Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan

    Summary
    EudraCT number
    		 2008-004767-19
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Mar 2009

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    6096A1-3003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00574795
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: B1851105
    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 7181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800 7181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Nov 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immune response to the 13 pneumococcal conjugates (1, 3, 4, 5, 6A, 6B, 7F,9V, 14, 18C, 19A, 19F, and 23F) induced by 13 valent pneumococcal conjugate vaccine (13vPnC) when measured 1 month after the infant series. To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2007
    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: 193
    Worldwide total number of subjects
    193
    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)
    193
    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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were recruited in Japan from September 2007 to February 2008.

    Pre-assignment
    Screening details
    		 Subjects were enrolled into the study according to inclusion/exclusion criteria without a screening period.

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

    Arms
    Arm title
    		 13vPnC Infant Series
    Arm description
    		 Subjects received one single dose of 13vPnC at approximately 2, 4 and 6 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 single 0.5 milliliter (mL) dose of 13vPnC at 2, 4, and 6 months of age.

    Number of subjects in period 1
    		13vPnC Infant Series
    Started
    193
    Vaccinated Dose 1
    193
    Vaccinated Dose 2
    190
    Vaccinated Dose 3
    190
    Completed
    188
    Not completed
    5
         Consent withdrawn by subject
    2
         Adverse Event
    1
         Protocol Violation
    2
    Period 2
    Period 2 title
    After Infant Series
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 13vPnC After Infant Series
    Arm description
    		 Included subjects who received 1 single dose of 13vPnC at 2, 4, and 6 months of age.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		13vPnC After Infant Series
    Started
    188
    Completed
    185
    Not completed
    3
         Consent withdrawn by subject
    1
         Adverse Event
    2
    Period 3
    Period 3 title
    Toddler Dose
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 13vPnC Toddler Dose
    Arm description
    		 Subjects received one single dose of 13vPnC at 12-15 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 single 0.5 mL dose of 13vPnC at 12-15 months of age.

    Number of subjects in period 3
    		13vPnC Toddler Dose
    Started
    185
    Completed
    184
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    		 Subjects received one single dose of 13vPnC at approximately 2, 4 and 6 months of age.

    Reporting group values
    		 13vPnC Infant Series Total
    Number of subjects
    		 193 193
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 3.7 ( 1.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 93 93
        Male
    		 100 100

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    		 Subjects received one single dose of 13vPnC at approximately 2, 4 and 6 months of age.
    Reporting group title
    13vPnC After Infant Series
    Reporting group description
    		 Included subjects who received 1 single dose of 13vPnC at 2, 4, and 6 months of age.
    Reporting group title
    13vPnC Toddler Dose
    Reporting group description
    		 Subjects received one single dose of 13vPnC at 12-15 months of age.

    Subject analysis set title
    13vPnC Dose 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC at approximately 2 months of age (infant series Dose 1).

    Subject analysis set title
    13vPnC Dose 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC at approximately 4 months of age (infant series Dose 2).

    Subject analysis set title
    13vPnC Dose 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC at approximately 6 months of age (infant series Dose 3).

    Subject analysis set title
    13vPnC Toddler Dose
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose).

    Primary: Percentage of Subjects Achieving Antibody Level Greater Than or Equal to (>=) 0.35 microgram per milliliter (mcg/mL) in the 13vPnC Group After the 3-Dose Infant Series

    		 Close Top of page
    End point title
    		 Percentage of Subjects Achieving Antibody Level Greater Than or Equal to (>=) 0.35 microgram per milliliter (mcg/mL) in the 13vPnC Group After the 3-Dose Infant Series [1]
    End point description
    Percentages of subjects achieving World Health Organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity population had valid and determinate assay results and had no other major protocol violations.
    End point type
    Primary
    End point timeframe
    One month after 3-dose infant series (at 7 months of age)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 13vPnC Infant Series
    Number of subjects analysed
    176
    Units: Percentage of subjects
    number (confidence interval 95%)
        Common Serotypes - Serotype 4
    100 (97.9 to 100)
        Common Serotypes - Serotype 6B
    98.3 (95.1 to 99.6)
        Common Serotypes - Serotype 9V
    100 (97.9 to 100)
        Common Serotypes - Serotype 14
    100 (97.9 to 100)
        Common Serotypes - Serotype 18C
    100 (97.9 to 100)
        Common Serotypes - Serotype 19F
    97.2 (93.5 to 99.1)
        Common Serotypes - Serotype 23F
    97.7 (94.3 to 99.4)
        Additional Serotypes - Serotype 1
    100 (97.9 to 100)
        Additional Serotypes - Serotype 3
    100 (97.9 to 100)
        Additional Serotypes - Serotype 5
    100 (97.9 to 100)
        Additional Serotypes - Serotype 6A
    100 (97.9 to 100)
        Additional Serotypes - Serotype 7F
    100 (97.9 to 100)
        Additional Serotypes - Serotype 19A
    100 (97.9 to 100)
    No statistical analyses for this end point

    Secondary: Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the 3-Dose Infant Series

    		 Close Top of page
    End point title
    		 Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the 3-Dose Infant Series
    End point description
    GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    One month after 3-dose infant series (at 7 months of age)
    End point values
    		 13vPnC Infant Series
    Number of subjects analysed
    176
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common Serotypes - Serotype 4
    6.76 (6.02 to 7.59)
        Common Serotypes - Serotype 6B
    4.77 (4.07 to 5.59)
        Common Serotypes - Serotype 9V
    3.39 (3.03 to 3.78)
        Common Serotypes - Serotype 14
    14.69 (13.26 to 16.26)
        Common Serotypes - Serotype 18C
    3.68 (3.27 to 4.14)
        Common Serotypes - Serotype 19F
    5.71 (4.9 to 6.65)
        Common Serotypes - Serotype 23F
    2.57 (2.21 to 3)
        Additional Serotypes - Serotype 1
    5.11 (4.48 to 5.82)
        Additional Serotypes - Serotype 3
    2.87 (2.55 to 3.24)
        Additional Serotypes - Serotype 5
    3.85 (3.42 to 4.33)
        Additional Serotypes - Serotype 6A
    3.77 (3.35 to 4.25)
        Additional Serotypes - Serotype 7F
    5.78 (5.19 to 6.45)
        Additional Serotypes - Serotype 19A
    6.97 (6.25 to 7.77)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Percentage of Subjects Achieving Antibody Level >= 0.35 mcg/mL in the 13vPnC Group After the Toddler Dose
    End point description
    Percentages of subjects achieving WHO predefined antibody threshold >= 0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    One month after the toddler dose (at 12 - 15 months of age)
    End point values
    		 13vPnC Toddler Dose
    Number of subjects analysed
    178
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotypes - Serotype 4
    100 (97.9 to 100)
        Common Serotypes - Serotype 6B
    100 (97.9 to 100)
        Common Serotypes - Serotype 9V
    100 (97.9 to 100)
        Common Serotypes - Serotype 14
    100 (97.9 to 100)
        Common Serotypes - Serotype 18C
    100 (97.9 to 100)
        Common Serotypes - Serotype 19F
    98.9 (96 to 99.9)
        Common Serotypes - Serotype 23F
    98.9 (96 to 99.9)
        Additional Serotypes - Serotype 1
    100 (97.9 to 100)
        Additional Serotypes - Serotype 3
    99.4 (96.9 to 100)
        Additional Serotypes - Serotype 5
    100 (97.9 to 100)
        Additional Serotypes - Serotype 6A
    100 (97.9 to 100)
        Additional Serotypes - Serotype 7F
    100 (97.9 to 100)
        Additional Serotypes - Serotype 19A
    100 (97.9 to 100)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Toddler Dose
    End point description
    GMC as measured by ELISA for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations.
    End point type
    Secondary
    End point timeframe
    One month after the toddler dose (at 12-15 months of age)
    End point values
    		 13vPnC Toddler Dose
    Number of subjects analysed
    178
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common Serotypes - Serotype 4
    9.7 (8.43 to 11.17)
        Common Serotypes - Serotype 6B
    14.61 (12.52 to 17.05)
        Common Serotypes - Serotype 9V
    4.49 (4 to 5.06)
        Common Serotypes - Serotype 14
    16.33 (14.49 to 18.41)
        Common Serotypes - Serotype 18C
    6.09 (5.34 to 6.95)
        Common Serotypes - Serotype 19F
    12.2 (10.37 to 14.35)
        Common Serotypes - Serotype 23F
    6.55 (5.53 to 7.75)
        Additional Serotypes - Serotype 1
    9.85 (8.62 to 11.27)
        Additional Serotypes - Serotype 3
    2.06 (1.83 to 2.32)
        Additional Serotypes - Serotype 5
    7.31 (6.52 to 8.2)
        Additional Serotypes - Serotype 6A
    11.03 (9.69 to 12.55)
        Additional Serotypes - Serotype 7F
    8.31 (7.39 to 9.35)
        Additional Serotypes - Serotype 19A
    15.97 (14.07 to 18.13)
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Percentage of Subjects Reporting Pre-Specified Local Reactions
    End point description
    Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimetres [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than [>] 7.0 cm). Subjects may be represented in more than 1 category. The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after each dose
    End point values
    		 13vPnC Dose 1 13vPnC Dose 2 13vPnC Dose 3 13vPnC Toddler Dose
    Number of subjects analysed
    193
    190
    190
    185
    Units: percentage of subjects
    number (not applicable)
        Tenderness - Any (n=165,156,147,143)
    13.3
    19.9
    14.3
    18.2
        Tenderness - Significant (n=160,152,143,132)
    0.6
    0
    0
    0
        Swelling - Any (n=176,173,165,163)
    47.2
    53.8
    53.9
    57.1
        Swelling - Mild (n=174,171,163,154)
    46
    49.1
    50.3
    44.2
        Swelling - Moderate (n=167,164,150,151)
    14.4
    28.7
    29.3
    36.4
        Swelling - Severe (n=160,153,143,132)
    0
    1.3
    0.7
    2.3
        Redness - Any (n=186,180,171,166)
    74.2
    74.4
    67.8
    68.1
        Redness - Mild (n=183,179,162,156)
    68.3
    64.8
    55.6
    53.8
        Redness - Moderate (n=170,168,157,155)
    24.7
    43.5
    38.9
    40.6
        Redness - Severe (n=160,153,143,132)
    0
    1.3
    0.7
    1.5
    No statistical analyses for this end point

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

    		 Close Top of page
    End point title
    		 Percentage of Subjects Reporting Pre-Specified Systemic Events
    End point description
    Systemic events (fever >= 37.5 degrees Celsius [C], fever >= 38 C but <= 39 C, fever >39 C but <= 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Subjects may be represented in more than 1 category. The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of subjects reporting yes for at least 1 day or no for all days.
    End point type
    Other pre-specified
    End point timeframe
    Within 7 days after each dose
    End point values
    		 13vPnC Dose 1 13vPnC Dose 2 13vPnC Dose 3 13vPnC Toddler Dose
    Number of subjects analysed
    193
    190
    190
    185
    Units: percentage of subjects
    number (not applicable)
        Fever >=37.5°C (n=170,163,154,150)
    32.9
    33.1
    40.3
    50.7
        Fever >=38°C but <=39°C (n=163,156,146,137)
    6.7
    12.2
    10.3
    20.4
        Fever >39°C but <=40°C (n=161,153,143,133)
    1.2
    2.6
    2.8
    5.3
        Fever >40°C (n=160,152,143,132)
    0
    0.7
    0
    0
        Decreased appetite (n=163,158,144,138)
    11.7
    16.5
    9.7
    18.1
        Irritability (n=170,166,149,140)
    30.6
    36.1
    23.5
    26.4
        Increased sleep (n=175,160,153,139)
    40.6
    29.4
    22.2
    24.5
        Decreased sleep (n=169,160,145,138)
    21.3
    23.1
    15.9
    12.3
        Hives (n=160,152,143,132)
    1.3
    1.3
    0.7
    0
        Medication to treat symptoms (n=160,153,145,135)
    1.9
    6.5
    5.5
    8.1
        Medication to prevent symptoms (n=160,153,144,134)
    0.6
    3.3
    2.1
    3
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline through 1 month after last study vaccination (13 Months)
    Adverse event reporting additional description
    Version was not captured, hence 0.0 is mentioned for dictionary version.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    13vPnC Infant Series
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).

    Reporting group title
    13vPnC Post-Infant Series
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).

    Reporting group title
    13vPnC Toddler Dose
    Reporting group description
    		 Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months (toddler dose).

    Serious adverse events
    		 13vPnC Infant Series 13vPnC Post-Infant Series 13vPnC Toddler Dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 193 (4.66%)
    14 / 193 (7.25%)
    1 / 185 (0.54%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Subdural haematoma
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 193 (1.04%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    2 / 193 (1.04%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    1 / 193 (0.52%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 193 (0.52%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 193 (1.04%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pertussis
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 193 (1.04%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 13vPnC Infant Series 13vPnC Post-Infant Series 13vPnC Toddler Dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    192 / 193 (99.48%)
    19 / 193 (9.84%)
    171 / 185 (92.43%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphangioma
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences all number
    0
    1
    0
    Fibroma
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    163 / 193 (84.46%)
    0 / 193 (0.00%)
    115 / 185 (62.16%)
         occurrences all number
    554
    0
    172
    Injection site swelling
         subjects affected / exposed
    121 / 193 (62.69%)
    0 / 193 (0.00%)
    94 / 185 (50.81%)
         occurrences all number
    394
    0
    142
    Pyrexia
         subjects affected / exposed
    108 / 193 (55.96%)
    0 / 193 (0.00%)
    80 / 185 (43.24%)
         occurrences all number
    218
    0
    115
    Irritability
         subjects affected / exposed
    93 / 193 (48.19%)
    0 / 193 (0.00%)
    38 / 185 (20.54%)
         occurrences all number
    170
    0
    44
    Injection site pain
         subjects affected / exposed
    49 / 193 (25.39%)
    0 / 193 (0.00%)
    27 / 185 (14.59%)
         occurrences all number
    76
    0
    27
    Injection site induration
         subjects affected / exposed
    16 / 193 (8.29%)
    0 / 193 (0.00%)
    2 / 185 (1.08%)
         occurrences all number
    19
    0
    2
    Injection site mass
         subjects affected / exposed
    3 / 193 (1.55%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    3
    0
    1
    Injection site irritation
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site warmth
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Swelling
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination site induration
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Vessel puncture site reaction
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site eczema
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Fever >=38°C but <=39°C (mild) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    11 / 163 (6.75%)
    0 / 193 (0.00%)
    28 / 137 (20.44%)
         occurrences all number
    11
    0
    28
    Any fever (>=37.5°C) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    56 / 170 (32.94%)
    0 / 193 (0.00%)
    76 / 150 (50.67%)
         occurrences all number
    56
    0
    76
    Fever >39°C but <=40°C (moderate) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    2 / 161 (1.24%)
    0 / 193 (0.00%)
    7 / 133 (5.26%)
         occurrences all number
    2
    0
    7
    Decreased appetite Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    19 / 163 (11.66%)
    0 / 193 (0.00%)
    25 / 138 (18.12%)
         occurrences all number
    19
    0
    25
    Irritability Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    52 / 170 (30.59%)
    0 / 193 (0.00%)
    37 / 140 (26.43%)
         occurrences all number
    52
    0
    37
    Increased sleep Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    71 / 175 (40.57%)
    0 / 193 (0.00%)
    34 / 139 (24.46%)
         occurrences all number
    71
    0
    34
    Decreased sleep Infant Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    36 / 169 (21.30%)
    0 / 193 (0.00%)
    17 / 138 (12.32%)
         occurrences all number
    36
    0
    17
    Any fever (>=37.5°C) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    54 / 163 (33.13%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    54
    0
    0
    Fever >=38°C but <=39°C (mild) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    19 / 156 (12.18%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    19
    0
    0
    Fever >39°C but <=40°C (moderate) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    4 / 153 (2.61%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    4
    0
    0
    Fever >40°C Dose Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    1 / 152 (0.66%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Decreased appetite Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    26 / 158 (16.46%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    26
    0
    0
    Irritability Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    60 / 166 (36.14%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    60
    0
    0
    Increased sleep Infant Series Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    47 / 160 (29.38%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    47
    0
    0
    Decreased sleep Infant Dose 2
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    37 / 160 (23.13%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    37
    0
    0
    Fever >=38°C but <=39°C Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    15 / 146 (10.27%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    15
    0
    0
    Any fever (>=37.5°C) Infant Series Dose 3
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    62 / 154 (40.26%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    62
    0
    0
    Fever >39°C but <=40°C Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    4 / 143 (2.80%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    4
    0
    0
    Decreased appetite Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    14 / 144 (9.72%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    14
    0
    0
    Irritability Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    35 / 149 (23.49%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    35
    0
    0
    Increased sleep Infant Series Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    34 / 153 (22.22%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    34
    0
    0
    Decreased sleep Infant Dose 3
    Additional description: Subjects affected and occurrences for SE is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Systemic Events 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    23 / 145 (15.86%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    23
    0
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    3 / 193 (1.55%)
    8 / 193 (4.15%)
    0 / 185 (0.00%)
         occurrences all number
    3
    8
    0
    Milk allergy
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Solvent sensitivity
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    13 / 193 (6.74%)
    0 / 193 (0.00%)
    8 / 185 (4.32%)
         occurrences all number
    18
    0
    9
    Asthma
         subjects affected / exposed
    11 / 193 (5.70%)
    4 / 193 (2.07%)
    7 / 185 (3.78%)
         occurrences all number
    14
    5
    7
    Cough
         subjects affected / exposed
    4 / 193 (2.07%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    4
    0
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    8 / 193 (4.15%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    13
    0
    1
    Dysphonia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Wheezing
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Fibrinous bronchitis
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    66 / 193 (34.20%)
    0 / 193 (0.00%)
    17 / 185 (9.19%)
         occurrences all number
    111
    0
    18
    Head banging
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    3 / 193 (1.55%)
    0 / 193 (0.00%)
    3 / 185 (1.62%)
         occurrences all number
    3
    0
    3
    Contusion
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    3
    0
    0
    Animal bite
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Excoriation
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    1
    0
    1
    Joint dislocation
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Joint injury
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    3
    0
    1
    Skin laceration
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    2 / 185 (1.08%)
         occurrences all number
    1
    0
    2
    Thermal burn
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Clavicle fracture
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Mouth injury
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Congenital, familial and genetic disorders
    Dacryostenosis congenital
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Cryptorchism
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences all number
    0
    1
    0
    Pectus excavatum
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Pulmonary valve stenosis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Hypersomnia
         subjects affected / exposed
    101 / 193 (52.33%)
    0 / 193 (0.00%)
    34 / 185 (18.38%)
         occurrences all number
    172
    0
    37
    Crying
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    2 / 185 (1.08%)
         occurrences all number
    2
    0
    2
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    16 / 193 (8.29%)
    0 / 193 (0.00%)
    8 / 185 (4.32%)
         occurrences all number
    18
    0
    8
    Eye discharge
         subjects affected / exposed
    3 / 193 (1.55%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    4
    0
    1
    Keratitis
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    32 / 193 (16.58%)
    0 / 193 (0.00%)
    12 / 185 (6.49%)
         occurrences all number
    35
    0
    12
    Constipation
         subjects affected / exposed
    7 / 193 (3.63%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    7
    0
    1
    Vomiting
         subjects affected / exposed
    4 / 193 (2.07%)
    1 / 193 (0.52%)
    2 / 185 (1.08%)
         occurrences all number
    4
    1
    2
    Anal fissure
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    2 / 185 (1.08%)
         occurrences all number
    1
    0
    2
    Umbilical hernia
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Enterocolitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    Liver disorder
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Tenderness (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [23]
    22 / 165 (13.33%)
    0 / 193 (0.00%)
    26 / 143 (18.18%)
         occurrences all number
    22
    0
    26
    Tenderness (Significant) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    1 / 160 (0.63%)
    0 / 193 (0.00%)
    0 / 132 (0.00%)
         occurrences all number
    1
    0
    0
    Induration (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    83 / 176 (47.16%)
    0 / 193 (0.00%)
    93 / 163 (57.06%)
         occurrences all number
    83
    0
    93
    Induration (Mild) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    80 / 174 (45.98%)
    0 / 193 (0.00%)
    68 / 154 (44.16%)
         occurrences all number
    80
    0
    68
    Induration (Moderate) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    24 / 167 (14.37%)
    0 / 193 (0.00%)
    55 / 151 (36.42%)
         occurrences all number
    24
    0
    55
    Induration (Severe) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination
         subjects affected / exposed [28]
    0 / 160 (0.00%)
    0 / 193 (0.00%)
    3 / 132 (2.27%)
         occurrences all number
    0
    0
    3
    Erythema (Any) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    138 / 186 (74.19%)
    0 / 193 (0.00%)
    113 / 166 (68.07%)
         occurrences all number
    138
    0
    113
    Erythema (Mild) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    125 / 183 (68.31%)
    0 / 193 (0.00%)
    84 / 156 (53.85%)
         occurrences all number
    125
    0
    84
    Erythema (Moderate) Infant Series Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    42 / 170 (24.71%)
    0 / 193 (0.00%)
    63 / 155 (40.65%)
         occurrences all number
    42
    0
    63
    Erythema (Severe) Infant Dose 1 and Toddler Dose
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    0 / 160 (0.00%)
    0 / 193 (0.00%)
    2 / 132 (1.52%)
         occurrences all number
    0
    0
    2
    Tenderness (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    31 / 156 (19.87%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    31
    0
    0
    Induration (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    93 / 173 (53.76%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    93
    0
    0
    Induration (Mild) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    84 / 171 (49.12%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    84
    0
    0
    Induration (Moderate) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    47 / 164 (28.66%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    47
    0
    0
    Induration (Severe) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    2 / 153 (1.31%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Erythema (Any) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    134 / 180 (74.44%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    134
    0
    0
    Erythema (Mild) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    116 / 179 (64.80%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    116
    0
    0
    Erythema (Moderate) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    73 / 168 (43.45%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    73
    0
    0
    Erythema (Severe) Infant Series Dose 2
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    2 / 153 (1.31%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Tenderness (Any) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [42]
    21 / 147 (14.29%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    21
    0
    0
    Induration (Any) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [43]
    89 / 165 (53.94%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    89
    0
    0
    Induration (Mild) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [44]
    82 / 163 (50.31%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    82
    0
    0
    Induration (Moderate) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [45]
    44 / 150 (29.33%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    44
    0
    0
    Induration (Severe) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [46]
    1 / 143 (0.70%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema (Any) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [47]
    116 / 171 (67.84%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    116
    0
    0
    Erythema (Mild) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [48]
    90 / 162 (55.56%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    90
    0
    0
    Erythema (Moderate) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [49]
    61 / 157 (38.85%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    61
    0
    0
    Erythema (Severe) Infant Series Dose 3
    Additional description: Subjects affected and occurrences for LR is same as data collected through ediaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative dictionary used: Local Reactions 0.0
    alternative assessment type: Systematic
         subjects affected / exposed [50]
    1 / 143 (0.70%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    27 / 193 (13.99%)
    0 / 193 (0.00%)
    4 / 185 (2.16%)
         occurrences all number
    30
    0
    4
    Eczema
         subjects affected / exposed
    24 / 193 (12.44%)
    0 / 193 (0.00%)
    10 / 185 (5.41%)
         occurrences all number
    28
    0
    10
    Rash
         subjects affected / exposed
    14 / 193 (7.25%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    16
    0
    1
    Eczema infantile
         subjects affected / exposed
    8 / 193 (4.15%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    9
    0
    1
    Urticaria
         subjects affected / exposed
    7 / 193 (3.63%)
    0 / 193 (0.00%)
    4 / 185 (2.16%)
         occurrences all number
    8
    0
    4
    Dry skin
         subjects affected / exposed
    6 / 193 (3.11%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    6
    0
    0
    Erythema
         subjects affected / exposed
    6 / 193 (3.11%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    12
    0
    0
    Heat rash
         subjects affected / exposed
    6 / 193 (3.11%)
    0 / 193 (0.00%)
    8 / 185 (4.32%)
         occurrences all number
    7
    0
    8
    Petechiae
         subjects affected / exposed
    4 / 193 (2.07%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    4
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    3 / 193 (1.55%)
    2 / 193 (1.04%)
    0 / 185 (0.00%)
         occurrences all number
    3
    2
    0
    Dermatitis
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Hyperkeratosis
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Asteatosis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Blister
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Drug eruption
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema asteatotic
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    1
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    1
    0
    1
    Rash erythematous
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Vesicoureteric reflux
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    77 / 193 (39.90%)
    0 / 193 (0.00%)
    42 / 185 (22.70%)
         occurrences all number
    121
    0
    48
    Nasopharyngitis
         subjects affected / exposed
    41 / 193 (21.24%)
    0 / 193 (0.00%)
    15 / 185 (8.11%)
         occurrences all number
    66
    0
    17
    Bronchitis
         subjects affected / exposed
    24 / 193 (12.44%)
    1 / 193 (0.52%)
    12 / 185 (6.49%)
         occurrences all number
    36
    1
    12
    Exanthema subitum
         subjects affected / exposed
    24 / 193 (12.44%)
    0 / 193 (0.00%)
    7 / 185 (3.78%)
         occurrences all number
    24
    0
    7
    Gastroenteritis
         subjects affected / exposed
    19 / 193 (9.84%)
    0 / 193 (0.00%)
    5 / 185 (2.70%)
         occurrences all number
    23
    0
    5
    Influenza
         subjects affected / exposed
    9 / 193 (4.66%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    9
    0
    1
    Pharyngitis
         subjects affected / exposed
    9 / 193 (4.66%)
    0 / 193 (0.00%)
    8 / 185 (4.32%)
         occurrences all number
    11
    0
    9
    Varicella
         subjects affected / exposed
    9 / 193 (4.66%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    9
    0
    1
    Rhinitis
         subjects affected / exposed
    7 / 193 (3.63%)
    0 / 193 (0.00%)
    3 / 185 (1.62%)
         occurrences all number
    7
    0
    3
    Enteritis infectious
         subjects affected / exposed
    5 / 193 (2.59%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    7
    0
    1
    Otitis media
         subjects affected / exposed
    5 / 193 (2.59%)
    1 / 193 (0.52%)
    10 / 185 (5.41%)
         occurrences all number
    6
    2
    10
    Otitis media acute
         subjects affected / exposed
    5 / 193 (2.59%)
    0 / 193 (0.00%)
    4 / 185 (2.16%)
         occurrences all number
    11
    0
    4
    Bronchiolitis
         subjects affected / exposed
    4 / 193 (2.07%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    4
    0
    1
    Croup infectious
         subjects affected / exposed
    4 / 193 (2.07%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    5
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    4 / 193 (2.07%)
    0 / 193 (0.00%)
    4 / 185 (2.16%)
         occurrences all number
    4
    0
    4
    Molluscum contagiosum
         subjects affected / exposed
    4 / 193 (2.07%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    4
    0
    1
    Adenovirus infection
         subjects affected / exposed
    3 / 193 (1.55%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    3
    0
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    3 / 193 (1.55%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    3
    0
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    3
    0
    0
    Fungal skin infection
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    3
    0
    0
    Skin candida
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Viral rash
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Cellulitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Enterocolitis viral
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Enterovirus infection
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes simplex
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Impetigo
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    2 / 185 (1.08%)
         occurrences all number
    1
    0
    2
    Laryngitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Omphalitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Paronychia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Pertussis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Rotavirus infection
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Viral diarrhoea
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    1
    0
    0
    Viral infection
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    1
    0
    1
    Herpangina
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    4 / 185 (2.16%)
         occurrences all number
    0
    0
    4
    Adenoviral upper respiratory infection
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Bronchopneumonia
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Enterocolitis infectious
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    2
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    47 / 193 (24.35%)
    0 / 193 (0.00%)
    25 / 185 (13.51%)
         occurrences all number
    66
    0
    26
    Dehydration
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 193 (0.00%)
    0 / 185 (0.00%)
         occurrences all number
    2
    0
    0
    Lactose intolerance
         subjects affected / exposed
    2 / 193 (1.04%)
    1 / 193 (0.52%)
    0 / 185 (0.00%)
         occurrences all number
    2
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 193 (0.00%)
    0 / 193 (0.00%)
    1 / 185 (0.54%)
         occurrences all number
    0
    0
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [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. 
    [45] - 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. 
    [46] - 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. 
    [47] - 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. 
    [48] - 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. 
    [49] - 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. 
    [50] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2008
    A clarification was added to ensure that before the study closeout visit at each site, the investigator provided the sponsor with follow-up information on any AEs that had been ongoing at a subject's last visit.

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

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

    European Medicines Agency © 1995-Fri Apr 26 16:54:58 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA