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    Clinical Trial Results:
    A Phase 3, Open Label, Single Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Mexico

    Summary
    EudraCT number
    		 2009-017122-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    30 Mar 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    6096A1-3009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00708682
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 alias: B1851045
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Aug 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2010
    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) when measured 1 month after the 3-dose infant series. To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jul 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
    Mexico: 225
    Worldwide total number of subjects
    225
    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)
    2
    Infants and toddlers (28 days-23 months)
    223
    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
    		 Study was conducted in Mexico from 10 July 2008 to 30 March 2010.

    Period 1
    Period 1 title
    Infant Series
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

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

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

    Number of subjects in period 1
    		13vPnC Infant Series
    Started
    225
    Vaccinated Dose 1
    223
    Vaccinated Dose 2
    214
    Vaccinated Dose 3
    194
    Completed
    192
    Not completed
    33
         Adverse Event
    1
         'Not Specified '
    19
         Protocol Violation
    1
         Failed to Return
    2
         Lost to follow-up
    4
         Parent/Legal Guardian Request
    6
    Period 2
    Period 2 title
    After Infant Series
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 13vPnC After Infant Series
    Arm description
    		 Included subjects who received 13vPnC at 2, 4, and 6 months of age (infant series).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		13vPnC After Infant Series
    Started
    192
    Completed
    191
    Not completed
    1
         Parent/Legal Guardian Request
    1
    Period 3
    Period 3 title
    Toddler Dose
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

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

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Prevenar 13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13vPnC 0.5 mL dose administered IM at 12 months of age (toddler dose).

    Number of subjects in period 3
    		13vPnC Toddler Dose
    Started
    191
    Completed
    183
    Not completed
    8
         Failed to Return
    4
         Parent/Legal Guardian Request
    1
         Lost to follow-up
    3

    Baseline characteristics

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

    Reporting group values
    		 13vPnC Infant Series Total
    Number of subjects
    		 225 225
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 2.1 ( 0.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 109 109
        Male
    		 116 116

    End points

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    End points reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    		 13vPnC administered at 2, 4, and 6 months of age (infant series).
    Reporting group title
    13vPnC After Infant Series
    Reporting group description
    		 Included subjects who received 13vPnC at 2, 4, and 6 months of age (infant series).
    Reporting group title
    13vPnC Toddler Dose
    Reporting group description
    		 13vPnC administered at 12 months of age (toddler dose).

    Primary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series

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    End point title
    		 Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series [1]
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (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. Exact 2-sided CI based on the observed proportion of subjects. Evaluable 3-Dose Infant Immunogenicity population: eligible subjects who received treatments as assigned at all 3 doses, blood drawn within specified time frames, 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 end point.
    End point values
    		 13vPnC Infant Series
    Number of subjects analysed
    171
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Common serotypes - serotype 4
    100 (97.9 to 100)
        Common serotypes - serotype 6B
    97.7 (94.1 to 99.4)
        Common serotypes - serotype 9V
    98.2 (94.9 to 99.6)
        Common serotypes - serotype 14
    98.8 (95.8 to 99.9)
        Common serotypes - serotype 18C
    98.8 (95.8 to 99.9)
        Common serotypes - serotype 19F
    98.2 (95 to 99.6)
        Common serotypes - serotype 23F
    92.9 (87.9 to 96.3)
        Additional serotypes - serotype 1
    99.4 (96.8 to 100)
        Additional serotypes - serotype 3
    94.1 (89.4 to 97.1)
        Additional serotypes - serotype 5
    98.2 (95 to 99.6)
        Additional serotypes - serotype 6A
    98.8 (95.8 to 99.9)
        Additional serotypes - serotype 7F
    98.8 (95.8 to 99.9)
        Additional serotypes - serotype 19A
    99.4 (96.8 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series

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    End point title
    		 Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥0.35mcg/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. Exact 2-sided CI based on the observed proportion of subjects. Evaluable 2-Dose Infant Immunogenicity population: eligible subjects who received treatments as assigned at dose 1 and dose 2, blood drawn within specified time frames, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after dose 2 of the infant series (5 months of age)
    End point values
    		 13vPnC Infant Series
    Number of subjects analysed
    195
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Common serotypes - serotype 4
    100 (98.1 to 100)
        Common serotypes - serotype 6B
    80.9 (74.7 to 86.2)
        Common serotypes - serotype 9V
    95.9 (92.1 to 98.2)
        Common serotypes - serotype 14
    99 (96.3 to 99.9)
        Common serotypes - serotype 18C
    93.3 (88.9 to 96.4)
        Common serotypes - serotype 19F
    98.5 (95.5 to 99.7)
        Common serotypes - serotype 23F
    77.9 (71.5 to 83.6)
        Additional serotypes - serotype 1
    98.5 (95.6 to 99.7)
        Additional serotypes - serotype 3
    96.4 (92.7 to 98.5)
        Additional serotypes - serotype 5
    97.4 (94.1 to 99.2)
        Additional serotypes - serotype 6A
    94.9 (90.8 to 97.5)
        Additional serotypes - serotype 7F
    99 (96.3 to 99.9)
        Additional serotypes - serotype 19A
    99.5 (97.2 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose

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    End point title
    		 Percentage of Subjects Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥0.35mcg/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. Exact 2-sided CI based on the observed proportion of subjects. Evaluable Toddler Immunogenicity population: eligible subjects who received treatments as assigned at all 3 doses of the infant series and at the toddler dose, blood drawn within specified time frames, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose (13 months of age)
    End point values
    		 13vPnC Toddler Dose
    Number of subjects analysed
    155
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Common serotypes - serotype 4
    100 (97.6 to 100)
        Common serotypes - serotype 6B
    99.4 (96.5 to 100)
        Common serotypes - serotype 9V
    100 (97.6 to 100)
        Common serotypes - serotype 14
    100 (97.6 to 100)
        Common serotypes - serotype 18C
    100 (97.6 to 100)
        Common serotypes - serotype 19F
    100 (97.6 to 100)
        Common serotypes - serotype 23F
    99.4 (96.5 to 100)
        Additional serotypes - serotype 1
    100 (97.6 to 100)
        Additional serotypes - serotype 3
    96.7 (92.5 to 98.9)
        Additional serotypes - serotype 5
    100 (97.6 to 100)
        Additional serotypes - serotype 6A
    100 (97.6 to 100)
        Additional serotypes - serotype 7F
    100 (97.6 to 100)
        Additional serotypes - serotype 19A
    100 (97.6 to 100)
    No statistical analyses for this end point

    Other pre-specified: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series
    End point description
    Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. Evaluable 2-Dose Infant Immunogenicity population.
    End point type
    Other pre-specified
    End point timeframe
    1 month after dose 2 of infant series (5 months of age)
    End point values
    		 13vPnC Infant Series
    Number of subjects analysed
    195
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common serotypes - serotype 4
    3.54 (3.16 to 3.97)
        Common serotypes - serotype 6B
    0.84 (0.71 to 0.98)
        Common serotypes - serotype 9V
    1.82 (1.6 to 2.08)
        Common serotypes - serotype 14
    5.54 (4.72 to 6.5)
        Common serotypes - serotype 18C
    1.8 (1.56 to 2.07)
        Common serotypes - serotype 19F
    4.14 (3.59 to 4.78)
        Common serotypes - serotype 23F
    0.84 (0.71 to 0.99)
        Additional serotypes - serotype 1
    3.41 (3 to 3.89)
        Additional serotypes - serotype 3
    1.11 (1.01 to 1.23)
        Additional serotypes - serotype 5
    1.89 (1.67 to 2.13)
        Additional serotypes - serotype 6A
    1.86 (1.6 to 2.16)
        Additional serotypes - serotype 7F
    2.98 (2.7 to 3.29)
        Additional serotypes - serotype 19A
    3.52 (3.07 to 4.03)
    No statistical analyses for this end point

    Other pre-specified: GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series

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    End point title
    		 GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series
    End point description
    Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all subjects with available data for the specified blood draw. Evaluable 3-Dose Infant Immunogenicity population.
    End point type
    Other pre-specified
    End point timeframe
    1 month after dose 3 of infant series (7 months of age)
    End point values
    		 13vPnC Infant Series
    Number of subjects analysed
    171
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common serotypes - serotype 4
    3.48 (3.12 to 3.88)
        Common serotypes - serotype 6B
    5.02 (4.27 to 5.9)
        Common serotypes - serotype 9V
    2.34 (2.11 to 2.6)
        Common serotypes - serotype 14
    9.35 (8.07 to 10.82)
        Common serotypes - serotype 18C
    2.5 (2.23 to 2.81)
        Common serotypes - serotype 19F
    3.75 (3.28 to 4.29)
        Common serotypes - serotype 23F
    1.83 (1.55 to 2.17)
        Additional serotypes - serotype 1
    4.23 (3.73 to 4.79)
        Additional serotypes - serotype 3
    1.17 (1.03 to 1.33)
        Additional serotypes - serotype 5
    3.11 (2.75 to 3.52)
        Additional serotypes - serotype 6A
    4.08 (3.56 to 4.68)
        Additional serotypes - serotype 7F
    3.71 (3.34 to 4.12)
        Additional serotypes - serotype 19A
    4.19 (3.71 to 4.74)
    No statistical analyses for this end point

    Other pre-specified: GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose

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    End point title
    		 GMC for Serotype-specific Pneumococcal IgG Antibody After the Toddler Dose
    End point description
    Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all subjects with available data after the toddler dose. Evaluable Toddler Immunogenicity population subset.
    End point type
    Other pre-specified
    End point timeframe
    1 month after toddler dose (13 months of age)
    End point values
    		 13vPnC Toddler Dose
    Number of subjects analysed
    137 [2]
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common serotypes - serotype 4
    5.1 (4.41 to 5.89)
        Common serotypes - serotype 6B
    15.41 (12.92 to 18.38)
        Common serotypes - serotype 9V
    3.76 (3.29 to 4.29)
        Common serotypes - serotype 14
    10.62 (9.16 to 12.32)
        Common serotypes - serotype 18C
    3.93 (3.45 to 4.48)
        Common serotypes - serotype 19F
    11.33 (9.68 to 13.26)
        Common serotypes - serotype 23F
    5.7 (4.81 to 6.77)
        Additional serotypes - serotype 1
    5.86 (5.08 to 6.75)
        Additional serotypes - serotype 3
    1.62 (1.42 to 1.84)
        Additional serotypes - serotype 5
    4.75 (4.18 to 5.4)
        Additional serotypes - serotype 6A
    11.64 (9.93 to 13.64)
        Additional serotypes - serotype 7F
    5.81 (5.18 to 6.51)
        Additional serotypes - serotype 19A
    8.95 (7.84 to 10.23)
    Notes
    [2] - Subjects who had valid, determinate assay result for antibody GMC at infant dose 3 and toddler dose.
    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
    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 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than [>] 7.0 cm). Subjects may be represented in more than 1 category. Safety population: All subjects who received at least 1 dose of the study vaccine.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 1 of Infant Series (2 months of age)
    End point values
    		 13vPnC Infant Series
    Number of subjects analysed
    214 [3]
    Units: Percentage of Subjects
    number (not applicable)
        Tenderness: Any
    63.5
        Tenderness: Significant
    12.4
        Swelling: Any
    31.2
        Swelling: Mild
    25.1
        Swelling: Moderate
    11.9
        Swelling: Severe
    0
        Redness: Any
    33.8
        Redness: Mild
    27.9
        Redness: Moderate
    10.6
        Redness: Severe
    0
    Notes
    [3] - Subjects reporting yes for at least 1 day or no for all days for any local reaction.
    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
    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 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.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 2 of Infant Series (4 months of age)
    End point values
    		 13vPnC Infant Series
    Number of subjects analysed
    196 [4]
    Units: Percentage of Subjects
    number (not applicable)
        Tenderness: Any
    69.4
        Tenderness: Significant
    12.6
        Swelling: Any
    29.9
        Swelling: Mild
    20
        Swelling: Moderate
    13.3
        Swelling: Severe
    0
        Redness: Any
    28.9
        Redness: Mild
    19.5
        Redness: Moderate
    12.3
        Redness: Severe
    0
    Notes
    [4] - Subjects reporting yes for at least 1 day or no for all days for any local reaction.
    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
    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 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0c m). Subjects may be represented in more than 1 category. Safety population.
    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
    Number of subjects analysed
    168 [5]
    Units: Percentage of Subjects
    number (not applicable)
        Tenderness: Any
    61.3
        Tenderness: Significant
    15.4
        Swelling: Any
    29.4
        Swelling: Mild
    19
        Swelling: Moderate
    14.6
        Swelling: Severe
    0
        Redness: Any
    31.8
        Redness: Mild
    20.9
        Redness: Moderate
    13.9
        Redness: Severe
    0
    Notes
    [5] - Subjects reporting yes for at least 1 day or no for all days for any local reaction.
    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
    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 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.
    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
    Number of subjects analysed
    154 [6]
    Units: Percentage of Subjects
    number (not applicable)
        Tenderness: Any
    43.7
        Tenderness: Significant
    3.8
        Swelling: Any
    21.3
        Swelling: Mild
    8.1
        Swelling: Moderate
    15.8
        Swelling: Severe
    0
        Redness: Any
    22
        Redness: Mild
    8.8
        Redness: Moderate
    15.7
        Redness: Severe
    0
    Notes
    [6] - Subjects reporting yes for at least 1 day or no for all days for any local reaction.
    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
    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.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 1 of Infant Series (2 months of age)
    End point values
    		 13vPnC Infant Series
    Number of subjects analysed
    217 [7]
    Units: Percentage of Subjects
    number (not applicable)
        Fever ≥38 degrees C but ≤39 degrees C
    7
        Fever >39 degrees C but ≤40 degrees C
    0
        Fever >40 degrees C
    0
        Decreased appetite
    31
        Irritability
    69.8
        Increased sleep
    37.2
        Decreased sleep
    32.8
    Notes
    [7] - Subjects reporting yes for at least 1 day or no for all days for any systemic event.
    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
    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.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 2 of Infant Series (4 months of age)
    End point values
    		 13vPnC Infant Series
    Number of subjects analysed
    198 [8]
    Units: Percentage of Subjects
    number (not applicable)
        Fever ≥38 degrees C but ≤39 degrees C
    18.5
        Fever >39 degrees C but ≤40 degrees C
    0.6
        Fever >40 degrees C
    0
        Decreased appetite
    29.3
        Irritability
    62.2
        Increased sleep
    24.5
        Decreased sleep
    35.1
    Notes
    [8] - Subjects reporting yes for at least 1 day or no for all days for any systemic event.
    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
    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.
    End point type
    Other pre-specified
    End point timeframe
    Within 4 days after dose 3 of Infant Series (6 months of age)
    End point values
    		 13vPnC Infant Series
    Number of subjects analysed
    172 [9]
    Units: Percentage of Subjects
    number (not applicable)
        Fever ≥38 degrees C but ≤39 degrees C
    18.3
        Fever >39 degrees C but ≤40 degrees C
    2.2
        Fever >40 degrees C
    0
        Decreased appetite
    25.7
        Irritability
    63.2
        Increased sleep
    22.9
        Decreased sleep
    37.3
    Notes
    [9] - Subjects reporting yes for at least 1 day or no for all days for any systemic event.
    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
    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.
    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
    Number of subjects analysed
    162 [10]
    Units: Percentage of Subjects
    number (not applicable)
        Fever ≥38 degrees C but ≤39 degrees C
    23
        Fever >39 degrees C but ≤40 degrees C
    0
        Fever >40 degrees C
    0
        Decreased appetite
    33.8
        Irritability
    46.7
        Increased sleep
    17.9
        Decreased sleep
    22
    Notes
    [10] - Subjects reporting yes for at least 1 day or no for all days for any systemic event.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs: Baseline through visit 7 (1 Month after last study vaccination); AEs: from signing of ICF to visit 5(1 month after Dose 3) and then from visit 6 (Toddler Dose) to visit 7. Local reactions, systemic events assessed within 4 days after each dose
    Adverse event reporting additional description
    Same event may appear as both AE and serious AE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject, and nonserious in another or 1 subject may experience both serious, nonserious event during study. Local reactions (LRs), systemic events (SEs) were assessed for Infant and toddler dose groups only.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Infant Series 13vPnC
    Reporting group description
    		 13vPnC 0.5mL dose administered IM at 2, 4, and 6 months of age (infant series). Other AEs (non-serious events): the number affected (n) for non-systematic (non-solicited) Other AEs n=79; systematic (solicited) Any Local Reaction n=154, 139, and 112 for Dose 1, 2,and 3 of infant series, respectively; systematic (solicited) Any Systemic Event n=182, 144, and 126 for Dose 1, 2,and 3 of infant series, respectively.

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

    Reporting group title
    Toddler Dose 13vPnC
    Reporting group description
    		 13vPnC 0.5 mL dose administered IM at 12 months of age (toddler dose). Other AEs (non-serious events): the number affected (n) for non-systematic (non-solicited) Other AEs n=50; systematic (solicited) Any Local Reaction n=73; systematic (solicited) Any Systemic Event n=96.

    Serious adverse events
    		 Infant Series 13vPnC After the Infant Series 13vPnC Toddler Dose 13vPnC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 223 (1.35%)
    3 / 223 (1.35%)
    2 / 191 (1.05%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Kawasaki's disease
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocarditis
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure anoxic
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 223 (0.45%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Breath holding
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 223 (0.45%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 223 (0.45%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Infant Series 13vPnC After the Infant Series 13vPnC Toddler Dose 13vPnC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    182 / 223 (81.61%)
    3 / 223 (1.35%)
    96 / 191 (50.26%)
    Injury, poisoning and procedural complications
    Traumatic brain injury
         subjects affected / exposed
    2 / 223 (0.90%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    0
    Nervous system disorders
    Grand mal convulsion
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Cephalhaematoma
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Deficiency Anaemia
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    6 / 223 (2.69%)
    0 / 223 (0.00%)
    14 / 191 (7.33%)
         occurrences all number
    6
    0
    14
    Vaccination site pain
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    3 / 191 (1.57%)
         occurrences all number
    0
    0
    3
    Vaccination site erythema
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    0
    2
    Vaccination site swelling
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    0
    2
    Irritability
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    0
    1
    Fever ≥38°C but ≤39°C: Infant Series Dose 1 and Toddler dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    14 / 199 (7.04%)
    0 / 223 (0.00%)
    32 / 139 (23.02%)
         occurrences all number
    14
    0
    32
    Fever ≥38°C but ≤39°C: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    33 / 178 (18.54%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    33
    0
    0
    Fever ≥38°C but ≤39°C: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    26 / 142 (18.31%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    26
    0
    0
    Fever >39°C but ≤40°C: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
         subjects affected / exposed [4]
    1 / 175 (0.57%)
    0 / 223 (0.00%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    0
    Fever >39°C but ≤40°C: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    3 / 138 (2.17%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    3
    0
    0
    Decreased appetite: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    63 / 203 (31.03%)
    0 / 223 (0.00%)
    51 / 151 (33.77%)
         occurrences all number
    63
    0
    51
    Decreased appetite: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    55 / 188 (29.26%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    55
    0
    0
    Decreased appetite: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    38 / 148 (25.68%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    38
    0
    0
    Irritability: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    148 / 212 (69.81%)
    0 / 223 (0.00%)
    71 / 152 (46.71%)
         occurrences all number
    148
    0
    71
    Irritability: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    120 / 193 (62.18%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    120
    0
    0
    Irritability: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    103 / 163 (63.19%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    103
    0
    0
    Increased sleep: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    77 / 207 (37.20%)
    0 / 223 (0.00%)
    25 / 140 (17.86%)
         occurrences all number
    77
    0
    25
    Increased sleep: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    45 / 184 (24.46%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    45
    0
    0
    Increased sleep: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    35 / 153 (22.88%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    35
    0
    0
    Decreased sleep: Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    67 / 204 (32.84%)
    0 / 223 (0.00%)
    31 / 141 (21.99%)
         occurrences all number
    67
    0
    31
    Decreased sleep: Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    66 / 188 (35.11%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    66
    0
    0
    Decreased sleep: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    56 / 150 (37.33%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    56
    0
    0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 223 (0.00%)
    1 / 223 (0.45%)
    0 / 191 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    13 / 223 (5.83%)
    0 / 223 (0.00%)
    8 / 191 (4.19%)
         occurrences all number
    16
    0
    8
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 223 (2.69%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    6
    0
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Mucous stools
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    7 / 191 (3.66%)
         occurrences all number
    0
    0
    7
    Hepatobiliary disorders
    Hepatomegaly
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 223 (2.24%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    5
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    3 / 223 (1.35%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    5
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    2 / 223 (0.90%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    2
    0
    2
    Bronchospasm
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    3 / 223 (1.35%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    3
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    3 / 223 (1.35%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    3
    0
    0
    Rash morbilliform
         subjects affected / exposed
    2 / 223 (0.90%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    2 / 223 (0.90%)
    2 / 223 (0.90%)
    0 / 191 (0.00%)
         occurrences all number
    2
    2
    0
    Dermatitis atopic
         subjects affected / exposed
    1 / 223 (0.45%)
    1 / 223 (0.45%)
    0 / 191 (0.00%)
         occurrences all number
    1
    1
    0
    Eczema
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Heat rash
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    0
    1
    Prurigo
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    0
    1
    Tenderness (any): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    134 / 211 (63.51%)
    0 / 223 (0.00%)
    66 / 151 (43.71%)
         occurrences all number
    134
    0
    66
    Tenderness (any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    136 / 196 (69.39%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    136
    0
    0
    Tenderness (any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    100 / 163 (61.35%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    100
    0
    0
    Tenderness (significant): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    25 / 202 (12.38%)
    0 / 223 (0.00%)
    5 / 132 (3.79%)
         occurrences all number
    25
    0
    5
    Tenderness (significant): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    23 / 183 (12.57%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    23
    0
    0
    Tenderness (significant): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [23]
    22 / 143 (15.38%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    22
    0
    0
    Swelling (any): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    64 / 205 (31.22%)
    0 / 223 (0.00%)
    30 / 141 (21.28%)
         occurrences all number
    64
    0
    30
    Swelling (any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    56 / 187 (29.95%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    56
    0
    0
    Swelling (any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    45 / 153 (29.41%)
    0 / 153 (0.00%)
    0 / 141 (0.00%)
         occurrences all number
    45
    0
    0
    Swelling (mild): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    51 / 203 (25.12%)
    0 / 223 (0.00%)
    11 / 136 (8.09%)
         occurrences all number
    51
    0
    11
    Swelling (mild): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    37 / 185 (20.00%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    37
    0
    0
    Swelling (mild): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    28 / 147 (19.05%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    28
    0
    0
    Swelling (moderate): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    24 / 201 (11.94%)
    0 / 223 (0.00%)
    22 / 139 (15.83%)
         occurrences all number
    24
    0
    22
    Swelling (moderate): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    24 / 180 (13.33%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    24
    0
    0
    Swelling (moderate): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    21 / 144 (14.58%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    21
    0
    0
    Redness (any): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    69 / 204 (33.82%)
    0 / 223 (0.00%)
    31 / 141 (21.99%)
         occurrences all number
    69
    0
    31
    Redness (any): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    54 / 187 (28.88%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    54
    0
    0
    Redness (any): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    49 / 154 (31.82%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    49
    0
    0
    Redness (mild): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    57 / 204 (27.94%)
    0 / 223 (0.00%)
    12 / 136 (8.82%)
         occurrences all number
    57
    0
    12
    Redness (mild): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    36 / 185 (19.46%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    36
    0
    0
    Redness (mild): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    31 / 148 (20.95%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    31
    0
    0
    Redness (moderate): Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    21 / 199 (10.55%)
    0 / 223 (0.00%)
    22 / 140 (15.71%)
         occurrences all number
    21
    0
    22
    Redness (moderate): Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    22 / 179 (12.29%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    22
    0
    0
    Redness (moderate): Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    20 / 144 (13.89%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    20
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    33 / 223 (14.80%)
    0 / 223 (0.00%)
    8 / 191 (4.19%)
         occurrences all number
    40
    0
    10
    Viral upper respiratory tract infection
         subjects affected / exposed
    11 / 223 (4.93%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    13
    0
    0
    Pharyngitis
         subjects affected / exposed
    7 / 223 (3.14%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    9
    0
    1
    Bronchiolitis
         subjects affected / exposed
    6 / 223 (2.69%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    6
    0
    0
    Viral rhinitis
         subjects affected / exposed
    5 / 223 (2.24%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    5
    0
    0
    Rhinitis
         subjects affected / exposed
    4 / 223 (1.79%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    6
    0
    0
    Viral pharyngitis
         subjects affected / exposed
    4 / 223 (1.79%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    4
    0
    0
    Influenza
         subjects affected / exposed
    3 / 223 (1.35%)
    0 / 223 (0.00%)
    4 / 191 (2.09%)
         occurrences all number
    3
    0
    4
    Impetigo
         subjects affected / exposed
    2 / 223 (0.90%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    0
    Acarodermatitis
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Body tinea
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    1
    0
    2
    Conjunctivitis viral
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Croup infectious
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Cystitis
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Pyoderma
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    1
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    1
    0
    1
    Acute sinusitis
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    0
    1
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    0
    1
    Varicella
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 223 (0.00%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    0
    Decreased appetite
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 223 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    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.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

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

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