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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

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    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

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    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
         Death
    -
    1
    1
    1
         Parent or legal guardian request
    18
    29
    34
    14
         Failed to return
    5
    4
    4
    2
         Unknown
    -
    1
    -
    -
         Protocol Violation
    16
    8
    6
    3
         Investigator request
    4
    3
    3
    2
         Unspecified
    -
    2
    4
    -
         Adverse Event
    1
    2
    2
    -
         Lost to follow-up
    10
    11
    7
    6
    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
         Failed to return
    7
    6
    5
    1
         Parent or legal guardian request
    4
    11
    6
    3
         Unknown
    -
    1
    1
    1
         Investigator request
    -
    -
    -
    1
         Protocol Violation
    2
    4
    2
    2
         Unspecified
    -
    1
    -
    -
         Adverse Event
    2
    2
    -
    -
         Lost to Follow-up
    -
    -
    -
    2
         Lost to follow-up
    5
    5
    5
    -
    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)