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    Clinical Trial Results:
    A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of 3 Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States

    Summary
    EudraCT number
    		 2008-003688-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    09 Jun 2008

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    6096A1-3005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00444457
    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
    Clinical Trials.gov Call Center, Pfizer Inc, 001 800 7181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer Inc, 001 800 7181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Nov 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the immune responses induced by 3 lots of13 valent pneumococcal conjugate vaccine (13vPnC) are equivalent when measured 1 month after the infant series. To demonstrate that the immune responses induced by Pediarix given with 13vPnC are non-inferior to the immune responses induced by Pediarix given with 7 valent pneumococcal conjugate vaccine (7vPnC) when measured 1 month after the infant series.Responses to the following antigens in.Pediarix will be assessed: tetanus; poliovirus types 1, 2, and 3; and hepatitis B. To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Aug 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1712
    Worldwide total number of subjects
    1712
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    1712
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 1712 subjects from United States were enrolled in the study. The study started on 15 Aug 2007 and completed on 09 Jun 2008.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC (Pilot Lot 1) Infant Series
    Arm description
    		 Subjects received single dose of 13vPnC pilot lot 1 at 2, 4, and 6 months of age (infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available (Haemophilus influenzae type b) Hib vaccine at 2, 4, and 6 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13vPnC was administered at a dose of 0.5 (milliliter) mL into the anterolateral thigh muscle of the left leg at 2, 4, and 6 months of age (infant series).

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pediarix was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).

    Investigational medicinal product name
    Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Hib was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).

    Arm title
    		 13vPnC (Pilot Lot 2) Infant Series
    Arm description
    		 Subjects received 1 single dose of 13vPnC pilot lot 2 at 2, 4, and 6 months of age (infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC Pilot lot 2
    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 into the anterolateral thigh muscle of the left leg at 2, 4, and 6 months of age (infant series).

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pediarix was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).

    Investigational medicinal product name
    Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Hib was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).

    Arm title
    		 13vPnC (Manufacturing lot) Infant series
    Arm description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series; co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC (Manu lot)
    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 into the anterolateral thigh muscle of the left leg at 2, 4, and 6 months of age (infant series).

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pediarix was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pediarix was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).

    Arm title
    		 7vPnC Infant series
    Arm description
    		 Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    7vPnC Infant series
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    7vPnC was administered at a dose of 0.5 mL into the anterolateral thigh muscle of the left leg at 2, 4, and 6 months of age (infant series).

    Investigational medicinal product name
    Pediarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pediarix was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).

    Investigational medicinal product name
    Hib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Hib was administered at a dose of 0.5 mL on 2, 4, and 6 months of age (infant series).

    Number of subjects in period 1
    		13vPnC (Pilot Lot 1) Infant Series 13vPnC (Pilot Lot 2) Infant Series 13vPnC (Manufacturing lot) Infant series 7vPnC Infant series
    Started
    489
    488
    489
    246
    Vaccinated Dose 1
    486
    484
    485
    244
    Vaccinated Dose 2
    455
    447
    455
    228
    Vaccinated Dose 3
    442
    435
    438
    225
    Completed
    435
    427
    428
    218
    Not completed
    54
    61
    61
    28
         Parent or legal guardian request
    18
    29
    34
    14
         Failed to return
    5
    4
    4
    2
         Adverse Event
    1
    2
    2
    -
         Death
    -
    1
    1
    1
         Unknown
    -
    1
    -
    -
         Protocol Violation
    16
    8
    6
    3
         Unspecified
    -
    2
    4
    -
         Lost to follow-up
    10
    11
    7
    6
         Investigator request
    4
    3
    3
    2
    Period 2
    Period 2 title
    After Infant Series
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC (Pilot Lot 1) After Infant Series
    Arm description
    		 Subjects received single dose of 13vPnC pilot lot 1 at 2, 4, and 6 months of age (in infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 13vPnC (Pilot Lot 2) After Infant Series
    Arm description
    		 Subjects received single dose of 13vPnC pilot lot 2 at 2, 4, and 6 months of age (in infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 13vPnC (Manufacturing lot) After Infant series
    Arm description
    		 Subjects received single dose of 13vPnC manu lot at 2, 4, and 6 months of age (in infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 7vPnC After Infant series
    Arm description
    		 Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2 [1]
    		13vPnC (Pilot Lot 1) After Infant Series 13vPnC (Pilot Lot 2) After Infant Series 13vPnC (Manufacturing lot) After Infant series 7vPnC After Infant series
    Started
    435
    427
    427
    218
    Completed
    415
    397
    408
    208
    Not completed
    20
    30
    19
    10
         Parent or legal guardian request
    4
    11
    6
    3
         Failed to return
    7
    6
    5
    1
         Adverse Event
    2
    2
    -
    -
         Lost to Follow-up
    -
    -
    -
    2
         Unknown
    -
    1
    1
    1
         Protocol Violation
    2
    4
    2
    2
         Unspecified
    -
    1
    -
    -
         Lost to follow-up
    5
    5
    5
    -
         Investigator request
    -
    -
    -
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The subjects in this group received only the toddler dose.
    Period 3
    Period 3 title
    Toddler Dose
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC (Pilot Lot 1) Toddler Dose
    Arm description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 1 at 12 months of age (toddler dose); a commercially available (Measles, Mumps, and Rubella-varicella vaccine) MMR-varicella, or if not available, a commercially available MMR at 12 months of age and a commercially available varicella vaccine administered in separate injections; and a commercially available (hepatitis A vaccine) HAV administered at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13vPnC was administered at a dose of 0.5 (milliliter) mL into the anterolateral thigh muscle of the left leg at 2, 4, and 6 months of age (infant series).

    Investigational medicinal product name
    MMR-varicella
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MMR-varicella was administered at a dose of 0.5mL on 12 months (toddler dose) of age.

    Investigational medicinal product name
    HAV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HAV was administered at a dose of 0.5 mL on 12 months (toddler dose) of age.

    Arm title
    		 13vPnC (Pilot Lot 2) Toddler dose
    Arm description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 2 at 12 months of age (toddler dose); a commercially available MMR-varicella administered at 12 months of age, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    113vPnC was administered at a dose of 0.5 mL into the anterolateral thigh muscle of the left leg at 12 months of age (toddler dose).

    Investigational medicinal product name
    MMR-varicella
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MMR-varicella was administered at a dose of 0.5mL on 12 months (toddler dose) of age.

    Investigational medicinal product name
    HAV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HAV was administered at a dose of 0.5 mL on 12 months (toddler dose) of age.

    Arm title
    		 13vPnC (Manufacturing lot) Toddler dose
    Arm description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC manu lot at 12 months of age (toddler dose); a commercially available MMR-varicella administered at 12 months of age, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13vPnC was administered at a dose of 0.5 mL into the anterolateral thigh muscle of the left leg at 12 months of age (toddler dose).

    Investigational medicinal product name
    MMR-varicella
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MMR-varicella was administered at a dose of 0.5mL on 12 months (toddler dose) of age.

    Investigational medicinal product name
    HAV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HAV was administered at a dose of 0.5 mL on 12 months (toddler dose) of age.

    Arm title
    		 7vPnC Toddler Dose
    Arm description
    		 Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose); a commercially available MMR-varicella, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    7vPnC was administered at a dose of 0.5 mL into the anterolateral thigh muscle of the left leg at 12 months of age (toddler dose).

    Investigational medicinal product name
    MMR-varicella
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MMR-varicella was administered at a dose of 0.5mL on 12 months (toddler dose) of age.

    Investigational medicinal product name
    HAV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HAV was administered at a dose of 0.5 mL on 12 months (toddler dose) of age.

    Number of subjects in period 3
    		13vPnC (Pilot Lot 1) Toddler Dose 13vPnC (Pilot Lot 2) Toddler dose 13vPnC (Manufacturing lot) Toddler dose 7vPnC Toddler Dose
    Started
    415
    397
    408
    208
    Completed
    408
    391
    404
    200
    Not completed
    7
    6
    4
    8
         Parent or legal guardian request
    -
    3
    2
    1
         Failed to return
    2
    2
    1
    3
         Protocol Violation
    1
    -
    -
    1
         Lost to follow-up
    4
    1
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC (Pilot Lot 1) Infant Series
    Reporting group description
    		 Subjects received single dose of 13vPnC pilot lot 1 at 2, 4, and 6 months of age (infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available (Haemophilus influenzae type b) Hib vaccine at 2, 4, and 6 months of age.

    Reporting group title
    13vPnC (Pilot Lot 2) Infant Series
    Reporting group description
    		 Subjects received 1 single dose of 13vPnC pilot lot 2 at 2, 4, and 6 months of age (infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.

    Reporting group title
    13vPnC (Manufacturing lot) Infant series
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series; co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.

    Reporting group title
    7vPnC Infant series
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.

    Reporting group values
    		 13vPnC (Pilot Lot 1) Infant Series 13vPnC (Pilot Lot 2) Infant Series 13vPnC (Manufacturing lot) Infant series 7vPnC Infant series Total
    Number of subjects
    		 489 488 489 246 1712
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 2.2 ( 0.3 ) 2.2 ( 0.3 ) 2.2 ( 0.3 ) 2.2 ( 0.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 230 226 213 115 784
        Male
    		 259 260 275 131 925
        Unknown
    		 0 2 1 0 3

    End points

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    End points reporting groups
    Reporting group title
    13vPnC (Pilot Lot 1) Infant Series
    Reporting group description
    		 Subjects received single dose of 13vPnC pilot lot 1 at 2, 4, and 6 months of age (infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available (Haemophilus influenzae type b) Hib vaccine at 2, 4, and 6 months of age.

    Reporting group title
    13vPnC (Pilot Lot 2) Infant Series
    Reporting group description
    		 Subjects received 1 single dose of 13vPnC pilot lot 2 at 2, 4, and 6 months of age (infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.

    Reporting group title
    13vPnC (Manufacturing lot) Infant series
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series; co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.

    Reporting group title
    7vPnC Infant series
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.
    Reporting group title
    13vPnC (Pilot Lot 1) After Infant Series
    Reporting group description
    		 Subjects received single dose of 13vPnC pilot lot 1 at 2, 4, and 6 months of age (in infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.

    Reporting group title
    13vPnC (Pilot Lot 2) After Infant Series
    Reporting group description
    		 Subjects received single dose of 13vPnC pilot lot 2 at 2, 4, and 6 months of age (in infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.

    Reporting group title
    13vPnC (Manufacturing lot) After Infant series
    Reporting group description
    		 Subjects received single dose of 13vPnC manu lot at 2, 4, and 6 months of age (in infant series) co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.

    Reporting group title
    7vPnC After Infant series
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age.
    Reporting group title
    13vPnC (Pilot Lot 1) Toddler Dose
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 1 at 12 months of age (toddler dose); a commercially available (Measles, Mumps, and Rubella-varicella vaccine) MMR-varicella, or if not available, a commercially available MMR at 12 months of age and a commercially available varicella vaccine administered in separate injections; and a commercially available (hepatitis A vaccine) HAV administered at 12 months of age.

    Reporting group title
    13vPnC (Pilot Lot 2) Toddler dose
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 2 at 12 months of age (toddler dose); a commercially available MMR-varicella administered at 12 months of age, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.

    Reporting group title
    13vPnC (Manufacturing lot) Toddler dose
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC manu lot at 12 months of age (toddler dose); a commercially available MMR-varicella administered at 12 months of age, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.

    Reporting group title
    7vPnC Toddler Dose
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose); a commercially available MMR-varicella, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.

    Subject analysis set title
    Combined 13vPnC
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

    Subject analysis set title
    13vPnC (Pilot lot 2) Toddler dose
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 2 at 12 months of age (toddler dose); a commercially available MMR-varicella administered at 12 months of age, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age.

    Primary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 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 in the Three 13vPnC Groups 1 Month After the Infant Series
    End point description
    Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes (S) 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw.Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. n=number of subjects with IgG antibody concentration to given serotype for the three 13vPnC lots, respectively.
    End point type
    Primary
    End point timeframe
    1 Month after the infant series (7 Months of age)
    End point values
    		 13vPnC (Pilot Lot 1) After Infant Series 13vPnC (Pilot Lot 2) After Infant Series 13vPnC (Manufacturing lot) After Infant series
    Number of subjects analysed
    413
    404
    399
    Units: GMC microgram per milliliter (mcg/mL)
    geometric mean (confidence interval 95%)
        Common serotypes - serotype 4 (n=411, 404, 398)
    1.33 (1.24 to 1.43)
    1.34 (1.25 to 1.44)
    1.75 (1.63 to 1.88)
        Common serotypes - serotype 6B (n=409, 401, 396)
    2.89 (2.58 to 3.23)
    2.15 (1.91 to 2.42)
    2.54 (2.27 to 2.85)
        Common serotypes - serotype 9V (n=411, 403, 396)
    1.05 (0.98 to 1.12)
    1.11 (1.04 to 1.19)
    1.11 (1.04 to 1.19)
        Common serotypes - serotype 14 (n=398. 387, 387)
    4.97 (4.59 to 5.37)
    5.13 (4.7 to 5.59)
    5.18 (4.72 to 5.69)
        Common serotypes - serotype 18C (n=413, 401, 398)
    1.3 (1.22 to 1.38)
    1.34 (1.24 to 1.44)
    1.48 (1.38 to 1.58)
        Common serotypes - serotype 19F (n=408, 399, 398)
    1.85 (1.71 to 1.99)
    2.07 (1.92 to 2.24)
    2.59 (2.4 to 2.78)
        Common serotypes - serotype 23F (n=411, 402, 399)
    1.24 (1.13 to 1.36)
    1.27 (1.15 to 1.4)
    1.03 (0.94 to 1.14)
        Additional serotypes - serotype 1 (n=411, 403,395)
    1.62 (1.5 to 1.76)
    1.81 (1.66 to 1.98)
    1.91 (1.76 to 2.07)
        Additional serotypes - serotype 3 (n=406, 391,393)
    0.52 (0.48 to 0.55)
    0.56 (0.52 to 0.61)
    0.61 (0.57 to 0.66)
        Additional serotypes - serotype 5 (n=412, 402,393)
    1.35 (1.24 to 1.47)
    1.05 (0.96 to 1.14)
    1.35 (1.25 to 1.47)
        Additional serotypes - serotype 6A (n=413,402,398)
    2.4 (2.21 to 2.61)
    2.1 (1.92 to 2.29)
    2.12 (1.96 to 2.3)
        Additional serotypes - serotype 7F (n=412,401,397)
    2.54 (2.37 to 2.71)
    2.52 (2.35 to 2.7)
    2.67 (2.5 to 2.85)
        Additional serotype - serotype 19A (n=411,403,397)
    1.85 (1.71 to 2)
    2 (1.85 to 2.16)
    1.88 (1.74 to 2.02)
    Statistical analysis title
    		 S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 difference in log-transformed GM
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.09
    Statistical analysis title
    		 S4:13vPnC (Pilot Lot 1) vs 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.38
         upper limit
    		 -0.17
    Statistical analysis title
    		 S4:13vPnC (Pilot Lot 2) vs.13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 -0.16
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 0.46
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 1) vs 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.29
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 -0.01
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.04
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.04
    Statistical analysis title
    		 S9v:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.1
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.09
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.08
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.11
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 1) vs 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.07
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) After Infant series v 13vPnC (Pilot Lot 1) After Infant Series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 -0.03
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 -0.01
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 -0.11
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.11
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) After Infant series v 13vPnC (Pilot Lot 1) After Infant Series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 0.31
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 0.34
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0.01
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) After Infant series v 13vPnC (Pilot Lot 1) After Infant Series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 -0.04
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.06
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.02
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 -0.07
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.02
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 0.37
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.12
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 -0.13
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 0.25
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.24
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.11
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.1
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 0.04
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.04
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.03
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.09
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.17
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes. The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) After Infant series v 13vPnC (Pilot Lot 1) After Infant Series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.11

    Primary: Percentage of Subjects Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

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    End point title
    		 Percentage of Subjects Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of subjects. Combined 13vPnC group includes subjects randomized to pilot lot 1, pilot lot 2, or the manu lot. Evaluable immunogenicity population. Combined 13vPnC group includes subjects who received pilot lot 1, pilot lot 2, or manu lot.
    End point type
    Primary
    End point timeframe
    1 month after the infant series (7 months of age)
    End point values
    		 7vPnC After Infant series Combined 13vPnC
    Number of subjects analysed
    196
    184
    Units: observed percentage of subjects
        arithmetic mean (confidence interval 95%)
    98.5 (95.6 to 99.7)
    98.4 (95.3 to 99.7)
    Statistical analysis title
    		 Tetanus toxoid
    Statistical analysis description
    Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage. For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.
    Comparison groups
    7vPnC After Infant series v Combined 13vPnC
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 3

    Primary: Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

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    End point title
    		 Percentage of Subjects Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of subjects. Combined 13vPnC group includes subjects randomized to pilot lot 1, pilot lot 2, or the manufacturing lot. Evaluable immunogenicity population; N=number of subjects analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component; n)=number of subjects with an antibody titer ≥ prespecified level for given concomitant vaccine antigen for combined 13vPnC and 7vPnC, respectively.
    End point type
    Primary
    End point timeframe
    1 month after the infant series (7 months of age)
    End point values
    		 7vPnC After Infant series Combined 13vPnC
    Number of subjects analysed
    187
    183
    Units: observed percentage of subjects
    arithmetic mean (confidence interval 95%)
        Poliovirus type 1 (n=183, 187)
    100 (98 to 100)
    100 (98 to 100)
        Poliovirus type 2 (n=181, 186)
    99.5 (97.1 to 100)
    98.9 (96.1 to 99.9)
        Poliovirus type 3 (n=182, 186)
    99.5 (97.1 to 100)
    98.9 (98 to 100)
    Statistical analysis title
    		 Poliovirus type 1
    Statistical analysis description
    Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage. For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%. Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.
    Comparison groups
    7vPnC After Infant series v Combined 13vPnC
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 2
    Statistical analysis title
    		 Poliovirus type 2
    Statistical analysis description
    Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage. For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%. Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.
    Comparison groups
    7vPnC After Infant series v Combined 13vPnC
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 2
    Statistical analysis title
    		 Poliovirus type 3
    Statistical analysis description
    Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage. For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%. Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.
    Comparison groups
    7vPnC After Infant series v Combined 13vPnC
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 3

    Primary: Percentage of Subjects Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

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    End point title
    		 Percentage of Subjects Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of subjects. Combined 13vPnC group includes subjects randomized to pilot lot 1, pilot lot 2, or the manufacturing lot. Evaluable immunogenicity population; N=number of subjects analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.
    End point type
    Primary
    End point timeframe
    1 month after the infant series (7 months of age)
    End point values
    		 7vPnC After Infant series Combined 13vPnC
    Number of subjects analysed
    173
    153
    Units: observed percentage of subjects
        arithmetic mean (confidence interval 95%)
    100 (97.9 to 100)
    100 (97.6 to 100)
    Statistical analysis title
    		 Hepatitis B
    Statistical analysis description
    Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.
    Comparison groups
    7vPnC After Infant series v Combined 13vPnC
    Number of subjects included in analysis
    326
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 2.2

    Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series

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    End point title
    		 Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥0.35mcg/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) are presented. Exact 2-sided CI based on the observed proportion of subjects.Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.
    End point type
    Secondary
    End point timeframe
    1 month after the infant series (7 months of age)
    End point values
    		 13vPnC (Pilot Lot 1) After Infant Series 13vPnC (Pilot Lot 2) After Infant Series 13vPnC (Manufacturing lot) After Infant series
    Number of subjects analysed
    413
    404
    399
    Units: observed percentage of subjects
    arithmetic mean (confidence interval 95%)
        Common serotypes - serotype 4 (n=411, 404, 398)
    97.6 (95.6 to 98.8)
    95.5 (93 to 97.3)
    98.5 (96.7 to 99.4)
        Common serotypes - serotype 6B (n=409, 401, 396)
    94.9 (92.3 to 96.8)
    89.5 (86.1 to 92.3)
    94.4 (91.7 to 96.5)
        Common serotypes - serotype 9V (n=411, 403, 396)
    95.4 (92.9 to 97.2)
    95.5 (93 to 97.3)
    96.5 (94.1 to 98.1)
        Common serotypes - serotype 14 (n=398, 387, 387)
    99.2 (97.8 to 99.8)
    99 (97.4 to 99.7)
    98.2 (96.3 to 99.3)
        Common serotypes - serotype 18C (n=413, 401, 398)
    97.8 (95.9 to 99)
    95.8 (93.3 to 97.5)
    98.7 (96.1 to 99.1)
        Common serotypes - serotype 19F (n=408, 399, 398)
    97.8 (95.9 to 99)
    97.5 (95.4 to 98.8)
    98 (97.8 to 99.8)
        Common serotypes - serotype 23F (n=411, 402, 399)
    91.2 (88.1 to 93.8)
    88.1 (84.5 to 91.1)
    99.2 (83.5 to 90.3)
        Additional serotypes - serotype 1 (n=411, 403,395)
    97.8 (95.9 to 99)
    97 (94.9 to 98.5)
    87.2 (96.7 to 99.4)
        Additional serotypes - serotype 3 (n=406, 391,393)
    68.5 (63.7 to 73)
    72.4 (67.7 to 76.8)
    98.5 (74.8 to 83)
        Additional serotypes - serotype 5 (n=412, 402,393)
    94.2 (91.5 to 96.2)
    90.3 (87 to 93)
    79.1 (91.6 to 96.5)
        Additional serotypes - serotype 6A (n=413,402,398)
    98.1 (96.2 to 99.2)
    95.5 (93 to 97.3)
    94.4 (96.4 to 99.3)
        Additional serotypes - serotype 7F (n=412,401,397)
    99.8 (98.7 to 100)
    99 (97.5 to 99.7)
    98.2 (98.6 to 100)
        Additional serotype - serotype 19A (n=411,403,397)
    98.1 (96.2 to 99.2)
    99 (97.5 to 99.7)
    99.7 (97.1 to 99.6)
    Statistical analysis title
    		 S4: 13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Pilot Lot 1) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.09
         upper limit
    		 1.1
    Statistical analysis title
    		 S4:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.58
         upper limit
    		 -0.58
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.55
         upper limit
    		 9.19
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.77
         upper limit
    		 3.66
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Mau Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.82
         upper limit
    		 -1.1
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.13
         upper limit
    		 2.83
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.97
         upper limit
    		 1.73
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.81
         upper limit
    		 1.88
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.27
         upper limit
    		 1.95
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 3.01
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.04
         upper limit
    		 2.76
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.38
         upper limit
    		 4.74
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    1216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.33
         upper limit
    		 1.99
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.89
         upper limit
    		 0.23
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.93
         upper limit
    		 2.6
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.46
         upper limit
    		 0.28
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.87
         upper limit
    		 0.02
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.03
         upper limit
    		 7.46
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 8.39
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.75
         upper limit
    		 5.46
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.48
         upper limit
    		 3.18
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.78
         upper limit
    		 1.34
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.77
         upper limit
    		 0.67
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.27
         upper limit
    		 2.45
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -10.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.8
         upper limit
    		 -4.57
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.76
         upper limit
    		 -0.74
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 7.69
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.52
         upper limit
    		 3.09
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.92
         upper limit
    		 -0.36
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 5.23
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.22
         upper limit
    		 1.86
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.39
         upper limit
    		 -0.27
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    1216
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 2.3
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.12
         upper limit
    		 1.18
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 0.52
    Statistical analysis title
    		 S19A: 13PnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Pilot Lot 2) After Infant Series
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.91
         upper limit
    		 0.8
    Statistical analysis title
    		 S19A: 13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 1) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.69
         upper limit
    		 1.19
    Statistical analysis title
    		 S19A: 13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
    Comparison groups
    13vPnC (Pilot Lot 2) After Infant Series v 13vPnC (Manufacturing lot) After Infant series
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 2.04

    Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 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 in the Three 13vPnC Groups 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) are presented. Exact 2-sided CI based on the observed proportion of Subjects.Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose (13 months of age)
    End point values
    		 13vPnC (Pilot Lot 1) Toddler Dose 13vPnC (Pilot Lot 2) Toddler dose 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects analysed
    368
    344
    358
    Units: observed percentage of subjects
    arithmetic mean (confidence interval 95%)
        Common serotypes - serotype 4 (n=364, 342, 355)
    99.2 (97.6 to 99.8)
    99.1 (97.5 to 99.8)
    100 (99 to 100)
        Common serotypes - serotype 6B (n=368,341,357)
    100 (99 to 100)
    100 (98.9 to 100)
    100 (99 to 100)
        Common serotypes - serotype 9V (n=368,342,357)
    99.7 (98.5 to 100)
    99.7 (98.4 to 100)
    99.2 (97.6 to 99.8)
        Common serotypes - serotype 14 (n=366,344,358)
    100 (99 to 100)
    99.7 (98.4 to 100)
    100 (99 to 100)
        Common serotypes - serotype 18C (n=362,341,354)
    98.9 (97.2 to 99.7)
    98.5 (96.6 to 99.5)
    99.4 (98 to 99.9)
        Common serotypes - serotype 19F (n=362,342,353)
    98.3 (96.4 to 99.4)
    98.8 (97 to 99.7)
    99.4 (98 to 99.9)
        Common serotypes - serotype 23F (n=362,340,353)
    99.4 (98 to 99.9)
    99.1 (97.4 to 99.8)
    98.3 (96.3 to 99.4)
        Additional serotypes - serotype 1 (n=367,344,357)
    100 (99 to 100)
    99.1 (97.5 to 99.8)
    99.2 (97.6 to 99.8)
        Additional serotypes - serotype 3 (n=366,343,356)
    83.6 (79.4 to 87.3)
    80.8 (76.2 to 84.8)
    88.5 (84.7 to 91.6)
        Additional serotypes - serotype 5 (n=368,343,357)
    99.7 (98.5 to 100)
    99.4 (97.9 to 99.9)
    99.7 (98.4 to 100)
        Additional serotypes - serotype 6A (n=366,342,355)
    100 (99 to 100)
    100 (98.9 to 100)
    99.7 (98.4 to 100)
        Additional serotypes - serotype 7F (n=366,343,358)
    100 (99 to 100)
    99.4 (97.9 to 99.9)
    99.4 (98 to 99.9)
        Additional serotype - serotype 19A (n=362,341,353)
    100 (99 to 100)
    100 (98.9 to 100)
    100 (99 to 100)
    Statistical analysis title
    		 S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots. Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.61
         upper limit
    		 1.81
    Statistical analysis title
    		 S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.39
         upper limit
    		 0.23
    Statistical analysis title
    		 S4:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.54
         upper limit
    		 0.2
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.02
         upper limit
    		 1.11
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.13
         upper limit
    		 1.06
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.25
         upper limit
    		 1.37
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.76
         upper limit
    		 2.18
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.87
         upper limit
    		 2.18
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 1.62
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.03
         upper limit
    		 1.04
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.61
         upper limit
    		 0.76
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.52
         upper limit
    		 2.39
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 1.04
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.87
         upper limit
    		 0.74
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.55
         upper limit
    		 1.5
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.06
         upper limit
    		 0.57
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.21
         upper limit
    		 2.05
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 3.16
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 2.87
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 2.53
    Statistical analysis title
    		 S1:3vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.79
         upper limit
    		 1.66
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.85
         upper limit
    		 8.55
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.99
         upper limit
    		 0.21
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.14
         upper limit
    		 -2.37
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1.84
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.27
         upper limit
    		 1.3
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.84
         upper limit
    		 1.02
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.04
         upper limit
    		 1.08
    Statistical analysis title
    		 S6A13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.76
         upper limit
    		 1.56
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.83
         upper limit
    		 1.56
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 2.09
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 2
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.59
         upper limit
    		 1.49
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    712
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.04
         upper limit
    		 1.09
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 1.04
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.09
         upper limit
    		 1.07
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.03
         upper limit
    		 1.04
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    726
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 2.44
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.44
         upper limit
    		 1

    Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series

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    End point title
    		 Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥1.00 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) are presented. Exact 2-sided CI based on the observed proportion of subjects.Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the combined 13vPnC lot.
    End point type
    Secondary
    End point timeframe
    1 month after the infant series (7 months of age)
    End point values
    		 Combined 13vPnC
    Number of subjects analysed
    1216
    Units: observed percentage of subjects
    arithmetic mean (confidence interval 95%)
        Common serotypes - serotype 4 (n=1213)
    70.7 (78.4 to 82.9)
        Common serotypes - serotype 6B (n=1206)
    78.9 (68.1 to 73.3)
        Common serotypes - serotype 9V (n=1210)
    55.7 (76.4 to 81.1)
        Common serotypes - serotype 14 (n=1172)
    95.2 (52.9 to 58.5)
        Common serotypes - serotype 18C (n=1212)
    68.7 (93.8 to 96.4)
        Common serotypes - serotype 19F (n=1205)
    85.4 (66 to 71.3)
        Common serotypes - serotype 23F (n=1212)
    60.1 (83.3 to 87.3)
        Additional serotypes - serotype 1 (n=1209)
    75.2 (57.2 to 62.8)
        Additional serotypes - serotype 3 (n=1190)
    21.3 (72.7 to 77.6)
        Additional serotypes - serotype 5 (n=1207)
    60.3 (19 to 23.8)
        Additional serotypes - serotype 6A (n=1213)
    85.1 (57.5 to 63.1)
        Additional serotypes - serotype 7F (n=1210)
    92.8 (82.9 to 87)
        Additional serotypes - serotype 19A (n=1211)
    80.8 (91.2 to 94.2)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose

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    End point title
    		 Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥1.00 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) are presented. Exact 2-sided CI based on the observed proportion of subjects. Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose (13 months of age)
    End point values
    		 13vPnC (Pilot Lot 1) Toddler Dose 13vPnC (Pilot Lot 2) Toddler dose 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects analysed
    415
    397
    408
    Units: observed percentage of subjects
    arithmetic mean (confidence interval 95%)
        Common serotypes - serotype 4 (n=364,342,355)
    86 (82 to 89.4)
    87.4 (96.2 to 99.4)
    92.7 (89.5 to 95.2)
        Common serotypes - serotype 6B (n=368,341,357)
    99.5 (98.1 to 99.9)
    99.1 (93.6 to 98)
    99.7 (98.4 to 100)
        Common serotypes - serotype 9V (n=368,342,357)
    80.7 (76.3 to 84.6)
    84.5 (97.9 to 99.9)
    85.4 (81.3 to 88.9)
        Common serotypes - serotype 14 (n=366,344,358)
    98.6 (96.8 to 99.6)
    98.8 (83.4 to 90.7)
    98.3 (96.4 to 99.4)
        Common serotypes - serotype 18C (n=362,341,354)
    79.6 (75 to 83.6)
    85 (97.5 to 99.8)
    89.5 (85.9 to 92.5)
        Common serotypes - serotype 19F (n=362,342,353)
    94.5 (91.6 to 96.6)
    95.3 (80.2 to 88.2)
    97.7 (95.6 to 99)
        Common serotypes - serotype 23F (n=362,340,353)
    91.7 (88.4 to 94.3)
    91.2 (97 to 99.7)
    89.8 (86.2 to 92.8)
        Additional serotypes - serotype 1 (n=367,344,357)
    91.8 (88.5 to 94.4)
    91 (80.8 to 88.7)
    94.4 (91.5 to 96.5)
        Additional serotypes - serotype 3 (n=366,343,356)
    32 (27.2 to 37)
    30.3 (92.5 to 97.3)
    36.8 (31.8 to 42)
        Additional serotypes - serotype 5 (n=368,343,357)
    94 (91.1 to 96.2)
    91 (87.6 to 94)
    93.6 (90.5 to 95.9)
        Additional serotypes - serotype 6A (n=366,342,355)
    99.2 (97.6 to 99.8)
    98.2 (87.5 to 93.8)
    99.2 (97.6 to 99.8)
        Additional serotypes - serotype 7F (n=366,343,358)
    98.1 (96.1 to 99.2)
    96.2 (25.5 to 35.5)
    98.6 (96.8 to 99.5)
        Additional serotype - serotype 19A (n=362,341,353)
    100 (99 to 100)
    99.4 (87.4 to 93.8)
    99.7 (98.4 to 100)
    Statistical analysis title
    		 S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.52
         upper limit
    		 3.63
    Statistical analysis title
    		 S4: 13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -6.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.3
         upper limit
    		 -2.15
    Statistical analysis title
    		 S4: 13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.85
         upper limit
    		 0.79
    Statistical analysis title
    		 S6B: 13vPnC (Pilot Lot 2) vs. 13vPnC (Pilot Lot 1)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.19
         upper limit
    		 2.07
    Statistical analysis title
    		 S6B: 13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.69
         upper limit
    		 1.06
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.27
         upper limit
    		 0.75
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.46
         upper limit
    		 1.82
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -4.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.24
         upper limit
    		 0.76
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 4.41
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.14
         upper limit
    		 1.73
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.69
         upper limit
    		 2.39
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.46
         upper limit
    		 2.59
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.17
         upper limit
    		 0.2
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -10
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.31
         upper limit
    		 -4.7
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.55
         upper limit
    		 0.46
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.23
         upper limit
    		 2.52
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.35
         upper limit
    		 -0.4
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.44
         upper limit
    		 0.33
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.67
         upper limit
    		 4.8
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.38
         upper limit
    		 6.28
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.06
         upper limit
    		 5.82
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.34
         upper limit
    		 5.08
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.39
         upper limit
    		 1.18
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.45
         upper limit
    		 0.46
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 8.55
    Statistical analysis title
    		 S3:113vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.79
         upper limit
    		 2.16
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.51
         upper limit
    		 0.54
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 7.13
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.14
         upper limit
    		 4.11
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.72
         upper limit
    		 1.4
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.87
         upper limit
    		 3.02
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.62
         upper limit
    		 1.71
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 0.92
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.62
         upper limit
    		 4.67
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.67
         upper limit
    		 1.55
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.11
         upper limit
    		 -0.01
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 2) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 2.1
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    823
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.75
         upper limit
    		 1.58
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 2) Toddler dose
    Number of subjects included in analysis
    805
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.86
         upper limit
    		 1.05

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose
    End point description
    Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw. Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose (13 months of age)
    End point values
    		 13vPnC (Pilot Lot 1) Toddler Dose 13vPnC (Manufacturing lot) Toddler dose 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects analysed
    413
    399
    404
    Units: GMC mcg/mL
    arithmetic mean (confidence interval 95%)
        Common serotypes - serotype 4 (n=364,355,342)
    2.29 (2.11 to 2.48)
    3.06 (2.79 to 3.35)
    2.25 (2.07 to 2.44)
        Common serotypes - serotype 6B (n=368,357,341)
    11.14 (10.24 to 12.11)
    9.92 (9.15 to 10.75)
    9.33 (8.55 to 10.19)
        Common serotypes - serotype 9V (n=368,357,342)
    1.91 (1.76 to 2.06)
    1.99 (1.84 to 2.15)
    1.95 (1.8 to 2.1)
        Common serotypes - serotype 14 (n=366,358,344)
    6.61 (6.06 to 7.22)
    6.91 (6.32 to 7.56)
    7.05 (6.42 to 7.74)
        Common serotypes - serotype 18C (n=362,354,341)
    1.95 (1.78 to 2.12)
    2.48 (2.27 to 2.71)
    2.2 (2.01 to 2.41)
        Common serotypes - serotype 19F (n=362,353,342)
    4.51 (4.05 to 5.03)
    6.51 (5.91 to 7.18)
    4.67 (4.23 to 5.14)
        Common serotypes - serotype 23F (n=362,353,340)
    3.35 (3.02 to 3.71)
    3.1 (2.81 to 3.43)
    3.46 (3.14 to 3.82)
        Additional serotypes - serotype 1 (n=367,357,344)
    2.75 (2.53 to 2.99)
    3.01 (2.75 to 3.3)
    2.95 (2.68 to 3.24)
        Additional serotypes - serotype 3 (n=366,356,343)
    0.75 (0.69 to 0.81)
    0.8 (0.74 to 0.87)
    0.71 (0.65 to 0.77)
        Additional serotypes - serotype 5 (n=368,357,343)
    3.11 (2.87 to 3.37)
    2.8 (2.6 to 3.02)
    2.63 (2.42 to 2.87)
        Additional serotypes - serotype 6A (n=366,355,342)
    7.52 (6.93 to 8.17)
    6.83 (6.3 to 7.41)
    6.97 (6.41 to 7.59)
        Additional serotypes - serotype 7F (n=366,358,343)
    4.35 (4.01 to 4.72)
    4.58 (4.21 to 4.98)
    4.24 (3.86 to 4.66)
        Additional serotype - serotype 19A (n=362,353,341)
    8.41 (7.73 to 9.14)
    8.6 (7.91 to 9.36)
    8.32 (7.66 to 9.04)
    Statistical analysis title
    		 S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.13
    Statistical analysis title
    		 S4:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 -0.17
    Statistical analysis title
    		 S4:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.06
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 -0.19
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.3
    Statistical analysis title
    		 S6B:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.23
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.09
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.07
    Statistical analysis title
    		 S9V:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.09
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.08
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.15
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.01
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.11
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.51
         upper limit
    		 -0.22
    Statistical analysis title
    		 S19F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 -0.2
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.11
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.22
    Statistical analysis title
    		 S23F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.25
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.06
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.03
    Statistical analysis title
    		 S1:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.11
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.18
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.04
    Statistical analysis title
    		 S3:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 -0.01
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 0.28
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.21
    Statistical analysis title
    		 S5:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.05
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.19
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.21
    Statistical analysis title
    		 S6A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.14
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.15
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.07
    Statistical analysis title
    		 S7F:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.05
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.13
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Manufacturing lot) Toddler dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 0.1
    Statistical analysis title
    		 S19A:13vPnC (Pilot Lot 2) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    803
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.08
    Statistical analysis title
    		 S14:13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Pilot Lot 1) Toddler Dose v 13vPnC (Pilot lot 2) Toddler dose
    Number of subjects included in analysis
    817
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.06
    Statistical analysis title
    		 S18C:13vPnC (Pilot Lot 1) vs. 13vPnC (Manu Lot)
    Statistical analysis description
    The 2-sided 95% CI were constructed for the mean difference of the logarithmically transformed geometric mean IgG antibody concentration between the two lots.
    Comparison groups
    13vPnC (Manufacturing lot) Toddler dose v 13vPnC (Pilot Lot 1) Toddler Dose
    Number of subjects included in analysis
    812
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Difference in log-transformed GM
    Point estimate
    -0.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 -0.12

    Other pre-specified: Percentage of Subjects Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema 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: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of Subjects reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after dose 1 (2 months of age)
    End point values
    		 13vPnC (Pilot Lot 1) Infant Series 13vPnC (Pilot Lot 2) Infant Series 13vPnC (Manufacturing lot) Infant series 7vPnC Infant series
    Number of subjects analysed
    425
    416
    407
    214
    Units: percentage of subjects
    number (not applicable)
        Tenderness: Any (n=420, 409, 400, 212)
    62.4
    64.1
    62.5
    67
        Tenderness: Significant (n=348, 337, 345, 170)
    9.2
    10.4
    10.4
    12.9
        Induration: Any (n=356, 347, 352, 176)
    16.6
    19.6
    19.3
    18.2
        Induration: Mild (n=353, 344, 348, 173)
    14.7
    16.9
    15.5
    16.2
        Induration: Moderate (n=338, 328, 340, 167)
    3.6
    5.8
    5
    3.6
        Induration: Severe (n=333, 325, 335, 164)
    0
    0
    0
    0
        Erythema: Any (n=355, 352, 360, 180)
    19.4
    25
    23.1
    22.8
        Erythema: Mild (n=354, 352, 358, 180)
    18.1
    24.7
    21.2
    21.7
        Erythema: Moderate (n=334, 326, 337, 164)
    2.1
    0.6
    2.4
    1.2
        Erythema: Severe (n=333, 325, 335, 164)
    0
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after dose 2 (4 months of age)
    End point values
    		 13vPnC (Pilot Lot 1) Infant Series 13vPnC (Pilot Lot 2) Infant Series 13vPnC (Manufacturing lot) Infant series 7vPnC Infant series
    Number of subjects analysed
    361
    345
    349
    180
    Units: percentage of subjects
    number (not applicable)
        Tenderness: Any (n=354, 330, 337, 176)
    66.4
    67.3
    65
    64.8
        Tenderness: Significant (n=269, 231, 262, 132)
    9.7
    7.4
    12.2
    11.4
        Induration: Any (n=291, 248, 279, 141)
    24.4
    22.6
    28.7
    17.7
        Induration: Mild (n=288, 246, 276, 141)
    22.6
    22
    26.8
    17.7
        Induration: Moderate (n=270, 224, 255, 128)
    4.1
    1.3
    4.7
    3.9
        Induration: Severe (n=263, 221, 250, 127)
    0
    0
    0.4
    0
        Erythema: Any (n=292, 265, 281, 153)
    30.1
    35.8
    34.5
    30.1
        Erythema: Mild (n=289, 263, 279, 153)
    28.4
    34.6
    33.3
    28.8
        Erythema: Moderate (n=268, 223, 252, 128)
    3.4
    1.8
    3.2
    3.1
        Erythema: Severe (n=263, 221, 249, 127)
    0
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after dose 3 (6 months of age)
    End point values
    		 13vPnC (Pilot Lot 1) Infant Series 13vPnC (Pilot Lot 2) Infant Series 13vPnC (Manufacturing lot) Infant series 7vPnC Infant series
    Number of subjects analysed
    333
    321
    320
    165
    Units: percentage of subjects
    number (not applicable)
        Tenderness: Any (n=317, 304, 300, 156)
    62.5
    60.9
    55
    64.7
        Tenderness: Significant (n=248, 226, 237, 118)
    8.9
    7.5
    10.1
    11.9
        Induration: Any (n=263, 250, 262, 128)
    27
    23.6
    28.6
    30.5
        Induration: Mild (n=260, 249, 260, 127)
    24.6
    22.5
    27.3
    29.1
        Induration: Moderate (n=242, 221, 229, 114)
    4.1
    4.1
    3.9
    7
        Induration: Severe (n=237, 217, 227, 111)
    0
    0
    0
    0
        Erythema: Any (n=278, 262, 274, 137)
    39.6
    35.9
    37.6
    39.4
        Erythema: Mild (n=275, 260, 272, 135)
    37.1
    33.8
    36.4
    38.5
        Erythema: Moderate (n=243, 219, 231, 116)
    5.3
    4.1
    5.6
    7.8
        Erythema: Severe (n=237, 217, 227, 111)
    0
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 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: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any local reactions; (n)=number of subjects reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after dose (12 months of age)
    End point values
    		 7vPnC Toddler Dose Combined 13vPnC
    Number of subjects analysed
    106
    889
    Units: percentage of subjects
    number (not applicable)
        Tenderness: Any (n= 131,826)
    63.4
    57.3
        Tenderness: Significant (n= 97, 630)
    4.1
    6.7
        Induration: Any (n=110,698)
    43.6
    31.5
        Induration: Mild (n=107, 689)
    41.1
    28.9
        Induration: Moderate (n= 101,627)
    17.8
    8.5
        Induration: Severe (n= 93,603)
    0
    0
        Erythema: Any (n=121,749)
    52.9
    42.6
        Erythema: Mild (n=116,735)
    50
    39.2
        Erythema: Moderate (n=104,631)
    21.2
    10.6
        Erythema: Severe (n=93,603)
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)
    End point description
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after dose 1 (2 months of age)
    End point values
    		 13vPnC (Pilot Lot 1) Infant Series 13vPnC (Pilot Lot 2) Infant Series 13vPnC (Manufacturing lot) Infant series 7vPnC Infant series
    Number of subjects analysed
    465
    457
    456
    237
    Units: percentage of subjects
    number (not applicable)
        Fever ≥38 but ≤39 degrees C (n=353, 337, 353, 173)
    24.6
    23.4
    24.6
    26
        Fever >39 but ≤40 degrees C (n=328, 319, 333, 161)
    0.6
    0.3
    0.9
    1.2
        Fever >40 degrees C (n=328, 319, 331, 160)
    0
    0
    0.3
    0.6
        Decreased appetite (n=393, 385, 386, 200)
    50.6
    46
    50
    49
        Irritability (n=435, 432, 433, 226)
    85.7
    84.3
    89.1
    87.6
        Increased sleep (n=425, 417, 402, 212)
    71.5
    72.7
    69.4
    72.6
        Decreased sleep (n=379, 377, 377, 194)
    44.1
    46.9
    42.2
    46.4
        Hives [urticaria] (n=333, 328, 335, 164)
    0.6
    0.9
    0.6
    0
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)
    End point description
    Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after dose 2 (4 months of age)
    End point values
    		 13vPnC (Pilot Lot 1) Infant Series 13vPnC (Pilot Lot 2) Infant Series 13vPnC (Manufacturing lot) Infant series 7vPnC Infant series
    Number of subjects analysed
    400
    398
    410
    208
    Units: percentage of subjects
    number (not applicable)
        Fever ≥38 but ≤39 degrees C (n=290, 250, 290, 143)
    33.4
    36.4
    35.5
    28
        Fever >39 but ≤40 degrees C (n=263, 216, 248, 124)
    3.4
    3.2
    3.6
    0
        Fever >40 degrees C (n=259, 214, 245, 124)
    0.4
    0
    0
    0
        Decreased appetite (n=322, 293, 325, 164)
    48.4
    49.1
    48
    49.4
        Irritability (n=377, 370, 376, 201)
    86.5
    86.5
    84.6
    81.1
        Increased sleep (n=332, 318, 343, 177)
    64.8
    68.2
    67.3
    63.3
        Decreased sleep (n=324, 291, 305, 159)
    49.1
    48.8
    44.6
    48.4
        Hives [urticaria] (n=263, 225, 253, 127)
    0.4
    2.2
    1.6
    0.8
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)
    End point description
    Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after dose 3 (6 months of age)
    End point values
    		 13vPnC (Pilot Lot 1) Infant Series 13vPnC (Pilot Lot 2) Infant Series 13vPnC (Manufacturing lot) Infant series 7vPnC Infant series
    Number of subjects analysed
    373
    365
    373
    192
    Units: percentage of subjects
    number (not applicable)
        Fever ≥38 but ≤39 degrees C (n=266, 246, 252, 132)
    26.3
    27.6
    31.7
    32.6
        Fever >39 but ≤40 degrees C (n=237, 219, 231, 113)
    2.5
    3.7
    5.6
    6.2
        Fever >40 degrees C (n=234, 216, 224, 111)
    0
    0.5
    0
    0.9
        Decreased appetite (n=286, 273, 286, 144)
    45.8
    48
    50.7
    50
        Irritability (n=352, 339, 347, 186)
    79.5
    80.5
    82.7
    84.4
        Increased sleep (n=289, 289, 286, 138)
    55.4
    58.8
    59.8
    51.4
        Decreased sleep (n=282, 272, 289, 147)
    42.6
    50.4
    48.4
    56.5
        Hives [urticaria] (n=239, 218, 229, 112)
    1.7
    0.9
    1.7
    1.8
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)
    End point description
    Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. subjects may be represented in more than 1 category.~Safety population: all subjects who received at least 1 dose of study vaccine. N=number of subjects reporting any systemic events; (n)=number of subjects reporting yes for at least 1 day or no for all days for the combined 13vPnC group and 7vPnC, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after dose (12 months of age)
    End point values
    		 7vPnC Toddler Dose Combined 13vPnC
    Number of subjects analysed
    171
    1001
    Units: percentage of subjects
    number (not applicable)
        Fever ≥38 but ≤39 degrees C (n=667, 107)
    29.9
    28.8
        Fever >39 but ≤40 degrees C (n=592, 95)
    5.3
    4.4
        Fever >40 degrees C (n=586, 93)
    0
    1
        Decreased appetite (n=790, 115)
    50.4
    51.9
        Irritability (n=943, 160)
    80
    81.8
        Increased sleep (n=779, 126)
    47.6
    47.8
        Decreased sleep (n=770, 117)
    42.7
    46.9
        Hives [urticaria] (n=607, 96)
    5.2
    2.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through 6 Month Follow-up after last study vaccination (18 Months). Local reactions and systemic events assessed within 7 days of dose: Infant Series Dose 1, 2, and 3 at 2, 4, and 6 months of age, respectively; Toddler Dose at 12 months of age.
    Adverse event reporting additional description
    Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Infant Series 13vPnC (Pilot Lot 1)
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 1 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=407; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=373.

    Reporting group title
    Infant Series 13vPnC (Pilot Lot 2)
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 2 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=394; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=364.

    Reporting group title
    Infant Series 13vPnC (Manu lot)
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC manu lot at 2, 4, and 6 months of age (infant series); co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=402; systematic (solicited) Local Reactions N=250; systematic (solicited) Systemic Events N=386.

    Reporting group title
    Infant Series 7vPnC
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=207; systematic (solicited) Local Reactions N=142; systematic (solicited) Systemic Events N=198.

    Reporting group title
    After the Infant Series Combined 13vPnC
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 1, 2, or manu lot at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).

    Reporting group title
    After the Infant Series 7vPnC
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Hib vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).

    Reporting group title
    Toddler Dose Combined 13vPnC
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 1, 2, or manu lot at 12 months of age; co-administered with a commercially available MMR-varicella, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age. Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=434; systematic (solicited) Local Reactions N=473; systematic (solicited) Systemic Events N=771.

    Reporting group title
    Toddler Dose 7vPnC
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age; co-administered with a commercially available MMR-varicella, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age. Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=75; systematic (solicited) Local Reactions N=83; systematic (solicited) Systemic Events N=128.

    Reporting group title
    Post Toddler Dose 6-Month Follow-up Combined 13vPnC
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 13vPnC pilot lot 1, 2, or manu lot at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available MMR-varicella, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).

    Reporting group title
    Post Toddler Dose 6-Month Follow-up 7vPnC
    Reporting group description
    		 Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available MMR-varicella, or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available HAV administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).

    Serious adverse events
    		 Infant Series 13vPnC (Pilot Lot 1) Infant Series 13vPnC (Pilot Lot 2) Infant Series 13vPnC (Manu lot) Infant Series 7vPnC After the Infant Series Combined 13vPnC After the Infant Series 7vPnC Toddler Dose Combined 13vPnC Toddler Dose 7vPnC Post Toddler Dose 6-Month Follow-up Combined 13vPnC Post Toddler Dose 6-Month Follow-up 7vPnC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 486 (2.67%)
    23 / 483 (4.76%)
    17 / 483 (3.52%)
    15 / 244 (6.15%)
    25 / 1445 (1.73%)
    3 / 244 (1.23%)
    9 / 1210 (0.74%)
    1 / 208 (0.48%)
    21 / 1443 (1.46%)
    7 / 244 (2.87%)
         number of deaths (all causes)
    0
    1
    1
    1
    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
    Joint injury
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    1 / 244 (0.41%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Near drowning
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (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 / 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
    Skull fracture
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Accidental overdose
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (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 / 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
    Foreign body trauma
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (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
    Cardiac disorders
    Cyanosis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Pulmonary valve stenosis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    2 / 1443 (0.14%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    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
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 486 (0.00%)
    3 / 483 (0.62%)
    0 / 483 (0.00%)
    2 / 244 (0.82%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden infant death syndrome
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    1 / 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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritability
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Injection site rash
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    1 / 244 (0.41%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to vaccine
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 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
    Food allergy
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Eye disorders
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haematochezia
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Vomiting
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Respiratory, thoracic and mediastinal disorders
    Respiratory distress
         subjects affected / exposed
    1 / 486 (0.21%)
    3 / 483 (0.62%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Apparent life threatening event
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    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
    Hypoxia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Productive cough
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Stridor
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Aspiration
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    4 / 1443 (0.28%)
    2 / 244 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    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
    Skin and subcutaneous tissue disorders
    Petechiae
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    5 / 486 (1.03%)
    2 / 483 (0.41%)
    4 / 483 (0.83%)
    2 / 244 (0.82%)
    2 / 1445 (0.14%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
    0 / 4
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    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
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    2 / 486 (0.41%)
    5 / 483 (1.04%)
    4 / 483 (0.83%)
    2 / 244 (0.82%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 4
    0 / 2
    0 / 1
    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
    Pneumonia
         subjects affected / exposed
    2 / 486 (0.41%)
    1 / 483 (0.21%)
    2 / 483 (0.41%)
    2 / 244 (0.82%)
    1 / 1445 (0.07%)
    1 / 244 (0.41%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    3 / 1443 (0.21%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 3
    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
         subjects affected / exposed
    2 / 486 (0.41%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    2 / 1443 (0.14%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Urinary tract infection
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    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
    Croup infectious
         subjects affected / exposed
    0 / 486 (0.00%)
    3 / 483 (0.62%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    2 / 1445 (0.14%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    2 / 1443 (0.14%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    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
    Otitis media
         subjects affected / exposed
    0 / 486 (0.00%)
    3 / 483 (0.62%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    2 / 244 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess oral
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Influenza
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Meningitis aseptic
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Meningitis enteroviral
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Urosepsis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Viral infection
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    3 / 1445 (0.21%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    2 / 1443 (0.14%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    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
    Eczema herpeticum
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Perirectal abscess
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    Skin infection
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis pharyngeal
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Rectal abscess
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Viral rash
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (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
    Endocarditis bacterial
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (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
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    1 / 244 (0.41%)
         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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    3 / 483 (0.62%)
    2 / 244 (0.82%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    1 / 244 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 2
    0 / 1
    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
    Abnormal loss of weight
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Infant Series 13vPnC (Pilot Lot 1) Infant Series 13vPnC (Pilot Lot 2) Infant Series 13vPnC (Manu lot) Infant Series 7vPnC After the Infant Series Combined 13vPnC After the Infant Series 7vPnC Toddler Dose Combined 13vPnC Toddler Dose 7vPnC Post Toddler Dose 6-Month Follow-up Combined 13vPnC Post Toddler Dose 6-Month Follow-up 7vPnC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    434 / 486 (89.30%)
    428 / 483 (88.61%)
    451 / 483 (93.37%)
    227 / 244 (93.03%)
    88 / 1445 (6.09%)
    11 / 244 (4.51%)
    906 / 1210 (74.88%)
    152 / 208 (73.08%)
    37 / 1443 (2.56%)
    9 / 244 (3.69%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    1 / 486 (0.21%)
    4 / 483 (0.83%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    0
    0
    0
    0
    Haemangioma of skin
         subjects affected / exposed
    2 / 486 (0.41%)
    2 / 483 (0.41%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    1
    0
    0
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    1
    0
    0
    Benign neoplasm
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Benign penile neoplasm
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Lipoma
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Fibrous histiocytoma
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Cephalhaematoma
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Neonatal disorder
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Umbilical granuloma
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    43 / 486 (8.85%)
    49 / 483 (10.14%)
    40 / 483 (8.28%)
    25 / 244 (10.25%)
    38 / 1445 (2.63%)
    9 / 244 (3.69%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    53
    51
    46
    29
    38
    10
    0
    0
    0
    0
    Irritability
         subjects affected / exposed
    15 / 486 (3.09%)
    12 / 483 (2.48%)
    7 / 483 (1.45%)
    8 / 244 (3.28%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    15
    12
    8
    11
    0
    0
    1
    0
    0
    0
    Injection site erythema
         subjects affected / exposed
    1 / 486 (0.21%)
    4 / 483 (0.83%)
    1 / 483 (0.21%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    4
    1
    1
    0
    0
    3
    0
    0
    0
    Injection site swelling
         subjects affected / exposed
    2 / 486 (0.41%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    1
    1
    2
    0
    0
    1
    0
    0
    0
    Injection site induration
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    2
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 486 (0.00%)
    2 / 483 (0.41%)
    0 / 483 (0.00%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    0
    2
    0
    0
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Xerosis
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    2
    0
    1
    0
    Injection site reaction
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Cyst
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Injection site bruising
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site dryness
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Injection site haemorrhage
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Injection site rash
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Injection site haematoma
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Injection site urticaria
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Developmental delay
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Localised oedema
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Fever ≥38°C but ≤39°C Infant Series Dose 1 and Toddler Dose
    Additional description: 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]
    87 / 353 (24.65%)
    79 / 337 (23.44%)
    87 / 353 (24.65%)
    45 / 173 (26.01%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    192 / 667 (28.79%)
    32 / 107 (29.91%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    87
    79
    87
    45
    0
    0
    192
    32
    0
    0
    Fever >39°C but ≤40°C Infant Series Dose 1 and Toddler Dose
    Additional description: 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 [2]
    2 / 328 (0.61%)
    1 / 319 (0.31%)
    3 / 333 (0.90%)
    2 / 161 (1.24%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    26 / 592 (4.39%)
    5 / 95 (5.26%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    1
    3
    2
    0
    0
    26
    5
    0
    0
    Fever >40°C Dose Infant Series Dose 1 and Toddler Dose
    Additional description: 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]
    0 / 328 (0.00%)
    0 / 319 (0.00%)
    1 / 331 (0.30%)
    1 / 160 (0.63%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    6 / 586 (1.02%)
    0 / 93 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    6
    0
    0
    0
    Decreased appetite Infant Series Dose 1 and Toddler Dose
    Additional description: 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]
    199 / 393 (50.64%)
    177 / 385 (45.97%)
    193 / 386 (50.00%)
    98 / 200 (49.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    410 / 790 (51.90%)
    58 / 115 (50.43%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    199
    177
    193
    98
    0
    0
    410
    58
    0
    0
    Irritability Infant Series Dose 1 and Toddler Dose
    Additional description: 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]
    373 / 435 (85.75%)
    364 / 432 (84.26%)
    386 / 433 (89.15%)
    198 / 226 (87.61%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    771 / 943 (81.76%)
    128 / 160 (80.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    373
    364
    386
    198
    0
    0
    771
    128
    0
    0
    Increased sleep Infant Series Dose 1 and Toddler Dose
    Additional description: 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]
    304 / 425 (71.53%)
    303 / 417 (72.66%)
    279 / 402 (69.40%)
    154 / 212 (72.64%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    372 / 779 (47.75%)
    60 / 126 (47.62%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    304
    303
    279
    154
    0
    0
    372
    60
    0
    0
    Decreased sleep Infant Dose 1 and Toddler Dose
    Additional description: 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]
    167 / 379 (44.06%)
    177 / 377 (46.95%)
    159 / 377 (42.18%)
    90 / 194 (46.39%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    361 / 770 (46.88%)
    50 / 117 (42.74%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    167
    177
    159
    90
    0
    0
    361
    50
    0
    0
    Hives (urticaria) Infant Dose 1 and Toddler Dose
    Additional description: 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]
    2 / 333 (0.60%)
    3 / 328 (0.91%)
    2 / 335 (0.60%)
    0 / 164 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    13 / 607 (2.14%)
    5 / 96 (5.21%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    3
    2
    0
    0
    0
    13
    5
    0
    0
    Fever >39°C but ≤40°C Infant Series Dose 2
    Additional description: 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]
    9 / 263 (3.42%)
    7 / 216 (3.24%)
    9 / 248 (3.63%)
    0 / 124 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 607 (0.00%)
    0 / 96 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    9
    7
    9
    0
    0
    0
    0
    0
    0
    0
    Fever >40°C Dose Infant Series Dose 2
    Additional description: 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]
    1 / 259 (0.39%)
    0 / 214 (0.00%)
    0 / 245 (0.00%)
    0 / 124 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 607 (0.00%)
    0 / 96 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Decreased appetite Infant Series Dose 2
    Additional description: 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]
    156 / 322 (48.45%)
    144 / 293 (49.15%)
    156 / 325 (48.00%)
    81 / 164 (49.39%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 607 (0.00%)
    0 / 96 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    156
    144
    156
    81
    0
    0
    0
    0
    0
    0
    Irritability Infant Series Dose 2
    Additional description: 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]
    326 / 377 (86.47%)
    320 / 370 (86.49%)
    318 / 376 (84.57%)
    163 / 201 (81.09%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 607 (0.00%)
    0 / 96 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    326
    320
    318
    163
    0
    0
    0
    0
    0
    0
    Increased sleep Infant Series Dose 2
    Additional description: 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]
    215 / 332 (64.76%)
    217 / 318 (68.24%)
    231 / 343 (67.35%)
    112 / 177 (63.28%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 607 (0.00%)
    0 / 96 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    215
    217
    231
    112
    0
    0
    0
    0
    0
    0
    Decreased sleep Infant Dose 2
    Additional description: 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]
    159 / 324 (49.07%)
    142 / 291 (48.80%)
    136 / 305 (44.59%)
    77 / 159 (48.43%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    159
    142
    136
    77
    0
    0
    0
    0
    0
    0
    Hives (urticaria) Infant Dose 2
    Additional description: 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]
    1 / 263 (0.38%)
    5 / 225 (2.22%)
    4 / 253 (1.58%)
    1 / 127 (0.79%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    5
    4
    1
    0
    0
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C Infant Series Dose 3
    Additional description: 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]
    70 / 266 (26.32%)
    68 / 246 (27.64%)
    80 / 252 (31.75%)
    43 / 132 (32.58%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    70
    68
    80
    43
    0
    0
    0
    0
    0
    0
    Fever >39°C but ≤40°C Infant Series Dose 3
    Additional description: 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]
    6 / 237 (2.53%)
    8 / 219 (3.65%)
    13 / 231 (5.63%)
    7 / 113 (6.19%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    6
    8
    13
    7
    0
    0
    0
    0
    0
    0
    Fever >40°C Dose Infant Series Dose 3
    Additional description: 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]
    0 / 243 (0.00%)
    1 / 216 (0.46%)
    0 / 224 (0.00%)
    1 / 111 (0.90%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Decreased appetite Infant Series Dose 3
    Additional description: 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]
    131 / 286 (45.80%)
    131 / 273 (47.99%)
    145 / 286 (50.70%)
    72 / 144 (50.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    131
    131
    145
    72
    0
    0
    0
    0
    0
    0
    Irritability Infant Series Dose 3
    Additional description: 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]
    280 / 352 (79.55%)
    273 / 339 (80.53%)
    287 / 347 (82.71%)
    157 / 186 (84.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    280
    273
    287
    157
    0
    0
    0
    0
    0
    0
    Increased sleep Infant Series Dose
    Additional description: 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]
    160 / 289 (55.36%)
    170 / 289 (58.82%)
    171 / 286 (59.79%)
    71 / 138 (51.45%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    160
    170
    171
    71
    0
    0
    0
    0
    0
    0
    Decreased sleep Infant Dose 3
    Additional description: 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]
    120 / 282 (42.55%)
    137 / 272 (50.37%)
    140 / 289 (48.44%)
    83 / 147 (56.46%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    120
    137
    140
    83
    0
    0
    0
    0
    0
    0
    Hives (urticaria) Infant Dose 3
    Additional description: 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 [23]
    4 / 239 (1.67%)
    2 / 218 (0.92%)
    4 / 229 (1.75%)
    2 / 112 (1.79%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    4
    2
    4
    2
    0
    0
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C Infant Series Dose 2
    Additional description: 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]
    97 / 290 (33.45%)
    91 / 250 (36.40%)
    103 / 290 (35.52%)
    40 / 143 (27.97%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 143 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    97
    91
    103
    40
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Milk allergy
         subjects affected / exposed
    2 / 486 (0.41%)
    2 / 483 (0.41%)
    4 / 483 (0.83%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    2
    2
    4
    0
    1
    0
    0
    1
    0
    1
    Drug hypersensitivity
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    4 / 1445 (0.28%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    0 / 208 (0.00%)
    6 / 1443 (0.42%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    1
    4
    0
    3
    0
    6
    0
    Food allergy
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    4 / 1445 (0.28%)
    1 / 244 (0.41%)
    4 / 1210 (0.33%)
    0 / 208 (0.00%)
    3 / 1443 (0.21%)
    1 / 244 (0.41%)
         occurrences all number
    0
    1
    1
    0
    4
    1
    4
    0
    3
    1
    Hypersensitivity
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    2 / 1445 (0.14%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    2
    0
    0
    0
    Anaphylactic reaction
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Social circumstances
    Overfeeding of infant
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Vulval disorder
         subjects affected / exposed
    2 / 486 (0.41%)
    2 / 483 (0.41%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    2
    2
    1
    1
    0
    1
    0
    0
    0
    Penile adhesion
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    4 / 483 (0.83%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    4
    0
    0
    0
    1
    0
    0
    0
    Balanitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Breast cyst
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Genital discomfort
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gynaecomastia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Genital labial adhesions
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Genital rash
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Penile oedema
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    59 / 486 (12.14%)
    52 / 483 (10.77%)
    51 / 483 (10.56%)
    33 / 244 (13.52%)
    0 / 1445 (0.00%)
    1 / 244 (0.41%)
    22 / 1210 (1.82%)
    8 / 208 (3.85%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    65
    58
    61
    36
    0
    1
    23
    8
    0
    0
    Nasal congestion
         subjects affected / exposed
    43 / 486 (8.85%)
    48 / 483 (9.94%)
    34 / 483 (7.04%)
    15 / 244 (6.15%)
    0 / 1445 (0.00%)
    1 / 244 (0.41%)
    5 / 1210 (0.41%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    45
    45
    36
    16
    0
    1
    6
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    21 / 486 (4.32%)
    25 / 483 (5.18%)
    18 / 483 (3.73%)
    9 / 244 (3.69%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    22 / 1210 (1.82%)
    5 / 208 (2.40%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    22
    29
    21
    10
    1
    0
    22
    5
    0
    0
    Wheezing
         subjects affected / exposed
    18 / 486 (3.70%)
    10 / 483 (2.07%)
    15 / 483 (3.11%)
    5 / 244 (2.05%)
    3 / 1445 (0.21%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences all number
    22
    10
    17
    5
    3
    0
    3
    0
    1
    0
    Bronchial hyperreactivity
         subjects affected / exposed
    11 / 486 (2.26%)
    11 / 483 (2.28%)
    8 / 483 (1.66%)
    6 / 244 (2.46%)
    6 / 1445 (0.42%)
    2 / 244 (0.82%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    2 / 1443 (0.14%)
    0 / 244 (0.00%)
         occurrences all number
    11
    13
    8
    7
    6
    2
    1
    0
    2
    0
    Sneezing
         subjects affected / exposed
    3 / 486 (0.62%)
    3 / 483 (0.62%)
    2 / 483 (0.41%)
    3 / 244 (1.23%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    3
    4
    2
    3
    0
    0
    0
    0
    0
    0
    Asthma
         subjects affected / exposed
    1 / 486 (0.21%)
    3 / 483 (0.62%)
    4 / 483 (0.83%)
    1 / 244 (0.41%)
    4 / 1445 (0.28%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    1 / 208 (0.48%)
    10 / 1443 (0.69%)
    0 / 244 (0.00%)
         occurrences all number
    1
    4
    4
    1
    4
    0
    4
    1
    10
    0
    Rhinitis allergic
         subjects affected / exposed
    4 / 486 (0.82%)
    1 / 483 (0.21%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    10 / 1445 (0.69%)
    2 / 244 (0.82%)
    4 / 1210 (0.33%)
    1 / 208 (0.48%)
    4 / 1443 (0.28%)
    1 / 244 (0.41%)
         occurrences all number
    4
    1
    2
    1
    10
    2
    4
    1
    4
    1
    Sinus congestion
         subjects affected / exposed
    1 / 486 (0.21%)
    2 / 483 (0.41%)
    3 / 483 (0.62%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    2
    3
    1
    0
    0
    2
    1
    0
    0
    Pulmonary congestion
         subjects affected / exposed
    2 / 486 (0.41%)
    2 / 483 (0.41%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    3
    2
    2
    0
    0
    0
    0
    0
    0
    0
    Bronchospasm
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    3
    1
    0
    0
    0
    0
    0
    0
    Dysphonia
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 486 (0.00%)
    3 / 483 (0.62%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Pneumonitis
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Stridor
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Tracheomalacia
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Choking
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Lower respiratory tract inflammation
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Postnasal drip
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Rhinitis seasonal
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhonchi
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    Crying
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Agitation
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Breath holding
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Initial insomnia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Restlessness
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Screaming
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tic
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Cardiac murmur
         subjects affected / exposed
    0 / 486 (0.00%)
    2 / 483 (0.41%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    6 / 1210 (0.50%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    2
    1
    1
    0
    6
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Cardiac murmur functional
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Head circumference abnormal
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Weight increased
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood lead increased
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Body height below normal
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    3 / 483 (0.62%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    2
    3
    0
    0
    0
    1
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 486 (0.00%)
    2 / 483 (0.41%)
    3 / 483 (0.62%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    3
    0
    0
    0
    0
    0
    0
    0
    Traumatic brain injury
         subjects affected / exposed
    2 / 486 (0.41%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    0
    1
    0
    0
    Arthropod bite
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    2 / 208 (0.96%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    3
    2
    0
    0
    Excoriation
         subjects affected / exposed
    0 / 486 (0.00%)
    2 / 483 (0.41%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    Head injury
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    3
    0
    0
    0
    Accident
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Chemical burns of eye
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Concussion
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Corneal abrasion
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Lower limb fracture
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Skin laceration
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Thermal burn
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Animal bite
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Arthropod sting
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Burns second degree
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Joint sprain
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Mouth injury
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Torus fracture
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Vaccination complication
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Congenital, familial and genetic disorders
    Plagiocephaly
         subjects affected / exposed
    9 / 486 (1.85%)
    6 / 483 (1.24%)
    11 / 483 (2.28%)
    5 / 244 (2.05%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    9
    6
    11
    5
    0
    0
    0
    0
    0
    0
    Dacryostenosis congenital
         subjects affected / exposed
    2 / 486 (0.41%)
    3 / 483 (0.62%)
    1 / 483 (0.21%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    3
    1
    1
    0
    0
    0
    0
    0
    0
    Hydrocele
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    Macrocephaly
         subjects affected / exposed
    2 / 486 (0.41%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Pectus excavatum
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ankyloglossia congenital
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Atrial septal defect
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Brachycephaly
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hemihypertrophy
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hip dysplasia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Hypospadias
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Laryngomalacia
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Naevus flammeus
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Phimosis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Pulmonary valve stenosis congenital
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Skull malformation
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Ventricular septal defect
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Von Willebrand's disease
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Congenital naevus
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Tibial torsion
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Cardiac disorders
    Cyanosis
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Hypersomnia
         subjects affected / exposed
    1 / 486 (0.21%)
    2 / 483 (0.41%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    0
    0
    0
    0
    Hypertonia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Convulsion
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Head titubation
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hyporeflexia
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypotonia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Subdural effusion
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Febrile convulsion
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    2 / 1445 (0.14%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    Cerebral cyst
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Speech disorder developmental
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Gross motor delay
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 486 (0.41%)
    1 / 483 (0.21%)
    4 / 483 (0.83%)
    0 / 244 (0.00%)
    2 / 1445 (0.14%)
    0 / 244 (0.00%)
    4 / 1210 (0.33%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    1
    4
    0
    2
    0
    4
    1
    0
    0
    Leukocytosis
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    1
    0
    2
    0
    0
    0
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    2 / 486 (0.41%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    1
    0
    1
    0
    Lymphadenitis
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Thrombocythaemia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    6 / 486 (1.23%)
    7 / 483 (1.45%)
    6 / 483 (1.24%)
    8 / 244 (3.28%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    4 / 1210 (0.33%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    6
    7
    6
    9
    0
    0
    4
    1
    0
    2
    Middle ear effusion
         subjects affected / exposed
    1 / 486 (0.21%)
    2 / 483 (0.41%)
    4 / 483 (0.83%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    2
    4
    0
    0
    0
    3
    0
    0
    0
    Cerumen impaction
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    0
    2
    2
    0
    0
    0
    1
    0
    0
    Otorrhoea
         subjects affected / exposed
    0 / 486 (0.00%)
    2 / 483 (0.41%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    3
    0
    0
    0
    Deafness neurosensory
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    External ear inflammation
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Tympanic membrane disorder
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Deafness
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    35 / 486 (7.20%)
    37 / 483 (7.66%)
    44 / 483 (9.11%)
    26 / 244 (10.66%)
    0 / 1445 (0.00%)
    1 / 244 (0.41%)
    17 / 1210 (1.40%)
    3 / 208 (1.44%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    38
    39
    46
    28
    0
    1
    17
    3
    0
    0
    Dacryostenosis acquired
         subjects affected / exposed
    3 / 486 (0.62%)
    3 / 483 (0.62%)
    2 / 483 (0.41%)
    4 / 244 (1.64%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    3
    3
    2
    4
    1
    0
    1
    0
    0
    0
    Eye discharge
         subjects affected / exposed
    4 / 486 (0.82%)
    5 / 483 (1.04%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    4
    5
    2
    1
    0
    0
    1
    0
    0
    0
    Strabismus
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    2 / 244 (0.82%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    2
    1
    0
    0
    0
    0
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 486 (0.00%)
    2 / 483 (0.41%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    2
    0
    0
    0
    Blepharitis
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Eye swelling
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    Eyelid oedema
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Eyelid ptosis
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Dark circles under eyes
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Eye irritation
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Heterophoria
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Hypermetropia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Pupillary reflex impaired
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pupils unequal
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Scleral disorder
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    44 / 486 (9.05%)
    34 / 483 (7.04%)
    56 / 483 (11.59%)
    32 / 244 (13.11%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    37 / 1210 (3.06%)
    8 / 208 (3.85%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    54
    39
    61
    36
    1
    0
    37
    8
    0
    0
    Vomiting
         subjects affected / exposed
    26 / 486 (5.35%)
    23 / 483 (4.76%)
    30 / 483 (6.21%)
    25 / 244 (10.25%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    17 / 1210 (1.40%)
    4 / 208 (1.92%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    29
    25
    37
    30
    0
    0
    17
    4
    0
    0
    Constipation
         subjects affected / exposed
    15 / 486 (3.09%)
    31 / 483 (6.42%)
    17 / 483 (3.52%)
    17 / 244 (6.97%)
    1 / 1445 (0.07%)
    1 / 244 (0.41%)
    3 / 1210 (0.25%)
    3 / 208 (1.44%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    16
    34
    18
    18
    1
    1
    3
    3
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    28 / 486 (5.76%)
    20 / 483 (4.14%)
    18 / 483 (3.73%)
    10 / 244 (4.10%)
    2 / 1445 (0.14%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    29
    22
    20
    10
    2
    0
    3
    0
    0
    1
    Teething
         subjects affected / exposed
    5 / 486 (1.03%)
    11 / 483 (2.28%)
    9 / 483 (1.86%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    7 / 1210 (0.58%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    5
    11
    9
    2
    0
    0
    7
    1
    0
    0
    Infantile spitting up
         subjects affected / exposed
    3 / 486 (0.62%)
    5 / 483 (1.04%)
    5 / 483 (1.04%)
    4 / 244 (1.64%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    3
    5
    6
    4
    0
    0
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    2 / 486 (0.41%)
    6 / 483 (1.24%)
    3 / 483 (0.62%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    7
    3
    2
    0
    0
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    4 / 486 (0.82%)
    2 / 483 (0.41%)
    2 / 483 (0.41%)
    3 / 244 (1.23%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    4
    2
    3
    3
    0
    0
    0
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    3 / 486 (0.62%)
    0 / 483 (0.00%)
    5 / 483 (1.04%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    3
    0
    5
    2
    0
    0
    1
    0
    0
    0
    Stomach discomfort
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    3 / 483 (0.62%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    3
    0
    0
    0
    0
    0
    0
    0
    Umbilical hernia
         subjects affected / exposed
    0 / 486 (0.00%)
    2 / 483 (0.41%)
    1 / 483 (0.21%)
    1 / 244 (0.41%)
    2 / 1445 (0.14%)
    1 / 244 (0.41%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    1
    1
    2
    1
    0
    0
    0
    0
    Abnormal faeces
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    2
    0
    0
    0
    Anal fissure
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Colitis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Dysphagia
         subjects affected / exposed
    0 / 486 (0.00%)
    2 / 483 (0.41%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Infantile colic
         subjects affected / exposed
    0 / 486 (0.00%)
    2 / 483 (0.41%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal hernia
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Allergic colitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Dyschezia
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Enteritis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Gastritis
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Gingival cyst
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gingival ulceration
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Melaena
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Mouth cyst
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Oral disorder
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Regurgitation
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Retching
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Tongue discolouration
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Tongue geographic
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vomiting projectile
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Anal skin tags
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Aphthous stomatitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    45 / 486 (9.26%)
    28 / 483 (5.80%)
    42 / 483 (8.70%)
    21 / 244 (8.61%)
    12 / 1445 (0.83%)
    1 / 244 (0.41%)
    17 / 1210 (1.40%)
    0 / 208 (0.00%)
    6 / 1443 (0.42%)
    4 / 244 (1.64%)
         occurrences all number
    47
    31
    44
    22
    12
    1
    17
    0
    6
    4
    Dermatitis diaper
         subjects affected / exposed
    34 / 486 (7.00%)
    13 / 483 (2.69%)
    30 / 483 (6.21%)
    13 / 244 (5.33%)
    0 / 1445 (0.00%)
    1 / 244 (0.41%)
    31 / 1210 (2.56%)
    5 / 208 (2.40%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    34
    13
    34
    14
    0
    1
    31
    5
    0
    0
    Rash
         subjects affected / exposed
    22 / 486 (4.53%)
    20 / 483 (4.14%)
    18 / 483 (3.73%)
    13 / 244 (5.33%)
    3 / 1445 (0.21%)
    0 / 244 (0.00%)
    27 / 1210 (2.23%)
    2 / 208 (0.96%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    23
    21
    19
    13
    3
    0
    27
    2
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    12 / 486 (2.47%)
    12 / 483 (2.48%)
    11 / 483 (2.28%)
    12 / 244 (4.92%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    12
    13
    11
    13
    0
    0
    1
    0
    0
    1
    Dermatitis atopic
         subjects affected / exposed
    9 / 486 (1.85%)
    12 / 483 (2.48%)
    15 / 483 (3.11%)
    9 / 244 (3.69%)
    4 / 1445 (0.28%)
    0 / 244 (0.00%)
    4 / 1210 (0.33%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    9
    15
    17
    10
    4
    0
    4
    1
    0
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 486 (0.21%)
    11 / 483 (2.28%)
    8 / 483 (1.66%)
    3 / 244 (1.23%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    11
    8
    3
    0
    0
    0
    1
    0
    0
    Dermatitis
         subjects affected / exposed
    5 / 486 (1.03%)
    4 / 483 (0.83%)
    9 / 483 (1.86%)
    4 / 244 (1.64%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    5
    4
    9
    4
    1
    0
    1
    1
    0
    0
    Seborrhoea
         subjects affected / exposed
    1 / 486 (0.21%)
    7 / 483 (1.45%)
    7 / 483 (1.45%)
    3 / 244 (1.23%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    7
    7
    3
    0
    0
    0
    0
    0
    0
    Heat rash
         subjects affected / exposed
    4 / 486 (0.82%)
    3 / 483 (0.62%)
    8 / 483 (1.66%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    4
    3
    8
    2
    0
    0
    2
    0
    0
    0
    Dry skin
         subjects affected / exposed
    2 / 486 (0.41%)
    3 / 483 (0.62%)
    8 / 483 (1.66%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    4
    8
    2
    0
    0
    0
    1
    0
    0
    Rash papular
         subjects affected / exposed
    4 / 486 (0.82%)
    3 / 483 (0.62%)
    5 / 483 (1.04%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    4
    3
    5
    1
    0
    0
    0
    1
    0
    0
    Dandruff
         subjects affected / exposed
    2 / 486 (0.41%)
    2 / 483 (0.41%)
    6 / 483 (1.24%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    2
    6
    2
    0
    0
    1
    0
    0
    0
    Urticaria
         subjects affected / exposed
    5 / 486 (1.03%)
    4 / 483 (0.83%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    6 / 1210 (0.50%)
    2 / 208 (0.96%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    5
    4
    2
    1
    0
    0
    6
    2
    0
    0
    Rash erythematous
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    4 / 483 (0.83%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    4
    1
    0
    0
    1
    0
    0
    0
    Rash macular
         subjects affected / exposed
    2 / 486 (0.41%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Acne infantile
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Drug eruption
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    Intertrigo
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Skin lesion
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Acanthosis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Acne
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Ingrowing nail
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    Petechiae
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Post inflammatory pigmentation change
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    Skin disorder
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Skin irritation
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Cafe au lait spots
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    Dermographism
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Eczema infantile
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Livedo reticularis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nail discolouration
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pityriasis alba
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Psoriasis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Purpura
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Rash neonatal
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Rash vesicular
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Skin fissures
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Skin nodule
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Subcutaneous nodule
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urticaria papular
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Keratosis pilaris
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    2 / 1445 (0.14%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Vitiligo
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Acrodermatitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Blister
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Dermal cyst
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pityriasis rosea
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Tenderness (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: 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 [25]
    262 / 420 (62.38%)
    262 / 409 (64.06%)
    250 / 400 (62.50%)
    142 / 212 (66.98%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    473 / 826 (57.26%)
    83 / 131 (63.36%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    262
    262
    250
    142
    0
    0
    473
    83
    0
    0
    Tenderness (Significant) Infant Series Dose 1 and Toddler Dose
    Additional description: 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 [26]
    32 / 348 (9.20%)
    35 / 337 (10.39%)
    36 / 345 (10.43%)
    22 / 170 (12.94%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    42 / 630 (6.67%)
    4 / 97 (4.12%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    32
    35
    36
    22
    0
    0
    42
    4
    0
    0
    Induration (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: 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 [27]
    59 / 356 (16.57%)
    68 / 347 (19.60%)
    68 / 352 (19.32%)
    32 / 176 (18.18%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    220 / 698 (31.52%)
    48 / 110 (43.64%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    59
    68
    68
    32
    0
    0
    220
    48
    0
    0
    Induration (Mild) Infant Series Dose 1 and Toddler Dose
    Additional description: 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 [28]
    52 / 353 (14.73%)
    58 / 344 (16.86%)
    54 / 348 (15.52%)
    28 / 173 (16.18%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    199 / 689 (28.88%)
    44 / 107 (41.12%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    52
    58
    54
    28
    0
    0
    199
    44
    0
    0
    Induration (Moderate) Infant Series Dose 1 and Toddler Dose
    Additional description: 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 [29]
    12 / 338 (3.55%)
    19 / 328 (5.79%)
    17 / 340 (5.00%)
    6 / 167 (3.59%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    53 / 627 (8.45%)
    18 / 101 (17.82%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    12
    19
    17
    6
    0
    0
    53
    18
    0
    0
    Erythema (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: 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 [30]
    69 / 355 (19.44%)
    88 / 352 (25.00%)
    83 / 360 (23.06%)
    41 / 180 (22.78%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    319 / 749 (42.59%)
    64 / 121 (52.89%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    69
    88
    83
    41
    0
    0
    319
    64
    0
    0
    Erythema (Mild) Infant Series Dose 1 and Toddler Dose
    Additional description: 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: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    64 / 354 (18.08%)
    87 / 352 (24.72%)
    76 / 358 (21.23%)
    39 / 180 (21.67%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    288 / 735 (39.18%)
    58 / 116 (50.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    64
    87
    76
    39
    0
    0
    288
    58
    0
    0
    Erythema (Moderate) Infant Series Dose 1 and Toddler Dose
    Additional description: 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 [32]
    7 / 334 (2.10%)
    2 / 326 (0.61%)
    8 / 337 (2.37%)
    2 / 164 (1.22%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    67 / 631 (10.62%)
    22 / 104 (21.15%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    7
    2
    8
    2
    0
    0
    67
    22
    0
    0
    Tenderness (Any) Infant Series Dose 2
    Additional description: 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: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    235 / 354 (66.38%)
    222 / 330 (67.27%)
    219 / 337 (64.99%)
    114 / 176 (64.77%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    235
    222
    219
    114
    0
    0
    0
    0
    0
    0
    Tenderness (Significant) Infant Series Dose 2
    Additional description: 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 [34]
    26 / 269 (9.67%)
    17 / 231 (7.36%)
    32 / 262 (12.21%)
    15 / 132 (11.36%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    26
    17
    32
    15
    0
    0
    0
    0
    0
    0
    Induration (Any) Infant Series Dose 2
    Additional description: 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 [35]
    71 / 291 (24.40%)
    56 / 248 (22.58%)
    80 / 279 (28.67%)
    25 / 141 (17.73%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    71
    56
    80
    25
    0
    0
    0
    0
    0
    0
    Induration (Mild) Infant Series Dose 2
    Additional description: 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 [36]
    65 / 288 (22.57%)
    54 / 246 (21.95%)
    74 / 276 (26.81%)
    25 / 141 (17.73%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    65
    54
    74
    25
    0
    0
    0
    0
    0
    0
    Induration (Moderate) Infant Series Dose 2
    Additional description: 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 [37]
    11 / 270 (4.07%)
    3 / 224 (1.34%)
    12 / 255 (4.71%)
    5 / 128 (3.91%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    11
    3
    12
    5
    0
    0
    0
    0
    0
    0
    Erythema (Any) Infant Series Dose 2
    Additional description: 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 [38]
    88 / 292 (30.14%)
    95 / 265 (35.85%)
    97 / 281 (34.52%)
    46 / 153 (30.07%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    88
    95
    97
    46
    0
    0
    0
    0
    0
    0
    Erythema (Mild) Infant Series Dose 2
    Additional description: 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 [39]
    82 / 289 (28.37%)
    91 / 263 (34.60%)
    93 / 279 (33.33%)
    44 / 153 (28.76%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    82
    91
    93
    44
    0
    0
    0
    0
    0
    0
    Erythema (Moderate) Infant Series Dose 2
    Additional description: 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 [40]
    9 / 268 (3.36%)
    4 / 223 (1.79%)
    8 / 252 (3.17%)
    4 / 128 (3.13%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    9
    4
    8
    4
    0
    0
    0
    0
    0
    0
    Tenderness (Any) Infant Series Dose 3
    Additional description: 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 [41]
    198 / 317 (62.46%)
    185 / 304 (60.86%)
    165 / 300 (55.00%)
    101 / 156 (64.74%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    198
    185
    165
    101
    0
    0
    0
    0
    0
    0
    Tenderness (Significant) Infant Series Dose 3
    Additional description: 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 [42]
    22 / 248 (8.87%)
    17 / 226 (7.52%)
    24 / 237 (10.13%)
    14 / 118 (11.86%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    22
    17
    24
    14
    0
    0
    0
    0
    0
    0
    Induration (Any) Infant Series Dose 3
    Additional description: 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 [43]
    71 / 263 (27.00%)
    59 / 250 (23.60%)
    75 / 262 (28.63%)
    39 / 128 (30.47%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    71
    59
    75
    39
    0
    0
    0
    0
    0
    0
    Induration (Mild) Infant Series Dose 3
    Additional description: 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 [44]
    64 / 260 (24.62%)
    56 / 249 (22.49%)
    71 / 260 (27.31%)
    37 / 127 (29.13%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    64
    56
    71
    37
    0
    0
    0
    0
    0
    0
    Induration (Moderate) Infant Series Dose 3
    Additional description: 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 [45]
    10 / 242 (4.13%)
    9 / 221 (4.07%)
    9 / 229 (3.93%)
    8 / 114 (7.02%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    10
    9
    9
    8
    0
    0
    0
    0
    0
    0
    Erythema (Any) Infant Series Dose 3
    Additional description: 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 [46]
    110 / 278 (39.57%)
    94 / 262 (35.88%)
    103 / 274 (37.59%)
    54 / 137 (39.42%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    110
    94
    103
    54
    0
    0
    0
    0
    0
    0
    Erythema (Mild) Infant Series Dose 3
    Additional description: 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]
    102 / 275 (37.09%)
    88 / 260 (33.85%)
    99 / 272 (36.40%)
    52 / 135 (38.52%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    102
    88
    99
    52
    0
    0
    0
    0
    0
    0
    Erythema (Moderate) Infant Series Dose 3
    Additional description: 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]
    13 / 243 (5.35%)
    9 / 219 (4.11%)
    13 / 231 (5.63%)
    9 / 116 (7.76%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    13
    9
    13
    9
    0
    0
    0
    0
    0
    0
    Induration (Severe) Infant Series Dose 2
    Additional description: 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 Reaction 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [49]
    0 / 283 (0.00%)
    0 / 221 (0.00%)
    1 / 250 (0.40%)
    0 / 127 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Urine odour abnormal
         subjects affected / exposed
    0 / 486 (0.00%)
    3 / 483 (0.62%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    Dysuria
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Hydronephrosis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Vesicoureteric reflux
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    3 / 1445 (0.21%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    2
    0
    0
    0
    Renal tubular acidosis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Endocrine disorders
    Precocious puberty
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Torticollis
         subjects affected / exposed
    4 / 486 (0.82%)
    2 / 483 (0.41%)
    4 / 483 (0.83%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    4
    2
    4
    0
    2
    0
    0
    0
    0
    0
    Head deformity
         subjects affected / exposed
    2 / 486 (0.41%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Foot deformity
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    Muscle twitching
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Knee deformity
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    194 / 486 (39.92%)
    187 / 483 (38.72%)
    204 / 483 (42.24%)
    97 / 244 (39.75%)
    2 / 1445 (0.14%)
    0 / 244 (0.00%)
    62 / 1210 (5.12%)
    11 / 208 (5.29%)
    0 / 1443 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    254
    254
    268
    135
    2
    0
    62
    11
    0
    1
    Otitis media
         subjects affected / exposed
    142 / 486 (29.22%)
    125 / 483 (25.88%)
    135 / 483 (27.95%)
    85 / 244 (34.84%)
    4 / 1445 (0.28%)
    0 / 244 (0.00%)
    70 / 1210 (5.79%)
    20 / 208 (9.62%)
    1 / 1443 (0.07%)
    1 / 244 (0.41%)
         occurrences all number
    205
    164
    195
    131
    4
    0
    72
    20
    1
    1
    Bronchiolitis
         subjects affected / exposed
    72 / 486 (14.81%)
    75 / 483 (15.53%)
    66 / 483 (13.66%)
    44 / 244 (18.03%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    84
    83
    75
    49
    1
    0
    2
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    31 / 486 (6.38%)
    29 / 483 (6.00%)
    28 / 483 (5.80%)
    17 / 244 (6.97%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    12 / 1210 (0.99%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    35
    31
    29
    19
    0
    0
    12
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    21 / 486 (4.32%)
    32 / 483 (6.63%)
    19 / 483 (3.93%)
    15 / 244 (6.15%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    16 / 1210 (1.32%)
    3 / 208 (1.44%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    22
    32
    20
    15
    1
    0
    16
    3
    0
    0
    Viral infection
         subjects affected / exposed
    19 / 486 (3.91%)
    18 / 483 (3.73%)
    24 / 483 (4.97%)
    11 / 244 (4.51%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    20 / 1210 (1.65%)
    6 / 208 (2.88%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    20
    19
    27
    13
    0
    0
    20
    6
    0
    0
    Croup infectious
         subjects affected / exposed
    16 / 486 (3.29%)
    19 / 483 (3.93%)
    18 / 483 (3.73%)
    8 / 244 (3.28%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    10 / 1210 (0.83%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    17
    20
    20
    8
    0
    0
    10
    0
    0
    0
    Candidiasis
         subjects affected / exposed
    21 / 486 (4.32%)
    14 / 483 (2.90%)
    10 / 483 (2.07%)
    7 / 244 (2.87%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    2 / 208 (0.96%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    21
    16
    12
    7
    0
    0
    2
    2
    0
    0
    Sinusitis
         subjects affected / exposed
    16 / 486 (3.29%)
    15 / 483 (3.11%)
    11 / 483 (2.28%)
    10 / 244 (4.10%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    12 / 1210 (0.99%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    16
    18
    12
    12
    0
    0
    12
    0
    0
    0
    Otitis media acute
         subjects affected / exposed
    14 / 486 (2.88%)
    14 / 483 (2.90%)
    15 / 483 (3.11%)
    6 / 244 (2.46%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    8 / 1210 (0.66%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    16
    19
    19
    11
    0
    0
    8
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    11 / 486 (2.26%)
    16 / 483 (3.31%)
    13 / 483 (2.69%)
    6 / 244 (2.46%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    11 / 1210 (0.91%)
    2 / 208 (0.96%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    11
    18
    13
    6
    1
    0
    11
    2
    0
    0
    Pharyngitis
         subjects affected / exposed
    11 / 486 (2.26%)
    10 / 483 (2.07%)
    12 / 483 (2.48%)
    7 / 244 (2.87%)
    0 / 1445 (0.00%)
    1 / 244 (0.41%)
    11 / 1210 (0.91%)
    4 / 208 (1.92%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    14
    10
    12
    7
    0
    1
    11
    4
    0
    0
    Influenza
         subjects affected / exposed
    9 / 486 (1.85%)
    12 / 483 (2.48%)
    4 / 483 (0.83%)
    8 / 244 (3.28%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    9
    12
    4
    8
    0
    0
    1
    0
    0
    0
    Intertrigo candida
         subjects affected / exposed
    1 / 486 (0.21%)
    2 / 483 (0.41%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    1
    0
    0
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    7 / 486 (1.44%)
    7 / 483 (1.45%)
    10 / 483 (2.07%)
    7 / 244 (2.87%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    7
    7
    10
    7
    0
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    11 / 486 (2.26%)
    11 / 483 (2.28%)
    7 / 483 (1.45%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    12
    12
    7
    2
    0
    0
    3
    0
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    10 / 486 (2.06%)
    5 / 483 (1.04%)
    9 / 483 (1.86%)
    5 / 244 (2.05%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    10
    5
    10
    5
    0
    0
    2
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    8 / 486 (1.65%)
    6 / 483 (1.24%)
    12 / 483 (2.48%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    8
    6
    12
    2
    0
    0
    3
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    6 / 486 (1.23%)
    5 / 483 (1.04%)
    10 / 483 (2.07%)
    3 / 244 (1.23%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    6
    5
    10
    3
    1
    0
    2
    0
    0
    0
    Candida nappy rash
         subjects affected / exposed
    7 / 486 (1.44%)
    5 / 483 (1.04%)
    9 / 483 (1.86%)
    3 / 244 (1.23%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    7
    5
    9
    3
    0
    0
    2
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    9 / 486 (1.85%)
    5 / 483 (1.04%)
    6 / 483 (1.24%)
    4 / 244 (1.64%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    9
    5
    6
    4
    0
    0
    1
    0
    0
    0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    8 / 486 (1.65%)
    6 / 483 (1.24%)
    6 / 483 (1.24%)
    4 / 244 (1.64%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    8
    6
    6
    4
    0
    0
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    5 / 486 (1.03%)
    5 / 483 (1.04%)
    7 / 483 (1.45%)
    4 / 244 (1.64%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    5 / 1210 (0.41%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    7
    5
    9
    5
    0
    0
    5
    0
    0
    0
    Viral skin infection
         subjects affected / exposed
    3 / 486 (0.62%)
    7 / 483 (1.45%)
    3 / 483 (0.62%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    3
    7
    3
    1
    0
    0
    0
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    6 / 486 (1.23%)
    6 / 483 (1.24%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    6
    6
    0
    0
    0
    0
    3
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 486 (0.41%)
    3 / 483 (0.62%)
    4 / 483 (0.83%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    3
    4
    2
    0
    0
    1
    0
    0
    0
    Impetigo
         subjects affected / exposed
    2 / 486 (0.41%)
    2 / 483 (0.41%)
    2 / 483 (0.41%)
    3 / 244 (1.23%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    2
    2
    3
    0
    0
    3
    0
    0
    0
    Skin candida
         subjects affected / exposed
    1 / 486 (0.21%)
    4 / 483 (0.83%)
    3 / 483 (0.62%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    4
    3
    1
    0
    0
    2
    1
    0
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    3 / 483 (0.62%)
    3 / 244 (1.23%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    1
    3
    3
    0
    0
    0
    0
    0
    0
    Herpangina
         subjects affected / exposed
    2 / 486 (0.41%)
    2 / 483 (0.41%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    5 / 1210 (0.41%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    2
    2
    1
    0
    0
    5
    0
    0
    0
    Roseola
         subjects affected / exposed
    0 / 486 (0.00%)
    4 / 483 (0.83%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    4 / 1210 (0.33%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    4
    2
    1
    0
    0
    4
    0
    0
    0
    Acute sinusitis
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    3 / 244 (1.23%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    0
    1
    3
    0
    0
    1
    0
    0
    0
    Otitis externa
         subjects affected / exposed
    5 / 486 (1.03%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    5
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    3 / 244 (1.23%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    0
    0
    3
    0
    0
    2
    0
    0
    0
    Dacryocystitis
         subjects affected / exposed
    0 / 486 (0.00%)
    3 / 483 (0.62%)
    1 / 483 (0.21%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    3
    1
    1
    0
    0
    0
    0
    0
    0
    Conjunctivitis infective
         subjects affected / exposed
    2 / 486 (0.41%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    0
    1
    0
    0
    Eye infection
         subjects affected / exposed
    0 / 486 (0.00%)
    2 / 483 (0.41%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    0
    0
    0
    0
    0
    Viral pharyngitis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    2
    1
    0
    0
    1
    0
    0
    0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 486 (0.21%)
    2 / 483 (0.41%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Paronychia
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    1
    0
    0
    0
    Pneumonia viral
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    Varicella
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    2
    0
    1
    0
    2
    0
    0
    0
    Acarodermatitis
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    1 / 486 (0.21%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Body tinea
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    Dermatophytosis
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Enteritis infectious
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    2
    0
    0
    0
    Fungal infection
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Gastritis viral
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Hordeolum
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    3
    1
    0
    0
    Rash pustular
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    3 / 1210 (0.25%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    3
    0
    0
    0
    Tinea capitis
         subjects affected / exposed
    2 / 486 (0.41%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tinea infection
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Abscess oral
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Breast cellulitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Cellulitis of male external genital organ
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Cellulitis staphylococcal
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eczema herpeticum
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Eczema infected
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Erysipelas
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Erythema infectiosum
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Furuncle
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Genital candidiasis
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Parotitis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Perirectal abscess
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Rotavirus infection
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Scarlet fever
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Viraemia
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Viral diarrhoea
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Wound infection
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Otitis media chronic
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    3 / 1445 (0.21%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    2 / 1443 (0.14%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    1
    0
    2
    0
    Coxsackie viral infection
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    1
    0
    0
    Chronic sinusitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    1 / 244 (0.41%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Viral rash
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    11 / 1210 (0.91%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    11
    1
    0
    0
    Dermatitis infected
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Acute tonsillitis
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Adenovirus infection
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Exanthema subitum
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Lyme disease
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 486 (0.00%)
    2 / 483 (0.41%)
    5 / 483 (1.04%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    2
    5
    1
    0
    0
    1
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    4 / 486 (0.82%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    2 / 244 (0.82%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    4
    0
    2
    2
    0
    0
    0
    0
    0
    0
    Weight gain poor
         subjects affected / exposed
    3 / 486 (0.62%)
    0 / 483 (0.00%)
    2 / 483 (0.41%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    1 / 1210 (0.08%)
    1 / 208 (0.48%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    3
    0
    2
    0
    0
    0
    1
    1
    0
    0
    Food intolerance
         subjects affected / exposed
    3 / 486 (0.62%)
    1 / 483 (0.21%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    3
    1
    1
    0
    1
    0
    0
    0
    0
    0
    Feeding disorder neonatal
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Cow's milk intolerance
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Increased appetite
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Lactose intolerance
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    1 / 244 (0.41%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 486 (0.00%)
    1 / 483 (0.21%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Oral intake reduced
         subjects affected / exposed
    1 / 486 (0.21%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Overweight
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    1 / 483 (0.21%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Failure to thrive
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    1 / 1445 (0.07%)
    0 / 244 (0.00%)
    0 / 1210 (0.00%)
    0 / 208 (0.00%)
    1 / 1443 (0.07%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Underweight
         subjects affected / exposed
    0 / 486 (0.00%)
    0 / 483 (0.00%)
    0 / 483 (0.00%)
    0 / 244 (0.00%)
    0 / 1445 (0.00%)
    0 / 244 (0.00%)
    2 / 1210 (0.17%)
    0 / 208 (0.00%)
    0 / 1443 (0.00%)
    0 / 244 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    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.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Aug 2007
    Clarified that parent(s)/legal guardian(s) should contact the investigator by telephone if they suspected their child had hives, to determine whether the rash was likely to be urticaria.
    11 Mar 2008
    1. Interim safety analysis was to be performed following the infant phase of the study. 2. Toddler dose of Hib vaccine was removed from the study vaccinations given at the 12-month visit (visit 5)

    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
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