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    Clinical Trial Results:
    A Phase 3, Randomised, Active-controlled, Double-Blind Trial of the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given in a 2-, 3-, 4- and 11- to 12-Months Schedule With Routine Pediatric Vaccinations.

    Summary
    EudraCT number
    		 2005-004770-24
    Trial protocol
    		 DE  
    Global end of trial date
    26 Aug 2008

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    6096A1-006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00366340
    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 ClinicalTrials.gov Call Center, Pfizer, Inc., 1800 7181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 1800 7181021, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Sep 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To demonstrate that the immune responses to the 7 common pneumococcal conjugates induced by 13vPnC are non inferior to the immune responses induced by 7-valent Pneumococcal Conjugate Vaccine (7vPnC) when measured 1 month after the infant series. - To demonstrate that the immune responses to the 6 additional pneumococcal conjugates induced by 13-valent Pneumococcal Conjugate Vaccine (13vPnC) are non inferior to the lowest immune response, among the 7 common pneumococcal conjugates, induced by 7vPnC when measured 1 month after the infant series. - To demonstrate that the immune responses induced by Infanrix hexa given with 13vPnC are noninferior to the immune responses induced by Infanrix hexa given with 7vPnC when measured 1 month after the infant series. Safety objective: - To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local injection site reactions, systemic events, and adverse events (AEs)
    Protection of trial subjects
    The study was in compliance with with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 604
    Worldwide total number of subjects
    604
    EEA total number of subjects
    604
    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)
    604
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were recruited in Germany from October 2006 to April 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 Infant Series
    Arm description
    		 Subjects received one single dose of 13vPnC coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
    Arm type
    		 Experimental

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

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).

    Arm title
    		 7vPnC Infant Series
    Arm description
    		 Subjects received one single dose of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
    Arm type
    		 Experimental

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose of 7vPnC at 2, 3, 4 months (infant series).

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).

    Number of subjects in period 1
    		13vPnC Infant Series 7vPnC Infant Series
    Started
    301
    303
    Vaccinated Dose 1
    300
    303
    Vacccinated Dose 2
    296
    297
    Vaccinated Dose 3
    294
    293
    Completed
    293
    293
    Not completed
    8
    10
         Consent withdrawn by subject
    3
    3
         Adverse Event
    -
    2
         Protocol Violation
    3
    4
         Lost to follow-up
    1
    1
         Faliure to return
    1
    -
    Period 2
    Period 2 title
    After The 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 After the Infant Series
    Arm description
    		 Included subjects who received of 13vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3 and 4 months of age in the infant series.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 7vPnC After the Infant Series
    Arm description
    		 Included subjects who received of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3 and 4 months of age in the infant series.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		13vPnC After the Infant Series 7vPnC After the Infant Series
    Started
    293
    293
    Completed
    290
    287
    Not completed
    3
    6
         Failed to return
    -
    1
         Adverse Event
    -
    1
         Protocol Violation
    2
    2
         Parent\legal guardian request
    1
    1
         Lost to follow-up
    -
    1
    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 Toddler Dose
    Arm description
    		 Subjects who received 13vPnC in the infant series, received one single 0.5 mL dose of 13vPnC co administered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One single 0.5 mL dose of 13vPnC at 12 months of age (toddler dose).

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)

    Arm title
    		 7vPnC Toddler Dose
    Arm description
    		 Subjects who received 7vPnC in the infant series, received one single 0.5 mL dose of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
    Arm type
    		 Experimental

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose of 7vPnC at 12 months of age (toddler dose)

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)

    Number of subjects in period 3
    		13vPnC Toddler Dose 7vPnC Toddler Dose
    Started
    290
    287
    Completed
    289
    286
    Not completed
    1
    1
         Failed to return
    1
    -
         Parent\legal guardian request
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    		 Subjects received one single dose of 13vPnC coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).

    Reporting group title
    7vPnC Infant Series
    Reporting group description
    		 Subjects received one single dose of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).

    Reporting group values
    		 13vPnC Infant Series 7vPnC Infant Series Total
    Number of subjects
    		 301 303 604
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 2.5 ± 0.6 2.5 ± 0.6 -
    Gender categorical
    Units: Subjects
        Female
    		 151 127 278
        Male
    		 150 176 326

    End points

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    End points reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    		 Subjects received one single dose of 13vPnC coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).

    Reporting group title
    7vPnC Infant Series
    Reporting group description
    		 Subjects received one single dose of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
    Reporting group title
    13vPnC After the Infant Series
    Reporting group description
    		 Included subjects who received of 13vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3 and 4 months of age in the infant series.

    Reporting group title
    7vPnC After the Infant Series
    Reporting group description
    		 Included subjects who received of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3 and 4 months of age in the infant series.
    Reporting group title
    13vPnC Toddler Dose
    Reporting group description
    		 Subjects who received 13vPnC in the infant series, received one single 0.5 mL dose of 13vPnC co administered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).

    Reporting group title
    7vPnC Toddler Dose
    Reporting group description
    		 Subjects who received 7vPnC in the infant series, received one single 0.5 mL dose of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).

    Subject analysis set title
    13vPnC Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).

    Subject analysis set title
    7vPnC Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).

    Subject analysis set title
    13vPnC Dose 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).

    Subject analysis set title
    7vPnC Dose 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).

    Subject analysis set title
    13vPnC Dose 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).

    Subject analysis set title
    7vPnC Dose 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).

    Subject analysis set title
    13vPnC Before Toddler Dose
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).

    Subject analysis set title
    7vPnC Before Toddler Dose
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).

    Subject analysis set title
    13vPnC After Toddler Dose
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).

    Subject analysis set title
    7vPnC After Toddler Dose
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)

    Subject analysis set title
    13vPnC Toddler dose
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 13vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).

    Subject analysis set title
    7vPnC Toddler dose
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5 mL dose of 7vPnC coadministered with combined DTPa, Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)

    Primary: Percentage of Subjects Achieving Antibody Level greater than equal to (≥) 0.35 mcg/mL (microgram/milliliter) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

    		 Close Top of page
    End point title
    		 Percentage of Subjects Achieving Antibody Level greater than equal to (≥) 0.35 mcg/mL (microgram/milliliter) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
    End point description
    Percentage of subjects achieving World Health Organization (WHO) predefined antibody threshold >= 0.35 mcg/mL along with the corresponding 95 percent confidence interval (% CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) 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 After the Infant Series 7vPnC After the Infant Series
    Number of subjects analysed
    285
    279
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotypes-Serotype 4
    77.5 (96 to 99.4)
    98.2 (95.9 to 99.4)
        Common Serotypes-Serotype 6B
    98.6 (72.2 to 82.2)
    87.1 (82.5 to 90.8)
        Common Serotypes-Serotype 9V
    98.9 (96.4 to 99.6)
    96.4 (93.5 to 98.3)
        Common Serotypes-Serotype 14
    97.2 (96.9 to 99.8)
    97.5 (94.9 to 99)
        Common Serotypes-Serotype 18C
    95.8 (94.5 to 98.8)
    98.6 (96.3 to 99.6)
        Common Serotypes-Serotype 19F
    88.7 (92.7 to 97.8)
    96 (93 to 98)
        Common Serotypes-Serotype 23F
    98.2 (84.5 to 92.2)
    89.5 (85.3 to 92.9)
        Additional Serotypes-Serotype 1
    96.1 (93.2 to 98.1)
    1.4 (0.4 to 3.7)
        Additional Serotypes-Serotype 3
    98.2 (95.9 to 99.4)
    6.3 (3.7 to 9.8)
        Additional Serotypes-Serotype 5
    93 (89.3 to 95.6)
    31.6 (25.8 to 37.8)
        Additional Serotypes-Serotype 6A
    91.9 (88.1 to 94.8)
    31.6 (26.1 to 37.5)
        Additional Serotypes-Serotype 7F
    98.6 (96.4 to 99.6)
    4 (2 to 7)
        Additional Serotypes-Serotype 19A
    99.3 (97.5 to 99.9)
    79.2 (73.8 to 83.9)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 2.6
    Notes
    [1] - Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.
    Comparison groups
    7vPnC After the Infant Series v 13vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference
    Point estimate
    -9.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16
         upper limit
    		 -3.3
    Notes
    [2] - Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated .
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 5.2
    Notes
    [3] - Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 4.1
    Notes
    [4] - Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 1.2
    Notes
    [5] - Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 3.3
    Notes
    [6] - Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 4.5
    Notes
    [7] - Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.

    Primary: Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

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    End point title
    		 Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC 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. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated. 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 After the Infant Series 7vPnC After the Infant Series
    Number of subjects analysed
    285
    279
    Units: Microgram/milliliter
    geometric mean (confidence interval 95%)
        Common Serotypes - Serotype 4
    2.18 (1.98 to 2.4)
    2.99 (2.68 to 3.33)
        Common Serotypes - Serotype 6B
    0.98 (0.84 to 1.14)
    1.49 (1.27 to 1.75)
        Common Serotypes - Serotype 9V
    1.65 (1.51 to 1.8)
    1.96 (1.77 to 2.17)
        Common Serotypes - Serotype 14
    4.14 (3.68 to 4.66)
    4.61 (4.07 to 5.23)
        Common Serotypes - Serotype 18C
    1.94 (1.76 to 2.14)
    2.25 (2.04 to 2.49)
        Common Serotypes - Serotype 19F
    1.73 (1.56 to 1.92)
    2.86 (2.53 to 3.24)
        Common Serotypes - Serotype 23F
    1.26 (1.11 to 1.43)
    1.44 (1.25 to 1.65)
        Additional Serotypes - Serotype 1
    1.83 (1.64 to 2.04)
    0.03 (0.02 to 0.03)
        Additional Serotypes - Serotype 3
    1.55 (1.41 to 1.72)
    0.05 (0.04 to 0.06)
        Additional Serotypes - Serotype 5
    1.31 (1.17 to 1.46)
    0.2 (0.18 to 0.23)
        Additional Serotypes - Serotype 6A
    1.33 (1.18 to 1.49)
    0.23 (0.2 to 0.26)
        Additional Serotypes - Serotype 7F
    2.59 (2.36 to 2.85)
    0.04 (0.04 to 0.05)
        Additional Serotypes - Serotype 19A
    3.26 (2.97 to 3.59)
    0.64 (0.58 to 0.71)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.84
    Notes
    [8] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 0.82
    Notes
    [9] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 0.96
    Notes
    [10] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.07
    Notes
    [11] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [12]
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.99
    Notes
    [12] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [13]
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 0.71
    Notes
    [13] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [14]
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.06
    Notes
    [14] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).

    Primary: Percentage of Subjects Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series.

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    End point title
    		 Percentage of Subjects Achieving Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. [15]
    End point description
    Percentage of Subjects achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. 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; (n)=number of subjects with a determinate postinfant series OPA antibody titer to the given serotype.
    End point type
    Primary
    End point timeframe
    One month after 3-dose infant series (5 months of age)
    Notes
    [15] - 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 endpoint.
    End point values
    		 13vPnC After the Infant Series 7vPnC After the Infant Series
    Number of subjects analysed
    285
    279
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotypes - Serotype 4 (n=92,94)
    100 (96.1 to 100)
    100 (96.2 to 100)
        Common Serotypes - Serotype 6B (n=100,94)
    96 (90.1 to 98.9)
    98.9 (94.2 to 100)
        Common Serotypes - Serotype 9V (n=89,89)
    100 (95.9 to 100)
    100 (95.9 to 100)
        Common Serotypes - Serotype 14 (n=95,89)
    100 (96.2 to 100)
    100 (95.9 to 100)
        Common Serotypes - Serotype 18C (n=100,94)
    100 (96.4 to 100)
    98.9 (94.2 to 100)
        Common Serotypes - Serotype 19F (n=100,94)
    96 (90.1 to 98.9)
    93.6 (86.6 to 97.6)
        Common Serotypes - Serotype 23F (n=100,93)
    96 (90.1 to 98.9)
    95.7 (89.4 to 98.8)
        Additional Serotypes - Serotype 1 (n=100,92)
    93 (86.1 to 97.1)
    4.3 (1.2 to 10.8)
        Additional Serotypes - Serotype 3 (n=100,94)
    99 (94.6 to 100)
    24.5 (16.2 to 34.4)
        Additional Serotypes - Serotype 5 (n=100,94)
    99 (94.6 to 100)
    4.3 (1.2 to 10.5)
        Additional Serotypes - Serotype 6A (n=99,93)
    96 (90 to 98.9)
    72 (61.8 to 80.9)
        Additional Serotypes - Serotype 7F (n=99,94)
    100 (96.3 to 100)
    78.7 (69.1 to 86.5)
        Additional Serotypes - Serotype 19A (n=95,94)
    100 (96.2 to 100)
    17 (10.1 to 26.2)
    No statistical analyses for this end point

    Primary: Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

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    End point title
    		 Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [16]
    End point description
    Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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 of eligible subjects who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of subjects with a determinate antibody titer for the specified serotype.
    End point type
    Primary
    End point timeframe
    One month after 3-dose infant series (5 months of age)
    Notes
    [16] - 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 endpoint.
    End point values
    		 13vPnC After the Infant Series 7vPnC After the Infant Series
    Number of subjects analysed
    285
    279
    Units: titer
    geometric mean (confidence interval 95%)
        Common Serotypes -Serotype 4 (n=92,94)
    1573.29 (205.52 to 305.89)
    1860.79 (1540 to 2248.41)
        Common Serotypes - Serotype 6B (n=100,94)
    744.43 (1283.03 to 1929.21)
    1160.76 (921.46 to 1462.19)
        Common Serotypes - Serotype 9V (n=89,89)
    4937.84 (556.91 to 995.11)
    5379.51 (3935.51 to 7353.34)
        Common Serotypes - Serotype 14 (n=95,89)
    2139.65 (3614.78 to 6745.14)
    3345.19 (2473.27 to 4524.5)
        Common Serotypes - Serotype 18C (n=100,94)
    1509.65 (1570.1 to 2915.79)
    1780.26 (1382.42 to 2292.59)
        Common Serotypes - Serotype 19F (n=100,94)
    150.12 (1243.64 to 1832.56)
    165.69 (122.98 to 223.23)
        Common Serotypes - Serotype 23F (n=100,93)
    1089.92 (116.89 to 192.81)
    1070.83 (786.59 to 1457.78)
        Additional Serotypes - Serotype 1 (n=100,92)
    50.21 (795.2 to 1493.86)
    4.64 (3.96 to 5.43)
        Additional Serotypes - Serotype 3 (n=100,94)
    250.73 (39.39 to 64.02)
    6.13 (5.17 to 7.28)
        Additional Serotypes - Serotype 5 (n=100,94)
    162.02 (126.31 to 207.82)
    4.64 (3.96 to 5.43)
        Additional Serotypes - Serotype 6A (n=99,93)
    1228.45 (883.49 to 1708.11)
    122.4 (74.09 to 202.21)
        Additional Serotypes - Serotype 7F (n=99,94)
    11544.75 (9364.02 to 14233.34)
    115.45 (75.16 to 177.32)
        Additional Serotypes - Serotype 19A (n=95,94)
    442.48 (360.53 to 543.06)
    6.7 (5.19 to 8.66)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving Predefined Antibody Levels for Haemophilus influenzaeType b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose

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    End point title
    		 Percentage of Subjects Achieving Predefined Antibody Levels for Haemophilus influenzaeType b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
    End point description
    Predefined Antibody Levels for Haemophilus Influenzae (HI) Type b (0.15 mcg/mL or 1.0 mcg/mL), for Diphtheria Toxoid (0.01 or 0.1 International units [IU]/mL) and for Hepatitis B (≥ 10.0 milli international units/ milliliter (mIU/mL). Evaluable immunogenicity (per protocol) population 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 the infant series (5 months of age); one month after the toddler dose (13 months of age)
    End point values
    		 13vPnC After the Infant Series 7vPnC After the Infant Series 13vPnC After Toddler Dose 7vPnC After Toddler Dose
    Number of subjects analysed
    285 [17]
    279 [18]
    279 [19]
    268 [20]
    Units: percentage of subjects
    number (confidence interval 95%)
        HI type b 0.15 mcg/mL threshold
    89.5 (85.2 to 92.9)
    86.9 (82.1 to 90.8)
    99.3 (98.5 to 100)
    100 (98.5 to 100)
        HI type b 1.0 mcg/mL threshold
    58.4 (52.3 to 64.4)
    54 (47.6 to 60.2)
    100 (97.8 to 100)
    97.9 (95.2 to 100)
        Diphtheria toxoid at 0.01 IU/mL threshold
    100 (98.7 to 100)
    100 (98.6 to 100)
    99.6 (98.6 to 100)
    100 (98.6 to 100)
        Diphtheria toxoid at 0.1 IU/mL threshold
    89.7 (85.5 to 93)
    94.2 (90.6 to 96.7)
    100 (98.6 to 100)
    100 (98.6 to 100)
        Hepatitis B at ≥ 10.0 mIU/mL
    94.9 (91.7 to 97.2)
    96.3 (93.2 to 98.2)
    100 (97.4 to 99.9)
    98.5 (96.1 to 99.9)
    Notes
    [17] - N= Number of subjects with evaluable values.
    [18] - N= Number of subjects with evaluable values.
    [19] - N= Number of subjects with evaluable values.
    [20] - N= Number of subjects with evaluable values.
    Statistical analysis title
    		 HI Type b at 0.15 mcg/mL Threshold
    Statistical analysis description
    For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 mcg/mL threshold was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [21]
    Method
    Parameter type
    		 Difference
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 8.3
    Notes
    [21] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    		 HI Type b at 1.0 mcg/mL Threshold
    Statistical analysis description
    For Haemophilus influenzae (HI) type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 mcg/mL threshold was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [22]
    Method
    Parameter type
    		 Difference
    Point estimate
    4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 13
    Notes
    [22] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    		 Diphtheria Toxoid (DT) at 0.01 IU/mL Threshold
    Statistical analysis description
    For diphtheria toxoid the difference in percentages between the two groups(13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [23]
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.5
    Notes
    [23] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    		 DT at 0.1 IU/mL Threshold
    Statistical analysis description
    For DT the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [24]
    Method
    Parameter type
    		 Difference
    Point estimate
    -4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.3
         upper limit
    		 0.3
    Notes
    [24] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    		 HI Type b at 0.15 mcg/mL Threshold
    Statistical analysis description
    For Haemophilus Influenzae Type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 mcg/mL threshold was calculated.
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    547
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [25]
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 1.5
    Notes
    [25] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    		 Hepatitis B at ≥ 10.0 mIU/mL Threshold
    Statistical analysis description
    For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [26]
    Method
    Parameter type
    		 Difference
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 2.3
    Notes
    [26] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    		 HI Type b at 1.0 mcg/mL Threshold
    Statistical analysis description
    For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 mcg/mL threshold was calculated.
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    547
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [27]
    Method
    Parameter type
    		 Difference
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 4.4
    Notes
    [27] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    		 DT at 0.01 IU/mL Threshold
    Statistical analysis description
    For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    547
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [28]
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.4
    Notes
    [28] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    		 DT at 0.1 IU/mL Threshold
    Statistical analysis description
    For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    547
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [29]
    Method
    Parameter type
    		 Difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.4
    Notes
    [29] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
    Statistical analysis title
    		 Hepatitis B at ≥ 10.0 mIU/mL Threshold
    Statistical analysis description
    For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    547
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [30]
    Method
    Parameter type
    		 Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 3.3
    Notes
    [30] - Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.

    Primary: Geometric Mean Antibody Concentration of Haemophilus influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose

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    End point title
    		 Geometric Mean Antibody Concentration of Haemophilus influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
    End point description
    Evaluable immunogenicity (per protocol) population 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 the infant series (5 months of age); one month after the toddler dose (13 months of age)
    End point values
    		 13vPnC After the Infant Series 7vPnC After the Infant Series 13vPnC After Toddler Dose 7vPnC After Toddler Dose
    Number of subjects analysed
    267 [31]
    252 [32]
    252 [33]
    242 [34]
    Units: mcg/ml
        geometric mean (confidence interval 95%)
    1.23 (1.03 to 1.46)
    1 (0.83 to 1.2)
    11.79 (10.36 to 13.41)
    10.24 (8.88 to 11.82)
    Notes
    [31] - N=number of subjects with determinate antibody concentration for specified concomitant antigen
    [32] - N=number of subjects with determinate antibody concentration for specified concomitant antigen
    [33] - N=number of subjects with determinate antibody concentration for specified concomitant antigen
    [34] - N=number of subjects with determinate antibody concentration for specified concomitant antigen
    Statistical analysis title
    		 HI Type b GMC Ratio
    Statistical analysis description
    For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    519
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [35]
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.58
    Notes
    [35] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
    Statistical analysis title
    		 HI Type b mcg/mL GMC Ratio
    Statistical analysis description
    For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    7vPnC After Toddler Dose v 13vPnC After Toddler Dose
    Number of subjects included in analysis
    494
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [36]
    Method
    Parameter type
    		 Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.39
    Notes
    [36] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

    Primary: Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose

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    End point title
    		 Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
    End point description
    Evaluable immunogenicity (per protocol) population of eligible subjects who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N)= number of subjects with a determinate antibody concentration for the specified concomitant antigen.
    End point type
    Primary
    End point timeframe
    One month after the infant series (5 months of age); one month after the toddler dose (13 months of age)
    End point values
    		 13vPnC After the Infant Series 7vPnC After the Infant Series 13vPnC After Toddler Dose 7vPnC After Toddler Dose
    Number of subjects analysed
    272 [37]
    258 [38]
    269 [39]
    260 [40]
    Units: IU/mL
        geometric mean (confidence interval 95%)
    0.36 (0.32 to 0.41)
    0.53 (0.47 to 0.6)
    2.67 (2.44 to 2.93)
    3.08 (2.74 to 3.47)
    Notes
    [37] -  N=number of subjects with determinate antibody concentration for specified concomitant antigen 
    [38] -  N=number of subjects with determinate antibody concentration for specified concomitant antigen 
    [39] -  N=number of subjects with determinate antibody concentration for specified concomitant antigen 
    [40] -  N=number of subjects with determinate antibody concentration for specified concomitant antigen 
    Statistical analysis title
    		 Diphtheria Toxoid IU/mL GMC Ratio
    Statistical analysis description
    For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [41]
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.8
    Notes
    [41] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
    Statistical analysis title
    		 Diphtheria Toxoid IU/mL GMC Ratio
    Statistical analysis description
    For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    7vPnC After Toddler Dose v 13vPnC After Toddler Dose
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [42]
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.01
    Notes
    [42] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

    Primary: Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose

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    End point title
    		 Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose
    End point description
    Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity (per protocol) population 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 the infant series (5 months of age); one month after the toddler dose (13 months of age)
    End point values
    		 13vPnC After the Infant Series 7vPnC After the Infant Series 13vPnC After Toddler Dose 7vPnC After Toddler Dose
    Number of subjects analysed
    277 [43]
    268 [44]
    271 [45]
    259 [46]
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    145.19 (122.62 to 171.92)
    165.25 (140.33 to 194.61)
    1118.05 (935.26 to 1336.56)
    1195.82 (976.12 to 1464.98)
    Notes
    [43] -  N=number of subjects with determinate antibody concentration for specified concomitant antigen 
    [44] -  N=number of subjects with determinate antibody concentration for specified concomitant antigen 
    [45] -  N=number of subjects with determinate antibody concentration for specified concomitant antigen 
    [46] -  N=number of subjects with determinate antibody concentration for specified concomitant antigen 
    Statistical analysis title
    		 Hepatitis B mIU/mL GMC Ratio
    Statistical analysis description
    For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After the Infant Series v 7vPnC After the Infant Series
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [47]
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.11
    Notes
    [47] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
    Statistical analysis title
    		 Hepatitis B mIU/mL GMC Ratio
    Statistical analysis description
    For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated.
    Comparison groups
    13vPnC After Toddler Dose v 7vPnC After Toddler Dose
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [48]
    Method
    Parameter type
    		 Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.22
    Notes
    [48] - Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).

    Primary: Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose

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    End point title
    		 Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose [49]
    End point description
    Antibody concentration/geometric mean concentration as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose 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 of eligible subjects who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of subjects with a determinate antibody concentration for the specified concomitant antigen.
    End point type
    Primary
    End point timeframe
    Immediately before (12 months of age) and one month after the toddler dose (13 months of age)
    Notes
    [49] - 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 endpoint.
    End point values
    		 13vPnC Before Toddler Dose 7vPnC Before Toddler Dose 13vPnC After Toddler Dose 7vPnC After Toddler Dose
    Number of subjects analysed
    279
    268
    279
    268
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common Serotypes -Serotype 4 (n=277,264,276,263)
    0.46 (0.42 to 0.51)
    0.58 (0.53 to 0.64)
    4.16 (3.75 to 4.62)
    5.07 (4.53 to 5.67)
        Common Serotypes - Serotype 6B (n=275,261,273,251)
    0.97 (0.87 to 1.07)
    1.06 (0.94 to 1.2)
    9.14 (8.14 to 10.26)
    9.85 (8.66 to 11.22)
        Common Serotypes - Serotype 9V (n=277,265,277,262)
    0.46 (0.42 to 0.5)
    0.52 (0.48 to 0.57)
    2.75 (2.52 to 2.99)
    3.36 (3.02 to 3.73)
        Common Serotypes - Serotype 14 (n=273,263,276,260)
    2.2 (1.96 to 2.48)
    2.65 (2.34 to 3)
    8.34 (7.5 to 9.28)
    11.01 (9.87 to 12.29)
        Common Serotypes-Serotype 18C (n=277,265,276,263)
    0.33 (0.3 to 0.36)
    0.39 (0.36 to 0.43)
    2.79 (2.53 to 3.07)
    3.44 (3.08 to 3.84)
        Common Serotypes-Serotype 19F (n=276,264,276,263)
    0.68 (0.6 to 0.76)
    0.58 (0.52 to 0.66)
    5.99 (5.36 to 6.68)
    4.72 (4.12 to 5.41)
        Common Serotypes-Serotype 23F (n=275,264,277,264)
    0.33 (0.3 to 0.37)
    0.39 (0.34 to 0.45)
    3.36 (2.98 to 3.78)
    4.33 (3.75 to 5)
        Additional - Serotype 1 (n=277,260,278,257)
    0.52 (0.48 to 0.57)
    0.03 (0.02 to 0.03)
    4.25 (3.8 to 4.75)
    0.03 (0.03 to 0.04)
        Additional - Serotype 3 (n=275,261,278,255)
    0.25 (0.23 to 0.28)
    0.05 (0.05 to 0.06)
    1.02 (0.92 to 1.13)
    0.07 (0.06 to 0.08)
        Additional - Serotype 5 (n=275,222,276,220)
    0.74 (0.67 to 0.81)
    0.34 (0.3 to 0.39)
    3.56 (3.25 to 3.89)
    0.51 (0.45 to 0.58)
        Additional - Serotype 6A (n=276,259,274,255)
    0.76 (0.68 to 0.85)
    0.33 (0.29 to 0.37)
    5.88 (5.24 to 6.59)
    1.74 (1.51 to 2.01)
        Additional - Serotype 7F (n=277,262,278,263)
    0.99 (0.91 to 1.08)
    0.04 (0.04 to 0.04)
    4.79 (4.29 to 5.34)
    0.05 (0.04 to 0.05)
        Additional - Serotype 19A (n=277,259,271,260)
    1.28 (1.14 to 1.45)
    0.72 (0.65 to 0.8)
    9.58 (8.68 to 10.58)
    3.79 (3.4 to 4.21)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Pre-Specified Local Reactions

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Local Reactions [50]
    End point description
    Local reactions 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. Safety population, included subjects who received given dose; (n) = number of subjects reporting the specific characteristic.
    End point type
    Primary
    End point timeframe
    Day 1 through 4 after each dose
    Notes
    [50] - 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 endpoint.
    End point values
    		 13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Dose 3 7vPnC Dose 3 13vPnC Toddler dose 7vPnC Toddler dose
    Number of subjects analysed
    300
    303
    296
    297
    294
    293
    290
    287
    Units: Percentage of subjects
    number (not applicable)
        Tenderness-Any (n=267,267,250,241,229,221,206,96)
    33
    32.6
    29.2
    31.5
    27.1
    21.3
    53.4
    51.9
        Tenderness-Sig (n=260,258,236,226,215,209,176,158)
    7.7
    7
    4.7
    7.5
    4.2
    2.9
    10.8
    12.7
        Swelling-Any (n=266,263,244,242,226,224,190,176)
    28.2
    20.5
    26.6
    35.1
    26.1
    28.6
    36.8
    43.8
        Swelling-Mild (n=265,263,243,239,226,223,186,172)
    24.5
    19
    24.3
    33.5
    24.8
    27.8
    33.3
    40.7
        Swelling-Mod (n=261,256,235,227,217,211,174,158)
    7.3
    5.9
    7.7
    6.6
    6.9
    5.2
    12.1
    12.7
        Swelling-Severe(n=259,255,232,223,214,208,166,152)
    0
    0
    0
    0
    0
    0
    0
    0
        Redness-Any (n=266,272,247,252,238,231,196,184)
    28.2
    36.4
    34.4
    46.8
    34.9
    39.8
    47.4
    56
        Redness-Mild (n=265,271,247,250,237,229,191,180)
    27.2
    36.2
    33.6
    45.6
    34.2
    38.9
    44.5
    52.8
        Redness-Mod (n=260,256,232,224,217,210,173,158)
    1.9
    1.6
    1.7
    3.6
    4.6
    2.4
    11.6
    15.2
        Redness-Severe (n=259,255,232,222,214,208,166,153)
    0
    0
    0
    0
    0
    0
    0
    0.7
    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) [51]
    End point description
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, hives [urticaria], were reported using an electronic diary. subjects may be represented in more than 1 category.Safety population, subjects who received given dose; (n)= number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Primary
    End point timeframe
    Day 1 through 4 after each dose
    Notes
    [51] - 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 endpoint.
    End point values
    		 13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Dose 3 7vPnC Dose 3
    Number of subjects analysed
    300
    303
    296
    297
    294
    293
    Units: Percentage of Subjects
    number (not applicable)
        Fever≥38°Cbut(<=)≤39°C(n=269,266,248,250,242,232)
    43.5
    38.7
    46.8
    48.4
    46.3
    36.6
        Fever >39°C but ≤40°C (n=260,256,238,225,216,210)
    4.2
    1.6
    8.8
    4.4
    3.7
    1.4
        Fever >40°C (n=259,256,233,223,216,209)
    0
    0
    0
    0
    0
    0
        Decreased Appetite (n=269,267,249,245,236,225)
    33.1
    30.3
    33.7
    34.3
    33.1
    30.2
        Irritability (n=275,266,254,252,238,235)
    42.5
    45.1
    47.2
    55.2
    45.4
    48.9
        Increased Sleep (n=284,272,258,256,240,241)
    61.6
    58.8
    53.9
    66.8
    49.6
    49.4
        Decreased Sleep (n=266,264,240,234,230,221)
    25.2
    26.1
    23.8
    23.1
    20.9
    24.4
        Meds to Prevent Sx (n=261,262,237,234,220,220)
    8.8
    9.5
    10.1
    15.4
    10
    15
        Meds to Treat Sx (n=263,266,244,235,226,225)
    20.2
    21.1
    28.3
    27.2
    20.8
    19.1
    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) [52]
    End point description
    Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Subjects may be represented in more than 1 category.Safety population, subjects who received given dose; (n)= number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Primary
    End point timeframe
    Day 1 through 4 after each dose
    Notes
    [52] - 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 endpoint.
    End point values
    		 13vPnC Toddler Dose 7vPnC Toddler Dose
    Number of subjects analysed
    290
    287
    Units: Percentage of Subjects
    number (not applicable)
        Fever ≥38°C but ≤ 39°C (n=206,200)
    58.7
    62
        Fever >39°C but ≤40°C (n=174,157)
    12.6
    8.9
        Fever >40°C (n=166,152)
    0.6
    0
        Decreased Appetite (n=204,192)
    43.6
    46.4
        Irritability (n=213,200)
    55.4
    61
        Increased Sleep (n=202,197)
    56.4
    54.8
        Decreased Sleep (n=195,170)
    31.8
    28.8
        Medication to Prevent Symptoms (n=184,182)
    32.1
    33
        Medication to Treat Symptoms (n=178,167)
    18
    18.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were recorded from the signing of the ICF to visit 4 and from visit 5 to visit 6. SAEs were recorded from the signing of the ICF to 6 months after the final study vaccination.
    Adverse event reporting additional description
    Version was not captured, hence 0.0 is mentioned for dictionary version. Local reactions (LRs) and systemic events (SEs) were to be assessed only for infant series and toddler dose groups.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.

    Reporting group title
    7vPnC Infant Series
    Reporting group description
    		 Subjects received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.

    Reporting group title
    13vPnC Post-Infant Series
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from approximately one month after dose 3 to toddler dose.

    Reporting group title
    7vPnC Post-Infant Series
    Reporting group description
    		 Subjects received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.

    Reporting group title
    13vPnC Toddler Dose
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC at 12 months of age. Adverse events were collected for approximately one month after toddler dose

    Reporting group title
    7vPnC Toddler Dose
    Reporting group description
    		 Subjects received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age. Adverse events were collected for approximately one month after toddler dose.

    Reporting group title
    13vPnC 6-Month Follow-up
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last study vaccine.

    Reporting group title
    7vPnC 6-Month Follow-up
    Reporting group description
    		 Subjects received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last study vaccine.

    Serious adverse events
    		 13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Dose 7vPnC Toddler Dose 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 299 (4.01%)
    10 / 300 (3.33%)
    16 / 299 (5.35%)
    15 / 300 (5.00%)
    3 / 289 (1.04%)
    4 / 284 (1.41%)
    11 / 287 (3.83%)
    14 / 287 (4.88%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Brain contusion
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skeletal injury
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    2 / 299 (0.67%)
    3 / 300 (1.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chemical poisoning
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental exposure
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Vitello-intestinal duct remnant
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus paralytic
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Epididymitis
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Apnoeic attack
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle twitching
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    4 / 300 (1.33%)
    1 / 289 (0.35%)
    1 / 284 (0.35%)
    3 / 287 (1.05%)
    3 / 287 (1.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 4
    0 / 1
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 299 (0.67%)
    2 / 300 (0.67%)
    2 / 299 (0.67%)
    3 / 300 (1.00%)
    1 / 289 (0.35%)
    1 / 284 (0.35%)
    1 / 287 (0.35%)
    3 / 287 (1.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 3
    0 / 1
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 299 (0.67%)
    4 / 300 (1.33%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    2 / 300 (0.67%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 299 (0.00%)
    2 / 300 (0.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral tonsillitis
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed [1]
    0 / 299 (0.00%)
    0 / 299 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    2 / 287 (0.70%)
    1 / 287 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Feeding disorder neonatal
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acidosis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. 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.
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Dose 7vPnC Toddler Dose 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    256 / 299 (85.62%)
    253 / 300 (84.33%)
    13 / 299 (4.35%)
    25 / 300 (8.33%)
    217 / 289 (75.09%)
    208 / 284 (73.24%)
    11 / 287 (3.83%)
    8 / 287 (2.79%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    29 / 299 (9.70%)
    27 / 300 (9.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    14 / 289 (4.84%)
    28 / 284 (9.86%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    34
    31
    0
    0
    14
    29
    0
    0
    Injection site erythema
         subjects affected / exposed
    2 / 299 (0.67%)
    2 / 300 (0.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    4 / 289 (1.38%)
    5 / 284 (1.76%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    2
    0
    0
    4
    5
    0
    0
    Injection site swelling
         subjects affected / exposed
    3 / 299 (1.00%)
    4 / 300 (1.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    3 / 289 (1.04%)
    5 / 284 (1.76%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    4
    5
    0
    0
    3
    5
    0
    0
    Injection site pain
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    2 / 289 (0.69%)
    4 / 284 (1.41%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    2
    0
    0
    2
    4
    0
    0
    Injection site induration
         subjects affected / exposed
    1 / 299 (0.33%)
    3 / 300 (1.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    4 / 284 (1.41%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    5
    0
    0
    1
    4
    0
    0
    Irritability
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    3 / 289 (1.04%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    1
    0
    0
    Developmental delay
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    2
    1
    1
    0
    0
    0
    Granuloma
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Injection site haematoma
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    2 / 299 (0.67%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    117 / 269 (43.49%)
    103 / 266 (38.72%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    121 / 206 (58.74%)
    124 / 200 (62.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    117
    103
    0
    0
    121
    124
    0
    0
    Fever >39°C but ≤40°C Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    11 / 260 (4.23%)
    4 / 256 (1.56%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    22 / 174 (12.64%)
    14 / 157 (8.92%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    11
    4
    0
    0
    22
    14
    0
    0
    Fever >40°C Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    0 / 259 (0.00%)
    0 / 256 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 166 (0.60%)
    0 / 152 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Decreased appetite Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    89 / 269 (33.09%)
    81 / 267 (30.34%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    89 / 204 (43.63%)
    89 / 192 (46.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    89
    81
    0
    0
    89
    89
    0
    0
    Irritability Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    117 / 275 (42.55%)
    120 / 266 (45.11%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    118 / 213 (55.40%)
    122 / 200 (61.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    117
    120
    0
    0
    118
    122
    0
    0
    Increased sleep Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    175 / 284 (61.62%)
    160 / 272 (58.82%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    114 / 202 (56.44%)
    108 / 197 (54.82%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    175
    160
    0
    0
    114
    108
    0
    0
    Decreased sleep Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    67 / 266 (25.19%)
    69 / 264 (26.14%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    62 / 195 (31.79%)
    49 / 170 (28.82%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    67
    69
    0
    0
    62
    49
    0
    0
    Fever ≥38°C but ≤39°C Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    116 / 248 (46.77%)
    121 / 250 (48.40%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    116
    121
    0
    0
    0
    0
    0
    0
    Fever >39°C but ≤40°C Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    21 / 238 (8.82%)
    10 / 225 (4.44%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    21
    10
    0
    0
    0
    0
    0
    0
    Decreased appetite Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    84 / 249 (33.73%)
    84 / 245 (34.29%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    84
    84
    0
    0
    0
    0
    0
    0
    Irritability Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    120 / 254 (47.24%)
    139 / 252 (55.16%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    120
    139
    0
    0
    0
    0
    0
    0
    Increased sleep Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    139 / 258 (53.88%)
    171 / 256 (66.80%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    139
    171
    0
    0
    0
    0
    0
    0
    Decreased sleep Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    57 / 240 (23.75%)
    54 / 234 (23.08%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    57
    54
    0
    0
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    112 / 242 (46.28%)
    85 / 232 (36.64%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    112
    85
    0
    0
    0
    0
    0
    0
    Fever >39°C but ≤40°C Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    8 / 216 (3.70%)
    3 / 210 (1.43%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    8
    3
    0
    0
    0
    0
    0
    0
    Fever >40°C Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    2 / 216 (0.93%)
    0 / 209 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Decreased appetite Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    78 / 236 (33.05%)
    68 / 225 (30.22%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    78
    68
    0
    0
    0
    0
    0
    0
    Irritability Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    108 / 238 (45.38%)
    115 / 235 (48.94%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    108
    115
    0
    0
    0
    0
    0
    0
    Increased sleep Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    119 / 240 (49.58%)
    119 / 241 (49.38%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    119
    119
    0
    0
    0
    0
    0
    0
    Decreased sleep Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    48 / 230 (20.87%)
    54 / 221 (24.43%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    48
    54
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Food allergy
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Atopy
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Balanitis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Vulval disorder
         subjects affected / exposed
    5 / 299 (1.67%)
    7 / 300 (2.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    5
    7
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    2 / 300 (0.67%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    1 / 287 (0.35%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    1
    1
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    1 / 287 (0.35%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    1
    Tonsillar disorder
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Cough
         subjects affected / exposed
    12 / 299 (4.01%)
    7 / 300 (2.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    7 / 289 (2.42%)
    3 / 284 (1.06%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    15
    9
    0
    0
    7
    3
    0
    0
    Dysphonia
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    Bronchial obstruction
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Obstructive airways disorder
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Stridor
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Supraclavicular retraction
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Wheezing
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    3 / 289 (1.04%)
    3 / 284 (1.06%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    3
    3
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    3 / 289 (1.04%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    1
    0
    3
    0
    0
    0
    Screaming
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Agitation
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Crying
         subjects affected / exposed
    11 / 299 (3.68%)
    10 / 300 (3.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    2 / 284 (0.70%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    13
    13
    0
    0
    1
    2
    0
    0
    Restlessness
         subjects affected / exposed
    7 / 299 (2.34%)
    14 / 300 (4.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    3 / 289 (1.04%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    9
    15
    0
    0
    3
    1
    0
    0
    Investigations
    Cardiac murmur
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    1 / 287 (0.35%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Blood immunoglobulin e increased
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    0
    Contusion
         subjects affected / exposed
    3 / 299 (1.00%)
    2 / 300 (0.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    3
    2
    0
    0
    1
    0
    0
    0
    Laceration
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    Limb injury
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Mouth injury
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Thermal burn
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Concussion
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    1
    0
    Arthropod bite
         subjects affected / exposed
    1 / 299 (0.33%)
    2 / 300 (0.67%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    2
    1
    0
    1
    0
    0
    0
    Accidental exposure
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Skeletal injury
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    2 / 289 (0.69%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    2 / 287 (0.70%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    2
    Gastroenteritis
         subjects affected / exposed
    21 / 299 (7.02%)
    22 / 300 (7.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    16 / 289 (5.54%)
    11 / 284 (3.87%)
    3 / 287 (1.05%)
    3 / 287 (1.05%)
         occurrences all number
    25
    23
    0
    0
    16
    11
    3
    3
    Clavicle fracture
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Exposure to toxic agent
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Nicotine poisoning
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Brain contusion
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Congenital, familial and genetic disorders
    21-hydroxylase deficiency
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Cryptorchism
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    0
    0
    Dacryostenosis congenital
         subjects affected / exposed
    0 / 299 (0.00%)
    2 / 300 (0.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Congenital torticollis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Craniotabes
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Hereditary fructose intolerance
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Macrocephaly
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Naevus flammeus
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Pectus excavatum
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Plagiocephaly
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Hypokinesia
         subjects affected / exposed
    0 / 299 (0.00%)
    2 / 300 (0.67%)
    0 / 299 (0.00%)
    2 / 300 (0.67%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    0
    2
    0
    2
    0
    1
    0
    1
    Pseudoparalysis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Hypersomnia
         subjects affected / exposed
    3 / 299 (1.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    1
    0
    0
    High-pitched crying
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    Fine motor delay
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Coordination abnormal
         subjects affected / exposed
    3 / 299 (1.00%)
    7 / 300 (2.33%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    2 / 284 (0.70%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    3
    7
    0
    1
    0
    2
    0
    0
    Hypotonia
         subjects affected / exposed
    1 / 299 (0.33%)
    3 / 300 (1.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    0
    0
    Hypertonia
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Myotonia
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Febrile convulsion
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    2 / 287 (0.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 299 (0.67%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    1 / 289 (0.35%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    1
    0
    1
    1
    1
    0
    0
    Anaemia
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    0
    Mastocytosis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Middle ear effusion
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    1
    0
    0
    Middle ear disorder
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Ear pain
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Otosalpingitis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Eye disorders
    Hypermetropia
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    Strabismus
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    22 / 299 (7.36%)
    25 / 300 (8.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    9 / 289 (3.11%)
    6 / 284 (2.11%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    23
    30
    0
    0
    9
    6
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Eyelid disorder
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Dacryostenosis acquired
         subjects affected / exposed
    1 / 299 (0.33%)
    2 / 300 (0.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    Pupils unequal
         subjects affected / exposed
    2 / 299 (0.67%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Dacryoadenitis acquired
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Eye inflammation
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    21 / 299 (7.02%)
    14 / 300 (4.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    4 / 289 (1.38%)
    8 / 284 (2.82%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    23
    15
    0
    0
    4
    8
    1
    0
    Teething
         subjects affected / exposed
    6 / 299 (2.01%)
    8 / 300 (2.67%)
    0 / 299 (0.00%)
    2 / 300 (0.67%)
    4 / 289 (1.38%)
    3 / 284 (1.06%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    7
    9
    0
    2
    4
    3
    0
    0
    Vomiting
         subjects affected / exposed
    8 / 299 (2.68%)
    7 / 300 (2.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    3 / 289 (1.04%)
    2 / 284 (0.70%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    8
    7
    0
    0
    3
    2
    0
    0
    Constipation
         subjects affected / exposed
    11 / 299 (3.68%)
    6 / 300 (2.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    2 / 284 (0.70%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    12
    6
    0
    0
    1
    2
    0
    0
    Flatulence
         subjects affected / exposed
    11 / 299 (3.68%)
    8 / 300 (2.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    2 / 289 (0.69%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    13
    10
    0
    0
    2
    1
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    Dental discomfort
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    5 / 299 (1.67%)
    2 / 300 (0.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    2 / 289 (0.69%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    5
    2
    0
    0
    2
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    2 / 284 (0.70%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    2
    0
    0
    Aphthous stomatitis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    1
    Cheilitis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Enteritis
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Infantile colic
         subjects affected / exposed
    2 / 299 (0.67%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    0
    Anal prolapse
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Neurodermatitis
         subjects affected / exposed
    3 / 299 (1.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    1
    0
    Dermatitis diaper
         subjects affected / exposed
    22 / 299 (7.36%)
    25 / 300 (8.33%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    17 / 289 (5.88%)
    16 / 284 (5.63%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    24
    29
    0
    1
    17
    16
    0
    0
    Eczema
         subjects affected / exposed
    10 / 299 (3.34%)
    14 / 300 (4.67%)
    2 / 299 (0.67%)
    0 / 300 (0.00%)
    3 / 289 (1.04%)
    5 / 284 (1.76%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    10
    15
    2
    15
    3
    5
    0
    0
    Eczema infantile
         subjects affected / exposed
    6 / 299 (2.01%)
    6 / 300 (2.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    3 / 289 (1.04%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    6
    6
    1
    0
    3
    1
    0
    0
    Rash
         subjects affected / exposed
    4 / 299 (1.34%)
    5 / 300 (1.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    3 / 284 (1.06%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    5
    5
    0
    0
    1
    3
    0
    0
    Dermatitis
         subjects affected / exposed
    1 / 299 (0.33%)
    3 / 300 (1.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    3 / 289 (1.04%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    3
    0
    0
    3
    0
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    7 / 299 (2.34%)
    5 / 300 (1.67%)
    0 / 299 (0.00%)
    2 / 300 (0.67%)
    3 / 289 (1.04%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    7
    5
    0
    2
    3
    0
    0
    0
    Eczema asteatotic
         subjects affected / exposed
    3 / 299 (1.00%)
    4 / 300 (1.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    2 / 289 (0.69%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    3
    4
    0
    0
    2
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    Dry skin
         subjects affected / exposed
    2 / 299 (0.67%)
    3 / 300 (1.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    1
    0
    0
    Intertrigo
         subjects affected / exposed
    1 / 299 (0.33%)
    5 / 300 (1.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    5
    0
    0
    0
    1
    0
    0
    Rash generalised
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Xeroderma
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Heat rash
         subjects affected / exposed
    0 / 299 (0.00%)
    2 / 300 (0.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Hirsutism
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Petechiae
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Rash neonatal
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Rash papular
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Skin exfoliation
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Skin induration
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Vitiligo
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Tenderness (Any) Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    88 / 267 (32.96%)
    87 / 267 (32.58%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    110 / 206 (53.40%)
    96 / 185 (51.89%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    88
    87
    0
    0
    110
    96
    0
    0
    Tenderness (Significant) Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [23]
    20 / 260 (7.69%)
    18 / 258 (6.98%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    19 / 176 (10.80%)
    20 / 158 (12.66%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    20
    18
    0
    0
    19
    20
    0
    0
    Induration (Any) Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    75 / 266 (28.20%)
    54 / 263 (20.53%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    70 / 190 (36.84%)
    77 / 176 (43.75%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    75
    54
    0
    0
    70
    77
    0
    0
    Induration (Mild) Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    65 / 265 (24.53%)
    50 / 263 (19.01%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    62 / 186 (33.33%)
    70 / 172 (40.70%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    65
    50
    0
    0
    62
    70
    0
    0
    Induration (Moderate) Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    19 / 261 (7.28%)
    15 / 256 (5.86%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    21 / 174 (12.07%)
    20 / 158 (12.66%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    19
    15
    0
    0
    21
    20
    0
    0
    Erythema (Any) Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    75 / 266 (28.20%)
    99 / 272 (36.40%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    93 / 196 (47.45%)
    103 / 184 (55.98%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    75
    99
    0
    0
    93
    103
    0
    0
    Erythema (Mild) Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    72 / 265 (27.17%)
    98 / 271 (36.16%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    85 / 191 (44.50%)
    95 / 180 (52.78%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    72
    98
    0
    0
    85
    95
    0
    0
    Erythema (Moderate) Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    5 / 260 (1.92%)
    4 / 256 (1.56%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    20 / 173 (11.56%)
    24 / 158 (15.19%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    5
    4
    0
    0
    20
    24
    0
    0
    Erythema (Severe) Dose 1 and Toddler dose
    Additional description: Dose 1: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    0 / 259 (0.00%)
    0 / 255 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 166 (0.00%)
    1 / 153 (0.65%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Tenderness (Any) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    73 / 250 (29.20%)
    76 / 241 (31.54%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    73
    76
    0
    0
    0
    0
    0
    0
    Tenderness (Significant) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    11 / 236 (4.66%)
    17 / 226 (7.52%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    11
    17
    0
    0
    0
    0
    0
    0
    Induration (Any) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    65 / 244 (26.64%)
    85 / 242 (35.12%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    65
    85
    0
    0
    0
    0
    0
    0
    Induration (Mild) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    59 / 243 (24.28%)
    80 / 239 (33.47%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    59
    80
    0
    0
    0
    0
    0
    0
    Induration (Moderate) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    18 / 235 (7.66%)
    15 / 227 (6.61%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    18
    15
    0
    0
    0
    0
    0
    0
    Erythema (Any) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    85 / 247 (34.41%)
    118 / 252 (46.83%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    85
    118
    0
    0
    0
    0
    0
    0
    Erythema (Mild) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    83 / 247 (33.60%)
    114 / 250 (45.60%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    83
    114
    0
    0
    0
    0
    0
    0
    Erythema (Moderate) Dose 2
    Additional description: Dose 2: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: lo 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    4 / 232 (1.72%)
    8 / 224 (3.57%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    4
    8
    0
    0
    0
    0
    0
    0
    Tenderness (Any) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    62 / 229 (27.07%)
    47 / 221 (21.27%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    62
    47
    0
    0
    0
    0
    0
    0
    Tenderness (Significant) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    9 / 215 (4.19%)
    6 / 209 (2.87%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    9
    6
    0
    0
    0
    0
    0
    0
    Induration (Any) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    59 / 226 (26.11%)
    64 / 224 (28.57%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    59
    64
    0
    0
    0
    0
    0
    0
    Induration (Mild) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [42]
    56 / 226 (24.78%)
    62 / 223 (27.80%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    56
    62
    0
    0
    0
    0
    0
    0
    Induration (Moderate) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [43]
    15 / 217 (6.91%)
    11 / 211 (5.21%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    15
    11
    0
    0
    0
    0
    0
    0
    Erythema (Any) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [44]
    83 / 238 (34.87%)
    92 / 231 (39.83%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    83
    92
    0
    0
    0
    0
    0
    0
    Erythema (Mild) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [45]
    81 / 237 (34.18%)
    89 / 229 (38.86%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    81
    89
    0
    0
    0
    0
    0
    0
    Erythema (Moderate) Dose 3
    Additional description: Dose 3: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [46]
    10 / 217 (4.61%)
    5 / 210 (2.38%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    10
    5
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Urinary tract disorder
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Ureteric stenosis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Vesicoureteric reflux
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    Foot deformity
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    2 / 300 (0.67%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Posture abnormal
         subjects affected / exposed
    2 / 299 (0.67%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Arthropathy
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Exostosis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Head deformity
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Hypotonia neonatal
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    75 / 299 (25.08%)
    64 / 300 (21.33%)
    2 / 299 (0.67%)
    1 / 300 (0.33%)
    40 / 289 (13.84%)
    32 / 284 (11.27%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    95
    83
    2
    1
    43
    34
    0
    0
    Bronchitis
         subjects affected / exposed
    49 / 299 (16.39%)
    45 / 300 (15.00%)
    2 / 299 (0.67%)
    2 / 300 (0.67%)
    20 / 289 (6.92%)
    19 / 284 (6.69%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    52
    55
    3
    2
    22
    19
    0
    0
    Rhinitis
         subjects affected / exposed
    24 / 299 (8.03%)
    32 / 300 (10.67%)
    2 / 299 (0.67%)
    0 / 300 (0.00%)
    16 / 289 (5.54%)
    13 / 284 (4.58%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    29
    37
    2
    0
    16
    15
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    19 / 299 (6.35%)
    28 / 300 (9.33%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    10 / 289 (3.46%)
    14 / 284 (4.93%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    23
    33
    0
    1
    10
    16
    0
    0
    Otitis media
         subjects affected / exposed
    7 / 299 (2.34%)
    13 / 300 (4.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    12 / 289 (4.15%)
    10 / 284 (3.52%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    7
    14
    0
    0
    12
    10
    1
    0
    Viral infection
         subjects affected / exposed
    11 / 299 (3.68%)
    14 / 300 (4.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    5 / 289 (1.73%)
    8 / 284 (2.82%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    11
    14
    0
    0
    5
    8
    0
    1
    Febrile infection
         subjects affected / exposed
    7 / 299 (2.34%)
    10 / 300 (3.33%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    7 / 289 (2.42%)
    5 / 284 (1.76%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    8
    10
    0
    1
    7
    5
    0
    0
    Croup infectious
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    2 / 289 (0.69%)
    3 / 284 (1.06%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    0
    0
    0
    2
    3
    0
    0
    Exanthema subitum
         subjects affected / exposed
    4 / 299 (1.34%)
    4 / 300 (1.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    3 / 289 (1.04%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    4
    4
    0
    0
    3
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    9 / 299 (3.01%)
    12 / 300 (4.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    1 / 289 (0.35%)
    3 / 284 (1.06%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    9
    12
    0
    1
    1
    3
    0
    0
    Pharyngitis
         subjects affected / exposed
    2 / 299 (0.67%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    3 / 284 (1.06%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    1
    0
    0
    1
    3
    0
    0
    Candida nappy rash
         subjects affected / exposed
    4 / 299 (1.34%)
    5 / 300 (1.67%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    2 / 289 (0.69%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    4
    5
    0
    1
    2
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    2 / 289 (0.69%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    1
    0
    0
    Acute tonsillitis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    2 / 289 (0.69%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    Enteritis infectious
         subjects affected / exposed
    3 / 299 (1.00%)
    5 / 300 (1.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    1 / 284 (0.35%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    4
    5
    0
    0
    1
    1
    1
    0
    Influenza
         subjects affected / exposed
    2 / 299 (0.67%)
    4 / 300 (1.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    4
    0
    0
    1
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    1
    0
    0
    Bronchitis viral
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Bronchopneumonia
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Candidiasis
         subjects affected / exposed
    2 / 299 (0.67%)
    3 / 300 (1.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    3
    0
    0
    1
    0
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Infection
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Omphalitis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Oral fungal infection
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    0
    Otitis externa
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Otitis media acute
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Paronychia
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Pseudocroup
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    6 / 299 (2.01%)
    3 / 300 (1.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    6
    3
    0
    0
    0
    1
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 299 (0.00%)
    2 / 300 (0.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    0
    Rhinolaryngitis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Rotavirus infection
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Scarlet fever
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Tinea infection
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    Tracheitis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Tracheobronchitis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Viral skin infection
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Wound infection
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    Salmonellosis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    Varicella
         subjects affected / exposed
    3 / 299 (1.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    3 / 299 (1.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    1
    Bacterial infection
         subjects affected / exposed
    2 / 299 (0.67%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Bronchiolitis
         subjects affected / exposed
    2 / 299 (0.67%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Genital candidiasis
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Viral rash
         subjects affected / exposed
    2 / 299 (0.67%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    Abscess
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Bacterial rhinitis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Bronchitis bacterial
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Conjunctivitis infective
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Eczema infected
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Otitis media viral
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Pertussis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Postoperative wound infection
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Sinobronchitis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Tonsillitis streptococcal
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Viral diarrhoea
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Viral rhinitis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Burns second degree
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Skin candida
         subjects affected / exposed
    0 / 299 (0.00%)
    3 / 300 (1.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    2 / 284 (0.70%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    2
    0
    0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    3 / 287 (1.05%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    3
    Metabolism and nutrition disorders
    Feeding disorder neonatal
         subjects affected / exposed
    1 / 299 (0.33%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    1
    0
    Hyperphosphatasaemia
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    1 / 284 (0.35%)
    0 / 287 (0.00%)
    1 / 287 (0.35%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Weight gain poor
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    1 / 299 (0.33%)
    2 / 300 (0.67%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    2 / 284 (0.70%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    2
    2
    0
    0
    1
    2
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    1 / 289 (0.35%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    2 / 287 (0.70%)
    1 / 287 (0.35%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    1
    Acidosis
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Failure to thrive
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Obesity
         subjects affected / exposed
    0 / 299 (0.00%)
    1 / 300 (0.33%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Oral intake reduced
         subjects affected / exposed
    1 / 299 (0.33%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    0 / 287 (0.00%)
    0 / 287 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 299 (0.00%)
    0 / 300 (0.00%)
    0 / 289 (0.00%)
    0 / 284 (0.00%)
    1 / 287 (0.35%)
    0 / 287 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [45] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [46] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.

    More information

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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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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