 76.3)
        7F (n= 64, 65)
    68.8 (55.9 to 79.8)
    80 (68.2 to 88.9)
        19A (n= 68, 67)
    45.6 (33.5 to 58.1)
    67.2 (54.6 to 78.2)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.2
         upper limit
    		 9.9
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.5
         upper limit
    		 19
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12
         upper limit
    		 26.2
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.1
         upper limit
    		 13.3
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -17.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.6
         upper limit
    		 -0.3
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.6
         upper limit
    		 12.1
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -21.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.8
         upper limit
    		 -3.2
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 15.2
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22
         upper limit
    		 12
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -14.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.7
         upper limit
    		 -2.4
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -20.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.8
         upper limit
    		 -3
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -11.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.4
         upper limit
    		 4.1
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC Group 2 (Term Infant) v 13vPnC Group 1 (Preterm Infant)
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percent Difference
    Point estimate
    -21.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.7
         upper limit
    		 -4.6

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs/SAEs: recorded from 13vPnC infant dose 1 to 2-year follow-up after toddler dose. Subjects recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 7 days after each vaccine dose)
    Adverse event reporting additional description
    SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (nonsystematic assessment). Subjects who received specified dose and had safety data available were evaluable for safety.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    MedDRA
    Reporting groups
    Reporting group title
    13vPnC Group 1 (Preterm Infant) - Infant Series
    Reporting group description
    		 Preterm infant subjects (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.

    Reporting group title
    13vPnC Group 2 (Term Infant) - Infant Series
    Reporting group description
    		 Term infant subjects (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.

    Reporting group title
    13vPnC Group 1 (Preterm Infant) - After Infant Series
    Reporting group description
    		 Preterm infant subjects (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.

    Reporting group title
    13vPnC Group 2 (Term Infant) - After Infant Series
    Reporting group description
    		 Term infant subjects (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.

    Reporting group title
    13vPnC Group 1 (Preterm Infant) - Toddler Dose
    Reporting group description
    		 Preterm infant subjects (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.

    Reporting group title
    13vPnC Group 2 (Term Infant) - Toddler Dose
    Reporting group description
    		 Term infant subjects (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.

    Reporting group title
    13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up
    Reporting group description
    		 Preterm infant subjects (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.

    Reporting group title
    13vPnC Group 2 (Term Infant) - 1 Year Follow-up
    Reporting group description
    		 Term infant subjects (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.

    Reporting group title
    13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up
    Reporting group description
    		 Preterm infant subjects (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.

    Reporting group title
    13vPnC Group 2 (Term Infant) - 2 Year Follow-up
    Reporting group description
    		 Term infant subjects (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.

    Serious adverse events
    		 13vPnC Group 1 (Preterm Infant) - Infant Series 13vPnC Group 2 (Term Infant) - Infant Series 13vPnC Group 1 (Preterm Infant) - After Infant Series 13vPnC Group 2 (Term Infant) - After Infant Series 13vPnC Group 1 (Preterm Infant) - Toddler Dose 13vPnC Group 2 (Term Infant) - Toddler Dose 13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up 13vPnC Group 2 (Term Infant) - 1 Year Follow-up 13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up 13vPnC Group 2 (Term Infant) - 2 Year Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 100 (14.00%)
    5 / 100 (5.00%)
    8 / 100 (8.00%)
    9 / 100 (9.00%)
    2 / 99 (2.02%)
    1 / 97 (1.03%)
    13 / 99 (13.13%)
    8 / 97 (8.25%)
    6 / 88 (6.82%)
    8 / 88 (9.09%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Head injury
    alternative dictionary used: MedDRA MedDRA(U)
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hip dysplasia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral palsy
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    2 / 88 (2.27%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    CSF shunt operation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    1 / 88 (1.14%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depressed level of consciousness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    alternative dictionary used: MedDRA MedDRA (U
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    1 / 99 (1.01%)
    1 / 97 (1.03%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    2 / 97 (2.06%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst torsion
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Autism spectrum disorder
    alternative dictionary used: MedDRA MedDRA (U
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis reactive
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Adenoviral upper respiratory infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 100 (4.00%)
    2 / 100 (2.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    2 / 100 (2.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    2 / 99 (2.02%)
    0 / 97 (0.00%)
    1 / 88 (1.14%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 100 (1.00%)
    3 / 100 (3.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    4 / 99 (4.04%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    3 / 100 (3.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Human herpesvirus 6 infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral rash
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    1 / 97 (1.03%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    2 / 99 (2.02%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis viral
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis viral
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 13vPnC Group 1 (Preterm Infant) - Infant Series 13vPnC Group 2 (Term Infant) - Infant Series 13vPnC Group 1 (Preterm Infant) - After Infant Series 13vPnC Group 2 (Term Infant) - After Infant Series 13vPnC Group 1 (Preterm Infant) - Toddler Dose 13vPnC Group 2 (Term Infant) - Toddler Dose 13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up 13vPnC Group 2 (Term Infant) - 1 Year Follow-up 13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up 13vPnC Group 2 (Term Infant) - 2 Year Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    93 / 100 (93.00%)
    90 / 100 (90.00%)
    13 / 100 (13.00%)
    11 / 100 (11.00%)
    84 / 99 (84.85%)
    82 / 97 (84.54%)
    2 / 99 (2.02%)
    0 / 97 (0.00%)
    1 / 88 (1.14%)
    1 / 88 (1.14%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 100 (5.00%)
    3 / 100 (3.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    6
    3
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    4 / 100 (4.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    1 / 97 (1.03%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    2
    4
    1
    0
    1
    1
    0
    0
    0
    0
    Developmental delay
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    1 / 88 (1.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Fever ≥38 degree centigrade (°C ) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    10 / 86 (11.63%)
    12 / 88 (13.64%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    23 / 80 (28.75%)
    34 / 78 (43.59%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    10
    12
    0
    0
    23
    34
    0
    0
    0
    0
    Fever ≥38°C Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination
    alternative dictionary used: Systemic Events Systemic
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    22 / 79 (27.85%)
    25 / 79 (31.65%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    22
    25
    0
    0
    0
    0
    0
    0
    0
    0
    Fever ≥38°C Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    22 / 79 (27.85%)
    25 / 81 (30.86%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    22
    25
    0
    0
    0
    0
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    9 / 86 (10.47%)
    12 / 88 (13.64%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    22 / 80 (27.50%)
    33 / 77 (42.86%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    9
    12
    0
    0
    22
    33
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    22 / 79 (27.85%)
    24 / 79 (30.38%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    22
    24
    0
    0
    0
    0
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    21 / 78 (26.92%)
    25 / 81 (30.86%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    21
    25
    0
    0
    0
    0
    0
    0
    0
    0
    Fever >39°C but ≤40°C Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    1 / 86 (1.16%)
    0 / 85 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 74 (1.35%)
    3 / 71 (4.23%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    3
    0
    0
    0
    0
    Fever >39°C but ≤40°C Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    0 / 73 (0.00%)
    1 / 76 (1.32%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Fever >39°C but ≤40°C Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    1 / 75 (1.33%)
    2 / 78 (2.56%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Fever >40°C Dose 1(infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    0 / 86 (0.00%)
    0 / 85 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 74 (0.00%)
    1 / 70 (1.43%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Decreased Appetite (Any) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    56 / 92 (60.87%)
    37 / 89 (41.57%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    50 / 87 (57.47%)
    52 / 86 (60.47%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    56
    37
    0
    0
    50
    52
    0
    0
    0
    0
    Decreased Appetite (Any) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    55 / 89 (61.80%)
    39 / 84 (46.43%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    55
    39
    0
    0
    0
    0
    0
    0
    0
    0
    Decreased Appetite (Any) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    40 / 82 (48.78%)
    40 / 84 (47.62%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    40
    40
    0
    0
    0
    0
    0
    0
    0
    0
    Decreased Appetite (Mild) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    50 / 91 (54.95%)
    31 / 88 (35.23%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    43 / 86 (50.00%)
    47 / 84 (55.95%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    50
    31
    0
    0
    43
    47
    0
    0
    0
    0
    Decreased Appetite (Mild) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    49 / 88 (55.68%)
    35 / 84 (41.67%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    49
    35
    0
    0
    0
    0
    0
    0
    0
    0
    Decreased Appetite (Mild) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    30 / 82 (36.59%)
    39 / 84 (46.43%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    30
    39
    0
    0
    0
    0
    0
    0
    0
    0
    Decreased Appetite (Moderate) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    18 / 88 (20.45%)
    15 / 87 (17.24%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    20 / 78 (25.64%)
    17 / 73 (23.29%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    18
    15
    0
    0
    20
    17
    0
    0
    0
    0
    Decreased Appetite (Moderate) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    20 / 79 (25.32%)
    15 / 78 (19.23%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    20
    15
    0
    0
    0
    0
    0
    0
    0
    0
    Decreased Appetite (Moderate) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    13 / 74 (17.57%)
    13 / 79 (16.46%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    13
    13
    0
    0
    0
    0
    0
    0
    0
    0
    Decreased Appetite (Severe) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    1 / 86 (1.16%)
    0 / 85 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 75 (1.33%)
    1 / 69 (1.45%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Decreased Appetite (Severe) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    1 / 73 (1.37%)
    0 / 76 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Decreased Appetite (Severe) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    1 / 74 (1.35%)
    1 / 77 (1.30%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Increased Sleep (Any) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events Systemic
    alternative assessment type: Systematic
         subjects affected / exposed [23]
    65 / 96 (67.71%)
    66 / 95 (69.47%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    48 / 83 (57.83%)
    56 / 86 (65.12%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    65
    66
    0
    0
    48
    56
    0
    0
    0
    0
    Increased Sleep (Any) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    63 / 85 (74.12%)
    57 / 89 (64.04%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    63
    57
    0
    0
    0
    0
    0
    0
    0
    0
    Increased Sleep (Any) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    46 / 88 (52.27%)
    51 / 88 (57.95%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    46
    51
    0
    0
    0
    0
    0
    0
    0
    0
    Increased Sleep (Mild) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    58 / 96 (60.42%)
    57 / 93 (61.29%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    44 / 82 (53.66%)
    50 / 84 (59.52%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    58
    57
    0
    0
    44
    50
    0
    0
    0
    0
    Increased Sleep (Mild) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    58 / 83 (69.88%)
    52 / 88 (59.09%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    58
    52
    0
    0
    0
    0
    0
    0
    0
    0
    Increased Sleep (Mild) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    43 / 88 (48.86%)
    45 / 87 (51.72%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    43
    45
    0
    0
    0
    0
    0
    0
    0
    0
    Increased Sleep (Moderate) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    26 / 87 (29.89%)
    27 / 88 (30.68%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    14 / 76 (18.42%)
    18 / 74 (24.32%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    26
    27
    0
    0
    14
    18
    0
    0
    0
    0
    Increased Sleep (Moderate) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    27 / 78 (34.62%)
    23 / 78 (29.49%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    27
    23
    0
    0
    0
    0
    0
    0
    0
    0
    Increased Sleep (Moderate) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    13 / 77 (16.88%)
    16 / 80 (20.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    13
    16
    0
    0
    0
    0
    0
    0
    0
    0
    Increased Sleep (Severe) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    2 / 86 (2.33%)
    2 / 85 (2.35%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 74 (0.00%)
    2 / 70 (2.86%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    2
    0
    0
    0
    0
    Increased Sleep (Severe) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    2 / 73 (2.74%)
    1 / 76 (1.32%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Increased Sleep (Severe) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    1 / 73 (1.37%)
    1 / 77 (1.30%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Irritability or Decreased Sleep (Any) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    80 / 95 (84.21%)
    80 / 97 (82.47%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    76 / 90 (84.44%)
    73 / 91 (80.22%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    80
    80
    0
    0
    76
    73
    0
    0
    0
    0
    Irritability or Decreased Sleep (Any) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    85 / 95 (89.47%)
    74 / 95 (77.89%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    85
    74
    0
    0
    0
    0
    0
    0
    0
    0
    Irritability or Decreased Sleep (Any) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    73 / 92 (79.35%)
    77 / 95 (81.05%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    73
    77
    0
    0
    0
    0
    0
    0
    0
    0
    Irritability or Decreased Sleep (Mild) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    72 / 93 (77.42%)
    66 / 95 (69.47%)
    0 / 99 (0.00%)
    0 / 99 (0.00%)
    67 / 90 (74.44%)
    68 / 89 (76.40%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    72
    66
    0
    0
    67
    68
    0
    0
    0
    0
    Irritability or Decreased Sleep (Mild) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    73 / 90 (81.11%)
    66 / 92 (71.74%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    73
    66
    0
    0
    0
    0
    0
    0
    0
    0
    Irritability or Decreased Sleep (Mild) Dose 3 Infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    65 / 90 (72.22%)
    68 / 91 (74.73%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    65
    68
    0
    0
    0
    0
    0
    0
    0
    0
    Irritability or Decreased Sleep (Moderate) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    40 / 92 (43.48%)
    43 / 91 (47.25%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    35 / 78 (44.87%)
    36 / 80 (45.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    40
    43
    0
    0
    35
    36
    0
    0
    0
    0
    Irritability or Decreased Sleep (Moderate) Dose 2 Infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [42]
    55 / 85 (64.71%)
    38 / 86 (44.19%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    55
    38
    0
    0
    0
    0
    0
    0
    0
    0
    Irritability or Decreased Sleep (Moderate) Dose 3 Infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [43]
    27 / 80 (33.75%)
    31 / 87 (35.63%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    27
    31
    0
    0
    0
    0
    0
    0
    0
    0
    Irritability or Decreased Sleep (Severe) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [44]
    7 / 86 (8.14%)
    5 / 85 (5.88%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    5 / 76 (6.58%)
    3 / 69 (4.35%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    7
    5
    0
    0
    5
    3
    0
    0
    0
    0
    Irritability or Decreased Sleep (Severe) Dose 2 Infant
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [45]
    13 / 74 (17.57%)
    2 / 76 (2.63%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    13
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Irritability or Decreased Sleep (Severe) Dose 3 Infant
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [46]
    5 / 74 (6.76%)
    5 / 78 (6.41%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    5
    5
    0
    0
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Food allergy
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    Milk allergy
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Allergy to arthropod sting
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Allergic respiratory disease
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Cardiac murmur
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Craniotabes
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hydrocele
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Beckwith-Wiedemann syndrome
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Hypersomnia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 100 (3.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypotonia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Subdural hygroma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Loss of consciousness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Febrile convulsion
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
    alternative dictionary used: MedDRA MedDRA (U
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    Conjunctivitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye discharge
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Aphthous stomatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    3 / 100 (3.00%)
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    2 / 99 (2.02%)
    2 / 97 (2.06%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    3
    1
    1
    2
    2
    0
    0
    0
    0
    Dyspepsia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 100 (3.00%)
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    3
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Infantile colic
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Umbilical hernia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Teething
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    2 / 97 (2.06%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Hepatobiliary disorders
    Cholelithiasis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Dermatitis allergic
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Dermatitis atopic
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    2 / 100 (2.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    2
    0
    2
    0
    0
    0
    0
    0
    0
    Dermatitis diaper
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dry skin
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rash
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    1 / 88 (1.14%)
    0 / 88 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    0
    1
    0
    Seborrhoeic dermatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tenderness (Any) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [47]
    46 / 94 (48.94%)
    37 / 88 (42.05%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    60 / 86 (69.77%)
    47 / 85 (55.29%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    46
    37
    0
    0
    60
    47
    0
    0
    0
    0
    Tenderness (Any) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [48]
    41 / 85 (48.24%)
    34 / 88 (38.64%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    41
    34
    0
    0
    0
    0
    0
    0
    0
    0
    Tenderness (Any) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [49]
    32 / 82 (39.02%)
    24 / 84 (28.57%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    32
    24
    0
    0
    0
    0
    0
    0
    0
    0
    Tenderness (Mild) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [50]
    43 / 93 (46.24%)
    28 / 88 (31.82%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    57 / 86 (66.28%)
    44 / 85 (51.76%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    43
    28
    0
    0
    57
    44
    0
    0
    0
    0
    Tenderness (Mild) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [51]
    37 / 85 (43.53%)
    26 / 84 (30.95%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    37
    26
    0
    0
    0
    0
    0
    0
    0
    0
    Tenderness (Mild) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [52]
    29 / 81 (35.80%)
    22 / 84 (26.19%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    29
    22
    0
    0
    0
    0
    0
    0
    0
    0
    Tenderness (Moderate) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [53]
    16 / 90 (17.78%)
    14 / 85 (16.47%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    16 / 77 (20.78%)
    8 / 70 (11.43%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    16
    14
    0
    0
    16
    8
    0
    0
    0
    0
    Tenderness (Moderate) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [54]
    11 / 77 (14.29%)
    13 / 83 (15.66%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    11
    13
    0
    0
    0
    0
    0
    0
    0
    0
    Tenderness (Moderate) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [55]
    7 / 75 (9.33%)
    4 / 78 (5.13%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    7
    4
    0
    0
    0
    0
    0
    0
    0
    0
    Tenderness (Severe) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [56]
    0 / 86 (0.00%)
    0 / 85 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    2 / 74 (2.70%)
    0 / 69 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Tenderness (Severe) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [57]
    0 / 73 (0.00%)
    1 / 77 (1.30%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Swelling (Any) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [58]
    37 / 94 (39.36%)
    26 / 89 (29.21%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    35 / 81 (43.21%)
    28 / 80 (35.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    37
    26
    0
    0
    35
    28
    0
    0
    0
    0
    Swelling (Any) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [59]
    30 / 84 (35.71%)
    35 / 82 (42.68%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    30
    35
    0
    0
    0
    0
    0
    0
    0
    0
    Swelling (Any) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [60]
    25 / 83 (30.12%)
    35 / 85 (41.18%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    25
    35
    0
    0
    0
    0
    0
    0
    0
    0
    Swelling (Mild) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [61]
    34 / 91 (37.36%)
    25 / 89 (28.09%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    31 / 80 (38.75%)
    26 / 79 (32.91%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    34
    25
    0
    0
    31
    26
    0
    0
    0
    0
    Swelling (Mild) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [62]
    28 / 83 (33.73%)
    35 / 82 (42.68%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    28
    35
    0
    0
    0
    0
    0
    0
    0
    0
    Swelling (Mild) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [63]
    22 / 82 (26.83%)
    35 / 85 (41.18%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    22
    35
    0
    0
    0
    0
    0
    0
    0
    0
    Swelling (Moderate) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [64]
    8 / 91 (8.79%)
    7 / 85 (8.24%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    10 / 76 (13.16%)
    7 / 74 (9.46%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    8
    7
    0
    0
    10
    7
    0
    0
    0
    0
    Swelling (Moderate) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions Local Rea
    alternative assessment type: Systematic
         subjects affected / exposed [65]
    6 / 75 (8.00%)
    2 / 76 (2.63%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    6
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Swelling (Moderate) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions Local Rea
    alternative assessment type: Systematic
         subjects affected / exposed [66]
    4 / 75 (5.33%)
    4 / 79 (5.06%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    4
    4
    0
    0
    0
    0
    0
    0
    0
    0
    Swelling (Severe) Dose 1(infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [67]
    0 / 86 (0.00%)
    0 / 85 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 74 (1.35%)
    0 / 69 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Redness (Any) Dose 1(infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [68]
    31 / 92 (33.70%)
    26 / 87 (29.89%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    44 / 85 (51.76%)
    41 / 83 (49.40%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    31
    26
    0
    0
    44
    41
    0
    0
    0
    0
    Redness (Any) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [69]
    23 / 82 (28.05%)
    33 / 82 (40.24%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    23
    33
    0
    0
    0
    0
    0
    0
    0
    0
    Redness (Any) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [70]
    27 / 82 (32.93%)
    40 / 87 (45.98%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    27
    40
    0
    0
    0
    0
    0
    0
    0
    0
    Redness (Mild) Dose 1(infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [71]
    29 / 90 (32.22%)
    25 / 87 (28.74%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    44 / 85 (51.76%)
    40 / 83 (48.19%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    29
    25
    0
    0
    44
    40
    0
    0
    0
    0
    Redness (Mild) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [72]
    23 / 82 (28.05%)
    31 / 82 (37.80%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    23
    31
    0
    0
    0
    0
    0
    0
    0
    0
    Redness (Mild) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [73]
    27 / 82 (32.93%)
    40 / 87 (45.98%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    27
    40
    0
    0
    0
    0
    0
    0
    0
    0
    Redness (Moderate) Dose 1 (infant and toddler dose)
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [74]
    3 / 88 (3.41%)
    4 / 85 (4.71%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    5 / 75 (6.67%)
    8 / 75 (10.67%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    3
    4
    0
    0
    5
    8
    0
    0
    0
    0
    Redness (Moderate) Dose 2 infant
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [75]
    2 / 73 (2.74%)
    2 / 76 (2.63%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Redness (Moderate) Dose 3 infant
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [76]
    1 / 74 (1.35%)
    3 / 79 (3.80%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Acute sinusitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Bronchiolitis
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 100 (7.00%)
    6 / 100 (6.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    7
    8
    0
    1
    1
    0
    0
    0
    0
    0
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 100 (5.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    3 / 100 (3.00%)
    3 / 99 (3.03%)
    2 / 97 (2.06%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    6
    1
    0
    3
    3
    2
    0
    0
    0
    0
    Ear infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Exanthema subitum
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    2 / 99 (2.02%)
    2 / 97 (2.06%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    2
    0
    0
    0
    0
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    6 / 100 (6.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    3 / 99 (3.03%)
    2 / 97 (2.06%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    6
    1
    0
    3
    2
    0
    0
    0
    0
    Influenza
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Laryngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 100 (6.00%)
    5 / 100 (5.00%)
    0 / 100 (0.00%)
    2 / 100 (2.00%)
    6 / 99 (6.06%)
    4 / 97 (4.12%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    6
    6
    0
    2
    6
    4
    0
    0
    0
    0
    Oral candidiasis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Otitis media
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    2 / 97 (2.06%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    2
    0
    0
    0
    0
    Otitis media acute
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    2 / 97 (2.06%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    2
    0
    0
    0
    0
    Pharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    3 / 99 (3.03%)
    1 / 97 (1.03%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    1
    0
    1
    3
    1
    0
    0
    0
    0
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    1
    1
    0
    1
    0
    0
    0
    0
    0
    Respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 100 (8.00%)
    9 / 100 (9.00%)
    4 / 100 (4.00%)
    0 / 100 (0.00%)
    3 / 99 (3.03%)
    1 / 97 (1.03%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    9
    11
    4
    0
    3
    1
    0
    0
    0
    0
    Respiratory tract infection bacterial
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory tract infection viral
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhinitis
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 100 (5.00%)
    4 / 100 (4.00%)
    2 / 100 (2.00%)
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    5
    4
    2
    1
    0
    0
    0
    0
    0
    0
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 100 (8.00%)
    10 / 100 (10.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    5 / 99 (5.05%)
    4 / 97 (4.12%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    9
    13
    1
    0
    5
    4
    0
    0
    0
    0
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Viral infection
    alternative dictionary used: MedDRA MedDRA (U
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Viral rash
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 100 (1.00%)
    1 / 100 (1.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bronchopneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Herpangina
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 97 (1.03%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Tonsillitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    2 / 97 (2.06%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 100 (3.00%)
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 99 (0.00%)
    0 / 97 (0.00%)
    0 / 88 (0.00%)
    0 / 88 (0.00%)
         occurrences all number
    3
    2
    0
    0
    0
    0
    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.
    [43] - 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.
    [44] - 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.
    [45] - 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.
    [46] - 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.
    [47] - 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.
    [48] - 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.
    [49] - 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.
    [50] - 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.
    [51] - 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.
    [52] - 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.
    [53] - 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.
    [54] - 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.
    [55] - 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.
    [56] - 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.
    [57] - 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.
    [58] - 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.
    [59] - 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.
    [60] - 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.
    [61] - 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.
    [62] - 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.
    [63] - 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.
    [64] - 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.
    [65] - 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.
    [66] - 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.
    [67] - 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.
    [68] - 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.
    [69] - 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.
    [70] - 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.
    [71] - 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.
    [72] - 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.
    [73] - 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.
    [74] - 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.
    [75] - 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.
    [76] - 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? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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