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    Clinical Trial Results:
    A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations

    Summary
    EudraCT number
    		 2006-001685-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    04 Jun 2008

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    6096A1-009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00366548
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: B1851092
    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., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, 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?
    Yes
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Sep 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To demonstrate that the immune responses to the 13 common pneumococcal conjugates (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) induced by 13-valent pneumococcal conjugate vaccine (13vPnC) with polysorbate 80 (13vPnC+P80) were noninferior to the immune responses induced by 13vPnC without polysorbate 80 (13vPnC-P80) when measured 1 month after the infant series. 2) The safety objective of this study was to evaluate the acceptability of the safety profile of the 13vPnC+P80 and 13vPnC-P80, 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 the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on  Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Nov 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
    Poland: 500
    Worldwide total number of subjects
    500
    EEA total number of subjects
    500
    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)
    500
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited in Poland from November 2006 to December 2006.

    Pre-assignment
    Screening details
    		 Subjects were enrolled into the study according to inclusion or 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 with (+) Polysorbate 80 Infant Series
    Arm description
    		 Subjects received 13vPnC with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC + P80
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 milliliter (mL) dose of 13vPnC with P80 at approximately 2, 3 and 4 months of age.

    Investigational medicinal product name
    Pentaxim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) at 2, 3 and 4 months of age.

    Investigational medicinal product name
    Engerix B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age.

    Arm title
    		 13vPnC without (-) Polysorbate 80 Infant Series
    Arm description
    		 Subjects received of 13vPnC without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    13vPnC - P80
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of 13vPnC without P80 at approximately 2, 3 and 4 months of age.

    Investigational medicinal product name
    Pentaxim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) at 2, 3 and 4 months of age.

    Investigational medicinal product name
    Engerix B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age.

    Number of subjects in period 1
    		13vPnC with (+) Polysorbate 80 Infant Series 13vPnC without (-) Polysorbate 80 Infant Series
    Started
    250
    250
    Vaccinated Dose 1
    250
    250
    Vaccinated Dose 3
    246
    247
    Vaccinated Dose 2
    246
    249
    Completed
    246
    245
    Not completed
    4
    5
         Consent withdrawn by subject
    3
    1
         Adverse Event
    1
    3
         Protocol deviation
    -
    1
    Period 2
    Period 2 title
    After Infant Series
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC + Polysorbate 80 After Infant Series
    Arm description
    		 Included subjects who received one single 0.5 mL dose of 13vPnC with P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months of age in infant series.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 13vPnC - Polysorbate 80 After Infant Series
    Arm description
    		 Included subjects who received one single 0.5 mL dose of 13vPnC without P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months of age in 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 + Polysorbate 80 After Infant Series 13vPnC - Polysorbate 80 After Infant Series
    Started
    246
    245
    Completed
    240
    244
    Not completed
    6
    1
         Consent withdrawn by subject
    3
    1
         Adverse Event
    2
    -
         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+Polysorbate 80 After Toddler Dose
    Arm description
    		 Subjects received 13vPnC with P80 coadministered with Priorix at 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC + P80
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of 13vPnC with P80 at approximately 12 months of age.

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age.

    Arm title
    		 13vPnC - Polysorbate 80 After Toddler Dose
    Arm description
    		 Subjects received 13vPnC without P80 coadministered with Priorix at 12 months of age (toddler dose).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    13vPnC - P80
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of 13vPnC without P80 at approximately 12 months of age.

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received one single 0.5 mL dose of combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age.

    Number of subjects in period 3
    		13vPnC+Polysorbate 80 After Toddler Dose 13vPnC - Polysorbate 80 After Toddler Dose
    Started
    240
    244
    Completed
    240
    244

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC with (+) Polysorbate 80 Infant Series
    Reporting group description
    		 Subjects received 13vPnC with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age.

    Reporting group title
    13vPnC without (-) Polysorbate 80 Infant Series
    Reporting group description
    		 Subjects received of 13vPnC without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age.

    Reporting group values
    		 13vPnC with (+) Polysorbate 80 Infant Series 13vPnC without (-) Polysorbate 80 Infant Series Total
    Number of subjects
    		 250 250 500
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 2.1 ± 0.5 2.1 ± 0.5 -
    Gender categorical
    Units: Subjects
        Female
    		 122 122 244
        Male
    		 128 128 256

    End points

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    End points reporting groups
    Reporting group title
    13vPnC with (+) Polysorbate 80 Infant Series
    Reporting group description
    		 Subjects received 13vPnC with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age.

    Reporting group title
    13vPnC without (-) Polysorbate 80 Infant Series
    Reporting group description
    		 Subjects received of 13vPnC without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age.
    Reporting group title
    13vPnC + Polysorbate 80 After Infant Series
    Reporting group description
    		 Included subjects who received one single 0.5 mL dose of 13vPnC with P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months of age in infant series.

    Reporting group title
    13vPnC - Polysorbate 80 After Infant Series
    Reporting group description
    		 Included subjects who received one single 0.5 mL dose of 13vPnC without P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months of age in infant series.
    Reporting group title
    13vPnC+Polysorbate 80 After Toddler Dose
    Reporting group description
    		 Subjects received 13vPnC with P80 coadministered with Priorix at 12 months of age.

    Reporting group title
    13vPnC - Polysorbate 80 After Toddler Dose
    Reporting group description
    		 Subjects received 13vPnC without P80 coadministered with Priorix at 12 months of age (toddler dose).

    Subject analysis set title
    13vPnC + P80 Dose 1 Infant Series
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).

    Subject analysis set title
    13vPnC - P 80 Dose 1 Infant Series
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).

    Subject analysis set title
    13vPnC + P80 Dose 2 Infant Series
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).

    Subject analysis set title
    13vPnC - P80 Dose 2 Infant Series
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).

    Subject analysis set title
    13vPnC - P80 Dose 3 Infant Series
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).

    Subject analysis set title
    13vPnC + P80 Dose 3 Infant Series
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).

    Subject analysis set title
    13vPnC + P80 Toddler Dose
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).

    Subject analysis set title
    13vPnC - P80 Toddler Dose
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).

    Primary: Percentage of Subjects Achieving Antibody Level Greater Than or Equal to (>=) 0.35 microgram per milliliter (μg/mL) in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series

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    End point title
    		 Percentage of Subjects Achieving Antibody Level Greater Than or Equal to (>=) 0.35 microgram per milliliter (μg/mL) in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series
    End point description
    Percentages of subjects achieving World Health Organization (WHO) predefined antibody threshold >=0.35 μg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of subjects with an antibody concentration >=0.35 micro gram per milliliter (mcg/mL) for the given serotype.
    End point type
    Primary
    End point timeframe
    One month after 3-dose infant series (at 5 months of age)
    End point values
    		 13vPnC - Polysorbate 80 After Infant Series 13vPnC + Polysorbate 80 After Infant Series
    Number of subjects analysed
    238 [1]
    238 [2]
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotypes - Serotype 4 (n=222,224)
    94.1 (90.3 to 96.7)
    93.3 (89.3 to 96.1)
        Common Serotypes - Serotype 6B (n=145,158)
    66.4 (60 to 72.4)
    60.9 (54.4 to 67.2)
        Common Serotypes - Serotype 9V (n=231,232)
    97.5 (94.6 to 99.1)
    97.1 (94 to 98.8)
        Common Serotypes - Serotype 14 (n=225,232)
    97.5 (94.6 to 99.1)
    94.5 (90.8 to 97.1)
        Common Serotypes - Serotype 18C (n=233,233)
    97.9 (95.2 to 99.3)
    97.9 (95.2 to 99.3)
        Common Serotypes - Serotype 19F (n=228,234)
    98.3 (95.8 to 99.5)
    95.8 (92.4 to 98)
        Common Serotypes - Serotype 23F (n=205,220)
    92.4 (88.3 to 95.5)
    86.1 (81.1 to 90.3)
        Additional Serotypes - Serotype 1 (n=228,220)
    92.4 (88.3 to 95.5)
    95.8 (92.4 to 98)
        Additional Serotypes - Serotype 3 (n=233,236)
    99.2 (97 to 99.9)
    97.9 (95.2 to 99.3)
        Additional Serotypes - Serotype 5 (n=224,220)
    92.4 (88.3 to 95.5)
    94.1 (90.3 to 96.7)
        Additional Serotypes - Serotype 6A (n=206,205)
    86.1 (81.1 to 90.3)
    86.6 (81.6 to 90.6)
        Additional Serotypes - Serotype 7F (n=235,237)
    99.6 (97.7 to 100)
    98.7 (96.4 to 99.7)
        Additional Serotypes - Serotype 19A (n=235,238)
    100 (98.5 to 100)
    98.7 (96.4 to 99.7)
    Notes
    [1] - Subjects with a determinate antibody concentration for the specified serotype.
    [2] - Subjects with a determinate antibody concentration for the specified serotype.
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.4
         upper limit
    		 3.7
    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 greater than (>) -10%.
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.2
         upper limit
    		 3.3
    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 9V
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 2.8
    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 14
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC - Polysorbate 80 After Infant Series v 13vPnC + Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 0.7
    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 18C
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 3
    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%.
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 0.6
    Notes
    [8] - 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
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -6.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.1
         upper limit
    		 -0.7
    Notes
    [9] - 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 1
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 7.9
    Notes
    [10] - Non-inferiority for each additional 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 3
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 1.1
    Notes
    [11] - Non-inferiority for each additional 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 5
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [12]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 6.4
    Notes
    [12] - Non-inferiority for each additional 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 6A
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [13]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 6.7
    Notes
    [13] - Non-inferiority for each additional 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 7F
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC - Polysorbate 80 After Infant Series v 13vPnC + Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [14]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 1.2
    Notes
    [14] - Non-inferiority for each additional 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 19A
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [15]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 0.3
    Notes
    [15] - Non-inferiority for each additional 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 (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series

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    End point title
    		 Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series
    End point description
    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) were presented. Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Primary
    End point timeframe
    1 month after 3-dose infant series (at 5 months of age)
    End point values
    		 13vPnC - Polysorbate 80 After Infant Series 13vPnC + Polysorbate 80 After Infant Series
    Number of subjects analysed
    238 [16]
    238 [17]
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Common Serotypes - Serotype 4
    1.53 (1.36 to 1.72)
    1.47 (1.3 to 1.65)
        Common Serotypes - Serotype 6B
    0.57 (0.48 to 0.68)
    0.51 (0.44 to 0.6)
        Common Serotypes - Serotype 9V
    1.51 (1.38 to 1.65)
    1.46 (1.34 to 1.6)
        Common Serotypes - Serotype 14
    2.48 (2.2 to 2.8)
    2.37 (2.06 to 2.73)
        Common Serotypes - Serotype 18C
    1.87 (1.71 to 2.04)
    1.84 (1.67 to 2.03)
        Common Serotypes - Serotype 19F
    1.75 (1.6 to 1.91)
    1.46 (1.3 to 1.65)
        Common Serotypes - Serotype 23F
    1.11 (1 to 1.24)
    0.93 (0.83 to 1.05)
        Additional Serotypes - Serotype 1
    1.48 (1.32 to 1.66)
    1.39 (1.26 to 1.55)
        Additional Serotypes - Serotype 3
    1.62 (1.49 to 1.75)
    1.5 (1.38 to 1.63)
        Additional Serotypes - Serotype 5
    1.3 (1.16 to 1.44)
    1.26 (1.13 to 1.4)
        Additional Serotypes - Serotype 6A
    1.04 (0.92 to 1.17)
    0.99 (0.88 to 1.12)
        Additional Serotypes - Serotype 7F
    1.89 (1.73 to 2.06)
    1.98 (1.81 to 2.15)
        Additional Serotypes - Serotype 19A
    2.94 (2.69 to 3.21)
    2.68 (2.44 to 2.95)
    Notes
    [16] - Subjects with a determinate IgG antibody concentration to the specified serotype.
    [17] - Subjects with a determinate IgG antibody concentration to the specified serotype.
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [18]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.13
    Notes
    [18] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [19]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.1
    Notes
    [19] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [20]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.14
    Notes
    [20] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [21]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.15
    Notes
    [21] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [22]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.13
    Notes
    [22] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [23]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.97
    Notes
    [23] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [24]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 0.98
    Notes
    [24] - Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [25]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.1
    Notes
    [25] - Non-inferiority for each additional 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 3
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [26]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.04
    Notes
    [26] - Non-inferiority for each additional serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [27]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.13
    Notes
    [27] - Non-inferiority for each additional serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [28]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.13
    Notes
    [28] - Non-inferiority for each additional serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [29]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.18
    Notes
    [29] - Non-inferiority for each additional serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    GMC ratio (13vPnC+P80/13vPnC-P80) was calculated.
    Comparison groups
    13vPnC + Polysorbate 80 After Infant Series v 13vPnC - Polysorbate 80 After Infant Series
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [30]
    Method
    Parameter type
    		 GMC ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.04
    Notes
    [30] - Non-inferiority for each additional serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC+P80/13vPnC-P80) > 0.5 (2-fold criterion).

    Secondary: Percentage of Subjects Achieving Antibody Level >=0.35 μg/mL in the 13vPnC Group After the Toddler Dose

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    End point title
    		 Percentage of Subjects Achieving Antibody Level >=0.35 μg/mL in the 13vPnC Group After the Toddler Dose
    End point description
    Percentages of subjects achieving World Health Organization (WHO) predefined antibody threshold >=0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of subjects with a determinate IgG antibody concentration to the given serotype.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose (at 13 months of age)
    End point values
    		 13vPnC - Polysorbate 80 After Toddler Dose 13vPnC+Polysorbate 80 After Toddler Dose
    Number of subjects analysed
    238 [31]
    227 [32]
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotypes - Serotype 4 (n=226,238)
    99.6 (97.7 to 100)
    99.6 (97.6 to 100)
        Common Serotypes - Serotype 6B (n=225,237)
    99.2 (97 to 99.9)
    99.6 (97.5 to 100)
        Common Serotypes - Serotype 9V (n=226,238)
    100 (98.5 to 100)
    99.6 (97.6 to 100)
        Common Serotypes - Serotype 14 (n=226,238)
    99.6 (97.7 to 100)
    99.6 (97.6 to 100)
        Common Serotypes - Serotype 18C (n=226,238)
    99.6 (97.7 to 100)
    100 (98.4 to 100)
        Common Serotypes - Serotype 19F (n=226,237)
    98.7 (96.3 to 99.7)
    99.1 (96.8 to 99.9)
        Common Serotypes - Serotype 23F (n=226,238)
    99.6 (97.7 to 100)
    98.7 (96.2 to 99.7)
        Additional Serotypes - Serotype 1 (n=226,238)
    99.2 (97 to 99.9)
    100 (98.4 to 100)
        Additional Serotypes - Serotype 3 (n=223,236)
    94.5 (90.8 to 97)
    95.1 (91.3 to 97.5)
        Additional Serotypes - Serotype 5 (n=226,238)
    100 (98.5 to 100)
    99.6 (97.6 to 100)
        Additional Serotypes - Serotype 6A (n=226,237)
    100 (98.5 to 100)
    99.6 (97.6 to 100)
        Additional Serotypes - Serotype 7F (n=226,238)
    100 (98.5 to 100)
    100 (98.4 to 100)
        Additional Serotypes - Serotype 19A (n=226,238)
    100 (98.5 to 100)
    100 (98.4 to 100)
    Notes
    [31] - Subjects with a determinate antibody concentration for the specified serotype.
    [32] - Subjects with a determinate antibody concentration for the specified serotype.
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [33]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 1.9
    Notes
    [33] - 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
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [34]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 2.6
    Notes
    [34] - 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
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [35]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 1.1
    Notes
    [35] - 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
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [36]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 1.9
    Notes
    [36] - 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
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [37]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 2.3
    Notes
    [37] - 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
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [38]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 2.9
    Notes
    [38] - 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
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [39]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 1.1
    Notes
    [39] - 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 1
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [40]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 3
    Notes
    [40] - Non-inferiority for each additional 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 3
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [41]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 4.9
    Notes
    [41] - Non-inferiority for each additional 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 5
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [42]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 1.1
    Notes
    [42] - Non-inferiority for each additional 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 6A
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [43]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.4
         upper limit
    		 1.2
    Notes
    [43] - Non-inferiority for each additional 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 7F
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [44]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 1.6
    Notes
    [44] - Non-inferiority for each additional 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 19A
    Statistical analysis description
    Difference in percentages between the two groups (13vPnC+P80 - 13vPnC-P80) was calculated.
    Comparison groups
    13vPnC+Polysorbate 80 After Toddler Dose v 13vPnC - Polysorbate 80 After Toddler Dose
    Number of subjects included in analysis
    465
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [45]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 1.6
    Notes
    [45] - Non-inferiority for each additional serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.

    Secondary: Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose

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    End point title
    		 Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose
    End point description
    GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations, (n) = number of subjects with a determinate IgG antibody concentration for the specified serotype.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose (at 13 months of age)
    End point values
    		 13vPnC - Polysorbate 80 After Toddler Dose 13vPnC+Polysorbate 80 After Toddler Dose
    Number of subjects analysed
    227
    238
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Common Serotypes - Serotype 4 (n=226,238)
    13.2 (4.65 to 5.92)
    5.38 (4.78 to 6.07)
        Common Serotypes - Serotype 6B (n=225,237)
    5.25 (8.7 to 11.23)
    10.65 (9.4 to 12.06)
        Common Serotypes - Serotype 9V (n=226,238)
    9.89 (2.73 to 3.31)
    3.1 (2.8 to 3.42)
        Common Serotypes - Serotype 14 (n=226,238)
    3.01 (10.26 to 13.4)
    11.95 (10.42 to 13.71)
        Common Serotypes - Serotype 18C (n=226,238)
    11.72 (3.06 to 3.78)
    3.1 (2.79 to 3.45)
        Common Serotypes - Serotype 19F (n=226,238)
    3.4 (8.45 to 10.97)
    10.27 (8.99 to 11.73)
        Common Serotypes - Serotype 23F (n=226,238)
    9.63 (3.44 to 4.38)
    4.15 (3.73 to 4.62)
        Additional Serotypes - Serotype 1 (n=226,238)
    3.88 (5.36 to 6.78)
    6.11 (5.43 to 6.87)
        Additional Serotypes - Serotype 3 (n=223,236)
    6.03 (0.99 to 1.2)
    1.16 (1.05 to 1.29)
        Additional Serotypes - Serotype 5 (n=226,238)
    1.09 (3.41 to 4.23)
    3.98 (3.59 to 4.41)
        Additional Serotypes - Serotype 6A (n=226,237)
    3.8 (6.66 to 8.4)
    8.19 (7.38 to 9.09)
        Additional Serotypes - Serotype 7F (n=226,238)
    7.48 (4.89 to 5.88)
    4.95 (4.5 to 5.44)
        Additional Serotypes - Serotype 19A (n=226,238)
    5.36 (11.88 to 14.67)
    13.02 (11.88 to 14.27)
    No statistical analyses for this end point

    Other pre-specified: Percent of Subjects Reporting Pre-Specified Local Reactions

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    End point title
    		 Percent of Subjects Reporting Pre-Specified Local Reactions
    End point description
    Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Subjects may be represented in more than 1 category. The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Other pre-specified
    End point timeframe
    Within 4-days after each dose
    End point values
    		 13vPnC + P80 Dose 1 Infant Series 13vPnC - P 80 Dose 1 Infant Series 13vPnC + P80 Dose 2 Infant Series 13vPnC - P80 Dose 2 Infant Series 13vPnC + P80 Dose 3 Infant Series 13vPnC - P80 Dose 3 Infant Series 13vPnC + P80 Toddler Dose 13vPnC - P80 Toddler Dose
    Number of subjects analysed
    250
    250
    246
    249
    246
    247
    240
    244
    Units: percentage of subjects
    number (not applicable)
        Tenderness-Any (n=238,237,228,229,210,216,178,188)
    27.7
    32.9
    26.8
    32.8
    24.8
    23.1
    42.1
    43.1
        Tenderness-Sig (n=235,233,220,221,203,211,160,165)
    2.1
    4.3
    0.9
    0.5
    1.5
    1.9
    2.5
    1.2
        Swelling-Any (n=236,239,228,228,210,225,174,181)
    22.9
    30.5
    25
    36.4
    36.7
    38.2
    29.9
    34.8
        Swelling-Mild (n=236,236,227,226,209,221,169,178)
    18.2
    24.2
    20.3
    31.9
    32.5
    33.5
    26.6
    29.8
        Swelling-Mod (n=236,236,224,224,208,217,164,171)
    11.9
    14.4
    11.2
    14.3
    13.9
    17.5
    12.2
    19.9
        Swelling-Severe(n=235,233,220,221,203,211,159,164)
    0
    0
    0
    0
    0
    0
    0
    0
        Redness-Any (n=238,238,232,231,216,226,178,200)
    29.8
    39.5
    38.8
    48.5
    46.8
    50
    42.1
    52
        Redness-Mild (n=238,235,232,230,215,226,176,194)
    28.2
    35.7
    38.4
    47
    46.5
    46.9
    35.8
    46.4
        Redness-Mod (n=235,232,220,222,206,211,164,173)
    2.1
    4.3
    1.4
    3.2
    3.9
    9
    12.8
    19.7
        Redness-Severe (n=235,231,220,221,203,211,159,164)
    0
    0
    0
    0
    0
    0
    0
    0.6
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events

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    End point title
    		 Percentage of Subjects Reporting Pre-Specified Systemic Events
    End point description
    Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr) appetite, irritability, increased (incr)sleep, decreased sleep, hives, use of medication (meds) to treat symptoms (sx), and use of medication to prevent symptoms) were reported using an electronic diary. Subjects may be represented in more than 1 category. The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Other pre-specified
    End point timeframe
    Within 4-days after each dose
    End point values
    		 13vPnC + P80 Dose 1 Infant Series 13vPnC - P 80 Dose 1 Infant Series 13vPnC + P80 Dose 2 Infant Series 13vPnC - P80 Dose 2 Infant Series 13vPnC + P80 Dose 3 Infant Series 13vPnC - P80 Dose 3 Infant Series 13vPnC + P80 Toddler Dose 13vPnC - P80 Toddler Dose
    Number of subjects analysed
    250
    250
    246
    249
    246
    247
    240
    244
    Units: percentage of subjects
    number (not applicable)
        Fv ≥38°C, ≤39°C(n=236,235,224,229,208,218,170,172)
    14
    16.2
    18.3
    17
    19.7
    20.6
    22.9
    18
        Fv >39°C, ≤40°C(n=235,233,221,221,203,211,162,164)
    0.4
    0.4
    0.9
    0.5
    1
    0.9
    2.5
    1.8
        Fv >40°C (n=235,233,221,221,203,211,160,164)
    0
    0
    0
    0
    0
    0
    0
    0
        Decr appetite (n=237,237,221,224,210,222,172,183)
    21.5
    22.4
    16.3
    24.1
    21.4
    20.7
    26.2
    29
        Irritability (n=240,239,232,232,215,226,184,198)
    55
    55.2
    51.7
    53.9
    45.6
    50
    49.5
    56.1
        Incr sleep (n=242,242,231,229,209,221,174,182)
    46.3
    52.5
    35.9
    39.3
    25.8
    27.6
    19
    30.8
        Decr sleep (n=238,236,227,227,209,217,170,180)
    35.7
    29.7
    24.7
    26.4
    25.4
    24.4
    19.4
    25.6
        Meds-treat sx (n=236,235,222,226,205,218,172,168)
    14
    16.6
    15.3
    16.8
    15.1
    14.7
    21.5
    15.5
        Meds-prevent sx(n=235,234,220,223,205,217,171,171)
    14.5
    15.8
    16.4
    15.2
    15.1
    10.6
    18.7
    15.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 6 months after the last administration of study drug
    Adverse event reporting additional description
    EU BR specific AE tables were generated separately as per EU format. Latest coding dictionary has been used for EU BR tables.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    13vPnC + P80 Infant Series
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses).

    Reporting group title
    13vPnC - P 80 Infant Series
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses).

    Reporting group title
    13vPnC + P80 Post-Infant Series
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses).

    Reporting group title
    13vPnC - P80 Post-Infant Series
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses).

    Reporting group title
    13vPnC - P80 Toddler Dose
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC - P80 coadministered with Priorix at 12 months of age (toddler dose).

    Reporting group title
    13vPnC + P80 Toddler Dose
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC + P80 coadministered with Priorix at 12 months of age (toddler dose).

    Reporting group title
    13vPnC + P80 6-Month Follow-up
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).

    Reporting group title
    13vPnC - P80 6-Month Follow-up
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).

    Serious adverse events
    		 13vPnC + P80 Infant Series 13vPnC - P 80 Infant Series 13vPnC + P80 Post-Infant Series 13vPnC - P80 Post-Infant Series 13vPnC - P80 Toddler Dose 13vPnC + P80 Toddler Dose 13vPnC + P80 6-Month Follow-up 13vPnC - P80 6-Month Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 249 (6.02%)
    21 / 250 (8.40%)
    24 / 249 (9.64%)
    16 / 250 (6.40%)
    2 / 244 (0.82%)
    3 / 239 (1.26%)
    13 / 249 (5.22%)
    14 / 250 (5.60%)
         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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal neoplasm
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (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
    General disorders and administration site conditions
    Fibrosis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Immune system disorders
    Alloimmunisation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Hypersensitivity
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Bronchospasm
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Pneumonia aspiration
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Sleep apnoea syndrome
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Breath holding
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Ultrasound kidney abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Injury, poisoning and procedural complications
    Head injury
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    2 / 249 (0.80%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    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
    Limbic traumatic amputation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Radius fracture
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (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
    Thermal burn
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Nervous system disorders
    Balance disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    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
    Hydrocephalus
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Leukocytosis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Splenomegaly
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    2 / 250 (0.80%)
    4 / 249 (1.61%)
    3 / 250 (1.20%)
    0 / 244 (0.00%)
    1 / 239 (0.42%)
    3 / 249 (1.20%)
    4 / 250 (1.60%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
    0 / 3
    0 / 0
    0 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Gastritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 244 (0.41%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Inguinal hernia, obstructive
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Hepatobiliary disorders
    Hepatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Skin and subcutaneous tissue disorders
    Urticaria
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Renal and urinary disorders
    Calculus urinary
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Hypercalciuria
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Renal tubular disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 249 (1.61%)
    9 / 250 (3.60%)
    5 / 249 (2.01%)
    1 / 250 (0.40%)
    1 / 244 (0.41%)
    0 / 239 (0.00%)
    1 / 249 (0.40%)
    2 / 250 (0.80%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 9
    0 / 5
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    3 / 250 (1.20%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    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
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    1 / 250 (0.40%)
    4 / 249 (1.61%)
    3 / 250 (1.20%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
    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
    Gastroenteritis rotavirus
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Laryngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    2 / 250 (0.80%)
    0 / 244 (0.00%)
    1 / 239 (0.42%)
    3 / 249 (1.20%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis meningococcal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Meningococcal sepsis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Otitis media
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Pharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    2 / 249 (0.80%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    2 / 249 (0.80%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 249 (3.21%)
    3 / 250 (1.20%)
    6 / 249 (2.41%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    3 / 249 (1.20%)
    3 / 250 (1.20%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
    0 / 6
    0 / 1
    0 / 0
    0 / 0
    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
    Pneumonia primary atypical
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    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
    Rhinitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 250 (0.80%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Sepsis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (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
    Staphylococcal bacteraemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    1 / 249 (0.40%)
    2 / 250 (0.80%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    2 / 249 (0.80%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 13vPnC + P80 Infant Series 13vPnC - P 80 Infant Series 13vPnC + P80 Post-Infant Series 13vPnC - P80 Post-Infant Series 13vPnC - P80 Toddler Dose 13vPnC + P80 Toddler Dose 13vPnC + P80 6-Month Follow-up 13vPnC - P80 6-Month Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    132 / 249 (53.01%)
    132 / 250 (52.80%)
    15 / 249 (6.02%)
    9 / 250 (3.60%)
    111 / 244 (45.49%)
    91 / 239 (38.08%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    General disorders and administration site conditions
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 249 (2.01%)
    4 / 250 (1.60%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 244 (0.41%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    5
    4
    0
    0
    1
    1
    0
    0
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Injection site nodule
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    33 / 236 (13.98%)
    38 / 235 (16.17%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    31 / 172 (18.02%)
    39 / 170 (22.94%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    33
    38
    0
    0
    31
    39
    0
    0
    Fever ≥38°C but ≤39°C: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    41 / 224 (18.30%)
    39 / 229 (17.03%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    41
    39
    0
    0
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    41 / 208 (19.71%)
    45 / 218 (20.64%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    41
    45
    0
    0
    0
    0
    0
    0
    Fever >39°C but ≤40°C: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    1 / 235 (0.43%)
    1 / 233 (0.43%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 164 (1.83%)
    4 / 162 (2.47%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    3
    4
    0
    0
    Fever >39°C but ≤40°C: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    2 / 221 (0.90%)
    1 / 221 (0.45%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    0
    Fever >39°C but ≤40°C: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    2 / 203 (0.99%)
    2 / 211 (0.95%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    0
    Decreased appetite: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    51 / 237 (21.52%)
    53 / 237 (22.36%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    53 / 183 (28.96%)
    45 / 172 (26.16%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    51
    53
    0
    0
    53
    45
    0
    0
    Decreased appetite: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    36 / 221 (16.29%)
    54 / 224 (24.11%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    36
    54
    0
    0
    0
    0
    0
    0
    Decreased appetite: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    45 / 210 (21.43%)
    46 / 222 (20.72%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    45
    46
    0
    0
    0
    0
    0
    0
    Decreased sleep: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    85 / 238 (35.71%)
    70 / 236 (29.66%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    46 / 180 (25.56%)
    33 / 170 (19.41%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    85
    70
    0
    0
    46
    33
    0
    0
    Decreased sleep: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    56 / 227 (24.67%)
    60 / 227 (26.43%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    56
    60
    0
    0
    0
    0
    0
    0
    Decreased sleep: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    53 / 209 (25.36%)
    53 / 217 (24.42%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    53
    53
    0
    0
    0
    0
    0
    0
    Increased sleep: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    112 / 242 (46.28%)
    127 / 242 (52.48%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    56 / 182 (30.77%)
    33 / 174 (18.97%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    112
    127
    0
    0
    56
    33
    0
    0
    Increased sleep: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    83 / 231 (35.93%)
    90 / 229 (39.30%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    83
    90
    0
    0
    0
    0
    0
    0
    Increased sleep: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    54 / 209 (25.84%)
    61 / 221 (27.60%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    54
    61
    0
    0
    0
    0
    0
    0
    Irritability: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    132 / 240 (55.00%)
    132 / 239 (55.23%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    111 / 198 (56.06%)
    91 / 184 (49.46%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    132
    132
    0
    0
    111
    91
    0
    0
    Irritability: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    120 / 232 (51.72%)
    125 / 232 (53.88%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    120
    125
    0
    0
    0
    0
    0
    0
    Irritability: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    98 / 215 (45.58%)
    113 / 226 (50.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    98
    113
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Food allergy
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    3 / 250 (1.20%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 244 (0.41%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    3
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Interstitial lung disease
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Pharyngolaryngeal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Rhinitis allergic
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    0
    0
    0
    Psychiatric disorders
    Decreased activity
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Insomnia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Investigations
    Cardiac murmur functional
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 250 (0.80%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    Cardiac murmur
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Craniotabes
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Dacryostenosis congenital
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Brachycephaly
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Cryptorchism
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    1 / 244 (0.41%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    Ventricular septal defect
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Cardiac disorders
    Aortic valve incompetence
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Tricuspid valve incompetence
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Hypertonia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    3 / 250 (1.20%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    0
    0
    Hypotonia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    2 / 250 (0.80%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    0
    Iron deficiency anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Eye disorders
    Conjunctivitis
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 249 (2.01%)
    2 / 250 (0.80%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    3 / 244 (1.23%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    5
    2
    1
    0
    3
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 249 (2.01%)
    11 / 250 (4.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    5 / 244 (2.05%)
    4 / 239 (1.67%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    5
    12
    0
    0
    5
    4
    0
    0
    Vomiting
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    3 / 250 (1.20%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    3
    4
    0
    0
    0
    2
    0
    0
    Abdominal pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 250 (0.80%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    Haematochezia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Abdominal distension
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Aphthous stomatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Dyspepsia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    Infantile colic
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Umbilical hernia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    2 / 249 (0.80%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    Stomatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 249 (5.62%)
    7 / 250 (2.80%)
    3 / 249 (1.20%)
    1 / 250 (0.40%)
    1 / 244 (0.41%)
    2 / 239 (0.84%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
         occurrences all number
    14
    7
    3
    1
    1
    2
    0
    1
    Dermatitis allergic
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 249 (1.20%)
    8 / 250 (3.20%)
    1 / 249 (0.40%)
    2 / 250 (0.80%)
    1 / 244 (0.41%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    4
    8
    1
    2
    1
    0
    0
    0
    Rash
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 249 (2.01%)
    1 / 250 (0.40%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    5
    1
    1
    0
    0
    0
    0
    0
    Dermatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Dermatitis diaper
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 250 (0.40%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    0
    Heat rash
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Dermatitis contact
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Hyperhidrosis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Seborrhoeic dermatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Skin inflammation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Urticaria
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Tenderness (Any): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    45 / 181 (24.86%)
    59 / 181 (32.60%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    81 / 188 (43.09%)
    75 / 178 (42.13%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    45
    59
    0
    0
    81
    75
    0
    0
    Tenderness (Any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    43 / 176 (24.43%)
    63 / 176 (35.80%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    43
    63
    0
    0
    0
    0
    0
    0
    Tenderness (Any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    41 / 167 (24.55%)
    38 / 170 (22.35%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    41
    38
    0
    0
    0
    0
    0
    0
    Tenderness (significant): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    4 / 179 (2.23%)
    8 / 178 (4.49%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 165 (1.21%)
    4 / 160 (2.50%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    8
    0
    0
    2
    4
    0
    0
    Tenderness (significant): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [23]
    1 / 172 (0.58%)
    1 / 170 (0.59%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Tenderness (significant): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    2 / 163 (1.23%)
    2 / 165 (1.21%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    0
    Induration (Any): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    39 / 179 (21.79%)
    55 / 183 (30.05%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    63 / 181 (34.81%)
    52 / 174 (29.89%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    39
    55
    0
    0
    63
    52
    0
    0
    Induration (Any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    46 / 178 (25.84%)
    62 / 175 (35.43%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    46
    62
    0
    0
    0
    0
    0
    0
    Induration (Any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    59 / 165 (35.76%)
    67 / 175 (38.29%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    59
    67
    0
    0
    0
    0
    0
    0
    Induration (mild): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    33 / 179 (18.44%)
    41 / 180 (22.78%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    53 / 178 (29.78%)
    45 / 169 (26.63%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    33
    41
    0
    0
    53
    45
    0
    0
    Induration (mild): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    37 / 177 (20.90%)
    54 / 173 (31.21%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    37
    54
    0
    0
    0
    0
    0
    0
    Induration (mild): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    51 / 165 (30.91%)
    56 / 171 (32.75%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    51
    56
    0
    0
    0
    0
    0
    0
    Induration (moderate): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    18 / 179 (10.06%)
    28 / 182 (15.38%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    34 / 171 (19.88%)
    20 / 164 (12.20%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    18
    28
    0
    0
    34
    20
    0
    0
    Induration (moderate): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    22 / 175 (12.57%)
    24 / 172 (13.95%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    22
    24
    0
    0
    0
    0
    0
    0
    Induration (moderate): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    23 / 164 (14.02%)
    30 / 169 (17.75%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    23
    30
    0
    0
    0
    0
    0
    0
    Erythema (Any): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    58 / 181 (32.04%)
    73 / 183 (39.89%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    104 / 200 (52.00%)
    75 / 178 (42.13%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    58
    73
    0
    0
    104
    75
    0
    0
    Erythema (Any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    68 / 180 (37.78%)
    86 / 178 (48.31%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    68
    86
    0
    0
    0
    0
    0
    0
    Erythema (Any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    78 / 169 (46.15%)
    89 / 177 (50.28%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    78
    89
    0
    0
    0
    0
    0
    0
    Erythema (Mild): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    56 / 181 (30.94%)
    63 / 180 (35.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    90 / 194 (46.39%)
    63 / 176 (35.80%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    56
    63
    0
    0
    90
    63
    0
    0
    Erythema (Mild): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    68 / 180 (37.78%)
    82 / 177 (46.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    68
    82
    0
    0
    0
    0
    0
    0
    Erythema (Mild): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    78 / 169 (46.15%)
    82 / 177 (46.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    78
    82
    0
    0
    0
    0
    0
    0
    Erythema (Moderate): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    3 / 179 (1.68%)
    10 / 178 (5.62%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    34 / 173 (19.65%)
    21 / 164 (12.80%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    10
    0
    0
    34
    21
    0
    0
    Erythema (Moderate): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    2 / 172 (1.16%)
    6 / 171 (3.51%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    6
    0
    0
    0
    0
    0
    0
    Erythema (Moderate): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [42]
    5 / 164 (3.05%)
    16 / 165 (9.70%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    5
    16
    0
    0
    0
    0
    0
    0
    Erythema (Severe): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [43]
    0 / 179 (0.00%)
    0 / 177 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 164 (0.61%)
    0 / 159 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    23 / 249 (9.24%)
    19 / 250 (7.60%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    6 / 244 (2.46%)
    3 / 239 (1.26%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    24
    19
    0
    0
    6
    3
    0
    0
    Rhinitis
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 249 (7.63%)
    21 / 250 (8.40%)
    3 / 249 (1.20%)
    1 / 250 (0.40%)
    10 / 244 (4.10%)
    8 / 239 (3.35%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    25
    22
    3
    1
    11
    8
    0
    0
    Pharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 249 (6.83%)
    15 / 250 (6.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    19 / 244 (7.79%)
    10 / 239 (4.18%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    18
    17
    0
    0
    19
    10
    0
    0
    Upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 249 (6.83%)
    13 / 250 (5.20%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    17 / 244 (6.97%)
    9 / 239 (3.77%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    19
    14
    0
    0
    19
    9
    0
    0
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 249 (5.22%)
    13 / 250 (5.20%)
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    10 / 244 (4.10%)
    4 / 239 (1.67%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    16
    14
    1
    0
    10
    4
    0
    0
    Respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 249 (3.21%)
    6 / 250 (2.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 244 (0.41%)
    2 / 239 (0.84%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    9
    7
    0
    0
    1
    2
    0
    0
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 249 (2.81%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    7
    1
    0
    0
    0
    1
    0
    0
    Bronchopneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    3 / 250 (1.20%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    0
    0
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 249 (1.20%)
    2 / 250 (0.80%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    2 / 239 (0.84%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    3
    2
    0
    0
    0
    2
    0
    0
    Viral infection
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    3 / 250 (1.20%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 244 (0.41%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    3
    0
    0
    1
    1
    0
    0
    Ear infection
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    2 / 250 (0.80%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    0
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 249 (1.20%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 244 (0.41%)
    3 / 239 (1.26%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    3
    1
    0
    0
    1
    3
    0
    0
    Laryngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    4 / 244 (1.64%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    1
    0
    0
    4
    1
    0
    0
    Otitis media
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 249 (0.80%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    2 / 244 (0.82%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    2
    1
    0
    0
    2
    1
    0
    0
    Exanthema subitum
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    5 / 244 (2.05%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    1
    0
    0
    5
    0
    0
    0
    Viral upper respiratory tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    Candidiasis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Conjunctivitis infective
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Gastroenteritis staphylococcal
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Oral candidiasis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Perianal abscess
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Pneumonia primary atypical
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Tinea cruris
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Tonsillitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 244 (0.41%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    0
    0
    Varicella
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    1 / 244 (0.41%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    0
    0
    Viral diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Viral rash
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Hordeolum
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    Acute tonsillitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    2 / 244 (0.82%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    Influenza
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 244 (0.00%)
    1 / 239 (0.42%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Weight gain poor
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 249 (0.00%)
    0 / 250 (0.00%)
    0 / 249 (0.00%)
    1 / 250 (0.40%)
    0 / 244 (0.00%)
    0 / 239 (0.00%)
    0 / 249 (0.00%)
    0 / 250 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2006
    HBVAXPRO vaccine (not available for purchase) was replaced with Engerix-B vaccine and meningitis C vaccine was allowed to be given 14 days before study vaccination or after the post vaccination observation period.

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

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

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