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    Clinical Trial Results:
    A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Brazil

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2008-004768-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    22 Sep 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 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
    6096A1-012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00676091
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias Number: B1851003
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Clinical Trials.gov Call Center, Pfizer, Inc., 001 800 7181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Clinical Trials.gov Call Center, Pfizer, Inc., 001 800 7181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 May 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the pneumococcal immune responses induced by 13-valent Pneumococcal Conjugate Vaccine (13vPnC) relative to the pneumococcal immune responses induced by 7-valent pneumococcal conjugate vaccine (7vPnC) when measured 1 month after the infant series. To assess the immune responses induced by the diphtheria, tetanus, whole cell pertussis, and Haemophilus influenzae type b vaccine (DTP-Hib) given with 13vPnC relative to the immune responses induced by DTP-Hib given with 7vPnC when measured 1 month after the infant series. The following antigens in DTP-Hib were assessed: pertussis antigens (pertussis toxoid [PT], filamentous haemagglutinin [FHA], and pertactin [PRN]). To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 354
    Worldwide total number of subjects
    354
    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)
    354
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 354 were enrolled in the study. Subjects randomized in 13vPnC and 7vPnC arms were 177 and 177, respectively. From the randomized subjects, 163 and 162 subjects were vaccinated with Dose 1 for the respective arms.

    Period 1
    Period 1 title
    Infant Series
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC- Infant Series
    Arm description
    		 13vPnC administered intramuscularly at 2, 4, and 6 months of age (infant series).
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A 0.5 milliliter (mL) dose of 13vPnC was administered intramuscularly at 2, 4, and 6 months of age (infant series).

    Arm title
    		 7vPnC- Infant Series
    Arm description
    		 7vPnC administered intramuscularly at 2, 4, and 6 months of age (infant series).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A 0.5 mL dose of 7vPnC was administered intramuscularly at 2, 4, and 6 months of age (infant series).

    Number of subjects in period 1
    		13vPnC- Infant Series 7vPnC- Infant Series
    Started
    177
    177
    Vaccinated Dose 1
    163
    162
    Vaccinated Dose 2
    159
    162
    Vaccinated Dose 3
    158
    161
    Completed
    157
    159
    Not completed
    20
    18
         Parent or legal guardian request
    10
    8
         Adverse Event
    2
    3
         Failed to return
    1
    3
         Protocol Violation
    6
    3
         Lost to follow-up
    1
    -
         Died prior to receiving 7vPnC
    -
    1
    Period 2
    Period 2 title
    After Infant Series
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC- After the Infant Series
    Arm description
    		 13vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 7vPnC- After the Infant Series
    Arm description
    		 7vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		13vPnC- After the Infant Series 7vPnC- After the Infant Series
    Started
    157
    159
    Completed
    156
    156
    Not completed
    1
    3
         Failed to return
    1
    1
         Adverse Event
    -
    1
         Protocol Violation
    -
    1
    Period 3
    Period 3 title
    Toddler Dose
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC Toddler Dose
    Arm description
    		 13vPnC administered intramuscularly at 12 months of age (toddler dose).
    Arm type
    		 Experimental

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

    Arm title
    		 7vPnC Toddler Dose
    Arm description
    		 7vPnC administered intramuscularly at 12 months of age (toddler dose).
    Arm type
    		 Active comparator

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

    Number of subjects in period 3
    		13vPnC Toddler Dose 7vPnC Toddler Dose
    Started
    156
    156
    Completed
    153
    156
    Not completed
    3
    0
         Parent or legal guardian request
    1
    -
         Failed to return
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC- Infant Series
    Reporting group description
    		 13vPnC administered intramuscularly at 2, 4, and 6 months of age (infant series).

    Reporting group title
    7vPnC- Infant Series
    Reporting group description
    		 7vPnC administered intramuscularly at 2, 4, and 6 months of age (infant series).

    Reporting group values
    		 13vPnC- Infant Series 7vPnC- Infant Series Total
    Number of subjects
    		 177 177 354
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 1.2 ( 0.2 ) 1.2 ( 0.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 99 83 182
        Male
    		 78 94 172

    End points

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    End points reporting groups
    Reporting group title
    13vPnC- Infant Series
    Reporting group description
    		 13vPnC administered intramuscularly at 2, 4, and 6 months of age (infant series).

    Reporting group title
    7vPnC- Infant Series
    Reporting group description
    		 7vPnC administered intramuscularly at 2, 4, and 6 months of age (infant series).
    Reporting group title
    13vPnC- After the Infant Series
    Reporting group description
    		 13vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).

    Reporting group title
    7vPnC- After the Infant Series
    Reporting group description
    		 7vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age).
    Reporting group title
    13vPnC Toddler Dose
    Reporting group description
    		 13vPnC administered intramuscularly at 12 months of age (toddler dose).

    Reporting group title
    7vPnC Toddler Dose
    Reporting group description
    		 7vPnC administered intramuscularly at 12 months of age (toddler dose).

    Primary: Percentage of Subjects Achieving Serotype Specific immunoglobulin G (IgG) Antibody Concentration ≥0.35 Micrograms Per Milliliter (mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

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    End point title
    		 Percentage of Subjects Achieving Serotype Specific immunoglobulin G (IgG) Antibody Concentration ≥0.35 Micrograms Per Milliliter (mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series [1]
    End point description
    Percentage of subjects achieving predefined antibody threshold greater than or equal to (≥)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) are presented. Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.
    End point type
    Primary
    End point timeframe
    1 Month after the infant series (7 Months of age)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this outcome.
    End point values
    		 13vPnC- Infant Series 7vPnC- Infant Series
    Number of subjects analysed
    156 [2]
    158 [3]
    Units: percentage of subjects
    number (confidence interval 95%)
        Common serotypes - serotype 4
    100 (97.7 to 100)
    100 (97.7 to 100)
        Common serotypes - serotype 6B
    96.8 (92.7 to 99)
    95.6 (91.1 to 98.2)
        Common serotypes - serotype 9V
    98.7 (95.4 to 99.8)
    100 (97.7 to 100)
        Common serotypes - serotype 14
    98.1 (94.5 to 99.6)
    97.5 (93.6 to 99.3)
        Common serotypes - serotype 18C
    97.4 (93.6 to 99.3)
    98.1 (94.5 to 99.6)
        Common serotypes - serotype 19F
    94.2 (89.3 to 97.3)
    98.7 (95.5 to 99.8)
        Common serotypes - serotype 23F
    96.8 (92.7 to 99)
    93 (87.8 to 96.5)
        Additional serotypes - serotype 1
    99.4 (96.5 to 100)
    2.5 (0.7 to 6.4)
        Additional serotypes - serotype 3
    87.1 (80.8 to 91.9)
    4.4 (1.8 to 8.9)
        Additional serotypes - serotype 5
    98.7 (95.4 to 99.8)
    38.2 (30.4 to 46.4)
        Additional serotypes - serotype 6A
    97.4 (93.6 to 99.3)
    52.6 (44.4 to 60.6)
        Additional serotypes - serotype 7F
    100 (97.7 to 100)
    1.3 (0.2 to 4.6)
        Additional serotypes - serotype 19A
    99.4 (96.5 to 100)
    98.7 (95.4 to 99.8)
    Notes
    [2] - Number of subjects with a determinate IgG antibody concentration to the given serotype.
    [3] - Number of subjects with a determinate IgG antibody concentration to the given serotype.
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

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    End point title
    		 Percentage of Subjects Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series [4]
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (PT, FHA, and PRN) are presented. Evaluable immunogenicity population.
    End point type
    Primary
    End point timeframe
    1 month after the infant series (7 months of age)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this outcome.
    End point values
    		 13vPnC- Infant Series 7vPnC- Infant Series
    Number of subjects analysed
    156 [5]
    158 [6]
    Units: percentage of subjects
    number (confidence interval 95%)
        PT ≥5 EU/mL
    35.9 (28.4 to 44)
    32.3 (25.1 to 40.2)
        FHA ≥5 EU/mL
    70.1 (62.2 to 77.2)
    71.5 (63.8 to 78.4)
        PRN ≥5 EU/mL
    93.5 (88.5 to 96.9)
    96.2 (91.9 to 98.6)
    Notes
    [5] - Number of subjects with a determinate antibody concentration to given concomitant vaccine component.
    [6] - Number of subjects with a determinate antibody concentration to given concomitant vaccine component.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Serotype Specific IgG Antibody Concentration ≥0.35 mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose

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    End point title
    		 Percentage of Subjects Achieving Serotype Specific IgG Antibody Concentration ≥0.35 mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity population.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose (13 months of age)
    End point values
    		 13vPnC Toddler Dose 7vPnC Toddler Dose
    Number of subjects analysed
    152 [7]
    152 [8]
    Units: percentage of subjects
    number (confidence interval 95%)
        Common serotypes - serotype 4
    100 (97.6 to 100)
    100 (97.6 to 100)
        Common serotypes - serotype 6B
    97.4 (93.4 to 99.3)
    98.7 (95.3 to 99.8)
        Common serotypes - serotype 9V
    100 (97.6 to 100)
    100 (97.6 to 100)
        Common serotypes - serotype 14
    100 (97.6 to 100)
    99.3 (96.4 to 100)
        Common serotypes - serotype 18C
    99.3 (96.4 to 100)
    100 (97.6 to 100)
        Common serotypes - serotype 19F
    99.3 (96.4 to 100)
    98.7 (95.3 to 99.8)
        Common serotypes - serotype 23F
    98.7 (95.3 to 100)
    99.3 (96.4 to 100)
        Additional serotypes - serotype 1
    100 (97.6 to 100)
    2.7 (0.7 to 6.7)
        Additional serotypes - serotype 3
    92.1 (86.5 to 95.8)
    7.5 (3.8 to 13)
        Additional serotypes - serotype 5
    100 (97.6 to 100)
    72.1 (63.9 to 79.4)
        Additional serotypes - serotype 6A
    100 (97.6 to 100)
    72.1 (63.9 to 79.4)
        Additional serotypes - serotype 7F
    100 (97.6 to 100)
    4.2 (1.5 to 8.8)
        Additional serotypes - serotype 19A
    100 (97.6 to 100)
    100 (97.6 to 100)
    Notes
    [7] - Number of subjects with a determinate IgG antibody concentration to the given serotype.
    [8] - Number of subjects with a determinate IgG antibody concentration to the given serotype.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose

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    End point title
    		 Percentage of Subjects Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (PT, FHA, and PRN) are presented. Evaluable immunogenicity population.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose (13 months of age)
    End point values
    		 13vPnC Toddler Dose 7vPnC Toddler Dose
    Number of subjects analysed
    152 [9]
    152 [10]
    Units: percentage of subjects
    number (confidence interval 95%)
        PT ≥5 EU/mL
    50.7 (42.4 to 58.9)
    49.3 (41.1 to 57.6)
        FHA ≥5 EU/mL
    91.4 (85.8 to 95.4)
    88.8 (82.7 to 93.3)
        PRN ≥5 EU/mL
    99.3 (96.4 to 100)
    98.7 (95.3 to 99.8)
    Notes
    [9] - Number of subjects with a determinate antibody concentration to given concomitant vaccine component.
    [10] - Number of subjects with a determinate antibody concentration to given concomitant vaccine component.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)
    End point description
    Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimetre [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 1 (2 months of age)
    End point values
    		 13vPnC- Infant Series 7vPnC- Infant Series
    Number of subjects analysed
    145 [11]
    156 [12]
    Units: percentage of subejcts
    number (not applicable)
        Tenderness: Any
    60
    59.4
        Tenderness: Significant
    14
    12.8
        Swelling: Any
    13.9
    15
        Swelling: Mild
    10.3
    13.6
        Swelling: Moderate
    5.9
    1.4
        Swelling: Severe
    0
    0
        Redness: Any
    10.3
    13.4
        Redness: Mild
    8.8
    11.4
        Redness: Moderate
    2.9
    2.1
        Redness: Severe
    0
    0
    Notes
    [11] - Number of subjects reporting yes for at least 1 day or no for all days.
    [12] - Number of subjects reporting yes for at least 1 day or no for all days.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
    End point description
    Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 2 (4 months of age)
    End point values
    		 13vPnC- Infant Series 7vPnC- Infant Series
    Number of subjects analysed
    137 [13]
    145 [14]
    Units: percentage of subejcts
    number (not applicable)
        Tenderness: Any
    53.3
    53.8
        Tenderness: Significant
    9.4
    11.9
        Swelling: Any
    12.1
    13.8
        Swelling: Mild
    10.5
    10
        Swelling: Moderate
    2.4
    3.9
        Swelling: Severe
    0
    0
        Redness: Any
    9.3
    12.4
        Redness: Mild
    9.3
    11.6
        Redness: Moderate
    0
    1.6
        Redness: Severe
    0
    0
    Notes
    [13] - Number of subjects reporting yes for at least 1 day or no for all days.
    [14] - Number of subjects reporting yes for at least 1 day or no for all days.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
    End point description
    Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 3 (6 months of age)
    End point values
    		 13vPnC- Infant Series 7vPnC- Infant Series
    Number of subjects analysed
    134 [15]
    134 [16]
    Units: percentage of subejcts
    number (not applicable)
        Tenderness: Any
    48.1
    47.4
        Tenderness: Significant
    10.9
    8.8
        Swelling: Any
    14.6
    9.7
        Swelling: Mild
    12.2
    9.7
        Swelling: Moderate
    4.2
    0.9
        Swelling: Severe
    0
    0
        Redness: Any
    10.7
    14
        Redness: Mild
    10.7
    13.3
        Redness: Moderate
    0.8
    0.9
        Redness: Severe
    0
    0
    Notes
    [15] - Number of subjects reporting yes for at least 1 day or no for all days.
    [16] - Number of subjects reporting yes for at least 1 day or no for all days.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)
    End point description
    Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after toddler dose (12 months of age)
    End point values
    		 13vPnC Toddler Dose 7vPnC Toddler Dose
    Number of subjects analysed
    128 [17]
    128 [18]
    Units: percentage of subjects
    number (not applicable)
        Tenderness: Any
    64.3
    53.2
        Tenderness: Significant
    18.3
    13.3
        Swelling: Any
    11.5
    10.5
        Swelling: Mild
    8.1
    8.7
        Swelling: Moderate
    5.3
    3.9
        Swelling: Severe
    0
    0
        Redness: Any
    13.3
    8.7
        Redness: Mild
    12.4
    7.8
        Redness: Moderate
    0.9
    1
        Redness: Severe
    0
    0
    Notes
    [17] - Number of subjects reporting yes for at least 1 day or no for all days.
    [18] - Number of subjects reporting yes for at least 1 day or no for all days.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
    End point description
    Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 1 (2 months of age)
    End point values
    		 13vPnC- Infant Series 7vPnC- Infant Series
    Number of subjects analysed
    154 [19]
    154 [20]
    Units: percentage of subjects
    number (not applicable)
        Fever ≥38 but ≤39 degrees C
    18
    19.9
        Fever>39 but less than or equal to(≤)40 degrees C
    0
    0.7
        Fever >40 degrees C
    0
    0
        Decreased appetite
    26.6
    28
        Irritability
    80.3
    77.9
        Increased sleep
    56.6
    52.4
        Decreased sleep
    39.7
    27.5
    Notes
    [19] - Number of subjects reporting yes for at least 1 day or no for all days.
    [20] - Number of subjects reporting yes for at least 1 day or no for all days.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
    End point description
    Pre-specified systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 2 (4 months of age)
    End point values
    		 13vPnC- Infant Series 7vPnC- Infant Series
    Number of subjects analysed
    141 [21]
    157 [22]
    Units: percentage of subjects
    number (not applicable)
        Fever ≥38 but ≤39 degrees C
    23.8
    23
        Fever >39 but ≤40 degrees C
    3.2
    0.8
        Fever >40 degrees C
    0
    0
        Decreased appetite
    33.8
    29.6
        Irritability
    80.4
    79.2
        Increased sleep
    32.8
    38.7
        Decreased sleep
    25.8
    36
    Notes
    [21] - Number of subjects reporting yes for at least 1 day or no for all days.
    [22] - Number of subjects reporting yes for at least 1 day or no for all days.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
    End point description
    Pre-specified systemic events (any fever ≥ 38 degrees Celsius C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 3 (6 months of age)
    End point values
    		 13vPnC- Infant Series 7vPnC- Infant Series
    Number of subjects analysed
    148 [23]
    144 [24]
    Units: percentage of subjects
    number (not applicable)
        Fever ≥38 but ≤39 degrees C
    22.6
    22.4
        Fever >39 but ≤40 degrees C
    4.2
    3.5
        Fever >40 degrees C
    0.8
    0.9
        Decreased appetite
    37.9
    32.2
        Irritability
    76.9
    71.2
        Increased sleep
    35.7
    36.9
        Decreased sleep
    27.6
    34.1
    Notes
    [23] - Number of subjects reporting yes for at least 1 day or no for all days.
    [24] - Number of subjects reporting yes for at least 1 day or no for all days.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)

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    End point title
    		 Percentage of Subjects Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)
    End point description
    Pre-specified systemic events (any fever ≥ 38 degrees Celsius C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population: all subjects who received at least 1 dose of study vaccine.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after toddler dose (12 months of age)
    End point values
    		 13vPnC Toddler Dose 7vPnC Toddler Dose
    Number of subjects analysed
    132 [25]
    133 [26]
    Units: percentage of subjects
    number (not applicable)
        Fever ≥38 but ≤39 degrees C
    31
    29.9
        Fever >39 but ≤40 degrees C
    1.8
    3
        Fever >40 degrees C
    0.9
    0
        Decreased appetite
    33.3
    39
        Irritability
    67.2
    68.8
        Increased sleep
    30.8
    24.1
        Decreased sleep
    22.7
    20.6
    Notes
    [25] - Number of subjects reporting yes for at least 1 day or no for all days.
    [26] - Number of subjects reporting yes for at least 1 day or no for all days.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were reported from signing of informed consent form (ICF) to 28 to 56 days after third dose of infant series & from toddler dose to 28 to 56 days after toddler dose.SAEs were reported from signing of the ICF to 1 month after the last study vaccination
    Adverse event reporting additional description
    Safety population.AE may be reported as both a serious & non-serious, but are distinct events. AE =serious for 1 subject & =non-serious for other subject/ subject may have experienced both serious & non-serious episode of same event.Version was not captured, 0.0 is mentioned for dictionary version. LRs,SEs assessed for Infant & toddler groups only.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    		 13vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series).

    Reporting group title
    7vPnC Infant Series
    Reporting group description
    		 7vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series).

    Reporting group title
    After the Infant Series 13vPnC
    Reporting group description
    		 13vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series); assessment between 1 month after infant series and toddler dose.

    Reporting group title
    After the Infant Series 7vPnC
    Reporting group description
    		 7vPnC 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series); assessment between 1 month after infant series and toddler dose.

    Reporting group title
    13vPnC Toddler Dose
    Reporting group description
    		 13vPnC 0.5 mL dose administered intramuscularly at 12 months of age (toddler dose).

    Reporting group title
    7vPnC Toddler Dose
    Reporting group description
    		 7vPnC 0.5 mL dose administered intramuscularly at 12 months of age (toddler dose).

    Serious adverse events
    		 13vPnC Infant Series 7vPnC Infant Series After the Infant Series 13vPnC After the Infant Series 7vPnC 13vPnC Toddler Dose 7vPnC Toddler Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 163 (6.13%)
    10 / 162 (6.17%)
    10 / 163 (6.13%)
    5 / 162 (3.09%)
    2 / 155 (1.29%)
    3 / 156 (1.92%)
         number of deaths (all causes)
    0
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Congenital hydrocephalus
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Hypotonic-hyporesponsive episode
         subjects affected / exposed
    1 / 163 (0.61%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    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
    Umbilical hernia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    2 / 163 (1.23%)
    1 / 162 (0.62%)
    1 / 155 (0.65%)
    2 / 156 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Breath holding
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    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
    Pneumonia
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    2 / 163 (1.23%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia primary atypical
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    2 / 163 (1.23%)
    2 / 162 (1.23%)
    0 / 155 (0.00%)
    2 / 156 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle abscess
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis viral
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 13vPnC Infant Series 7vPnC Infant Series After the Infant Series 13vPnC After the Infant Series 7vPnC 13vPnC Toddler Dose 7vPnC Toddler Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    145 / 163 (88.96%)
    142 / 162 (87.65%)
    8 / 163 (4.91%)
    7 / 162 (4.32%)
    108 / 155 (69.68%)
    105 / 156 (67.31%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vascular disorders
    Hyperaemia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pallor
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    12 / 163 (7.36%)
    8 / 162 (4.94%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    2 / 155 (1.29%)
    3 / 156 (1.92%)
         occurrences all number
    14
    8
    0
    0
    2
    3
    Inflammation
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Injection site reaction
         subjects affected / exposed
    4 / 163 (2.45%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    4
    2
    0
    0
    0
    0
    Irritability
         subjects affected / exposed
    2 / 163 (1.23%)
    4 / 162 (2.47%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Tenderness
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Hypothermia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Injection site exfoliation
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vaccination site reaction
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Injection site induration
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Injection site scar
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Injection site swelling
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oedema
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Vaccination site erythema
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Vaccination site pain
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    25 / 139 (17.99%)
    28 / 141 (19.86%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    36 / 116 (31.03%)
    32 / 107 (29.91%)
         occurrences all number
    25
    28
    0
    0
    36
    32
    Fever >39°C but ≤40°C: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    0 / 135 (0.00%)
    1 / 138 (0.72%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    2 / 110 (1.82%)
    3 / 100 (3.00%)
         occurrences all number
    0
    1
    0
    0
    2
    3
    Fever >40°C: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Sysetmic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    0 / 135 (0.00%)
    0 / 138 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 110 (0.91%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Decreased appetite: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    38 / 143 (26.57%)
    40 / 143 (27.97%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    39 / 117 (33.33%)
    46 / 118 (38.98%)
         occurrences all number
    38
    40
    0
    0
    39
    46
    Irritability: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    122 / 152 (80.26%)
    116 / 149 (77.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    84 / 125 (67.20%)
    86 / 125 (68.80%)
         occurrences all number
    122
    116
    0
    0
    84
    86
    Increased sleep: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    81 / 143 (56.64%)
    77 / 147 (52.38%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    36 / 117 (30.77%)
    26 / 108 (24.07%)
         occurrences all number
    81
    77
    0
    0
    36
    26
    Decreased sleep: Infant Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    56 / 141 (39.72%)
    38 / 138 (27.54%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    27 / 119 (22.69%)
    22 / 107 (20.56%)
         occurrences all number
    56
    38
    0
    0
    27
    22
    Fever ≥38°C but ≤39°C: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    31 / 130 (23.85%)
    31 / 135 (22.96%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    31
    31
    0
    0
    0
    0
    Fever >39°C but ≤40°C: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    4 / 124 (3.23%)
    1 / 128 (0.78%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    4
    1
    0
    0
    0
    0
    Decreased appetite: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    44 / 130 (33.85%)
    40 / 135 (29.63%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    44
    40
    0
    0
    0
    0
    Irritability: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    111 / 138 (80.43%)
    122 / 154 (79.22%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    111
    122
    0
    0
    0
    0
    Increased sleep: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    41 / 125 (32.80%)
    55 / 142 (38.73%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    41
    55
    0
    0
    0
    0
    Decreased sleep: Infant Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    33 / 128 (25.78%)
    49 / 136 (36.03%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    33
    49
    0
    0
    0
    0
    Fever ≥38°C but ≤39°C: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    28 / 124 (22.58%)
    26 / 116 (22.41%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    28
    26
    0
    0
    0
    0
    Fever >39°C but ≤40°C: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    5 / 119 (4.20%)
    4 / 113 (3.54%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    5
    4
    0
    0
    0
    0
    Fever >40°C : Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    1 / 119 (0.84%)
    1 / 112 (0.89%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Decreased appetite Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    50 / 132 (37.88%)
    39 / 121 (32.23%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    50
    39
    0
    0
    0
    0
    Irritability: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    110 / 143 (76.92%)
    99 / 139 (71.22%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    110
    99
    0
    0
    0
    0
    Increased sleep: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through e diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    46 / 129 (35.66%)
    45 / 122 (36.89%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    46
    45
    0
    0
    0
    0
    Decreased sleep: Infant Series Dose 3
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    35 / 127 (27.56%)
    43 / 126 (34.13%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    35
    43
    0
    0
    0
    0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    2 / 163 (1.23%)
    5 / 162 (3.09%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    2
    5
    0
    0
    0
    0
    Milk allergy
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Food allergy
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 163 (4.91%)
    12 / 162 (7.41%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences all number
    8
    13
    0
    0
    1
    0
    Bronchospasm
         subjects affected / exposed
    4 / 163 (2.45%)
    5 / 162 (3.09%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    2 / 155 (1.29%)
    4 / 156 (2.56%)
         occurrences all number
    4
    7
    0
    0
    2
    4
    Allergic cough
         subjects affected / exposed
    3 / 163 (1.84%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    3
    3
    0
    0
    0
    0
    Asthmatic crisis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Upper airway obstruction
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    2 / 162 (1.23%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    4 / 163 (2.45%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
    2 / 162 (1.23%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    4
    0
    1
    2
    0
    0
    Psychiatric disorders
    Breath holding
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    3 / 163 (1.84%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    3
    1
    0
    0
    0
    1
    Traumatic brain injury
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    Hydrocele
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Ventricular septal defect
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Glucose-6-phosphate dehydrogenase deficiency
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Hypokinesia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Poor quality sleep
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Psychomotor skills impaired
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 163 (2.45%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    1 / 156 (0.64%)
         occurrences all number
    4
    3
    0
    0
    1
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hypoacusis
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    4 / 163 (2.45%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    4
    3
    0
    0
    0
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Strabismus
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Eye discharge
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    14 / 163 (8.59%)
    10 / 162 (6.17%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    2 / 155 (1.29%)
    3 / 156 (1.92%)
         occurrences all number
    14
    10
    0
    0
    2
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    8 / 163 (4.91%)
    9 / 162 (5.56%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    8
    9
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    9 / 163 (5.52%)
    6 / 162 (3.70%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    3 / 156 (1.92%)
         occurrences all number
    9
    6
    0
    0
    0
    3
    Abdominal pain
         subjects affected / exposed
    9 / 163 (5.52%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    9
    3
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    6 / 163 (3.68%)
    4 / 162 (2.47%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences all number
    6
    4
    0
    1
    1
    0
    Inguinal hernia
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    Abnormal faeces
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oral mucosal discolouration
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Regurgitation
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    2 / 155 (1.29%)
    3 / 156 (1.92%)
         occurrences all number
    0
    1
    0
    0
    2
    3
    Umbilical hernia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    7 / 163 (4.29%)
    4 / 162 (2.47%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    7
    4
    0
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    2 / 163 (1.23%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences all number
    2
    3
    0
    0
    1
    0
    Dermatitis contact
         subjects affected / exposed
    3 / 163 (1.84%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    3
    2
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    2 / 163 (1.23%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    1 / 163 (0.61%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Dry skin
         subjects affected / exposed
    1 / 163 (0.61%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Pityriasis alba
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Prurigo
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Rash generalised
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Heat rash
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Tenderness (Any): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    87 / 145 (60.00%)
    92 / 155 (59.35%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    81 / 126 (64.29%)
    67 / 126 (53.17%)
         occurrences all number
    87
    92
    0
    0
    81
    67
    Tenderness (Significant): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    19 / 136 (13.97%)
    18 / 141 (12.77%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    21 / 115 (18.26%)
    14 / 105 (13.33%)
         occurrences all number
    19
    18
    0
    0
    21
    14
    Swelling (Any): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [23]
    19 / 137 (13.87%)
    21 / 140 (15.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    13 / 113 (11.50%)
    11 / 105 (10.48%)
         occurrences all number
    19
    21
    0
    0
    13
    11
    Swelling (Mild): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    14 / 136 (10.29%)
    19 / 140 (13.57%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    9 / 111 (8.11%)
    9 / 103 (8.74%)
         occurrences all number
    14
    19
    0
    0
    9
    9
    Swelling (Moderate): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    8 / 136 (5.88%)
    2 / 138 (1.45%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    6 / 113 (5.31%)
    4 / 102 (3.92%)
         occurrences all number
    8
    2
    0
    0
    6
    4
    Redness (Any): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    14 / 136 (10.29%)
    19 / 142 (13.38%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    15 / 113 (13.27%)
    9 / 103 (8.74%)
         occurrences all number
    14
    19
    0
    0
    15
    9
    Redness (Mild): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    12 / 136 (8.82%)
    16 / 140 (11.43%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    14 / 113 (12.39%)
    8 / 102 (7.84%)
         occurrences all number
    12
    16
    0
    0
    14
    8
    Redness (Moderate): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    4 / 136 (2.94%)
    3 / 140 (2.14%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 110 (0.91%)
    1 / 101 (0.99%)
         occurrences all number
    4
    3
    0
    0
    1
    1
    Tenderness (Any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    72 / 135 (53.33%)
    78 / 145 (53.79%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    72
    78
    0
    0
    0
    0
    Tenderness (Significant): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    12 / 127 (9.45%)
    16 / 134 (11.94%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    12
    16
    0
    0
    0
    0
    Swelling (Any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    15 / 124 (12.10%)
    18 / 130 (13.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    15
    18
    0
    0
    0
    0
    Swelling (Mild): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    13 / 124 (10.48%)
    13 / 130 (10.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    13
    13
    0
    0
    0
    0
    Swelling (Moderate): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    3 / 124 (2.42%)
    5 / 128 (3.91%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    3
    5
    0
    0
    0
    0
    Redness (Any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    12 / 129 (9.30%)
    16 / 129 (12.40%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    12
    16
    0
    0
    0
    0
    Redness (Mild): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    12 / 129 (9.30%)
    15 / 129 (11.63%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    12
    15
    0
    0
    0
    0
    Redness (Moderate): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    0 / 123 (0.00%)
    2 / 128 (1.56%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Tenderness (Any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Recations 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    63 / 131 (48.09%)
    63 / 133 (47.37%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    63
    63
    0
    0
    0
    0
    Tenderness (Significant): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    13 / 119 (10.92%)
    10 / 114 (8.77%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    13
    10
    0
    0
    0
    0
    Swelling (Any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    18 / 123 (14.63%)
    11 / 113 (9.73%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    18
    11
    0
    0
    0
    0
    Swelling (Mild): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    15 / 123 (12.20%)
    11 / 113 (9.73%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    15
    11
    0
    0
    0
    0
    Swelling (Moderate): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    5 / 120 (4.17%)
    1 / 113 (0.88%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    5
    1
    0
    0
    0
    0
    Redness (Any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [42]
    13 / 121 (10.74%)
    16 / 114 (14.04%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    13
    16
    0
    0
    0
    0
    Redness (Moderate): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [43]
    1 / 120 (0.83%)
    1 / 113 (0.88%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Renal and urinary disorders
    Pyelocaliectasis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    3 / 163 (1.84%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    2 / 156 (1.28%)
         occurrences all number
    3
    2
    0
    0
    1
    2
    Arthralgia
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    54 / 163 (33.13%)
    54 / 162 (33.33%)
    2 / 163 (1.23%)
    0 / 162 (0.00%)
    11 / 155 (7.10%)
    7 / 156 (4.49%)
         occurrences all number
    74
    81
    2
    0
    12
    7
    Nasopharyngitis
         subjects affected / exposed
    55 / 163 (33.74%)
    43 / 162 (26.54%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    19 / 155 (12.26%)
    16 / 156 (10.26%)
         occurrences all number
    77
    66
    0
    0
    19
    17
    Gastroenteritis
         subjects affected / exposed
    10 / 163 (6.13%)
    12 / 162 (7.41%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    1 / 156 (0.64%)
         occurrences all number
    12
    12
    0
    0
    1
    1
    Perineal infection
         subjects affected / exposed
    7 / 163 (4.29%)
    9 / 162 (5.56%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    9
    9
    0
    0
    0
    0
    Bronchiolitis
         subjects affected / exposed
    9 / 163 (5.52%)
    5 / 162 (3.09%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences all number
    10
    6
    0
    0
    1
    0
    Oral candidiasis
         subjects affected / exposed
    2 / 163 (1.23%)
    12 / 162 (7.41%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    3
    16
    0
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    5 / 163 (3.07%)
    4 / 162 (2.47%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences all number
    7
    6
    0
    0
    1
    0
    Ear infection
         subjects affected / exposed
    5 / 163 (3.07%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    3 / 155 (1.94%)
    1 / 156 (0.64%)
         occurrences all number
    5
    2
    0
    0
    3
    1
    Varicella
         subjects affected / exposed
    6 / 163 (3.68%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    2 / 156 (1.28%)
         occurrences all number
    6
    1
    0
    0
    0
    2
    Exanthema subitum
         subjects affected / exposed
    3 / 163 (1.84%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    3
    3
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    3 / 163 (1.84%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    2 / 155 (1.29%)
    2 / 156 (1.28%)
         occurrences all number
    3
    3
    0
    0
    2
    2
    Otitis media
         subjects affected / exposed
    3 / 163 (1.84%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    2 / 155 (1.29%)
    3 / 156 (1.92%)
         occurrences all number
    3
    4
    0
    0
    2
    3
    Tracheobronchitis
         subjects affected / exposed
    3 / 163 (1.84%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    2 / 156 (1.28%)
         occurrences all number
    3
    3
    0
    0
    0
    2
    Viral rash
         subjects affected / exposed
    2 / 163 (1.23%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    2
    3
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 163 (0.61%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    2 / 155 (1.29%)
    0 / 156 (0.00%)
         occurrences all number
    1
    3
    0
    0
    2
    0
    Viral infection
         subjects affected / exposed
    1 / 163 (0.61%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    1
    3
    0
    1
    0
    1
    Bronchopneumonia
         subjects affected / exposed
    2 / 163 (1.23%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    1 / 156 (0.64%)
         occurrences all number
    2
    1
    0
    0
    1
    1
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    1
    2
    0
    0
    0
    1
    Laryngitis
         subjects affected / exposed
    0 / 163 (0.00%)
    3 / 162 (1.85%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    2 / 155 (1.29%)
    0 / 156 (0.00%)
         occurrences all number
    0
    3
    0
    0
    2
    0
    Pharyngitis
         subjects affected / exposed
    2 / 163 (1.23%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    3 / 155 (1.94%)
    1 / 156 (0.64%)
         occurrences all number
    2
    1
    0
    0
    3
    1
    Sinusitis
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    3
    0
    0
    0
    0
    1
    Asymptomatic bacteriuria
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Conjunctivitis viral
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Impetigo
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Otitis media acute
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    6 / 156 (3.85%)
         occurrences all number
    2
    0
    0
    0
    0
    7
    Pyoderma
         subjects affected / exposed
    1 / 163 (0.61%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 163 (0.00%)
    2 / 162 (1.23%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    Candidiasis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Conjunctivitis infective
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Herpangina
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Injection site abscess
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pertussis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pharyngitis bacterial
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pneumonia primary atypical
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Roseola
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Skin bacterial infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin infection
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    6 / 155 (3.87%)
    3 / 156 (1.92%)
         occurrences all number
    0
    1
    0
    0
    6
    3
    Viral diarrhoea
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Viral tonsillitis
         subjects affected / exposed
    0 / 163 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    2 / 155 (1.29%)
    0 / 156 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Tonsillitis bacterial
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 163 (0.61%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    Abnormal weight gain
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    0 / 156 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Weight gain poor
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    Dehydration
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    1 / 155 (0.65%)
    0 / 156 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Lactose intolerance
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
    0 / 162 (0.00%)
    0 / 155 (0.00%)
    1 / 156 (0.64%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Aug 2008
    Revised the visit 5 and visit 7 windows (7- and 13-month visits) from the original 28 to 42 days to a range of 28 to 56 days for blood draws and AE collection.

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

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

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