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    Clinical Trial Results:
    A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given with a 7-valent Pneumococcal Conjugate Vaccine in Japan.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2014-004177-16
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    24 Mar 2012

    Results information
    Results version number
    v2(current)
    This version publication date
    29 Jul 2016
    First version publication date
    02 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Not completed reason having type "Other" with same other reason text

    Trial information

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    Trial identification
    Sponsor protocol code
    B1841007
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01250756
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Alias: 6107A1-4000
    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
    24 May 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Mar 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by diphtheria, tetanus, and acellular pertussis vaccine (DTaP) given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone when measured 1 month after the 3-dose infant series. 2. To measure the immune response to 7vPnC 1 month after a 3-dose infant series as measured by serum immunoglobulin G (IgG) levels. 3. To evaluate the safety profile of 7vPnC given with DTaP 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 Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Nov 2010
    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
    Japan: 321
    Worldwide total number of subjects
    321
    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)
    321
    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
    The study was conducted in Japan from 25 November 2010 to 24 March 2012.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    7vPnC + DTaP - Infant Series
    Arm description
    Subjects at 3 to 6 months of age received a single dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series). A single dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
    Arm type
    Experimental

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Prevenar
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects at 3 to 6 months of age received a single 0.5 mL dose of 7vPnC subcutaneously followed by 2 single 0.5 milliliter (mL) doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series).

    Investigational medicinal product name
    DTaP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of DTaP subcutaneously followed by 2 single 0.5 mL doses of DTaP subcutaneously, 4 to 8 weeks after each previous dose (infant series)

    Arm title
    DTaP (Catch-up 7vPnC) - Infant Series
    Arm description
    Subjects at 3 to 6 months of age received a single DTaP dose subcutaneously followed by 2 single DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously at 4 to 6 weeks apart.
    Arm type
    Experimental

    Investigational medicinal product name
    DTaP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects at 3 to 6 months of age received a single 0.5 mL dose of DTaP subcutaneously followed by 2 single 0.5 mL doses of DTaP subcutaneously, 4 to 8 weeks after each previous dose (infant series).

    Number of subjects in period 1
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC) - Infant Series
    Started
    161
    160
    Vaccinated Dose 1
    159
    158
    Vaccinated Dose 2
    147
    157
    Vaccinated Dose 3
    133
    155
    Completed
    133
    153
    Not completed
    28
    7
         Randomized, Not Vaccinated
    2
    2
         Unspecified
    22
    -
         Consent withdrawn by subject
    4
    5
    Period 2
    Period 2 title
    After Infant Series
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    7vPnC + DTaP - After the Infant Series
    Arm description
    Subjects at 3 to 6 months of age received a single dose of 7vPnC subcutaneously followed by 2 single doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series). A single dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    DTaP (Catch-up 7vPnC) - After the Infant Series
    Arm description
    Subjects at 3 to 6 months of age received a single DTaP dose subcutaneously followed by 2 single DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart.
    Arm type
    Experimental

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Prevenar
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 2 single catch-up doses of 7vPnC (Prevenar) administered subcutaneously, 4 to 6 weeks apart.

    Number of subjects in period 2
    7vPnC + DTaP - After the Infant Series DTaP (Catch-up 7vPnC) - After the Infant Series
    Started
    133
    153
    Completed
    122
    149
    Not completed
    11
    4
         Adverse event, non-fatal
    5
    2
         Unspecified
    2
    1
         Consent withdrawn by subject
    4
    1
    Period 3
    Period 3 title
    Toddler Dose
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    7vPnC + DTaP - Toddler Dose
    Arm description
    Subjects received a single dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
    Arm type
    Experimental

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Prevenar
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose).

    Investigational medicinal product name
    DTaP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single 0.5 mL dose of DTaP subcutaneously at 12 to 15 months of age (toddler dose).

    Arm title
    DTaP (Catch-up 7vPnC) - Toddler Dose
    Arm description
    Subjects received a single DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
    Arm type
    Experimental

    Investigational medicinal product name
    DTaP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose).

    Number of subjects in period 3
    7vPnC + DTaP - Toddler Dose DTaP (Catch-up 7vPnC) - Toddler Dose
    Started
    122
    149
    Completed
    122
    148
    Not completed
    0
    1
         Adverse Event
    -
    1
    Period 4
    Period 4 title
    After Toddler Dose
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    DTaP (Catch-up 7vPnC) - After the Toddler Dose
    Arm description
    Subjects received a single DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
    Arm type
    Experimental

    Investigational medicinal product name
    7vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subject received a single 0.5 mL CU dose of 7vPnC (Prevenar) 4 to 6 weeks post-toddler dose.

    Number of subjects in period 4 [1]
    DTaP (Catch-up 7vPnC) - After the Toddler Dose
    Started
    148
    Completed
    147
    Not completed
    1
         Adverse event, non-fatal
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Since no subject continued in 7vPnC + DTaP arm after the toddler dose, so data for DTaP (Catch-up 7vPnC) arm has been reported.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    7vPnC + DTaP - Infant Series
    Reporting group description
    Subjects at 3 to 6 months of age received a single dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series). A single dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.

    Reporting group title
    DTaP (Catch-up 7vPnC) - Infant Series
    Reporting group description
    Subjects at 3 to 6 months of age received a single DTaP dose subcutaneously followed by 2 single DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously at 4 to 6 weeks apart.

    Reporting group values
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC) - Infant Series Total
    Number of subjects
    161 160 321
    Age categorical
    Units: Subjects
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    3.8 ± 0.91 3.9 ± 0.94 -
    Gender, Male/Female
    Units: participants
        Female
    80 82 162
        Male
    81 78 159

    End points

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    End points reporting groups
    Reporting group title
    7vPnC + DTaP - Infant Series
    Reporting group description
    Subjects at 3 to 6 months of age received a single dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series). A single dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.

    Reporting group title
    DTaP (Catch-up 7vPnC) - Infant Series
    Reporting group description
    Subjects at 3 to 6 months of age received a single DTaP dose subcutaneously followed by 2 single DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously at 4 to 6 weeks apart.
    Reporting group title
    7vPnC + DTaP - After the Infant Series
    Reporting group description
    Subjects at 3 to 6 months of age received a single dose of 7vPnC subcutaneously followed by 2 single doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series). A single dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.

    Reporting group title
    DTaP (Catch-up 7vPnC) - After the Infant Series
    Reporting group description
    Subjects at 3 to 6 months of age received a single DTaP dose subcutaneously followed by 2 single DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart.
    Reporting group title
    7vPnC + DTaP - Toddler Dose
    Reporting group description
    Subjects received a single dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.

    Reporting group title
    DTaP (Catch-up 7vPnC) - Toddler Dose
    Reporting group description
    Subjects received a single DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
    Reporting group title
    DTaP (Catch-up 7vPnC) - After the Toddler Dose
    Reporting group description
    Subjects received a single DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.

    Primary: Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series

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    End point title
    Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series [1]
    End point description
    Percentage of subjects achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of subjects . Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA). Evaluable infant immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Primary
    End point timeframe
    1 month after the infant series
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC) - Infant Series
    Number of subjects analysed
    132
    149
    Units: Percentage of subjects
    number (confidence interval 95%)
        Diphtheria
    100 (97.2 to 100)
    100 (97.6 to 100)
        Tetanus
    100 (97.2 to 100)
    100 (97.6 to 100)
        Pertussis toxoid (PT)
    100 (97.2 to 100)
    100 (97.6 to 100)
        Filamentous hemagglutinin (FHA)
    100 (97.2 to 100)
    100 (97.6 to 100)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series

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    End point title
    Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series [2]
    End point description
    Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies. Evaluable infant immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Primary
    End point timeframe
    1 month after the infant series
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC) - Infant Series
    Number of subjects analysed
    132
    149
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Diphtheria
    1.38 (1.27 to 1.49)
    0.99 (0.91 to 1.09)
        Tetanus
    1.91 (1.69 to 2.16)
    2.05 (1.83 to 2.29)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series

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    End point title
    Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series [3]
    End point description
    GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies. Evaluable infant immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Primary
    End point timeframe
    1 month after the infant series
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC) - Infant Series
    Number of subjects analysed
    132
    149
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Pertussis toxoid (PT)
    76.79 (70.81 to 83.28)
    83.56 (77.54 to 90.05)
        Filamentous hemagglutinin (FHA)
    72.89 (65.8 to 80.74)
    77.85 (71.01 to 85.35)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 microgram 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 microgram per milliliter (mcg/mL) 1 Month After the Infant Series [4] [5]
    End point description
    Percentage of subjects achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of subjects. Evaluable infant immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Primary
    End point timeframe
    1 month after the infant series
    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 endpoint.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for 7vPnC + DTaP - Infant Series reporting group only.
    End point values
    7vPnC + DTaP - Infant Series
    Number of subjects analysed
    132
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serotype 4
    100 (97.2 to 100)
        Serotype 6B
    99.2 (95.9 to 100)
        Serotype 9V
    100 (97.2 to 100)
        Serotype 14
    99.2 (95.9 to 100)
        Serotype 18C
    99.2 (95.8 to 100)
        Serotype 19F
    97.7 (93.5 to 99.5)
        Serotype 23F
    98.5 (94.6 to 99.8)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series

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    End point title
    Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series [6] [7]
    End point description
    Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw. Evaluable infant immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Primary
    End point timeframe
    1 month after the infant series
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint was planned to be assessed for 7vPnC + DTaP - Infant Series reporting group only.
    End point values
    7vPnC + DTaP - Infant Series
    Number of subjects analysed
    132
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Serotype 4
    11.82 (10.5 to 13.31)
        Serotype 6B
    4.23 (3.61 to 4.97)
        Serotype 9V
    5.96 (5.37 to 6.62)
        Serotype 14
    16.61 (14.66 to 18.81)
        Serotype 18C
    5.48 (4.76 to 6.31)
        Serotype 19F
    8.85 (7.54 to 10.4)
        Serotype 23F
    4.17 (3.54 to 4.91)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose

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    End point title
    Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
    End point description
    Percentage of subjects achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of subjects. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose
    End point values
    7vPnC + DTaP - Toddler Dose DTaP (Catch-up 7vPnC) - Toddler Dose
    Number of subjects analysed
    121
    146
    Units: Percentage of subjects
    number (confidence interval 95%)
        Diphtheria
    100 (97 to 100)
    100 (97.5 to 100)
        Tetanus
    100 (97 to 100)
    100 (97.5 to 100)
        Pertussis toxoid (PT)
    100 (97 to 100)
    100 (97.5 to 100)
        Filamentous hemagglutinin (FHA)
    100 (97 to 100)
    100 (97.5 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose

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    End point title
    Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
    End point description
    GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose
    End point values
    7vPnC + DTaP - Toddler Dose DTaP (Catch-up 7vPnC) - Toddler Dose
    Number of subjects analysed
    121
    146
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Diphtheria
    2.56 (2.35 to 2.78)
    2.14 (1.94 to 2.35)
        Tetanus
    2.53 (2.26 to 2.82)
    3.04 (2.74 to 3.38)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose

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    End point title
    Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
    End point description
    GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose
    End point values
    7vPnC + DTaP - Toddler Dose DTaP (Catch-up 7vPnC) - Toddler Dose
    Number of subjects analysed
    121
    146
    Units: EU/mL
    geometric mean (confidence interval 95%)
        PT
    106.54 (96.1 to 118.12)
    130.62 (119.6 to 142.65)
        FHA
    120.99 (109.75 to 133.39)
    145.38 (132.41 to 159.63)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose

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    End point title
    Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 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 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of subjects. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose
    End point values
    7vPnC + DTaP - Toddler Dose
    Number of subjects analysed
    121
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serotype 4
    100 (97 to 100)
        Serotype 6B
    100 (97 to 100)
        Serotype 9V
    100 (97 to 100)
        Serotype 14
    100 (97 to 100)
        Serotype 18C
    99.2 (95.5 to 100)
        Serotype 19F
    99.2 (95.5 to 100)
        Serotype 23F
    100 (97 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

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    End point title
    Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
    End point description
    Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all subjects with available data for the specified blood draw. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after the toddler dose
    End point values
    7vPnC + DTaP - Toddler Dose
    Number of subjects analysed
    121
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Serotype 4
    12.15 (10.35 to 14.26)
        Serotype 6B
    10.66 (8.96 to 12.68)
        Serotype 9V
    6.43 (5.57 to 7.42)
        Serotype 14
    15.83 (13.81 to 18.14)
        Serotype 18C
    6.53 (5.49 to 7.76)
        Serotype 19F
    9.7 (8.15 to 11.56)
        Serotype 23F
    10.17 (8.58 to 12.07)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose

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    End point title
    Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
    End point description
    Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results. Evaluable toddler immunogenicity set: eligible subjects who received vaccine to which they were randomized at all 4 doses, had blood drawn within protocol-specified time, had at least 1 valid, determinate assay result after toddler dose for analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    Pre-toddler dose, 1 month after the toddler dose
    End point values
    7vPnC + DTaP - Toddler Dose
    Number of subjects analysed
    121
    Units: Fold Rise
    geometric mean (confidence interval 95%)
        Serotype 4
    6.74 (5.75 to 7.9)
        Serotype 6B
    5.89 (5.09 to 6.81)
        Serotype 9V
    4.34 (3.81 to 4.93)
        Serotype 14
    3.63 (3.22 to 4.09)
        Serotype 18C
    6.9 (6.06 to 7.85)
        Serotype 19F
    6.37 (5.35 to 7.59)
        Serotype 23F
    8.1 (7.01 to 9.35)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Catch-up Dose 3

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    End point title
    Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After Catch-up Dose 3
    End point description
    Percentage of subjects achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of subjects. Catch-up immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after the catch-up dose 3
    End point values
    DTaP (Catch-up 7vPnC) - After the Toddler Dose
    Number of subjects analysed
    148
    Units: Percentage of subjects
    number (confidence interval 95%)
        Serotype 4
    100 (97.5 to 100)
        Serotype 6B
    99.3 (96.3 to 100)
        Serotype 9V
    100 (97.5 to 100)
        Serotype 14
    100 (97.5 to 100)
        Serotype 18C
    99.3 (96.3 to 100)
        Serotype 19F
    100 (97.5 to 100)
        Serotype 23F
    99.3 (96.3 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3

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    End point title
    Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
    End point description
    Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all subjects with available data for the specified blood draw. Catch-up immunogenicity population: eligible subjects who received the vaccine to which they were randomized at all 3 catch-up doses, had blood drawn within the protocol-specified time frames, had at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    1 month after the catch-up dose 3
    End point values
    DTaP (Catch-up 7vPnC) - After the Toddler Dose
    Number of subjects analysed
    148
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Serotype 4
    6.63 (5.91 to 7.44)
        Serotype 6B
    4.3 (3.75 to 4.93)
        Serotype 9V
    3.48 (3.12 to 3.89)
        Serotype 14
    11.55 (10.3 to 12.95)
        Serotype 18C
    3.1 (2.69 to 3.57)
        Serotype 19F
    5.16 (4.45 to 5.99)
        Serotype 23F
    4.41 (3.78 to 5.14)
    No statistical analyses for this end point

    Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'=subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Dose 1 of the infant series
    End point values
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC) - Infant Series
    Number of subjects analysed
    152 [8]
    154 [9]
    Units: Percentage of subjects
    number (not applicable)
        Erythema-Any (n= 152, 152)
    57.2
    14.5
        Erythema-Mild (n= 152, 151)
    52.6
    12.6
        Erythema-Moderate (n= 148, 152)
    14.9
    2
        Erythema-Severe (n= 148, 151)
    0
    0
        Induration-Any (n= 149, 153)
    40.3
    7.8
        Induration-Mild (n= 149, 153)
    38.3
    7.8
        Induration-Moderate (n= 148, 151)
    10.1
    0
        Induration-Severe (n= 148, 151)
    0
    0
        Tenderness-Any (n= 148, 151)
    12.2
    0.7
        Tenderness-Significant (n= 148, 151)
    0
    0
        Any local reaction (n= 152, 154)
    66.4
    15.6
    Notes
    [8] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.
    [9] - N= 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 to 8 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Dose 2 of the infant series
    End point values
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC) - Infant Series
    Number of subjects analysed
    143 [10]
    151 [11]
    Units: Percentage of subjects
    number (not applicable)
        Erythema-Any (n= 142, 150)
    64.1
    39.3
        Erythema-Mild (n= 142, 150)
    58.5
    33.3
        Erythema-Moderate (n= 134, 147)
    32.1
    6.8
        Erythema-Severe (n= 133, 147)
    0
    0
        Induration-Any (n= 137, 150)
    51.8
    30
        Induration-Mild (n= 137, 150)
    49.6
    28.7
        Induration-Moderate (n= 134, 148)
    23.9
    6.8
        Induration-Severe (n= 133, 147)
    0
    0
        Tenderness-Any (n= 133, 147)
    7.5
    4.1
        Tenderness-Significant (n= 133, 147)
    0
    0
        Any local reaction (n= 143, 151)
    69.2
    45
    Notes
    [10] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.
    [11] - N= 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 (5 to 10 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Dose 3 of the infant series
    End point values
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC) - Infant Series
    Number of subjects analysed
    126 [12]
    145 [13]
    Units: Percentage of subjects
    number (not applicable)
        Erythema-Any (n= 123, 144)
    52.8
    30.6
        Erythema-Mild (n= 123, 143)
    46.3
    28
        Erythema-Moderate (n= 120, 139)
    20
    5.8
        Erythema-Severe (n= 118, 138)
    0
    0
        Induration-Any (n= 124, 144)
    44.4
    19.4
        Induration-Mild (n= 124, 144)
    42.7
    19.4
        Induration-Moderate (n= 119, 139)
    11.8
    2.2
        Induration-Severe (n= 118, 138)
    0
    0
        Tenderness-Any (n= 119, 138)
    5
    3.6
        Tenderness-Significant (n= 118, 138)
    0
    0
        Any local reaction (n= 126, 145)
    61.1
    33.1
    Notes
    [12] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.
    [13] - N= 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 to 15 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after the toddler dose
    End point values
    7vPnC + DTaP - Toddler Dose DTaP (Catch-up 7vPnC) - Toddler Dose
    Number of subjects analysed
    110 [14]
    138 [15]
    Units: Percentage of subject
    number (not applicable)
        Erythema-Any (n= 108, 137)
    51.9
    32.1
        Erythema-Mild (n= 106, 137)
    48.1
    28.5
        Erythema-Moderate (n= 102, 134)
    23.5
    7.5
        Erythema-Severe (n= 98, 133)
    0
    0
        Induration-Any (n= 108, 137)
    42.6
    23.4
        Induration-Mild (n= 108, 137)
    40.7
    19.7
        Induration-Moderate (n= 99, 133)
    16.2
    6.8
        Induration-Severe (n= 98, 133)
    0
    0
        Tenderness-Any (n= 99, 136)
    11.1
    4.4
        Tenderness-Significant (n= 98, 133)
    0
    0
        Any local reaction (n= 110, 138)
    56.4
    39.1
    Notes
    [14] - N= subjects reporting yes for at least 1 day or no for all days for any local reaction.
    [15] - N= 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: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Catch-up Dose 1
    End point values
    DTaP (Catch-up 7vPnC) - After the Infant Series
    Number of subjects analysed
    141 [16]
    Units: Percentage of subjects
    number (not applicable)
        Erythema-Any (n= 139)
    51.8
        Erythema-Mild (n= 139)
    45.3
        Erythema-Moderate (n= 136)
    10.3
        Erythema-Severe (n= 135)
    0
        Induration-Any (n= 138)
    34.8
        Induration-Mild (n= 138)
    32.6
        Induration-Moderate (n= 135)
    8.1
        Induration-Severe (n= 135)
    0
        Tenderness-Any (n= 136)
    8.1
        Tenderness-Significant (n= 135)
    0
        Any local reaction (n= 141)
    54.6
    Notes
    [16] - N= 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: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Catch-up Dose 2
    End point values
    DTaP (Catch-up 7vPnC) - After the Infant Series
    Number of subjects analysed
    145 [17]
    Units: Percentage of subjects
    number (not applicable)
        Erythema-Any (n= 144)
    50.7
        Erythema-Mild (n= 144)
    45.1
        Erythema-Moderate (n= 140)
    13.6
        Erythema-Severe (n= 138)
    0
        Induration-Any (n= 144)
    32.6
        Induration-Mild (n= 143)
    30.1
        Induration-Moderate (n= 140)
    15
        Induration-Severe (n= 138)
    0
        Tenderness-Any (n= 139)
    5
        Tenderness-Significant (n= 138)
    0
        Any local reaction (n= 145)
    55.2
    Notes
    [17] - N= 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: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to 16.5 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). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Subjects may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Catch-up Dose 3
    End point values
    DTaP (Catch-up 7vPnC) - After the Toddler Dose
    Number of subjects analysed
    137 [18]
    Units: Percentage of subjects
    number (not applicable)
        Erythema-Any (n= 134)
    32.1
        Erythema-Mild (n= 133)
    27.1
        Erythema-Moderate (n= 131)
    9.9
        Erythema-Severe (n= 130)
    0
        Induration-Any (n= 134)
    27.6
        Induration-Mild (n= 133)
    24.8
        Induration-Moderate (n= 131)
    9.9
        Induration-Severe (n= 130)
    0
        Tenderness-Any (n= 132)
    6.8
        Tenderness-Significant (n= 130)
    0
        Any local reaction (n= 137)
    40.9
    Notes
    [18] - N= 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 (3 to 6 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
    End point description
    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Dose 1 of the infant series
    End point values
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC) - Infant Series
    Number of subjects analysed
    154 [19]
    153 [20]
    Units: Percentage of subjects
    number (not applicable)
        Fever >=37.5 but =<39 degrees C(n=149,152)
    18.8
    15.8
        Fever >39 but =<40.0 degrees C(n=148,151)
    2
    2
        Fever >40 degrees C(n=148,151)
    0
    0
        Decreased appetite(n=148,151)
    8.8
    7.9
        Irritability(n=151,151)
    15.2
    9.3
        Increased sleep(n=150,153)
    32
    25.5
        Decreased sleep(n=151,151)
    16.6
    15.2
        Hives (urticaria)(n=148,151)
    1.4
    0.7
        Antipyretic medication to treat symptom(n=148,151)
    1.4
    1.3
        Any systemic event(n=154,153)
    57.8
    48.4
    Notes
    [19] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.
    [20] - N= 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 to 8 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
    End point description
    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Dose 2 of the infant series
    End point values
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC) - Infant Series
    Number of subjects analysed
    142 [21]
    153 [22]
    Units: Percentage of subjects
    number (not applicable)
        Fever >=37.5 but =<39 degrees C(n=138,149)
    25.4
    15.4
        Fever >39 but =<40.0 degrees C(n=135,147)
    2.2
    0
        Fever >40 degrees C(n=133,147)
    0
    0.7
        Decreased appetite(n=135,147)
    11.9
    5.4
        Irritability(n=134,149)
    19.4
    12.1
        Increased sleep(n=136,148)
    19.1
    12.8
        Decreased sleep(n=140,151)
    17.1
    15.2
        Hives (urticaria)(n=133,147)
    3
    0
        Antipyretic medication to treat symptom(n=134,147)
    2.2
    2
        Any systemic event(n=142,153)
    53.5
    38.6
    Notes
    [21] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.
    [22] - N= 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 (5 to 10 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
    End point description
    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Dose 3 of the infant series
    End point values
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC) - Infant Series
    Number of subjects analysed
    122 [23]
    143 [24]
    Units: Percentage of subjects
    number (not applicable)
        Fever >=37.5 but =<39 degrees C(n=120,141)
    19.2
    14.9
        Fever >39 but =<40.0 degrees C(n=118,138)
    1.7
    0.7
        Fever >40 degrees C(n=118,138)
    0
    0
        Decreased appetite(n=119,138)
    8.4
    6.5
        Irritability(n=118,139)
    10.2
    7.2
        Increased sleep(n=119,141)
    16
    18.4
        Decreased sleep(n=120,140)
    6.7
    14.3
        Hives (urticaria)(n=119,138)
    1.7
    0
        Antipyretic medication to treat symptom(n=119,138)
    1.7
    2.2
        Any systemic event(n=122,143)
    39.3
    36.4
    Notes
    [23] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.
    [24] - N= 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 to 15 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
    End point description
    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after the toddler dose
    End point values
    7vPnC + DTaP - Toddler Dose DTaP (Catch-up 7vPnC) - Toddler Dose
    Number of subjects analysed
    108 [25]
    138 [26]
    Units: Percentage of subjects
    number (not applicable)
        Fever >=37.5 but =<39 degrees C(n=103,135)
    34
    22.2
        Fever >39 but =<40.0 degrees C(n=99,132)
    5.1
    2.3
        Fever >40 degrees C(n=98,132)
    1
    0
        Decreased appetite(n=100,133)
    9
    8.3
        Irritability(n=100,134)
    17
    9.7
        Increased sleep(n=103,135)
    20.4
    15.6
        Decreased sleep(n=101,133)
    10.9
    7.5
        Hives (urticaria)(n=98,133)
    1
    0.8
        Antipyretic medication to treat symptom(n=98,133)
    4.1
    4.5
        Any systemic event(n=108,138)
    52.8
    39.9
    Notes
    [25] - N= subjects reporting yes for at least 1 day or no for all days for any systemic event.
    [26] - N= 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: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
    End point description
    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Catch-up Dose 1
    End point values
    DTaP (Catch-up 7vPnC) - After the Infant Series
    Number of subjects analysed
    139 [27]
    Units: Percentage of subjects
    number (not applicable)
        Fever >=37.5 but =<39 degrees C(n=139)
    32.4
        Fever >39 but =<40.0 degrees C(n=135)
    2.2
        Fever >40 degrees C(n=135)
    0
        Decreased appetite(n=136)
    8.1
        Irritability(n=136)
    12.5
        Increased sleep(n=136)
    17.6
        Decreased sleep(n=136)
    11.8
        Hives (urticaria)(n=135)
    0.7
        Antipyretic medication to treat symptom(n=136)
    5.9
        Any systemic event(n=139)
    49.6
    Notes
    [27] - N= 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: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
    End point description
    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Catch-up Dose 2
    End point values
    DTaP (Catch-up 7vPnC) - After the Infant Series
    Number of subjects analysed
    141 [28]
    Units: Percentage of subjects
    number (not applicable)
        Fever >=37.5 but =<39 degrees C(n=140)
    32.1
        Fever >39 but =<40.0 degrees C(n=138)
    5.1
        Fever >40 degrees C(n=138)
    0.7
        Decreased appetite(n=138)
    10.9
        Irritability(n=138)
    11.6
        Increased sleep(n=138)
    15.9
        Decreased sleep(n=139)
    10.1
        Hives (urticaria)(n=138)
    2.2
        Antipyretic medication to treat symptom(n=138)
    5.1
        Any systemic event(n=141)
    47.5
    Notes
    [28] - N= 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: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)

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    End point title
    Percentage of Subjects Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
    End point description
    Systemic events (any fever >= 37.5 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]), were reported using an electronic diary. Subjects may be represented in more than 1 category. Safety population included all subjects who received at least 1 dose of study vaccine. 'n'= subjects reporting yes for at least 1 day or no for all days for the specified local reaction for each group, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after Catch-up Dose 3
    End point values
    DTaP (Catch-up 7vPnC) - After the Toddler Dose
    Number of subjects analysed
    136 [29]
    Units: Percentage of subjects
    number (not applicable)
        Fever >=37.5 but =<39 degrees C(n=134)
    26.9
        Fever >39 but =<40.0 degrees C(n=130)
    0.8
        Fever >40 degrees C(n=130)
    0
        Decreased appetite(n=130)
    6.2
        Irritability(n=131)
    9.2
        Increased sleep(n=131)
    10.7
        Decreased sleep(n=131)
    6.9
        Hives (urticaria)(n=131)
    0.8
        Antipyretic medication to treat symptom(n=130)
    1.5
        Any systemic event(n=136)
    39
    Notes
    [29] - N= 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
    AEs: from signing ICF to visit 4(CU Dose 1: 28 to 42 days) for Group 1/visit 6(28 to 42 days)for Group 2 and from visit 7(Dose 4: 28 to 42 days)to visit 8(CU Dose 3: 28 to 42 days) for Group 1/to visit 9(28 to 42 days) for Group 2. SAEs: ICF to last visit
    Adverse event reporting additional description
    Safety population: subjects who receive at least 1 dose of study vaccine. SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on case report form at each visit (nonsystematic assessment).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    7vPnC + DTaP - Infant Series
    Reporting group description
    Subjects who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.

    Reporting group title
    DTaP (Catch-up 7vPnC)- Infant Series
    Reporting group description
    Subjects who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.

    Reporting group title
    7vPnC + DTaP - After the Infant Series
    Reporting group description
    Subjects who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.

    Reporting group title
    DTaP (Catch-up 7vPnC) - After the Infant Series
    Reporting group description
    Subjects who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.

    Reporting group title
    7vPnC + DTaP - Toddler Dose
    Reporting group description
    Subjects who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.

    Reporting group title
    DTaP (Catch-up 7vPnC) - Toddler Dose
    Reporting group description
    Subjects who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.

    Reporting group title
    DTaP (Catch-up 7vPnC) - After the Toddler Dose
    Reporting group description
    Subjects who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.

    Serious adverse events
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC)- Infant Series 7vPnC + DTaP - After the Infant Series DTaP (Catch-up 7vPnC) - After the Infant Series 7vPnC + DTaP - Toddler Dose DTaP (Catch-up 7vPnC) - Toddler Dose DTaP (Catch-up 7vPnC) - After the Toddler Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 159 (1.89%)
    7 / 158 (4.43%)
    10 / 159 (6.29%)
    7 / 158 (4.43%)
    0 / 122 (0.00%)
    4 / 149 (2.68%)
    1 / 149 (0.67%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Kawasaki's disease
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Cryptorchism
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infantile asthma
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    4 / 159 (2.52%)
    2 / 158 (1.27%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    1 / 149 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 2
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Weight gain poor
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    2 / 159 (1.26%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    2 / 149 (1.34%)
    0 / 149 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    7vPnC + DTaP - Infant Series DTaP (Catch-up 7vPnC)- Infant Series 7vPnC + DTaP - After the Infant Series DTaP (Catch-up 7vPnC) - After the Infant Series 7vPnC + DTaP - Toddler Dose DTaP (Catch-up 7vPnC) - Toddler Dose DTaP (Catch-up 7vPnC) - After the Toddler Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    123 / 159 (77.36%)
    126 / 158 (79.75%)
    20 / 159 (12.58%)
    129 / 158 (81.65%)
    72 / 122 (59.02%)
    96 / 149 (64.43%)
    85 / 149 (57.05%)
    Immune system disorders
    Food allergy
         subjects affected / exposed
    2 / 159 (1.26%)
    1 / 158 (0.63%)
    6 / 159 (3.77%)
    6 / 158 (3.80%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    4
    1
    6
    9
    1
    0
    0
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Milk allergy
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    0
    Allergy to animal
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    Anaphylactic reaction
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Vaccination site erythema
         subjects affected / exposed
    5 / 159 (3.14%)
    10 / 158 (6.33%)
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    9
    13
    0
    2
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    5 / 159 (3.14%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    4 / 158 (2.53%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    5
    0
    0
    4
    0
    1
    0
    Vaccination site induration
         subjects affected / exposed
    1 / 159 (0.63%)
    4 / 158 (2.53%)
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    4
    0
    2
    0
    0
    0
    Injection site induration
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    Vaccination site swelling
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Application site erythema
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Injection site haemorrhage
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Fever≥37.5°C but≤39°C:Infant Series Dose 1/After Infant Series Dose1/Toddler Dose/After 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]
    28 / 149 (18.79%)
    24 / 152 (15.79%)
    0 / 159 (0.00%)
    45 / 139 (32.37%)
    35 / 103 (33.98%)
    30 / 135 (22.22%)
    36 / 134 (26.87%)
         occurrences all number
    28
    24
    0
    45
    35
    30
    36
    Fever ≥37.5°C but ≤39°C: Infant Series Dose 2 / After 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]
    35 / 138 (25.36%)
    23 / 149 (15.44%)
    0 / 159 (0.00%)
    45 / 140 (32.14%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    35
    23
    0
    45
    0
    0
    0
    Fever ≥37.5°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]
    23 / 120 (19.17%)
    21 / 141 (14.89%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    23
    21
    0
    0
    0
    0
    0
    Fever>39°C but ≤40°C: Infant Series Dose 1/After Infant Series Dose 1/Toddler Dose/After Toddle Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    3 / 148 (2.03%)
    3 / 151 (1.99%)
    0 / 159 (0.00%)
    3 / 135 (2.22%)
    5 / 99 (5.05%)
    3 / 132 (2.27%)
    1 / 130 (0.77%)
         occurrences all number
    3
    3
    0
    3
    5
    3
    1
    Fever>39°C but ≤40°C: Infant Series Dose 2 / After Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    3 / 135 (2.22%)
    0 / 147 (0.00%)
    0 / 159 (0.00%)
    7 / 138 (5.07%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    3
    0
    0
    7
    0
    0
    0
    Fever>39°C but ≤40°C: Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    2 / 118 (1.69%)
    1 / 138 (0.72%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    Fever >40.0°C: Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    0 / 148 (0.00%)
    0 / 151 (0.00%)
    0 / 159 (0.00%)
    0 / 135 (0.00%)
    1 / 98 (1.02%)
    0 / 132 (0.00%)
    0 / 130 (0.00%)
         occurrences all number
    0
    151
    0
    0
    1
    0
    0
    Fever >40.0°C: Infant Series Dose 2 / After Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    0 / 133 (0.00%)
    1 / 147 (0.68%)
    0 / 159 (0.00%)
    1 / 138 (0.72%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Decreased appetite- Infant Series Dose 1/After Infant Series Dose 1/Toddler Dose/After 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]
    13 / 148 (8.78%)
    12 / 151 (7.95%)
    0 / 159 (0.00%)
    11 / 136 (8.09%)
    9 / 100 (9.00%)
    11 / 133 (8.27%)
    8 / 130 (6.15%)
         occurrences all number
    13
    12
    0
    11
    9
    11
    8
    Decreased appetite- Infant Series Dose 2 / After 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]
    16 / 135 (11.85%)
    8 / 147 (5.44%)
    0 / 159 (0.00%)
    15 / 138 (10.87%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    16
    8
    0
    15
    0
    0
    0
    Decreased appetite- Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    10 / 119 (8.40%)
    9 / 138 (6.52%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    10
    9
    0
    0
    0
    0
    0
    Irritability- Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose / After 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]
    23 / 151 (15.23%)
    14 / 151 (9.27%)
    0 / 159 (0.00%)
    17 / 136 (12.50%)
    17 / 100 (17.00%)
    13 / 134 (9.70%)
    12 / 131 (9.16%)
         occurrences all number
    23
    14
    0
    17
    17
    13
    12
    Irritability- Infant Series Dose 2 / After 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]
    26 / 134 (19.40%)
    18 / 149 (12.08%)
    0 / 159 (0.00%)
    16 / 138 (11.59%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    26
    18
    0
    16
    0
    0
    0
    Irritability- Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    12 / 118 (10.17%)
    10 / 139 (7.19%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    12
    10
    0
    0
    0
    0
    0
    Increased sleep- Infant Series Dose 1 / After Infant Series Dose 1/Toddler Dose/After 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]
    48 / 150 (32.00%)
    39 / 153 (25.49%)
    0 / 159 (0.00%)
    24 / 136 (17.65%)
    21 / 103 (20.39%)
    21 / 135 (15.56%)
    14 / 131 (10.69%)
         occurrences all number
    48
    39
    0
    24
    21
    21
    14
    Increased sleep- Infant Series Dose 2 / After 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]
    26 / 136 (19.12%)
    19 / 148 (12.84%)
    0 / 159 (0.00%)
    22 / 138 (15.94%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    26
    19
    0
    22
    0
    0
    0
    Increased sleep- Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    19 / 119 (15.97%)
    26 / 141 (18.44%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    19
    26
    0
    0
    0
    0
    0
    Decreased sleep- Infant Series Dose 1/After Infant Series Dose 1/Toddler Dose/After 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 [18]
    25 / 151 (16.56%)
    23 / 151 (15.23%)
    0 / 159 (0.00%)
    16 / 136 (11.76%)
    11 / 101 (10.89%)
    10 / 133 (7.52%)
    9 / 131 (6.87%)
         occurrences all number
    25
    23
    0
    16
    11
    10
    9
    Decreased sleep- Infant Series Dose 2 / After 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 [19]
    24 / 140 (17.14%)
    23 / 151 (15.23%)
    0 / 159 (0.00%)
    14 / 139 (10.07%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    24
    23
    0
    14
    0
    0
    0
    Decreased sleep- Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    8 / 120 (6.67%)
    20 / 140 (14.29%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    8
    20
    0
    0
    0
    0
    0
    Hives (urticaria)- Infant Series Dose 2 / After 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 [21]
    4 / 133 (3.01%)
    0 / 147 (0.00%)
    0 / 159 (0.00%)
    3 / 138 (2.17%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    4
    0
    0
    3
    0
    0
    0
    Hives (urticaria)- Infant Series Dose 1/After Infant Series Dose 1/Toddler Dose/After 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 [22]
    2 / 148 (1.35%)
    1 / 151 (0.66%)
    0 / 159 (0.00%)
    1 / 135 (0.74%)
    1 / 98 (1.02%)
    1 / 133 (0.75%)
    1 / 131 (0.76%)
         occurrences all number
    2
    1
    0
    1
    1
    1
    1
    Hives (urticaria)- 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 [23]
    2 / 119 (1.68%)
    0 / 138 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Genital rash
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    2
    0
    1
    1
    0
    0
    Contusion
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    3 / 149 (2.01%)
    1 / 149 (0.67%)
         occurrences all number
    1
    0
    0
    0
    0
    3
    1
    Joint dislocation
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Thermal burn
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 122 (0.82%)
    1 / 149 (0.67%)
    2 / 149 (1.34%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    2
    Arthropod bite
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    4 / 158 (2.53%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    6
    1
    0
    0
    Wound
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Arthropod sting
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    Face injury
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Fall
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Lip injury
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Wolff-Parkinson-White syndrome
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    2 / 159 (1.26%)
    2 / 158 (1.27%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    2
    3
    2
    4
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    1 / 159 (0.63%)
    3 / 158 (1.90%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    1
    1
    4
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Asthma
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    1
    Infantile asthma
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Rhinitis perennial
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    6 / 159 (3.77%)
    14 / 158 (8.86%)
    0 / 159 (0.00%)
    9 / 158 (5.70%)
    1 / 122 (0.82%)
    4 / 149 (2.68%)
    2 / 149 (1.34%)
         occurrences all number
    6
    14
    0
    12
    1
    5
    2
    Eye discharge
         subjects affected / exposed
    3 / 159 (1.89%)
    3 / 158 (1.90%)
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    2 / 149 (1.34%)
         occurrences all number
    3
    3
    0
    2
    1
    0
    2
    Keratitis
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Eyelid oedema
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    8 / 159 (5.03%)
    8 / 158 (5.06%)
    0 / 159 (0.00%)
    6 / 158 (3.80%)
    1 / 122 (0.82%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    9
    8
    0
    10
    1
    1
    0
    Diarrhoea
         subjects affected / exposed
    7 / 159 (4.40%)
    9 / 158 (5.70%)
    1 / 159 (0.63%)
    8 / 158 (5.06%)
    6 / 122 (4.92%)
    6 / 149 (4.03%)
    2 / 149 (1.34%)
         occurrences all number
    9
    12
    1
    8
    6
    7
    2
    Haematochezia
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Ileus
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Intussusception
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    2
    1
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Aphthous stomatitis
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    26 / 159 (16.35%)
    22 / 158 (13.92%)
    2 / 159 (1.26%)
    4 / 158 (2.53%)
    2 / 122 (1.64%)
    3 / 149 (2.01%)
    5 / 149 (3.36%)
         occurrences all number
    35
    32
    3
    5
    2
    3
    5
    Eczema infantile
         subjects affected / exposed
    6 / 159 (3.77%)
    8 / 158 (5.06%)
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    9
    13
    1
    1
    0
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    16 / 159 (10.06%)
    13 / 158 (8.23%)
    1 / 159 (0.63%)
    13 / 158 (8.23%)
    7 / 122 (5.74%)
    2 / 149 (1.34%)
    4 / 149 (2.68%)
         occurrences all number
    23
    19
    2
    14
    7
    2
    4
    Asteatosis
         subjects affected / exposed
    5 / 159 (3.14%)
    4 / 158 (2.53%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    1 / 122 (0.82%)
    1 / 149 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    9
    7
    0
    1
    1
    1
    1
    Dry skin
         subjects affected / exposed
    1 / 159 (0.63%)
    6 / 158 (3.80%)
    1 / 159 (0.63%)
    2 / 158 (1.27%)
    1 / 122 (0.82%)
    1 / 149 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    2
    14
    2
    2
    1
    1
    1
    Heat rash
         subjects affected / exposed
    3 / 159 (1.89%)
    3 / 158 (1.90%)
    0 / 159 (0.00%)
    16 / 158 (10.13%)
    2 / 122 (1.64%)
    1 / 149 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    3
    4
    0
    24
    2
    1
    1
    Dermatitis atopic
         subjects affected / exposed
    4 / 159 (2.52%)
    0 / 158 (0.00%)
    3 / 159 (1.89%)
    2 / 158 (1.27%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    8
    0
    3
    3
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    1 / 159 (0.63%)
    3 / 158 (1.90%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    0
    0
    Dermatitis contact
         subjects affected / exposed
    3 / 159 (1.89%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    3
    0
    0
    0
    1
    0
    0
    Erythema
         subjects affected / exposed
    2 / 159 (1.26%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    0
    Rash generalised
         subjects affected / exposed
    0 / 159 (0.00%)
    3 / 158 (1.90%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    1 / 159 (0.63%)
    3 / 158 (1.90%)
    0 / 122 (0.00%)
    2 / 149 (1.34%)
    1 / 149 (0.67%)
         occurrences all number
    1
    1
    1
    3
    0
    2
    1
    Petechiae
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    1
    Rash
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    2 / 122 (1.64%)
    1 / 149 (0.67%)
    2 / 149 (1.34%)
         occurrences all number
    1
    0
    0
    1
    2
    1
    2
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Generalised erythema
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Dermal cyst
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Eczema asteatotic
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Erythema (Any)- Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Dictionary version was not captured, hence 0.0 is mentioned. 
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    87 / 152 (57.24%)
    22 / 152 (14.47%)
    0 / 158 (0.00%)
    72 / 139 (51.80%)
    56 / 108 (51.85%)
    44 / 137 (32.12%)
    0 / 122 (0.00%)
         occurrences all number
    87
    22
    0
    72
    56
    44
    0
    Erythema (Any)- Infant Series Dose 2 / After 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]
    91 / 142 (64.08%)
    59 / 150 (39.33%)
    0 / 159 (0.00%)
    73 / 144 (50.69%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    91
    59
    0
    73
    0
    0
    0
    Erythema (Any)- Infant Series Dose 3 / After Toddler 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]
    65 / 123 (52.85%)
    44 / 144 (30.56%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    43 / 134 (32.09%)
         occurrences all number
    65
    44
    0
    0
    0
    0
    43
    Erythema (Mild)- Infant Series Dose 2 / After 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 [27]
    83 / 142 (58.45%)
    50 / 150 (33.33%)
    0 / 159 (0.00%)
    65 / 144 (45.14%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    93
    50
    0
    65
    0
    0
    0
    Erythema (Mild)- Infant Series Dose 1 / After Infant Series Dose 1 / Toddler Dose
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    80 / 152 (52.63%)
    19 / 151 (12.58%)
    0 / 159 (0.00%)
    63 / 139 (45.32%)
    51 / 106 (48.11%)
    39 / 137 (28.47%)
    0 / 122 (0.00%)
         occurrences all number
    80
    19
    0
    63
    51
    39
    0
    Erythema (Mild)- Infant Series Dose 3 / After Toddler 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]
    57 / 123 (46.34%)
    40 / 143 (27.97%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    36 / 133 (27.07%)
         occurrences all number
    57
    40
    0
    0
    0
    0
    36
    Erythema (Moderate)- Infant Series Dose 1 / After Infant Series Dose 1 / 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]
    22 / 148 (14.86%)
    3 / 152 (1.97%)
    0 / 159 (0.00%)
    14 / 136 (10.29%)
    24 / 102 (23.53%)
    10 / 134 (7.46%)
    0 / 149 (0.00%)
         occurrences all number
    22
    3
    0
    14
    24
    10
    0
    Erythema (Moderate)- Infant Series Dose 2 / After 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]
    43 / 134 (32.09%)
    10 / 147 (6.80%)
    0 / 159 (0.00%)
    19 / 140 (13.57%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    43
    10
    0
    19
    0
    0
    0
    Erythema (Moderate)- Infant Series Dose 3 / After Toddler 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]
    24 / 120 (20.00%)
    8 / 139 (5.76%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    13 / 131 (9.92%)
         occurrences all number
    24
    8
    0
    0
    0
    0
    13
    Induration (Any)- Infant Series Dose 1 / After Infant Series Dose 1 / 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]
    60 / 149 (40.27%)
    12 / 153 (7.84%)
    0 / 159 (0.00%)
    48 / 138 (34.78%)
    46 / 108 (42.59%)
    32 / 137 (23.36%)
    0 / 149 (0.00%)
         occurrences all number
    60
    12
    0
    48
    46
    32
    0
    Induration (Any)- Infant Series Dose 2 / After 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]
    71 / 137 (51.82%)
    45 / 150 (30.00%)
    0 / 159 (0.00%)
    47 / 144 (32.64%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    71
    45
    0
    47
    0
    0
    0
    Induration (Any)- Infant Series Dose 3 / After Toddler 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]
    55 / 124 (44.35%)
    28 / 144 (19.44%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    37 / 134 (27.61%)
         occurrences all number
    55
    28
    0
    0
    0
    0
    37
    Induration (Mild)- Infant Series Dose 1 / After Infant Series Dose 1 / 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 / 149 (38.26%)
    12 / 153 (7.84%)
    0 / 159 (0.00%)
    45 / 138 (32.61%)
    44 / 108 (40.74%)
    27 / 137 (19.71%)
    0 / 149 (0.00%)
         occurrences all number
    57
    12
    0
    45
    44
    27
    0
    Induration (Mild)- Infant Series Dose 2 / After 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]
    68 / 137 (49.64%)
    43 / 150 (28.67%)
    0 / 159 (0.00%)
    43 / 143 (30.07%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    68
    43
    0
    43
    0
    0
    0
    Induration (Mild)- Infant Series Dose 3 / After Toddler 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]
    53 / 124 (42.74%)
    28 / 144 (19.44%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    33 / 133 (24.81%)
         occurrences all number
    53
    28
    0
    0
    0
    0
    33
    Induration (Moderate)- Infant Series Dose 1 / After Infant Series Dose 1 / 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]
    15 / 148 (10.14%)
    0 / 151 (0.00%)
    0 / 158 (0.00%)
    11 / 135 (8.15%)
    16 / 99 (16.16%)
    9 / 133 (6.77%)
    0 / 149 (0.00%)
         occurrences all number
    15
    0
    0
    11
    16
    9
    0
    Induration (Moderate)- Infant Series Dose 2 / After 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]
    32 / 134 (23.88%)
    10 / 148 (6.76%)
    0 / 158 (0.00%)
    21 / 140 (15.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    32
    10
    0
    21
    0
    0
    0
    Induration (Moderate)- Infant Series Dose 3 / After Toddler 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]
    14 / 119 (11.76%)
    3 / 139 (2.16%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    13 / 131 (9.92%)
         occurrences all number
    14
    3
    0
    0
    0
    0
    13
    Tenderness (Any)- Infant Series Dose 1 / After Infant Series Dose 1 / 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 [42]
    18 / 148 (12.16%)
    1 / 151 (0.66%)
    0 / 159 (0.00%)
    11 / 136 (8.09%)
    11 / 99 (11.11%)
    6 / 136 (4.41%)
    0 / 149 (0.00%)
         occurrences all number
    18
    1
    0
    11
    11
    6
    0
    Tenderness (Any)- Infant Series Dose 2 / After 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 [43]
    10 / 133 (7.52%)
    6 / 147 (4.08%)
    0 / 159 (0.00%)
    7 / 139 (5.04%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    10
    6
    0
    7
    0
    0
    0
    Tenderness (Any)- Infant Series Dose 3 / After Toddler 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 [44]
    6 / 119 (5.04%)
    5 / 138 (3.62%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    9 / 132 (6.82%)
         occurrences all number
    6
    5
    0
    0
    0
    0
    9
    Metabolism and nutrition disorders
    Lactose intolerance
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    3
    0
    1
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    49 / 159 (30.82%)
    59 / 158 (37.34%)
    1 / 159 (0.63%)
    63 / 158 (39.87%)
    27 / 122 (22.13%)
    43 / 149 (28.86%)
    42 / 149 (28.19%)
         occurrences all number
    84
    107
    1
    96
    30
    45
    44
    Upper respiratory tract infection
         subjects affected / exposed
    35 / 159 (22.01%)
    22 / 158 (13.92%)
    5 / 159 (3.14%)
    27 / 158 (17.09%)
    17 / 122 (13.93%)
    19 / 149 (12.75%)
    10 / 149 (6.71%)
         occurrences all number
    55
    31
    5
    38
    18
    21
    10
    Gastroenteritis
         subjects affected / exposed
    19 / 159 (11.95%)
    12 / 158 (7.59%)
    0 / 159 (0.00%)
    13 / 158 (8.23%)
    2 / 122 (1.64%)
    4 / 149 (2.68%)
    8 / 149 (5.37%)
         occurrences all number
    24
    12
    0
    14
    2
    4
    8
    Bronchitis
         subjects affected / exposed
    10 / 159 (6.29%)
    11 / 158 (6.96%)
    0 / 159 (0.00%)
    17 / 158 (10.76%)
    11 / 122 (9.02%)
    12 / 149 (8.05%)
    9 / 149 (6.04%)
         occurrences all number
    11
    11
    0
    25
    11
    13
    9
    Influenza
         subjects affected / exposed
    16 / 159 (10.06%)
    12 / 158 (7.59%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    16
    12
    0
    0
    0
    1
    1
    Exanthema subitum
         subjects affected / exposed
    6 / 159 (3.77%)
    13 / 158 (8.23%)
    0 / 159 (0.00%)
    21 / 158 (13.29%)
    2 / 122 (1.64%)
    7 / 149 (4.70%)
    4 / 149 (2.68%)
         occurrences all number
    7
    13
    0
    23
    2
    7
    4
    Gastroenteritis viral
         subjects affected / exposed
    7 / 159 (4.40%)
    3 / 158 (1.90%)
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    8
    3
    0
    2
    0
    0
    1
    Varicella
         subjects affected / exposed
    5 / 159 (3.14%)
    3 / 158 (1.90%)
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    2 / 122 (1.64%)
    3 / 149 (2.01%)
    2 / 149 (1.34%)
         occurrences all number
    5
    3
    0
    2
    2
    3
    2
    Otitis media
         subjects affected / exposed
    5 / 159 (3.14%)
    2 / 158 (1.27%)
    0 / 159 (0.00%)
    9 / 158 (5.70%)
    4 / 122 (3.28%)
    2 / 149 (1.34%)
    2 / 149 (1.34%)
         occurrences all number
    5
    2
    0
    11
    4
    2
    2
    Impetigo
         subjects affected / exposed
    2 / 159 (1.26%)
    5 / 158 (3.16%)
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    1 / 149 (0.67%)
         occurrences all number
    3
    5
    0
    3
    0
    1
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    2 / 159 (1.26%)
    5 / 158 (3.16%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    2 / 122 (1.64%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    5
    0
    0
    2
    0
    0
    Bronchiolitis
         subjects affected / exposed
    5 / 159 (3.14%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    5
    1
    0
    0
    0
    1
    0
    Otitis media acute
         subjects affected / exposed
    0 / 159 (0.00%)
    5 / 158 (3.16%)
    0 / 159 (0.00%)
    4 / 158 (2.53%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    6
    0
    6
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 159 (0.63%)
    5 / 158 (3.16%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    4 / 149 (2.68%)
         occurrences all number
    2
    6
    0
    0
    0
    0
    4
    Enteritis infectious
         subjects affected / exposed
    0 / 159 (0.00%)
    3 / 158 (1.90%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    5
    0
    1
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 158 (1.27%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    3 / 149 (2.01%)
    1 / 149 (0.67%)
         occurrences all number
    1
    2
    0
    0
    0
    3
    1
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Molluscum contagiosum
         subjects affected / exposed
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    4
    0
    2
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    0
    Otitis externa
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Paronychia
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    0
    2
    0
    0
    0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    1 / 122 (0.82%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    2
    0
    1
    1
    1
    0
    Adenovirus infection
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    Conjunctivitis viral
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Croup infectious
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    Fungal infection
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    Genital candidiasis
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    11 / 158 (6.96%)
    4 / 122 (3.28%)
    6 / 149 (4.03%)
    2 / 149 (1.34%)
         occurrences all number
    2
    0
    0
    13
    4
    6
    2
    Mucocutaneous candidiasis
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    Hordeolum
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Rotavirus infection
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    Staphylococcal scalded skin syndrome
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Vaccination site infection
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Viral rash
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    1 / 122 (0.82%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    1
    0
    0
    1
    1
    1
    0
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    2 / 158 (1.27%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    Candidiasis
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    Herpangina
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    1
    Herpes simplex
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Localised infection
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Otitis media bacterial
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    1 / 158 (0.63%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    Candida nappy rash
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    1 / 122 (0.82%)
    0 / 149 (0.00%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Bronchopneumonia
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    1 / 149 (0.67%)
    0 / 149 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Acute sinusitis
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Gastroenteritis adenovirus
         subjects affected / exposed
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 159 (0.00%)
    0 / 158 (0.00%)
    0 / 122 (0.00%)
    0 / 149 (0.00%)
    1 / 149 (0.67%)
         occurrences all number
    0
    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.
    [44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here, number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.

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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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