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    Clinical Trial Results:
    A Phase 3, Open Label Trial Evaluating the Safety,Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Aged 15 Months to 17 Years in the United States

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2009-017304-88
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Aug 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Jul 2016
    First version publication date
    01 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    reporting periods and duplicate AEs in their data

    Trial information

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    Trial identification
    Sponsor protocol code
    6096A1-3011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00761631
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias ID: B1851010
    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., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Mar 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Aug 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1-To assess the pneumococcal immune responses induced by 13-valent pneumococcal conjugate vaccine (13vPnC) when measured 1 month after the last scheduled dose of 13vPnC in each of 4 age groups. 2- To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and AEs. This objective is applicable to all 4 groups and both cohorts.
    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
    18 Nov 2008
    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
    United States: 1200
    Worldwide total number of subjects
    1200
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    302
    Children (2-11 years)
    671
    Adolescents (12-17 years)
    227
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were stratified by age group. Group 1 included subjects aged greater than (>) 15 months to less than (<) 2 years. Group 2 included subjects aged greater than or equal to (>=) 2 to <5 years. Group 3 included subjects aged >=5 to <10 years. Group 4 included subjects aged >=10 to <18 years.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC Group 1 (Cohort 1)
    Arm description
    		 13vPnC administered at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Subjects must have previously received at least 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC). Includes subjects enrolled prior to protocol amendment to increase sample size (Cohort 1).
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 milliliter (mL) dose of 13vPnC at baseline and anytime from Day 56 to Day 70 for a total of 2 doses.

    Arm title
    		 13vPnC Group 2 (Cohort 1)
    Arm description
    		 13vPnC administered at baseline. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled prior to protocol amendment to increase sample size (Cohort 1).
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 13vPnC 0.5 mL dose at baseline.

    Arm title
    		 13vPnC Group 1 (Cohort 2)
    Arm description
    		 13vPnC administered at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled after protocol amendment to increase sample size (Cohort 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL dose of 13vPnC dose at baseline and anytime from Day 56 to Day 70 for a total of 2 doses.

    Arm title
    		 13vPnC Group 2 (Cohort 2)
    Arm description
    		 13vPnC administered at baseline. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled after protocol amendment to increase sample size (Cohort 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL dose of 13vPnC at baseline.

    Arm title
    		 13vPnC Group 3
    Arm description
    		 13vPnC administered at baseline. Subjects must have previously received at least 1 dose of 7vPnC.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL dose of 13vPnC at baseline.

    Arm title
    		 13vPnC Group 4
    Arm description
    		 13vPnC administered at baseline. Subjects must not have received 7vPnC or any other pneumococcal vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 0.5 mL dose of 13vPnC at baseline.

    Number of subjects in period 1
    		13vPnC Group 1 (Cohort 1) 13vPnC Group 2 (Cohort 1) 13vPnC Group 1 (Cohort 2) 13vPnC Group 2 (Cohort 2) 13vPnC Group 3 13vPnC Group 4
    Started
    126
    181
    176
    119
    299
    299
    Vaccinated Dose 1
    124
    179
    175
    118
    294
    298
    Vaccinated Dose 2
    112
    0 [1]
    165
    0 [2]
    0 [3]
    0 [4]
    Completed
    111
    174
    160
    116
    277
    294
    Not completed
    15
    7
    16
    3
    22
    5
         Physician decision
    1
    -
    -
    -
    -
    -
         Failed to return
    1
    -
    1
    1
    5
    2
         Parent/legal guardian request
    8
    3
    8
    -
    5
    -
         Unspecified
    -
    -
    -
    -
    1
    1
         Lost to follow-up
    2
    4
    7
    1
    6
    1
         Randomized, not treated
    1
    -
    -
    -
    -
    -
         Protocol deviation
    2
    -
    -
    1
    5
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects in 13vPnC Group 2 were planned to receive only dose 1 of 13vPnC.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects in 13vPnC Group 2 were planned to receive only dose 1 of 13vPnC.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects in 13vPnC Group 3 were planned to receive only dose 1 of 13vPnC.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects in 13vPnC Group 4 were planned to receive only dose 1 of 13vPnC.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC Group 1 (Cohort 1)
    Reporting group description
    		 13vPnC administered at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Subjects must have previously received at least 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC). Includes subjects enrolled prior to protocol amendment to increase sample size (Cohort 1).

    Reporting group title
    13vPnC Group 2 (Cohort 1)
    Reporting group description
    		 13vPnC administered at baseline. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled prior to protocol amendment to increase sample size (Cohort 1).

    Reporting group title
    13vPnC Group 1 (Cohort 2)
    Reporting group description
    		 13vPnC administered at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled after protocol amendment to increase sample size (Cohort 2).

    Reporting group title
    13vPnC Group 2 (Cohort 2)
    Reporting group description
    		 13vPnC administered at baseline. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled after protocol amendment to increase sample size (Cohort 2).

    Reporting group title
    13vPnC Group 3
    Reporting group description
    		 13vPnC administered at baseline. Subjects must have previously received at least 1 dose of 7vPnC.

    Reporting group title
    13vPnC Group 4
    Reporting group description
    		 13vPnC administered at baseline. Subjects must not have received 7vPnC or any other pneumococcal vaccine.

    Reporting group values
    		 13vPnC Group 1 (Cohort 1) 13vPnC Group 2 (Cohort 1) 13vPnC Group 1 (Cohort 2) 13vPnC Group 2 (Cohort 2) 13vPnC Group 3 13vPnC Group 4 Total
    Number of subjects
    		 126 181 176 119 299 299 1200
    Age categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 126 0 176 0 0 0 302
        Children (2-11 years)
    		 0 181 0 119 299 72 671
        Adolescents (12-17 years)
    		 0 0 0 0 0 227 227
    Gender categorical
    Units: Subjects
        Female
    		 65 74 83 65 155 136 578
        Male
    		 61 107 93 54 144 163 622

    End points

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    End points reporting groups
    Reporting group title
    13vPnC Group 1 (Cohort 1)
    Reporting group description
    		 13vPnC administered at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Subjects must have previously received at least 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC). Includes subjects enrolled prior to protocol amendment to increase sample size (Cohort 1).

    Reporting group title
    13vPnC Group 2 (Cohort 1)
    Reporting group description
    		 13vPnC administered at baseline. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled prior to protocol amendment to increase sample size (Cohort 1).

    Reporting group title
    13vPnC Group 1 (Cohort 2)
    Reporting group description
    		 13vPnC administered at baseline and anytime from Day 56 to Day 70 for a total of 2 doses. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled after protocol amendment to increase sample size (Cohort 2).

    Reporting group title
    13vPnC Group 2 (Cohort 2)
    Reporting group description
    		 13vPnC administered at baseline. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled after protocol amendment to increase sample size (Cohort 2).

    Reporting group title
    13vPnC Group 3
    Reporting group description
    		 13vPnC administered at baseline. Subjects must have previously received at least 1 dose of 7vPnC.

    Reporting group title
    13vPnC Group 4
    Reporting group description
    		 13vPnC administered at baseline. Subjects must not have received 7vPnC or any other pneumococcal vaccine.

    Primary: Percentage of Subjects Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (>=) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2

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    End point title
    		 Percentage of Subjects Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (>=) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 [1] [2]
    End point description
    Percentage of subjects achieving world health organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of subjects. Evaluable Immunogenicity Population (EIP): all subjects who met all inclusion criteria, received all assigned doses of study vaccine, had at least 1 valid and determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis and no major protocol violations.
    End point type
    Primary
    End point timeframe
    28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be reported for reporting group 13vPnC Group 1 (Cohort 1) and 13vPnC Group 2 (Cohort 1) only.
    End point values
    		 13vPnC Group 1 (Cohort 1) 13vPnC Group 2 (Cohort 1)
    Number of subjects analysed
    109
    175
    Units: Percentage of subjects
    number (confidence interval 95%)
        Common serotypes - serotype 4
    98.2 (93.5 to 99.8)
    100 (97.9 to 100)
        Common serotypes - serotype 6B
    100 (96.7 to 100)
    100 (97.9 to 100)
        Common serotypes - serotype 9V
    100 (96.7 to 100)
    100 (97.9 to 100)
        Common serotypes - serotype 14
    100 (96.7 to 100)
    100 (97.9 to 100)
        Common serotypes - serotype 18C
    100 (96.7 to 100)
    100 (97.9 to 100)
        Common serotypes - serotype 19F
    100 (96.7 to 100)
    100 (97.9 to 100)
        Common serotypes - serotype 23F
    99.1 (95 to 100)
    100 (97.9 to 100)
        Additional serotypes - serotype 1
    100 (96.7 to 100)
    98.9 (95.9 to 99.9)
        Additional serotypes - serotype 3
    94.5 (88.4 to 98)
    92 (86.9 to 95.5)
        Additional serotypes - serotype 5
    100 (96.7 to 100)
    98.9 (95.9 to 99.9)
        Additional serotypes - serotype 6A
    100 (96.7 to 100)
    100 (97.9 to 100)
        Additional serotypes - serotype 7F
    100 (96.7 to 100)
    100 (97.9 to 100)
        Additional serotypes - serotype 19A
    100 (96.7 to 100)
    100 (97.9 to 100)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 [3] [4]
    End point description
    Antibody GMC 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. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all subjects with available data for after dose 1 blood draw. EIP: subjects who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations.
    End point type
    Primary
    End point timeframe
    28 to 42 days after dose 1 for Group 3
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be reported for reporting group 13vPnC Group 3 only.
    End point values
    		 13vPnC Group 3
    Number of subjects analysed
    171 [5]
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common serotypes - serotype 4
    8.45 (7.24 to 9.87)
        Common serotypes - serotype 6B
    53.56 (45.48 to 63.07)
        Common serotypes - serotype 9V
    9.51 (8.38 to 10.78)
        Common serotypes - serotype 14
    29.36 (24.78 to 34.78)
        Common serotypes - serotype 18C
    8.23 (7.13 to 9.51)
        Common serotypes - serotype 19F
    17.58 (14.95 to 20.67)
        Common serotypes - serotype 23F
    11.26 (9.79 to 12.95)
        Additional serotypes - serotype 1
    3.57 (3.05 to 4.18)
        Additional serotypes - serotype 3
    2.38 (2.07 to 2.74)
        Additional serotypes - serotype 5
    5.52 (4.82 to 6.32)
        Additional serotypes - serotype 6A
    21.51 (18.15 to 25.51)
        Additional serotypes - serotype 7F
    6.24 (5.49 to 7.08)
        Additional serotypes - serotype 19A
    17.18 (15.01 to 19.67)
    Notes
    [5] - Subjects with determinate antibody concentration.
    No statistical analyses for this end point

    Primary: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4

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    End point title
    		 Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 [6]
    End point description
    Serotype-specific OPA GMTs 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 determined in the blood samples of all the subjects using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all subjects with available data for after dose 1 blood draw. EIP: subjects who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations.
    End point type
    Primary
    End point timeframe
    28 to 42 days after dose 1 for Group 3 and 4
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be reported for reporting group 13vPnC Group 3 and 13vPnC Group 4 only.
    End point values
    		 13vPnC Group 3 13vPnC Group 4
    Number of subjects analysed
    189
    181
    Units: titer
    geometric mean (confidence interval 95%)
        Common serotypes - serotype 4
    6912 (6101.2 to 7831.4)
    4629 (4017.2 to 5334.3)
        Common serotypes - serotype 6B
    14224 (12316.4 to 16427.3)
    14996 (13164.1 to 17083.1)
        Common serotypes - serotype 9V
    4485 (4001.1 to 5027.5)
    4733 (4203.3 to 5328.4)
        Common serotypes - serotype 14
    6894 (6028.3 to 7884)
    4759 (4120.4 to 5497)
        Common serotypes - serotype 18C
    6263 (5436.4 to 7215.1)
    8815 (7738.2 to 10041)
        Common serotypes - serotype 19F
    2280 (1949.4 to 2667.6)
    1559 (1293.3 to 1878.9)
        Common serotypes - serotype 23F
    3808 (3354.7 to 4322.6)
    3245 (2818.8 to 3735.5)
        Additional serotypes - serotype 1
    319 (271.2 to 376)
    187 (160.4 to 218.6)
        Additional serotypes - serotype 3
    114 (100.4 to 129.4)
    202 (180.9 to 226.3)
        Additional serotypes - serotype 5
    336 (270.3 to 417.6)
    491 (426.3 to 565.3)
        Additional serotypes - serotype 6A
    9928 (8457 to 11654.8)
    7514 (6350.8 to 8890.7)
        Additional serotypes - serotype 7F
    6584 (5829.4 to 7435.5)
    10334 (9099 to 11736.8)
        Additional serotypes - serotype 19A
    1276 (1131.7 to 1439)
    1180 (1047.5 to 1329.4)
    Statistical analysis title
    		 Serotype 4
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.24
         upper limit
    		 1.8
    Notes
    [7] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 6B
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 3 v 13vPnC Group 4
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.15
    Notes
    [8] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 9V
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.12
    Notes
    [9] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 14
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.19
         upper limit
    		 1.76
    Notes
    [10] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 18C
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.86
    Notes
    [11] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 19F
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [12]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.15
         upper limit
    		 1.86
    Notes
    [12] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 23F
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [13]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.42
    Notes
    [13] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [14]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.36
         upper limit
    		 2.13
    Notes
    [14] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [15]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 0.67
    Notes
    [15] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 5
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [16]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 0.89
    Notes
    [16] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [17]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 1.67
    Notes
    [17] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [18]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 0.76
    Notes
    [18] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).
    Comparison groups
    13vPnC Group 4 v 13vPnC Group 3
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [19]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.28
    Notes
    [19] - Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.

    Primary: Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457)

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    End point title
    		 Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457) [20] [21]
    End point description
    End point type
    Primary
    End point timeframe
    28 to 42 days after dose 1
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be reported for reporting group 13vPnC Group 3 only.
    End point values
    		 13vPnC Group 3
    Number of subjects analysed
    0 [22]
    Units: mcg/mL
        arithmetic mean (standard deviation)
    ( )
    Notes
    [22] - Data not reported because analysis population includes subjects who were not enrolled in this study.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Prespecified Local Reactions Within 7 Days of Dose 1

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    End point title
    		 Percentage of Subjects Reporting Prespecified Local Reactions Within 7 Days of Dose 1
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Dose 1 Safety Population: all subjects who received the first dose of 13vPnC.'n'=number of subjects with known values for specified local reaction for each group respectively. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    From the day of dose 1 (Day 1) to Day 7 after dose 1
    End point values
    		 13vPnC Group 1 (Cohort 1) 13vPnC Group 2 (Cohort 1) 13vPnC Group 1 (Cohort 2) 13vPnC Group 2 (Cohort 2) 13vPnC Group 3 13vPnC Group 4
    Number of subjects analysed
    110 [23]
    158 [24]
    151 [25]
    102 [26]
    270 [27]
    285 [28]
    Units: Percentage of subjects
    number (not applicable)
        Tenderness Any (n=108,155, 148,102,265,283)
    50.9
    61.9
    45.3
    62.7
    86.8
    89
        Tenderness Significant (n=92,141,133,92,221,242)
    7.6
    10.6
    5.3
    13
    19.5
    43.8
        Swelling Any (n=97,144,142,90,226,233)
    25.8
    22.2
    17.6
    20
    37.6
    36.9
        Swelling Mild (n=94,143,141,89,220,221)
    21.3
    20.3
    14.2
    13.5
    21.8
    22.6
        Swelling Moderate (n=94,141,135,89,219,226)
    9.6
    5.7
    7.4
    11.2
    21.9
    21.2
        Swelling Severe (n=90,138,131,88,211,214)
    0
    0
    0
    1.1
    3.3
    1.9
        Redness Any (n=103,149,143,91,233,232)
    39.8
    34.9
    18.9
    36.3
    42.9
    30.2
        Redness Mild (n=99,146,143,90,226,226)
    31.3
    31.5
    16.8
    31.1
    27.9
    21.2
        Redness Moderate (n=94,142,135,89,218,221)
    12.8
    9.9
    5.9
    14.6
    22
    14
        Redness Severe (n=90,138,131,88,212,213)
    0
    0
    0.8
    1.1
    3.3
    1.9
    Notes
    [23] - Subjects with known values for any local reaction.
    [24] - Subjects with known values for any local reaction.
    [25] - Subjects with known values for any local reaction.
    [26] - Subjects with known values for any local reaction.
    [27] - Subjects with known values for any local reaction.
    [28] - Subjects with known values for any local reaction.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Prespecified Local Reactions Within 7 Days of Dose 2

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    End point title
    		 Percentage of Subjects Reporting Prespecified Local Reactions Within 7 Days of Dose 2 [29]
    End point description
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Dose 2 Safety Population: all subjects who received 2 doses of 13vPnC. Here, 'n'=number of subjects with known values for specified local reaction for each group respectively. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    From the day of dose 2 (Day 1) to Day 7 of dose 2
    Notes
    [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be reported for reporting group 13vPnC Group 1 (Cohort 1) and 13vPnC Group 2 (Cohort 1) only.
    End point values
    		 13vPnC Group 1 (Cohort 1) 13vPnC Group 1 (Cohort 2)
    Number of subjects analysed
    90 [30]
    131 [31]
    Units: Percentage of subjects
    number (not applicable)
        Tenderness Any (n=87, 125)
    57.5
    55.2
        Tenderness Significant (n=68, 101)
    8.8
    9.9
        Swelling Any (n=73, 105)
    23.3
    17.1
        Swelling Mild (n=72, 104)
    22.2
    15.4
        Swelling Moderate (n=69, 102)
    2.9
    7.8
        Swelling Severe (n=68, 98)
    0
    0
        Redness Any (n=76, 110)
    35.5
    23.6
        Redness Mild (n=74, 108)
    33.8
    18.5
        Redness Moderate (n=70, 100)
    7.1
    6
        Redness Severe (n=68, 98)
    0
    0
    Notes
    [30] - Subjects with known values for any local reaction.
    [31] - Subjects with known values for any local reaction.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Prespecified Systemic Events Within 7 Days of Dose 1

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    End point title
    		 Percentage of Subjects Reporting Prespecified Systemic Events Within 7 Days of Dose 1
    End point description
    Systemic events (any fever >=38 degrees [deg] Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Dose 1 Safety Population: all subjects who received the first dose of 13vPnC. Here, 'n'=number of subjects with known values for specified systemic events for each group respectively. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    From the day of dose 1 (Day 1) to Day 7 of dose 1
    End point values
    		 13vPnC Group 1 (Cohort 1) 13vPnC Group 2 (Cohort 1) 13vPnC Group 1 (Cohort 2) 13vPnC Group 2 (Cohort 2) 13vPnC Group 3 13vPnC Group 4
    Number of subjects analysed
    112 [32]
    157 [33]
    165 [34]
    107 [35]
    250 [36]
    253 [37]
    Units: Percentage of subjects
    number (not applicable)
        Fever >=38 to <=39 degC(n=92,138,137,90,212,214)
    16.3
    5.1
    17.5
    14.4
    4.2
    5.1
        Fever >39 but <=40 degC(n=90,138,130,89,212,212)
    4.4
    0.7
    4.6
    3.4
    2.4
    0.5
        Fever >40 degC (n=90,138,130,88,210,212)
    0
    0.7
    0
    1.1
    0.5
    0.5
        Decreased appetite (n=99,149,146,94,227,223)
    42.4
    24.8
    39.7
    34
    22.9
    22.9
        Irritability (n=108,151,156,102,234,234)
    60.2
    39.7
    72.4
    52
    31.2
    25.2
        Increased sleep (n=98,145,146,97,226,229)
    32.7
    15.9
    37
    23.7
    21.2
    26.6
        Decreased sleep (n=97,143,140,91,212,224)
    22.7
    14
    32.1
    18.7
    5.7
    18.8
        Hives (urticaria) (n=90,139,131,88,213,214)
    1.1
    0.7
    1.5
    4.5
    1.9
    1.4
    Notes
    [32] - Subjects with known values for any systemic events.
    [33] - Subjects with known values for any systemic events.
    [34] - Subjects with known values for any systemic events.
    [35] - Subjects with known values for any systemic events.
    [36] - Subjects with known values for any systemic events.
    [37] - Subjects with known values for any systemic events.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Prespecified Systemic Events Within 7 Days of Dose 2

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    End point title
    		 Percentage of Subjects Reporting Prespecified Systemic Events Within 7 Days of Dose 2 [38]
    End point description
    Systemic events (any fever >=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Subjects may have been represented in more than 1 category. Percentage of subjects = number of subjects reporting specified systemic event divided by number of subjects reporting yes for at least 1 day or no for all days. Dose 2 Safety Population: all subjects who received 2 doses of 13vPnC. Here, 'n'=number of subjects with known values for specified systemic events for each group respectively. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    From the day of dose 2 (Day 1) to Day 7 of dose 2
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be reported for reporting group 13vPnC Group 1 (Cohort 1) and 13vPnC Group 1 (Cohort 2) only.
    End point values
    		 13vPnC Group 1 (Cohort 1) 13vPnC Group 1 (Cohort 2)
    Number of subjects analysed
    91 [39]
    137 [40]
    Units: Percentage of subjects
    number (not applicable)
        Fever >=38 but <=39 degC (n=70,101)
    14.3
    11.9
        Fever >39 but <=40 degC (n=68, 100)
    4.4
    2
        Fever >40 degC (n=68, 98)
    0
    1
        Decreased appetite (n=77, 113)
    40.3
    34.5
        Irritability (n=86, 126)
    65.1
    61.1
        Increased sleep (n=75, 109)
    29.3
    23.9
        Decreased sleep (n=77, 112)
    28.6
    26.8
        Hives (urticaria) (n=68, 98)
    2.9
    0
    Notes
    [39] - Subjects with known values for any systemic events.
    [40] - Subjects with known values for any systemic events.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose)
    Adverse event reporting additional description
    SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment). Version was not captured, hence 0.0 is mentioned for dictionary version.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    13vPnC Group 1 (Cohort 1) Dose 1
    Reporting group description
    		 13vPnC (0.5mL dose) administered intramuscularly at baseline. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled prior to protocol amendment to increase sample size (Cohort 1).

    Reporting group title
    13vPnC Group 1 (Cohort 1) Dose 2
    Reporting group description
    		 13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled prior to protocol amendment to increase sample size (Cohort 1).

    Reporting group title
    13vPnC Group 2 (Cohort 1) Dose 1
    Reporting group description
    		 13vPnC (0.5mL dose) administered intramuscularly at baseline. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled prior to protocol amendment to increase sample size (Cohort 1).

    Reporting group title
    13vPnC Group 1 (Cohort 2) Dose 1
    Reporting group description
    		 13vPnC (0.5mL dose) administered intramuscularly at baseline. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled after protocol amendment to increase sample size (Cohort 2).

    Reporting group title
    13vPnC Group 1 (Cohort 2) Dose 2
    Reporting group description
    		 13vPnC (0.5mL dose) administered intramuscularly anytime from Day 56 to Day 70. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled after protocol amendment to increase sample size (Cohort 2).

    Reporting group title
    13vPnC Group 2 (Cohort 2) Dose 1
    Reporting group description
    		 13vPnC (0.5mL dose) administered intramuscularly at baseline. Subjects must have previously received at least 3 doses of 7vPnC. Includes subjects enrolled after protocol amendment to increase sample size (Cohort 2).

    Reporting group title
    6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)
    Reporting group description
    		 6-month follow-up telephone contact for subjects in Group 1 (Cohort 1 and 2).

    Reporting group title
    6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)
    Reporting group description
    		 6-month follow-up telephone contact for subjects in Group 2 (Cohort 1 and 2).

    Reporting group title
    13vPnC Group 3
    Reporting group description
    		 13vPnC (0.5mL dose) administered intramuscularly at baseline. Subjects must have previously received at least 1 dose of 7vPnC.

    Reporting group title
    6-Month Follow-up 13vPnC Group 3
    Reporting group description
    		 6-month follow-up telephone contact for subjects in Group 3.

    Reporting group title
    13vPnC Group 4
    Reporting group description
    		 13vPnC (0.5mL dose) administered intramuscularly at baseline. Subjects must not have received 7vPnC or any other pneumococcal vaccine.

    Reporting group title
    6-Month Follow-up 13vPnC Group 4
    Reporting group description
    		 6 -Month Follow-up Telephone Contact for subjects in Group 4.

    Serious adverse events
    		 13vPnC Group 1 (Cohort 1) Dose 1 13vPnC Group 1 (Cohort 1) Dose 2 13vPnC Group 2 (Cohort 1) Dose 1 13vPnC Group 1 (Cohort 2) Dose 1 13vPnC Group 1 (Cohort 2) Dose 2 13vPnC Group 2 (Cohort 2) Dose 1 6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2) 6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2) 13vPnC Group 3 6-Month Follow-up 13vPnC Group 3 13vPnC Group 4 6-Month Follow-up 13vPnC Group 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 124 (0.00%)
    2 / 112 (1.79%)
    1 / 179 (0.56%)
    1 / 175 (0.57%)
    4 / 165 (2.42%)
    0 / 118 (0.00%)
    3 / 299 (1.00%)
    1 / 297 (0.34%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    1 / 298 (0.34%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Near drowning
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal injury
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    1 / 299 (0.33%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    1 / 299 (0.33%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    1 / 299 (0.33%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    1 / 297 (0.34%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    1 / 299 (0.33%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 112 (0.89%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 112 (0.89%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 13vPnC Group 1 (Cohort 1) Dose 1 13vPnC Group 1 (Cohort 1) Dose 2 13vPnC Group 2 (Cohort 1) Dose 1 13vPnC Group 1 (Cohort 2) Dose 1 13vPnC Group 1 (Cohort 2) Dose 2 13vPnC Group 2 (Cohort 2) Dose 1 6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2) 6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2) 13vPnC Group 3 6-Month Follow-up 13vPnC Group 3 13vPnC Group 4 6-Month Follow-up 13vPnC Group 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    88 / 124 (70.97%)
    71 / 112 (63.39%)
    112 / 179 (62.57%)
    134 / 175 (76.57%)
    99 / 165 (60.00%)
    74 / 118 (62.71%)
    2 / 299 (0.67%)
    2 / 297 (0.67%)
    242 / 294 (82.31%)
    7 / 294 (2.38%)
    258 / 298 (86.58%)
    4 / 298 (1.34%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 124 (4.03%)
    3 / 112 (2.68%)
    3 / 179 (1.68%)
    7 / 175 (4.00%)
    5 / 165 (3.03%)
    4 / 118 (3.39%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    7 / 294 (2.38%)
    0 / 294 (0.00%)
    3 / 298 (1.01%)
    0 / 298 (0.00%)
         occurrences all number
    5
    3
    3
    7
    5
    5
    0
    0
    7
    0
    3
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    Injection site reaction
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    2 / 298 (0.67%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    2 / 298 (0.67%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Injection site pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Fever >=38 degrees C but <=39 degrees C
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    15 / 92 (16.30%)
    10 / 70 (14.29%)
    7 / 138 (5.07%)
    24 / 137 (17.52%)
    12 / 101 (11.88%)
    13 / 90 (14.44%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    9 / 212 (4.25%)
    0 / 294 (0.00%)
    11 / 214 (5.14%)
    0 / 298 (0.00%)
         occurrences all number
    15
    10
    7
    24
    12
    13
    0
    0
    9
    0
    11
    0
    Fever >39 degrees C but <=40 degrees C
    Additional description: Subjects affected and occurrences for LR and SE is same as e-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    4 / 90 (4.44%)
    3 / 68 (4.41%)
    1 / 138 (0.72%)
    6 / 130 (4.62%)
    2 / 100 (2.00%)
    3 / 89 (3.37%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    5 / 212 (2.36%)
    0 / 294 (0.00%)
    1 / 212 (0.47%)
    0 / 298 (0.00%)
         occurrences all number
    4
    3
    1
    6
    2
    3
    0
    0
    5
    0
    1
    0
    Fever >40 degrees C
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    0 / 90 (0.00%)
    0 / 68 (0.00%)
    1 / 138 (0.72%)
    0 / 130 (0.00%)
    1 / 98 (1.02%)
    1 / 88 (1.14%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 210 (0.48%)
    0 / 294 (0.00%)
    1 / 212 (0.47%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    0
    1
    0
    1
    0
    Decreased appetite
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    42 / 99 (42.42%)
    31 / 77 (40.26%)
    37 / 149 (24.83%)
    58 / 146 (39.73%)
    39 / 113 (34.51%)
    32 / 94 (34.04%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    52 / 227 (22.91%)
    0 / 294 (0.00%)
    51 / 223 (22.87%)
    0 / 298 (0.00%)
         occurrences all number
    42
    31
    37
    58
    39
    32
    0
    0
    52
    0
    51
    0
    Irritability
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    65 / 108 (60.19%)
    56 / 86 (65.12%)
    60 / 151 (39.74%)
    113 / 156 (72.44%)
    77 / 126 (61.11%)
    53 / 102 (51.96%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    73 / 234 (31.20%)
    0 / 294 (0.00%)
    59 / 234 (25.21%)
    0 / 298 (0.00%)
         occurrences all number
    65
    56
    60
    113
    77
    53
    0
    0
    73
    0
    59
    0
    Increased sleep
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    32 / 98 (32.65%)
    22 / 75 (29.33%)
    23 / 145 (15.86%)
    54 / 146 (36.99%)
    26 / 109 (23.85%)
    23 / 97 (23.71%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    48 / 226 (21.24%)
    0 / 294 (0.00%)
    61 / 229 (26.64%)
    0 / 298 (0.00%)
         occurrences all number
    32
    22
    23
    54
    26
    23
    0
    0
    48
    0
    61
    0
    Decreased sleep
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    22 / 97 (22.68%)
    22 / 77 (28.57%)
    20 / 143 (13.99%)
    45 / 140 (32.14%)
    30 / 112 (26.79%)
    17 / 91 (18.68%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    12 / 212 (5.66%)
    0 / 294 (0.00%)
    42 / 224 (18.75%)
    0 / 298 (0.00%)
         occurrences all number
    22
    22
    20
    45
    30
    17
    0
    0
    12
    0
    42
    0
    Hives (urticaria)
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    1 / 90 (1.11%)
    2 / 68 (2.94%)
    1 / 139 (0.72%)
    2 / 131 (1.53%)
    0 / 98 (0.00%)
    4 / 88 (4.55%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    4 / 213 (1.88%)
    0 / 294 (0.00%)
    3 / 214 (1.40%)
    0 / 298 (0.00%)
         occurrences all number
    1
    2
    1
    2
    0
    4
    0
    0
    4
    0
    3
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Reproductive system and breast disorders
    Vulvovaginal discomfort
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Penile adhesion
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 124 (4.03%)
    0 / 112 (0.00%)
    7 / 179 (3.91%)
    6 / 175 (3.43%)
    7 / 165 (4.24%)
    3 / 118 (2.54%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    10 / 294 (3.40%)
    0 / 294 (0.00%)
    5 / 298 (1.68%)
    0 / 298 (0.00%)
         occurrences all number
    5
    0
    7
    6
    7
    4
    0
    0
    10
    0
    5
    0
    Rhinorrhoea
         subjects affected / exposed
    5 / 124 (4.03%)
    2 / 112 (1.79%)
    4 / 179 (2.23%)
    5 / 175 (2.86%)
    4 / 165 (2.42%)
    3 / 118 (2.54%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    6
    2
    4
    5
    4
    4
    0
    0
    1
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 112 (0.89%)
    1 / 179 (0.56%)
    2 / 175 (1.14%)
    2 / 165 (1.21%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    3 / 294 (1.02%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    1
    1
    1
    2
    2
    1
    0
    0
    3
    0
    1
    0
    Pneumonitis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sinus congestion
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Wheezing
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Asthma
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    4 / 179 (2.23%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    3 / 118 (2.54%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    2 / 294 (0.68%)
    2 / 298 (0.67%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    4
    0
    1
    3
    0
    0
    2
    2
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    1 / 175 (0.57%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    5 / 298 (1.68%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    5
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    2 / 175 (1.14%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    1 / 299 (0.33%)
    1 / 297 (0.34%)
    0 / 294 (0.00%)
    1 / 294 (0.34%)
    0 / 298 (0.00%)
    1 / 298 (0.34%)
         occurrences all number
    0
    0
    1
    2
    1
    0
    1
    1
    0
    1
    0
    1
    Bronchospasm
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Interstitial lung disease
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    2 / 294 (0.68%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    2
    0
    0
    Paranasal sinus hypersecretion
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Sneezing
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Psychiatric disorders
    Breath holding
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    1 / 297 (0.34%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Asperger's disorder
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    1 / 297 (0.34%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Attention deficit/hyperactivity disorder
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    1 / 297 (0.34%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Depression
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    1 / 298 (0.34%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Investigations
    Cardiac murmur
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Heart rate decreased
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Excoriation
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lower limb fracture
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Head injury
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
    Laceration
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Mouth injury
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Burns second degree
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Traumatic brain injury
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Ulna fracture
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Eye injury
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Hand fracture
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    2 / 298 (0.67%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    Periorbital haematoma
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Arthropod bite
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Foot fracture
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Limb injury
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Muscle strain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Wrist fracture
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    2 / 118 (1.69%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    3 / 294 (1.02%)
    0 / 294 (0.00%)
    10 / 298 (3.36%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    2
    0
    0
    3
    0
    11
    0
    Speech disorder developmental
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Syncope
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    2 / 298 (0.67%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Migraine
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    1 / 298 (0.34%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Somnolence
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    3 / 175 (1.71%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    1
    3
    1
    0
    0
    0
    1
    0
    0
    0
    Eustachian tube dysfunction
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    2 / 124 (1.61%)
    4 / 112 (3.57%)
    2 / 179 (1.12%)
    2 / 175 (1.14%)
    3 / 165 (1.82%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    2 / 294 (0.68%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    2
    4
    2
    2
    3
    0
    0
    0
    2
    0
    0
    0
    Hypermetropia
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Eye swelling
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Myopia
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    1 / 294 (0.34%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    7 / 124 (5.65%)
    1 / 112 (0.89%)
    1 / 179 (0.56%)
    2 / 175 (1.14%)
    3 / 165 (1.82%)
    3 / 118 (2.54%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    8 / 294 (2.72%)
    0 / 294 (0.00%)
    4 / 298 (1.34%)
    0 / 298 (0.00%)
         occurrences all number
    7
    1
    1
    2
    3
    3
    0
    0
    9
    0
    4
    0
    Diarrhoea
         subjects affected / exposed
    6 / 124 (4.84%)
    1 / 112 (0.89%)
    4 / 179 (2.23%)
    6 / 175 (3.43%)
    3 / 165 (1.82%)
    2 / 118 (1.69%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    3 / 294 (1.02%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    1 / 298 (0.34%)
         occurrences all number
    6
    1
    4
    6
    3
    2
    0
    0
    3
    0
    1
    1
    Constipation
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 112 (0.89%)
    1 / 179 (0.56%)
    2 / 175 (1.14%)
    1 / 165 (0.61%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    1
    1
    2
    1
    1
    0
    0
    0
    0
    1
    0
    Tongue coated
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 112 (0.89%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Duodenogastric reflux
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    2 / 165 (1.21%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    1
    0
    Lip dry
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Teething
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    3 / 298 (1.01%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    1 / 294 (0.34%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Uvulitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 124 (1.61%)
    2 / 112 (1.79%)
    2 / 179 (1.12%)
    5 / 175 (2.86%)
    0 / 165 (0.00%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    2
    2
    2
    5
    0
    1
    0
    0
    0
    0
    1
    0
    Dermatitis
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 112 (0.89%)
    0 / 179 (0.00%)
    6 / 175 (3.43%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    1
    0
    6
    1
    0
    0
    0
    0
    0
    0
    0
    Eczema
         subjects affected / exposed
    1 / 124 (0.81%)
    2 / 112 (1.79%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    1 / 118 (0.85%)
    1 / 299 (0.33%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    2
    0
    0
    1
    1
    1
    0
    1
    0
    0
    0
    Skin disorder
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Ingrowing nail
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Acne
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    2 / 298 (0.67%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Acanthosis nigricans
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Tenderness (any)
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    55 / 108 (50.93%)
    50 / 87 (57.47%)
    96 / 155 (61.94%)
    67 / 148 (45.27%)
    69 / 125 (55.20%)
    64 / 102 (62.75%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    230 / 265 (86.79%)
    0 / 294 (0.00%)
    252 / 283 (89.05%)
    0 / 298 (0.00%)
         occurrences all number
    55
    50
    96
    67
    69
    64
    0
    0
    230
    0
    252
    0
    Tenderness (significant)
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    7 / 92 (7.61%)
    6 / 68 (8.82%)
    15 / 141 (10.64%)
    7 / 133 (5.26%)
    10 / 101 (9.90%)
    12 / 92 (13.04%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    43 / 221 (19.46%)
    0 / 294 (0.00%)
    106 / 242 (43.80%)
    0 / 298 (0.00%)
         occurrences all number
    7
    6
    15
    7
    10
    12
    0
    0
    43
    0
    106
    0
    Swelling (any)
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    25 / 97 (25.77%)
    17 / 73 (23.29%)
    32 / 144 (22.22%)
    25 / 142 (17.61%)
    18 / 105 (17.14%)
    18 / 90 (20.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    85 / 226 (37.61%)
    0 / 294 (0.00%)
    86 / 233 (36.91%)
    0 / 298 (0.00%)
         occurrences all number
    25
    17
    32
    25
    18
    18
    0
    0
    85
    0
    86
    0
    Swelling (mild)
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    20 / 94 (21.28%)
    16 / 72 (22.22%)
    29 / 143 (20.28%)
    20 / 141 (14.18%)
    16 / 104 (15.38%)
    12 / 89 (13.48%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    48 / 220 (21.82%)
    0 / 294 (0.00%)
    50 / 221 (22.62%)
    0 / 298 (0.00%)
         occurrences all number
    20
    16
    29
    20
    16
    12
    0
    0
    48
    0
    50
    0
    Swelling (moderate)
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    9 / 94 (9.57%)
    2 / 69 (2.90%)
    8 / 141 (5.67%)
    10 / 135 (7.41%)
    8 / 102 (7.84%)
    10 / 89 (11.24%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    48 / 219 (21.92%)
    0 / 294 (0.00%)
    48 / 226 (21.24%)
    0 / 298 (0.00%)
         occurrences all number
    9
    2
    8
    10
    8
    10
    0
    0
    48
    0
    48
    0
    Swelling (severe)
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    0 / 90 (0.00%)
    0 / 68 (0.00%)
    0 / 138 (0.00%)
    0 / 131 (0.00%)
    0 / 98 (0.00%)
    1 / 88 (1.14%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    7 / 211 (3.32%)
    0 / 294 (0.00%)
    4 / 214 (1.87%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    7
    0
    4
    0
    Redness (any)
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    41 / 103 (39.81%)
    27 / 76 (35.53%)
    52 / 149 (34.90%)
    27 / 143 (18.88%)
    26 / 110 (23.64%)
    33 / 91 (36.26%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    100 / 233 (42.92%)
    0 / 294 (0.00%)
    70 / 232 (30.17%)
    0 / 298 (0.00%)
         occurrences all number
    41
    27
    52
    27
    26
    33
    0
    0
    100
    0
    70
    0
    Redness (mild)
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    31 / 99 (31.31%)
    25 / 74 (33.78%)
    46 / 146 (31.51%)
    24 / 143 (16.78%)
    20 / 108 (18.52%)
    28 / 90 (31.11%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    63 / 226 (27.88%)
    0 / 294 (0.00%)
    48 / 226 (21.24%)
    0 / 298 (0.00%)
         occurrences all number
    31
    25
    46
    24
    20
    28
    0
    0
    63
    0
    48
    0
    Redness (moderate)
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    12 / 94 (12.77%)
    5 / 70 (7.14%)
    14 / 142 (9.86%)
    8 / 135 (5.93%)
    6 / 100 (6.00%)
    13 / 89 (14.61%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    48 / 218 (22.02%)
    0 / 294 (0.00%)
    31 / 221 (14.03%)
    0 / 298 (0.00%)
         occurrences all number
    12
    5
    14
    8
    6
    13
    0
    0
    48
    0
    31
    0
    Redness (severe)
    Additional description: Subjects affected and occurrences for LR and SE is same as e­-diaries could not distinguish 1 occurrence from other within a subject/vaccination. Dictionary version not captured, hence 0.0 is mentioned.LR and SE not assessed during 6-month follow-up.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    0 / 90 (0.00%)
    0 / 68 (0.00%)
    0 / 138 (0.00%)
    1 / 131 (0.76%)
    0 / 98 (0.00%)
    1 / 88 (1.14%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    7 / 212 (3.30%)
    0 / 294 (0.00%)
    4 / 213 (1.88%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    7
    0
    4
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    2 / 298 (0.67%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    Neck pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Torticollis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Otitis media
         subjects affected / exposed
    15 / 124 (12.10%)
    5 / 112 (4.46%)
    12 / 179 (6.70%)
    12 / 175 (6.86%)
    11 / 165 (6.67%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    3 / 294 (1.02%)
    0 / 294 (0.00%)
    2 / 298 (0.67%)
    0 / 298 (0.00%)
         occurrences all number
    17
    5
    12
    12
    11
    1
    0
    0
    3
    0
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 124 (7.26%)
    9 / 112 (8.04%)
    3 / 179 (1.68%)
    15 / 175 (8.57%)
    14 / 165 (8.48%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    2 / 294 (0.68%)
    0 / 294 (0.00%)
    3 / 298 (1.01%)
    0 / 298 (0.00%)
         occurrences all number
    9
    9
    3
    16
    14
    1
    0
    0
    2
    0
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 124 (3.23%)
    1 / 112 (0.89%)
    1 / 179 (0.56%)
    7 / 175 (4.00%)
    2 / 165 (1.21%)
    3 / 118 (2.54%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    3 / 294 (1.02%)
    0 / 294 (0.00%)
    3 / 298 (1.01%)
    0 / 298 (0.00%)
         occurrences all number
    4
    1
    1
    7
    2
    3
    0
    0
    3
    0
    3
    0
    Sinusitis
         subjects affected / exposed
    3 / 124 (2.42%)
    3 / 112 (2.68%)
    4 / 179 (2.23%)
    4 / 175 (2.29%)
    1 / 165 (0.61%)
    2 / 118 (1.69%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    3 / 294 (1.02%)
    0 / 294 (0.00%)
    5 / 298 (1.68%)
    0 / 298 (0.00%)
         occurrences all number
    3
    3
    4
    5
    1
    2
    0
    0
    3
    0
    5
    0
    Rhinitis
         subjects affected / exposed
    3 / 124 (2.42%)
    0 / 112 (0.00%)
    2 / 179 (1.12%)
    8 / 175 (4.57%)
    3 / 165 (1.82%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    3
    0
    2
    10
    3
    0
    0
    0
    0
    0
    0
    0
    Otitis media acute
         subjects affected / exposed
    3 / 124 (2.42%)
    1 / 112 (0.89%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    3
    1
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    Viral infection
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 112 (0.89%)
    5 / 179 (2.79%)
    4 / 175 (2.29%)
    3 / 165 (1.82%)
    3 / 118 (2.54%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    3 / 294 (1.02%)
    0 / 294 (0.00%)
    4 / 298 (1.34%)
    0 / 298 (0.00%)
         occurrences all number
    2
    1
    5
    4
    3
    3
    0
    0
    3
    0
    4
    0
    Croup infectious
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 112 (0.89%)
    2 / 179 (1.12%)
    7 / 175 (4.00%)
    1 / 165 (0.61%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    2
    1
    2
    7
    1
    1
    0
    0
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 112 (0.00%)
    2 / 179 (1.12%)
    2 / 175 (1.14%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    2
    0
    2
    2
    1
    0
    0
    0
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    3 / 118 (2.54%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    2 / 294 (0.68%)
    0 / 294 (0.00%)
    5 / 298 (1.68%)
    0 / 298 (0.00%)
         occurrences all number
    2
    0
    1
    0
    1
    3
    0
    0
    2
    0
    5
    0
    Ear infection
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    2 / 294 (0.68%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 112 (0.89%)
    3 / 179 (1.68%)
    2 / 175 (1.14%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    1
    3
    2
    0
    0
    0
    0
    1
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 112 (0.89%)
    1 / 179 (0.56%)
    3 / 175 (1.71%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    1
    1
    1
    5
    0
    0
    0
    0
    0
    0
    1
    0
    Bronchiolitis
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 112 (0.89%)
    0 / 179 (0.00%)
    2 / 175 (1.14%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    1
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    Eye infection
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Impetigo
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    2 / 175 (1.14%)
    0 / 165 (0.00%)
    2 / 118 (1.69%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    3 / 294 (1.02%)
    0 / 294 (0.00%)
    5 / 298 (1.68%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    2
    0
    0
    3
    0
    5
    0
    Lice infestation
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Otitis media chronic
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Paronychia
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pneumonia viral
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    1 / 179 (0.56%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cellulitis streptococcal
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 112 (0.89%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Coxsackie viral infection
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 112 (0.89%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dermatitis infected
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 112 (0.89%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 112 (0.89%)
    0 / 179 (0.00%)
    2 / 175 (1.14%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    6 / 294 (2.04%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    1
    0
    2
    1
    0
    0
    0
    6
    0
    0
    0
    Viral rash
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 112 (0.89%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Intertrigo candida
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Urethritis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    1 / 175 (0.57%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Otitis externa
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    1 / 118 (0.85%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    2 / 298 (0.67%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    Erythema infectiosum
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    2 / 165 (1.21%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    1 / 165 (0.61%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Acarodermatitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Dermatophytosis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Viral pharyngitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    1 / 294 (0.34%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Acute sinusitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Furuncle
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    1 / 298 (0.34%)
    0 / 298 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lactose intolerance
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 112 (0.00%)
    0 / 179 (0.00%)
    0 / 175 (0.00%)
    0 / 165 (0.00%)
    0 / 118 (0.00%)
    0 / 299 (0.00%)
    0 / 297 (0.00%)
    0 / 294 (0.00%)
    0 / 294 (0.00%)
    0 / 298 (0.00%)
    0 / 298 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed 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.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2009
    1- The sample size was increased to 300 subjects in each group to enhance the immunogenicity and safety assessments. 2- An OPA analysis on a subset of subjects in groups 3 and 4 was added. 3- The total volume of blood collected was increased to 10 mL.

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

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