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    Clinical Trial Results:
    A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine

    Summary
    EudraCT number
    2006-006204-11
    Trial protocol
    PL  
    Global end of trial date
    18 Sep 2008

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

    Trial information

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    Trial identification
    Sponsor protocol code
    6096A1-3000
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00464945
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer, Inc., Pfizer ClinicalTrials.gov Call Center, 1 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer, Inc., Pfizer ClinicalTrials.gov Call Center, 1 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000036-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jan 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Sep 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: To assess the pneumococcal immune responses induced by manufacturing scale 13-valent pneumococcal conjugate vaccine (13vPnC) relative to the immune responses induced by pilot scale 13vPnC when measured 1month after the infant series. To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Jun 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
    Poland: 269
    Worldwide total number of subjects
    269
    EEA total number of subjects
    269
    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)
    269
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited in Poland from June 2007 to August 2007.

    Pre-assignment
    Screening details
    Subjects were enrolled into the study according to inclusion/exclusion criteria without a screening period.

    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 Manufacturing Infant Series
    Arm description
    Subjects received manufacturing scale dose of 13vPnC coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Subjects received manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
    Arm type
    Experimental

    Investigational medicinal product name
    13vPnC Manufacturing Scale
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5mL manufacturing scale dose of 13vPnC administered at 2, 3, 4 months (infant series).

    Investigational medicinal product name
    DTaP-IPV-Hib
    Investigational medicinal product code
    Other name
    Pentaxim
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    DTaP-IPV-Hib administered at 2, 3, 4 months (infant series).

    Investigational medicinal product name
    HBV
    Investigational medicinal product code
    Other name
    Engerix-B
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HBV administered at month 2 (infant series).

    Arm title
    13vPnC Pilot Infant Series
    Arm description
    Subjects received pilot scale dose of 13vPnC coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Subjects received pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
    Arm type
    Active comparator

    Investigational medicinal product name
    13vPnC Pilot Scale
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5mL pilot scale dose of 13vPnC administered at 2, 3, 4 months (infant series).

    Investigational medicinal product name
    DTaP-IPV-Hib
    Investigational medicinal product code
    Other name
    Pentaxim
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    DTaP-IPV-Hib administered at 2, 3, 4 months (infant series).

    Investigational medicinal product name
    HBV
    Investigational medicinal product code
    Other name
    Engerix-B
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    HBV administered at month 2 (infant series).

    Number of subjects in period 1
    13vPnC Manufacturing Infant Series 13vPnC Pilot Infant Series
    Started
    135
    134
    Vaccinated Dose 1
    134
    134
    Vaccinated Dose 3
    132
    133
    Vaccinated Dose 2
    132
    133
    Completed
    131
    133
    Not completed
    4
    1
         Protocol Violation
    1
    -
         Withdrawal by parent/guardian request
    2
    1
         Lost to follow-up
    1
    -
    Period 2
    Period 2 title
    After Infant Series
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    13vPnC Manufacturing After Infant Series
    Arm description
    Included subjects who received manufacturing scale dose of 13vPnC coadministered with combined DTaP-IPV-Hib and HBV at 2 months (infant series, dose 1) and manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    13vPnC Pilot After Infant Series
    Arm description
    Included subjects who received pilot scale dose of 13vPnC coadministered with combined DTaP-IPV-Hib and HBV at 2 months (infant series, dose 1) and pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    13vPnC Manufacturing After Infant Series 13vPnC Pilot After Infant Series
    Started
    131
    133
    Completed
    131
    131
    Not completed
    0
    2
         Consent withdrawn by subject
    -
    2
    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 Manufacturing Toddler Dose
    Arm description
    Subjects received manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) at 12 months of age (toddler dose).
    Arm type
    Experimental

    Investigational medicinal product name
    13vPnC Manufacturing Scale
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5mL manufacturing scale dose administered at 12 months of age (toddler dose).

    Investigational medicinal product name
    MMR
    Investigational medicinal product code
    Other name
    Priorix
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MMR administered at 12 months of age (toddler dose).

    Arm title
    13vPnC Pilot Toddler Dose
    Arm description
    Subjects received pilot scale dose of 13vPnC coadministered with MMR at 12 months of age (toddler dose).
    Arm type
    Active comparator

    Investigational medicinal product name
    MMR
    Investigational medicinal product code
    Other name
    Priorix
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    MMR administered at 12 months of age (toddler dose).

    Investigational medicinal product name
    13vPnC Pilot Scale
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5mL pilot scale dose of 13vPnC administered at 12 months of age (toddler dose).

    Number of subjects in period 3
    13vPnC Manufacturing Toddler Dose 13vPnC Pilot Toddler Dose
    Started
    131
    131
    Completed
    131
    130
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC Manufacturing Infant Series
    Reporting group description
    Subjects received manufacturing scale dose of 13vPnC coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Subjects received manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).

    Reporting group title
    13vPnC Pilot Infant Series
    Reporting group description
    Subjects received pilot scale dose of 13vPnC coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Subjects received pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).

    Reporting group values
    13vPnC Manufacturing Infant Series 13vPnC Pilot Infant Series Total
    Number of subjects
    135 134 269
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    2.1 ± 0.6 2.1 ± 0.5 -
    Gender categorical
    Units: Subjects
        Female
    65 67 132
        Male
    70 67 137

    End points

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    End points reporting groups
    Reporting group title
    13vPnC Manufacturing Infant Series
    Reporting group description
    Subjects received manufacturing scale dose of 13vPnC coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Subjects received manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).

    Reporting group title
    13vPnC Pilot Infant Series
    Reporting group description
    Subjects received pilot scale dose of 13vPnC coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Subjects received pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
    Reporting group title
    13vPnC Manufacturing After Infant Series
    Reporting group description
    Included subjects who received manufacturing scale dose of 13vPnC coadministered with combined DTaP-IPV-Hib and HBV at 2 months (infant series, dose 1) and manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).

    Reporting group title
    13vPnC Pilot After Infant Series
    Reporting group description
    Included subjects who received pilot scale dose of 13vPnC coadministered with combined DTaP-IPV-Hib and HBV at 2 months (infant series, dose 1) and pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
    Reporting group title
    13vPnC Manufacturing Toddler Dose
    Reporting group description
    Subjects received manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) at 12 months of age (toddler dose).

    Reporting group title
    13vPnC Pilot Toddler Dose
    Reporting group description
    Subjects received pilot scale dose of 13vPnC coadministered with MMR at 12 months of age (toddler dose).

    Subject analysis set title
    13vPnC Manufacturing Dose 1
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib and HBV at 2 months (infant series, dose 1).

    Subject analysis set title
    13vPnC Pilot Dose 1
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib and HBV at 2 months (infant series, dose 1).

    Subject analysis set title
    13vPnC Manufacturing Dose 2
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).

    Subject analysis set title
    13vPnC Pilot Dose 2
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).

    Subject analysis set title
    13vPnC Pilot Dose 3
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).

    Subject analysis set title
    13vPnC Manufacturing Dose 3
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).

    Subject analysis set title
    13vPnC Manufacturing Toddler Dose
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with MMR at 12 months of age (toddler dose).

    Subject analysis set title
    13vPnC Pilot Toddler Dose
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL pilot scale dose of 13vPnC coadministered with MMR at 12 months of age (toddler dose).

    Primary: Percentage of Subjects Achieving Antibody Level Greater than or Equal to (≥) 0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series

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    End point title
    Percentage of Subjects Achieving Antibody Level Greater than or Equal to (≥) 0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
    End point description
    Percentages of subjects achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.Evaluable immunogenicity (per protocol) population consisting of eligible subjects who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Primary
    End point timeframe
    One month after 3-dose infant series (5 months of age)
    End point values
    13vPnC Manufacturing Infant Series 13vPnC Pilot Infant Series
    Number of subjects analysed
    128
    131
    Units: Percentage of subjects
    number (confidence interval 95%)
        Common Serotypes-Serotype 4
    97.7 (93.3 to 99.5)
    96.9 (92.4 to 99.2)
        Common Serotypes-Serotype 6B
    77.3 (69.1 to 84.3)
    74 (65.7 to 81.3)
        Common Serotypes-Serotype 9V
    98.4 (94.5 to 99.8)
    96.2 (91.3 to 98.7)
        Common Serotypes-Serotype 14
    92.9 (87 to 96.7)
    94.5 (89.1 to 97.8)
        Common Serotypes-Serotype 18C
    96.1 (91.1 to 98.7)
    93.1 (87.4 to 96.8)
        Common Serotypes-Serotype 19F
    98.4 (94.4 to 99.8)
    97.7 (93.5 to 99.5)
        Common Serotypes-Serotype 23F
    82.8 (75.1 to 88.9)
    81.7 (74 to 87.9)
        Additional Serotypes-Serotype 1
    93 (87.1 to 96.7)
    90.8 (84.5 to 95.2)
        Additional Serotypes-Serotype 3
    93.7 (88 to 97.2)
    95.4 (90.3 to 98.3)
        Additional Serotypes-Serotype 5
    90.6 (84.2 to 95.1)
    88.5 (81.8 to 93.4)
        Additional Serotypes-Serotype 6A
    85.2 (77.8 to 90.8)
    86.3 (79.2 to 91.6)
        Additional Serotypes-Serotype 7F
    100 (97.2 to 100)
    100 (97.2 to 100)
        Additional Serotypes-Serotype 19A
    99.2 (95.7 to 100)
    99.2 (95.8 to 100)
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 4
    Statistical analysis description
    For serotype 4 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.9
         upper limit
    5.6
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 6B
    Statistical analysis description
    For serotype 6B the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Pilot Infant Series v 13vPnC Manufacturing Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    3.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.3
         upper limit
    13.8
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 9V
    Statistical analysis description
    For serotype 9V the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    2.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.1
         upper limit
    7.3
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 14
    Statistical analysis description
    For serotype 14 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    -1.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.2
         upper limit
    4.7
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 18C
    Statistical analysis description
    For serotype 18C the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.8
         upper limit
    9.2
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 19F
    Statistical analysis description
    For serotype 19F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.5
         upper limit
    5.1
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 23F
    Statistical analysis description
    For serotype 23F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.4
         upper limit
    10.6
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 1
    Statistical analysis description
    For serotype 1 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.8
         upper limit
    9.2
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 3
    Statistical analysis description
    For serotype 3 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    -1.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -7.9
         upper limit
    4.2
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 5
    Statistical analysis description
    For serotype 5 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.6
         upper limit
    9.9
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 6A
    Statistical analysis description
    For serotype 6A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    -1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.9
         upper limit
    7.6
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 7F
    Statistical analysis description
    For serotype 7F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    2.8
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 19A
    Statistical analysis description
    For serotype 19A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.6
         upper limit
    3.5

    Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions

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    End point title
    Percentage of Subjects Reporting Pre-Specified Local Reactions [1]
    End point description
    Local reactions (LRs) were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (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 (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Subjects may be represented in more than 1 category. The safety population included all subjects who received at least 1 dose of vaccine; (n) = number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Primary
    End point timeframe
    During the 4-day period after each dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this outcome measure.
    End point values
    13vPnC Manufacturing Dose 1 13vPnC Pilot Dose 1 13vPnC Manufacturing Dose 2 13vPnC Pilot Dose 2 13vPnC Manufacturing Dose 3 13vPnC Pilot Dose 3 13vPnC Manufacturing Toddler Dose 13vPnC Pilot Toddler Dose
    Number of subjects analysed
    134
    134
    132
    133
    132
    133
    131
    131
    Units: Percentage of subjects
    number (not applicable)
        Tenderness-Any (n=133,130,128,128,124,119,115,117)
    18.8
    20
    20.3
    17.2
    15.3
    12.6
    24.3
    29.1
        Tenderness-Sig (n=131,129,128,128,124,119,112,114)
    0.8
    3.9
    1.6
    3.1
    1.6
    0
    1.8
    3.5
        Swelling-Any (n=132,130,129,129,126,122,113,115)
    25
    20
    30.2
    27.1
    29.4
    30.3
    22.1
    26.1
        Swelling-Mild (n=132,130,129,129,126,121,113,115)
    22.7
    17.7
    29.5
    25.6
    27
    25.6
    22.1
    25.2
        Swelling-Mod (n=132,129,128,128,124,120,113,114)
    6.1
    7
    8.6
    8.6
    8.9
    13.3
    8.8
    8.8
        Swelling-Severe(n=131,129,128,128,124,119,112,113)
    0
    0
    0
    0
    0
    0
    0
    0
        Redness-Any (n=132,131,129,131,125,123,115,116)
    28.8
    24.4
    37.2
    33.6
    40
    34.1
    37.4
    42.2
        Redness-Mild (n=132,131,129,131,125,123,115,115)
    28.8
    22.9
    36.4
    33.6
    38.4
    33.3
    33.9
    36.5
        Redness-Mod (n=131,129,128,128,124,119,113,114)
    0
    1.6
    3.1
    1.6
    5.6
    3.4
    10.6
    12.3
        Redness-Severe(n=131,129,128,128,124,119,112,113)
    0
    0
    0
    0
    0
    0
    0
    0.9
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events (Infant Series)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Systemic Events (Infant Series) [2]
    End point description
    Systemic events (SEs) (fever greater than or equal to [>=] 38 degrees Celsius [C] but less than or equal to[=<] 39 C, fever more than [>]39 C but [=<] 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Subjects may be represented in more than 1 category. The safety population included all subjects (268) who received at least 1 dose of vaccine; (n) = number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Primary
    End point timeframe
    During the 4-day period after each dose
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this outcome measure.
    End point values
    13vPnC Manufacturing Dose 1 13vPnC Pilot Dose 1 13vPnC Manufacturing Dose 2 13vPnC Pilot Dose 2 13vPnC Manufacturing Dose 3 13vPnC Pilot Dose 3
    Number of subjects analysed
    134
    134
    132
    133
    132
    133
    Units: Percentage of subjects
    number (not applicable)
        Fever >=38 C but =<39C (n=132,130,129,130,124,121)
    18.2
    19.2
    16.3
    20
    11.3
    17.4
        Fever >39 C but =<40 C (n=131,129,128,128,124,119)
    0.8
    0.8
    0.8
    1.6
    0
    3.4
        Fever >40 C (n=131,129,128,128,124,119)
    0
    0
    0
    0
    0
    0
        Decreased appetite (n=133,129,129,128,125,121)
    20.3
    24
    14.7
    15.6
    16.8
    19
        Irritability (n=134,131,130,131,127,123)
    50
    51.9
    53.8
    49.6
    41.7
    37.4
        Increased sleep (n=132,129,128,129,124,121)
    41.7
    39.5
    25
    29.5
    20.2
    30.6
        Decreased sleep (n=132,130,129,129,124,123)
    27.3
    32.3
    24
    20.9
    18.5
    19.5
        Meds to treat sx (n=132,130,128,128,124,123)
    12.9
    17.7
    13.3
    14.1
    8.9
    14.6
        Meds to prevent sx (n=132,130,128,129,124,121)
    12.9
    9.2
    11.7
    10.1
    10.5
    8.3
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Systemic Events (Toddler Series)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Systemic Events (Toddler Series) [3]
    End point description
    Systemic events (fever >= 38 C but =< 39 C, fever >39 C but =< 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Subjects may be represented in more than 1 category. The safety population included all subjects who received at least 1 dose of vaccine; (n) = number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Primary
    End point timeframe
    During the 4-day period after toddler dose
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this outcome measure.
    End point values
    13vPnC Manufacturing Infant Series 13vPnC Pilot Infant Series
    Number of subjects analysed
    131
    131
    Units: Percentage of subjects
    number (not applicable)
        Fever >=38 degrees C but =<39 degrees C(n=114,114)
    14
    13.2
        Fever >39 degrees C but =<40 degrees C (n=112,113)
    0.9
    0.9
        Fever >40 degrees C (n=112,113)
    0
    0
        Decreased appetite (n=115,117)
    20.9
    23.1
        Irritability (n=119,123)
    40.3
    44.7
        Increased sleep (n=114,119)
    18.4
    16.8
        Decreased sleep (n=116,117)
    13.8
    13.7
        Medication to treat symptoms (n=113,115)
    17.7
    17.4
        Medication to prevent symptoms (n=114,114)
    12.3
    12.3
    No statistical analyses for this end point

    Primary: Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series

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    End point title
    Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series
    End point description
    Antibody concentration/geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity (per protocol) population were subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Primary
    End point timeframe
    One month after 3-dose infant series (5 months of age)
    End point values
    13vPnC Manufacturing Infant Series 13vPnC Pilot Infant Series
    Number of subjects analysed
    128
    131
    Units: microgram per milliliter
    geometric mean (confidence interval 95%)
        Common Serotypes-Serotype 4
    2.09 (1.81 to 2.4)
    1.55 (1.34 to 1.79)
        Common Serotypes - Serotype 6B
    0.8 (0.65 to 0.98)
    0.83 (0.66 to 1.06)
        Common Serotypes - Serotype 9V
    1.28 (1.13 to 1.43)
    1.21 (1.08 to 1.37)
        Common Serotypes - Serotype 14
    2.15 (1.77 to 2.61)
    2.3 (1.91 to 2.77)
        Common Serotypes - Serotype 18C
    1.6 (1.38 to 1.87)
    1.51 (1.31 to 1.75)
        Common Serotypes - Serotype 19F
    1.6 (1.4 to 1.83)
    1.64 (1.44 to 1.86)
        Common Serotypes - Serotype 23F
    0.82 (0.69 to 0.98)
    0.92 (0.77 to 1.1)
        Additional Serotypes - Serotype 1
    1.42 (1.21 to 1.66)
    1.29 (1.1 to 1.51)
        Additional Serotypes - Serotype 3
    1.2 (1.05 to 1.38)
    1.21 (1.06 to 1.37)
        Additional Serotypes - Serotype 5
    0.96 (0.84 to 1.09)
    1 (0.87 to 1.16)
        Additional Serotypes - Serotype 6A
    0.87 (0.74 to 1.03)
    1.05 (0.89 to 1.25)
        Additional Serotypes - Serotype 7F
    2 (1.77 to 2.25)
    2.14 (1.89 to 2.42)
        Additional Serotypes - Serotype 19A
    2.19 (1.91 to 2.5)
    2.31 (2.05 to 2.61)
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 4
    Statistical analysis description
    For serotype 4 the GMC ratio was calculated.
    Comparison groups
    13vPnC Pilot Infant Series v 13vPnC Manufacturing Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    1.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.1
         upper limit
    1.65
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 6B
    Statistical analysis description
    For serotype 6B the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    0.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    1.31
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 9V
    Statistical analysis description
    For serotype 9V the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    1.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.89
         upper limit
    1.24
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 14
    Statistical analysis description
    For serotype 14 the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.71
         upper limit
    1.22
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 18C
    Statistical analysis description
    For serotype 18C the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    1.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.86
         upper limit
    1.3
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 19F
    Statistical analysis description
    For serotype 19F the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    1.17
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 23F
    Statistical analysis description
    For serotype 23F the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    1.15
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 1
    Statistical analysis description
    For serotype 1 the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.88
         upper limit
    1.37
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 3
    Statistical analysis description
    For serotype 3 the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.83
         upper limit
    1.2
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 5
    Statistical analysis description
    For serotype 5 the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    0.95
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.79
         upper limit
    1.16
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 6A
    Statistical analysis description
    For serotype 6A the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    0.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.66
         upper limit
    1.05
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 7F
    Statistical analysis description
    For serotype 7F the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.79
         upper limit
    1.11
    Statistical analysis title
    13vPnC Manufacturing vs 13vPnC Pilot-Serotype 19A
    Statistical analysis description
    For serotype 19A the GMC ratio was calculated.
    Comparison groups
    13vPnC Manufacturing Infant Series v 13vPnC Pilot Infant Series
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Ratio
    Point estimate
    0.95
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.79
         upper limit
    1.13

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were reported from signing of informed consent from (ICF) to 1 month after third dose in infant series & from toddler dose to 1 month after last study vaccination. SAEs were reported from the signing of the ICF to 1 month after last study vaccination
    Adverse event reporting additional description
    SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local,systemic reactions for 13vPnC; systematic assessment) and AEs collected on case report form at each visit (non systematic assessment). Subjects who received specified dose and had safety data available were evaluable for safety.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    13vPnC Manufacturing Infant Series
    Reporting group description
    Subjects received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib and HBV at 2 months (infant series, dose 1). Subjects received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).

    Reporting group title
    13vPnC Pilot Infant Series
    Reporting group description
    Subjects received one single 0.5mL pilot scale dose of 13vPnC coadministered withDTaP-IPV-Hib and HBV at 2 months (infant series, dose 1). Subjects received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).

    Reporting group title
    13vPnC Manufacturing Post-Infant Series
    Reporting group description
    Subjects received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib and HBV at 2 months (infant series, dose 1). Subjects received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.

    Reporting group title
    13vPnC Pilot Post-Infant Series
    Reporting group description
    Subjects received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib and HBV at 2 months (infant series, dose 1). Subjects received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.

    Reporting group title
    13vPnC Manufacturing Toddler Series
    Reporting group description
    Subjects received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with MMR at 12 months of age (toddler dose).

    Reporting group title
    113vPnC Pilot Toddler Series
    Reporting group description
    Subjects received one single 0.5mL pilot scale dose of 13vPnC coadministered with MMR at 12 months of age (toddler dose).

    Serious adverse events
    13vPnC Manufacturing Infant Series 13vPnC Pilot Infant Series 13vPnC Manufacturing Post-Infant Series 13vPnC Pilot Post-Infant Series 13vPnC Manufacturing Toddler Series 113vPnC Pilot Toddler Series
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 134 (2.99%)
    2 / 134 (1.49%)
    10 / 134 (7.46%)
    11 / 134 (8.21%)
    0 / 131 (0.00%)
    1 / 131 (0.76%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    2 / 134 (1.49%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Crying
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    2 / 134 (1.49%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroesophageal reflux disease
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    2 / 134 (1.49%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    2 / 134 (1.49%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    2 / 134 (1.49%)
    3 / 134 (2.24%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    1 / 134 (0.75%)
    2 / 134 (1.49%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    3 / 134 (2.24%)
    4 / 134 (2.99%)
    0 / 131 (0.00%)
    1 / 131 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia primary atypical
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    13vPnC Manufacturing Infant Series 13vPnC Pilot Infant Series 13vPnC Manufacturing Post-Infant Series 13vPnC Pilot Post-Infant Series 13vPnC Manufacturing Toddler Series 113vPnC Pilot Toddler Series
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 134 (52.24%)
    68 / 134 (50.75%)
    3 / 134 (2.24%)
    7 / 134 (5.22%)
    48 / 131 (36.64%)
    55 / 131 (41.98%)
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Milk allergy
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 134 (1.49%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    2 / 131 (1.53%)
    0 / 131 (0.00%)
         occurrences all number
    2
    0
    0
    0
    2
    0
    Irritability
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C: Infant series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    24 / 132 (18.18%)
    25 / 130 (19.23%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    16 / 114 (14.04%)
    15 / 114 (13.16%)
         occurrences all number
    24
    25
    0
    0
    16
    15
    Fever >39°C but ≤40°C: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    1 / 131 (0.76%)
    1 / 129 (0.78%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 112 (0.89%)
    1 / 113 (0.88%)
         occurrences all number
    1
    1
    0
    0
    1
    1
    Decreased appetite: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    27 / 133 (20.30%)
    31 / 129 (24.03%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    24 / 115 (20.87%)
    27 / 117 (23.08%)
         occurrences all number
    27
    31
    0
    0
    24
    27
    Irritability: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    67 / 134 (50.00%)
    68 / 131 (51.91%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    48 / 119 (40.34%)
    55 / 123 (44.72%)
         occurrences all number
    67
    68
    0
    0
    48
    55
    Increased sleep: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    55 / 132 (41.67%)
    51 / 129 (39.53%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    21 / 114 (18.42%)
    20 / 119 (16.81%)
         occurrences all number
    55
    51
    0
    0
    21
    20
    Decreased sleep: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    36 / 132 (27.27%)
    42 / 130 (32.31%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    16 / 116 (13.79%)
    16 / 117 (13.68%)
         occurrences all number
    36
    42
    0
    0
    16
    16
    Fever ≥38°C but ≤39°C: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    21 / 129 (16.28%)
    26 / 130 (20.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    21
    26
    0
    0
    0
    0
    Fever >39°C but ≤40°C: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    1 / 128 (0.78%)
    2 / 128 (1.56%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Decreased appetite: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    19 / 129 (14.73%)
    20 / 128 (15.63%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    19
    20
    0
    0
    0
    0
    Irritability: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    70 / 130 (53.85%)
    65 / 131 (49.62%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    70
    65
    0
    0
    0
    0
    Increased sleep: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    32 / 128 (25.00%)
    38 / 129 (29.46%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    32
    38
    0
    0
    0
    0
    Decreased sleep: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    31 / 129 (24.03%)
    27 / 129 (20.93%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    31
    27
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    14 / 124 (11.29%)
    21 / 121 (17.36%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    14
    21
    0
    0
    0
    0
    Fever >39°C but ≤40°C: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    0 / 124 (0.00%)
    4 / 119 (3.36%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    Decreased appetite: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    21 / 125 (16.80%)
    23 / 121 (19.01%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    21
    23
    0
    0
    0
    0
    Irritability: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    53 / 127 (41.73%)
    46 / 123 (37.40%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    53
    46
    0
    0
    0
    0
    Increased sleep: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    25 / 124 (20.16%)
    37 / 121 (30.58%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    25
    37
    0
    0
    0
    0
    Decreased sleep: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    23 / 124 (18.55%)
    24 / 123 (19.51%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    23
    24
    0
    0
    0
    0
    Psychiatric disorders
    Crying
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Psychomotor retardation
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Reproductive system and breast disorders
    Posthitis
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Corneal abrasion
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Hip dysplasia
         subjects affected / exposed
    1 / 134 (0.75%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Atrial septal defect
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Dacryostenosis congenital
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hydrocele
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Plagiocephaly
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 134 (1.49%)
    2 / 134 (1.49%)
    0 / 134 (0.00%)
    2 / 134 (1.49%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    2
    2
    0
    4
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lymphadenitis
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    1 / 131 (0.76%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    2 / 134 (1.49%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Asthma
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    1 / 131 (0.76%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Dysphonia
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Hypertonia
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypotonia
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    1 / 131 (0.76%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    5 / 134 (3.73%)
    4 / 134 (2.99%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 131 (0.76%)
    0 / 131 (0.00%)
         occurrences all number
    5
    5
    0
    0
    1
    0
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Eyelid oedema
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 134 (2.99%)
    3 / 134 (2.24%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    3 / 131 (2.29%)
    1 / 131 (0.76%)
         occurrences all number
    5
    3
    0
    0
    3
    1
    Dyspepsia
         subjects affected / exposed
    1 / 134 (0.75%)
    4 / 134 (2.99%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    1 / 134 (0.75%)
    2 / 134 (1.49%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Enlarged uvula
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Infantile colic
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Infrequent bowel movements
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Teething
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    1 / 134 (0.75%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    1 / 131 (0.76%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 134 (1.49%)
    2 / 134 (1.49%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    3
    2
    0
    0
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    1 / 134 (0.75%)
    2 / 134 (1.49%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    1 / 131 (0.76%)
    1 / 131 (0.76%)
         occurrences all number
    1
    2
    1
    0
    1
    1
    Dermatitis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    1 / 131 (0.76%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Eczema
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    2 / 134 (1.49%)
    1 / 131 (0.76%)
    0 / 131 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    Tenderness (any): Infant series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    25 / 133 (18.80%)
    26 / 130 (20.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    28 / 115 (24.35%)
    34 / 117 (29.06%)
         occurrences all number
    25
    26
    0
    0
    28
    34
    Tenderness (significant): Infant series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    1 / 131 (0.76%)
    5 / 129 (3.88%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    2 / 112 (1.79%)
    4 / 114 (3.51%)
         occurrences all number
    1
    5
    0
    0
    2
    4
    Induration (any): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    33 / 132 (25.00%)
    26 / 130 (20.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    25 / 113 (22.12%)
    30 / 115 (26.09%)
         occurrences all number
    33
    26
    0
    0
    25
    30
    Induration (mild): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    30 / 132 (22.73%)
    23 / 130 (17.69%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    25 / 113 (22.12%)
    29 / 115 (25.22%)
         occurrences all number
    30
    23
    0
    0
    25
    29
    Induration (moderate): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
         subjects affected / exposed [23]
    8 / 132 (6.06%)
    9 / 129 (6.98%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    10 / 113 (8.85%)
    10 / 114 (8.77%)
         occurrences all number
    8
    9
    0
    0
    10
    10
    Erythema (any): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    38 / 132 (28.79%)
    32 / 131 (24.43%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    43 / 115 (37.39%)
    49 / 116 (42.24%)
         occurrences all number
    38
    32
    0
    0
    43
    49
    Erythema (mild): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    38 / 132 (28.79%)
    30 / 131 (22.90%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    39 / 115 (33.91%)
    42 / 115 (36.52%)
         occurrences all number
    38
    30
    0
    0
    39
    42
    Erythema (moderate): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
         subjects affected / exposed [26]
    0 / 131 (0.00%)
    2 / 129 (1.55%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    12 / 113 (10.62%)
    14 / 114 (12.28%)
         occurrences all number
    0
    2
    0
    0
    12
    14
    Erythema (severe): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 112 (0.00%)
    1 / 113 (0.88%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Tenderness (any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    26 / 128 (20.31%)
    22 / 128 (17.19%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    26
    22
    0
    0
    0
    0
    Tenderness (significant): Infant series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    2 / 128 (1.56%)
    4 / 128 (3.13%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    Induration (any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    39 / 129 (30.23%)
    35 / 129 (27.13%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    39
    35
    0
    0
    0
    0
    Induration (mild): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    38 / 129 (29.46%)
    33 / 129 (25.58%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    38
    33
    0
    0
    0
    0
    Induration (moderate): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    11 / 128 (8.59%)
    11 / 128 (8.59%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    11
    11
    0
    0
    0
    0
    Erythema (any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    48 / 129 (37.21%)
    44 / 131 (33.59%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    48
    44
    0
    0
    0
    0
    Erythema (mild): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    47 / 129 (36.43%)
    44 / 131 (33.59%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    47
    44
    0
    0
    0
    0
    Erythema (moderate): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    4 / 128 (3.13%)
    2 / 128 (1.56%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    4
    2
    0
    0
    0
    0
    Tenderness (any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    19 / 124 (15.32%)
    15 / 119 (12.61%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    19
    15
    0
    0
    0
    0
    Tenderness(significant): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    2 / 124 (1.61%)
    0 / 119 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Induration (any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    37 / 126 (29.37%)
    37 / 122 (30.33%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    37
    37
    0
    0
    0
    0
    Induration (mild): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    34 / 126 (26.98%)
    31 / 121 (25.62%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    34
    31
    0
    0
    0
    0
    Induration (moderate): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    11 / 124 (8.87%)
    16 / 120 (13.33%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    11
    16
    0
    0
    0
    0
    Erythema (any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    50 / 125 (40.00%)
    42 / 123 (34.15%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    50
    42
    0
    0
    0
    0
    Erythema (mild): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [42]
    48 / 125 (38.40%)
    41 / 123 (33.33%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    48
    42
    0
    0
    0
    0
    Erythema (moderate): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [43]
    7 / 124 (5.65%)
    4 / 119 (3.36%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    7
    4
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Rickets
         subjects affected / exposed
    1 / 134 (0.75%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Posture abnormal
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    12 / 134 (8.96%)
    10 / 134 (7.46%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 131 (0.76%)
    2 / 131 (1.53%)
         occurrences all number
    12
    11
    0
    0
    1
    2
    Pharyngitis
         subjects affected / exposed
    9 / 134 (6.72%)
    10 / 134 (7.46%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    5 / 131 (3.82%)
    5 / 131 (3.82%)
         occurrences all number
    10
    10
    0
    0
    5
    5
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 134 (5.97%)
    11 / 134 (8.21%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    2 / 131 (1.53%)
    1 / 131 (0.76%)
         occurrences all number
    8
    12
    0
    0
    2
    2
    Nasopharyngitis
         subjects affected / exposed
    8 / 134 (5.97%)
    9 / 134 (6.72%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 131 (0.76%)
    2 / 131 (1.53%)
         occurrences all number
    8
    10
    0
    0
    1
    2
    Bronchitis
         subjects affected / exposed
    5 / 134 (3.73%)
    7 / 134 (5.22%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 131 (0.76%)
    2 / 131 (1.53%)
         occurrences all number
    5
    8
    0
    0
    1
    2
    Candidiasis
         subjects affected / exposed
    2 / 134 (1.49%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    2 / 134 (1.49%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Exanthema subitum
         subjects affected / exposed
    2 / 134 (1.49%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    1 / 131 (0.76%)
         occurrences all number
    2
    1
    0
    0
    0
    1
    Viral infection
         subjects affected / exposed
    2 / 134 (1.49%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 131 (0.76%)
    3 / 131 (2.29%)
         occurrences all number
    2
    1
    0
    0
    1
    3
    Bronchopneumonia
         subjects affected / exposed
    1 / 134 (0.75%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    0 / 131 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    2 / 131 (1.53%)
    2 / 131 (1.53%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    Laryngitis
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    2 / 131 (1.53%)
    0 / 131 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 131 (0.76%)
    1 / 131 (0.76%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Otitis media acute
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 131 (0.00%)
    1 / 131 (0.76%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    0 / 134 (0.00%)
    1 / 131 (0.76%)
    0 / 131 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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